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Found 3123 cases where Vaccine is VARZOS and Vaccine description contains 'shingrix' and Vaccination Date on/after '2017-01-01'

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Table

   
Vaccine NamesCountPercent
DTAP / DTAP (INFANRIX)10.03%
FLU3 / INFLUENZA (SEASONAL) (AFLURIA)10.03%
FLU3 / INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)10.03%
FLU4 / INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT)50.16%
FLU4 / INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)20.06%
FLU4 / INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)30.1%
FLUA3 / INFLUENZA (SEASONAL) (FLUAD)20.06%
FLUC4 / INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)30.1%
FLUR4 / INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT)10.03%
HEP / HEP B (ENGERIX-B)40.13%
HEPA / HEP A (HAVRIX)120.38%
HEPA / HEP A (NO BRAND NAME)10.03%
HEPA / HEP A (VAQTA)20.06%
HEPAB / HEP A + HEP B (TWINRIX)60.19%
HIBV / HIB (ACTHIB)10.03%
IPV / POLIO VIRUS, INACT. (IPOL)20.06%
MMR / MEASLES + MUMPS + RUBELLA (MMR II)20.06%
PNC10 / PNEUMO (SYNFLORIX)10.03%
PNC13 / PNEUMO (PREVNAR13)341.09%
PPV / PNEUMO (NO BRAND NAME)30.1%
PPV / PNEUMO (PNEUMOVAX)742.37%
RAB / RABIES (RABAVERT)10.03%
TD / TD ADSORBED (NO BRAND NAME)10.03%
TD / TD ADSORBED (TENIVAC)20.06%
TDAP / TDAP (ADACEL)190.61%
TDAP / TDAP (BOOSTRIX)220.7%
TDAP / TDAP (NO BRAND NAME)20.06%
TTOX / TETANUS TOXOID (NO BRAND NAME)10.03%
TYP / TYPHOID VI POLYSACCHARIDE (TYPHIM VI)20.06%
VARZOS / ZOSTER (SHINGRIX)3124100.03%
TOTAL† 3335† 106.79%
† Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 3123 (the number of cases found), and the Total Percentage is greater than 100.

Case Details

VAERS ID: 730301 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Male  
Location: North Dakota  
Vaccinated:2017-12-04
Onset:2017-12-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chills, Fatigue, Headache, Pain, Peripheral swelling, Pyrexia, Rash, Stomatitis, Ultrasound scan, Urine analysis, X-ray
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, JANUVIA, Co-Q 10
Current Illness: none
Preexisting Conditions: Diabetes type II
Allergies: Milk
Diagnostic Lab Data: Lab- Blood tests, urine; Xrays- Chest Xray, Ultrasound of legs
CDC Split Type:

Write-up: I. Body aches, headache, Fever, Chills, Leg swelling, rash on chest and legs, sores in mouth, and fatigue. II. IV steroids and oral steroids. III. Symptoms have resolved, but still taking steroids.


VAERS ID: 730431 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2017-12-11
Onset:2017-12-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Diarrhoea, Fluid intake reduced, Hypophagia, Malaise, Muscle spasms, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient received the vaccine at 10:00 AM on 12/11/17 and started feeling ill (nausea) around 3:00-4:00 PM on 12/11/17. Around 7:00 PM that same day, patient started having diarrhea and vomiting. That same evening he experienced leg cramps throughout the night. He continued to feel ill and have muscle cramps until about 11:00 AM on 12/13/17. The illness subsided on its own - the patient did not seek medical treatment or take any medications for the illness. However, he was unable to eat or drink much during the course of the illness.


VAERS ID: 731013 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-04
Onset:0000-00-00
Submitted: 2017-12-12
Entered: 2017-12-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Drug hypersensitivity, sensitivity to other medications and contrast injection in the past
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017188285

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 66-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concurrent medical conditions included drug allergy (sensitivity to other medications and contrast injection in the past). On 4th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2017, 12 hrs after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling and injection site pain. The patient was treated with diphenhydramine. On an unknown date, the outcome of the injection site warmth, injection site swelling and injection site pain were recovering/resolving. The reporter considered the injection site warmth, injection site swelling and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient receiving SHINGRIX vaccine in left deltoid at 9:45 am after working 3rd shift. The patient experienced warmth, swelling and soreness at the site of SHINGRIX, which began approximately 12 hours following injection. The patient returned to the health care professional 2 days after the injection whereupon the health care professional confirmed the reaction and administered oral diphenhydramine. The patient was scheduled to report results to the health care professional this afternoon.


VAERS ID: 731120 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: Illinois  
Vaccinated:2017-12-12
Onset:2017-12-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol, Diclofenac, MegaRed Krill Oil, Calcium, Vit D, Vit B-6, Multiple Vitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was given vaccine on 12/12/17 and had no reaction or problems on date given. Patient noticed soreness to right upper arm deltoid area at site where vaccine given sore and warm to touch. Patient reports warmth to area lasted about 2 days and soreness to area about 5 days.


VAERS ID: 731663 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: Florida  
Vaccinated:2017-12-22
Onset:2017-12-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diazepam, amphetamine salts
Current Illness: N/A
Preexisting Conditions:
Allergies: morphine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very red expanding out 2 inches on either side of injection site, warm to touch, patient reports very painful, woke her up in middle of the night after receiving vaccine, also reports that site is very hard.


VAERS ID: 731778 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Female  
Location: Virginia  
Vaccinated:2017-12-20
Onset:2017-12-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site warmth, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Bactrim Allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stated she had a reaction to the SHINGRIX vaccine in which she experienced fever, headache, nausea and chills. She had an injection site reaction and her upper arm became red and hot to the touch. Patient stated it was just a little bit itchy. Her symptoms lasted around 48 hours. She has never had a reaction to a vaccine in the past. She noted that these were all reactions listed that may happen but wanted to report the reaction she experienced because it was out of the ordinary for her since she has never had any reaction to other vaccines in the past.


VAERS ID: 732039 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Female  
Location: Virginia  
Vaccinated:2017-12-22
Onset:2017-12-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Chills, Headache, Injection site pain, Nausea, Presyncope, Pyrexia, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydoxyurea (WBC count is above 4.0); SYNTHROID; ASA
Current Illness: Essential thrombocytopenia; Hypothyroidism
Preexisting Conditions: Essential thrombocytopenia; Hypothyroidism
Allergies: KEFLEX; PYRIDIUM
Diagnostic Lab Data: None done
CDC Split Type:

Write-up: Typical pain at injection site within a few hours, but about 12 hours after injection I had near fainting, nausea, severe shaking/chills, headache. Developed a fever about an hour later. In the morning I felt much better, but still weak, queasy and head-achy. The second morning (about 48 hours after the injection) I was back to nearly normal.


VAERS ID: 732192 (history)  
Form: Version 2.0  
Age: 69.0  
Gender: Male  
Location: Indiana  
Vaccinated:2017-12-27
Onset:2017-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 179603 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported no initial reaction, however, the following morning injection site redness, swelling, welting, hot feeling began. The reported symptoms have continued for 3 days post-injection at this time.


VAERS ID: 732219 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: New York  
Vaccinated:2017-12-28
Onset:2017-12-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 324KL / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called the pharmacy stating her right arm was red, swollen and sore around the injection site. I referred her to be seen by a physician in the case that it was cellulitis. Patient was seen in the ER with dx of cellulitis and given a 7 day course of doxycycline.


VAERS ID: 732489 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-11
Onset:0000-00-00
Submitted: 2017-12-22
Entered: 2018-01-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017GSK192625

Write-up: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy. On 11th December 2017, the patient received SHINGRIX. In December 2017, several hours after receiving SHINGRIX, the patient experienced stomach pain, headache, fever and chills. In December 2017, the outcome of the stomach pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving. The reporter considered the stomach pain, headache, fever and chills to be possibly related to SHINGRIX. Additional details were reported as follows: Concomitant products included vitamins. At 10:00 hours (in morning), the patient received SHINGRIX. The patient experienced stomach ache, headache, fever and chills in night. All events were resolved, however she still had slight headache at the time of reporting. It was reported that this case was reported previously, however, no duplicate case was found.


VAERS ID: 732491 (history)  
Form: Version 1.0  
Age: 49.0  
Gender: Female  
Location: California  
Vaccinated:2017-12-13
Onset:2017-12-14
   Days after vaccination:1
Submitted: 2017-12-22
   Days after onset:8
Entered: 2018-01-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 5Z5LX / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chills, Cough, Injection site pain, Lymphadenitis, Malaise, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CENTRUM MVI; Vitamin B supplements
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017GSK194028

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th October 2020). Concomitant products included CENTRUM MVI and Vitamin B Supplements. On 13th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2017, 1 days after receiving SHINGRIX, the patient experienced injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise. On an unknown date, the outcome of the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise were not recovered/not resolved. The reporter considered the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported for herself. The patient received CENTRUM and Vitamin B supplements. The patient felt like she had been ''run over by a truck'' and was ''sick as a dog''. When the patient woke up to go to work, she experienced uncontrollable shivering, malaise, general weakness, soreness at injection site, inflamed cervical lymph nodes on the left side, nausea and non-productive cough. The patient described that the shivering ''comes and goes''. The patient had denied permission to contact their physician.


VAERS ID: 732506 (history)  
Form: Version 2.0  
Age: 56.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2018-01-02
Onset:2018-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Arthralgia, Pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: folic acid, methotrexate, mesalamine, lidoderm, carvedilol, niacin, cyclobenzaprine, butalbital
Current Illness: none
Preexisting Conditions: unsure
Allergies: NKA
Diagnostic Lab Data: none yet
CDC Split Type:

Write-up: Patient noted that almost immediately after receiving vaccine his opposite arm became sore as well, within a few hours his entire body was sore also - basically full body aches and pain in all joints by the end of the day.


VAERS ID: 732520 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-09
Onset:2017-12-17
   Days after vaccination:8
Submitted: 2017-12-22
   Days after onset:5
Entered: 2018-01-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acne, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017195727

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 9th December 2017, the patient received SHINGRIX (intramuscular) .5 ml. On 17th December 2017, 8 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash and pimples. On an unknown date, the outcome of the itchy rash, erythematous rash and pimples were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, erythematous rash and pimples to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their employees received the SHINGRIX vaccine. The patient broke out in a rash. Rash was all over torso and was bothersome but not life-threatening. Rash was described as being itchy, red and pimply.


VAERS ID: 732522 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-13
Onset:0000-00-00
Submitted: 2017-12-29
Entered: 2018-01-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BREO; PRILOSEC; Trazodone; Zolpidem tartrate; ARMOUR THYROID; Azithromycin; Ethambutol; Metoprolol; Rifampin; Rosuvastatin; TRAVATAN Z; Triamcinolone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017196862

Write-up: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included BREO, PRILOSEC, trazodone, ARMOUR THYROID, azithromycin, ethambutol, Metoprolol, Rifampin, rosuvastatin, TRAVATAN Z and triamcinolone. On 13th December 2017, the patient received the 1st dose of SHINGRIX. In December 2017, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. The reporter considered the pain in arm, swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. Concomitant products also included CLODERM and hormone replacement therapy. The patient received SHINGRIX on the left arm and experienced pain in her left arm, redness on her left arm, and swelling on her left arm. This case has been linked with US2017GSK200906, reported by same reporter.


VAERS ID: 732605 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2017-12-27
Onset:2017-12-27
   Days after vaccination:0
Submitted: 2018-01-02
   Days after onset:6
Entered: 2018-01-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Grimacing, Injection site pain
SMQs:, Dyskinesia (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017201545

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201546, reported by the same reporter.


VAERS ID: 732607 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-21
Onset:2017-12-21
   Days after vaccination:0
Submitted: 2017-12-27
   Days after onset:6
Entered: 2018-01-04
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Injection site pain, Malaise
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017199056

Write-up: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. On 21st December 2017, the patient received SHINGRIX. In December 2017, several hours after receiving SHINGRIX, the patient experienced malaise and headache. On 21st December 2017, the patient experienced injection site pain. In December 2017, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the malaise and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, malaise and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a dentist who herself was the patient. Four hours after vaccination, the healthcare professional experienced pain at the injection site. The healthcare professional did not provide the date of birth, lot number and expiration date of the vaccine.


VAERS ID: 732611 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2017-12-27
Onset:2017-12-27
   Days after vaccination:0
Submitted: 2018-01-02
   Days after onset:6
Entered: 2018-01-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Grimacing, Immediate post-injection reaction, Injection site pain
SMQs:, Dyskinesia (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017201546

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a adult female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201545, reported by the same reporter.


VAERS ID: 732616 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Male  
Location: Unknown  
Vaccinated:2017-12-22
Onset:2017-12-23
   Days after vaccination:1
Submitted: 2017-12-29
   Days after onset:6
Entered: 2018-01-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fatigue, Gastrointestinal pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2017200799

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of gastrointestinal pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 22nd December 2017, the patient received SHINGRIX. In December 2017, 1 day after receiving SHINGRIX, the patient experienced gastrointestinal pain, nausea, fatigue and dizziness. On an unknown date, the outcome of the gastrointestinal pain and nausea were recovering/resolving and the outcome of the fatigue and dizziness were unknown. It was unknown if the reporter considered the gastrointestinal pain, nausea, fatigue and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The healthcare professional reported that about 24 hours after receiving a dose of SHINGRIX, the patient developed gastrointestinal pain, nausea, fatigue and dizziness. The patient still has gastrointestinal pain up to six days post administration of vaccine. No further information was reported regarding the event.


VAERS ID: 732837 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-05
Onset:2018-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Confusional state, Disorientation, Feeling abnormal, Feeling cold, Influenza like illness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: chlorphenermine (new, started same day vaccine administered), doxazosin, valacyclovir, letrozole, Uribel, hydrocodone/APAP, tramadol, Vyvanse
Current Illness: Allergies
Preexisting Conditions:
Allergies: tetracyclines
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt stated felt "different" right away, then confused as drove home (wasn''t sure where was), and later at home around 5PM felt cold/shaking like had flu. Denied fever and said seems to be doing better now.


VAERS ID: 732874 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-26
Onset:2017-12-27
   Days after vaccination:1
Submitted: 2018-01-05
   Days after onset:9
Entered: 2018-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Feeling abnormal, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018000604

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On 26th December 2017, the patient received SHINGRIX. In December 2017, 12 hrs after receiving SHINGRIX, the patient experienced fever, myalgia and general body pain. On 27th December 2017, the patient experienced feels awful. In December 2017, the outcome of the feels awful was recovered/resolved. On 28th December 2017, the outcome of the fever, myalgia and general body pain were recovered/resolved. The reporter considered the fever and myalgia to be unrelated to SHINGRIX. It was unknown if the reporter considered the general body pain and feels awful to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the patient. The age at vaccination was not reported. On 27th December 2017, the patient woke during the night with fever, myalgia and severe body aches. On 27th December 2017, 1 day after vaccination, the patient felt terrible for about 12 hours and then symptoms resolved on their own. The hospital or physician''s intervention was not required. The pharmacist called from home on her day off, so lot and expiration date were not available.


VAERS ID: 732876 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2018-01-05
Onset:2018-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL:01302020 / 1 LA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Influenza like illness, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfur base medications
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe soreness of upper left arm where shot was given - time frame/ beginning Saturday early morning 1-6 to Sunday night 1-7. Beginning on Saturday (1-6) early morning around 1:00 am, experienced a severe headache, weakness of entire body and extremely tired. I could not get out of bed the entire day and could not eat any food. I took one Advil Saturday morning which helped my headache a little but it continued for the rest of the day. I slept until 5:00 Sunday morning and although still weak I felt better and continued to feel better throughout the day. This morning (1-8) I am feeling normal. During the time frame that I mentioned being sick it felt like I had a version of the flu so I thought I would report these side effects even though they were listed on the paperwork the Pharmacy provided me.


VAERS ID: 733000 (history)  
Form: Version 2.0  
Age: 56.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-08
Onset:2018-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 324KL / 1 LA / SC

Administered by: PHM?       Purchased by: ?
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine was administered SQ instead of IM patient sis report pain and redness at the injection site the following day.


VAERS ID: 733541 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Male  
Location: Illinois  
Vaccinated:2018-01-09
Onset:2018-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED XT59606 / UNK LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Feeling hot, Flushing, Malaise, Migraine
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: NOTE: Patient also received AFLURIA 2017-18 (Lot XT59606) simultaneously on the same left arm (higher location). Patient expressed symptoms of flushing on his face hours after receiving the vaccines. He also experienced warm sensation on his arm. He sensed he was going to get sick and bundled up for bed (jogging pants, thick socks, etc.). He woke up the next day feeling better but was experiencing a migraine which was a relieved with a dose of sumatriptan. Patient felt better/normal later that night 1/10/18.


VAERS ID: 733630 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Male  
Location: Maryland  
Vaccinated:2018-01-11
Onset:2018-01-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed a fever and chills 12 hours after injection.


VAERS ID: 733801 (history)  
Form: Version 2.0  
Age: 65.0  
Gender: Female  
Location: Washington  
Vaccinated:2018-01-03
Onset:2018-01-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Injection site swelling, Malaise, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cevimeline, lunesta, xiidra
Current Illness:
Preexisting Conditions: blindness post shingles outbreak in the past
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient has malaise and general fatigue for 48 hours after dose. Patient also had significant swelling at the injection site and red-patchy rash that lasted 5 days. Patient experienced significant soreness at injection site that also lasted about 5 days.


VAERS ID: 733863 (history)  
Form: Version 2.0  
Age: 57.0  
Gender: Female  
Location: Alabama  
Vaccinated:2018-01-12
Onset:2018-01-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 525LX / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported swelling and redness of right upper arm the evening after the shot given on 01/12/2018. Reported to pharmacy on 1/15/2018 for pharmacist to evaluate. Erythema reaction with pain, recommended tylenol and report any further progression or worsening of symptoms.


VAERS ID: 733877 (history)  
Form: Version 2.0  
Age: 58.0  
Gender: Female  
Location: New York  
Vaccinated:2018-01-03
Onset:2018-01-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: metformin, lisinopril, levothyroxine, omeprazole, alprazolam
Current Illness:
Preexisting Conditions: unknown
Allergies: macrolides, sulfites
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm pain at and around injection site.


VAERS ID: 733880 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Male  
Location: Kansas  
Vaccinated:2018-01-02
Onset:2018-01-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Feeling cold, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan; Escitalopram
Current Illness: None
Preexisting Conditions: Hypertension; Depression
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported extreme pain in his left arm - similar to when he had rotator cuff surgery. He was nauseous and incredibly cold (was in bed under the covers with his heavy coat on). His symptoms lasted for approximately 24 hours.


VAERS ID: 733886 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2018-01-11
Onset:2018-01-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown - patient does not fill Rx at our pharmacy
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: NKDA
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient received injection and then approximately one day later developed a fever with aches. Called to report to pharmacy. Largely resolved after an additional day.


VAERS ID: 733945 (history)  
Form: Version 2.0  
Age: 53.0  
Gender: Female  
Location: Maryland  
Vaccinated:2018-01-14
Onset:2018-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Lymph node pain, Pain, Pain in extremity, Pyrexia, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Topiramate; Levothyroxine; Losartan; Aspirin; Asmanex; Nasacort; Zantac; Claritin; Zyrtec; Multi Vitamin; D3, Calcium; Advil
Current Illness: stomach flu (during Christmas)
Preexisting Conditions: High blood pressure, migraines, asthma, reflux, Hashimotos, environmental allergies
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, chills, possible fever, body aches, pain at site of injection, pain in arm and glands under arm of injection site. Chills and fever lasted ~6hours - disrupting sleep first night. Headache lasted 24+ hours. Body aches, soreness around injection site and glands under arm lasted $g48 hours. Recovering - but not completely over symptoms. Advil, rest, and fluids. Like a minor flu.


VAERS ID: 734019 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: New York  
Vaccinated:2018-01-10
Onset:2018-01-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Erythema, Feeding disorder, Mobility decreased, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: baby aspirin ( 81mg) w/ calcium , Vitamin D, MegaRed Omega-3 Krill oil . atenolol, losartan potassium , atorvastatin , hydrochlorothiazid
Current Illness: one month prior -- stomach/gastro virus
Preexisting Conditions: none
Allergies: Photosensitivity when taking hydrochlorothiazid
Diagnostic Lab Data: None
CDC Split Type:

Write-up: As you describe in your literature, my arm was quite sorea and red and could not raise over head for about 2 days. But the most troubling reaction was tat I literally could not get out of bed for 24 hours, could not eat, had upset stomach...almost like a severe case of mono. After 24 hours, I started to regain energy, but still fit wiped out and, appetite and ability to eat came back in a couple of days.


VAERS ID: 734078 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2018-01-05
Onset:2018-01-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Fatigue, Influenza like illness, Myalgia, Pruritus, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: First shingles vaccine at age 60. Localized skin reaction
Other Medications: Simvastatin; SYNTHROID; Timolol, latanoprost, vitamin C, vitamin D3, vitamin B12, biotin, Calcium, Krill oil, Move Free, multivitamin, ibuprofen
Current Illness: N/A
Preexisting Conditions: Hashimoto''s Thyroiditis, Glaucoma
Allergies: N/A
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Flu like symptoms, fever, myalgia, cough, fatigue, itchy skin eruptions.


VAERS ID: 734100 (history)  
Form: Version 2.0  
Age: 73.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2018-01-16
Onset:2018-01-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 324KLL / N/A RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Insomnia, Pain in extremity, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: At age 9, I was given a Smallpox vaccination that resulted in a Cowpox reaction. My body was covered with itchy red bumps. Howev
Other Medications: Clonazepam (Klonopin); Crestor; Doxepin Oral Sol; Folic Acid; Omeprazole; Timolol Maleate; Zetia
Current Illness: None
Preexisting Conditions: BPH; Acid Reflux
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was given the SHINGRIX vaccine at around 11:00 a.m. on January 16, 2018. A couple of hours later, my right arm became sore at the injection site and following down my right arm. At about 9:00 p.m. on the same date, I started to have flu-like symptoms. My fever rose to 101 degrees F, and I became very shaky. I had difficulty sleeping and I finally got out of bed around 11:00 a.m. the next morning (01/17/2018). I still have a slightly elevated temperature level (100.3), but I feel better--if not very drained. I called the pharmacy and spoke with the pharmacist who was filling in for the day. He was not the administrator of the shot. However, he was helpful in describing some possible side effects although he did not think my condition arose from the vaccination, but rather the current flu that is quickly traveling around the country. I countered his comments with the observation that I thought it was an unlikely coincidence that I had flu-like symptoms after receiving the vaccination.


VAERS ID: 734101 (history)  
Form: Version 2.0  
Age: 48.0  
Gender: Female  
Location: Unknown  
Vaccinated:2017-12-26
Onset:2017-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 RA / UN

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Avelox
Diagnostic Lab Data:
CDC Split Type:

Write-up: After injection was given, a painful, inflamed, swollen, red bump appeared at the injection site. The patient reported that the spot was so painful that it hurt to put clothes on or sleep on. After it healed, it left a brown spot, like a scar.


VAERS ID: 734110 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Male  
Location: Arizona  
Vaccinated:2018-01-05
Onset:2018-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS FJ57S / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; LOSARTAN
Current Illness: NONE
Preexisting Conditions: HYPERTENSION DEPRESSION
Allergies: NO KNOWN ALLERGY
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT REPORTED TO PHARMACY ON 1/18/2018 THAT HE HAS HAD BACK PAIN STARTING TWO DAYS AFTER IMMUNIZATION WAS ADMINISTERED. BEEN TAKING IBUPROFEN BUT IT''S BEEN TWO WEEKS NOW AND STILL NOW RELIEF. INFORMED HIM TO ALSO REPORT TO DR. GAVE PATIENT ANOTHER COPY OF VIS TO REPORT TO CDC. TO CHECK IN WITH ME IN A FEW DAYS.


VAERS ID: 734122 (history)  
Form: Version 2.0  
Age: 69.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2018-01-16
Onset:2018-01-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multi-vitamin; vitamin B-12; vitamin K2; Magnesium L-Threonate; vitamin D3; Tumeric with Meriva 500 mg; Probiotic
Current Illness: none
Preexisting Conditions: none
Allergies: Penicillin, Sulfa; mucosal sensitivity to raw onion
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore arm; severe chills, fever (100.6 F), fatigue, nausea, moderately severe headache.


VAERS ID: 734371 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Female  
Location: Indiana  
Vaccinated:2018-01-14
Onset:2018-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: valsartan; PREMARIN; TRADJENTA; glipizide ER; celecoxib; metformin
Current Illness: none that I''m aware of
Preexisting Conditions: diabetes
Allergies: nkda listed on her profile
Diagnostic Lab Data: unknown
CDC Split Type:

Write-up: Pt called reporting that she had a fever after getting vaccinated. She also reported that the injection site was red and swollen and that area was "the size of her hand".


VAERS ID: 734372 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Male  
Location: Washington  
Vaccinated:2018-01-16
Onset:2018-01-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Fatigue, Injection site erythema, Pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tamsulosin, Dutasteride, Flaxseed Oil 1400 Mg
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness around injection site, fist size. Felt tired and weak, aches lasting about 24 hours. Day naps and 8 hr night sleep.


VAERS ID: 734392 (history)  
Form: Version 2.0  
Age: 66.0  
Gender: Male  
Location: Montana  
Vaccinated:2018-01-17
Onset:2018-01-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / N/A RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Hypersomnia, Rash, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient woke up this morning with a hot red rash around his trunk. He received the SHINGRIX on 1/17/2018 and slept most of the day on 1/18/2018. He called on 1/19/2018 at about 3pm complaining of the rash. I advised him to take some Benadryl to see if that would help reduce the symptoms.


VAERS ID: 734427 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-16
Onset:2018-01-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Gait disturbance, Muscle fatigue, Myalgia, Neuralgia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported vomiting, severe muscle fatigue, muscle pain, fever, nerve pain in neck and leg which caused difficulty walking. Patient reports symptoms began ~10-12 hours after vaccine and lasted 36 hours. He reports no lasting side effects and did not seek medical care and has fully recovered at time or reporting.


VAERS ID: 734527 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2018-01-20
Onset:2018-01-20
   Days after vaccination:0
Submitted: 2018-01-21
   Days after onset:1
Entered: 2018-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 195238 / UNK UN / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK76P / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain upper, Dizziness, Headache, Musculoskeletal pain, Nausea, Neck pain, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Low grade fever 99 degrees F, worst stomach cramps, nausea and vomiting, headache, shoulders and neck ache, dizzy, started at about 7pm (vaccine admin 5:30PM).


VAERS ID: 734587 (history)  
Form: Version 2.0  
Age: 56.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2018-01-19
Onset:2018-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Complication associated with device, Ear swelling, Eye swelling, Injection site pain, Malaise, Mouth swelling, Musculoskeletal stiffness, Oral pain, Pain, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: No report of illness or fever at the time of vaccine administration; Unknown about illnesses prior to one month prior
Preexisting Conditions: Unknown
Allergies: Penicillin; Metronidazole
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient received the first injection of SHINGRIX on 01/19 around noon and later that evening she had some achiness, malaise, stiff neck, pain at the injection site. As time went on, she experience right ear and right eye swelling and also itching. The itching was at the same site on top of her head where she had shingles in the past. She also reported the roof of her mouth being sore and having some swelling in her mouth. She stated she was not able to wear a dental appliance because of the swelling. The patient was treating the pain and soreness with over the counter ibuprofen. No visits to the doctor was reported.


VAERS ID: 734648 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Female  
Location: Virginia  
Vaccinated:2018-01-18
Onset:2018-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt lightheaded immediately after receiving vaccine. With 3-4 minute, she lost consciousness. She was laid on floor and breathing was monitored. After approximately 1 minute, she regained consciousness. She was able to answer questions such as her name and where she was. EMS was called and they checked vitals and monitored. She refused additional treatment and transport to hospital.


VAERS ID: 734664 (history)  
Form: Version 1.0  
Age: 89.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-11
Onset:0000-00-00
Submitted: 2018-01-22
Entered: 2018-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site discomfort, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018009452

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 89-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 11th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort, incorrect storage of drug and vaccination error. On an unknown date, the outcome of the injection site discomfort, incorrect storage of drug and vaccination error were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX (on left deltoid) after it was stored in the freezer, which led to incorrect storage of drug and vaccination error. The patient experienced no side effects except discomfort at the injection site. The case has been linked with case US2018009454, reported by the same reporter.


VAERS ID: 734697 (history)  
Form: Version 1.0  
Age: 48.0  
Gender: Female  
Location: Maryland  
Vaccinated:2017-12-26
Onset:0000-00-00
Submitted: 2018-01-19
Entered: 2018-01-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRISTIQ
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018007759

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 48-year-old female patient who received SHINGRIX. Concomitant products included PRISTIQ. On 26th December 2017, the patient received the 1st dose of SHINGRIX (subcutaneous). On 26th December 2017, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site itching, injection site induration, injection sire discoloration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site itching, injection site induration, injection site discoloration, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provide as follows: The patient received the vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. Almost immediately, the site of injection turned red and the redness was spreading around bigger and bigger. The reporter said that the site of injection itched, hurt and was hard. She said that it even hurt if something touched it. The redness and other symptoms went away after one week and a half. After the redness went away, the patient started having discoloration or brownness at the injection site. The patient said that she had an x-ray that same day before having the injection, and she hoped that would not be a problem.


VAERS ID: 734700 (history)  
Form: Version 2.0  
Age: 72.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2018-01-15
Onset:2018-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P3777 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Patient had a doctor confirmed case of shingles due to the shingles vaccine SHINGRIX
CDC Split Type:

Write-up: Patient got shingles after getting the SHINGRIX vaccine.


VAERS ID: 734716 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-10
Onset:0000-00-00
Submitted: 2018-01-17
Entered: 2018-01-23
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Local reaction, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018005862

Write-up: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 10th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site induration were unknown and the outcome of the fatigue, myalgia, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site induration, fatigue, myalgia, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a very severe local reaction with pain and tenderness, erythema and induration. The erythema was extended approximately 3 inches in diameter around the injection site. The patient had myalgias and fevers and some intermittent nausea with fatigue. All the symptoms and signs were improving at the time of reporting although the injection site remains erythematous indurated and quite painful. No additional information provided.


VAERS ID: 734722 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-19
Onset:2018-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Arthralgia, Headache, Injection site pain, Lethargy, Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stated she started with soreness at the injection site and then the next day she had headache, joint pain, lethargy and muscle weakness/pain which lasted for 4 days. She would like to know if she should risk getting the second dose. She is worried the symptoms might be worse the next time.


VAERS ID: 734767 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Female  
Location: Nevada  
Vaccinated:2018-01-15
Onset:2018-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / N/A RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient said she is experiencing severe pain in her upper arm and shoulder even 6 days after the immunization.


VAERS ID: 734803 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: Ohio  
Vaccinated:2018-01-16
Onset:2018-01-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS FJ57S / UNK RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Gait disturbance, Hypersomnia, Middle insomnia, Mobility decreased, Pain, Peripheral swelling, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient actually received the SHINGRIX (NOT the ZOSTAVAX), but it was not an option to select above so I selected ZOSTAVAX. Following the night of the day she got the vaccine, patient woke up in the middle of the night with pain and soreness from head to toe. Patient said she could barely walk, move, get out of bed, or get dressed the next day. She also reported frequent sleeping for long periods of time during the 36 hours following vaccination. Patient also reported that her arm was red, swollen, and warm.


VAERS ID: 734842 (history)  
Form: Version 2.0  
Age: 74.0  
Gender: Male  
Location: California  
Vaccinated:2018-01-17
Onset:2018-01-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Injection site reaction, Malaise, Pyrexia, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate; atorvastatin; folic acid; levothyroxine; albuterol; ADVAIR; Vitamin D; Vitamin E
Current Illness: Patient had nose surgery week prior to remove papillomas, states he was experiencing symptoms of cold, runny nose
Preexisting Conditions: Psoriatic arthritis; asthma
Allergies: No known allergies
Diagnostic Lab Data: Patient will follow up with Dr. next week
CDC Split Type:

Write-up: Patient states he had a round, orange sized, red, itchy rash around the injection site since the injection date. Rash was visibly not noticible on 1/24/18 but patient complained site still was itchy. He also stated he had feelings of weakness, fever, malaise since injection. He stated he had been applying calamine lotion on the itch as well as another unknown cream to help the itching.


VAERS ID: 734847 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: California  
Vaccinated:2018-01-22
Onset:2018-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: WRK?       Purchased by: ?
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: super vitamin B; calcium; magnesium
Current Illness: none
Preexisting Conditions: Eczema
Allergies: ciprofloxacin
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Local erythema and swelling, approximately 10cm in greatest diameter.


VAERS ID: 734893 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-01
Onset:2018-01-01
   Days after vaccination:0
Submitted: 2018-01-24
   Days after onset:23
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010904

Write-up: This case was reported by a consumer and described the occurrence of injection site pain in a male patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter''s husband and she received the 1st dose of SHINGRIX on Friday. The patient had no side effects other than sore injection site. The reporter stated that I did not know if GSK wanted this to be reported or not. This case has been linked with case US2018GSK010905 (wife''s case), reported by the same reporter.


VAERS ID: 734897 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-20
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Headache, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010900

Write-up: This case was reported by a consumer via out of hour services and described the occurrence of stiffness in a female patient who received SHINGRIX. On 20th January 2018, the patient received SHINGRIX. In January 2018, 1 day 3 hrs after receiving SHINGRIX, the patient experienced stiffness, shivering and headache. On an unknown date, the outcome of the stiffness, shivering and headache were unknown. It was unknown if the reporter considered the stiffness, shivering and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At time of reporting, the reporter stated that approximately 27 hours ago she had SHINGRIX vaccine and the same morning the patient woke up feeling stiff and had been progressing throughout the day, had shivers, and slight headache. The aching the patient had a question on how long it would last. The reporter did not know what to expect and had gone on different websites.


VAERS ID: 734900 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-20
Onset:2018-01-20
   Days after vaccination:0
Submitted: 2018-01-24
   Days after onset:4
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Drug administered to patient of inappropriate age, Influenza like illness, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010907

Write-up: This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 39-year-old female patient who received SHINGRIX. On 20th January 2018, the patient received the 2nd dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, the patient experienced inappropriate age at vaccine administration. On 21st January 2018, the patient experienced fever, injection site pain and weakness. On an unknown date, the outcome of the influenza-like symptoms, weakness and inappropriate age at vaccine administration were unknown and the outcome of the fever and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. The reporter considered the fever, injection site pain and weakness to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The 39 year old patient received SHINGRIX, which led to inappropriate age at vaccine administration. Last night from the day of reporting, less than a day after vaccination, the patient experienced flu like symptoms. One day after vaccination, the patient had weakness, fever and injection site pain.


VAERS ID: 734987 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Male  
Location: Washington  
Vaccinated:2018-01-16
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Injection site warmth, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin
Current Illness: Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018010096

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 58-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concurrent medical conditions included hyperthyroidism. Concomitant products included atorvastatin. On 16th January 2018, the patient received the 1st dose of SHINGRIX .5 ml. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, sleepiness and generalized joint pain. In January 2018, the outcome of the injection site warmth and sleepiness were recovering/resolving and the outcome of the generalized joint pain was recovered/resolved. The reporter considered the injection site warmth and generalized joint pain to be related to SHINGRIX. The reporter considered the sleepiness to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was notified on the day of reporting by the patient about the side effects he experienced and if the second dose of the vaccine should be given. The patient did not give any timeframes as to when the side effects started after receiving the vaccine. When the patient came into the pharmacy on the day of reporting, the reporter could feel that the skin at the injection site was still warm to the touch. The reporter felt the skin through the patient''s shirt. The body aches were experienced in the joints in the entire body of the patient. The reporter was told by the patient that he had sleepiness and could not stay awake. The reporter said that sleepiness was atypical for this patient.


VAERS ID: 735066 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: Utah  
Vaccinated:2018-01-23
Onset:2018-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: eliquis, tramadol, trazodone, lidocaine 5% patch, Rabeprazole, lisinopril, metformin, Celebrex, topiramate.
Current Illness: none
Preexisting Conditions: none
Allergies: NSAIDS
Diagnostic Lab Data: Referred to primary care doctor for follow up
CDC Split Type:

Write-up: Patient was given the shot and developed shingle symptoms a little over 24 hours later on the left leg.


VAERS ID: 735071 (history)  
Form: Version 2.0  
Age: 65.0  
Gender: Male  
Location: Ohio  
Vaccinated:2018-01-17
Onset:2018-01-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ZOSTAVAX diluent mixed with SHINGRIX drug.


VAERS ID: 735108 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Male  
Location: Michigan  
Vaccinated:2018-01-12
Onset:2018-01-18
   Days after vaccination:6
Submitted: 2018-01-25
   Days after onset:7
Entered: 2018-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Computerised tomogram normal, Headache, Influenza like illness, Lumbar puncture normal, Mental status changes, Positron emission tomogram normal
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PRILOSEC; Lisinopril
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/21/2018, Computerised tomogram, negative; 01/21/2018, Lumbar puncture, negative; 01/21/2018, Positron emission tomogram, negative
CDC Split Type: US2018011293

Write-up: This case was reported by a other health professional via call center representative and described the occurrence of memory loss in a 56-year-old male patient who received SHINGRIX (batch number P539L, expiry date 31st January 2020). Concomitant products included PRILOSEC and lisinopril. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, 6 days after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization). On 19th January 2018, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 20th January 2018, the patient experienced memory loss (serious criteria hospitalization, disability and other: As per reporter) and mental status changes (serious criteria hospitalization). On 21st January 2018, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. In January 2018, the outcome of the memory loss, mental status changes, headache and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the positron emission tomogram, computerized tomogram and lumbar puncture were unknown. The reporter considered the memory loss, mental status changes, headache and influenza-like symptoms to be possibly related to SHINGRIX. It was unknown if the reporter considered the positron emission tomogram, computerized tomogram and lumbar puncture to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX vaccine in the left deltoid. On 19th January 2018, 7 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, 8 days after receiving SHINGRIX, the patient experienced memory loss and mental status changes. The patient''s memory issues involved not being able to recall names and not recognizing his wife or children. On 21st January 2018, 9 days after receiving SHINGRIX, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. The patient was taken to the hospital and positron emission tomography, computerized tomography and lumbar tap were done and those were all negative. No evidence of stroke, transient ischemic attack or bacterial infection was present. The symptoms resolved after lumbar tap. The patient remained in the hospital, at the time of reporting.


VAERS ID: 735201 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2018-01-15
Onset:2018-01-16
   Days after vaccination:1
Submitted: 2018-01-25
   Days after onset:9
Entered: 2018-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash, Rash pustular, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL; spironolactone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018008604

Write-up: This case was reported by a nurse via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX. Concomitant products included ADDERALL and spironolactone. On 15th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pustule. On an unknown date, the outcome of the rash and pustule were not recovered/not resolved. It was unknown if the reporter considered the rash and pustule to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in right arm and noticed a rash containing pustules on both legs, with the right leg being worse. Issue worsened last night on 16th January 2018 but had improved today on 17th January 2018. The patient thought the rash appeared to resemble a shingles type of rash.


VAERS ID: 735205 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Male  
Location: California  
Vaccinated:2018-01-22
Onset:2018-01-22
   Days after vaccination:0
Submitted: 2018-01-25
   Days after onset:3
Entered: 2018-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / SYR

Administered by: Other       Purchased by: Private
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Baby aspirin; Losartan
Current Illness: Unknown
Preexisting Conditions: Drug hypersensitivity; Food allergy, peanut hypersensitivity; Herpes zoster, several years ago; Herpes zoster, last year
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018012431

Write-up: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old male patient who received SHINGRIX. The patient''s past medical history included shingles (several years ago) and shingles (last year). Concurrent medical conditions included penicillin allergy and peanut allergy. Concomitant products included Baby Aspirin and Losartan. On 22nd January 2018 10:00, the patient received the 1st dose of SHINGRIX. On 22nd January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 22nd January 2018 12:00, the patient experienced shivering. On 22nd January 2018 23:00, the patient experienced tiredness, pain and headache. In January 2018, the outcome of the headache and shivering were recovered/resolved. On an unknown date, the outcome of the tiredness, pain and injection site pain were recovering/resolving. The reporter considered the tiredness, pain, injection site pain, headache and shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient''s concomitant medication included Atorvastatin. The patient received SHINGRIX in the left deltoid. Two hours after vaccination, the patient experienced shivering. Thirteen hours after vaccination, the patient experienced tiredness, soreness on his upper body and headache.


VAERS ID: 735280 (history)  
Form: Version 2.0  
Age: 55.0  
Gender: Female  
Location: California  
Vaccinated:2018-01-23
Onset:2018-01-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site reaction, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: same rash after flu shot
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 80 small itchy bumps occurred 2 days after shot at injection site. Patient put steroid cream on site with no relief. Bumps were "hive-like" but not red.


VAERS ID: 735310 (history)  
Form: Version 2.0  
Age: 52.0  
Gender: Female  
Location: Indiana  
Vaccinated:2018-01-25
Onset:2018-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram, Metformin
Current Illness: cough and congestion
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: The next morning there was pain and redness at the injection site. The area felt warm. The area was hard like a knot. The pain has subsided but it is still painful when touched. On Sunday, the redness was estimated to be about 6 to 7 cm. The patient says it feels like it is slowly getting better.


VAERS ID: 735344 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-18
Onset:2018-01-21
   Days after vaccination:3
Submitted: 2018-01-25
   Days after onset:4
Entered: 2018-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Chills, Dizziness, Gait disturbance, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018011292

Write-up: This case was reported by a consumer via call center representative and described the occurrence of balance disorder in a 75-year-old female patient who received SHINGRIX. Concomitant products included LIPITOR. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On 19th January 2018, the patient experienced shivering. On 21st January 2018, the patient experienced balance disorder, dizziness and stumbling. On an unknown date, the outcome of balance disorder, dizziness and stumbling were not recovered/not resolved and the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were recovering/resolving and the outcome of the shivering was recovered/resolved. The reporter considered the balance disorder, injection site swelling, injection site itching, dizziness, injection site lump, stumbling, shivering and injection site erythema to be related to SHINGRIX. Additional details were provide as follows: This case was reported by the patient herself. On 18th January 2018 at 10:00, the patient received a dose of SHINGRIX vaccine. The site reactions began almost right away. The reporter described the lump as 4 inches wide and 2 inches thick. It was itchy and very red but these reactions were subsiding. On 19th January 2018, 1 day after receiving SHINGRIX, the patient experienced shivering (began on Friday and lasted about 24 hours). On 21st January 2018, 3 days after receiving SHINGRIX, the patient experienced balance disorder, dizziness and stumbling. The patient did not experience any shivering since then. Then on Sunday morning she woke and felt dizzy and off balance. On the day of reporting, in morning, when the patient woke up, the feeling of being off balance was worse and she was stumbling. The patient had consulted with her doctor. The patient did ask for product information.


VAERS ID: 735350 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-01
Onset:2018-01-01
   Days after vaccination:0
Submitted: 2018-01-24
   Days after onset:23
Entered: 2018-01-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK010905

Write-up: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, fatigue, headache, shivering, fever and nausea. On an unknown date, the outcome of the injection site pain, general body pain, headache, shivering, fever and nausea were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, general body pain, fatigue, headache, shivering, fever and nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX on Friday. The patient had experienced sore injection site, in addition to that on Saturday, general body aches, fatigue, headache, shivers, fever, and slight nausea feeling was also experienced. On Sunday, the patient was better, but still tired. The reporter stated that she did not know if GSK wanted this to be reported or not. In 2 months the patient intended to get the 2nd dose of SHINGRIX. She asked if she should expect the same results. This case was linked to case US2018GSK010904 (husband''s case), reported by the same reporter.


VAERS ID: 735442 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Male  
Location: Maine  
Vaccinated:2018-01-16
Onset:2018-01-18
   Days after vaccination:2
Submitted: 2018-01-29
   Days after onset:11
Entered: 2018-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abnormal faeces, Diarrhoea, Frequent bowel movements
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANTOVEN; Amlodipine; Atenolol; Baby aspirin; hydrochlorothiazide; Losartan; Simvastatin
Current Illness: Unknown
Preexisting Conditions: Gastrointestinal disorder, bowel problems and suspected that the patient had irritable bowel disease; ZOSTAVAX, Prophylaxis, received 2 to 3 years before the reporting date
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018013059

Write-up: This case was reported by a consumer via call center representative and described the occurrence of loose stools in a 65-year-old male patient who received SHINGRIX. The patient''s past medical history included gastrointestinal disorder (bowel problems and suspected that the patient had irritable bowel disease). Previously administered products included ZOSTAVAX (received 2 to 3 years before the reporting date). Concomitant products included amlodipine, atenolol, Baby Aspirin, Losartan, simvastatin, JANTOVEN and hydrochlorothiazide. On 16th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th January 2018, 2 days after receiving SHINGRIX, the patient experienced loose stools and stool odor abnormal. On 23rd January 2018, the patient experienced upset stomach. On an unknown date, the outcome of the loose stools was not recovered/not resolved and the outcome of the stool odor abnormal and upset stomach were unknown. The reporter considered the loose stools, stool odor abnormal and upset stomach to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter stated that her husband received SHINGRIX in the left deltoid. The patient started experiencing frequent, almost uncontrollable, loose stools. They occurred off and on over the next few days. They thought he was getting better, but the day before reporting date (7 days after vaccination), he had a bad bout and had been experiencing an upset stomach. The patient''s loose stools also had a funny metallic or medicinal smell.


VAERS ID: 735541 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Washington  
Vaccinated:2018-01-24
Onset:2018-01-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash macular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide, Amlodipine, Omeprazole, Metoprolol Succinate, Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidemia, Hypertension
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt reports that the reaction began on 1/25/18, and by 1/26/18, the injection site was "all welted up," hot, painful to touch, and felt like someone punched her really hard in the arm. When she came in to the pharmacy today on 1/29/18 to physically show me her arm, it still had some red blotches, she said it was still a little sore but for the most part was resolving on its own.


VAERS ID: 735674 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-18
Onset:2018-01-18
   Days after vaccination:0
Submitted: 2018-01-29
   Days after onset:11
Entered: 2018-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Chills, General physical health deterioration, Influenza like illness, Injection site pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018013055

Write-up: This case was reported by a physician via call center representative and described the occurrence of chills in a 71-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th January 2018, the patient experienced chills, influenza like illness, general physical health deterioration and arthralgia. In January 2018, the outcome of the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain were recovered/resolved. The reporter considered the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to manufacturer. This case was reported by the physician who himself was the patient. The patient experienced severe pain and tenderness at the injection site (right deltoid) which started the evening after the vaccination. The next day, the patient began to experience shaking chills, severe arthralgia, and stated that he felt extremely fluish, like he wanted to die and was totally laid up. The reporter gave permission to be contacted regarding his experience. He was unable to provide the lot number and expiration date for the product administered.


VAERS ID: 735776 (history)  
Form: Version 2.0  
Age: 73.0  
Gender: Female  
Location: Alaska  
Vaccinated:2018-01-11
Onset:2018-01-25
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2018-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Herpes zoster, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN, BUDESONIDE, REQUIP
Current Illness:
Preexisting Conditions:
Allergies: RIZATRIPTAN, BENZODIAZEPINES, PCN, IODINE AND POSSIBLY QUINOLONES
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT EXPERIENCE PAIN IN ARM-STILL CAUSING PAIN 3 WEEKS LATER. AT 2 WEEKS SHE DEVELOPED SHINGLES IN THE PUBIC AREA. SHE HAS HAD SHINGLES BEFORE.


VAERS ID: 735780 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-01-29
Onset:2018-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: dust, mold
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 101.2, chills, dull headache.


VAERS ID: 735797 (history)  
Form: Version 2.0  
Age: 69.0  
Gender: Female  
Location: Ohio  
Vaccinated:2018-01-29
Onset:2018-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N019983 / N/A RA / IM
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 627011A / N/A LA / IM
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB A108A / N/A LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Injection site erythema, Loss of personal independence in daily activities, Pain in extremity, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Meloxicam
Current Illness:
Preexisting Conditions: Osteoarthritis in knees
Allergies: Insects/bee stings
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right arm is red, painful, and mildly itchy. Redness starts at site of injection(s) and spreads about 2 inches towards elbow. Client states arm is painful at rest and tender to the touch. Pain interfered with exercise.


VAERS ID: 735826 (history)  
Form: Version 1.0  
Age: 80.0  
Gender: Male  
Location: Texas  
Vaccinated:2018-01-17
Onset:2018-01-17
   Days after vaccination:0
Submitted: 2018-01-30
   Days after onset:13
Entered: 2018-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; Liothyronine; Omeprazole; REGLAN
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018012384

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Liothyronine, omeprazole and REGLAN. On 17th January 2018 11:00, the patient received SHINGRIX 50 mcg/mg. On 17th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. In January 2018, the outcome of the injection site pain and injection site erythema were recovered/resolved. The reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. After receiving SHINGRIX, the patient experienced redness and soreness at the injection site and red circle approximately one inch in diameter and spread to one and half inches after a day or two. The symptoms were resolved after 4 days. Treatment was provided by the pharmacy.


VAERS ID: 735835 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 2018-01-30
   Days after onset:0
Entered: 2018-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK RL / UN
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Pruritus, Skin warm, Tremor, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown-None per patient
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: SHINGRIX admin 1030AM; patient experienced hives, red and itchy skin, warmth and redness all over, shaking. S/S developed approximately 2PM.


VAERS ID: 735852 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-16
Onset:2018-01-23
   Days after vaccination:7
Submitted: 2018-01-30
   Days after onset:7
Entered: 2018-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR - / UNK RA / UN
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Extensive swelling of vaccinated limb, Heart rate increased, Injection site erythema, Injection site warmth, Local reaction
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018013081

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included FLUZONE QUADRIVALENT. On 16th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site warmth (serious criteria hospitalization) and heart rate increased (serious criteria hospitalization). In January 2018, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm and FLUZONE on right arm. The healthcare professional (HCP) reported that, the patient developed a localized reaction of a red, swollen area about 4 by 5 inches in diameter, which was hot or warm to the touch, after receiving SHINGRIX. The patient also developed increased heart rate which resulted in hospitalization for one day and the patient received treatment to lower the heart rate. No further information was reported regarding the event.


VAERS ID: 735870 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-01
Onset:2018-01-01
   Days after vaccination:0
Submitted: 2018-01-30
   Days after onset:29
Entered: 2018-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018014367

Write-up: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINRIX. Additional details were provided as follows: The patient received their 1st dose of SHINGRIX last Friday. The patient experienced symptoms of chills and shivers since the administration of the vaccine. The patient called because they are concerned about how long was expected that symptoms would be remain and what was the recommendation on receiving the 2nd dose in series. Remote disconnected from the patient during warm transfer, however the GSK360 request had been opened and placed in the patient call back folder for follow-up. The patient did not want to provide the health care professional name for follow up but could send her the letter. No further information was reported regarding the event.


VAERS ID: 735883 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Dizziness, Hypertension, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had chills in the evening, very dizzy and heart beating fast/racing. The pt was still very dizzy and blood pressure was high the next day when he came in. I told the patient to take some acetaminophen and rest and give it another day and to call md if symptoms got worse or did not improve in another day.


VAERS ID: 735895 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-23
Onset:2018-01-24
   Days after vaccination:1
Submitted: 2018-01-30
   Days after onset:6
Entered: 2018-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018013846

Write-up: This case was reported by a nurse vial call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. On 23rd January 2018, the patient received SHINGRIX. On 24th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with VASELINE. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were recovering/resolving. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be almost certainly related to SHINGRIX. Additional details were provided as follows: The case was reported by a nurse practitioner who was the patient. There was no other medical history or medication history or concomitant vaccines reported by caller. The patient received SHINGRIX in left deltoid. The reporter stated that symptoms were getting better and no other medical treatment besides VASELINE at site had occurred. She did not have batch number or expiration. There was no address was provided for facility. The reporting nurse practitioner stated that she was not calling to report adverse event.


VAERS ID: 735912 (history)  
Form: Version 2.0  
Age: 66.0  
Gender: Female  
Location: Utah  
Vaccinated:2018-01-29
Onset:2018-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 324KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Pravastatin, Norco, Synthroid, Soma, Prozac
Current Illness: none
Preexisting Conditions: Diabetes
Allergies: None
Diagnostic Lab Data: nothing yet
CDC Split Type:

Write-up: Redness, swelling, heat, and patient says it feels like a rock at the injection site. Patients is taking tylenol and using a cold pack. We suggusted on 1/31/18 that the patient go to the doctor if no improvement.


VAERS ID: 735934 (history)  
Form: Version 2.0  
Age: 53.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2018-01-27
Onset:2018-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Rash, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRACE vaginal cream
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none as of yet
CDC Split Type:

Write-up: Patient called to describe a red splotchy rash on left arm. She stated it had grown since yesterday but was not sure if it was warm to the touch.


VAERS ID: 735960 (history)  
Form: Version 2.0  
Age: 83.0  
Gender: Male  
Location: Colorado  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / SC

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PEPCID; SINEMET; ZOCOR; Aspirin; OTC and Herbal meds unknown
Current Illness: Unknown
Preexisting Conditions: Adenocarcinoma prostate; Hyperlipidemia; GERD; Idiopathic Parkinson''s; Polyp/Colon; Hearing loss
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient was given immunization SHINGRIX by SQ instead of IM.


VAERS ID: 735989 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-16
Onset:0000-00-00
Submitted: 2018-02-01
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; meloxicam; Methotrexate
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018013120

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number FJ578 ?, expiry date 30th January 2020). Concomitant products included folic acid, meloxicam and methotrexate. On 16th January 2018, the patient received SHINGRIX. In January 2018, 12 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness. In January 2018, the outcome of the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist stated there were no concomitant vaccines, and was not aware of any other medical history for the patient. The patient was administered SHINGRIX in the right deltoid and experienced pain head to toe, sleepiness, and injection site redness, swelling, and warmth to touch. The events lasted for 36 hours. The reporting pharmacist stated that she was not aware of the patient seeking medical attention for symptoms. The reported batch number FJ578, was not available in sales data sheet.


VAERS ID: 735990 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-24
Onset:0000-00-00
Submitted: 2018-02-01
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Heart rate increased, Injection site pain
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/2018, Heart rate increased, slight elevated
CDC Split Type: US2018013895

Write-up: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 75-year-old female patient who received SHINGRIX. On 24th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced heart rate increased and injection site pain. On an unknown date, the outcome of the heart rate increased and injection site pain were unknown. It was unknown if the reporter considered the heart rate increased and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A day after vaccination, the patient had contacted in regards to a slightly elevated heart rate and also mentioned she was a little sore at the injection site. Contact details of the prescribing physician was provided, however unsure if the details corresponded to vaccine administration details.


VAERS ID: 735998 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: Michigan  
Vaccinated:2018-01-25
Onset:2018-01-25
   Days after vaccination:0
Submitted: 2018-02-01
   Days after onset:7
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018015517

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On 25th January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 25th January 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received SHINGRIX subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The patient experienced redness of 6-inch diameter after receiving vaccination. The reporter stated that it occurred within hours of the vaccine, but unsure of specifics. No lot number, expiry date and patient details were provided. The reporter was not 100 percent certain about the vaccination date and thought it was last Thursday before the reporting date. The health care professional had limited information about the adverse event. The health care professional was the pharmacist who dispensed the vaccine, but did not administer.


VAERS ID: 735999 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-12
Onset:2018-01-13
   Days after vaccination:1
Submitted: 2018-02-01
   Days after onset:19
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blister, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018014389

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a female patient who received SHINGRIX. On 12th January 2018, the patient received SHINGRIX. In January 2018, 1 days after receiving SHINGRIX, the patient experienced blister and skin lesion. On an unknown date, the outcome of the blister and skin lesion were unknown. It was unknown if the reporter considered the blister and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One or 2 days after being vaccinated with SHINGRIX, the patient developed lesions or blisters in her nostrils and under her ear. The pharmacist that called in was not the healthcare professional who vaccinated this patient, so he did not have any other details. No further information was provided.


VAERS ID: 736003 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2018-01-12
Onset:2018-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chest X-ray normal, Chills, Electrocardiogram normal, Headache, Influenza virus test negative, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None. Went to hospital and got checked for flu and test was negative.
Preexisting Conditions: None.
Allergies: Non-steroidal anti-inflammatory medications (Ibuprofen, MOBIC, etc)
Diagnostic Lab Data: EKG, Rapid flu test, and chest x-ray. They were all negative/normal.
CDC Split Type:

Write-up: Patient woke up the next day with fever, chills, headache, and muscle aches. She went to hospital because she thought she had the flu. She was checked with EKG, flu test, and other exams all negative. She had chest x-ray negative. She got IV fluids and took TYLENOL. She felt better after 6-12 hours on TYLENOL.


VAERS ID: 736011 (history)  
Form: Version 2.0  
Age: 80.0  
Gender: Male  
Location: New York  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS LN9TL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Blood pressure increased, Condition aggravated
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lisinopril, amlodipine, aspirin
Current Illness:
Preexisting Conditions: hypertension
Allergies: no known drug allergies
Diagnostic Lab Data: BP: 223/93 (2/1/18 @ around 5:30pm)
CDC Split Type:

Write-up: Patient experienced raised blood pressure some time after administration of SHINGRIX. Patient started on blood pressure medications and had blood pressure controlled on the medications. Patient called us in the afternoon stating blood pressure rose to around 240. Later around 5:30pm came to pharmacy and I had rechecked his blood pressure at the pharmacy and it was still 223/93. Spoke with his interal medicine doctor''s office and arranged for him to go see the doctor immediately.


VAERS ID: 736013 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Male  
Location: New York  
Vaccinated:2018-01-27
Onset:2018-01-28
   Days after vaccination:1
Submitted: 2018-02-01
   Days after onset:4
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; Amlodipine; Trazodone
Current Illness: Unknown
Preexisting Conditions: ZOSTAVAX, prophylaxis, received 1.5 years ago before the reporting date
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018015569

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 1.5 years ago before the reporting date). Concomitant products included CRESTOR, amlodipine and trazodone. On 27th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, fatigue and injection site erythema. On 29th January 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site swelling, injection site pain, fatigue and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. On the reporting date, the patient and swelling had gone down a lot, though there was still redness.


VAERS ID: 736019 (history)  
Form: Version 2.0  
Age: 53.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blister, Cold sweat, Fall, Gait disturbance, Hyperhidrosis, Injection site inflammation, Joint swelling, Motor dysfunction, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dexilant DR, Lisinopril-HCTZ, Docusate sodium, Vyvanse
Current Illness:
Preexisting Conditions:
Allergies: Amlodipine
Diagnostic Lab Data:
CDC Split Type:

Write-up: SHINGRIX Zoster Vaccine. Symptoms: Injection site reaction 5p area inflammed from neck to right arm injection site, vomiting, nausea, body ache, fever, cold and hot sweats, reduced motor skills (cannot walk a few feet without tumbling down), ankles swollen, blister formation face


VAERS ID: 736044 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: New York  
Vaccinated:2018-01-26
Onset:2018-01-26
   Days after vaccination:0
Submitted: 2018-02-02
   Days after onset:7
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018015515

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 26th January 2018, the patient received the 1st dose of SHINGRIX. On 26th January 2018, 8 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was the patient for this adverse event. The patient received SHINGRIX in left deltoid.


VAERS ID: 736058 (history)  
Form: Version 2.0  
Age: 78.0  
Gender: Female  
Location: Maine  
Vaccinated:2018-01-31
Onset:2018-02-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported an injection-site reaction, consisting of swelling, redness, and itching around the injection site. The site was also painful to touch.


VAERS ID: 736110 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: Nevada  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS FJ57S / 1 RA / SC

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lisinopril, metoprolol tartrate, lisinopril-HCTZ, omeprazole
Current Illness:
Preexisting Conditions:
Allergies: azithromycin, gabapentin, penicillin, opioid analogues
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness and swelling at injection site. No trouble breathing or itching.


VAERS ID: 736130 (history)  
Form: Version 2.0  
Age: 82.0  
Gender: Male  
Location: Georgia  
Vaccinated:2018-01-29
Onset:2018-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS FJ57S / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Insomnia, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient''s arm is still sore, red, and swollen among his entire upper right extremity. His most concerned side effect is insomnia.


VAERS ID: 736149 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Male  
Location: Virginia  
Vaccinated:2018-01-25
Onset:2018-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: PHM?       Purchased by: ?
Symptoms: Contusion, Erythema, Immediate post-injection reaction, Injection site pain, Livedo reticularis, Local reaction, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: January 25th: very painful shot, arm sore immediately afterwards took Ibuprofen. 26th: sore arm all day. 27th: sore arm all day, dusky red, 3 inches by 4 inches (Grade 3 local reaction), took Ibuprofen. 28th: sore arm, applying alternating hot and cold compress. 29th: mottled local reaction with some bruising, arm still sore and itchy. 30th Feb 2nd: arm slightly sore and itchy.


VAERS ID: 736150 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Virginia  
Vaccinated:2018-01-25
Onset:2018-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Flushing, Headache, Immediate post-injection reaction, Injection site pain, Lividity, Local reaction, Malaise, Pain in extremity, Pruritus, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Jan 25: very painful shot, arm sore immediately. 26: sore arm all day. 27: sore arm, livid reaction, 3 inches by 2 inches (Grade 3 local reaction), flushed skin on face, malaise, headache and shivering, went to bed early with Ibuprofen. 28: headache, malaise, sore and itchy arm, hot compresses. 29-31: local reaction much less livid, sore and itchy arm but not as sore, mostly better by day''s end. Feb 1: itchy and discolored arm.


VAERS ID: 736151 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Male  
Location: California  
Vaccinated:2018-02-02
Onset:2018-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS EK279 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Influenza like illness, Pain, Pain in extremity, Respiratory tract congestion, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin 80mg qd
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt discussed arm pain and flu-like symptoms (body aches, congestion, sneezing) but no fever. Pt taking TYLENOL and ibuprofen to alleviate.


VAERS ID: 736152 (history)  
Form: Version 2.0  
Age: 93.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Injection site pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE, BUMETANIDE, TRAMADOL, LISINOPRIL, POLYETHYLENE GLYCOL, FLUTICASONE PROPIONATE NASAL SPRAY, CENTRUM SILVER MULTIVITAMIN, VITAMIN C ORAL SUPPLEMENT
Current Illness: No known illnesses, per patient the Dr. said "you are in good health" at her last visit.
Preexisting Conditions: High blood pressure, under control currently with medications. No other known medical conditions.
Allergies: No known allergies.
Diagnostic Lab Data:
CDC Split Type:

Write-up: A roughly 5 to 6 inch area of redness, non-raised, non-broken, was presented by the patient on 2/3/18 around 3:00pm. She noted that this reaction started the evening of 2/1/18 when the vaccine was given. She described it as "hot to the touch", but not worsening or changing significantly in the last 36 hours or so since first noticing it. She also claims no systemic fever, although she has no thermometer at home to measure this. She also describes no other symptoms, other than injection-site pain.


VAERS ID: 736153 (history)  
Form: Version 2.0  
Age: 77.0  
Gender: Male  
Location: Mississippi  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: B-12, aspirin, multivitamin, D, E, Tumeric, folic acid, C, iron
Current Illness: none
Preexisting Conditions: MGUS
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Very large red area and warm on arm.


VAERS ID: 736156 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Illinois  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Injection site nodule, Joint range of motion decreased, Pain in extremity, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Sore arm after PREVNAR13 at age 64, lasted less than 2 days
Other Medications: WELLBUTRIN, letrozole, DEXILANT, CRESTOR, SINGULAR, BENICAR, XANAX, CITRACAL, melatonin, biotin, probiotic, low-dose aspirin, CO-Q10, krill oil, GTF chromium, multi-vite & fiber gummies
Current Illness: None
Preexisting Conditions: Obesity, asthma, hypertension, breast cancer (2.5 yrs ago, hence the letrozole), GERD, depression, osteopenia
Allergies: Penicillins, CIPRO, sulfa antibiotics (rash); zithromycin (palpitations)
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore arm, ltd. ROM and nodule at injection point initially; next day swollen red warm patch appeared not at injection point but about 2" below. Dimensions: at 24 hrs., golf ball size; 48 hrs, tennis ball size; 96 hrs 3" wide x 6"long, spreading downward and back towards elbow. Warm & tender to touch. Each day, the new expansion area is swollen but the prior days'' swelling has receded. But entire area is red, warm and sore to touch. No fever, headache, other myalgias, or GI symptoms. My primary care doc not sure whether it''s a reaction or cellulitis. Now 96 hrs and the reaction keeps progressing.


VAERS ID: 736158 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: D.C.  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENICAR, Rosuvastatin Calcium, SYNTHROID, montelukast SOD, CO Q 10, VITRON-C, D3, ZYRTEC, Fish Oil
Current Illness: Sinus Infection
Preexisting Conditions: Acid Reflux, Hiatal Hernia
Allergies: Vancomycin; Flax, onions, garlic
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received shot at about 9.30 am. Within a half hour experienced a more than moderate pain on inside of arm from elbow to wrist. Happened 3 times for a duration of about 10 seconds. I have never had that pain before and it happened only those three times. By 5pm tired, some muscle pain and injection site quite sore. The next day was the worst, with muscle aches, headache, moving the arm was somewhat painful, swelling and redness of injection site and body was cold...not shivering but close to it. Extremely tired.


VAERS ID: 736208 (history)  
Form: Version 2.0  
Age: 74.0  
Gender: Female  
Location: Maryland  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Erythema, Pain, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril, pravastatin, multivitamin, vitamin c, vitamin d, co q 10, fish oil, PREMARIN cream, ACTONEL
Current Illness: None
Preexisting Conditions: High blood pressure, hyperlipidemia, carotid stenosis, osteopenia
Allergies: Penicillin, mango, beer, pet dander
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Redness, swelling, itching: lasted about 3 1/2 days. Morning after the shot woke feeling chills, aches: lasted approximately one day.


VAERS ID: 736277 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2018-01-22
Onset:2018-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Contusion, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain, bruising, tingling down the arm.


VAERS ID: 736278 (history)  
Form: Version 2.0  
Age: 54.0  
Gender: Male  
Location: Ohio  
Vaccinated:2018-02-03
Onset:2018-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / SC

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Hypoaesthesia, Incorrect route of drug administration, Pain, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: do not know
Current Illness: No
Preexisting Conditions: No
Allergies: NKA
Diagnostic Lab Data: Patient went to emergency room under advise from doctor - still waiting on outcome
CDC Split Type:

Write-up: Gave vaccine subq instead of im in left arm 2/3/18. On 2/5/18 patient presented with welt, redness, swelling, pain and numbness.


VAERS ID: 736297 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2018-01-29
Onset:2018-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Pain, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had pain, redness, swelling and itching. pain was only on night 1 and is resolved. At day 7 she has only itching per pt.


VAERS ID: 736347 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Female  
Location: Colorado  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 179202 / UNK UN / UN
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Cellulitis, Erythema, Inflammation, Insomnia, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: went to see MD, who prescribed KEFLEX in case of cellulitis
CDC Split Type:

Write-up: Red, inflamed, sore to touch, cannot sleep on that arm.


VAERS ID: 736348 (history)  
Form: Version 2.0  
Age: 66.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL HFA; doxycycline; ESTRACE cream; PROZAC; losartan; PRILOSEC; progesterone; RESTASIS; AMBIEN; testosterone cream
Current Illness:
Preexisting Conditions: hypertension; depression; anxiety; insomnia; herpes labialis
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Area of injection site produced a large red swollen and warm to touch from deltoid down to middle of arm.


VAERS ID: 736351 (history)  
Form: Version 2.0  
Age: 56.0  
Gender: Female  
Location: Michigan  
Vaccinated:2018-02-02
Onset:2018-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORCO, CYMBALTA, NEURONTIN, VALIUM, OMEPRAZOLE, PAMELOR, LIPITOR, SYNTHROID
Current Illness:
Preexisting Conditions:
Allergies: NO KNOWN
Diagnostic Lab Data:
CDC Split Type:

Write-up: REDNESS AND SWELLING WITH DISCOMFORT DUE TO SWELLING RANGING FROM INJECTION SITE DOWN TO ELBOW.


VAERS ID: 736377 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-30
Onset:2018-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUSPAR; CYMBALTA; jakafi; EFFEXOR; SINGULAIR; Calcium and vitamin D gummies; baby aspirin; latartidine
Current Illness: Polycythemia vers; asthma
Preexisting Conditions:
Allergies: Dust; pollen; mold; polycillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had the SHINGRIX vaccine on Tuesday, Jan, 30, was told side effects were confined to the injection site: For two days I felt like I had the flu, with headache, achiness, fatigue, sleepiness.


VAERS ID: 736378 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-18
Onset:2018-01-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood test normal, Influenza like illness, Influenza virus test negative, Mobility decreased, Streptococcus test negative, Vaccination complication
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: All tests and lab work came out negative for flu. Nothing out of the ordinary found.
CDC Split Type:

Write-up: Had SHINGRIX 50MCG SUSR vaccination on afternoon of 1/18/18. So weak the next morning I could not get out of bed. Weak and flu like symptoms for several days. Had to cancel appointments and could not get up the strength to get dressed. Went to Urgent Care on 1/24/18 and tested for the flu and strep. Tests were negative but given Rx for TAMIFLU as a precaution. Returned to Urgent Care on 1/26/18 as illness had not abated. Blood work done that day showed nothing unusual. Made an appointment to see my Primary Care provider the following Thursday 2/1/18. Doctor seemed to think that my illness was a reaction to the vaccine and asked me to contact FDA. She is doing the same. I am still very weak but getting a little stronger each day.


VAERS ID: 736386 (history)  
Form: Version 2.0  
Age: 92.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2018-01-25
Onset:2018-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SHINGRIX given SQ instead of IM, led to pronounced adverse affects namely pain at injection site, erythema, heat, and swelling.


VAERS ID: 736466 (history)  
Form: Version 2.0  
Age: 57.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2018-02-04
Onset:2018-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celecoxib; Simvastatin; Hydrochlorothiazide; Lisinopril; Loratadine
Current Illness:
Preexisting Conditions: Rheumatoid Arthritis
Allergies: Seasonal, environmental allergies
Diagnostic Lab Data: NO Medical tests or lab results were done
CDC Split Type:

Write-up: Headache, Fever, Muscle Aches, pain where shot was given, tired, weak.


VAERS ID: 736492 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Michigan  
Vaccinated:2018-02-06
Onset:2018-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: No adverse event, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL; FOSAMAX
Current Illness:
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component on the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer after 4 weeks. The patient and her primary care doctor''s office was informed of the this incident and to come back sometimes after February 21st 2018 to redo the first dose. Patient had no adverse reaction to this error.


VAERS ID: 736498 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Male  
Location: Michigan  
Vaccinated:2018-01-09
Onset:2018-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. N016805 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; atorvastatin; PERCOCET; IMURAN
Current Illness:
Preexisting Conditions:
Allergies: No Known Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component in the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer in four weeks after the failed vaccine administration. Patient and prescriber office was contacted to have the vaccine done on February 6th.


VAERS ID: 736499 (history)  
Form: Version 2.0  
Age: 55.0  
Gender: Female  
Location: California  
Vaccinated:2018-02-02
Onset:2018-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Cold sweat, Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROAIR; Cefdinir; Losartan; KLOR-CON; Lactulose
Current Illness:
Preexisting Conditions: high blood pressure due to Cushing''s disease
Allergies: cephalosporins; penicillin; sulfonamides; fluoroquinolones; macrolide; fish
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.


VAERS ID: 736547 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Arizona  
Vaccinated:2018-01-29
Onset:2018-01-29
   Days after vaccination:0
Submitted: 2018-02-06
   Days after onset:8
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Feeling hot, Influenza, Injection site pain, Middle insomnia, Myalgia, Pain, Pain in extremity, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Triamcinolone; bupropion XL; nystatin; Vitamin B12; Vitamin D; Vitamin E; aspirin; calcium
Current Illness: Varicella; Rash, diagnosed a couple of months ago; Measles, twice as a child
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018016401

Write-up: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included chickenpox, measles (twice as a child) and rash (diagnosed a couple of months ago). Concomitant products included Vitamin B12, vitamin D, vitamin E, aspirin, calcium, bupropion XL and nystatin. On 29th January 2018, the patient received the 1st dose of SHINGRIX. On 29th January 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, tremor and nocturnal awakening. On 30th January 2018, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. In January 2018, the outcome of the tremor was recovered/resolved. On 29th January 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the feeling of warmth, muscle pain, flu symptoms and pain in arm were not recovered/not resolved and the outcome of the nocturnal awaking, general body pain and injection site pain were unknown. The reporter considered the shivering, feeling of warmth, muscle pain, flu symptoms, tremor and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Yesterday at 1:48 PM, the patient received the first dose of SHINGRIX and woke up in the middle of the night and was shivering and shaking uncontrollably. One day after vaccination, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. The patient said that everything felt warm and the shaking and shivering lasted a good 45 minutes before it resolved. On 30th January 2018 the day of reporting, she had a sore right arm and aching all over which she described as flu like aching. The patient''s muscles hurt and everything aches. She also experienced a sore right arm at the injection site. The reporter related the symptoms to the SHINGRIX vaccine. Reporter was surprised by her response because she only had two medications that did not agree with her which include Codeine and Lidocaine over the years.


VAERS ID: 736549 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-28
Onset:2018-01-29
   Days after vaccination:1
Submitted: 2018-02-06
   Days after onset:8
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; COQ10; Fiber; MUCINEX; Naproxen; Omega 3; PEPCID; PERCOCET; SYNTHROID; ZOLOFT
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018017931

Write-up: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX. Concomitant products included atenolol, MUCINEX, naproxen, Omega 3, PEPCID, PERCOCET, SYNTHROID, ZOLOFT and Coq10. On 28th January 2018, the patient received SHINGRIX. On 29th January 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and influenza-like symptoms. On an unknown date, the outcome of the swelling arm was not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the swelling arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a lot of swelling on her arm and the swelling had gotten bigger at approximately 4 inches in diameter.


VAERS ID: 736550 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-31
Onset:0000-00-00
Submitted: 2018-02-05
Entered: 2018-02-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site rash, Product administered at inappropriate site
SMQs:, Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018017977

Write-up: This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 31st January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 31st January 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A dose of SHINGRIX was inadvertently administered subcutaneously in the upper left arm of the patient, instead of the intended left deltoid, which led to inappropriate route of vaccination and vaccine administered at inappropriate site. In 2018, less than a week after receiving SHINGRIX, the patient developed a rash at the injection site. The expiration date was unknown. The patient did not require an emergency room visit or medical intervention. The healthcare professional did not believe the rash was life threatening, or disabling, and the patient did not require hospitalization.


VAERS ID: 736551 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 2018-02-06
   Days after onset:5
Entered: 2018-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 79N59 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018018518

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 1st February 2018, the patient received SHINGRIX .5 ml. On 1st February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria other). The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated they have administered SHINGRIX to their first patient the day before reporting and on the day of reporting the patient called to state she had quarter size red area at the injection site. The reporter advised the patient to monitor the area and call MD if worsened. The reporter called to ask if this was a usual reaction or was there anything else recommended to do.


VAERS ID: 736553 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-31
Onset:0000-00-00
Submitted: 2018-02-06
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Peripheral swelling, Rash erythematous
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK019481

Write-up: This case was reported by a consumer and described the occurrence of swelling arm in a male patient who received SHINGRIX. On 31st January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm, bruising of arm and erythematous rash. On an unknown date, the outcome of the swelling arm, bruising of arm and erythematous rash were unknown. It was unknown if the reporter considered the swelling arm, bruising of arm and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th February 2018, the reporter stated that, he received his SHINGRIX shot on Wednesday evening and he had some swelling and bruising on the arm that he had the shot and a red rash. The reporter wanted to know if that was normal. On 5th February 2018, an attempt was made to contact the patient, however he did not answer.


VAERS ID: 736593 (history)  
Form: Version 2.0  
Age: 59.0  
Gender: Male  
Location: California  
Vaccinated:2018-01-25
Onset:2018-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No Meds
Current Illness: Good Health
Preexisting Conditions: None
Allergies: No Allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore Muscle at injection site, Chills that Night.


VAERS ID: 736615 (history)  
Form: Version 2.0  
Age: 62.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Hypersensitivity, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Uterine dilation and curettage
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Active Outpatient Medications Status 1) ALBUTEROL 90MCG (CFC-F) 200D ORAL INHL INHALE 2 PUFFS ACTIVE (S) BY MOUTH EVERY 6 HOURS AS NEEDED FOR BREATHING AND/OR SHORTNESS OF BREATH 2) ALBUTEROL SO4 0.083% INHL 3ML UD USE ONE
Current Illness: denied
Preexisting Conditions: chronic pain
Allergies: LEVAQUIN; hydromorphone; soy products; oxycodone; glutens
Diagnostic Lab Data:
CDC Split Type:

Write-up: Allergic reaction to Zoster Vaccine. Pt states the night of the vaccine, he began to experience pain to BUE, stiffness, arms locking up, SOB, and dizziness and it lasted for the next 2 days. States he contacted Triage RN on phone the next day to report it and was told to go to nearest ED, pt states he declined to go to ED due to feeling slightly better and having his wife with him to watch him. Pt states he will not be able to receive the second dose but states he feels great now. Pt denies, SOB, N/V/D, chest pain, pain to BUE, stiffness, dizziness, muscle cramps at this time.


VAERS ID: 736622 (history)  
Form: Version 2.0  
Age: 72.0  
Gender: Male  
Location: Virginia  
Vaccinated:2018-02-05
Onset:2018-02-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Aches/pain within 6 to 8 hours; fever/chills next day.


VAERS ID: 736627 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: Utah  
Vaccinated:2018-02-02
Onset:2018-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / UNK LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injected limb mobility decreased, Pyrexia, Vaccination site pain, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Morphine, PERCOCET
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient''s upper arm got all swollen on the side where she got the vaccine. She said it "swelled up to the size of her thigh". It was sore to the touch and had limited range of motion. She was instructed to watch it, and if it looked like the swelling was getting worse, or if she had fevers, to go see a doctor. She started feeling worse, and had fevers up to 103 degrees. She went in to the Dr, and was not given an antibiotic, for they felt it was just a strong response to the vaccine. BENADRYL was prescribed, and helped to decrease the swelling and reaction. At the time she saw the MD, the injection site swelling was the size of a baseball, and they marked it with a pen. It didn''t get worse, and today when she came to tell me about this, the site looked much better, and was not raised, nor fevered.


VAERS ID: 736695 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-18
Onset:0000-00-00
Submitted: 2018-02-07
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Breast pain, Injection site erythema, Pain, Pain in extremity, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; atorvastatin; levothyroxine; lisinopril; aspirin
Current Illness: Unknown
Preexisting Conditions: Neoplasm, spine tumor years ago
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018016380

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX. The patient''s past medical history included neoplasm (spine tumor years ago). Concomitant products included atenolol, atorvastatin, levothyroxine, lisinopril and aspirin (Baby). On 18th January 2018, the patient received the 1st dose of SHINGRIX. In January 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and pain. On 20th January 2018, the patient experienced pain in arm and breast pain. The patient was treated with VICODIN. In January 2018, the outcome of the injection site erythema, pain in arm and breast pain were recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved. The reporter considered the injection site erythema, pain in arm, pain and breast pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had a red arm which she described as angry on her left upper arm near the injection site. Two days later, she was sore to the touch and had pain under her left breast which was a striking pain like lightening. She had the pain for 4 days and then it resolved. This morning she awoke with the same pain under her right breast and she took VICODIN to help resolve the pain. She had a spine tumor years ago and experienced the same pain and she believed that her nerves were affected. She contacted her neurologist after the pain started under her left breast and they wanted to do an MRI but the pain resolved. The patient believed that her nerves could be weakened or susceptible which was causing the pain but she related the pain to the SHINGRIX vaccine.


VAERS ID: 736696 (history)  
Form: Version 1.0  
Age: 75.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-31
Onset:2018-01-31
   Days after vaccination:0
Submitted: 2018-02-07
   Days after onset:7
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK RA / UN
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Cold sweat, Retching, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: ZOSTAVAX, Prophylaxis, Headache, experienced severe probable reaction as headache after receiving 10 years before the time of reporting
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018017965

Write-up: This case was reported by a physician via call center representative and described the occurrence of chills in a 75-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX with an associated reaction of headache (experienced severe probable reaction as headache after receiving 10 years before the time of reporting). Concomitant products included PNEUMOVAX. On 31st January 2018 15:00, the patient received SHINGRIX. On 31st January 2018 17:00, 2 hrs after receiving SHINGRIX, the patient experienced chills. On an unknown date, the patient experienced cold sweat and dry heaves. The patient was treated with ZOFRAN. On an unknown date, the outcome of the chills, cold sweat and dry heaves were recovering/resolving. The reporter considered the chills, cold sweat and dry heaves to be probably related to SHINGRIX. Additional details were provided as follows: The reporting healthcare professional was the patient. The patient received SHINGRIX on the left arm and PNEUMOVAX on the right arm concomitantly on the same day. The reporter did not have lot number or expiry date for the SHINGRIX or PNEUMOVAX. The patient experienced shaking chills, dry heaves and cold sweats on standing, hours after receiving a SHINGRIX administration. The patient received ZOFRAN after developing dry heaves in the middle of the night and the symptoms were alleviated the little.


VAERS ID: 736697 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Nevada  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 2018-02-07
   Days after onset:6
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site discomfort
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018019853

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 60-year-old female patient who received SHINGRIX. Concomitant products included ADACEL. On 1st February 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 1st February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In February 2018, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort and intramuscular formulation administered by other route were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist report that he gave the 1st dose of SHINGRIX in the left arm subcutaneously, which led to inappropriate route of vaccination. The patient called yesterday and notified that no issues except usual discomfort at site. The pharmacist reported technicians in the pharmacy remove the vials and place in amber vial in fridge, pharmacist checked the NDC number, but he did not see the box that mentions intramuscular. He stated he was under the pretense this was like ZOSTAVAX and was a live vaccine to be given subcutaneously. The pharmacist was made aware this is a recombinant vaccine and to be given intramuscularly. The pharmacist was not at the location of the vaccination and could not provide lot number and expiration date of SHINGRIX product during time of this call.


VAERS ID: 736700 (history)  
Form: Version 2.0  
Age: 54.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-02-05
Onset:2018-02-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Injection site pain, Insomnia, Mobility decreased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid; Vitamin D; Probiotic Florastor; Progesterone SR; triturate; Bioidentical Estrogen - Estradiol SR; Imipramine; Miralax L-Methylfolate 15mg + Cofactors (B12 and Magnesium & B6 & Folate); Testosterone 2mg Triturate; Zinc; Selenium;
Current Illness: none
Preexisting Conditions: hypothyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: First night, pain at sight. 2nd day, pain at sight, sore muscles, headache, upset stomach, tiredness, insomnia - took Tylenol and nap, didn''t eat much. 3rd day, pain at sight, extremely sore muscles, could barely move neck and shoulders, upset stomach, took Tylenol & Tramdol. 4th day, pain at sight, muscle pain in neck and shoulder was less extreme - took Tylenol.


VAERS ID: 736702 (history)  
Form: Version 2.0  
Age: 53.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2018-02-07
Onset:2018-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine, atorvastatin, losartan
Current Illness:
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore right arm at injection site. Relieved with ibuprofen.


VAERS ID: 736739 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Male  
Location: Florida  
Vaccinated:2018-02-06
Onset:2018-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu like times 10.


VAERS ID: 736743 (history)  
Form: Version 2.0  
Age: 52.0  
Gender: Female  
Location: Colorado  
Vaccinated:2018-02-05
Onset:2018-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: No
CDC Split Type:

Write-up: Fever after 24 hours; muscle aches; head ache; dizziness; general malaise/fatigue; red and swollen arm at injection site 48 hours after; lingering headache, dizziness and muscle aches after 72 hours.


VAERS ID: 736745 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: California  
Vaccinated:2018-02-01
Onset:2018-02-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N023650 / 1 RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK74P / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: None
Diagnostic Lab Data: Urgent care on 2/5. Prescribed antibiotics. Visit with primary care physician on 2/6.
CDC Split Type:

Write-up: Patient received Pneumovax 23 and Shingrix vaccines on 2/1/18. On 2/3 and 2/4, reported to pharmacist that patient experienced redness, swelling and severe pain in the injection area. On 2/5, patient went to Urgent Care and was given antibiotics as a precaution.


VAERS ID: 736812 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2018-02-02
Onset:2018-02-03
   Days after vaccination:1
Submitted: 2018-02-08
   Days after onset:5
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018019821

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that side effects as injections site reactions. The patient planned to follow-up with his physician on an unknown date. Only partial information was provided. The patient was at work and wanted to get back to work. The vaccine was prescribed by Family Medicine.


VAERS ID: 736833 (history)  
Form: Version 2.0  
Age: 58.0  
Gender: Male  
Location: Colorado  
Vaccinated:2018-02-06
Onset:2018-02-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Dizziness, Headache, Injection site pain, Insomnia, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pantoprazole, simvastatin
Current Illness: Minor Shingle outbreak 10 days prior
Preexisting Conditions:
Allergies: Codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shot was not painful; soreness started at local site after 3 hours, made sleeping difficult. Arm pain worse next day, followed by mild fever appx. 18 hours after injection. Fever continued up to 100 at 24 hrs after injection, as well as dizziness/severe headache. Headache could not be overcome by aspirin/ibuprofen. Fever relented at 48 hrs after injection; headache subsided by 60 hours after injection.


VAERS ID: 736835 (history)  
Form: Version 2.0  
Age: 80.0  
Gender: Female  
Location: Vermont  
Vaccinated:2018-02-08
Onset:2018-02-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Hypersensitivity, Hypoaesthesia oral, Injection site pain, Injection site paraesthesia, Injection site warmth
SMQs:, Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None Known
Current Illness: No illness reported
Preexisting Conditions: Hypertension
Allergies: Latex Allergy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: After 5 minutes of receiving the vaccination, the patient complained of a warm, tingly sensation at the site of injection (normal reaction) but then added that her lips felt numb, which was puzzling to me. After consulting drug reference materials and the package insert, there was no mention of "numbing" sensations. It was possible that she was experiencing an allergic reaction so I sat with her and kept her talking to keep her relaxed and calm. I then asked her specific questions regarding the areas of affect including "Does it feel as though your tongue is swelling" and "Have you noticed a change in your heart rate or breathing pattern?" She answered no to both of those questions. I had her remain seated for approx. 30min following the vaccination to watch for signs of worsening symptoms or anaphylaxis to which there were none. I had the patient stand up and she said she felt fine except for local pain at the injection site (normal) and the numb lips (abnormal). I let her go home and told her that if anything changed or worsened that she needed to call me or her PCP. Around 4:30pm or so, she had contacted her PCP''s office and talked with the Triage nurse who contacted me for more information. We then collaborated on possible reasons for her adverse reaction including her latex allergy (I wasn''t using latex gloves and all of the materials used in the vaccination were all latex-free) but ruled everything else out except for a generally mild (but alarming to the patient) allergic reaction. The Triage nurse then told the patient to report to the ER should she find her symptoms worsening or anything else that felt abnormal. The Triage nurse was then going to contact the patient in the morning to follow up. The following morning (2/9/18), the patient reported that she was fine and that everything was normal again.


VAERS ID: 736841 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-12
Onset:2018-01-12
   Days after vaccination:0
Submitted: 2018-02-08
   Days after onset:27
Entered: 2018-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal pain, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018019813

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 58-year-old female patient who received SHINGRIX. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th January 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, muscle pain and pain burning. SHINGRIX was continued with no charge. On an unknown date, the outcome of the shoulder pain, muscle pain and pain burning were recovering/resolving. The reporter considered the shoulder pain, muscle pain and pain burning to be related to SHINGRIX. Additional details were reported as follows: The patient stated that the muscle pain, shoulder pain and burning have lessoned but had not completely resolved. The healthcare professional was transferred to MI for additional assistance.


VAERS ID: 736881 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2018-02-05
Onset:2018-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK74P / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Blister, Increased tendency to bruise, Peripheral swelling, Pruritus
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: oxybutynin, pantoprazole, ventolin, montelukast
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patients arm is swollen, sensitive to touch, itching and contains small blisters. Patient stated she has not put anything on it or treated it yet.


VAERS ID: 736921 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: Washington  
Vaccinated:2018-01-03
Onset:2018-01-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR - / 1 RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Rash, Skin ulcer
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 100 mg (1 tab daily), Gabapentin 300 mg (4 capsules daily), Wellbutrin SR 150 mg (1 tab daily), Hydrochlorothiazide 25 mg (1 tab daily), Mirtazapine 15 mg (1 tab daily).
Current Illness: None.
Preexisting Conditions: None.
Allergies: None
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Developed Shingles rash on right upper back. Itching, sharp intermittent pain, redness, sores. Currently on 2/9/2018 Shingles are still present. Diagnosis confirmed by family physician on 1/29/2018.


VAERS ID: 736927 (history)  
Form: Version 2.0  
Age: 77.0  
Gender: Female  
Location: California  
Vaccinated:2018-02-02
Onset:2018-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: simvastatin, famotidine, DIOVAN, levothyroxine, potassium, LASIX, warfarin, LANOXIN
Current Illness: none
Preexisting Conditions:
Allergies: nka
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Localized red and itchy at injection site.


VAERS ID: 736929 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Female  
Location: Michigan  
Vaccinated:2017-02-08
Onset:2017-02-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Feeling hot, Headache, Injection site pain, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril, Metoprolol, Levothyroxine, ZYRTEC, Vitamin D
Current Illness: Multiple Sclerosis, fungal infection, high blood pressure
Preexisting Conditions: MS, HBP
Allergies: LEVAQUIN, Mycin antibiotics, morphine, peanuts/nuts
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Soreness of upper left arm, chills, upset stomach, feeling hot all over but no fever, headache, muscle aches, malaise.


VAERS ID: 736944 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Male  
Location: New York  
Vaccinated:2018-02-01
Onset:2018-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 539A2 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient called a few days after his vaccine to report 2 stripes on his forearm, not in injection site. The stripe was 1/4 inch wide, bright red and itched intermittently BENADRYL and cortisone helped the symptoms. He stated the only new drug he had was the vaccine.


VAERS ID: 736957 (history)  
Form: Version 2.0  
Age: 69.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2018-02-10
Onset:2018-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: penicillins and sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: REDNESS AROUND SITE OF INJECTION.


VAERS ID: 736960 (history)  
Form: Version 2.0  
Age: 58.0  
Gender: Female  
Location: Florida  
Vaccinated:2018-02-05
Onset:2018-02-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Headache, Injection site induration, Injection site rash, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient felt headache, Body ache and tiredness. After one day she had Rash and red hard bump at inject site.


VAERS ID: 736967 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2018-02-10
Onset:2018-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS EK279 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Heart Disease, thyroid problems
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: The day after the injection the patient reported that his left arm is numb and tingly and also his right thumb is numb. He says that it comes and goes.


VAERS ID: 736970 (history)  
Form: Version 2.0  
Age: 65.0  
Gender: Female  
Location: Washington  
Vaccinated:2018-02-07
Onset:2018-02-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient states she had extreme muscle pains from head to toe but injection site itself was ok. Pain lasted for few days.


VAERS ID: 737110 (history)  
Form: Version 2.0  
Age: 56.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2018-02-09
Onset:2018-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 LA / IM

Administered by: SCH?       Purchased by: ?
Symptoms: Arthralgia, Chills, Groin pain, Headache, Hypersomnia, Middle insomnia, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUAVEE, supplements: such as soy lecithin, MSN, flaxseed oil, and vitamin D
Current Illness:
Preexisting Conditions:
Allergies: NKDA (according to Vaccine Administration Record)
Diagnostic Lab Data:
CDC Split Type:

Write-up: According to the patient: "I just wanted to let you know that I had a reaction to the shingles vaccine. I woke up in the middle of the night shivering, and running a fever. I had a headache, a sore throat, and every joint in my body hurt. I could not even turn sideways because I could not stand the pain in my knee. I slept the whole day Saturday (2/10/18), as I had a fever the whole day. I woke up Sunday (2/11/18) much better, but my left knee is still hurting today, and the pain goes up my inner thigh to my groin."


VAERS ID: 737125 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2018-02-03
Onset:2018-02-04
   Days after vaccination:1
Submitted: 2018-02-08
   Days after onset:4
Entered: 2018-02-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Feeling hot, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK019462

Write-up: This case was reported by a consumer and described the occurrence of pain in a patient who received SHINGRIX. On 3rd February 2018, the patient received SHINGRIX. On 4th February 2018, 1 days after receiving SHINGRIX, the patient experienced erythema. In February 2018, the patient experienced pain, swelling and feeling of warmth. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the swelling, erythema and feeling of warmth were unknown. It was unknown if the reporter considered the pain, swelling, erythema and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Less than a week after receiving SHINGRIX, the patient experienced some pain, swelling and warm.


VAERS ID: 737130 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 2018-02-09
   Days after onset:7
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018018491

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On 1st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, fatigue and headache. In February 2018, the patient experienced myalgia. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia and fever were not recovered/not resolved and the outcome of the fatigue and headache were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Reporter was inquiring on behalf of his wife (patient). The patient received her first injection in a series of two for the SHINGRIX vaccine yesterday in her HCP''s office. On 2nd February 2018, the patient woke up in the morning with complaints of pain, redness and swelling at the injection site, fatigue, headache and low grade fever. Less than a week after vaccination, the patient experienced myalgia. The reporter was inquiring whether she can take TYLENOL for her symptoms or if we recommend anything else. Informed the caller we could not provide medical advice and advised the caller to contact the doctor''s office where the vaccine was administered.


VAERS ID: 737133 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-30
Onset:2018-01-31
   Days after vaccination:1
Submitted: 2018-02-09
   Days after onset:9
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Feeling hot, Injection site erythema, Neuralgia
SMQs:, Peripheral neuropathy (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018021681

Write-up: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old male patient who received SHINGRIX. On 30th January 2018, the patient received SHINGRIX. On 31st January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 5th February 2018, the patient experienced neuralgia and localized feeling of warmth. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the neuralgia and localized feeling of warmth were not recovered/not resolved. The reporter considered the injection site erythema and neuralgia to be possibly related to SHINGRIX. It was unknown if the reporter considered the localized feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to any one. The patient vaccinated with SHINGRIX in the left arm by staff pharmacist. In the next morning, the patient had redness at the injection site. On 5th January 2018, 6 days after receiving SHINGRIX, the patient awoke with some back nerve-like pain, described as a warm sensation on his back. At the time of reporting, the patient noted that the nerve pain in the back only occurs at night.


VAERS ID: 737134 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-02-04
Onset:0000-00-00
Submitted: 2018-02-09
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash, Injection site swelling, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018020847

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old male patient who received SHINGRIX. On 4th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and erythromacular rash. On an unknown date, the outcome of the injection site swelling, injection site rash and erythromacular rash were unknown. It was unknown if the reporter considered the injection site swelling, injection site rash and erythromacular rash to be related to SHINGRIX. Additional details were reported as follows: The patient had little raised red spots around the injection site. The reporter reported that it was not itchy. The pharmacist refused to go through the adverse events.


VAERS ID: 737135 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-02-04
Onset:0000-00-00
Submitted: 2018-02-09
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Injection site warmth
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018021730

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 71-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 4th February 2018, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved. The reporter considered the injection site warmth to be probably related to SHINGRIX. Additional details were provided as follows: The case was reported by a Registered pharmacist. The patient received SHINGRIX in left deltoid. The reporter saw patient today (at the time of reporting) and the patient reported having warmth in the arm where she received the injection. The reporter referred her to urgent care but the patient said she was just going to call her physician. She did not have access to urgent care.


VAERS ID: 737139 (history)  
Form: Version 1.0  
Age: 97.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2018-01-31
Onset:2018-01-31
   Days after vaccination:0
Submitted: 2018-02-09
   Days after onset:9
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Headache, Neck pain, Pain
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Alendronate; Carvedilol; ELIQUIS; Furosemide; Levothyroxine
Current Illness: Unknownel
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018021755

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 97-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included carvedilol, Alendronate, Furosemide, Levothyroxine and ELIQUIS. On 31st January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st January 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, neck pain and headache. On an unknown date, the outcome of the general body pain, neck pain and headache were not recovered/not resolved. The reporter considered the general body pain, neck pain and headache to be probably related to SHINGRIX. Additional information was reported as follows: The pharmacist reported that the patient planned to continue follow-up with his physician on an unknown date.


VAERS ID: 737206 (history)  
Form: Version 2.0  
Age: 79.0  
Gender: Female  
Location: Maryland  
Vaccinated:2018-02-09
Onset:2018-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl, proair, cosopt, simvastatin, latanoprost
Current Illness: None known
Preexisting Conditions:
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt has red area (circle in shape) not at the injection site but underneath the injection site. Pt says does not itch and not swollen or hard to touch. Pt says she has been on Benadryl so that may be why spot is not itching. Patient says only painful when lying on that arm.


VAERS ID: 737240 (history)  
Form: Version 2.0  
Age: 82.0  
Gender: Male  
Location: California  
Vaccinated:2018-02-08
Onset:2018-02-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Injection site reaction, Injection site warmth, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B-12, Aleve, Fish oil, Vitamin-D, probiotics, glucosamine with chondroiton, multivitamin for men, vitamin b-complex
Current Illness: no
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient came in to the pharmacy to describe some of the side effects he experienced after receiving the SHINGRIX shot. He stated that approximately 24 hours after the shot, he was extremely fatigued but has improved since. He had also developed a rash which he noticed after he removed his band-aid 24 hours after the shot was initially administered. The rash appeared as of his visit on 2/12/18 at approximately 3:00 pm to be light-medium pink in color and approximately 3 to 4 inches in diameter. He stated that it was slightly warm and slightly painful. He stated that he does not have a fever and is otherwise fine. Patient was recommended to continue observing the rash to see if it spreads or gets more warm or painful or intolerable, and if so he was instructed to inform his primary care physician.


VAERS ID: 737241 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Female  
Location: Illinois  
Vaccinated:2018-02-07
Onset:2018-02-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / 1 LA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Injection site reaction, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amino acid complex, turmeric, vitamin D, omega-3 krill oil, biotin, grape seed & resveratrol, One-a-day women''s vitamin, Neocell super collagen
Current Illness: none
Preexisting Conditions: none
Allergies: latex
Diagnostic Lab Data: None as of this time. Waiting for result of taking Benadryl and will notify doctor on Tuesday, 2/13/2018 per doctor''s order.
CDC Split Type:

Write-up: Fatigue and itchy, red rash directly below injection site, appeared 3 days after injection. Rash area is approximately 2.5 inches by 5 inches. Notified pharmacy and Dr. Advised to take Benadryl.


VAERS ID: 737244 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: California  
Vaccinated:2018-01-29
Onset:2018-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3DT97 / UNK RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 539A2 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site discomfort, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluarix IM administered at the same time, different arm
Current Illness: None
Preexisting Conditions: Migraines, Insomnia
Allergies: Fentanyl
Diagnostic Lab Data: none
CDC Split Type:

Write-up: When vaccine given pt experienced "pressure" as it was going in. Ached all night (pain scale of 6-7 per pt). Arm sore the next day. Gone by day 2 post shot.


VAERS ID: 737322 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-02-05
Onset:2018-02-05
   Days after vaccination:0
Submitted: 2018-02-12
   Days after onset:7
Entered: 2018-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptives
Current Illness: Arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018021713

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Oral Contraceptives. On 5th February 2018, the patient received SHINGRIX. On 5th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient had no medical history except for arthritis. The patient received oral contraceptives as concomitant medications. The patient experienced soreness in site of SHINGRIX administration shortly after receiving vaccine. No medical intervention had been taken except for ibuprofen at night. The pharmacist reported that this was definitely related to vaccine administration and that soreness was about the same since two days ago. No other reported medical history except for arthritis and only reported medication is oral contraceptives.


VAERS ID: 737435 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Michigan  
Vaccinated:2018-02-08
Onset:2018-02-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N022650 / UNK RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 22X79 / UNK RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK74P / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Rash, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: phenylephrine, acetaminophen, Lyrica, atorvastatin, esomeprazole, fluticasone, Cymbalta, cyclobenzaprine, simvastatin
Current Illness: common cold (viral)
Preexisting Conditions: history of cancer
Allergies: sulfa, penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient said that she started to develop redness in both arms on Friday, the 9th after the vaccines but the next day she had "hives" on the left arm, which she received the SHINGRIX vaccine. I questioned her about what the hives looked like and she said it was like little pimples so it sounds more like a rash and not hives. I advised that unless she was very concerned that she should take Benadryl and just keep an eye on it but to see a doctor if it got worse or if she was very worried about it. Today, after calling to check up on her she said it is improving but is still warm and red, which I again explained can be a normal side effect of the vaccines. She wants this reported but I am leary about saying that it is a true allergic reaction or whether it is a normal reaction. She didn''t want to go in to be seen by the doctor if she didn''t have to since influenza is so rampant right now and she didn''t want to be exposed.


VAERS ID: 737449 (history)  
Form: Version 2.0  
Age: 58.0  
Gender: Female  
Location: California  
Vaccinated:2018-02-07
Onset:2018-02-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: Neg.
Preexisting Conditions: Autoimmune thyroiditis
Allergies: Pollen, Avocado, Melon, Codeine, Minocycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: At about 72 hours post vaccine, rash has developed, rash still bothersome 2/13/2018 a week later, burning itching raised area about 3 x 3" upper left arm. Called Dr on advice of (physically revisiting) pharmacist, no other action taken. Wondering if second dose is advisable. Spoke with PC, advised I should come for office visit. No insurance.


VAERS ID: 737451 (history)  
Form: Version 2.0  
Age: 70.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-02-13
Onset:2018-02-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Injection site pain, Musculoskeletal stiffness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Myalgias, chills, headache, stiff neck, very sore arm at injection site.


VAERS ID: 737514 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-30
Onset:0000-00-00
Submitted: 2018-02-13
Entered: 2018-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Tension
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018019832

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date January 2019). On 30th January 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient received SHINGRIX and it bothered her. The reporter thought it was maybe soreness but was uncertain. The reporter stated that the patient''s tenseness might had contributed to adverse event. The case was linked with the case US2018019800, reported by the same reporter for spouse.


VAERS ID: 737536 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Foreign  
Vaccinated:2018-02-01
Onset:0000-00-00
Submitted: 2018-02-13
Entered: 2018-02-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Eye haemorrhage, Eye pain, Feeling hot, Headache, Injection site reaction, Lacrimation increased, Nausea, Peripheral swelling, Photosensitivity reaction, Rash macular
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Retinal disorders (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Migraine with aura
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2018GSK023423

Write-up: This case was reported by a nurse via call center representative and described the occurrence of broken blood vessel in eye in a elderly female patient who received SHINGRIX. Concurrent medical conditions included ophthalmic migraine. On 1st February 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant), nausea, swelling arm, red blotches, localized feeling of warmth, headache, eye pain, eyes tearing, photosensitivity and injection site reaction. The patient was treated with BENADRYL and Zinc Ointment. On an unknown date, the outcome of the broken blood vessel in eye, nausea, swelling arm, red blotches, localized feeling of warmth, headache, eye pain, eyes tearing and photosensitivity were not reported and the outcome of the injection site reaction was recovered/resolved. It was unknown if the reporter considered the broken blood vessel in eye, nausea, swelling arm, red blotches, localized feeling of warmth, headache, eye pain, eyes tearing, photosensitivity and injection site reaction to be related to SHINGRIX. Additional information was provided as follows: The case was reported by a retired nurse (the patient). The lot number and expiry date was not provided. The patient felt yuck, nauseous, swelling in the arm, red blotch developed and which got bigger everyday begin itchy and wrapped around the arm (4 inches by 2), hot to touch area, headache, both eyes got painful (more in the left eye), left eye was tearing, and was rubbing eye, light sensitive. On an unknown date (2 days ago), the patient experienced blood vessel burst in the eye and the eye was hurting. She had ocular migraines before but not like this. At the time of receipt of the case, the patient was on Benadryl and zinc ointment and the local injection site reaction has settled down.


VAERS ID: 737540 (history)  
Form: Version 2.0  
Age: 57.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2018-02-09
Onset:2018-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (TENIVAC) / SANOFI PASTEUR U5856AA / N/A LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS35Y / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Influenza like illness, Lethargy, Pain, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metamucil powder
Current Illness: none
Preexisting Conditions: elevated hemoglobin
Allergies: dust, pollen
Diagnostic Lab Data:
CDC Split Type:

Write-up: Starting the evening of getting vaccines had flu like symptoms. Body aches, excess lethargy and about 12 hours later a very itchy rash which started behind his knees and spread throughout his body. Caladryl lotion helped decrease the itching but did require BENADRYL in order to sleep.


VAERS ID: 737541 (history)  
Form: Version 2.0  
Age: 50.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-02-09
Onset:2018-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 - / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine, simvastatin, podiapn
Current Illness:
Preexisting Conditions: hypothyroidism, hypercholesterolemia
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt called pharmacy 3 days after receiving the vaccine complaining of swelling in the arm.


VAERS ID: 737579 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2018-01-26
Onset:2018-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. N013866 / 1 LA / SC
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: fibromylagia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called late 2/13/17 to notify the pharmacy that she has had a fever since the day after the vaccination 2/27/2018. She stated that she was tired and achy but that could be due to her underlying fibromyalgia. She stated that taking OTC TYLENOL does bring the fever down.


VAERS ID: 737601 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Female  
Location: Idaho  
Vaccinated:2018-02-13
Onset:2018-02-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Headache, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: NONE
Preexisting Conditions: UNKNOWN
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT CALLED ON 2/14/18 AROUND 10 AM TO REPORT THAT A FEW HOURS AFTER RECEIVING HER FIRST DOSE OF SHINGRIX VACCINE SHE HAD A FEVER, SHAKES AND HEADACHE. SHE TOOK TYLENOL TO RELIEVE SOME OF SYMPTOMS BUT FEVER STILL AROUND 100 DEGREES F, THIS MORNING.


VAERS ID: 737620 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: California  
Vaccinated:2018-01-27
Onset:2018-02-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S92740 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Patient saw the her doctor today (2/14/18) and he confirmed that she had shingles.
CDC Split Type:

Write-up: Patient said that she got shingles a few days after receiving the shingles vaccine.


VAERS ID: 737675 (history)  
Form: Version 1.0  
Age: 78.0  
Gender: Female  
Location: Indiana  
Vaccinated:2018-02-07
Onset:2018-02-08
   Days after vaccination:1
Submitted: 2018-02-14
   Days after onset:6
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Blood pressure increased, Chills, Dizziness, Headache, Injection site pain, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/2018, Blood pressure increased, 183/85
CDC Split Type: US2018023176

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, dizziness, headache, skin warm, chills and increased blood pressure. In February 2018, the outcome of the injection site pain, skin warm and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the dizziness, headache and chills were unknown. The reporter considered the injection site pain, dizziness, headache, skin warm, chills and increased blood pressure to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced a little soreness at the injection site, facial warmth and her blood pressure was elevated to 183 per 85 however it was back to normal at the time of reporting. The reporter advised the patient to consult with her doctor. The patient told to the reporter that, she wanted to be contacted by someone directly.


VAERS ID: 737678 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2018-02-10
Onset:2018-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Feeling abnormal, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Soreness/redness in arm and feeling "under the weather" for more than 4 days after vaccination. Recommended ADVIL and BENADRYL for symptoms.


VAERS ID: 737681 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-02-02
Onset:2018-02-02
   Days after vaccination:0
Submitted: 2018-02-14
   Days after onset:12
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018022519

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 51-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2010) and (batch number 5942P ?, expiry date unknown). Concurrent medical conditions included hypothyroidism. On 2nd February 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. On 2nd February 2018 06:00, 6 hrs after receiving SHINGRIX, the patient experienced chills and pain in extremity. On 2nd February 2018, the outcome of the chills and pain in extremity were recovered/resolved. The reporter considered the chills and pain in extremity to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient had shivering, chills, shooting pain in foot and leg all occurred at the same time and patient was in bed for 36 hours post vaccine administration. The vaccine was given at 12 pm and the side effects happened 6 hours after administration at 6 pm. The reported Adjuvant Lot number 942P did not match with any GlaxoSmithKline lot number. Clarification has been requested. The SHINGRIX lot number and expiration date was listed above in the form.


VAERS ID: 737682 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-02-08
Onset:2018-02-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P539L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Induration, Mobility decreased, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient came to pharmacy on the evening of 2-13-18 at approximately 7 pm. She stated that the evening that she received shot she experienced extreme pain in her arm and was hardly able to lift it. This progressed to large area of redness from the deltoid to about half way down to the elbow. Area was hard with constant itching. When she came to the pharmacy she stated that she had gone to see her doctor because she was concerned that it was still red so long after the shot. She said her doctor told her to come to our pharmacy and have us fill out this report. She also stated that the doctor had recommended she use cold compress and BENADRYL for itching.


VAERS ID: 737685 (history)  
Form: Version 2.0  
Age: 50.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2018-02-13
Onset:2018-02-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started with arm pain and swelling following the vaccine administration that evening. She treated with IBU to help resolve the pain and ice for the swelling. The next morning she woke up with hives down her whole arm. On 2/15 contacted me for advice and recommendations. She will continue IBU every 4-6 hours and ice, but will also take BENADRYL in the evening to help with the allergic reaction.


VAERS ID: 737706 (history)  
Form: Version 2.0  
Age: 63.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-01-22
Onset:2018-01-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 UN / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Flushing, Intranasal hypoaesthesia, Nasal congestion, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stated that after 1 hour later of getting the SHINGRIX vaccine, she developed facial flushing, nasal numbness and tingling, mucus and swollen of the nostrils, and the right cleared up a day later, but the left one still swollen. Patient did see her doctor for it but doctor doesn''t think it''s life-threatening.


VAERS ID: 737713 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Foreign  
Vaccinated:2018-02-01
Onset:2018-02-02
   Days after vaccination:1
Submitted: 2018-02-15
   Days after onset:13
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 77G7M / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood culture positive, Chills, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Insomnia, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/2018, Blood culture, confirms a cellulitis
CDC Split Type: CA2018GSK023426

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 70-year-old female patient who received SHINGRIX (batch number 77G7M, expiry date March 2020). On 1st February 2018, the patient received the 1st dose of SHINGRIX. On 2nd February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria hospitalization), injection site erythema, injection site induration, injection site pain, chills and difficulty sleeping. The patient was treated with cephalexin and Antibiotics (Brands Names Not Known). On an unknown date, the outcome of the injection site cellulitis, injection site erythema, injection site induration, injection site pain, chills and difficulty sleeping were not reported. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site induration, injection site pain, chills and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. On 2nd February 2018, the patient started to have pain in the right arm (the one injected) in the morning, redness at the level of the injection site with induration at the middle. In the evening, the patient had chills and increased pain. The patient could not sleep because of the pain. On 3rd February 2018, the redness had a diameter of 3 inches (one fourth). The patient took a picture and send it to her son who was a doctor. The son told her to go to the hospital emergency department because it looked like cellulitis. At the emergency of the hospital a blood culture was made which confirms a cellulitis. The patient hospitalized and undergoing intravenous antibiotic treatment. On 4th February 2018, the patient was discharged from the hospital with a prescription for oral Cephalexin 500 mg 3 times per day for 5 days. The pharmacist would like to know whether this patient should receive her 2nd dose of SHINGRIX.


VAERS ID: 737754 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2018-02-05
Onset:2018-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pantoprazole; donepezil; nadolol; ramipril; amlodipine besylate; metoprolol succinate ER; TRADJENTA; cholecalciferol; multivitamin with minerals; calcioum carbonate
Current Illness:
Preexisting Conditions: Anxiety disorder, unspecified; Essential (primary) hypertension; Pure hypercholesterolemia, unspecified; Thrombocytopenia; Lichen sclerosus et atrophicus; Age-related osteoporosis without current pathological fracture; Atypical ductal hyperplasia of breast; Actinic keratosis; Rosacea, unspecified; Xerosis cutis; Other specified disorders of pigmentation; Unspecified cirrhosis of liver; History of nasal cavity, middle ear, or sinus malignancy; Basal cell carcinoma, face; Insulin long-term use; Mild dementia; Splenic sequestration; Proliferative diabetic retinopathy of both eyes associated with type 2 diabetes mellitus, unspecified proliferative retinopathy type; Bilateral presbyopia; Myopia of left eye
Allergies: Allergies: latex, ciprofloxacin, meperidine, naproxen, acetaminophen, aspirin, propoxyphene, perphenazine, procaine, penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s HHA noted a red, hot, puffy spot just below her deltoid on the left arm.


VAERS ID: 737763 (history)  
Form: Version 2.0  
Age: 77.0  
Gender: Female  
Location: Oregon  
Vaccinated:2018-02-08
Onset:2018-02-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / UNK RA / SYR

Administered by: PHM?       Purchased by: ?
Symptoms: Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine, hydrochlorothiazide, estradiol, benazepril, simvastatin, aspirin, Vitamin D3, Omega 3 krill oil
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I woke up lightheaded the following morning which prompted me to take my BP. It was extremely low for me at 109/66. Three hours later it was 101/62 with temp of 99.2. By 2:30 on same day it was up to 127/72 which is still lower than my normal.


VAERS ID: 737765 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Female  
Location: Washington  
Vaccinated:2018-02-10
Onset:2018-02-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS P935L / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site pain, Pruritus, Rash erythematous, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: hypertension, insomnia
Allergies: no known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Had injection site pain from time of injection. 2 days later notice red rash. At day 5, rash is from elbow to shoulder. Slightly swollen, itchy, and warm to touch.


VAERS ID: 737792 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2018-01-14
Onset:2018-01-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Herpes zoster, Infection, Varicella virus test positive
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-13
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Furosemide, Benazepril, Meloxicam, Shingrix, Oxybutynin, Trazodone, Xeljanz, Janumet, Esomeprazole, Gabapentin, Dutasteride, Tamsulosin, Pravastatin, Ibuprofen
Current Illness:
Preexisting Conditions: Rheumatoid Arthritis, Hypertension, Diabetes
Allergies:
Diagnostic Lab Data: Tested positive for shingles
CDC Split Type:

Write-up: Infection. Tested positive for shingles.


VAERS ID: 737803 (history)  
Form: Version 2.0  
Age: 67.0  
Gender: Female  
Location: Iowa  
Vaccinated:2018-02-12
Onset:2018-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 539A2 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Skin exfoliation, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen, tramadol, clonazepam, duloxetine, trazodone, metformin
Current Illness: none
Preexisting Conditions: fibromyalgia, DM
Allergies: DEMEROL; KEFLEX; codeine
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt stated she had red face, swollen face and an exfoliating feeling on her face. Resolved itself after 24 hours.


VAERS ID: 737806 (history)  
Form: Version 2.0  
Age: 51.0  
Gender: Male  
Location: Washington  
Vaccinated:2018-02-14
Onset:2018-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS LN9TL / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: naproxen 220 mg
Current Illness: none
Preexisting Conditions: arthritis (knees)
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 16 hours after vaccine was administered, woke up with muscle aches and pains. Was able to get back to sleep after taking 2 Naproxen Sodium 220mg along with half a dose of Diphenhydramine Hcl. Aches continued the next day, along with soreness of left arm.


VAERS ID: 737809 (history)  
Form: Version 2.0  
Age: 66.0  
Gender: Male  
Location: California  
Vaccinated:2018-02-13
Onset:2018-02-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S58704 / 1 LA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS NX952 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure; acid reducer
Current Illness: none known
Preexisting Conditions: blood pressure
Allergies: none indicated
Diagnostic Lab Data: None so far. Keeping eye on it if redness and swelling still persists will consult dr.
CDC Split Type:

Write-up: Patient came in on 2/15/18 and said he received SHINGRIX and PREVNAR on 02/13/2018 and that same day his arm showed big red circle swollen with pain and fever. But on 02/15/18 his arm still red and slightly swollen but no fever. Will keep eye on it if redness and swelling still there he will consult dr.


VAERS ID: 737811 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-02-14
Onset:2018-02-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK74P / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Haematochezia, Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt LP received SHINGRIX vaccine 2/14/18. Pt is extremely hard of hearing. His wife came in to the store on 2/15/18 and reported pt had blood coming from his rectum yesterday 8 hours after receiving SHINGRIX. He has had about 5 spouts of rectal bleeding, bright red - some with stools. Wife did not know if he has a history of hemorrhoids. He takes 81mg of ASA. I contacted his primary care doctor whom did not know if he had hemorrhoids. His nurse, did say he has refused colonoscopies d/t having a son that died from colon cancer. I called the manufacture they did not have any reports of blood spewing from the rectum, blood in stools, etc. Only GI - nausea, vomiting, diarrhea, and abdominal pain. Cannot determine if vaccine caused ADR or not. Pt has follow up with PCP on Monday.


VAERS ID: 737815 (history)  
Form: Version 2.0  
Age: 61.0  
Gender: Female  
Location: Colorado  
Vaccinated:2018-02-09
Onset:2018-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Lymphadenopathy, Migraine, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1/2 of a .125 mg pill of SYNTHROID per day, maintenance dose since 2000.
Current Illness: None.
Preexisting Conditions: None, other than allergies and thyroid.
Allergies: ALLERGIC TO: Anaphylactic: Bees, Yellow Jackets, Cats, Mosquito, Hornets, Citrus, Wine, Molds; Vomiting for days/migraine/pass out: Codeine, Penicillin, PERCOCET, VICODIN, Fentanyl, VERSED, Tetracycline; Sneezing/coughing/nose/throat: Trees, Grass, Dogs, Pollens, Mites, Pepper, Newsprint/some toners; Rash, swollen, itch: Cow, Horse, Latex, Adhesive/Band Aids, POLYSPORIN, NEOSPORIN, Shrimp (+ welts), Spiders (+ welts + hospital), Ace bandages on skin (10d post-surgery, huge swollen, itchy welt/rash); Tested allergic to or had a previous reaction to: Phenol, Formaldehyde, Iodine, DOLOBID, Ant, Roach, Novocaine, Cricket, Tomato, SYMMETREL, TUSSI-ORGANIN, Glycerin, Ethanol; Tested allergic to but have no reaction to: Chicken, Wheat, Sugar, Pork, Yeast, Peanuts, Beef, Rice, Coffee, Milk, Malt, Egg, Soy
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: On Saturday, 2/10/18, huge swelling in armpit, lymph nodes, but I felt fine. I took pictures if you want them & my doctor has a set of them, too. On Sunday, 2/11/18, an intense migraine started and lasted for a few days, accompanied by vomiting, sweating, and freezing. I saw the doctor on 2/13/18, she told me what to watch for regarding the lymph nodes and to come back if any of them occurred. She said I should get the second dose, but move it further out in the 2 - 6 mo window. She gave me a script to help with migraine, if I get one on the second dose. I was able to keep down water & broth on 2/13/18 and solid food by 2/14/18. Today, I''m just exhausted.


VAERS ID: 737885 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2018-01-11
Onset:2018-01-11
   Days after vaccination:0
Submitted: 2018-02-15
   Days after onset:35
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Immediate post-injection reaction, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018023177

Write-up: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received SHINGRIX. On 11th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th January 2018, immediately after receiving SHINGRIX, the experienced decreased appetite and injection site pain. On 12th January 2018, the patient experienced fatigue, upset stomach, fever and headache. On an unknown date, the outcome of the fatigue, upset stomach, decreased appetite, injection site pain, fever, and headache were recovered/resolved. The reporter considered the fatigue, upset stomach, decreased appetite, injection site pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event on SHINGRIX injection. The patient requested to remain anonymous and offered limited information pertaining to the adverse event. The patient stated she received a SHINRIX injection on 11th January 2018 at a local pharmacy. She stated immediately after the injection, she had localized pain at the injection site and decrease hunger. She stated the next day after the injection she had severe fatigue, headache, fever and upset stomach. The patient stated since the reaction happened in January, she was not sure how long it lasted. She did not have the lot number or expiration. The patient requested information about what adverse reactions to expect from the second shot in the series. The agent referred the caller to the SHINGRIX website and PI. The agent instructed the caller to contact her health care professional with medical issues. The patient denied receiving additional vaccines at the time of the SHINGRIX vaccine or within 4 weeks. The patient has denied permission to contact their physician.


VAERS ID: 737907 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-01-31
Onset:2018-01-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Retching, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin; Pantoprazole; Vit d
Current Illness:
Preexisting Conditions: Prostate cancer; hyperlipidemia; no smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received the new SHINGRIX vaccination and had very bad side effect for 15 hours including shivering, sweats, nausea, wretching vomiting, and light headedness.


VAERS ID: 737911 (history)  
Form: Version 2.0  
Age: 54.0  
Gender: Male  
Location: Unknown  
Vaccinated:2018-02-11
Onset:2018-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion; Simvastatin; XARELTO; Sotalol; AXIRON; Multivitamin; Vitamin D; Glucosamine chondroitin
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data: Taking TYLENOL. Had similar reaction to tetanus vaccine about seven years ago.
CDC Split Type:

Write-up: Got shingles vaccine Sunday about 5PM. Experiencing muscle and joint pain all over!


VAERS ID: 737922 (history)  
Form: Version 1.0  
Age: 78.0  
Gender: Female  
Location: Unknown  
Vaccinated:2018-01-22
Onset:0000-00-00
Submitted: 2018-02-15
Entered: 2018-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018024351

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) and (batch number FJ573 ?, expiry date 30th January 2020). On 22nd January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with steroids and muscle relaxants. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: On 22nd January 2018 at 11:25 hours, the patient received SHINGRIX in left deltoid. The patient came into the pharmacy on the day of reporting and stated that her left arm was severely sore. The patient went to her physician and received steroids and a muscle relaxant but neither medication provided any relief. The reported lot number (batch number FJ573 ?) does not match any GSK lot number and clarification has been raised for the same.


VAERS ID: 737944 (history)  
Form: Version 2.0  
Age: 54.0  
Gender: Male  
Location: Indiana  
Vaccinated:2018-02-12
Onset:2018-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 9XC39 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm was red, itched, burned, raised welts within hours of injection. 4 days later, the symptoms have lessened but are still present.


VAERS ID: 737945 (history)  
Form: Version 2.0  
Age: 64.0  
Gender: Female  
Location: Illinois  
Vaccinated:2018-01-26
Onset:2018-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 539A2 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELEBREX 200MG, MULTI VITAMIN AND FLONASE
Current Illness:
Preexisting Conditions: ARTHRITIS
Allergies: AUGMENTIN, AVACADO, STRAWBERRIES
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt has had sore arm since the day she got the vaccination. She stated it has been burning recently.


VAERS ID: 737946 (history)  
Form: Version 2.0  
Age: 71.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-02-15
Onset:2018-02-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS EK279 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Incorrect product formulation administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: furosemide, fluorocort, metoprolol er, pantoprazole, citalopram, diclofenac gel, tramadol
Current Illness:
Preexisting Conditions: see medication list, HF, depression,pain, low BP, stomach acid
Allergies: Penicillin fluoroquinolone
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injected liquid diluent only in L arm.


VAERS ID: 737967 (history)  
Form: Version 2.0  
Age: 60.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2018-02-13
Onset:2018-02-01
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 3Z4KL / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor, aspirin, lisin/hctz, metoprolol tartrate.
Current Illness:
Preexisting Conditions: obesity, bph, htn, a-fib, thoracic aorta anuryseum, aortic valve replacement, pacemaker, kidney cyst.
Allergies: sulfa
Diagnostic Lab Data: none.
CDC Split Type:

Write-up: Swollen , red , hot arm body ache.


VAERS ID: 737974 (history)  
Form: Version 2.0  
Age: 73.0  
Gender: Female  
Location: Texas  
Vaccinated:2018-02-14
Onset:2018-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS DK74P / 1 - / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Erythema, Nodule, Pain, Rash, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline 100mg
Current Illness: Sinusitis
Preexisting Conditions: None noted
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extremely sore about six inches from injection site with red, warm rash. One place has a "knot" under the rash.


VAERS ID: 737991 (history)  
Form: Version 2.0  
Age: 68.0  
Gender: Female  
Location: Oregon  
Vaccinated:2018-02-10
Onset:2018-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS YS53Y / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Asthenia, Chills, Dyspnoea, Injection site pain, Injection site swelling, Migraine, Myalgia, Nausea, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports that roughly 2 hours after receiving the vaccine, she developed a sore, swollen arm (near the injection site). Over the next few hours, she became weak, experienced extreme shivering (no fever), muscle aches, and a tingling sensation that spread from her arm, across her chest, down her legs. The patient also reported a severe migraine headache, nausea, and some difficulty breathing. She reported using her asthma inhaler (albuterol), but this proved ineffective. She stated that the breathing difficult was "too bad", but that she still felt short of breath. Today (6 days after the injection), the patient is feeling somewhat better...though the tingling sensation remains.


VAERS ID: 738000 (history)  
Form: Version 2.0  
Age: 55.0  
Gender: Male  
Location: Washington  
Vaccinated:2018-02-09
Onset:2018-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N022650 / 1 RA / IM
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 324KL / 1 RA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: Diabetes; High blood pressure
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Redness and slight swelling at injection site, slight pain on movement of arm.


VAERS ID: 738003 (history)  
Form: Version 2.0  
Age: 69.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2018-02-16
Onset:2018-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin, Lisinopril, levothyroxine
Current Illness: None
Preexisting Conditions: Hypothyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very sore left arm and fever approximately 6 hours after vaccination. Treated with Naprosyn. Symptoms not present next morning.


VAERS ID: 738004 (history)  
Form: Version 2.0  
Age: 57.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2018-02-16
Onset:2018-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 180475514191060 / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain, Nausea, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen, Omega 3, Vitamins C, D, E, Magnesium, Co Q10.
Current Illness: None
Preexisting Conditions: Back pain due to Scoliosis (Harrington Rod).
Allergies: None known.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain in arm at injection site. Hot and red at injection site. Arm hurts when moving. Aching shoulders, aching knees, overall aching. Stomach upset, felt like throwing up. Low grade fever, 99.3F. Took Zantac for upset stomach which improved. Afraid to try ibuprofen or acetaminophen due to stomach upset.


VAERS ID: 738005 (history)  
Form: Version 2.0  
Age: 83.0  
Gender: Male  
Location: Virginia  
Vaccinated:2018-02-16
Onset:2018-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: PHM?       Purchased by: ?
Symptoms: Chills, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO, Atorvastatin, Metoprolol, Levothyroxine, AZOR, Aspirin, PRESERVISION, Vitamin D, and a Multivtamin.
Current Illness: None
Preexisting Conditions: High Blood Pressure
Allergies: Latex
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Chills, fever, and lethargic.


VAERS ID: 738006 (history)  
Form: Version 2.0  
Age: 75.0  
Gender: Male  
Location: Florida  
Vaccinated:2018-02-12
Onset:2018-02-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Fatigue, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: NO
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fatigue - heart racing - MOST IMPORTANT - Dizziness.


VAERS ID: 738008 (history)  
Form: Version 2.0  
Age: 50.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2018-02-09
Onset:2018-02-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 374KL / 1 LA / IM

Administered by: PHM?       Purchased&nb