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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 332 out of 7,116

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VAERS ID: 1706439 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium


VAERS ID: 1706700 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper, Bowel movement irregularity, Dyspepsia, Heart rate decreased, Muscle spasms, Scar inflammation, Scar pain, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: VITAMINS NOS
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: I feel like it''s inflamed; yesterday I was very uncomfortable because I had a full meal after a long time; when I eat something, it burns; when I eat something, it hurts; c-section scar was burning and hurting; I felt some cramps; I did not pass stool for a week; my heart rate dropped for a whole week after getting the shot; I''ve lost 12 lbs since taking shot since I can''t eat much; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), WEIGHT DECREASED (I''ve lost 12 lbs since taking shot since I can''t eat much) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot). On 03-Aug-2021, the patient experienced DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts) and SCAR PAIN (c-section scar was burning and hurting). On 15-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time). On an unknown date, the patient experienced SCAR INFLAMMATION (I feel like it''s inflamed). The patient was treated with MACROGOL 3350 (MIRALAX) for Bowel movement irregularity, at a dose of 1 dosage form and PROBIOTICS NOS at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (I felt some cramps), BOWEL MOVEMENT IRREGULARITY (I did not pass stool for a week), DYSPEPSIA (when I eat something, it burns), ABDOMINAL PAIN UPPER (when I eat something, it hurts), SCAR PAIN (c-section scar was burning and hurting), SCAR INFLAMMATION (I feel like it''s inflamed), WEIGHT DECREASED (I''ve lost 12 lbs since taking shot since I can''t eat much), ABDOMINAL DISCOMFORT (yesterday I was very uncomfortable because I had a full meal after a long time) and HEART RATE DECREASED (my heart rate dropped for a whole week after getting the shot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medicine included colon cleanser for natural bowel movements. This case was linked to US-MODERNATX, INC.-MOD-2021-287626 (E2B Linked Report).; Sender''s Comments: US-MODERNATX, INC.-MOD-2021-287626:same reporter


VAERS ID: 1707688 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Feeling hot, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100980921

Write-up: Redness in my chest, in my arm, between the shoulder and on my ear; I feel like warm/ it is like getting hot/ My body getting hot; I also feel itching; This is a spontaneous report from a contactable reporter (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 26Jul2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient reported that, on 30Jul2021 had redness in my chest, in my arm, between the shoulder and on my ear, I feel like warm/ it is like getting hot/ my body getting hot and I also feel itching. Reporter stated, "I did get the vaccine on Monday this week, I was fine until today that is Friday, so I have like redness in my chest, in my arm, between the shoulder and on my ear, it is like getting hot and my body getting hot, so I feel like warm, and I also feel itching." It was the Pfizer, the first shot yeah. Reporter stated, "No, ''just want to know what''s going on'' (incomplete sentence), yeah yeah." Reporter stated, "What I am going to do ''this is what I want to understand, what medicine should I take or what I am going to do?" Reporter seriousness for the events were unspecified. Outcome of all the events were unknown. Comment: Reporter type could not be probed hence captured as reporter or other non-health profession in tab. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707693 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Condition aggravated, Pruritus, Rash, Stress
SMQs:, Anaphylactic reaction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100985342

Write-up: rash all over the back and stomach; rash all over the back and stomach was reported as worsened; itching around the arm and down; pain in the chest and a heavy feeling; pain in the chest and a heavy feeling; I am also under stress.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 14:00 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none reported. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, Lot Number: EW0185; Expiration Date: Unknown), administered in Left Arm on 02Jul2021 (at the age of 41-year-old) for COVID-19 immunization. Facility where COVID-19 vaccine was administered at Pharmacy. Patient Vaccination was not administered at Military Facility. Patient any additional vaccines administered on same date of the Pfizer Suspect was none reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was none reported. Patient experienced adverse events prior vaccinations was none reported. Patient family medical history relevant to adverse events was none reported. Patient experienced rash all over the back and stomach was reported as worsened on an unspecified date in 2021. Patient stated received the second dose on 23Jul2021. A week later she started experiencing rash all over the back and stomach (30Jul2021) and noticed some itching around the arm and down (2021). Patient noticed once in a while a pain in the chest and a heavy feeling (2021). I could take breaths. I could also take deep breaths. I was also under stress (2021). Patient stated she was uncertain if she was having a side effect. She had the second vaccine a week ago this past Friday; for the last three days or so she has had a weird rash all over her stomach and back. Patient stated the rash began 30Jul2021, Friday. Stated it was getting worse. It was on her stomach and back, mentions that it was not on her bottom. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to report. Patient stated she was planning on calling her doctor once she spoke with someone at Pfizer. Verified she was calling to see if this was a side effect from the Covid Vaccine. Patient was not visited emergency room and physician office. There was no investigation assessment. Patient relevant tests were none reported. The clinical outcome of event was rash all over the back and stomach was not recovered and for another events outcome was unknown. Follow-up activities closed. Batch/lot number available for [vaccine/BNT162B2].


VAERS ID: 1707702 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acne, Fatigue, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (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: USPFIZER INC202100986180

Write-up: chest acne at about 48 hours; numbness or a desensitization on the left side of the body/she felt like it was numb on top of her back and neck area and left leg, arm, and upper back on same side; feeling tired although not as fatigued as she had been; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 30Jul2021 17:00 as dose 2, single (age at vaccination: 42 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number EN0196) via an unspecified route of administration in arm right on 09Jul2021 as dose 1, single (age at vaccination: 42 years) for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. The adverse events following prior vaccinations was none. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. On 30Jul2021, she experienced numbness or a desensitization on the left side of the body within 30 minutes of vaccine administration and it went away quickly within 15 minutes or so. On 01Aug2021, she had chest acne at about 48 hours and wanted to know if this was normal and had been previously reported. On an unspecified date 2021, she was also complaining of feeling tired although not as fatigued as she had been. And asked how long the vaccine is supposed to last (as in months), and if a booster will or is needed and if the current doses of the Pfizer covid 19 vaccine she received will protect her. It was stated that she had a bunch of chest acne and it did not itch or bother her, and she sent pictures to her dermatologist. Does not know who else to call. Was given this number from a friend and from the pamphlet. Wanted to know if this is a normal thing. When she got the second dose, she felt like it was numb on top of her back and neck area and left leg, arm, and upper back on same side she got the second shot. She had someone to ask the pharmacy to see if it was okay and they said this could happen. Said it was not the medicine itself, but from the nerves itself. Stated it was hard to read the writing on card given and she sent her sister a text picture of the acne. States her defensive patient, or kind of numbness left within 30 minutes of getting the shot. The adverse event did not result in emergency Room/Physician Office visit. Unable to provide expiry, or dose for the second dose and provides a lot number of what she thinks like start with either FA or FP7485 in left arm/shoulder area. Response received was Pfizer and BioNTech Provide Update on Booster Program in Light of the Variant: Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the variant. While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the variant. The Companies anticipate the clinical studies to begin in Aug, subject to regulatory approvals vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. She said that it had been about 72 hours since her second dose. She asked if she was in the clear with any dangerous side effects. Response received was in Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. States her daughter is due for the meningitis and HPV vaccines and they were delayed because she wanted to get the Covid vaccine first. She is fully vaccinated and now she wanted to know how long after getting the Covid vaccines can she get the meningitis and HPV vaccines or is it safe to get. Also asks how long is the Covid vaccine supposed to last 3-6 months or will a booster. The clinical outcome of the event feeling tired although not as fatigued as she had been was unknown and rest of the events was not resolved. Information on the lot/batch number has been requested.


VAERS ID: 1707707 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Alabama  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Eye pain, Fatigue, Headache, Malaise, Myalgia, Nausea, Pyrexia, Sinus pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100986773

Write-up: Tiredness; Headache; Muscle pain; Joint pain; Fever; Nausea; Feeling unwell; Chills; Diarrhea; Sinus pain; Pain by my eye; This is a spontaneous report from a contactable consumer (patient). A 34-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 28Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Jul2021, the patient experienced tiredness, headache, muscle pain, joint pain, fever, nausea, feeling unwell, chills, diarrhea, sinus pain, pain by eye. Consumer stated, on Wednesday had first shot. Consumer stated, it was still the same. It has not worsened or improved. Yes, it was still here it has not worsened or improved. Consumer stated I don''t know that I have no idea about lot number and did not make an appointment it was just a walk in. The patient has been taking Sudafed (sinus medicine) because of sinus pain, pain by eye, headache, fever. The outcome of events was reported as not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707711 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Hypersensitivity, Mobility decreased, Nasopharyngitis, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: USPFIZER INC202100987648

Write-up: I felt bad; Chills; Headache; Arms were like really hurting a lot and I can barely move it; Arms were like really hurting a lot and I can barely move it; Had little bit of nausea; Two three different areas were just like red, its looks like I would have an allergy or something; Two three different areas were just like red, its looks like I would have an allergy or something; My body feels weird like I have catch a cold or something; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 29Jul2021 08:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, the patient went on Thursday like 08:15 for vaccination and then the next day on 30Jul2021 at 20:15 the patient got the reaction, "I felt bad", chills, the patient went to the bed and had headache. On the same day, the patient had little bit of nausea too and patient reported "arms were like really hurting a lot and I can barely move it". Then the following day, on Sunday is when the patient was able to get up and felt little bit better but when the patient came to work (today in the morning, because the patient did vaccination in left hand and not in right hand), the patient did not realize and when someone sat next and they said, what''s wrong. In the arm where they gave the shot not around it, like "two three different areas were just like red, its looks like I would have an allergy or something" on an unspecified date in 2021. The patient got to work yesterday feeling bad and just have to go home, "I really felt bad". "My body feels weird like I have catch a cold or something" on an unspecified date in 2021. The patient started to have a headache, the patient needed to go home and the patient went home and then started feeling really bad like in the afternoon may be like 2 o'' clock or something like that. The patient did not know if it is normal. The patient was concerned and wanted to make sure that it was okay, that what the patient was seeing on arm. The patient took Tylenol (extra strength, maybe 500 or something) as treatment for the events. The patient reported that product details said that the patient had to go back on 19Aug2021. The little sticker was put at the site of vaccination. The call was hung up abruptly by the patient hence, limited information was available over the call. The outcome of the events was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.


VAERS ID: 1707741 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (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: SUBOXONE; PANTOPRAZOLE; HYDROXYZINE; MESALAMINE; ZOFRAN [ONDANSETRON]; BACLOFEN; ALEVE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; GERD; Penicillin allergy; Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Covid-19; Result Unstructured Data: Test Result:Negative
CDC Split Type: USPFIZER INC202101000328

Write-up: severe headache; I have pretty significant and persistent pain in the back of my neck; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 42 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 20:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included crohn''s disease from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; mesalamine (MESALAMINE) taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN [ONDANSETRON]) taken for an unspecified indication, start and stop date were not reported; baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced hypersensitivity, flexeril [cefixime] and experienced hypersensitivity. The patient experienced severe headache on 30Jul2021 22:00 with outcome of not recovered. Also, significant and persistent pain in the back of her neck on 30Jul2021 22:00 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1518201 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Tinnitus
SMQs:, Hearing impairment (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: Klonopin, hormonal birth control, OTC pain killers
Current Illness: Mental health - panic attacks, GAD, OCD, clinnical depression
Preexisting Conditions: Mental health mentioned above
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: ?Covid arm? developing second day after shot. Louder tinnitus, worsen anxiety.


VAERS ID: 1518377 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7221 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Injection site pain, Oedema peripheral, Pain
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was just feeling muscle pain in the application region the day I was vaccinated. From the next day, I began to feel discomfort in the armpit region, and noticed that there is a swelling in this region, which causes pain and discomfort, especially when closing the arm.


VAERS ID: 1519162 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injected limb mobility decreased, 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: Nothing taken before vaccination, Ibuprofen after
Current Illness:
Preexisting Conditions: Asthma, also having a higher BMI (over 40)
Allergies: Allergic to: - Soj - Nuts - Fish (lethal) - Raw Apples, Pear, Carrots, Kiwi, ...
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme pain and soreness in the left arm where I?ve gotten the vaccine. Started slowly a couple hours after getting the shot, ongoing for the past 2 days. Stronger in the morning and in the evening, unable to move the arm above ellbow. cooling the area does not help. Ibuprofen reduces the pain temporarily. No improvement seen within last 2 days.


VAERS ID: 1527249 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Fear of injection, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: Test Name: BP; Result Unstructured Data: 113/85
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; fear of needles; Syncope; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and THROMBOSIS (blood clots) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and FEAR OF INJECTION (fear of needles). On 30-Jul-2021, SYNCOPE (Syncope) had resolved. At the time of the report, THROMBOSIS (blood clots) and FEAR OF INJECTION (fear of needles) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 113/85 (normal) 113/85. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Approximately 10 minutes after vaccination patient had felt lightheaded and had a syncope episode. Patient is not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1527251 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Confusional state, Dyspnoea, Epilepsy, Influenza, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Lupus erythematosus; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: flu symptoms; had first vaccination and felt rubbish for several weeks; Fainting; Difficulty breathing; Abdominal pain; Confusion; Shivering; This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (had first vaccination and felt rubbish for several weeks) and SYNCOPE (Fainting) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Lupus erythematosus and Suspected COVID-19 since 26-Jun-2021. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal pain), CONFUSIONAL STATE (Confusion) and CHILLS (Shivering). On an unknown date, the patient experienced EPILEPSY (had first vaccination and felt rubbish for several weeks) (seriousness criteria disability and medically significant) and INFLUENZA (flu symptoms). At the time of the report, EPILEPSY (had first vaccination and felt rubbish for several weeks) and INFLUENZA (flu symptoms) outcome was unknown, SYNCOPE (Fainting) and CONFUSIONAL STATE (Confusion) had resolved and DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal pain) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. After the patient had the first vaccination and on 28-Jun-2021, it was confirmed she had COVID infection. She then was bed bound for a couple of weeks. She still had experienced getting very tired when she had the second dose of vaccine and then she had developed flu symptoms within a few hours. Twelve hours, after the second dose she had felt weak and fainted to the floor. While being helped to the toilet she had collapsed again. She had spent an hour shivering and convulsing and drifting in and out of consciousness. Difficulty breathing, unable to speak, unable to remember own address. Ambulance called but symptoms subsided before it arrived. Treatment information was not reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Epilepsy could have been preexisting prior to vaccination but we don''t have information. Very limited information has been provided at this time. No further information is expected; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Epilepsy could have been preexisting prior to vaccination but we don''t have information. Very limited information has been provided at this time. No further information is expected


VAERS ID: 1527254 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (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: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Aching joints; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Aching joints) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1527963 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: TAMPLUS
Current Illness: Alcohol use (Patient drinks alcoholic beverages); Cardiac disorder; Food allergy; Smoker (smokes 5-10 sticks a day)
Preexisting Conditions: Medical History/Concurrent Conditions: Quadruple vessel bypass graft
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive; Comments: Positive (+) for Covid-19 as of 30-Jul-2021
CDC Split Type: PHJNJFOC20210803313

Write-up: PAIN IN INJECTION SITE ON THE LEFT ARM; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 57 year old male of unknown race and ethnicity. The patient''s past medical history included quadruple bypass surgery performed in 2013, and concurrent conditions included unspecified heart condition since birth, cheese and chicken allergy. The patient usually smoke 5 to 10 sticks and drank alcoholic beverages. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, frequency 1 total, administered on 22-JUL-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. Concomitant medications included finasteride/tamsulosin hydrochloride. On 30-JUL-2021, the patient turned out positive for covid-19 infection upon performing swab test with the symptoms including fever, headache, chills, and difficulty of breathing. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient experienced pain in injection site on the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in injection site on the left arm and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210803313-covid-19 vaccine ad26.cov2.s-Confirmed COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1528057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (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: Test Date: 20210730; Test Name: SARS-CoV-2 serology test; Result Unstructured Data: IgG negative (VT equal to 0,42), IgM negative (VT equal to 0,07); Comments: had no antibodies for COVID-19
CDC Split Type: PTJNJFOC20210801488

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 53 year old male of unknown race and ethnic origin. Initial information was processed with additional information received from patient on 01-AUG-2021 The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974, expiry: Unknown) dose was not reported, 1 total, administered at left deltoid on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. Patient reported that on 30-JUL-2021 he underwent immunity serologic test as part of a study at a hospital which had zero degree for immunity and had confirmed immunological vaccine failure. Patient further claimed that he believes most people that was vaccinated with this lot had the same issue, but then admitted having no access to their test results. He enquired whether he would be recalled for another dose of vaccine. On 30-JUL-2021, Laboratory data included: SARS-CoV-2 serology test (NR: not provided) IgG negative (Test Value (VT) equal to 0, 42), IgM negative (VT equal to 0, 07). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210801803. This report was associated with product quality complaint:90000188002; Sender''s Comments: V0: 20210801488- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1529646 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-30
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Inappropriate schedule of product administration, Rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Inappropriate schedule of vaccine administration; Diarrhea; Rash; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Company Comment:This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot# 3002332/3003608 with AEs of Diarrhea, Rash and Fatigue. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot# 3002332/3003608 with AEs of Diarrhea, Rash and Fatigue. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.


VAERS ID: 1529891 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Cardiac flutter, Chest discomfort, Dizziness, Dyspnoea, Head discomfort, Heart rate increased, Loss of consciousness, Malaise, Menstrual disorder, Pain, Palpitations, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain; Increased heart rate; Heart fluttering; Heart racing; Shortness of breath; Tight chest; Menstruation abnormal; Menstrual disorder; Joint pain; Feeling sick; Shaking; Dizzy; Head discomfort; Tremor; Feverish; Blacked out; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tight chest), MENSTRUAL DISORDER (Menstruation abnormal), MENSTRUAL DISORDER (Menstrual disorder), ARTHRALGIA (Joint pain), MALAISE (Feeling sick), TREMOR (Shaking), DIZZINESS (Dizzy), HEAD DISCOMFORT (Head discomfort), TREMOR (Tremor), PYREXIA (Feverish), LOSS OF CONSCIOUSNESS (Blacked out), PAIN (Pain) and HEART RATE INCREASED (Increased heart rate) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 14-May-2021. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant), MENSTRUAL DISORDER (Menstrual disorder) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant), HEAD DISCOMFORT (Head discomfort) (seriousness criterion medically significant), TREMOR (Tremor) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and HEART RATE INCREASED (Increased heart rate) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart racing), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tight chest), MENSTRUAL DISORDER (Menstruation abnormal), MENSTRUAL DISORDER (Menstrual disorder), ARTHRALGIA (Joint pain), MALAISE (Feeling sick), TREMOR (Shaking), DIZZINESS (Dizzy), HEAD DISCOMFORT (Head discomfort), TREMOR (Tremor) and PYREXIA (Feverish) had not resolved, LOSS OF CONSCIOUSNESS (Blacked out) outcome was unknown and PAIN (Pain) and HEART RATE INCREASED (Increased heart rate) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that the patient had symptoms of long COVID for over 3 months. Reportedly, ten (10) minutes after the vaccination, the patient felt quite ill but it passed off. The patient started to feel better as the week went on but in the morning, on 30-JUL-2021, her period started and the pain was extreme and patient was close to blacking out. The patient''s body temp went right up. The patient''s chest issues were constant and it was reported that the increased heart rate comes and goes. Patient has not tested positive for COVID-19 since having the vaccine. No concomitant medication information was reported. No treatment information was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1529897 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Hallucination, Injected limb mobility decreased, Pyrexia, Seizure, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Temperature; Result Unstructured Data: 40, high temperature
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cannot lift the arm very much; 12 hours after the vaccine i woke up convulsing with chills; fever; High temperature; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills), PYREXIA (fever) and PYREXIA (High temperature) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) (seriousness criterion medically significant), CHILLS (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) and HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) (seriousness criterion medically significant). 30-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (cannot lift the arm very much), VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, INJECTED LIMB MOBILITY DECREASED (cannot lift the arm very much), SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), CHILLS (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) and HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) outcome was unknown and VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills), PYREXIA (fever) and PYREXIA (High temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 40 (High) 40, high temperature. Relevant concomitant medications were not reported. Treatment information was not provided. It was reported that batch number of the suspect product was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1529906 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate
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: Test Date: 20210730; Test Name: Heart rate; Result Unstructured Data: Very high heart rate 110 bpm
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heart rate; This regulatory authority case was reported by a consumer and describes the occurrence of HEART RATE (Heart rate) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant). At the time of the report, HEART RATE (Heart rate) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Heart rate: 110 (High) Very high heart rate 110 bpm. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient had a COVID-19 virus test and the result was negative. Treatment information was not provided by the reporter. company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1529907 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (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: AMLODIPINE; NORTRIPTYLINE; PERINDOPRIL
Current Illness: Arthritis; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Neck pain; Shoulder blade pain; This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder blade pain) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Hypertension and Arthritis. Concomitant products included NORTRIPTYLINE from 01-Jan-2010 to an unknown date for Arthritis, AMLODIPINE from 01-Nov-2016 to an unknown date and PERINDOPRIL from 01-Nov-2016 to an unknown date for Blood pressure high. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder blade pain) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder blade pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial No treatment medication details was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events don?t seem to be serious by medical judgement, but they were assessed serious as per regulatory authority report. However, patient?s history of arthritis could be a confounding factor for the events. Further information is not expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events don?t seem to be serious by medical judgement, but they were assessed serious as per regulatory authority report. However, patient?s history of arthritis could be a confounding factor for the events. Further information is not expected.


VAERS ID: 1529911 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Aching joints; Headache; Chills; Nausea; Painful arm; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), ARTHRALGIA (Aching joints), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL for Pain. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). an unknown date, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), PYREXIA (Fever), ARTHRALGIA (Aching joints) and HEADACHE (Headache) had not resolved, CHILLS (Chills) outcome was unknown and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1529918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Heavy menstrual bleeding, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: shivers; Headache; Heavy periods; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), PYREXIA (Fever), HEADACHE (Headache) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On 31-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, CHILLS (shivers) outcome was unknown, HEADACHE (Headache) had resolved and HEAVY MENSTRUAL BLEEDING (Heavy periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. No concomitant medication were reported No treatment medication were reported. Patient developed body ache, Early period (1week) unusually heavy and more painful. Patient was not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. Company comment Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1529923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), COVID-19 (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: PARACETAMOL
Current Illness: Generalised muscle aches
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chills; Fever; Vomited; Generalised muscle aches; Headache fullness; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomited), MYALGIA (Generalised muscle aches), HEADACHE (Headache fullness) and PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Generalised muscle aches. Concomitant products included PARACETAMOL from 31-Jul-2021 to an unknown date for Generalised muscle aches. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and HEADACHE (Headache fullness) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Generalised muscle aches), HEADACHE (Headache fullness) and PAIN IN EXTREMITY (Painful arm) had not resolved and VOMITING (Vomited) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1529924 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swelling arm; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swelling arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported by reporter. No concomitant medications were reported by reporter. The patient did not had symptoms associated with COVID-19 nor had a COVID-19 test. The patient was not tested positive for COVID-19 since receiving the vaccine. The patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1529925 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-30
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Body temperature 39.6.; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Painful arm; Headache; Fatigue; Nausea; Dizziness; The patient received the second dose on 30-Jul-2021 , 57 days from the first dose; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003607 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and (The patient received the second dose on 30-Jul-2021 , 57 days from the first dose). 30-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 31-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 30-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the second dose on 30-Jul-2021 , 57 days from the first dose) had resolved. At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39.6 (High) Body temperature 39.6.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. Company comment This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 3003607 and 3002332) with associated adverse events reported as pain in extremity, pyrexia, headache, fatigue and nausea. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious.; Sender''s Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 3003607 and 3002332) with associated adverse events reported as pain in extremity, pyrexia, headache, fatigue and nausea. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious.


VAERS ID: 1529947 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-30
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Malaise, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (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: TESTOSTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: stomach aches; dizzy; shivering; Chills; Abdominal pain; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (stomach aches), DIZZINESS (dizzy) and ABDOMINAL PAIN (Abdominal pain) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 on 30-Jul-2021. Concomitant products included TESTOSTERONE for Testosterone deficiency. On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache). On 31-Jul-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced MALAISE (stomach aches) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant) and CHILLS (shivering). At the time of the report, MALAISE (stomach aches), DIZZINESS (dizzy) and CHILLS (shivering) outcome was unknown and ABDOMINAL PAIN (Abdominal pain), HEADACHE (Headache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient reported that she was taking regular steroid treatment (e.g. orally or rectally). Treatment information, if any, was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1530044 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: vitamin c, paracetamol
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: none yet
CDC Split Type:

Write-up: injection time 3:45pm pain on shoulders, feeling of nausea, at night slept and felt severe headache cannot sleep till the whole next day headache and body pains


VAERS ID: 1530277 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: Thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in July 2021 due to THROMBOSIS. The patient was treated with Surgery for Thrombosis. At the time of the report, THROMBOSIS (Thrombosis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was not exact hospitalization date whether it is 30-JUL-2021 or 31-JUL-2021. No concomitant medications were provided by the reporter. Company comment: Very limited information regarding the events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding the events has been provided at this time. No further information is expected.


VAERS ID: 1531225 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cold sweat, Hypoaesthesia, Lymphadenopathy, Myalgia, Peripheral swelling, SARS-CoV-2 test, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre 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), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Glands swollen; Numbness in hand; Muscular pains; Tension headaches; Cold sweat; Swollen arm; Shivering; This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), MYALGIA (Muscular pains), LYMPHADENOPATHY (Glands swollen), TENSION HEADACHE (Tension headaches), COLD SWEAT (Cold sweat), PERIPHERAL SWELLING (Swollen arm) and CHILLS (Shivering) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced MYALGIA (Muscular pains) (seriousness criterion medically significant), TENSION HEADACHE (Tension headaches) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant). On 31-Jul-2021, COLD SWEAT (Cold sweat) and CHILLS (Shivering) had resolved. At the time of the report, HYPOAESTHESIA (Numbness in hand), MYALGIA (Muscular pains), LYMPHADENOPATHY (Glands swollen) and PERIPHERAL SWELLING (Swollen arm) had not resolved and TENSION HEADACHE (Tension headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. Treatment information was not provided. The patient had no symptoms associated with COVID 19 and was not currently breastfeeding. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1533249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (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: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tight chest; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight chest) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced CHEST DISCOMFORT (Tight chest). At the time of the report, CHEST DISCOMFORT (Tight chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications are reported . No treatment medications are reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1533681 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Depressed level of consciousness, Dyspnoea, Nausea, Oxygen saturation, Oxygen saturation decreased, Retching
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
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: EPIPEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99; Comments: at 14:25; Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:83; Comments: at 14:53
CDC Split Type: JPPFIZER INC202100977661

Write-up: Oxygen saturation decreased to 83; Depressed level of consciousness; Dyspnoea; Anaphylaxis; Vomiturition; Queasy; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21119462. The patient was a 53-year and 3-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. The patient''s medical histories included asthma and anaphylaxis. Concomitant medication included epinephrine (EPIPEN) from an unspecified date and ongoing. On 30Jul2021 at 14:14 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient experienced anaphylaxis on 30Jul2021 14:17 (life-threatening, medically significant) with outcome of unknown, Depressed level of consciousness (life-threatening, medically significant) on 30Jul2021 14:50 with outcome of unknown, vomiturition (non serious) on 30Jul2021 14:17 with outcome of unknown, queasy (non serious) on 30Jul2021 14:17 with outcome of unknown, dyspnoea (non serious) on 30Jul2021 14:25 with outcome of unknown, oxygen saturation decreased to 83 (non serious) on 30Jul2021 14:53 with outcome of unknown. The course of the events was as follows: On 30Jul2021 at 14:17, the patient experienced queasy and vomiturition. Rash (-) The level of consciousness was normal. On 30Jul2021 at 14:25, the patient experienced dyspnoea. SpO2 was 99. On 30Jul2021 at 14:32, as for dyspnoea and vomiturition were still lasting, the patient received adrenaline 0.3 ml intramuscularly. On 30Jul2021 at 14:41, the events got better. On 30Jul2021 at 14:50, dyspnoea became worsen. The patient experienced depressed level of consciousness and SpO2 decreased. On 30Jul2021 at 14:53, the patient received adrenaline 0.3 ml intramuscularly. SpO2 decreased to 83. O2 stared from 2L to 10L. On 30Jul2021 at 14:55, the patient requested for emergency. It met the reporting criteria of anaphylaxis. The reporting physician classified the events anaphylaxis and depressed level of consciousness as serious (life-threatening) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The events were considered as anaphylaxis shock. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1535805 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia
SMQs:, Arrhythmia related investigations, signs and symptoms (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: PHJNJFOC20210809791

Write-up: BRADYCARDIA; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095265] concerned a 67 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212c21a, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 17:35 the patient experienced bradycardia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bradycardia. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20210809791 -Covid-19 vaccine ad26.cov2. s Bradycardia - This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1537629 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045F21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest pain, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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: Methadose
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Inflamed heart stabbing pains started 3 hours after injection 6 days later two trips to Emergency room told my heart is inflamed


VAERS ID: 1546081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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:
Current Illness: Barrett''s oesophagus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: COVID-19 is over
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210815940

Write-up: TACHYCARDIA; This spontaneous report received from a consumer via a Regulatory Authority [Regulatory Authority, ES-AEMPS-963437] concerned a 48 year old male. The patient''s weight was 68 kilograms, and height was 167 centimeters. The patient''s past medical history included: covid-19, and concurrent conditions included: Barrett''s oesophagus, and other pre-existing medical conditions reported that COVID-19 was over. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-04, and expiry: unknown) dose was not reported, 1 total administered on right arm on 29-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced tachycardia. Treatment with Covid-19 vaccine ad26.cov2.s was withdrawn on 29-JUL-2021. The patient was recovering from tachycardia. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210815940-covid-19 vaccine ad26.cov2.s-Tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1546294 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Diarrhoea, Fatigue, Nausea, Neuropathy peripheral, Pain, Pulmonary pain, Pyrexia, Sensitive skin
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy (for breast cancer)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996525

Write-up: Thoracic pain (sternum); Atypical lung pain; Body aches; Fever moderate 38.9 ? C; Weakness; Diarrhea; Nausea; Tiredness; Hypersensitivity skin and hair roots, EVERYTHING hurt; Neuropathy on face, jaw, cheekbones, eye sockets; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 55-years-old female patient unknown if pregnant received bnt162b2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 29Jul2021 15:15 (at the age of 55 years old) (Batch/Lot Number: J07BX03) as dose 2, single; dose 1 via an unspecified route of administration on 30Jun2021 15:15 (at the age of 55 years old) (Batch/Lot number J07BX03) as dose 1 single for COVID-19 immunisation. Medical history included chemotherapy from 2010 to 2011 for breast cancer and breast cancer. The patient''s concomitant medications were not reported. The patient previously took ibuprofen and experienced drug intolerance. On 30Jul2021, the patient experienced neuropathy on face, jaw, cheekbones, eye sockets. On 30Jul2021 at 04:15, the patient experienced Thoracic pain (sternum), Atypical lung pain, Body aches, Fever moderate 38.9 ? C, Weakness, Diarrhea, Nausea, Tiredness, and Hypersensitivity skin and hair roots, EVERYTHING hurt. Clinical course included: on 30Jul2021 04:15, exactly 12 hours after the injection, the patient experienced first vaccinal reactions which include Body aches, Fever moderate 38.9?C, Weakness, Diarrhea, Nausea, Nausea, Tiredness and Hypersensitivity skin and hair roots, everything hurts. First administration of Paracetamol 1000 around 4:00 a.m. No significant improvement during the day. Second administration at 7:00 p.m. After 36 hours the patient experienced severe neuropathies in the face, jaw, cheekbones, eye sockets, Chest pain and atypical lung pain. No breathing difficulties, no shortness of breath. The whole frame trunk hurts infinitely, the periphery has calmed down. Perhaps classic symptoms of poisoning for a former chemo patient who can no longer even tolerate an Ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.


VAERS ID: 1547171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210812406

Write-up: SYMPTOMS SIMILAR TO STROKE ATTACK; FEVER; This spontaneous report received from a consumer concerned a 67 year old female. Initial information was processed along with the additional information received on 09-AUG-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes mellitus, hypertension, and stroke on may 2021 was still recovering from it. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, the patient experienced fever. On 01-AUG-2021, the patient experienced symptoms similar to stroke attack was rushed to the hospital. The patient was at the hospital at time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms similar to stroke attack and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210812406-covid-19 vaccine ad26.cov2.s-symptoms similar to stroke attack. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1547285 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210815926

Write-up: VERTIGO SENSATION; MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-5529] concerned a 32 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-04 expiry: UNKNOWN) .5 ml, 1 total, administered on 30-JUL-2021 for covid-19 immunisation. The drug start period (latency) was 30 minutes. No concomitant medications were reported. On 30-JUL-2021, the patient experienced vertigo sensation and malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo sensation, and malaise on 30-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: No Medication Error Occurred; Sender''s Comments: V0: 20210815926-Covid-19 vaccine ad26.cov2.-Vertigo sensation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210815926-Covid-19 vaccine ad26.cov2.-Malaise. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1547286 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210815999

Write-up: VASO-VAGAL REACTION (SYNCOPE, WITH OR WITHOUT CONVULSIVE MOVEMENTS), SUDORESIS, DIZZINESS; SUDORESIS; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-5532] concerned a 23 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 21c10-04 and expiry: Unknown) 0.5 ml, 1 total administered on 30-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient experienced vaso-vagal reaction (syncope, with or without convulsive movements), sudoresis and had dizziness. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient was recovering from vaso-vagal reaction (syncope, with or without convulsive movements), sudoresis, dizziness, sudoresis, and dizziness. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Medication Error Occurred?-No; Sender''s Comments: V0:20210815999-COVID-19 VACCINE AD26.COV2.S-Vaso-vagal reaction (syncope, with or without convulsive movements), sudoresis, dizziness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1549889 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Heart rate, Hyperhidrosis, Malaise, Raynaud's phenomenon, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (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: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Heart rate; Result Unstructured Data: faster heart rate than usual; Test Date: 20210731; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shivering; Unwell; Dizziness; Headache; Raynauds; Sweating; Dizzy spells; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), MALAISE (Unwell), DIZZINESS (Dizziness), HEADACHE (Headache), RAYNAUD''S PHENOMENON (Raynauds), HYPERHIDROSIS (Sweating) and DIZZINESS (Dizzy spells) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3003608) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant), MALAISE (Unwell) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), RAYNAUD''S PHENOMENON (Raynauds) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), MALAISE (Unwell), DIZZINESS (Dizziness), HEADACHE (Headache), RAYNAUD''S PHENOMENON (Raynauds), HYPERHIDROSIS (Sweating) and DIZZINESS (Dizzy spells) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Heart rate: faster (High) faster heart rate than usual. On 31-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. It was reported that patient had the 2nd dose around midday, by 4pm patient started to feel unwell, by early evening he developed headaches and shivering. throughout the night patient had a faster heart rate than usual, sweating and struggled to sleep with headache and dizziness. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding the event of Raynaud''s phenomena has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, very limited information regarding the event of Raynaud''s phenomena has been provided at this time. No further information is expected at this time


VAERS ID: 1550027 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: Maternal vaccine exposure (COVID-19 vaccine exposure during pregnancy week: 2)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210817233

Write-up: COVID-19 VACCINE EXPOSURE DURING PREGNANCY WEEK: 2; MISSED MENSTRUATION AND EVENTUALLY MISCARRIED 11 WEEKS LATER; This spontaneous pregnancy report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00650114] concerned a 29 year old female of unspecified race and ethnic origin. The patient''s weight was 55 kilograms, and height was 168 centimeters. The patient''s concurrent conditions included maternal vaccine exposure. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: XD955, and expiry: unknown) 1 dosage forms, 1 total administered on 30-APR-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient missed menstruation and eventually had miscarriage 11 weeks later. On an unspecified date, she had vaccine exposure during second week of pregnancy. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The outcome of the covid-19 vaccine exposure during pregnancy week: 2 and missed menstruation and eventually miscarried 11 weeks later was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210817233 -covid-19 vaccine ad26.cov2.s- missed menstruation and eventually miscarried 11 weeks later, covid-19 vaccine exposure during pregnancy week: 2. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1553482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101007391

Write-up: This is a spontaneous report from a contactable other HCP, received via the regulatory authority (report number: 595185). A 23-year-old female patient received BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The patient experienced seizure on Jul 30, 2021. The outcome of seizure: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1553603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain
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: TRYPTIZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: COVID-19 has passed
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210817913

Write-up: AXILLARY PAIN; This spontaneous report received from a consumer via a Regulatory Authority [ES-AEMPS-963497] concerned a 44year old female. The patient''s weight was 48 kilograms, and height was 162 centimeters. The patient''s past medical history included: covid-19, and other pre-existing medical conditions included: COVID-19 has passed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, duration of drug administration 1 day, drug start period and drug last period 2 days, 1 total administered to right arm on 29-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included amitriptyline hydrochloride (Tryptizole) for irritable colon. On 30-JUL-2021, the patient experienced axillary pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from axillary pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: v0-20210817913-covid-19 vaccine ad26.cov2.s-AXILLARY PAIN. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554658 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Test Name: body temperature; Result Unstructured Data: Test Result:37.5
CDC Split Type: GRPFIZER INC202100997148

Write-up: covid-19 infection; covid-19 infection; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 58-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jun2021 as dose 2, single and received first dose (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced covid-19 infection. On an unspecified date, the patient developed loss of taste, loss of smell and fever. It was reported that, patient got a corovirus from his family and he got a disease on 30Jul2021. he has a loss of taste and smell and a little fever, 37.5. Patient wanted to know if he can take Ponstan for the fever. The patient underwent lab tests and procedures which included body temperature: 37.5 on an unspecified date. The outcome of the events was unknown.


VAERS ID: 1554738 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Pulmonary artery thrombosis
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:120/80 mmHg; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Test Date: 20210726; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Comments: before the second vaccination; Test Date: 20210730; Test Name: Chest imaging CT; Result Unstructured Data: Test Result:revealed thrombus in the pulmonary artery; Test Date: 20210730; Test Name: D-dimer; Result Unstructured Data: Test Result:23.7; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:100; Test Date: 20210730; Test Name: spo2; Test Result: 89 %
CDC Split Type: JPPFIZER INC202100987480

Write-up: Pulmonary artery thrombosis; dyspnoea; SPO2 89% (RA); heart rate 100; a high level of D-dimer 23.7; This is a spontaneous report from a contactable other health professional received from the Agency . Regulatory authority report number is v21122100. A 77-year-old (age at vaccination) male patient received second dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, solution for injection), via an unspecified route of administration on 26Jul2021 at 11:15 as dose 2, single for covid-19 immunisation. Body temperature before the vaccination was 36.7 degrees Centigrade on 26Jul2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2, (COVID-19 vaccine, Manufacturer unknown, lot number; not provided), via an unspecified route of administration on 05Jul2021 at 11:15 for covid-19 immunisation. On 30Jul2021 at 10:00 (4 days after the vaccination), the patient experienced pulmonary artery thrombosis, dyspnoea, SPO2 89% (RA), heart rate 100 and a high level of D-dimer 23.7. On an unspecified date, the patient was admitted to the hospital. The course of the event was as follows: On 30Jul2021 at about 10:00, the patient felt dyspnoea during body movement. The patient was emergency transported due to no improvement after observation. When visiting the hospital, SPO2 89 percent (RA), blood pressure 120/80 mmHg, heart rate 100, and the blood test showed a high level of D-dimer 23.7. Chest imaging CT revealed thrombus in the pulmonary artery and diagnosed as pulmonary artery thrombosis. The reporting other health professional classified the event as serious (hospitalized) and assessed that the event was unrelated to bnt162b2. Other possible cause of the event such as any other diseases was pulmonary artery thrombosis. The outcome of events was unknown. The lot number for the vaccine was not provided and will be requested during follow up.


VAERS ID: 1554849 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809263

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 62 year old female unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021,at 19:20 the patient experienced elevated blood pressure. On 30-JUL-2021 Laboratory data included: Blood pressure (NR: not provided) 200/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended: Event seriousness.; Sender''s Comments: V1: Follow up version created to amend previously reported information : Event seriousness. 20210809263-Covid-19 vaccine ad26.cov2.S- Elevated Blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554853 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/90 mmHg, elevated
CDC Split Type: PHJNJFOC20210809432

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095270] concerned a 55 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported,1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 11:44, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/90 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021.Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from non-serious to serious.; Sender''s Comments: V1: Additional version created as following information was amended seriousness level of event (elevated blood pressure) was updated from non serious to serious 20210809432-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. Follow-up received regarding Other Information: non serious to serious. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554854 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809501

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095291] concerned a 59 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported,1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 05.30 PM, the patient experienced elevated blood pressure Laboratory data included (On 30-JUL-2021): Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021.Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from non serious to serious..; Sender''s Comments: V0:20210809501 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- elevated blood pressure- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554856 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 210/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809552

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095281] concerned a 63 year old male ,unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 13:13 the patient experienced elevated blood pressure 210/100. Laboratory data included: Blood pressure (NR: not provided) 210/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case narrative: Event seriousness.; Sender''s Comments: V2:20210809552-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554862 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg, elevated
CDC Split Type: PHJNJFOC20210809780

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095317] concerned a 43 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported,1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 19:30 hours the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from nonserious to serious.; Sender''s Comments: V2: Following information was amended in this version: Seriousness criteria for the event of elevated BP was changed to serious from non serious. 20210809780-covid-19 vaccine ad26.cov2.s -Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event


VAERS ID: 1554864 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg
CDC Split Type: PHJNJFOC20210809911

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095321] concerned a 50 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021,18:08 the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 190/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from nonserious to serious.; Sender''s Comments: V0: 20210809911-Covid-19 vaccine ad26.cov2.s -Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1554871 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg
CDC Split Type: PHJNJFOC20210811243

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095112]] concerned a 41 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patients laboratory data included blood pressure was (NR: not provided) 190/100 mmHg (at 09:19 hours) which showed elevated blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021.Upon review following information was amended: Event seriousness (elevated blood pressure) seriousness was updated to serious (other Medically Important Condition).; Sender''s Comments: V1: This version is created to amend previously reported information on 05-AUG-2021.Upon review following information was amended: Event seriousness (elevated blood pressure) seriousness was updated to serious (other Medically Important Condition). 20210811243-COVID-19 VACCINE AD26.COV2.S-elevated blood pressure. Follow-up received regarding Other Information: Seriousness updated from non-serious to serious. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1554883 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809610

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095145] concerned a 41 year old male patient of unknown ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: Unknown) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 08:19 hours the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended. Event elevated blood pressure reassessed as serious (other medically important condition) and event start time was added in narrative.; Sender''s Comments: V2-The current version updates the following in the narrative, Event elevated blood pressure reassessed as serious (other medically important condition) and event start time was added. The additional information received changes the causality of the case from non-serious to serious. 20210809610-COVID-19 VACCINE AD26.COV2.S-Blood Pressure Elevated. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1554884 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107301715; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210809631

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095327] concerned a 51 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 17:15, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case: Event seriousness for event of Elevated blood pressure updated to Other Medically Important Condition, Narrative updated.; Sender''s Comments: V1: Additional information received updates: Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case: Event seriousness for event of Elevated blood pressure updated to Other Medically Important Condition, Narrative updated. 20210809631- Covid-19 vaccine ad26.cov2.s -Elevated blood pressure . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1555490 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea
SMQs:, Fertility 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: ESPIDIFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210817772

Write-up: CESSATION OF MENSTRUATION; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-963581] concerned a 43 year old female of unspecified race and ethnic origin. The patient''s weight was 70 kilograms, and height was 169 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 to left arm for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included Espidifen (ibuprofen arginine) 600 mg granulate for oral solution mint flavor EFG (Generic Pharmaceutical Equivalent), 40 sachets and administered as one sachet diluted in half a glass of water for pain menstrual. On 30-JUL-2021, the patient experienced cessation of menstruation. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from cessation of menstruation. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210817772-Covid-19 vaccine ad26.cov2.s-cessation of menstruation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS


VAERS ID: 1555566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-30
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation irregular
SMQs:, Fertility 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977119

Write-up: Irregular periods; This is a spontaneous report from a contactable consumer or other non hcp received from the products Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107301442168410-7BUW8. A 32-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FE1510, Expiration date was not reported), dose 1 via an unspecified route of administration on 02Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included Lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced irregular periods on 30Jul2021. patient menstrual cycle for seven years and always on time. Never late never early. This month she had come on unexpectedly with an 18day cycle instead of her usual 28day cycle. More than a week early. she have read the vaccine can cause periods to be different and wanted to report it as she can think of no other reason. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1555574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Haemorrhage, Pain, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: MILLINETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976810

Write-up: vaginal bleeding; exhaustion; aches; pains; Bleeding; This is a spontaneous report from a contactable consumer or other non hcp received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107310924402680-DVZMR. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, suspected covid-19 from 28Mar2020 to an unknown date Unsure when symptoms stopped , contraception from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, gestodene (MILLINETTE) taken for contraception, start and stop date were not reported. The patient experienced vaginal bleeding (vaginal haemorrhage) (medically significant) on an unspecified date with outcome of not recovered , exhaustion (fatigue) (medically significant) on an unspecified date with outcome of not recovered , bleeding (haemorrhage) (medically significant) on 30Jul2021 with outcome of not recovered , aches (pain) (medically significant) on an unspecified date with outcome of unknown , pains (pain) (medically significant) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable.


VAERS ID: 1555578 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977027

Write-up: Patient was exposed to the medicine first-trimester (1-12 weeks).; Miscarriage; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311613306250-I8N9I, Safety Report Unique Identifier is GB-MHRA-ADR 25737276. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 37-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 27Jul2021 as dose 2, single for COVID-19 immunization. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), folic acid supplementation. Concomitant medication included Folic acid as Folic acid supplementation. Patient was pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test Patient was not currently breastfeeding. On an unspecified date, patient experienced maternal exposure during pregnancy, On 30Jul2021, patient experienced miscarriage. The mother reported she became pregnant while taking BNT162B2. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. BNT162B2 vaccine has affected on aspect of the pregnancy because the patient had miscarriage after pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). The outcome of the event miscarriage was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1555640 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Hyperventilation, Hypotension, Hypoxia, Loss of consciousness, Oxygen saturation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary arterial stent insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:138/84; Comments: at 9:13; Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:74/33; Comments: as low as 74/33 on ambulance arrival; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210730; Test Name: SpO2; Test Result: 91 %; Comments: SpO2 as low as 91; Test Date: 20210730; Test Name: SpO2; Test Result: 91 %; Comments: SpO2 91 lasted about 30 minutes
CDC Split Type: JPPFIZER INC202100977679

Write-up: Transient loss of consciousness/ sudden loss of consciousness; Hyperpnoea; vomiting; hypoxia/ SpO2 as low as 91; hypotension/ as low as 74/33 on ambulance arrival; This is a spontaneous report from a contactable physician received from the Regulatory Authority; the Regulatory Authority report number is v21119481. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY) Solution for injection) batch/lot number: EY5422 and expiration date: 31Aug2021) via an unspecified route of administration at 81 years old on 30Jul2021 at 09:00 (the day of vaccination), as DOSE 2, SINGLE for COVID-19 immunization. The patient''s body temperature before vaccination was 36.4 Centigrade. The patient''s medical history included coronary arterial stent insertion on an unknown date. The patient had no family history. Concomitant medications included acetylsalicylic acid (BAYASPIRIN tablets 100mg) and warfarin (WARFARIN tablets), therapy dates and indications for both were not reported. On 30Jul2021 at 09:00 (the day of vaccination), the patient experienced hypotension, hypoxia, vomiting, and loss of consciousness (reported as transient loss of consciousness/ sudden loss of consciousness). On 30Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 30Jul2021 (the day of vaccination), the outcome of the events was reported as not recovered. The course of the events was as follows: A second dose of Comirnaty was administered at 9:00. At 9:13, the patient had hyperpnoea, vomiting, and loss of consciousness (reported as reported as transient loss of consciousness/ sudden loss of consciousness). Blood pressure at this time was 138/84, as low as 74/33 on ambulance arrival, and SpO2 as low as 91. At 9:40 hours, Noradrenaline was administered intramuscularly and transported by ambulance to a private hospital where transient loss of consciousness was about 10 minutes later with improvement of oxygen by 3 liters and SpO2 91 lasted about 30 minutes. The reporting physician classified the events as serious (patient was hospitalized from 30Jul2021) and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Sudden loss of consciousness, hypotension, and hypoxia.


VAERS ID: 1555651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-30
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Fall, Foaming at mouth
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Convulsions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:unknown Centigrade
CDC Split Type: JPPFIZER INC202100977902

Write-up: Cerebral infarction; foam from the mouth; found the patient was lying down; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119441. An 83-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 18Jun2021 (Batch/Lot Number: unknown) at the age of 83 years old as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was unknown. On 30Jul2021 at 07:00 (1 month and 12 days after the vaccination), the patient experienced Cerebral infarction. On 30Jul2021 (1 month and 12 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 30Jul2021 at about 07:00, the patient''s family went to see the patient, and found the patient was lying down and foam was from the mouth, requested for an ambulance. The outcome of the event was not provided (unknown). The reporting physician classified the event as serious (hospitalized from 30Jul2021 to an unknown date), and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not provided. Information on the lot/batch number was not provided and will be requested.


VAERS ID: 1555710 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809073

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095286] concerned a 69 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 16:30, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case narrative: Event seriousness.; Sender''s Comments: V2: Version created for amendments. Event upgraded to serious with seriousness- Other Medically Important Condition. 20210809073-COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1555714 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210809656

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095325] concerned a 42 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, frequency time 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 17:20, the patient''s blood pressure (BP) elevated to 200/120 mmHg. The action taken with Covid-19 vaccine was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review, following information was amended: The case was reassessed as serious.; Sender''s Comments: V1:This follow-up version amended-previously reported information on 05-AUG-2021. Upon review, following information was amended: The case was reassessed as serious. 20210809656-COVID-19 VACCINE-Elevated BP. Follow-up received regarding Clinical Details. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1555722 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210810045

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095305] concerned a 46 year old male unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021,at 17:35, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure.. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case narrative: Event seriousness.; Sender''s Comments: V1: Follow up version created to amend previously reported information : Event seriousness. 20210810045-Covid-19 vaccine ad26.cov2.S- Elevated Blood pressure.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1557979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dehydration, Fatigue, Hyperpyrexia, Paraesthesia, Peripheral coldness, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), COVID-19 (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: NORTRIPTYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100977365

Write-up: by 3pm took temp from armpit using mercury thermometer; felt fatigued; Cold hands; Fever/showed above 42c; Shivering; Joint pain; Tingling feet/hands; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311530051260-V03U7, Safety Report Unique Identifier GB-MHRA-ADR 25737236. A 34-year-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included suspected covid-19 from 05Mar2020 to an unknown date Unsure when symptoms stopped , migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline (NORTRIPTYLINE) taken for migraine from 27Jun2021 to an unspecified stop date. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) included first dose of with COVID-19 immunisation. Patient is not enrolled in clinical trial. The patient experienced dehydration (by 3pm took temp from armpit using mercury thermometer) (medically significant) on an unspecified date with outcome of recovering , fever/showed above 42c (medically significant) on 31Jul2021 with outcome of not recovered , shivering (medically significant) on 31Jul2021 with outcome of not recovered , joint pain (arthralgia) (medically significant) on 31Jul2021 with outcome of not recovered , tingling feet/hands (paraesthesia) (medically significant) on 30Jul2021 with outcome of not recovered , cold hands (peripheral coldness) (medically significant) on 31Jul2021 with outcome of not recovered , felt fatigued (fatigue) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1558020 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Dizziness, Dyspnoea, Heart rate, Oxygen saturation, Pallor, Presyncope, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:120/67; Comments: 30 minutes after the beginning of O2 treatment.; Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:100/40; Comments: 5 minutes after the vaccination.; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.; Test Date: 20210730; Test Name: pulse rate; Result Unstructured Data: Test Result:84; Comments: 30 minutes after the beginning of O2 treatment.; Test Date: 20210730; Test Name: pulse rate; Result Unstructured Data: Test Result:89; Comments: 5 minutes after the vaccination.; Test Date: 20210730; Test Name: SpO2; Test Result: 100 %; Comments: 30 minutes after the beginning of O2 treatment.; Test Date: 20210730; Test Name: SpO2; Test Result: 99 %; Comments: 5 minutes after the vaccination.
CDC Split Type: JPPFIZER INC202100981012

Write-up: Dyspnoea; vasovagal reflects; Giddiness; blurring his vision; Cold sweat; Pallor facial; Blood pressure was 100/40; This is a spontaneous report from a contactable nurse received from the regulatory authority, report number is v21122005. A 19-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Jul2021 at 09:25 (Lot Number: FA7338; Expiration Date: 30Sep2021) (at the age of 19-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. On 30Jul2021 at 09:25 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 30Jul2021 at 09:30 (5 minutes after the vaccination), the patient experienced vasovagal reflects. The course of the event was as follows: about 5 minutes after the vaccination, the patient complained dyspnoea. A giddiness overcame the patient, blurring his vision. The patient experienced cold sweat and pallor facial. Blood pressure was 100/40, pulse rate was 89, SpO2 was 99%. Intravenous drip was performed for route keep. The patient started to receive 02 2L treatment. Sound of bronchostenosis could not be heard. 30 minutes after the beginning of O2 treatment, the blood pressure was 120/67, pulse rate was 84, SpO2 was 100%. The patient went home since the symptoms got improved. On 30Jul2021 (the same day of vaccination), the outcome of the events was recovering. The reporting nurse classified the event as non-serious and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1558583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (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: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100975497

Write-up: Pain in arm; Armpit pain; Common cold syndrome; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107300448183470-6M7WZ, Safety Report Unique Identifier: GB-MHRA-ADR 25730308. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included desogestrel, ethinylestradiol (GEDAREL). The patient experienced armpit pain and common cold syndrome on 30Jul2021; and pain in arm on an unspecified date. Clinical course reported: pain in armpit severe enough to keep awake and bring to tears. Travels through lower part of upper arm and well into armpit. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The outcome of all the events was not recovered. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1558593 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Lateral position, Pruritus, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (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: Test Date: 2021; Test Name: Lateral flow; Test Result: Negative
CDC Split Type: GBPFIZER INC202100977060

Write-up: Itchy rash; hives; itchy; Numbness; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301611242140-HQHDC. Safety Report Unique Identifier is GB-MHRA-ADR 25734079. A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8813), via an unspecified route of administration on 23Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not enrolled in clinical trial. The patient received historical vaccine including bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced numbness, hives and ''itchy''. On 30Jul2021, the patient experienced itchy rash. The clinical course was as follows: The patient experienced itchy hands, then feet, then legs and torso. The patient had hives on legs and torso. The patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included lateral flow (lateral position): negative on unspecified date in 2021. The outcome of the event itchy rash was recovered on 30Jul2021. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1558616 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1310 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Fatigue, Migraine, Myalgia, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), COVID-19 (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977373

Write-up: body aches; Migraine; Nausea; Chills; Generalised muscle aches; Fever; Appetite lost; Fatigue; soreness at injection site; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107311535396580-5AR54. Safety Report Unique Identifier GB-MHRA-ADR 25737245. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot Number: FE1310) (at age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included lactation decreased, migraine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications were not reported. On 30Jul2021 patient experienced body aches, migraine, nausea, chills, generalised muscle aches, fever, appetite lost, fatigue, soreness at injection site. Events considered serious as disability and medically significant. It was reported that symptoms began in the hours following the vaccine starting with soreness at injection site increasing to fever, body aches, chills, and migraine into the late evening/early morning. Unable to consume food or water the day after injection due to nausea and migraine symptoms. Slept until late afternoon the day after injection. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent laboratory tests and procedures which included sars-cov-2 test: negative on 15May2021 No - Negative COVID-19 test. Outcome of the events body aches and soreness at injection site was unknown, patient had not recovered from migraine, generalised muscle aches, fever, appetite lost, fatigue and she was recovering from the other mentioned events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1558635 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984659

Write-up: Numbness localised; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108012227173210-OFACF, Safety Report Unique Identifier GB-MHRA-ADR 25738456. A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 30Jul2021 (at the age of 34-years-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 30Jul2021, the patient experienced numbness localized. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No - Negative COVID-19 test. The outcome of event was recovered on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1558657 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Fatigue, Lymph node pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), 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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100979354

Write-up: arrhythmia; pain at the neck glands; fatigue; sleepiness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (COMIRNATY, Lot number was not reported), intramuscular on 30Jul2021 (at the age of 35-years-old) as dose 2, single for covid-19 immunisation. The patient had no medical history. There was no concomitant medications. The patient previously received bnt162b2 (COMIRNATY) on an unspecified date as 1st dose for covid-19 immunisation. On 30Jul2021, the patient experienced fatigue and sleepiness. On 31Jul2021, the patient experienced arrhythmia and pain at the neck glands. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1558670 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram thorax, Pneumothorax
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MUCOSOLVAN L; BEZATOL; ETHYL ICOSAPENTATE; FEBURIC; DIFENIDOL HYDROCHLORIDE
Current Illness: Alveolar proteinosis; Dizziness; Hyperlipidaemia; Hyperuricaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 20210730; Test Name: Chest CT; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202100974227

Write-up: Pneumothorax; SPECIAL INVESTIGATION OF COMIRNATY INTRAMUSCULAR INJECTION (INVESTIGATION OF PATIENTS WITH UNDERLYING DISEASE CONSIDERED TO BE AT HIGH RISK OF AGGRAVATION OF COVID-19) This is a report from a Non-Interventional Study source, obtained from an investigator of this study. A 47-year-old (age at the time of the onset and vaccination) subject of an unspecified gender received 1st dose of BNT162b2 (Lot Number: EW0201, Expiration Date: 30Sep2021) via an unspecified route of administration in left deltoid on 24Jul2021 at 15:51 at 0.3 ml as a single dose for covid-19 immunisation. Antifebrile was not used around the day of vaccination. Medical history included alveolar proteinosis from 27Apr2020 and ongoing, hyperlipidaemia from 06Jan2021 and ongoing, hyperuricaemia from 08Feb2021 and ongoing and dizziness from 09Jun2021 and ongoing. The subject had no family history related to the adverse event. Concomitant medications included ambroxol hydrochloride (MUCOSOLVAN L TABLET 45MG) taken orally for alveolar proteinosis from 27Apr2020 and ongoing; bezafibrate (BEZATOL SR TABLET 200MG) taken orally for hyperlipidaemia from 06Jan2021 and ongoing; ethyl icosapentate (ETHYL ICOSAPENTATE GRANULAR CAPSULES 900) taken orally for hyperlipidaemia from 06Jan2021 and ongoing; febuxostat (FEBURIC TABLET 10MG) taken orally for hyperuricaemia from 08Feb2021 and ongoing; difenidol hydrochloride (DIFENIDOL HYDROCHLORIDE TABLETS 25MG) taken orally for dizziness from 09Jun2021 and ongoing. It was reported that there was no adverse event after administration of previous vaccine. On 30Jul2021 at 10:56, the subject experienced pneumothorax. The subject required to visit a medical institution for the event. The subject was admitted to the hospital for the event. The subject underwent lab tests and procedures which included Chest X-ray: unknown results on 30Jul2021 and Chest CT: unknown results on 30Jul2021. The outcome of the event was not recovered. The investigator classified the event as serious (hospitalization/prolongation of hospitalization) and considered that there was no reasonable possibility that the event was related to the study drug and concomitant drugs.; Sender''s Comments: Based on the information in the case report the reported event Pneumothorax may be related to underlying medical history and not related to suspect drug BNT162B2 .


VAERS ID: 1558680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Flushing, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Atopy
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100978194

Write-up: Generalised itching; flushing of face and flushing of both hands; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. The Regulatory Authority report number is v21119429. A 45-year-old female patient (reported as 45-year and 9-month-old) received the second dose of BNT162B2 (COMIRNATY) Solution for injection (batch/lot number: FC9909 and expiration date: 30Sep2021) via an unspecified route of administration on 21Jul2021 at 11:15 (the day of vaccination) as DOSE 2, SINGLE for COVID-19 immunization. The patient''s body temperature before vaccination was 36.4 degrees Centigrade. The patient''s medical history included allergic to atopy from an unknown date. Patient''s family history and concomitant medications were not provided. There were no points to be considered on the vaccine screening questionnaire. The onset date/time was reported as 31Jul2021 (10 after the vaccination). On unspecified time, the outcome of the events was recovered. The course of the events was as follows: On 21Jul2021, the patient received the second dose of vaccination. On 30Jul2021, in the morning, the patient experienced generalised itching, flushing of face, and flushing of both hands. The patient was originally allergic to atopy. Took one tablet of celestamine, but did not improve, and came to clinic. Received fresh food 500ml, solu-medrol 250mg IV. After the infusion, patient improved. The primary reporter classified the events as non-serious and the causality between the events and BNT162B2 was not provided. The other possible cause of the events such as any other diseases was not provided, and the primary reporter''s comment was not provided.


VAERS ID: 1558721 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg
CDC Split Type: PHJNJFOC20210809543

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095280] concerned a 68 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Unknown. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 12:30, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. The action taken with covid-19 vaccine was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: Event (elevated blood pressure) seriousness was updated from nonserious to serious.; Sender''s Comments: V1: 20210809543-Covid-19 vaccine Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1558724 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107300910; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated; Test Date: 202107300925; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg, Elevated; Test Date: 202107300940; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated; Test Date: 202107300955; Test Name: Blood pressure; Result Unstructured Data: 170/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809976

Write-up: Transient Hypertension; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095309] concerned a 50 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 09:10, the patient experienced transient hypertension, patient blood pressure was 180/110 mmHg, On the same day at 09:25 patient had Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. Patient was given clonidine 75mcg tablet via Sublingual (SL) route for transient hypertension, now (to start losartan 100mg/tab daily(OD). At 09:40 blood pressure was 180/110 mmHg and at 09:55, blood pressure was 170/100 mmHg. Patient was discharged. The action taken with covid-19 vaccine was not applicable. The patient recovered from transient hypertension. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case narrative: Event seriousness.; Sender''s Comments: V1-20210809976 - Covid-19 vaccine ad26.cov2.s-transient hypertension. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1558736 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-07-30
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombophlebitis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: RSPFIZER INC202100999407

Write-up: Thrombosis of the right lower leg; thrombophlebitis of the lower right leg; This is a spontaneous report from a contactable consumer or other non hcp. This report is received via regulatory authority. A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EL8723) via an unspecified route of administration on 18Feb2021 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EL8723) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunization. On 30Jul2021, the patient experienced thrombosis of the right lower leg and thrombophlebitis of the lower right leg. Event thrombosis of the right lower leg was considered as medically significant. Doctor was interested in whether thrombosis 6 months after vaccination can be associated with the vaccine. Outcome of the events were unknown. Follow up attempts are completed. No further information is expected.


VAERS ID: 1565979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Lymphadenopathy, Maternal exposure during breast feeding
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976710

Write-up: Swollen lymph nodes; Maternal exposure during breast feeding; Pain in stomach intimitantly; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107310732206210-WV9LL. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25736597. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 29Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history included ongoing breast feeding from unknown start date. The patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial, not had a COVID-19 test and was not pregnant. Concomitant medication included unspecified steroid inhaler daily twice a day start date and stop dates were not mentioned. The patient previously took methylprednisolone acetate (DEPO-MEDRONE) from unknown start date and unknown if ongoing. The patient received historical vaccine including bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced maternal exposure during breast feeding and ''pain in stomach intimitantly''. On 30Jul2021, the patient experienced swollen lymph nodes. It was reported that the patient had pain in stomach ''intimitantly''. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event swollen lymph nodes was not recovered. The outcome of the event ''pain in stomach intimitantly'' was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1566012 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Hypersensitivity, Obstructive airways disorder, Oxygen saturation, Oxygen saturation decreased, Physical examination
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Bronchitis chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210730; Test Name: medical examination; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202100978307

Write-up: Airways obstruction; Dyspnoea; experienced a sudden cough; Oxygen saturation decreased; allergic reaction; This is a spontaneous report from a contactable healthcare professional received from the Agency. Regulatory authority report number is v21122677. An 84-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection), dose 2 at vaccination age of 84-year-old via an unspecified route of administration on 30Jul2021 (the day of vaccination) at 11:27 (Lot Number: EY0583; Expiration Date: 31Oct2021) as a single dose (dose 2, single) for covid-19 immunisation. Medical history included Bronchitis chronic. Body temperature before vaccination was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 30Jul2021 at 11:43 (16 minutes after the vaccination), the patient experienced cough and airways obstruction. On 30Jul2021, the outcome of the event was recovering. The course of the event was as follows: On 30Jul2021 13 minutes after vaccination (11:40), the patient experienced Dyspnea and Cough (event also reported to have occurred 16 minutes after the vaccination). And the patient received a medical examination (unknown results). The patient received a drug of ?2-stimulants via inhalation and returned home after her body condition improved. The reporter classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was Bronchitis chronic which was the medical history. The reporter commented as follows: after vaccination (30Jul2021), the patient experienced a sudden cough and Oxygen saturation decreased. The possibility of an Allergic reaction (30Jul2021) could not be denied. The adverse events required physician office visit. The outcome of the events was recovering.


VAERS ID: 1566035 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107300945; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809583

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095262] concerned a 50 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, one total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 09:45, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case: Event seriousness for event of Elevated blood pressure updated to Other Medically Important Condition, Narrative updated.; Sender''s Comments: V1: Version created to amend Event seriousness for event of Elevated blood pressure updated to Other Medically Important Condition, Narrative updated. This updated information makes the case serious. MAC is assessed as follows. 20210809583- Covid-19 vaccine ad26.cov2.s- Elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1571320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dehydration, Disturbance in attention, Dizziness, Dizziness postural, Eye pain, Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (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: IMPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977224

Write-up: Dizzy on standing; Sore throat; Felt faint; Concentration loss; Dehydration; Sore eyes; Weakness; Headache; Muscle pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202107301736081180-EBOHT, Safety Report Unique Identifier GB-MHRA-ADR 25734576. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 29Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history included suppressed lactation and contraception. The patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial, was not pregnant and was not currently breastfeeding. Concomitant medication included etonogestrel (IMPLANON) taken for contraception. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On 30Jul2021, the patient experienced headache, dizzy on standing, sore throat, weakness, felt faint, muscle pain, fever, concentration loss, dehydration, fatigue and sore eyes. The patient stated that she felt okay after vaccine, but the side effects set in when she woke up the next day and got stronger through the day. The patient underwent lab tests and procedures on an unspecified date, which included sars-cov-2 test: no - negative covid-19 test. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571328 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Headache, Musculoskeletal stiffness, Peripheral swelling, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), 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), COVID-19 (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: Hypothyroidism; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: burning sensation; swollen arm; Rash; Fever; Headache; Shoulder stiff; This regulatory authority case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), PERIPHERAL SWELLING (swollen arm), RASH (Rash), PYREXIA (Fever), HEADACHE (Headache) and MUSCULOSKELETAL STIFFNESS (Shoulder stiff) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Suspected COVID-19 since 30-Jul-2021 and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Shoulder stiff) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (burning sensation) and MUSCULOSKELETAL STIFFNESS (Shoulder stiff) outcome was unknown and PERIPHERAL SWELLING (swollen arm), RASH (Rash), PYREXIA (Fever) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. On an unknown date the patient reports taking a Covid-19 virus test. The results of the test were negative. The patient also reports that the injection site was hard and lumpy with large red circles. She also complained of stiff shoulder. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571335 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Cold sweat, Dizziness, Dizziness postural, Dysstasia, Fatigue, Feeding disorder, Feeling cold, Hallucination, Headache, Heavy menstrual bleeding, Myalgia, Pain of skin, Peripheral coldness, Piloerection, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (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: IMPLANON
Current Illness: Lactation decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: high; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hallucinations; Fever; Cold sweat; Difficulty in standing; Dizziness; Muscle soreness; Vertigo; Unable to eat; Heavy periods; Skin pain; Abdominal pain; Hallucination; Headache; High temperature; Muscle pain; Exhaustion; Dizzy on standing; Feeling cold; Goose bumps; Coldness of skin; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), PYREXIA (Fever), COLD SWEAT (Cold sweat), DYSSTASIA (Difficulty in standing), DIZZINESS (Dizziness), MYALGIA (Muscle soreness), VERTIGO (Vertigo), FEEDING DISORDER (Unable to eat), HEAVY MENSTRUAL BLEEDING (Heavy periods), PAIN OF SKIN (Skin pain), ABDOMINAL PAIN (Abdominal pain), HALLUCINATION (Hallucination), HEADACHE (Headache), PYREXIA (High temperature), MYALGIA (Muscle pain), FATIGUE (Exhaustion), DIZZINESS POSTURAL (Dizzy on standing), FEELING COLD (Feeling cold), PILOERECTION (Goose bumps) and PERIPHERAL COLDNESS (Coldness of skin) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lactation decreased. Concomitant products included ETONOGESTREL (IMPLANON) for Contraception. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant), PAIN OF SKIN (Skin pain) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), HALLUCINATION (Hallucination) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), FEELING COLD (Feeling cold) (seriousness criterion medically significant), PILOERECTION (Goose bumps) (seriousness criterion medically significant) and PERIPHERAL COLDNESS (Coldness of skin) (seriousness criterion medically significant). On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), DYSSTASIA (Difficulty in standing) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant) and FEEDING DISORDER (Unable to eat) (seriousness criterion medically significant). On 31-Jul-2021, HALLUCINATION (Hallucination) and PILOERECTION (Goose bumps) had resolved. At the time of the report, HALLUCINATION (Hallucinations), PYREXIA (Fever), COLD SWEAT (Cold sweat), DYSSTASIA (Difficulty in standing), DIZZINESS (Dizziness), MYALGIA (Muscle soreness), VERTIGO (Vertigo) and FEEDING DISORDER (Unable to eat) outcome was unknown, HEAVY MENSTRUAL BLEEDING (Heavy periods), HEADACHE (Headache), PYREXIA (High temperature), MYALGIA (Muscle pain) and FATIGUE (Exhaustion) had not resolved and PAIN OF SKIN (Skin pain), ABDOMINAL PAIN (Abdominal pain), DIZZINESS POSTURAL (Dizzy on standing), FEELING COLD (Feeling cold) and PERIPHERAL COLDNESS (Coldness of skin) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The patient had extremely cold to touch, felt frozen throughout entire body and had goosebumps from the cold, Continued headache after injection less than 12 hours. The period bleeding when patient did not have periods due to contraception. The patient was feeling of exhaustion and unable to eat. Obvious vertigo and dizziness when standing and hallucinations when high fever. Treatment medication were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. All events were classified as serious by regulatory authority (seriousness criteria: medically important condition). Events seriousness captured as per Regulatory Authority assessment; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. All events were classified as serious by regulatory authority (seriousness criteria: medically important condition). Events seriousness captured as per Regulatory Authority assessment


VAERS ID: 1571336 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Maternal exposure during breast feeding, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (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:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Fever; Muscle ache; Tiredness; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), PYREXIA (Fever), MYALGIA (Muscle ache), FATIGUE (Tiredness) and ARTHRALGIA (Joint pain) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and PYREXIA (Fever), MYALGIA (Muscle ache), FATIGUE (Tiredness) and ARTHRALGIA (Joint pain) had not resolved. No concomitant medication use was reported. No treatment information was provided. This is a case of maternal exposure during breastfeeding with associated AEs of pyrexia, myalgia, fatigue, and arthralgia for this 33-years-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality for the maternal exposure during breastfeeding is not applicable.; Sender''s Comments: This is a case of maternal exposure during breastfeeding with associated AEs of pyrexia, myalgia, fatigue, and arthralgia for this 33-years-old female. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Causality for the maternal exposure during breastfeeding is not applicable.


VAERS ID: 1571339 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspepsia, Headache, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), COVID-19 (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: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976927

Write-up: Headache; Heartburn; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311958204990-RLW7R, Safety Report Unique Identifier GB-MHRA-ADR 25737513. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Jul2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 30Jul2021, the patient experienced headache and heartburn. Since the vaccination, the patient had not been tested positive for COVID-19. The events were serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test negative on unspecified date. Outcome of the event heartburn was recovered on unspecified date in 2021. Outcome of the event headache was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571340 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-30
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Feeling abnormal, Heart rate increased, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Tachyarrhythmia terms, nonspecific (narrow), Medication errors (narrow), Dehydration (broad), COVID-19 (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: increased heart rate; Feeling of increased adrenaline; Inappropriate schedule of vaccine administered; Heart fluttering; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), HEART RATE INCREASED (increased heart rate) and FEELING ABNORMAL (Feeling of increased adrenaline) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). 30-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced HEART RATE INCREASED (increased heart rate) (seriousness criterion medically significant) and FEELING ABNORMAL (Feeling of increased adrenaline) (seriousness criterion medically significant). On 30-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, CARDIAC FLUTTER (Heart fluttering) was resolving and HEART RATE INCREASED (increased heart rate) and FEELING ABNORMAL (Feeling of increased adrenaline) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. The patient had a feeling of increased adrenaline and increased heart rate. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1571343 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, 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: Medical History/Concurrent Conditions: Immunodeficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977102

Write-up: Swollen glands; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108010606537170-WTTSQ, Safety Report Unique Identifier GB-MHRA-ADR 25737789. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as single dose for COVID-19 immunisatio. Medical history included immunodeficiency. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced swollen glands (medically significant) on 30Jul2021 with outcome of not recovered. No follow-up attempts are needed, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1571354 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pain; Shoulder pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain) and ARTHRALGIA (Shoulder pain) in a 30-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form and PARACETAMOL for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (pain) and ARTHRALGIA (Shoulder pain) was resolving. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571362 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: CLENIL MODULITE; FLUOXETINE; TOPIRAMATE
Current Illness: Asthma; Depression; Migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Rash; Nausea; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and RASH (Rash) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Asthma, Depression and Migraine. Concomitant products included BECLOMETASONE DIPROPIONATE (CLENIL MODULITE) from 20-Mar-2019 to an unknown date for Asthma, FLUOXETINE from 14-Sep-2017 to an unknown date for Depression, TOPIRAMATE from 10-May-2021 to an unknown date for Migraine. On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 31-Jul-2021, the patient experienced RASH (Rash). On 31-Jul-2021, RASH (Rash) had resolved. At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided Patient was sleeping most of the time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1571363 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Maternal exposure during breast feeding, Pyrexia, Rash, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal exposures via breast milk (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:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Joint pain; Fever; Blotched rash; Chills; Maternal exposure during breast feeding; Rash; Generalised joint pain; High temperature; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever), RASH MACULAR (Blotched rash), CHILLS (Chills), RASH (Rash), ARTHRALGIA (Generalised joint pain), PYREXIA (High temperature) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced ARTHRALGIA (Generalised joint pain) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), RASH MACULAR (Blotched rash) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Fever), RASH MACULAR (Blotched rash), CHILLS (Chills) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown, RASH (Rash) and ARTHRALGIA (Generalised joint pain) had not resolved and PYREXIA (High temperature) was resolving. Concomitant product was not provided by the reporter. Patient reported that she experienced chills, fever, aches, and joint pain. She developed blotched rashes around neck, jab site, armpits, tummy button and groin. Treatment information was not provided. Company comment- Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: Other). However, as per medical criteria none of the events was serious (not IME listed); Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: Other). However, as per medical criteria none of the events was serious (not IME listed)


VAERS ID: 1571365 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Pruritus, Rash, SARS-CoV-2 test, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (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: BOOTS ALLERGY RELIEF; SERTRALIN [SERTRALINE]
Current Illness:
Preexisting Conditions: Comments: No medical history information was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Itchy; Headache; extremely tired; sweating; red, swollen, tenderness; Skin warm; This regulatory authority case was reported by a consumer and describes the occurrence of SKIN WARM (Skin warm), PRURITUS (Itchy), HEADACHE (Headache), FATIGUE (extremely tired), HYPERHIDROSIS (sweating) and RASH (red, swollen, tenderness) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history information was reported. Concomitant products included SERTRALINE (SERTRALIN [SERTRALINE]) from July 2020 to an unknown date for Depression, CHLORPHENAMINE MALEATE (BOOTS ALLERGY RELIEF) for Hay fever. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced SKIN WARM (Skin warm) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (Itchy) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (extremely tired) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and RASH (red, swollen, tenderness) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN WARM (Skin warm) had not resolved and PRURITUS (Itchy), HEADACHE (Headache), FATIGUE (extremely tired), HYPERHIDROSIS (sweating) and RASH (red, swollen, tenderness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Two raised, red, itchy, warm, tender and solid patches on arm. One golf ball sized, one tennis ball sized around the first and second injection sites. Treatment cold compress and antihistamine. Excessive sweating, migraine like headache and extremely tired. Treatment bed rest and paracetamol. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of event captured per RA report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of event captured per RA report.


VAERS ID: 1571366 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Graves'' disease
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38.3; Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 38; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Low; Test Date: 20210409; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: High temperature; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 04-Apr-2021. Concurrent medical conditions included Graves'' disease. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. On 30-Jul-2021, Body temperature: 38 High. On 01-Aug-2021, Body temperature: 37.3 (Low) Low. On an unknown date, Body temperature: 38.3 High. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Had a temperature 38 and headache that was not cured by my regular medication with Sumatriptan. Took paracetamol Saturday morning temperature was 38.3 and decreased after paracetamol. Was about 38 all day long, felt weakness.; Sender''s Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (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), COVID-19 (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: Medical History/Concurrent Conditions: Gallbladder inflammation; Gallbladder removal (2 years ago.)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Glands; Head pain; Muscle ache; Tiredness; Neck; Pain legs; Gland in neck; This case was received via Regulatory Authority (Reference number: 25744902) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain legs), SWELLING (Neck), LYMPHADENOPATHY (Gland in neck), LYMPHADENOPATHY (Glands), HEADACHE (Head pain), MYALGIA (Muscle ache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Gallbladder inflammation and Gallbladder removal (2 years ago.). Previously administered products included for Product used for unknown indication: MORPHINE. Past adverse reactions to the above products included Allergic reaction with MORPHINE. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced LYMPHADENOPATHY (Gland in neck) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain legs) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Neck) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands) (seriousness criterion medically significant), HEADACHE (Head pain) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain legs), LYMPHADENOPATHY (Gland in neck) and HEADACHE (Head pain) had not resolved and SWELLING (Neck), LYMPHADENOPATHY (Glands), MYALGIA (Muscle ache) and FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. The patient experienced pain in armpit of injection site 4 days after vaccine. The patient had general body aches, pustules on tonsils, and slight pressure in head. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571426 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Cold sweat, Dysphoria, Heart rate, Heart rate decreased, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:64/33; Comments: 15:18; Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:103/47; Comments: 16:00; Test Date: 20210730; Test Name: heart rate; Result Unstructured Data: Test Result:48; Comments: 15:18; Test Date: 20210730; Test Name: heart rate; Result Unstructured Data: Test Result:69; Comments: 16:00; Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:98%; Comments: 15:18
CDC Split Type: JPPFIZER INC202100978267

Write-up: Anaphylactic shock; experienced Dysphoria; experienced a lot of cold sweat; HR48; BP 64/33/BP103/47; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21119448. A 48-year-old (also reported as: ''48-year and 5-month-old'') female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, at age 48 years, on 30Jul2021 15:18 (the day of vaccination) (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes rheumatoid arthritis. During the process of venipuncture and injection, the patient did not experience dysphoria or allergy. Body temperature before vaccination was not provided. The patient''s family history was not provided. The patient''s concomitant medications were not reported. Patient previously took methotrexate (RHEUMATREX) and folic acid (FOLIAMIN) on unspecified dates for rheumatoid arthritis. The event onset date was reported as 30Jul2021 in the afternoon. The course of the event was as follows: on 30Jul2021 at 15:18, the patient received COMIRNATY intramuscular injection. About 10 minutes later, the patient experienced Dysphoria and a lot of cold sweat. BP was 64/33, HR was 48, SPO2 was 98%, consciousness ''illegible characters'', The patient was diagnosed with Anaphylactic shock. The patient received BOSMIN intramuscular injection 0.5mg, Lactec 500ML, and Polaramine 1A DIV. On 30Jul2021 at 16:00, subjective symptoms were disappeared. The patient recovered to BP103/47, HR69 (the level was same as usual). Observation was required. On 30Jul2021, the outcome of the events was recovered. The reporter classified the event as non-serious and assessed that the event was related to bnt162b2. Reporter''s Comment: Observation was required. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Observation was required.


VAERS ID: 1571438 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:131/78; Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210730; Test Name: P; Result Unstructured Data: Test Result:78; Test Date: 20210730; Test Name: SpO2; Test Result: 98 %; Comments: RA; Test Date: 20210730; Test Name: respiratory rate; Result Unstructured Data: Test Result:15; Comments: /min,
CDC Split Type: JPPFIZER INC202100986335

Write-up: Anaphylaxis Grade 2; This is a spontaneous report from a contactable physician received from a regulatory authority. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jul2021 15:25 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) (at the age of 30 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.0 centigrade. The patient previously took minocycline, vibramycine, roxithromycin and experienced Grade 2 anaphylactic reaction. The patient experienced anaphylaxis grade 2 on 30Jul2021 with outcome of recovered. Therapeutic measures were taken as a result of anaphylaxis grade 2. The course of event was as follows: On 30Jul2021 at 15:40 (15 minutes after the vaccination), the patient experienced anaphylaxis. Clinical course was reported as follows: Mild dyspnoea feeling and skin itching appeared 15 minutes after the vaccination. P78, SpO2 98% (RA), BP 131/78, respiratory rate 15/min, body temperature 36.5 centigrade. No abnormalities in the patient''s consciousness level. Cough of small amount, no abnormalities in the respiratory sound. Hot flushes were noted. Anaphylaxis of Grade 2 was diagnosed. On 30Jul2021 at 16:15 (35 minutes after the vaccination), POLARAMINE 1A was administered. On 30Jul2021 at 16:30 (50 minutes after the vaccination), the symptoms disappeared. Risk of biphasic anaphylaxis was explained to the patient, and the patient went back to her parent''s house for her monitoring. On 30Jul2021 (after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and that the event was related to bnt162b2. There were no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Reporting as anaphylaxis caused by COMIRNATY. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporting as anaphylaxis caused by COMIRNATY.


VAERS ID: 1571439 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:100/70; Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100986364

Write-up: Anaphylaxis; loss of consciousness; fell; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21119581. The patient was a 46-year old (at the time of vaccination) female. Body temperature before vaccination was 36.5 centigrade. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included more than 35 years ago when the patient was in an elementary school, the patient experienced giddiness after group vaccination. On 30Jul2021 at 11:50 (the day of vaccination), the patient previously received the first dose of bnt162b2 (COMIRNATY Lot number FD0348, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jul2021 at 11:55 (5 minutes after the vaccination), the patient experienced anaphylaxis after receiving COMIRNATY. Clinical course was reported as follows: About 5 minutes after receiving the COMIRNATY, the patient suddenly experienced loss of consciousness and fell while the patient was under observation at the waiting room. A route was secured and normal saline 100ml was intravenously injected at the treatment room. 0.3 mg of adrenaline 0.1% was intramuscularly injected to the front part of the right thigh. At that time, blood pressure was 100/70. The patient could respond to calling although in a small voice. The patient called emergency aid team and was taken to hospital emergency room by ambulance. On 30Jul2021 (the day of the vaccination), the outcome of the events was recovered. The reporting physician classified the event as serious (Medically Significant) and that the event was related to bnt162b2. There were no other possible cause of the event such as any other diseases. The events resulted in emergency room visit, and therapeutic measures were taken as result of all the adverse events. Outcome of the events was recovered on 30Jul2021. The reporting physician commented as follows: It was good that the event improved by taking measures with Adrenaline intramuscular injection etc. However, if the measures were delayed, there was a possibility that the event could be more severe. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1571512 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 210/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809327

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095276] concerned a 58 year old male with unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: unknown) dose was not reported, frequency time 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 18:23 the patient experienced elevated blood pressure (BP). Laboratory data included: Blood pressure (NR: not provided) 210/120 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021, the following information was updated and incorporated into case narrative: Seriousness criteria for elevated blood pressure was updated as Other Medically Important Condition.; Sender''s Comments: V1: 20210809327- Covid-19 vaccine ad26.cov2.s- Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1571519 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809478

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095292] concerned a 49 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 18:20, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), event onset time updated; Sender''s Comments: V1: Following information was amended in this version: seriousness level of event (elevated BP) was updated to serious from non-serious. 20210809478-covid-19 vaccine ad26.cov2.s -Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1571520 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 220/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210809505

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095294] concerned a 66 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 18:00, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 220/100 mmHg (elevated). The action taken with covid-19 vaccine was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), and event onset time updated.; Sender''s Comments: V1:Upon review following information was amended: event elevated blood pressure reassessed as serious (other medically important condition), and event onset time updated. 20210809505- covid-19 vaccine-ELEVATED BLOOD PRESSURE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1571530 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809811

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095161] concerned a 48 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, at 10:49 the patient''s blood pressure (BP) was elevated and measurements were 200/110 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review, following information was amended: The case was reassessed as serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210809811-COVID-19 VACCINE AD26.COV2.S. Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1571532 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Blood pressure; Result Unstructured Data: 200/80 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809826

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095277] concerned a 65 year old male. The patient''s height, weight and pre-existing medical conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 12:48, the patient experienced elevated BP (blood pressure). The patient''s blood pressure reading was 200/80 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP (blood pressure). This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-AUG-2021. Upon review following information was amended: case was re-assessed as serious and seriousness level of event elevated BP (blood pressure) was updated to serious from non-serious.; Sender''s Comments: V1:20210809826 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- elevated blood pressure- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1571537 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107301134; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210809999

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095268] concerned a 66 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 11:34, the patient experienced elevated blood pressure 180/100. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 05-Aug-2021. Upon review the following information was amended and incorporated into the case: Event seriousness for event of Elevated blood pressure updated to Other Medically Important Condition, Narrative updated.; Sender''s Comments: V1-Version created to amend previously reported information and case was reassessed as serious. 20210809999-COVID-19 VACCINE AD26.COV2.S-Elevated Blood Pressure. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


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