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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 309 out of 7,116

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VAERS ID: 1673341 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Insomnia
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101090332

Write-up: first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021; she can''t sleep; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for herself) communicated to Pfizer sponsored Program. A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 02Aug2021, as single for covid-19 immunisation. On an unspecified date in Aug2021, the patient cannot sleep. Patient stated she received her first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021 and wanted to know if that was ok. She stated she received the first vaccine then went back and got her second at 2 weeks and one day and she was not sure how this happened because (withheld) did not say a word that she was there early. She stated she cannot sleep and should she be freaked out. This case was reported as non-Serious. The patient outcome of the event she cannot sleep was unknown at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673350 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101090747

Write-up: red rashes over my arms, in my elbows, in my face; red rashes on arms, face and elbows, and her arms and face were also itching badly; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm was just a little stiff. The patient got the vaccine and in Aug2021 was having these red rashes on arms, face and elbows, and her arms and face were also itching badly. She wanted to get an idea how long this rash will last. The arm was a little swollen and sore, and felt warm to the touch, but at the time of reporting it seemed that the swelling was down, arm was cool, but the rash. The outcome of feeling of warmth was recovered in Aug2021, outcome of swelling was recovering, and outcome of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1673353 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Fluid retention, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Medical History/Concurrent Conditions: COVID-19; Immunocompromised; Renal surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: low grade fever; Result Unstructured Data: Test Result:99.1
CDC Split Type: USPFIZER INC202101090868

Write-up: low grade fever last night of 99.1; felt like balloons, retaining water/weird feeling; That night her legs were really sore and last night her legs were in a lot of pain; both legs being swollen; large indentations like she was retaining water and they were pretty bad last night and her legs felt like balloons; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3183), via an unspecified route on 21Aug2021 (at the age of 38-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included COVID-19 on Feb2020, immunocompromised and had Major Surgery (half of her kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice) kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice on 18May2021. The patient concomitant medications included HPV VACCINE Injection on 20Aug2021 for unspecified indication. On 21Aug2021, the patient experienced night her legs were really sore and last night her legs were in a lot of pain. They felt like balloons, retaining water and this morning when she checked her socks she had sock lines- she took a bath and still had the sock lines. They are major indentations. It only happens at night when she''s at rest. She also had a low grade fever last night of 99.1. The sock lines really hurt, annoyingly and in both legs. Last night after it was more painful and this morning when she was retaining water she figured she would call and see if this was a normal side effect. Patient stated that she know soreness is a normal side effect but the fact she got sock lines and her legs were like balloons and she felt like she needed those things you get after surgery that they put on your legs and her legs are painful. Patient had a weird feeling. Patient was assured that HPV Vaccine the day before the Covid Vaccine would not interfere with Covid Vaccine. Patient stated that she took pictures of her sock lines on her legs and showed her friend who told her she should call Pfizer. She states the symptoms only seem to occur when her legs are at rest at night. Says they are sore the next morning, but that it goes away. Patient did not visited to Emergency Room/ Physician Office. The outcome of the events was unknown.


VAERS ID: 1673359 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Indiana  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Flushing, Illness, Limb discomfort, Malaise, Musculoskeletal discomfort, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101090997

Write-up: fever; body aches; didn''t feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; This is a spontaneous report from a contactable consumer (patient''s wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization. The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported. Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven''t changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it''s burning really hard again and it''s all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1673361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Loss of consciousness, Pain in extremity, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure increased (few years ago her husband died suddenly from cardiac arrest and her blood pressure increased).
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101091163

Write-up: lose consciousness or pass out; weakness in the legs and arms; woke up with severe pain in legs and arms; Dizziness/light headed; blurred vision; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3180), via an unspecified route of administration, administered in left arm on 30Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included blood pressure increased (few years ago her husband died suddenly from cardiac arrest and her blood pressure increased). The patient''s concomitant medications were not reported. Caller stated she was calling about the Covid vaccine. She worked part time as a caregiver. This past Monday night she started feeling like she was going to lose consciousness or pass out. It started severely on Monday evening. She called her doctor, and she was going to call rescue and then she fell asleep, and it passed. The next day she did not seem to have it then last night it started again but not as severe. Treatment - She went to the doctor as soon as side effects began, within 48 hours after the vaccine. She was not expecting flu like symptoms and fatigue. She clarified she did not get flu like symptoms and fatigue. Weakness in the arms and pain - It was the first thing, and she went to the doctor for that. Attempted to clarify with caller if this was on the first report. Caller clarified that weakness in the arms and pain was on the first report. She woke up with severe pain and weakness in legs and arms. She got her vaccine on 30Jul2021. It started in the middle of the night on 02Aug2021. Weakness in the legs and arms - It has not gone away, and she still has some pain. Treatment ? She went to the primary care every week but both times she was too sick to go into the office. She goes back to doctor next week. This was her third visit at the doctors since having the vaccine with the side effects. If she gets up too quickly, stand up too quickly she gets dizziness, lightheaded and blurred vision. A few years ago, her husband died suddenly from cardiac arrest and her blood pressure increased and she had to go on medication then she was off of it. She had to go back on the blood pressure medication when she had first started feeling like she was going to lose consciousness after the vaccine. She did not want to get the vaccine she got it because she was a caregiver. She went to pharmacy. She was not taking the second dose due to the side effects of the first one. The outcome of the event dizziness/lightheaded and blurred vision was unknown; event weakness in the legs and arms was not resolved; event lose consciousness or pass out and severe pain in legs and arms were resolved on an unknown date in Aug2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Musculoskeletal chest pain, Myalgia, Pain, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101098275

Write-up: Muscle pain and ache; Fever; Bad chills; Injection site pain; Fatigue all throughout that led her to sleep a lot; Fatigue all throughout that led her to sleep a lot; Pain all over her body and ribcage; Pain all over her body and ribcage; Headache including the muscles on it (the one that connects to the bone).; This is a spontaneous report received from a non-contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced muscle pain and ache, fever, bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, pain all over her body and ribcage and headache including the muscles on it. Patient got both doses of the COMIRNATY vaccine and had her 2nd dose 19Aug2021 (Thursday). Post vaccination up until today (5 days to date), she reported experiencing muscle pain and ache. Patient had alongside muscle ache, she also experienced fever and bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, headache including the muscles on it (the one that connects to the bone). She generally reported being down all weekend that led her not to be able to come to work. Additionally, she reported she called urgent care to check if someone has reported to come in with the same AEs that she had. She was also concerned that AEs were because the dose she got was contaminated. The outcome of event was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1673392 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-22
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Facial paralysis, Headache, Laboratory test, Neurological examination, Pain in extremity, Palpitations, Paraesthesia, Paralysis, Skin burning sensation
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (had since she was 16 years old); Pre-diabetes (1-2 years, not on treatment 3 years); Reflux gastritis (the last 10 years had for 7-8 years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: blood work; Result Unstructured Data: Test Result:fine; Test Date: 202108; Test Name: full work up; Result Unstructured Data: Test Result:fine; Test Date: 202108; Test Name: neuro test; Result Unstructured Data: Test Result:fine
CDC Split Type: USPFIZER INC202101102568

Write-up: There''s some funky drooping on this side of the caller''s face/ Facial paralysis; really bad headaches; The pain is gone in the caller''s right arm/ right arm was sore; Stomach pain; skin was being pricked from the inside out; her skin felt like it was burning from the inside out; She had a terrible feeling of her heart racing; Paralysis/ she had right side paralysis; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FC3184, Expiry date was not reported), (at the age 55-year-old) via an unspecified route of administration, administered in Arm Right on 22Aug2021 11am-12noon. as dose 1, 0.3 ML single for COVID-19 immunization at Pharmacy/drug store. Medical history included ongoing asthma had since she was 16 years old, ongoing reflux gastritis the last 10 years had for 7-8 years, ongoing Pre-diabetes 1-3years, not on treatment 3 years. The concomitant medications was not reported. Historical vaccine includes Flu shot on an unspecified date. On Aug2021 patient experienced paralysis/ she had right side paralysis, on 22Aug2021 there''s some funky drooping on this side of the caller''s face/ facial paralysis, really bad headaches, right side was still numb on the caller''s face, the pain was gone in the caller''s right arm/ right arm was sore, stomach pain, skin was being pricked from the inside out, her skin felt like it was burning from the inside out and she had a terrible feeling of her heart racing. Caller was very concerned about the Pfizer COVID-19 vaccine that she received in Aug2021 at withheld. She states that she was experiencing "a lot of side effects" and called VAERS to report her side effects and was told that the lot # she provided, FC3185, was not a valid lot number for the Pfizer COVID-19 vaccine. The caller has spoken with the withheld Pharmacy and two employees verified that this lot number written on her vaccination card was the "correct." The caller also states that maybe the lot # was actually FL3185 due to the inability to read the person''s handwriting on the vaccination card. Placed caller on hold and spoke with withheld in Customer Service. withheld confirmed that neither FC3185 nor FL3185 are valid lot numbers for the Pfizer COVID-19 vaccine. Caller states that she will go to Pharmacy and see the vial and lot number for herself so that she can verify and will call back and report to Drug Safety. The caller was physically looking at the box and the vials. The caller originally thought the lot number was FC3185 but it was confirmed that that lot number was not a Pfizer lot number either according to VAERS and Pfizer. It was reported that the several hours after the vaccine she had side effects. It was reported that the event, right side was still numb on the caller''s face, she had right side paralysis. It was reported that the caller had paralysis and really bad headaches, so she went to the emergency room. The caller''s blood work was fine, neuro test was fine, and full work up was fine. Time the Vaccination Was Given: Between 11 and noon. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The AE require a visit to emergency Room for 4 hours for observation. No prior vaccinations within 4 weeks. The caller declines to elaborate on the side effects that she experienced, as she has already reported this with VAERS. The caller was calling today to report the event involving the incorrect lot number. Caller was really concerned about side effects, she had a really miserable time after the first shot. How much protection does she have with just one dose. She also questioned the lot number, which lot number she actually got. She was having some facial paralysis on the right side face and it has her concerned. There was some numbness in her face. She has been to the doctor and they and they ruled out stroke. Also her heart and blood work was fine. She thinks it was bells palsy that was mentioned with the vaccine. The other concern was the pharmacy that gave her the shot doesn''t have the proper lot number, they mis-represented the product given so she doesn''t even know what she was given. Caller remarks she was in general good health. Caller explains they put the wrong lot on the card. She called and they told her it was right. She explains the Lot provided on the card was FC3185 but it should have been EC3185. It was given on 22Aug2021. The facial numbness on the right side started about an hour after getting the shot, it got worse but now it was about the same and she doesn''t think it will get worse. She was hoping it will wear off and was just a normal side effect. Caller remarks she had loads of side effects but the only one she was concerned with was the facial paralysis. Caller reports after the shot her stomach was in a lot of pain, she had sharp pain in her stomach. It lasted a couple minutes then stopped, it just zipped through her gut. After the shot her skin felt like it was burning from the inside out. Caller clarified this as feeling like her skin was being pricked from the inside out. This started the first day but was better as of last night, 24Aug2021. She had a terrible feeling of her heart racing and almost wanted to faint, she doesn''t think it was nerves either. This lasted about a 2-3 minutes after getting the shot and then resolved. It was hard to sit up in the chair after the shot because of this. She has had really bad headaches since getting the shot. The have been going on for 3 days but are getting better. She couldn''t lay down without a headache but when she got up and walked around it felt better, it was bad. This was why they brought her in to confirm she wasn''t having a stroke. Caller remarks that she got the shot in her right arm and it was sore, but it has resolved at this point. she went to the emergent care and they did a bunch of blood work, it was beautiful and was told she had a strong heart. She was in touch with the top people at withheld and she needs confirmation. It was specifically withheld in the town withheld, it was the only withheld in the town, the withheld number was withheld. She initially called to ask to see if the Lot number can be identified, Lot FC3184. If this was correct. She has photos of the vials and boxed; they all say Pfizer on them. She was able to provide pictures if needed. She has facial numbness that was different now; that was better but was still there. She has no other new events. Time of vaccination was reported as 11am-12noon. The patient underwent lab tests and procedures which included blood test was fine, laboratory test was fine and neurological examination was fine on an unspecified date Aug2021. The outcome of Paralysis/ she had right side paralysis was unknown, there''s some funky drooping on this side of the caller''s face/ Facial paralysis was not resolved and really bad headaches was recovering. On unspecified date in Aug2021, the events the pain is gone in the caller''s right arm/ right arm was sore resolved. On 22Aug2021, the event Stomach pain and She had a terrible feeling of her heart racing resolved. 24-AUG-2021, the event skin was being pricked from the inside out and her skin felt like it was burning from the inside out was resolved. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101103855 Pfizer


VAERS ID: 1673404 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101109334

Write-up: bad headache; felt lethargic; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021,at the age of 45 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced he had bad headache on Aug2021 and felt lethargic on Aug2021.The outcome of the event was recovered.Upon followup received on 26 aug 2021,The patient stated that he took the first shot 3 weeks ago and within 15 mins he got a real bad headache for 3 days with being real lethargic.After second shot of Pfizer vaccine,the headache started 15 to 20 minutes after and he didn''t feel right.The patient didn''t visit the doctor.His employer said he would get fired if he didn''t have a shot. Now he feels terrible and he doesn''t know what to do. Response received from DSU end was,6 OVERALL SAFETY SUMMARY In clinical studies, adverse reactions in participants 16 years of age fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0 Revised: 23 August 2021 Follow-up (26Aug2021): This is a follow-up spontaneous report received from a contactable consumer. This 45-year-old male consumer (patient) reported for himself that Dates for same experience, only worse and the headache start 15 to 20 minutes after was unspecified,He just wants to make someone aware and to see if its normal. His left side of his head down to his neck and face is on fire.Patient wanted to know whether these adverse events are related to the Pfizer covid vaccine.Address, Alternative Telephone, Email address - Caller declined to provide at this time. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673409 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Malaise, Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 Test; Test Result: Positive
CDC Split Type: USPFIZER INC202101110060

Write-up: husband tested positive for Covid-19 infection after the first dose of the vaccine; not feeling well; their arms were sore and tender; fever; chills; cold; coughing; diarrhea; Tension headache; This is a spontaneous report from contactable consumer (Patient''s wife). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient tested positive for COVID-19 infection after the first dose of the vaccine on 23Aug2021, not feeling well, their arms were sore and tender, fever, chills, cold, coughing, diarrhea, tension headache. It was reported that the Comirnaty vaccine and she had questions for herself and mentioned that her husband got it a week and a half ago and he tested positive after getting the 1st vaccine. Caller stated that they both had their Pfizer COVID vaccine on Monday 16Aug2021 and her husband tested positive for Covid on 23Aug2021. States they are scheduled for the 2nd dose 06Sep2021. The patient takes no medication and was very healthy, that if it was not for working with, that with his way of life. The patient normally would not have taken the vaccine but because of he did what was required. Caller stated that the patient was fine and she thought it was Thursday night into Friday he started not feeling well and he doesn''t take any medications and was very healthy. Caller stated after they got their vaccines they sat for half an hour and they both were ok, their arms were sore and tender on the 2nd day they had very tender arms. States her husband did not feel anything and he thought it was just symptoms until Saturday and it was more severe Saturday into Sunday or Sunday into Monday he had chills, was cold, coughing, diarrhea and fever. Caller states her husband was very healthy and had a strict way of eating and living and he wears a mask, sometimes too much for her. Caller states they did get documents, information along with their card and was did not go into great detail and it was worrisome and it was not approved and did not consider how long after the 1st injection, it could be up to 7 days for side effect and it was still in clinical trials. States that now he felt warm today and was resting and has a tension headache since last night on the sides of his head. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Aug2021. The outcome for all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673411 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: CHLOROQUINE
Current Illness: Lupus erythematosus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Immunosuppression
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101110249

Write-up: numbness and tingling in both right and left arm from elbow down; numbness and tingling in both right and left arm from elbow down; weakness in right arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that a 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021), intramuscular, administered in deltoid right on 30Jul2021 (age at vaccination: 30-years-old) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing Lupus, Covid virus from Nov2020. The patient was immunosuppressed. Concomitant medication included ongoing chloroquine taken for Lupus. Historical vaccine included Hepatitis B, as dose 1, single and Second dose of Hepatitis B Series that was not administered at their location was given 10 days prior to Covid vaccine. The patient was received first dose of Pfizer Covid 19 vaccine on 30Jul2021 and no second dose to date. On an unknown date in Aug2021, within 5 to 7 Days she developed numbness and tingling in both right and left arm from elbow down. It was less in left arm and experiencing weakness in right arm. No weakness in her left arm. This was bilateral from the elbow down and not involving the shoulder. The patient experienced side effects after dose 1 of Pfizer Covid 19 vaccine but not the second dose as to date. During conversation between agent and Pharmacist timing of second dose noted. Pharmacist noted that he would refer to HCP and was aware that second dose could be given as late as 42 days. The patient was also immunosuppressed and the patient would like to get the second and third dose. The events of numbness and tingling in both right and left arm from elbow down and weakness in right arm were considered as serious (Medically significant) by reporter (pharmacist). The pharmacist has chosen medical significant since weakness was a part of it. The patient was not visited emergency Room and Physician Office. Relevant tests were none. The outcome of the all events was recovered on an unknown date in Aug2021. Causality was unknown. Post marketing reports for paresthesia as of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. "Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving Pfizer-BioNTech COVID-19 vaccine at any time point is not known, and 3) a causal relationship between Pfizer-BioNTech COVID-19 vaccine and these cases has not been established. Pfizer is unable to make any recommendations regarding the treatment of paresthesia following administration of Pfizer/BioNTech COVID-19 Vaccine; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken." Post marketing reports for paresthesia as of 02Jul2021, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 Vaccine revealed that we have received spontaneous reports of Guillain-Barre syndrome since the market introduction (including conditional marketing authorization and/or emergency use authorization) of Pfizer-BioNTech COVID-19 Vaccine. Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving for Pfizer-BioNTech COVID-19 Vaccine at any time point is not known, and 3) a causal relationship between for Pfizer-BioNTech COVID-19 Vaccine and these cases has not been established. MANAGEMENT GUIDELINES: Pfizer does not have any recommendations regarding the management of Guillain-Barre syndrome in patients who have received Pfizer-BioNTech COVID-19 Vaccine. Clinical judgement based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken".; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events tingling, numbness and weakness of arm and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1673414 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Chills, Feeling hot, Headache, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101110440

Write-up: burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; fever; chills; headache; burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 45-years) on 25Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and experienced bad headache and felt lethargic. On an unspecified date in Aug2021, the patient experienced worse side effects including a burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face, fever, chills and headache. It was further reported that caller wanted to know if headache, feeling of lethargic, fever, chills, and feeling warm from the left side of his head down to his neck including the face is a reported adverse events after getting the Pfizer BionTech Covid-19 Vaccine. In clinical studies, adverse reactions in participants 16 years of age fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0. No information specific to warm sensation on the left side of the body.The clinical outcome for all the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1673417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101110679

Write-up: Rectal bleeding; This is a spontaneous report from a contactable Pharmacist. An adult female Pharmacist (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experiencing rectal bleeding (medically significant). The outcome of event was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up; Sender''s Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rectal Bleeding. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1673419 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Discomfort, Heart rate, Heart rate increased, Heart rate irregular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Beats; Result Unstructured Data: Test Result:140,138; Comments: her beats per minute has went up
CDC Split Type: USPFIZER INC202101111530

Write-up: Its 140, 138, beats per minute. It is persisting, her beats per minute has went up; Heart irregularities/ sky rocketing pulse rates and irregularity; Chest pain; Chest discomfort; Just uncomfortable/uneasy feeling; This is a spontaneous report from a contactable consumer. This contactable consumer (patients husband) reported for a 58-year-old female patient (reporters wife) that, A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 26Jul2021 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included as none. There were no concomitant medications. It was reported that the patient received second dose of COVID vaccine (Lot number- FD8448). In Aug2021 the patient experienced its 140, 138, beats per minute. it is persisting, her beats per minute has went up (medically significant), In 2021 heart irregularities/ sky rocketing pulse rates and irregularity (intermittent and random morning and night), chest pain, chest discomfort, just uncomfortable/uneasy feeling in 2021. Caller was calling because his wife received the covid vaccine. She received her first dose on 26Jul2021 and her second dose on 16Aug2021. After the first dose she experienced an adverse event. She had heart irregularities, chest pain and chest discomfort. She went to her primary care provider and had a physical. She followed up with her physical based on her pulse. She was having skyrocketing pulse rates and irregularity. They are referring her to a cardiologist to fit her for a heart monitor device. It''s been really erratic she can pull up her information from her heart rate. The event heart irregularities was started the first of august week after the dose. In the middle of the night, she was not in pain just uncomfortable and she looked at her watch and its 140, 138, beats per minute. It was persisting, her beats per minute have went up and it''s an uneasy feeling. For the treatment it was reported not yet she was waiting for the appointment to be fitted for a heart monitoring device. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. The AE require a visit to physician Office. No Prior Vaccinations within 4 weeks. AE did not occur following prior vaccinations. Patient underwent lab test and procedure which included Heart rate 140,138 her beats per minute has went up 2021.The outcome of the event its 140, 138, beats per minute. it was persisting, her beats per minute has went up, Heart irregularities/ sky rocketing pulse rates and irregularity was reported as not recovered and the outcome of the events Chest pain, Chest discomfort and Just uncomfortable/uneasy feeling was reported as unknown. No follow-up attempts are possible, no further information expected.


VAERS ID: 1673420 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484. / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram abnormal, Headache, Loss of personal independence in daily activities, Malaise, Myocarditis, Rash, Sleep disorder, Troponin, Troponin abnormal
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: echo; Result Unstructured Data: Test Result:Normal; Test Date: 20210811; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Comments: EKG was ok; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:elevated; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result:0; Comments: troponin came down to zero.; Test Date: 20210819; Test Name: Troponin; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC202101112022

Write-up: the troponin levels were elevated; headache and his chest felt off; headache and his chest felt off; diagnosed with myocarditis; Dizziness; he was not feeling well 6 hours after receiving the vaccine; he couldn''t sleep; he also had a rash too; States the patient can''t do sports or anything; EKG was elevated/once that that resolved the EKG was ok; This is a spontaneous report from a contactable consumer. A male patient of 15-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FA7484), first dose on left arm via an unspecified route of administration on 12-AUG-2021 11:15 at unknown DOSE 1, SINGLE for COVID-19 immunization. No medical history reported. No concomitant medications reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. He was diagnosed a week later with the myocarditis but he was not feeling well 6 hours after receiving the vaccine and it took him seeing so many HCPs and he was just observed and said it was a reaction to the vaccine except that they did Troponin levels at the hospital and the troponin levels were elevated and he was rushed to the Hospital. He states the Troponin levels were done a week after the vaccine was administered and the levels of the troponin were 47 or 46 and thinks it was 46 or 45 and then it dropped down after another couple of hours later down to 37 and in 24 hours the troponin came down to zero. He States the Troponin level was drawn on 19Aug2021 around 2:00 or something and in another hospital two days prior to that he was not feeling well and mostly was going into the hospital due to headache and his chest felt off and they did the troponin levels there per protocol after the Pfizer vaccine and the troponin levels were normal at that time on Tuesday and on Thursday the troponin level was elevated. He States the patient''s headache and dizziness began right after the vaccine about 6 hours later and he couldn''t sleep and she took him to doctors and ENTs. He States the scary part was that he did not have massive chest pain.States the headache resolved about two days ago and the dizziness he still is a little dizzy at times. He States she took him to the cardiologist the day before the vaccine on 11Aug2021 to make sure and they did the echo and EKG because she herself is so neurotic and cleared the patient to get it and the echo and EKG were all normal. He saw the cardiologist prior to the vaccine to make sure he was fine and had no underlying conditions and took him to the pediatrician two times and the ENT and went to another hospital and said he also had a rash too and that was a reaction to the Pfizer covid vaccine and then he got just so much worse so they went to White Plains by ambulance to the (#) because of his Troponin levels. States the rash began and happened after the vaccine 3 days later and is off and on; states the EKG was elevated when the troponin levels were elevated and once that that resolved the EKG was ok and they did the echo after and it was ok and he has to go back for another echo on Monday but there is still pressure in his chest and that is ongoing and maybe a tiny bit better; states the chest pressure has not stopped and began probably around 3-4 days after the vaccine. The outcome for Events for myocarditis, troponin , Malaise, sleep disorder, rash, Loss of personal independence was unknown and for events headache, dizziness, chest discomfort was not recovered. Additional Context: Caller states she was speaking to someone before, states her son got myocarditis because of this Pfizer Covid vaccine, states this is already reported, no reference number provided, caller developed myocarditis after his first dose of the Pfizer Covid vaccine, caller wants to know what do we know about myocarditis and this vaccine as well as if we can guarantee that her son will be okay after getting this vaccine that everyone is pushing. Caller states she provided the Lot number of the vaccine her son received on her previous report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1674607 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-02
Onset:2021-08-01
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001A21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chills, Diarrhoea, Facial pain, Fatigue, Loss of personal independence in daily activities, Paranasal sinus discomfort, Respiratory tract congestion, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PCOS related: Metformin, ovasitol, vitamin D, vitamin B12 ADD: Adderall XR Allergies: Xyzol, Singulair, Flonase, allergy shots HBP: Lisinipril
Current Illness: None
Preexisting Conditions: PCOS, severe seasonal allergies (allergy shots for 11+ years), slightly elevated BP, ADD
Allergies: No know food/medication Environmental/Seasonal: pollen (trees, weeds, grass, etc), cats, horses, dust, molds
Diagnostic Lab Data: COVID-19 test performed on 8/2/21 after telemedicine visit with APRN in my GP?s office. Resulted late on 8/3/2021
CDC Split Type:

Write-up: Started with what I thought was a sinus infection- pain on one side of my face and congestion. Had serious chills and fatigue on Day 1 Fatigue, diarrhea, sinus pressure/congestion Days 2-4 Mild Chest tightening in addition to the symptoms mentioned above on days 4-9 (O2 saturation remained above 97), but ultimately went away and did not require intervention Mild Fatigue continued for ~2 weeks to to the point that I could not maintain my regular work out schedule


VAERS ID: 1674797 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-03-03
Onset:2021-08-01
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Bronchitis, Cough, Dyspnoea, Lower respiratory tract congestion, SARS-CoV-2 test negative, Wheezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase, vitamin D, Zyrtek
Current Illness: None
Preexisting Conditions: Seasonal allergies
Allergies: Iodine, contact fragrance
Diagnostic Lab Data: SARS-CoV-2 RT-PCR (Non-Surgical) TaqPath on Aug 6 2021 - negative
CDC Split Type:

Write-up: Bronchial congestion, wheezing, coughing ... hard to breathe. Initally went to clinic on Aug 6 where I received a COVID 19 test and prescription for Albuterol. After several weeks with no appreciable improvement, saw my PCP. He diagnosed the condition as bronchitis (viral) and prescribed an 8-day course of prednisone which I started on Sep 2. Condition appears to be improving. I have had this sort of bronchitis in years past significantly prior to the COVID pandemic.


VAERS ID: 1674818 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Fatigue, Muscle spasms, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Anti-anxiety Migraine Pain Diabetes
Current Illness: Diabetes Hypertension Fibromyalgia High cholesterol Arthritis Degeneration of the spine Alot more
Preexisting Conditions: Yes
Allergies: Sulfa Gluten
Diagnostic Lab Data: CT scan Bllodtest Chest xray
CDC Split Type:

Write-up: After some time I ended up with shortness of breath, weakness, chest pain, leg cramps, severe fatigue. Went to the ER nothing was found. Went to My PCP as a followup she put me on steroids to see if it would help with shortness of breath as another patient who took vaccine had the same symptoms and ended up in the ER. Dr may think the lining around my heart was inflamed from the vaccine...the steroids helped.


VAERS ID: 1674944 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-25
Onset:2021-08-01
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Vitreous detachment, Vitreous floaters
SMQs:, Accidents and injuries (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flecainide Warfarin Digoxin Finasteride Alfuzosin Vitamin D3
Current Illness:
Preexisting Conditions: Atrial Fibrillation CLL
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Approx 8/09/2021 suffered a ''large'' floater'' in my left eye. Went to see a doctor at Eye Clinic a few days later. Floater was mostly transparent with dark material around the outside of the specimen. Doctor examined and diagnosis was ''Vitreous Detachment''. No medication or other course of treatment is available. Floater is still barely visible with some dark material at the left edge. Retina was not seemingly damaged per the doctor''s examination. Followup appointment in about two weeks (approx 9/18/2021)


VAERS ID: 1675159 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amenorrhoea, Anxiety, Dizziness, Feeling abnormal, Headache, Hot flush, Malaise, Nausea, Night sweats
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Np thyroid
Current Illness: None known
Preexisting Conditions: Hypothyroidism
Allergies: Penicillin
Diagnostic Lab Data: Talked to PA. Was prescribed medicine to try to relieve some of the symptoms
CDC Split Type:

Write-up: Between first and second dose I did not feel good. Thought it was my thyroid but blood work came back good. After second dose, I was thrown into every menopause symptom. Skipped period, headaches, nausea, dizziness, brain fog, anxiety, hot flashes, night sweats.


VAERS ID: 1675298 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-03
Onset:2021-08-01
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Chest pain, Fatigue, Headache, Menstruation irregular, Myalgia, Nausea, Oropharyngeal pain, Tinnitus, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Headacke, vomits, nauseas, chest pain, tremors, noise in my ears, anxiety, sorethroat , muscle pain. Change in period cicle, tireness.


VAERS ID: 1675680 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Dizziness, Immediate post-injection reaction, Lip swelling, Oropharyngeal pain, Periorbital swelling, Pruritus, Swelling, Swelling face, Swollen tongue, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Near immediate swelling, and some itchiness throughout body. Face most severe, lips swelled so they didn?t quite meet. Tongue felt huge. Eyes swollen puffy. Throat scratchy, sore. Stomach upset, also felt kind of scratchy, hard to describe. As it worsened slight dizziness faintish feeling, Pharmacist prepped epinephren but started with anti-histamine, drank lots of water. Swelling gradually slowed. Remained nearby for observation for approximately two hours following vaccination. Symptoms gradually decreased, took more antihistamine at few hours as still feeling mild symptoms


VAERS ID: 1675701 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-28
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: No adverse reactions. Patient received 2 different doses (Moderna as the first dose and Pfizer as the second dose).


VAERS ID: 1675764 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-20
Onset:2021-08-01
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain lower, Abdominal tenderness, Chest pain, Computerised tomogram abdomen abnormal, Electrocardiogram normal, Ovarian cyst, Pain, Troponin normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

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

Write-up: I started feeling abdominal pain/bloating on August 1 around 10am. On August 2 it turned into a more acute pain in my lower right abdomen, so I went to the urgent care. They performed a number of tests and determined it was a 4cm right ovarian cyst. After another day or two the pain went away on it''s own. I haven''t gotten another scan to confirm that the cyst is gone, but the pain is gone. Here''s the Narrative from the note: Patient reports here with abdominal pain as above, exam with right lower quadrant tenderness concern for differential including ileitis, appendicitis ovarian adnexal pathology. Also reported episode of atypical chest pain here EKG and troponin reassuring. Abdominal CT with no signs of obvious colitis ileitis or appendicitis, adnexal cyst appreciated in follow-up on showing 4.0 right centimeter ovarian cyst with avascular septation but no torsion. Patient was here nontoxic-appearing, doubt acute appendicitis or torsion detorsion given history. We discussed close monitoring, strict return precaution and follow-up with primary care provider and OB/GYN for cyst evaluation and if symptoms return or occur or worsen she is instructed to present to the emergency department for follow-up and GYN evaluation as needed


VAERS ID: 1676482 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-30
Onset:2021-08-01
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Extrasystoles, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), 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? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: diabetes
Allergies: flu vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: I FEEL HEART PALPITATIONS, SKIPS A BEAT AND FLUTTERS. wILL SEEK MEDICAL ADVICE


VAERS ID: 1676790 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-24
Onset:2021-08-01
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood iron, Cerebral venous thrombosis, Chills, Dizziness, Haemoglobin decreased, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations: Cerebral venous thrombosis 42 years
Other Medications: Eutirox, Metformin. But when the symptoms of thrombosis began was when I started a hormone treatment. Estarylla.
Current Illness:
Preexisting Conditions: Teeth. Thyroid
Allergies:
Diagnostic Lab Data: Iron and low hemoglobin. Clots in the head.
CDC Split Type:

Write-up: I suffered cerebral venous thrombosis, I was hospitalized for 7 days, I had never stained problems in my blood, I had severe headaches, dizziness, vomiting, chills, I am currently medicated


VAERS ID: 1677071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cold sweat, Fall, Fatigue, Feeling abnormal, Migraine, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210902719

Write-up: FALL; HURT MY KNEES; FELT LIKE I GOT HIT BY A TRUCK; BODY ACHES SO BAD; MIGRAINE; COLD SWEATS ARE INSANE/SWEATING; EXHAUSTED SO TIRED; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches so bad. On AUG-2021, the patient experienced migraine. On AUG-2021, the patient experienced cold sweats are insane/sweating. On AUG-2021, the patient experienced exhausted so tired. On AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt like i got hit by a truck. On an unspecified date, the patient experienced fall, and hurt my knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats are insane/sweating, and the outcome of body aches so bad, migraine, exhausted so tired, fever, felt like i got hit by a truck, fall and hurt my knees was not reported. This report was non-serious.


VAERS ID: 1677077 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Haematochezia, Rectal haemorrhage, Thrombosis, White blood cell count, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADALIMUMAB
Current Illness: Rectal bleeding; Ulcerative colitis
Preexisting Conditions: Comments: No known allergies
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: White blood cells; Result Unstructured Data: Increased
CDC Split Type: USJNJFOC20210904116

Write-up: BRIGHT RED BLOOD IN STOOL; ABDOMINAL PAIN; INCREASED WHITE BLOOD CELLS; POSSIBLE BLOOD CLOT; RECTAL BLEEDING; This spontaneous report received from a patient concerned a 40 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included ulcerative colitis, and rectal bleeding, and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) started on 27-Jul-2021 for moderate to severe ulcerative colitis. On AUG-2021, the patient experienced possible blood clot, rectal bleeding, and white blood cells was increased. On 25-AUG-2021, the patient experienced bright red blood in stool, and abdominal pain. On the same day she visited emergency room (ER) on early hours, and was admitted for increased white cell count, rectal bleeding and possible blood clot. She was hospitalized for 1 day and discharged late on 26-AUG-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased white blood cells, possible blood clot, rectal bleeding, bright red blood in stool, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender''s Comments: V0: 20210904116-COVID-19 VACCINE AD26.COV2.S -Possible blood clot, Increased white blood cells. 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. 20210904116-COVID-19 VACCINE AD26.COV2.S - Rectal bleeding, Bright red blood in stool, Abdominal pain. 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, UNDERLYING DISEASE


VAERS ID: 1677078 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210905531

Write-up: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a male of unspecified age. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 30-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210906607.


VAERS ID: 1677162 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C2A1 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to animals; Allergy to nuts; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Patient was Covid positive back in April of 2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Confusion; Back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C2A1) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (Patient was Covid positive back in April of 2021) in April 2021. Concurrent medical conditions included Allergy to nuts, Allergy to animals and Penicillin allergy. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain). At the time of the report, CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.


VAERS ID: 1677202 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: White blood cell count; Result Unstructured Data: High- Before vaccination
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Just a very sore arm for a while, lasted of couple a weeks; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (just a very sore arm for a while, lasted of couple a weeks) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MYALGIA (just a very sore arm for a while, lasted of couple a weeks). At the time of the report, MYALGIA (just a very sore arm for a while, lasted of couple a weeks) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High- Before vaccination. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient said that last summer went to ER because a problem with intestines and that white blood cells high (before vaccination) so was taking medication for that. Patient did not take medication to treat symptoms. No Concomitant medications were provided.


VAERS ID: 1677240 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Limb discomfort
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: USMODERNATX, INC.MOD20212

Write-up: "one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal"; infall her limbs; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs). At the time of the report, CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient''s CBC including platelets is normal. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1677271 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-22
Onset:2021-08-01
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042L20A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alopecia
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: CARDIZEM [DILTIAZEM HYDROCHLORIDE]; CRESTOR; FOLIC ACID; PREMARIN; NEURONTIN; ASPIRIN (E.C.); CENTRUM VITAMINTS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Hair loss, entire strand including the bulb; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, entire strand including the bulb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020BZ1A) for COVID-19 vaccination. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID, ESTROGENS CONJUGATED (PREMARIN), GABAPENTIN (NEURONTIN), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CENTRUM VITAMINTS for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (Hair loss, entire strand including the bulb). At the time of the report, ALOPECIA (Hair loss, entire strand including the bulb) outcome was unknown. No Treatment medications were reported.


VAERS ID: 1677292 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Cough, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache, Myocardial necrosis marker, Oxygen saturation, Palpitations, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELDERBERRY [SAMBUCUS NIGRA]; CITRUCEL
Current Illness:
Preexisting Conditions: Comments: No medical history information provided.
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: EKG; Test Result: Inconclusive ; Result Unstructured Data: heart was little jumpy; Test Date: 20210827; Test Name: Heart enzymes; Result Unstructured Data: normal; Test Date: 20210827; Test Name: oxygen levels; Result Unstructured Data: good; Test Date: 20210827; Test Name: vitals; Result Unstructured Data: good
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: heart was a little jumpy; chest began to feel heavy/Chest pressure /pain then would move from my heart to my right side back to the center over and over, constant; Chest pain / The chest pain then began to make me feel almost faint; weak feeling; Tiredness/fatigue; Headache; feel almost faint; hard to catch my breath; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was a little jumpy), ASTHENIA (weak feeling), DIZZINESS (feel almost faint), CHEST DISCOMFORT (chest began to feel heavy/Chest pressure /pain then would move from my heart to my right side back to the center over and over, constant), CHEST PAIN (Chest pain / The chest pain then began to make me feel almost faint), HEADACHE (Headache) and FATIGUE (Tiredness/fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information provided. Concomitant products included METHYLCELLULOSE (CITRUCEL) for Constipation, ELDERBERRY [SAMBUCUS NIGRA] from 2020 to an unknown date for an unknown indication. On 25-Aug-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (feel almost faint) (seriousness criterion hospitalization), DYSPNOEA (hard to catch my breath) and COUGH (Dry cough). On 26-Aug-2021 at 5:00 AM, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization). On 26-Aug-2021 at 2:00 PM, the patient experienced ASTHENIA (weak feeling) (seriousness criterion hospitalization) and FATIGUE (Tiredness/fatigue) (seriousness criterion hospitalization). On 26-Aug-2021 at 6:00 PM, the patient experienced CHEST PAIN (Chest pain / The chest pain then began to make me feel almost faint) (seriousness criterion hospitalization). On 27-Aug-2021, the patient experienced PALPITATIONS (heart was a little jumpy) (seriousness criterion hospitalization) and CHEST DISCOMFORT (chest began to feel heavy/Chest pressure /pain then would move from my heart to my right side back to the center over and over, constant) (seriousness criterion hospitalization). The patient was hospitalized on 27-Aug-2021 due to ASTHENIA, CHEST DISCOMFORT, CHEST PAIN, DIZZINESS, FATIGUE, HEADACHE and PALPITATIONS. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 30-Aug-2021, FATIGUE (Tiredness/fatigue) had resolved. On 31-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, PALPITATIONS (heart was a little jumpy), ASTHENIA (weak feeling), DIZZINESS (feel almost faint), DYSPNOEA (hard to catch my breath) and COUGH (Dry cough) outcome was unknown and CHEST DISCOMFORT (chest began to feel heavy/Chest pressure /pain then would move from my heart to my right side back to the center over and over, constant) and CHEST PAIN (Chest pain / The chest pain then began to make me feel almost faint) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Electrocardiogram: heart was little jumpy (Inconclusive) heart was little jumpy. On 27-Aug-2021, Myocardial necrosis marker: normal (normal) normal. On 27-Aug-2021, Oxygen saturation: good (normal) good. On 27-Aug-2021, Vital signs measurement: good (normal) good. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that some urine and blood samples were taken. Patient was treated with anti-inflammatory drugs and administered IV bag. Patient was advised to take ibuprofen. Patient was scheduled to take second dose of vaccine on 22-Sep-21. 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. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added reporter details, patient details, lab data, suspect details, concomitant and treatment medications, added events.; 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. Further information has been requested.


VAERS ID: 1677359 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Bone swelling, Dysgeusia, Mass, Pain, Palpitations, Pyrexia, Swelling, Thirst
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Medical History/Concurrent Conditions: Blood pressure high; Mitral regurgitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101023576

Write-up: 48 hours after multiple lumps; Lumps on collarbone, armpit 7pm; Lumps on collarbone, armpit 7pm; Weird chemical taste in mouth; Fever chills; So thirsty; Radiating pain left side; Heart palps; Back pain; Swelling; Left upper side of body stilltender/sore; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 02Aug2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve regurgitation and blood pressure high (reported healthy otherwise). The patient was allergic to PHENERGAN. Prior to the vaccination ,it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 01:30, 14 hours after shot the patient had fever chills, thirsty, radiating pain left side, heart palpitations and back pain. On 03Aug2021 at 19:00, approximately 30 hours after shot the patient had lumps on collarbone, armpit and had weird chemical taste in mouth. On 4Aug2021, 48 hours after multiple lumps felt swelling. On an unknown date in Aug2021, one week after shot the patient had collarbone swelling and left upper side of body was tender/sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever chills, so thirsty, radiating pain left side, heart palpitations, back pain, lumps on collarbone, armpit, weird chemical taste in mouth, multiple lumps felt, swelling and left upper side of body still tender/sore were not recovered at the time of this report


VAERS ID: 1677360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: Penicillin); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101023661

Write-up: Minor joint pain, mainly in knees; Minor headache; Feeling blah (washed out); Soreness in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in Aug2021, on day one, the patient experienced minor joint pain, mainly in knees that lasted one day, minor headache that lasted one day, feeling blah (washed out) lasted one day and soreness in the arm that lasted three days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events minor joint pain, mainly in knees, minor headache, feeling blah (washed out) were resolved on an unknown date in Aug2021, after a duration of one day; while that of the soreness in arm was resolved on unknown date in Aug2021, after a duration of three days. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1677371 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Nausea, Oropharyngeal pain, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101029755

Write-up: Sweats; Chills; Body aches; Nausea; Vomiting; Diarrhea; Headache; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced sweats, chills, body aches, nausea, vomiting, diarrhea, headache, sore throat. Patient reported as got everything except for the taste and the fever from it. The outcome of the events was unknown.


VAERS ID: 1677384 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Varicella
SMQs:, Opportunistic infections (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: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19? : Yes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101034989

Write-up: Chicken pox; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jul2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 01Aug2021 at 14:00, the patient had chicken pox. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported event which included treatment with unspecified medications. The clinical outcome of event chicken pox was not resolved at the time of this report.


VAERS ID: 1677398 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Lip pruritus, Lymphadenopathy, Oral pruritus, Pain in extremity, Pruritus, Sinus pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS (Known allergy: yes); Blood pressure high; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101040233

Write-up: Itchy mouth and lips; Itchy mouth and lips; Itchiness; Sore arm; Headache; sinus pain for one day; Enlarged lymph nodes under arm, right breast, under neck and down sides of neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 01Aug2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood pressure high and unspecified allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had known (unspecified) allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 13:30, the patient experienced itchy mouth and lips, itchiness, sore arm, headache, sinus pain for one day, enlarged lymph nodes under arm, right breast, under neck and down sides of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sinus pain for one day was recovered on unknown date in Aug2021 and of the itchy mouth and lips, itchiness, sore arm, headache and enlarged lymph nodes under arm, right breast, under neck and down sides of neck was not recovered at the time of this report.


VAERS ID: 1677416 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: CLONAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Panic attacks; Tinnitus (My tinnitus loudness has tripled. It was barely noticeable before the shot,)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101050060

Write-up: My tinnitus loudness has tripled. It was barely noticeable before the shot, now it is very noticeable; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FL3180), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included Prone to panic attacks, anxiety, tinnitus. Tinnitus loudness has tripled. It was barely noticeable before the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clonazepam. The patient experienced "my tinnitus loudness has tripled. it was barely noticeable before the shot, now it is very noticeable" in Aug2021. Facility where the most recent COVID-19 vaccine was administered pharmacy or drug Store. The case was non serious as it did not meet any of the seriousness criteria. No treatment was given for the event. The event did not cause hospitalization Prolongation. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1677423 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Pain, 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:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Because he did had Covid back in Dec.)
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: USPFIZER INC202101051483

Write-up: Fever; Body ache; Headache; He just did not feel good; Chills; This is a spontaneous report from a contactable Consumer (Reporter''s husband). A male patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on 11Aug2021, as a single dose for COVID-19 immunization. The patient''s medical history included COVID-19 on Dec2020. The patient''s concomitant medications were not reported. On an unspecified date Aug2021, the patient experienced Fever, Body ache, Headache, He just did not feel good, and Chills. On an unspecified date Dec2020, the patient underwent lab tests and procedures which included Covid-19 test: Positive. The outcome for all the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1677427 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7N85 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Blood test, Body temperature, Feeling abnormal, Illness, Laboratory test, Liver function test, Mucosal infection, Oropharyngeal pain, Pain in extremity, Pulmonary function test, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: SYNTHROID; COUMADIN
Current Illness: Hearing decreased; Thyroid disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (Verbatim: had a stroke about 10 years ago)
Allergies:
Diagnostic Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown; Test Name: Fever; Result Unstructured Data: Test Result:99.6; Test Name: Fever; Result Unstructured Data: Test Result:98.4; Test Name: Fever; Result Unstructured Data: Test Result:It goes up and down but doesn''t go past 100; Test Name: Kidney; Result Unstructured Data: Test Result:excellent; Test Name: Liver; Result Unstructured Data: Test Result:excellent; Test Name: Lungs; Result Unstructured Data: Test Result:excellent
CDC Split Type: USPFIZER INC202101057753

Write-up: She has been experiencing fevers on and off and loss of sense of taste.; She states that her arm began hurting almost immediately after the injection/It just started aching like crazy down her finger tips; She is still sick; She states that her arm began hurting almost immediately after the injection/It just started aching like crazy down her finger tips; She was going crazy and has lost her taste buds; So much mucous is coming back up. She has some mucous and guesses that it is a mucous infection or something.; Slight sore throat on one side of the throat; Feeling miserable/She was going crazy; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FA7N85), via an unspecified route of administration, administered in Arm Left (top part left arm) on 02Aug2021 (probably 13:00 in the afternoon) (age at vaccination was 91-year-old) as DOSE 1, SINGLE for covid-19 immunization. The medical history of the patient included stroke about 10 years ago, ongoing thyroid and she commented she was 91 and was slightly losing a little hearing. Patient concomitant medications included levothyroxine sodium (SYNTHROID), has been taking for years for thyroid and warfarin sodium (COUMADIN) for stroke, her doctor insists that she takes it all of the time. Had blood work a week or so before. Her kidneys and liver are excellent, her lungs are excellent. Her doctor said to keep doing what she was doing, that she was in good shape. Now, she is going downhill. Prior to vaccinations (within 4 weeks), patient Not, took any things. Patient stated that she was calling regarding the Pfizer shot that she got the first of this month. States that she does not know which one, that she got it at the withheld. Clarified that it was the Pfizer shot for the Covid virus. She got the shot Monday (02Aug2021), the first of the month (clarified date was 02Aug2021). She was going into a group at her church and about 100 people were going to be there, so she got the shot. She went Tuesday, Wednesday, Thursday and then Friday morning (07Aug2021), her arm started killing her where she got the shot. It was hurting her and then it finally left. Then, she got a fever and has had a fever for 11 days. She does not know what to do. She was going crazy and has lost her taste buds. What was she to do? During interaction she commented she was 91 and was slightly losing a little hearing. It started Friday that her arm starting killing her, hurting it was the whole arm. It just started aching like crazy down her finger tips. States she was still sick. She just wants to know what to do about this. Does she had Covid? She has been feeling miserable for 11 days with a fever. It hasn''t gone past 99.6 but has gone down to 98.4. It goes up and down but doesn''t go past 100. Caller was advised to contact her primary care provider for any medical advice. When probed for details about the pain in her arm she initially provided it started after the first, so it was 06Aug2021. She initially stated she has had it for 11 days, the pain in her arm. When probed for outcome, she later stated, the pain, she got it, it hurt like crazy and then went away that day, that morning. Then the fever set in. She confirmed the fever set in on 07Aug2021. It has gone up and down, every day and every night. It was still going on today. Patient called her doctor and he said to take some Tylenol. She took Tylenol for the fever and it kind of subsided and she felt a little better. Then, she got sleepy and went to sleep. The patient stated that, she has much mucous was coming back up. She has some mucous and guesses that it is a mucous infection or something. What a sad case. This has been going on for 11 days. She might have had a slight infection. She was not sure if it was infected. She has a slight sore throat on one side of the throat that she had before she went for the Covid. Clarified with the caller that the loss of her taste buds has been occurring during these 11 days. Water tastes bad, taste of food is terrible, it is terrible trying to eat anyway, sick. At the time of this report event arm began hurting almost immediately after the injection was recovered on an unknown date in Aug2021, events fevers on and off and still sick was not recovered other event outcome was unknown.


VAERS ID: 1677436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Influenza like illness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101064938

Write-up: flu like symptoms; headache; some muscle ache; This is a spontaneous report received from contactable consumer (patient''s husband). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 16Aug2021 (lot number: FA7485) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, some muscle ache and headache on an unknown date Aug2021. Consumer stated, "Now the symptoms are very mild just got some muscle ache and headache. The outcome of the events was unknown. Information on the lot/ batch number has been requested.


VAERS ID: 1677438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB-EW0191 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Discomfort, Mouth ulceration, Oral disorder
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065083

Write-up: ulcerations in her mouth; She got lesions in her mouth; my wife is in a lot of discomfort; This is a spontaneous report from a contactable consumer. This consumer (patient''s husband) reported for a female patient (reporter''s wife). A female patient received bnt162b2 (COMIRNATY, solution for injection Batch/Lot Number: FB-EW0191), via an unspecified route of administration on 16Aug2021, dose 1, single for covid-19 immunization. Patient medical history and patient concomitant medications were not reported. On 16Aug2021 (same day of the vaccination) 4 hours after they got home his wife had adverse reactions. She got lesions in her mouth and dentist called it ulcerations in her mouth. Patient is in a lot of discomfort. The outcome events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1677442 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Feeling abnormal, Illness, Pyrexia, Thinking abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Test Date: 20210817; Test Name: Fever; Result Unstructured Data: Test Result:102
CDC Split Type: USPFIZER INC202101065906

Write-up: Feeling so sick right now, I can''t even think straight; Feeling so sick right now, I can''t even think straight; Full body chills; Fever of 102; Feel bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 09Aug2021 16:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then evening started to have really bad adverse effects, had full body chills, a fever of 102, on 17Aug2021, feeling so sick right now, patient could not even think straight and Feel bad. The patient underwent lab tests and procedures which included body temperature: 102 degree centigrade on 17Aug2021. The patient was suggested to reach out to nearest Physician in case of emergency room in case of any medical emergency. The outcome of the event feel bad was unknown and other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1677476 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cerebrovascular accident, Dizziness, Fatigue, Feeling jittery, Headache, Heart rate, Heart rate increased, Hypertension, Hypoaesthesia, Inflammation, Nausea, Pain in extremity, Paraesthesia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (always had it, Runs in her family); Congestive heart failure (Diagnosed with Congestive heart failure prior to the vaccine).
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:200s/ high; Comments: her blood pressure was running in the 200s; Test Date: 20210811; Test Name: Heart rate/ pulse; Result Unstructured Data: Test Result: Increased/ irregular; Comments: Increased heart rate with rapid pulse/ my pulse race really hard.
CDC Split Type: USPFIZER INC202101091368

Write-up: Increased heart rate with rapid pulse/ pulse racing; Weakness, tingling, numbness in both arms and legs; Weakness, tingling, numbness in both arms and legs; Weakness, tingling, numbness in both arms and legs; Feeling real real tired; Feeling jittery; Nausea; Headache; Sore arm/ clarified sore in the injection arm; Sore arm/ clarified sore in the injection arm; Her blood pressure was running in the 200s.; She knew it was inflammation around the heart, lungs, and liver that can cause a problem; dizzy; don''t know if that a sign of having stroke; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC3181), via an unspecified route of administration, administered in right arm on 10Aug2021 at 19:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunization. Medical history included family history of high blood pressure (and patient always had it, As high as 200) and Patient diagnosed with congestive heart failure from an unknown date and unknown if ongoing (prior to the vaccine). There were no concomitant medications. On 10Aug2021, after vaccination, sore arm or sore in the injection arm (began 3 to 4 hours after the vaccine), nausea (5 to 6 hours after the vaccine, lasted couple hours), headache (and every day since the vaccine, but getting better, comes and goes), feeling real real tired (Began right after the vaccine, Feels energy drained) and feeling jittery (Began after the shot, hasn''t stopped, it''s on and off, it''s better after the blood pressure. Can feel her pulse real fast and heart like it''s beating out of her chest). On 11Aug2021 at 02:00, patient experienced increased heart rate with rapid pulse or pulse racing; weakness, tingling, numbness in both arms and legs (Clarified it went on 4-5 days). On an unknown date in Aug2021, patient had blood pressure running in the 200s, inflammation around the heart, lungs, and liver that can cause a problem, sign of having stroke and dizzy. It was reported patient had symptoms of a sore arm which she can handle, patient work in the medical field, she had nausea, headache everyday and all that, Patient looked online and it says if you had allergic reaction and it had a list of the symptoms well the same day maybe 2 or 3 hours later heart, patient have a high blood pressure, heartbeat felt like it was going to beat out of body and pulse was racing, heartbeat and the pulse, And patient wants to know is that normal and states she could have an allergic reaction and asks if you have irregular heartbeat, how high. Patient arms and legs feel numb and feel jittery, and don''t know if that a sign of having stroke but feel jittery and arms and legs for 4 or 5 days and rapid heart beat came on the same night she took a shot, 5 hours later her chest and pulse was racing. Patient went to work night shift at 2:00 it hit her with racing pulse and heartbeat lasted an hour got up dizzy. It just scared her; she could stand there and feel how bad her heart and pulse was beating. She needed to go to the ER but couldn''t leave. Patient went to emergency room because she had a headache and her blood pressure was running in the 200s. Had to get an IV to bring it down. Patient had Numbness and tingling in arms for 5 to 6 days. Patient tried to get an appointment to have her heart checked out and blood work done, but can''t get an appointment for 2-3 months. Sore lasted just a couple days, it''s gone. Patient knows it''s inflammation around the heart, lungs, and liver that can cause a problem and asks is there something to get rid of that, and asks if to take shots of antioxidants and B12. Patient was scheduled to get her second shot on 31Aug2021 and wanted to know if she could get the second dose because she read about an allergic reaction, and doesn''t know if she''s going to take the chance and get the second shot. Patient want to be protected by and was scared to take it because of the reaction after getting the first vaccine, because it made blood pressure and pulse race really hard. Patient states vaccine could kills her or stops her heart, and may lead to ended up dying or something she don''t know what to do. Patient wants a letter by Health Care Professional that she had allergic reaction to vaccine which she can take to work. The patient underwent lab tests and procedures which included blood pressure resulted 200s or high in Aug2021 (her blood pressure was running in the 200s) and heart rate resulted as increased or irregular on 11Aug2021 (increased heart rate with rapid pulse or my pulse race really hard). Therapeutic measures were taken as a result of her blood pressure was running in the 200s. The event her blood pressure was running in the 200s resulted in emergency room visit. The outcome of the event inflammation around the heart, lungs, and liver that can cause a problem and sign of having stroke was unknown; outcome of feeling real real tired was not recovered; outcome of feeling jittery and headache was recovering; outcome of events nausea recovered on 10Aug2021, increased heart rate with rapid pulse or pulse racing recovered on 11Aug2021, and rest of the events recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1677495 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lower respiratory tract infection, Menstruation irregular, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bee sting hypersensitivity; Breast cancer; Milk allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101097695

Write-up: Chest cold symptoms; Missed period X5 days (still awaiting cycle as of date); extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose); This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Aug2021 at 10:0 AM, at the age of 38 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included breast cancer, allergy to taxol chemo drug, dairy and bee venom. The patient received the first dose of BNT162B2 vaccine on 13Jul2021 at 10:00 AM, at the age of 38 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On an unspecified date in Aug2021, after the second dose, the patient experienced chest cold symptoms for 3 weeks, missed period for 5 days (still awaiting cycle as of date), extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose). The events required treatment with OTC pain medications. Events outcome was unknown. COVID was not tested after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1677501 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: TYLENOL; NYQUIL; VITAMIN C [ASCORBIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to molds (Illness/AE: Seasonal Allergies, mostly mold. Onset Date: 2-3 years ago.); Seasonal allergy (Illness/AE: Seasonal Allergies, mostly mold. Onset Date: 2-3 years ago.)
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID 19 RTQ PCR; Test Result: Positive ; Comments: Positive released 23 Aug 2021 at 5:16 am. Blood PCR test
CDC Split Type: USPFIZER INC202101098249

Write-up: Body aches; Her wife got the first dose of the Pfizer BioNTech covid-19 vaccine on 17Aug2021 and tested positive for covid last 23Aug2021; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 17Aug2021 12:47 (at the age of 39 years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included Seasonal Allergies, mostly mold from onset Date: 2-3 years ago, from an unknown date and unknown if ongoing. Concomitant medications paracetamol (TYLENOL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL), vitamin c [ascorbic acid] taken for an unspecified indication start and stop date were not reported. The patient experienced her wife got the first dose of the pfizer biontech covid-19 vaccine on 17aug2021 and tested positive for covid last 23Aug2021 on 23Aug2021 05:16, nausea on unknown date in Aug2021, body aches on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test is positive on 23Aug2021: Positive released 23 Aug 2021 at 5:16 am. Blood PCR test is done. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.s


VAERS ID: 1677514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bowel movement irregularity, Chills, Confusional state, Disturbance in attention, Dyspnoea, Gait inability, Hypersomnia, Loss of consciousness, Movement disorder, Musculoskeletal stiffness, Pain, Pruritus, Swelling, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101100495

Write-up: feeling like I was going to pass out; aches, and pains; itching of my torso; left arm wouldn''t raise up all the way; shortness of breath; confusion; I couldn''t concentrate; uncontrollable bowel movements; started sleeping all the time; I have got vertigo really-really bad/this vertigo just keeps getting worse; my neck is been stiff/I started getting stiff in my neck from below my lower left right ear down to the front of my collarbone; I can''t even walk/I couldn''t walk; swelling; chills; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD8448, Expiry Date: Unknown) via an unspecified route of administration on 12Aug2021 (two weeks ago, Thursday) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had lots of side effects from the shot I had 11 days ago, she had got vertigo really-really bad to the point I can''t even sometimes function and so bad two days ago, I can''t even walk and my neck is been stiff had swelling and the chills and other symptoms when she first got it. Within two hours she began experiencing chills, aches, and pains, itching of my torso, and my left arm wouldn''t raise up all the way (12Aug2021). And then around the same time she started getting stiff in her neck from below my lower left right ear down to the front of my collarbone (on an unspecified date in Aug2021); was really painful and then she started sleeping all the time (on an unspecified date in Aug2021), and I got vertigo (on an unspecified date in Aug2021) that just kept getting worse instead of better. And by the seventh day she could barely move her neck at all, was having trouble balancing or walking because of the vertigo. By the eighth day I couldn''t walk. The neck wasn''t quite as bad; the vertigo was still there. The stiffness, she had uncontrollable bowel movements (on an unspecified date in Aug2021), got shortness of breath (on an unspecified date in Aug2021), confusion, feeling like she was going to pass out (on an unspecified date in Aug2021), she could not concentrate (on an unspecified date in Aug2021). And just walking to the bathroom she felt like she ran five miles and am out of breath, her torso was still itching but not as bad. The patient questioned how long does this last and do you know there on the CDC website in their website it does not say anything about. How long it last or what going on with it? Does this someone percent reported it? she stated that she did not have a doctor, and everyone, including the vaccination provider keeps referring her back to her doctor. And then she was told to call Pfizer, she does not have insurance and asked if Pfizer was going to cover the costs of her medical care, she declined contact information for Pfizer Legal, stating she would call back another time when someone can write it down for her since she cannot concentrate well right now, she asked if she should get the second dose of the Pfizer Covid-19 Vaccine after experiencing these side effects after the first dose. The patient was instructed that as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. her healthcare provider knows your health situation and has access to information that could better help inform this decision. The patient explained that those were the only reference numbers she has but she has filed a report with Pfizer specifically, she filed a report with everyone. When providing the spelling to her name, she missed to speak a letter and remarked she was sorry, she has some confusion. The patient took treatment with Benadryl and it let off some of the symptoms (unspecified). And today (on an unspecified date in 2021) she felt a little bit better as far as most of the symptoms (unspecified) but the vertigo keeps coming on, she was scared to drive, was still having aches and pains. The event of feeling like I was going to pass out was considered as Serious (Medically Significant). The outcome of the events aches, and pains was of not recovered, i have got vertigo really-really bad/this vertigo just keeps getting worse was not recovered, the outcome of events my neck is been stiff/i started getting stiff in my neck from below my lower left right ear down to the front of my collarbone, i can''t even walk/i couldn''t walk, swelling, chills was of recovered on an unspecified date in Aug2021, The outcome of events feeling like i was going to pass out, itching of my torso, left arm wouldn''t raise up all the way, shortness of breath, confusion, i couldn''t concentrate, uncontrollable bowel movements, started sleeping all the time was unknown.


VAERS ID: 1677520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Malaise
SMQs:, Anaphylactic reaction (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: Heart disorder (need for new heart and lung (further not clarified)); Lung disorder (need for new heart and lung (further not clarified))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101103237

Write-up: Keep coughing, it is so hard on heart and really bad dry cough; he is not doing very well; not doing very well; This is a spontaneous report from a contactable consumer reporting for the son. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date on 21Aug2021 (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history included need for new heart and lung (further not clarified). The concomitant medications were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date in 2021 3 weeks ago (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation (received in the Hospital) and experienced needed "new Heart and Lung". In Aug2021 the patient experienced got so hard and kept coughing, it was so hard on heart and really bad dry cough; he was not doing very well with outcome of unknown. Coughing was so hard on his heart. This report was not related to a study or programme. Information about lot/batch number has been requested.


VAERS ID: 1677529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-10
Onset:2021-08-01
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Platelet count, Platelet count decreased, Rash, T-lymphocyte count decreased, White blood cell count, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: Medical History/Concurrent Conditions: Chronic kidney disease; Congestive heart failure
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: platelet count; Result Unstructured Data: Test Result:down; Comments: my platelet count is down.; Test Date: 2021; Test Name: T-cell count; Result Unstructured Data: Test Result:down; Comments: my T-cell count.; Test Date: 2021; Test Name: white count; Result Unstructured Data: Test Result:down; Comments: My white count is down.
CDC Split Type: USPFIZER INC202101110587

Write-up: My face had broken out a little bit by my cheek and at the base of one of the sides of my nose; my platelet count is down; white count is down; my T-cell count is down; This is a spontaneous report from a contactable consumer or other non hcp. A 8-decade-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac failure congestive from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced my t-cell count is down on 2021, my face had broken out a little bit by my cheek and at the base of one of the sides of my nose on Aug2021, my platelet count is down on 2021, white count is down on 2021. The patient underwent lab tests and procedures which included platelet count: down on 2021 my platelet count is down, t-lymphocyte count decreased: down on 2021 my T-cell count, white blood cell count: down on 2021 My white count is down. Therapeutic measures were taken as a result of my face had broken out a little bit by my cheek and at the base of one of the sides of my nose was Amoxicillin 500mg three times daily and bacitracin and cortisone via topical route of administration. The outcome of the events t-lymphocyte count decreased, rash, platelet count decreased, white blood cell count decreased was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1677540 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache, Illness, Immune system disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (I had COVID last year)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101123458

Write-up: Bad immune system; Sick; Headache; Diarrhea; throwing up; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A 68-year-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FC3180, expiration date: Oct2021) (age at the time of vaccination was 68 years) via an unspecified route of administration on 06Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history included COVID 19. Concomitant medication was not reported. The patient had an immune (Clarification unknown) and a lot of health issue, her first dose of the vaccine was given on 06Aug2021. The patient stated that I had my first shot and I had COVID (later clarified as medical history) so when I got my shot I had the same symptoms headache, throwing up, everything that was in about a week. I have a very bad immune system and lot of things going on but I am 68, I will be 69 in October, no big deal but I take care of myself as best as I can. Consumer further stated, so my first Injection I got sick immediately, headache, throwing up, diarrhea and I felt like (incomplete sentence) and I had a headache every day, it''s like a week and half, every day. The outcome of the events was unknown. Follow-up attempts are completed. No further information was expected.


VAERS ID: 1677551 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-27
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenopia, Discomfort, Ear swelling, Eye disorder, Eye movement disorder, Eye swelling, Feeling abnormal, Flushing, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Injection site paraesthesia, Lip swelling, Nerve injury, Neurological examination, Pain, Pain in extremity, Paraesthesia, Paraesthesia oral, Swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: neurological test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202101127527

Write-up: tingling on the left side of my face/felt like the tingling in my arm was because the guy hit my nerve.; my eyes nothing else was drooping.; left eye was smaller you know like saggy you know like a tired eye and below my cheek bone; my left eye was not moving as good as the right eye; tingling sensation from the injection site to elbow after getting the Vaccine; my jawline, my bottom lip, my cheek on the left side off underneath my left eye, to my ear lobe was numb/ left side of face, jaw, lips and under her eye, were going numb.; my jawline, my bottom lip, my cheek on the left side off underneath my left eye, to my ear lobe was numb/ left side of face, jaw, lips and under her eye, were going numb.; my jawline, my bottom lip, my cheek on the left side off underneath my left eye, to my ear lobe was numb/ left side of face, jaw, lips and under her eye, were going numb.; But he felt like the tingling in my are was because the guy hit my nerve/nerve may have been hit.; tingling sensation from the injection site to elbow after getting the Vaccine; felt flush; rolling pain like someone stabbing me; very weird sensation mainly under cheekbones, to my ear lobes, down to my neck about 3 inches; The arm today is a little sore and I can feel the numbness only when I lay on it; The arm today is a little sore and I can feel the numbness only when I lay on it; my lower lip, only on the left side is got some swelling around it, goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line.; my lower lip, only on the left side is got some swelling around it, goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line.; my lower lip, only on the left side is got some swelling around it, goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line.; my lower lip, only on the left side is got some swelling around it, goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line.; my lower lip, only on the left side is got some swelling around it, goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line.; feels heavy; still my left lip I have tingling; This is a spontaneous report from a contactable consumer. A contactable female consumer (patient) reported for herself that: A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administered in Arm Left on 27Aug2021 (at the age of 56-year-old) as single dose for covid-19 immunisation at drug store. The patient medical history was not reported. There were no concomitant medications. The patient previously took lidocaine and experienced drug allergic. Patient was not received any other vaccine four weeks prior vaccination. Patient reported she received the Pfizer (Comirnaty) vaccine on 27Aug2021. When the pharmacist gave the shot, she began symptoms on 27Aug2021, feel a tingling sensation from arm to elbow, left side of face, jaw, lips and under her eye, were going numb. Went to urgent care and was told nerve may have been hit. As I was getting the shot, I felt a tingling from the injection site all the way down to my elbow almost like needles, felt flush, and sat down, rolling pain like someone stabbing me. 15 minutes went to my car and I took my mask, I realized that my jawline, my bottom lip, my cheek on the left side off underneath my left eye, to my ear lobe was numb. It''s like getting Novocain at the dentist and coming off it, and you feel like pryingly, and numb, a very weird sensation mainly under cheekbones, to my ear lobes, down to my neck about 3 inches. like getting Novocain at the dentist. Went home got in bed because of h/a, woke up the next morning on 28Aug2021, with my left eye half open and had all this tingling on the left side of my face, besides my eyes nothing else was drooping. I could move my face, but it takes effort. I went to urgent care, did a neurological test and noticed that my left eye was not moving as good as the right eye. But he felt like the tingling in my arm was because the guy hit my nerve I don''t want to be on steroid. The arm today is a little sore and I can feel the numbness only when I lay on it. my lower lip, only on the left side is got some swelling around it now, and it feels heavy, and when I touch it, it feels different than the right side, just tingly, and it goes underneath my eye, goes to my ears and is going down to my neck, underneath my jaw line. I have a follow up with the doctor, but it is not until the 7th of September. When I got the shot immediately after the shot I had a tingling between the injection site and my elbow sort of like water droplets drips on your arm but deeper tingling and so I waited out for the pharmacy you know I got I waited for the 10 minutes to they suggest the told the pharmacist she didn''t know what''s to say she was like I got never heard of that before and then when I was leaving about 10-15 minutes after the shot I took my mask off in the car and I realized that''s only the left side of my face I got the injection on my left side only the left side of my lips were numb and my face below my eye was numb sort of like you are coming off Novocain from a dentist, you know that sensation of like numbness and so I went back in they didn''t have any suggestions so they said can you go home I said yes so I went home and went to bed like afternoon and this morning I was my in left eye was smaller you know like saggy you know like a tired eye and below my cheek bone and still my left lip I have tingling and that is side of my face only the left face so I thought call because I didn''t know I was having an allergic reaction and if it''s safe even attempt to get the second dose you know some type of reaction is that make sense. I just want to make sure. Patients scheduled for second dose on 16Sep2021. The patient underwent lab tests and procedures which included neurological examination: unknown results on Aug2021. Event resulted to visit emergency room. No therapeutic measures were taken as a result of the events. The outcome of the event still my left lip I have tingling was not recovered rest all were unknown.


VAERS ID: 1677569 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphasia, Euphoric mood, Feeling abnormal, Memory impairment
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (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: Bell''s palsy; Insect sting allergy (Known allergies: Bee stings); Latex allergy (Known allergies: Latex)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101133160

Write-up: Brain fog; Could not remember simple things such as house address; Felt like had a marijuana high and looked very high; Hard time forming words and sentences and answering questions; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FC3180) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included bell''s palsy, allergy to bee stings and latex. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified birth control pills (MANUFACTURER UNKNOWN) within two weeks of vaccination. On an unknown date in Aug2021 at 17:30, the patient had brain fog, could not remember simple things such as her house address and felt like had a marijuana high. The patient had a hard time forming words and sentences. When her husband asked her questions she had a hard time answering him. Her husband also commented that she looked very high. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events.. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, could not remember simple things such as house address, felt like had a marijuana high, had a hard time forming words and sentences and answering questions were recovered on an unknown date in Aug2021.


VAERS ID: 1677594 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-30
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Vaccination site pain
SMQs:, Osteonecrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: Penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101138764

Write-up: Bruning sensation while administering vaccine.; Joint pain; Aching in bones; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to Penicillin. Concomitant medication received within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 30Aug2021, the patient experienced bruning sensation while administering vaccine. On an unknown date in Aug2021, the patient experienced joint pain, aching in bones. The clinical outcome of the events bruning sensation while administering vaccine, joint pain, aching in bones was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1677595 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Dizziness, Electrocardiogram, Fatigue, Headache, Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Heart rate with a pulse oximeter; Result Unstructured Data: Test Result:160; Comments: bpm; Test Date: 2021; Test Name: Heart rate with a pulse oximeter; Result Unstructured Data: Test Result:145; Comments: bpm (heart rate was 145 bpm upon EMS arrival); Test Date: 2021; Test Name: Heart rate with a pulse oximeter; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Heart rate with a pulse oximeter; Result Unstructured Data: Test Result:178; Comments: bpm (her daughter is back in the Emergency Room because her heart rate got as high as 178 bpm)
CDC Split Type: USPFIZER INC202101138787

Write-up: she said that she felt like her heart was "beating out of her chest." /a rapid heart rate/her heart rate was 160 beats per minute (bpm)./ her heart rate got as high as 178 bpm; headache; dizziness; tiredness; This is a spontaneous report from a non-contactable consumer or other non hcp (parent). A 16-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 05Aug2021 (age at vaccination: 16-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical and concomitant medications were not reported. Reporter (parent) stated her daughter received the first dose of Comirnaty on 05Aug2021, and one week after receiving her first dose of Comirnaty, complained of a bad headache, dizziness, and tiredness, on 12Aug2021 she came down for breakfast and she said that she felt like her heart was "beating out of her chest." Reporter stated she contacted the doctor but did not get a return call, stated on 13Aug2021 her daughter again complained of a rapid heart rate, stated she checked her daughter''s heart rate with a pulse oximeter and it showed her heart rate was 160 beats per minute (bpm). Reporter also states she called EMS who then came to the house, her daughter''s heart rate was 145 bpm upon EMS arrival. EMS transported her daughter to the hospital. On EMS arrival her heart rate was "normal." Blood work and EKG were also "normal." Reporter stated that her daughter was released from the hospital with instructions for a Holter Monitor. Caller stated she also reached out to her daughter''s pediatrician who recommended some other follow up tests. Reporter also stated she was concerned because now her daughter was back in the Emergency Room because her heart rate got as high as 178 bpm, and she had gotten no definitive information regarding Holter Monitor results or diagnosis, stated she had called the pediatrician to ask if her daughter should receive the second dose of Comirnaty, but had not yet head back from her. Reporter was asking if her daughter can safely get the second dose of Comirnaty since it is scheduled for tomorrow, 02Sep2021. The reporter was informed that: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision and also as per the CDC, the second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (21 days). But if it is not possible to give the second dose at 3-weeks and a delay cannot be avoided, it may be given up to 6 weeks (42 days) after the first dose. The patient underwent lab tests and procedures which included blood work and EKG: normal, Heart rate with a pulse oximeter: 160 bpm, 145 bpm, normal and 178 bpm on an unspecified date in 2021. The event heart rate increased resulted in emergency room visit. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1678142 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-14
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Mobility decreased, Muscular weakness, Myalgia, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LABETALOL
Current Illness: Genital tract inflammation (GTI); Hypertension (High blood pressure); Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Excruciating pain; Muscle weakness; Excruciating pain started on her neck; Excruciating pain in back/excruciating pain in multiple spots in her back; Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers; It is so bad she can barely move; Excruciating pain in shoulder; Muscle pain/muscle burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back) and PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers) in a 28-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. Concurrent medical conditions included Hypertension (High blood pressure), Genital tract inflammation (GTI) and Pain. Concomitant products included LABETALOL for Hypertension. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning). At the time of the report, PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included patient was on antibiotic for GTI and on medication for the pain. It was stated that since the following Monday 16-Aug-2021 or Tuesday 17-Aug-2021 (patient did not remember which day) she has been experiencing excruciating pain, muscle pain and burning and weakness, starting on her neck, shoulder, then her back (multiple spots in her back), legs, hands and fingers. On a scale from 1 to 10 (where 10 was the worst pain a person could feel) she would describe her pain as a 12. It was so bad she could barely move and it was not getting any better.


VAERS ID: 1678181 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: C-reactive protein increased, Chest discomfort, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Magnetic resonance imaging thoracic abnormal, Myocarditis, Pain in jaw, Red blood cell sedimentation rate increased, Troponin
SMQs:, Anaphylactic reaction (broad), Cardiomyopathy (broad), Osteonecrosis (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Daily multivitamin and birth control pill
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Troponin level of 3.2 when I went to the ER (8/2), MRI on 8/2 which revealed inflammation in the myocardium. Elevated CRP, elevated ESR levels. I also received an echo, EKG, and was attached to a holter monitor.
CDC Split Type:

Write-up: I was hospitalized for myocarditis. It started Sunday 8/1 with chest tightness and then pain under my jaw. I went in Monday morning to the ER and was hospitalized for 3 days. I was diagnosed with myocarditis related to the COVID vaccine.


VAERS ID: 1678237 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTIN; IRON; PANTOPRAZOLE
Current Illness: COPD; Drug allergy (tramadol); Drug allergy (Melaxicom); Hypertension; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Knee replacement; Rotator cuff tear
Allergies:
Diagnostic Lab Data:
CDC Split Type: PVIUS2021001188

Write-up: Headaches severe; tiredness; body aches; dizziness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), LETHARGY (lethargy), HEADACHE (Headaches severe), FATIGUE (tiredness) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Rotator cuff tear, Arthritis and Knee replacement. Concurrent medical conditions included Osteoporosis, COPD, Hypertension, Drug allergy (Melaxicom) and Drug allergy (tramadol). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), IRON and PANTOPRAZOLE for an unknown indication. On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches). On 18-Aug-2021, the patient experienced HEADACHE (Headaches severe) and FATIGUE (tiredness). On 21-Aug-2021, DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (Headaches severe) and FATIGUE (tiredness) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product also included Vitamin D4. No treatment medications reported. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up was received and patient details, relevant medical history, concomitant products and events were updated.


VAERS ID: 1678242 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010A21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Erythema, Feeling hot, Gait inability, Heart rate, Joint swelling, Lymphadenopathy, Pulmonary mass
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Blood pressure; Result Unstructured Data: 186 over 108, sent to the hospital because of her blood pressure and heart rate; Test Name: Heart rate; Result Unstructured Data: Sent to the hospital because of her blood pressure and heart rate
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Two huge lymph nodes in lungs (both); Both her knees down to her feet are swollen; Hot to the touch; Six spots that are really really red; Can not walk; One huge lymph protruding from the side of her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red) and GAIT INABILITY (Can not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck). On an unknown date, the patient experienced PULMONARY MASS (Two huge lymph nodes in lungs (both)). At the time of the report, PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 186 (High) 186 over 108, sent to the hospital because of her blood pressure and heart rate. On an unknown date, Heart rate: 117 (High) Sent to the hospital because of her blood pressure and heart rate. Concomitant medication use information was provided by reporter that includes Blood pressure medicine. Treatment medication use information was not provided by reporter. Patient was healthy up until the shot. Patient reported that side effects were not improving even though was seen by physicians. Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received on 29- Aug-2021, added reporter contact details, event outcome updated from unknown to not recovered , added information in I narrative.


VAERS ID: 1678936 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002A21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Asthenia, Malaise, Streptococcus test positive
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Senior Vitamin for Women; Baby Aspirin
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Strep throat test positive, Blood pressure 183/92
CDC Split Type: vsafe

Write-up: The morning of August 2, 2021 I went to the urgent care and they did a Strep throat test and it came back positive. An then by Wednesday August 4, 2021 I couldn''t smell or taste anything. I went to be and I was sick for about two weeks. I had no energy and I was very weak and couldn''t do anything. I believe that I had come down with COVID-19. But I didn''t have a fever at all. Urgent care prescribe me, Amoxicillin for 10 days. As of today Sept. 07, 2021 I still can''t taste or smell.


VAERS ID: 1679531 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Anxiety, Arthralgia, Blood calcium normal, Brain natriuretic peptide normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills, Electrocardiogram normal, Full blood count, Hyperhidrosis, Hypersensitivity, Laboratory test normal, Lipase normal, Liver function test normal, Musculoskeletal pain, Pain, Pain in jaw, Pneumonia, Pneumothorax, Pruritus, Rash, Troponin normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No known medications at the time of vaccination
Current Illness:
Preexisting Conditions: NO significant PMH
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: "Pt w/ no significant PMH. Pt was vaccinated at pharmacy @ 15:05. Pt presented to the ED for evaluation of sudden shivering @16:50. Patient also reports of chest pain. He denies any fever, vomiting, shortness of breath, difficulty breathing, or abdominal pain. Benign past medical history. Patient is seen shivering upon arrival to the emergency department. He is immediately roomed for further evaluation. Physical Exam significant for a patient in acute distress. He is diaphoretic and is noted to have a skin rash. All other observations are WNL. Labs: Hemogram w/ diff, Panel 7, Calcium, LFTs all WNL Troponin negative x1 ECG without signs of SVTs, A. fib, or ventricular dysrhythmia. Chest x-ray unremarkable. Pt was discharged home w/ diagnosis of allergic rxn to COVID vaccine and Atypical chest pain. Discharge medications include diphenhydramine25mg PO Q6hrs PRN itching and famotidine 40mg PO QHS PRN heartburn. Pt was advised not to get 2nd dose. 8/28 pt presented to ED with chills and itchiness on the torso. Pt states that he feels nervous and that the exact same thing happened after receiving the first Pfizer vaccine. Patient denies any rashes, shortness of breath or tongue swelling. No medications prior to arrival. Pt was administered diphenhydramine in case of allergic rxn but was ultimately diagnosed w/ anxiety and discharged home with strict return instructions. 8/29 Pt presents again to the ED. Pt c/o left sided chest pain/pressure radiating to jaw and shoulder. Pt denies anxiety. PMD referred to ED for EKG. Labs: Hemogram w/ diff, Panel 7, Calcium, LFTs, Lipase all WNL Troponin negative x1 BNP 38 12 lead EKG Normal Intervals Axis Rate: 62 P: 73 PR: 185 QRS: 52 QRSD: 92 T: 58 QT: 382 QTc: 388 Chest X-Ray - No acute cardiopulmonary disease noted. Pt administered ASA 325mg PO x1 Per MD, Differential diagnosis includes: Acute coronary syndrome, musculoskeletal pain, pneumonia, pneumothorax. I do not suspect pulmonary embolism due to negative PERC criteria.. I do not suspect aortic dissection as the pain is not ripping/tearing, does not radiate to the back, no history of Marfan syndrome or connective tissue disorder, the patient has equal bilateral upper extremity pulses. Finally in reference to the possibility of cardiac etiology, the patient is low risk given age/risk factors, and as such the combination of a nonischemic electrocardiogram and negative troponin are reassuring. Advised patient to follow-up with his primary care physician. Patient given strict ER return precautions to return to ED with any worsening chest pain or shortness of breath in the next 12 to 48 hours."


VAERS ID: 1679728 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient reports several skin conditions, but lack of access to medical care.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported a small red spot at injection site (left arm) after receiving her first dose of the Moderna COVID-19 vaccine. This red spot grew in size over the course of that week and became red, hot, and itchy. Since that time, the redness and swelling has decreased into a scaly, irregular red rash that is itchy and warm to the touch. Patient reports that the symptoms worsen with exercise.


VAERS ID: 1679974 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Dizziness, Feeling abnormal, Nausea, Neurological examination, Vaccine positive rechallenge, Vertigo, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Diarrhea at soccer game weekend of July 31
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Aug 22 neuro eval
CDC Split Type:

Write-up: 10-12 days after first shot he developed dizziness, vertigo type symptoms with nausea and vision issues. Was pretty severe for 2-3 days. Symptoms seemed to subside with rest. 2nd shot was august 7- the weekend of Aug 21, he complained of the same type of symptoms. Dizziness. Vertigo, nausea, difficulty foCausing eyes.Symptoms persisted for over a week. We did see our Pediatrician at our annual check up on Aug 3-right in the midst of the initial symptoms after the first shot. We did visit the walk in on the 22nd because of symptoms. Neuro tests were performed. Was pretty much chalked up to be anxiety. My son is not an anxious kid or a worrier. He?s active and healthy and was absolutely not himself after either shot.


VAERS ID: 1680142 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Feeling abnormal, Influenza like illness, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Within 3 days of getting the vaccine i experienced fever chills lose of strength flu like systems which have lingered for 4 weeks. I''m still not feeling feel at all. I went from a healthy active lifetime feeling like I''m going to die. 3 episodes of feeling like I was going to have a heart attack.


VAERS ID: 1681442 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Nerve compression
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Accidents and injuries (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure (ON MEDICATION FOR YEARS); Cholesterol (ON MEDICATION FOR YEARS); Seasonal allergy.
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: CAT scan; Result Unstructured Data: PINCHED NERVE.
CDC Split Type: USJNJFOC20210902851

Write-up: POSSIBLE GUILLAIN BARRE SYNDROME; PINCHED NERVE; This spontaneous report received from a consumer concerned a 63 year old male with unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cholesterol, blood pressure, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, 1 in Total administered on 11-AUG-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 patient felt tired ever since. on AUG-2021 he complained of achiness and weakness in his legs, he complained of muscle pain that was not consistently in the same area, and even felt like his muscles were tight. He went to the emergency room (ER) on 28-AUG-2021 where he was treated with tramadol. On 29-AUG-2021 patient experienced tingling and numbness in both hands and arms, then developed tingling in his lips and difficulty swallowing. He went back on 30-AUG-2021 for the emergency room (ER) where his laboratory data included: CAT scan (NR: not provided) and diagnosed with a pinched nerve. On AUG-2021, the patient experienced possible Guillain Barre Syndrome and pinched nerve. They were at the third emergency room (ER) visit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible Guillain Barre Syndrome and pinched nerve was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20210902851- covid-19 vaccine ad26.cov2.s - Possible Guillain Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1681451 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210906607

Write-up: OUT OF SPECIFICATION PRODUCT USE; VACCINE WAS REFRIGERATED THEN REFROZEN AT MINIMUM TEMPERATURE -11.6F AND MAXIMUM AT 3.7F; This spontaneous report received from a health care professional concerned a 38 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 (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f. On 30-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905531.


VAERS ID: 1681508 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA; ASPIRIN ACTIV; ADDERALL; ASMANEX HFA; XOPENEX HFA
Current Illness: Erythromelalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: her period started a week earlier; her period was heavier than usual; tingling in arm and hand while driving; Had a head to toe rash/head to toe rash with welts; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual), PARAESTHESIA (tingling in arm and hand while driving) and RASH (Had a head to toe rash/head to toe rash with welts) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. Concurrent medical conditions included Erythromelalgia. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (ASPIRIN ACTIV), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), MOMETASONE FUROATE (ASMANEX HFA) and LEVOSALBUTAMOL TARTRATE (XOPENEX HFA) for an unknown indication. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Had a head to toe rash/head to toe rash with welts). On an unknown date, the patient experienced MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual) and PARAESTHESIA (tingling in arm and hand while driving). At the time of the report, MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual), PARAESTHESIA (tingling in arm and hand while driving) and RASH (Had a head to toe rash/head to toe rash with welts) had resolved. 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. Patient also took concomitant medications of Cranberry Pill and Antiarin. No treatment medications are provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow Up received on 30-AUg-2021 contains additional primary reporter and mentioned additional AE contact.


VAERS ID: 1681543 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-22
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Off label use, Red blood cell count decreased, White blood cell count
SMQs:, Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (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: CELEBREX
Current Illness: Anaemia; Arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Red blood cell count decreased; Result Unstructured Data: Anemic; Test Name: White blood cell count; Result Unstructured Data: Low
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Anaemia. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.On 22-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced OFF LABEL USE (Off label use). In August 2021, OFF LABEL USE (Off label use) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available)On an unknown date, Red blood cell count decreased: low (Low) Anemic. On an unknown date, White blood cell count: low (Low) Low.Patient states that also she takes an unknown medication to treat anemia and her healthcare provider advised her to get the third dose out of caution due to the medical conditions she has received third dose. She received first dose on JAN 2021 and Second dose on 09FEB2021. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.Reporter did not allow further contact


VAERS ID: 1681565 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Muscle tightness, Musculoskeletal stiffness
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: dizzy spells; stiffness in face; tightness in face; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face). At the time of the report, DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient does not use insulin for diabetes. He just does exercise and takes a blood thinner. Patient has tried to correct the events with exercise. No concomitant medications were reported.


VAERS ID: 1681603 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Poor quality product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients). In August 2021, EXPIRED PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. The Moderna vaccine vial what was punctured at 9:07am on 17-Aug-2021. This vaccine vial was punctured beyond 12 hours and was given to a total of 8 patients for their 3rd dose. Some patients received it on 19-Aug-2021 between 01 pm and 09 pm. Some patients received it on 20-Aug-2021 between 02pm-07pm and two patients received it on 23-Aug-2021, which was 6 days after the vial was punctured. Pharmacist provided BTIN number: 00380777273983. Pharmacist asked what they should do. Agent forgot to obtain safety follow up consent, but pharmacist consented to follow up from Medical Affairs. Treatment information was not provided.


VAERS ID: 1681631 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016C21A / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: sore right injection site arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore right injection site arm) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications was provided. No Treatment medications was provided.


VAERS ID: 1681653 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-22
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Heart rate irregular, Pain in extremity
SMQs:, Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NP THYROID
Current Illness:
Preexisting Conditions: Comments: The medical history information was not provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Faster heart rate that came and went periodically
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Sore arm; Faster heart rate that came and went periodically; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The medical history information was not provided by the reporter. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEART RATE IRREGULAR (Faster heart rate that came and went periodically) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Heart rate: irregular (abnormal) Faster heart rate that came and went periodically. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Patient reported experiencing the symptoms beginning a day and a half ago after the first dose. Patient did not take any medication for symptoms. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received on 27-Aug-2021, Updated patient''s date of birth, age, vaccine start date and vaccine facility information.


VAERS ID: 1681655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Contracted COVID). At the time of the report, COVID-19 (Contracted COVID) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided. Treatment information was not provided.


VAERS ID: 1681671 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-14
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Illness, Vaccination complication
SMQs:, 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:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: I think he had covid but did not get tested; He got sick like I did a week before me; He had a reaction to the vaccine really bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (He got sick like I did a week before me) and VACCINATION COMPLICATION (He had a reaction to the vaccine really bad). On an unknown date, the patient experienced COVID-19 (I think he had covid but did not get tested). At the time of the report, ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had a reaction to the vaccine really bad. No concomitant medications were reported. No treatment information was reported.


VAERS ID: 1681676 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Vaccination site pain
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; really bad headache/headache; arm is sore and hurting; feel exhausted; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore and hurting), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), FATIGUE (feel exhausted) and HEADACHE (really bad headache/headache) in a 91-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache). In August 2021, the patient experienced VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Headache, at an unspecified dose and frequency. On 04-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient was pregnant before she received her vaccination and currently, she was 32 weeks pregnant. Her second dose would be due on 30-Aug-2021. She had headache on the 1st day and went away. That evening, she got really bad headache and took some Tylenol, and she thinks it had gone now. On the second day and third day, she felt exhausted. Her arm was sore and hurting. She read about Moderna COVID 19 vaccine and that people can get blood clot. Although she didn''t get blood clot with her first dose, she was worried that she can get it with the second dose. She asked if she could get blood clot with the second dose. Also, she wants information on blood clot like what types of people can get it and why. She was frustrated that agent didn''t have information on this, and she didn''t feel comfortable about providing further information about herself. She disconnected the call immediately after agent sated no information.; Sender''s Comments: This is a case of product exposure during pregnancy with associated adverse events for this 91-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events headache, vaccination site pain and fatigue, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring during the pregnancy. Patient?s date of birth confirmation has been requested.


VAERS ID: 1681691 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-03-03
Onset:2021-08-01
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025A21A / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Body temperature, Dyspnoea, Headache, Hypersomnia, Muscular weakness, Myelitis, Pain of skin, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: PROLIA; REMICADE; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]
Current Illness: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: 101.5 to 102
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: He had difficulty breathing; Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can''t get temperature controlled/ not getting better; Terrible headache; Weak legs/legs feel like jello; Back ache; Sleeping 3-4 hours during the day; The skin on face hurt to touch, face and scalp; He states this is like myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS (He states this is like myelitis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. E01721A, 025A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised. Concomitant products included DENOSUMAB (PROLIA), INFLIXIMAB (REMICADE) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MYELITIS (He states this is like myelitis) (seriousness criterion medically significant) and PAIN OF SKIN (The skin on face hurt to touch, face and scalp). On 21-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can''t get temperature controlled/ not getting better) and HEADACHE (Terrible headache). On 29-Aug-2021, the patient experienced DYSPNOEA (He had difficulty breathing). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 3000 mg around the clock and TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, MYELITIS (He states this is like myelitis), MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PAIN OF SKIN (The skin on face hurt to touch, face and scalp), DYSPNOEA (He had difficulty breathing) and HEADACHE (Terrible headache) outcome was unknown and PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can''t get temperature controlled/ not getting better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 101.5 to 102 (High) 101.5 to 102. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that the fever goes down, but spikes when the acetaminophen runs out and was not getting better. On 29 Aug 2021, patient went to urgent care. Patient tested the fever with various thermometers for confirmation. Patient took a COVID test, but the results were not available at the time of this report. 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: 1681697 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Back pain, Diarrhoea, Dyspepsia, Gastrooesophageal reflux disease, Impaired driving ability, Insomnia, Lichen planus, Limb discomfort, Nausea, Oesophageal pain, Pain, Pain in extremity, Rash, Vertigo, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Ninguno
Current Illness: Low Ferritin
Preexisting Conditions: Ulcerative colitis, mild
Allergies: No
Diagnostic Lab Data: I have not done any yet
CDC Split Type:

Write-up: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).


VAERS ID: 1681744 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Drug hypersensitivity, Dysphonia, Hypoaesthesia, Paraesthesia, Swelling, Swelling face, Urticaria, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC DUO; FAMOTIDINE; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Allergy to molds; Food allergy; Grass allergy; Hypothyroidism (5 to 10 years ago); Pollen allergy; Polycystic ovarian syndrome (5 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100978472

Write-up: slight allergic reaction including hives; slight allergic reaction including hives; her face was swollen; face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling; Felt like it was burning and chills; within 15 minutes injection felt like it was burning; have slight hives on arms/ hives on both arm including around injection site; slight swelling; numbness in face; nasal voice; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in Arm Right on 01Aug2021 11:30 (age at vaccination: 36 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn''t receive other vaccines within 4 weeks prior to vaccination, patient received other medications Famotidine, Levothyroxine, Zyrtec-D within 2 weeks of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing 5 to 10 years ago, polycystic ovaries from an unknown date and unknown if ongoing 5 years ago, seasonal allergy from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, mycotic allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity from an unspecified start date and ongoing; famotidine (FAMOTIDINE) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine (LEVOTHYROXINE) taken for biopsy thyroid gland abnormal, start and stop date were not reported. Patient didn''t had COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. The patient experienced within 15 minutes injection felt like it was burning on 01Aug2021 12:00, have slight hives on arms/ hives on both arm including around injection site on 01Aug2021 12:00, slight swelling on 01Aug2021 12:00 ,numbness in face on 01Aug2021 12:00, slight allergic reaction including hives on an unspecified date, slight allergic reaction including hives on an unspecified date, her face was swollen on an unspecified date, nasal voice on 01Aug2021 , face is not as swollen and it is only kind of tingly/ face was swollen, numb, tingling on an unspecified date, felt like it was burning and chills on an unspecified date. No therapeutic measures were taken for the events. The outcome of the events vaccination site pain, urticaria, swelling, hypoaesthesia, dysphonia was recovering, the outcome of the events drug hypersensitivity, urticaria, swelling face, paraesthesia, chills was unknown. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1681783 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 RA / -

Administered by: Military       Purchased by: ?
Symptoms: Condition aggravated, Fasciitis, Gait disturbance, Swelling, Tendon pain, Tendonitis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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: ADVIL; VITAMIN D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Family Medical History Relevant to AE(s): None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101057529

Write-up: Pain she is having in her Achilles that started getting swollen and hard 2 days ago; Pain she is having in her Achilles that started getting swollen and hard 2 days ago; Saturday the pain in the caller''s Achilles got worse; Flip flips caused tendonitis or something or fasciitis; Flip flips caused tendonitis or something or fasciitis; Limping; This is a spontaneous report received from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0217; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jul2021 at 1:30 (at the age of 73-years-old) as a DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient Medical history included osteoporosis from an unknown date and unknown if ongoing and family Medical History Relevant to the event was none. Concomitant medications included ibuprofen (ADVIL) 2 every morning taken for osteoarthritis, start and stop date were not reported and colecalciferol (VITAMIN D) 1,000 every other day taken for an unspecified indication, start and stop date were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) and event following prior vaccinations were none. On Aug2021, the patient experienced pain she was having in her achilles that started getting swollen and hard 2 days ago, on an unspecified date in 2021 flip flips caused tendonitis or something or fasciitis, limping and saturday the pain in the reporter''s achilles got worse on Aug2021. Reporter was asking with a question about the Covid vaccine. Reporter reported that she received her first vaccine dose on 28Jul, Lot number ew0217 and was due for her second dose on Wednesday but she has been needing to take Advil for pain she was having in her Achilles that started getting swollen and hard 2 days ago. Now it''s completely swollen and hard. Reporter reported that she has her family there and has been doing work in the garage, lifting things and running around in flip flops. Reporter states "it looks like I had a trauma, but there was no trauma I have been running around in flip flops and began having weird pains and limping the whole week now I''m worried it might rupture". Reporter reported that yesterday she took 4 Advil, today she took 2, and while she normally takes 2 Advil ad day she now asked if that would interfere with the vaccine she was planning to get on Wednesday? Reporter reported that she was planning on going to the doctor because she doesn''t usually have this and its weird and unusual, she doesn''t normally have this much swelling. Reporter did also report having a history of a bone spur in her heel, but she doesn''t remember which heel. Reporter asked, "When am I fully protected after getting the vaccine?" weird pain in her Achilles was reported as worsened. It was reported that, other Conditions was in her hips. Diagnosed many years ago, when she was 50 years old (unspecified). It was reported that, the reporter received her first dose on 28Jul2021, lot EW0217. The reporter is due for her second dose this coming Wednesday but is worried. The reporter had family around and was running around in flip flops. The reporter started getting a weird pain in her Achilles. 2 days ago, it started looking swollen and hard and looks like there is trauma but has no trauma. The reporter took 4 Advil yesterday and 2 today. Normally the reporter takes 2 Advil a day. Can the reporter take that? Will it interfere with vaccine? The withheld agent provided the reporter with this information prior to transfer. The reporter also has a history of bone spurs in one of her heels. The reporter saw the Achilles 2 days ago or yesterday and immediately took 4 Advil, 2 around 3:00 am and then 2 more at 9:00. The reporter got really scared because it was sticking out and hard and she thought if she couldn''t get the swelling down it may rupture. The reporter applied a bandage and relaxed. The reporter walked around but had a bandage on yesterday and walked around in sneakers, her flip flops may have caused this. The reporter wears flip flops every summer and has never had this. The reporter had been limping for a week or a week and half because she felt something hurt. The reporter''s kids thought the flip flips caused tendonitis or something or fasciitis. The reporter was worried it is going to get worse and wanted to get the second dose. The reporter feels it is getting better with rest and the bandage. It was reported that, a week ago the reporter couldn''t walk naturally and thought it was plantar fasciitis. The reporter was running around a lot and didn''t stop using her flip flops. The reporter thinks she has allergies to heat and doesn''t have air conditioning and it has been almost 100 degrees where she lives. Saturday the pain in the reporter''s Achilles got worse, at 6:00 am she noticed the swelling on her Achilles. The limping has been going on for about a week, maybe since last Monday. The reporter was taking a book off a shelf and lifting a box and thought this could have caused this issue. The swelling has gone down, but the reporter''s Achilles is wider and still swollen. The pain has gone down but the reporter has adjusted by walking on the other leg, so it doesn''t get worse. If this gets work the reporter was afraid, she will have to go to the doctor and delay her second dose and she doesn''t want that. The reporter slipped in the bathroom 2 weeks ago and hurt her back because she took her bathmats out. Could this have caused this? The reporter feels like she may have tendonitis in her back. The reporter stopped taking Oscal because she didn''t want kidney stones so now, she just drinks milk. The reporter takes 1,000 of vitamin D every other day and sits in the sun. Reporter asked whether she could continue taking Advil? Event did not require a visit to, Emergency Room or Physician Office. Family Medical History Relevant to the evet were none. Relevant Tests were none. Reporter seriousness for the events were unspecified. Outcome of the pain she was having in her achilles that started getting swollen and hard 2 days ago and saturday the pain in the reporter''s achilles got worse were not recovered, flip flips caused tendonitis or something or fasciitis was unknown whereas, limping was recovered in 2021. Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1681800 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Feeling hot, Headache, Hyperhidrosis, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101069912

Write-up: headaches; she felt weak; having a little bit of a temperature; had to ice arm because it felt swollen and painful; had to ice arm because it felt swollen and painful; sweating; felt hot; This is a spontaneous report from a contactable consumer reported for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Aug2021 (at the age 42-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. On 16Aug2021 (Monday), having headaches after injection of Pfizer covid-19 vaccine. On Monday, when patient got it, patient felt weak. Patient read the paper they gave her that said it was normal and little bit of a temperature, but that was fine. Yesterday, patient felt really weak, had headaches, and had to ice arm because it felt swollen and painful. The headaches come and go. This morning, patient could not even get out of bed; felt really weak. Describes headache as the top portion of it (her head) was pulsating, hurting. States this was too much. Patient was tearful. States that patient knows it was part of the side effects, but thought it was more with the second dose. Patient works in front of computer, but can''t with this. Patient was trying to clean up a little bit, but was sweating like crazy. Patient told her son it felt hot, he said its not hot. Patient was supposed to go back to work yesterday and today, but could not. Asked what patient should do, keep taking Tylenol. The outcome of the event pyrexia was unknown while other events were not recovered. The lot number was not provided. Information on lot number has been requested during follow up.


VAERS ID: 1681802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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 INC202101069972

Write-up: shortness of breath/ she is gasping for air.; This is a spontaneous report from contactable Physician. A 69-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 16Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Aug2021, the patient experienced shortness of breath. Reporter stated that patient had been having shortness of breath when talking. She had been fine when going up and down stairs and when walking. But when talking it''s like she is gasping for air. The event was assessed as non-serious. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1681820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result: 101.2; Test Date: 2021; Test Name: Temperature; Result Unstructured Data: Test Result: 100.
CDC Split Type: USPFIZER INC202101076819

Write-up: Temperature is 101.2; She is now, it is 100; Nauseous; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a female (reporter''s daughter) patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date in Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Reporter stated, "My daughter yesterday took Pfizer second shot, and her temperature is 101.2 and she is feeling nauseous. So, I am very concerned, what should I do? I think, it got down, the last time I took it was 100, it was 100. It was 101.2, she took the shot yesterday, the second one and she was running 101.2 and so, I gave her Tylenol (further clarification unknown). She is now, it is 100". Reporter further stated, "So, if there is anything, we need to take her to the hospital if it gets worse, right? We take her to the hospital if it gets worse?". Reporter was informed that Pfizer medical information was the concerned department for all queries. Reporter further stated, "So, this is Pfizer where we get in touch to let them know what happened, right? Reporter was informed that this was the department for reporting events and provided with the number of Pfizer Medical Information. Reporter further stated, "I don''t want to do this now, you are telling me to call another number you gave. No, I can''t do this survey. You are telling me to call another number ''to dial'', so let me go and call other extension right now". Reporter stated, "It is Pfizer, the number, I don''t have the paper, I put the paper up". The patient underwent lab tests and procedures which included temperature was 101.2 and 100 (units was not provided) on an unknown date in 2021. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1681830 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hand-foot-and-mouth disease, Viral infection
SMQs:, Oropharyngeal infections (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: USPFIZER INC202101083614

Write-up: virus infection; guess it still within in my body like it still little contagious; Hand, foot and mouth disease; This is a spontaneous report from a contactable consumer. A patient with an unknown age and gender received first dose of BNT162B2 (Pfizer covid-19 vaccine, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration on an unspecified date in Aug2021 as a DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced Hand, foot and mouth disease, virus infection; guess it still within in my body like it still little contagious. The patient had first shot 2 weeks ago and due for second shot and about also 2 weeks ago, as patient had a virus infection and over it now, but the patient guess it was still within body like it still little contagious and had a Hand, foot, mouth disease. The patient was wondering if it was ok you can check. The patient had hand foot and mouth disease, so it was wondering was it for me to get the second shot now even though they say it was still contagious. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1681837 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101084386

Write-up: very weak; tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2(PFIZER COVID-19 VACCINE ,Solution for injection, Batch/Lot number was not reported, expiry date was unknown), dose 1 via an unspecified route of administration on Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced on Aug2021 patient got the Pfizer shot last Saturday and patient have been very weak and tired and wanted know if that''s normal. The clinical outcome of the events were unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1681839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Lethargy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:104
CDC Split Type: USPFIZER INC202101084465

Write-up: Fever 104; Nauseous; Lethargic; This is a spontaneous report from a contactable consumer (wife). This consumer reported for a male (husband) patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Aug2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter stated, she actually calling about her husband. He got the COVID Vaccine yesterday around 2 o''clock the Pfizer one. It was his second dose, he has started having a fever 104 and he was super nauseous and really lethargic on an unspecified date in Aug2021 and she just wanted to know if those were normal reaction. She tried calling the pharmacy, but they were closed but the people works there said to give you guys a call if there were any reaction like this. The patient underwent lab test and procedure included body temperature 104 on an unspecified date in Aug2021. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.


VAERS ID: 1681857 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ear pain, Eructation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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: SPRYCEL; LEVOTHYROXINE; AMLODIPINE; ROSUVASTIN; CLOPIDOGREL; VITAMIN C; VITAMIN D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (Diagnosed about 30-40 years ago.); Chronic kidney disease (about 6 years ago but its stable); Hearing aid user (The caller does have hearing aids.); Leukemia (for about 19 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101090336

Write-up: Burping; her left ear was hurting; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW0217, Expiry date:30-Sep-2021), via an unspecified route of administration, administered in Arm Left on 27Jul2021 13:30 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included leukaemia , chronic kidney disease ,hypertension ,hearing aid user from an unknown date and unknown if ongoing . The patient had no known allergies. The patient''s concomitant medications included Sprycel, Levothyroxine, Amlodipine, Rosuvastin, Clopidogrel, vitamin C, vitamin D. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first dose on 27Jul2021 and after that her left ear was hurting and that went away. The patient experienced burping on 13Aug2021. This started about two weeks after the first shot, or 1.5 weeks something like that. She received the second dose on 17Aug2021, and her right ear started throbbing and it is constant. She stated right now she is "so-so" because her ear is irritating her. The caller stated she is waiting until 8 to see if she can get in to see her doctor. She asked if this is a known side effect or if anyone has been reporting this. The caller went to urgent care on 19Aug2021 because she couldn''t see her primary care provider. The caller was burping and every time she did, it caused the throbbing in her ears. The urgent care provider thought that the caller may be having acid reflux. The burping has gone away but the right ear is constantly throbbing whereas the left ear would come and go. left ear hurting. The outcome of the event burping was recovering and outcome of the other event was recovered on 21Aug2021.


VAERS ID: 1681860 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Bedridden, Body temperature, Cough, Decreased appetite, Dysgeusia, Fatigue, Headache, Lymphadenopathy, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Clotting disorder; Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: low grade fever; Result Unstructured Data: Test Result:99.7
CDC Split Type: USPFIZER INC202101090462

Write-up: a severe metallic taste in mouth/metallic taste was unbearable; Nausea; low grade fever 99.7; swollen lymph nodes; aching muscles, joints; aching muscles, joints; terrible headache; cough/lingering cough; general feeling of illness; bedridden for approx. 36 hours; didn''t want to eat anything; tired; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot FD8448) on 19Aug2021 at 02:30 PM, at the age of 57 years, as the second single dose, in left arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included blood clotting disorder and food allergies. The patient received the first dose of BNT162B2 vaccine on 29Jul2021 at 02:30 PM (lot FA7485), at the age of 57 years, in left arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On 19Aug2021 at 15:30, within an hour of 2nd vaccination, the patient developed a severe metallic taste in mouth. This lasted approximately 24 hours. Nausea developed within 6 hours followed by low grade fever 99.7, swollen lymph nodes, aching muscles, joints, etc., terrible headache, cough and general feeling of illness. Paracetamol (TYLENOL) was taken every 4 hours to manage symptoms. She was bedridden for approximately 36 hours and didn''t want to eat anything. Improvements began slowly after 36 hours. Now 72 hours later she was really tired with a lingering cough. The metallic taste was unbearable. The events resolved on an unspecified date in Aug2021.


VAERS ID: 1681865 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Erectile dysfunction, Insomnia, Polydipsia, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sexual dysfunction (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101090862

Write-up: erection problems / lost erection / c an''t have sex; chills; fever; drinking more like 5 liters a day; couldn''t sleep well; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program . A 37-year-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy, administered via an unspecified route in left deltoid on 19Aug2021 15:00, at 37 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical and family history was none. There were no concomitant medications. The patient didn''t receive any other vaccination in the previous 4 weeks before COVID-19 vaccine. The day after vaccination (20Aug2021) the patient had chills, fever, erection problems and has been drinking more. The patient usually drinks 2-3 liters a day and now he was drinking more, like 5 liters a day. He stated that he had a "normal sex life before this and after the vaccine he lost erection and can''t have sex". The caller did not have a fever on 22Aug2021, but he had it at the report date (23Aug2021), that''s why he couldn''t sleep well. No relevant test was performed. The reported events didn''t require a visit to Emergency Room or Physician Office. At the time of the report the reported events had not resolved yet, except for Chills which were resolving and insomnia, whose outcome was unknown. The lot number for BNT162b2, was not provided and will be requested during follow up.


VAERS ID: 1681869 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: 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 INC202101090890

Write-up: Two, Three front teeth, My upper lip and then, My whole nose went numb after, I got the shot yesterday.; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21Aug2021 as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in Aug2021 patient experienced two, three front teeth, my upper lip and then, my whole nose went numb after, consumer got the shot yesterday. The outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up. FUP (PRD/SRD 02Sep2021): Follow-up activities closed. Batch/lot number not available.


VAERS ID: 1681872 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:Slight temp
CDC Split Type: USPFIZER INC202101090957

Write-up: I have a slight and running, Just a very slight temp not very much.; Little bit of chills, Off and on.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Aug2021 10:00 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had second Covid shot yesterday morning (21Aug2021) at 10 O''clock and was taking elderly mother to an appointment today (22Aug2021) and patient was having just a couple side-effects. It was nothing bad. Just need to know, if should be around other people. Had a slight and running, just a very slight temperature (slight fever) not very much and a little bit of chills, off and on, that was it on an unspecified date in Aug2021. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1681873 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Decreased appetite, Depressed mood, Headache, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:a 101 for like 2 hours; Comments: I had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back
CDC Split Type: USPFIZER INC202101090965

Write-up: Headache; I am feeling down always like I want to be sleeping everyday; I am not hungry; I had a temperature twice; I am feeling down; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Aug2021, patient experienced headache, feeling down always like want to be sleeping everyday, not hungry and had a temperature twice. The patient got first vaccine last Monday and was good till Tuesday, like maybe, the patient would say 15, it was 12 hours after I put it on, the patient started having like headache, felt down and not hungry. The patient stated nothing like that, but the worst thing was got headache. The patient had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back but right now felt a lot of headache and not hungry and feeling down always like wanted to be sleeping every day. The patient was wondering was that normal. On an unspecified date in Aug 2021, the patient underwent lab tests body temperature with results a 101 for like 2 hours. The outcome of the event body temperature increased was recovered on an unspecified date in Aug 2021. Outcome of the other events were unknown. The lot number for the vaccine [bnt162b2] was not provided and would be requested during follow up.


VAERS ID: 1681889 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Bedridden, Chills, Fatigue, Feeding disorder, Headache, Myalgia, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (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: Estroven
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Coagulation disorder (Verbatim: Blood disorder); COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 202011; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result: Positive.
CDC Split Type: USPFIZER INC202101091597

Write-up: The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can''t eat; I couldn''t get out of my bed; This is a spontaneous report received from a contactable consumer(patient). A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation . Medical history included coagulopathy, breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported. The patient experienced injection site pain that hurt all day (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever (non-serious) on Aug2021 with outcome of unknown , tiredness (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous (non-serious) on Aug2021 with outcome of unknown , pain in arm (non-serious) on Aug2021 with outcome of unknown , i can''t eat (non-serious) on Aug2021 with outcome of unknown , i couldn''t get out of my bed (non-serious) on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Nov2020 . Follow-up attempts are completed. No further information is expected.


VAERS ID: 1681891 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Appetite disorder, Arthralgia, Blood test, Chills, Diarrhoea, Extra dose administered, Fatigue, Gait disturbance, Increased appetite, Nausea, Nightmare, Off label use, Pain, Pyrexia, Somnolence, Thirst, Urine analysis, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Medical History/Concurrent Conditions: HIV disease
Allergies:
Diagnostic Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Unknown results; Test Name: urine; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202101091807

Write-up: Pain in the injection site; Fever; Chills; Joint pain; Body pain; Fatigue/sleepy like tired; Loss of appetite but at the same time you are hungry; Loss of appetite but at the same time you are hungry; Cannot walk too much because I tend to fall; Nightmares; Thirsty; Diarrhea; Nausea; sleepy like tired; I got the first one, the second one and then I got a new one, a third one; I got the first one, the second one and then I got a new one, a third one; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received third dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0175, expiration date: 31Aug2021) (age at the time of vaccination was 25 years) via an unspecified route of administration on 20Aug2021 in arm left as DOSE 3, SINGLE for COVID-19 immunisation. The patient''s medical history included recently diagnosed with HIV in Aug2021. Concomitant medication was not reported. The patient previously received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) (age at the time of vaccination was 25 years) via an unspecified route of administration on 05Jan2021 in arm left as DOSE 2, SINGLE for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) (age at the time of vaccination was 24 years) via an unspecified route of administration in Dec2021 in arm left as DOSE 1, SINGLE for COVID-19 immunisation. Consumer stated, I am having side effects from my shot 3, from Covid-19 Vaccine (Pfizer Covid-19 Vaccine). It was not too bad. I just wanted to report what I am feeling. Consumer stated, Well, pain in the injection site which was normal, a bit of fever, chills like I am cold, joint pain, body pain, like if I touch my body it kind of hurts a little bit, fatigue, I guess, loss of appetite but at the same time you are hungry and I guess like I cannot walk too much because I tend to fall like obviously my joints kind of like bother me and I think, I guess it was nightmares, sleepy like tired, I get thirsty. It was like relaxing away. I think that my immune system and I think that is like overall what it is, it is more off this Covid shot. So, it was I think that the second shot was like way worse. This was not too bad. When clarified if the consumer receive the third dose of Pfizer Covid-19 Vaccine, in response Consumer stated, I got the first one, the second one and then I got a new one, a third one. That was the new booster that was happening. I think so approximately I would say 8 hours after the shot. When probed for the safety report, Consumer stated, And also that the symptoms are less severe than the second shot, if that helps. So, the first one was kind of, I am feeling kind of like the same effects that I got from the first one. But not entirely. So, it is like it was like alright and then it was like really bad for the second one and now it was like not too much. I was having a little bit of nausea that is the only thing. But that is the only medication (Unspecified Medication) I just started. So, I think that was because I have not eaten anything. Start date of events: Consumer stated, the first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something is happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water- going to the bathroom, drinking water- going to the bathroom and then just like sleeping. At the same time sleeping- water- bathroom. Consumer stated, My left arm. All of them have been in my left arm. Consumer stated, No, I was recently diagnosed with HIV. So, that is why I got my first shot. So, I was recently diagnosed with HIV for my shot no.3. So, that is why it was this past Monday. I guess you can say 16Aug or Aug17. Consumer stated, I just started the HIV medication. I mean I take the other ones. But I do take any other medication when I took the vaccine. I have the medication. But I just started it yesterday. After you like always after my shot. So, the medication is not showing any side effects yet like this. This is how my immune response reacts usually. So, does not have to do anything to do with it. Laboratory work: Consumer stated, Yes, I got blood and I got urine. Blood & urine. I am sorry I just had another thing to add, I had an antibacterial injection like antibiotic, I mean, and I got an antibiotic injection. But it should not be that. Only it is like side effect of and many medication, it was just like may be like diarrhea. But it is still nothing to do with my immune system. The patient did not receive any treatment for the events. The outcome of the events was unknown.


VAERS ID: 1681902 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Dizziness, Dyspnoea, Extra dose administered, Fatigue, Feeling cold, Headache, Hot flush, Hyperhidrosis, Hypoaesthesia, Illness, Insomnia, Malaise, Myalgia, Nasal congestion, Off label use, Oropharyngeal pain, Presyncope, Sinus congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101094015

Write-up: her left hand middle finger was numb and it was moving to her first fingers; really bad headache; muscle aches; fatigue; freezing cold, with chills; freezing cold, with chills; sweating; nasal congestion; couldn''t breathe; lightheaded; slight cough; mild sore throat; was really bad and she didn''t sleep/feels very drained; was really bad and she didn''t sleep; hot flashes; sinus congestion; like a vasovagal response; received her third dose booster shot; received her third dose booster shot; still pretty sick; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3180, and Expiration date: Unknown), dose 3 via an unspecified route of administration, administered in left arm on 20Aug2021 11:30 (at the age of 41-year-old) as dose 3, single for COVID-19 immunisation. Medical history reported none. There were no concomitant medications. Previously the patient received first dose of BNT162B2 on 23Dec2020 (Lot Number: EL0142, Expiration Date: Unknown) and second dose on 11Jan2021 (Lot Number: EL0142, Expiration Date: Unknown) (both at the age of 41-year-old). The patient had zero side effects after her first shot, only a sore arm. After her second dose for the first 24-36 hours she had slight chills, muscle pain, and fatigue. The patient said being a physical therapist who had to work with COVID patients. She said she "received her third dose booster shot", clarified to being Pfizer COVID-19 vaccine. She said she got the third dose booster because her "son is immunocompromised" and she and her husband wanted to get the booster. The patient did not have any primary care provider. The reported that the third dose kicked her butt, it felt like a full on flu response was going on. She said she got it at 11:30AM on 20Aug2021(Friday), then at 09:30AM on the 21Aug2021 (Saturday) she had a really bad headache, muscle aches, and fatigue. Later in the same day she was freezing cold, with chills, and would periodically break out in a sweat (sweating). She said she would lay down through the day and rest, then that night she was congested (nasal congestion) and couldn''t breathe through her nose, and when she would get up to do anything, she would feel lightheaded like a vasovagal response. She took Advil as treatment, around the clock. She clarified that she was not short of breath, that was not accurate, she "couldn''t breathe" out of her nose, she was very congested in her nose. She had no chest pain. The patient took Advil 600mg probably three times a day. She said her congestion had gotten better, it started getting better Sunday morning when she woke up on the 22Aug2021. She said her muscle aches and fatigue were better, but she still did not go to work today because she did not think she can take care of patients. She said that "she is sweating right now actually", and she took a shower earlier because she was freezing cold and put on sweatpants and a sweatshirt and had to take the sweatshirt off. The patient said that she felt like she was missing some things that she wanted to tell call handler. She said on 21Aug2021, Saturday evening she started having a slight cough, not like she was very congested, just coughing, she felt the need to cough. She said she had a mild sore throat. She took more Ibuprofen when things were happening then. On Saturday night it "was really bad and she didn''t sleep" the whole night and finally got up at 04:30AM and took over the counter Advil Cold and Sinus medication and used a nasal spray, an Afrin-type nasal spray then went to sleep around 05:00AM then at 08:00AM she woke up on 22Aug2021, Sunday and did not have sinus congestion anymore. She said on Sunday she felt better than she did all day Saturday. She said she started coughing more and having more episodes of periodic sweating and freezing cold and all that. She said last night she slept pretty good and stayed asleep all night, and she took another Advil Cold and Sinus last night and used another puff of nasal spray. The patient said on 23Aug2021, (today) she felt fatigued still and could not go to work, she "feels very drained". She said then something really weird happened (this) 23Aug2021, morning, that was why she called. She said this morning she was very relaxed, she was watching TV, and she felt freezing cold, about 09:30AM. She clarified she was eating and watching TV and all of a sudden, the middle finger on her right hand nail bed and the tip of her finger were completely numb. She said she tried to warm her hand up and then "her left hand middle finger was numb and it was moving to her first fingers". She said she took a hot shower which did relieve her fingers being numb. She went to go lay down for 30 minutes after the shower and then taking Acetaminophen because she had hot flashes and sweating again. The patient reported that she was still home and "still pretty sick". There was no investigation assessment. She said that she did not need attention, she just wanted to recommend staggering it, because she did not want people to hear about negative side effects for a bunch of people and not get it, she would like Pfizer to be ahead of it and not behind it, to better encourage people to get the vaccine. The outcome of the events "was really bad and she didn''t sleep (insomnia)" and sinus congestion was reported as resolved on 22Aug2021. The outcome of the event "her left hand middle finger was numb and it was moving to her first fingers" was reported as resolved on 23Aug2021. The outcome of the events muscle aches and nasal congestion was resolving. The outcome of the events fatigue, freezing cold, with chills (feeling cold), sweating, slight cough, "was really bad and she didn''t sleep/feels very drained", hot flashes, and "still pretty sick" was not resolved. The outcome of the events really bad headache, freezing cold, with chills (chills), "couldn''t breathe", lightheaded, like a vasovagal response, and mild sore throat was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1681903 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 3 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Atrial fibrillation, Extra dose administered, Off label use, Pneumonia
SMQs:, Supraventricular tachyarrhythmias (narrow), Eosinophilic pneumonia (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENTYVIO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Pneumonia (Approximately 10 years prior to the initial reporting (approximately in 2011), or maybe more.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101094203

Write-up: Pneumonia; 3rd single dose of BNT162b2; 3rd single dose of BNT162b2; And then went to the A-Fibrillation; This is a spontaneous report from a contactable consumer (patient''s wife). An 84-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular injection in the left arm, on 19Aug2021, at around 10:30 - 11:00 AM (Batch/Lot Number: FC3182), at the age of 84 years old, as 3rd single dose, for COVID-19 immunisation. Medical history included Crohn''s disease, pneumonia approximately 10 years prior to the initial reporting (approximately in 2011), or maybe more. Concomitant medication included vedolizumab (ENTYVIO) every 6 weeks 2-6 weeks, for Crohn''s disease. Prior vaccinations included flu vaccine yearly, but not received in 2021 at the time of the initial reporting. The patient received the 1st single dose of BNT162b2 (lot number: EL3246) on 03Jan2021, and the 2nd single dose (lot number: EL9262) on 26Jan2021, all as intramuscular injections in the arm, at the age of 84 years old. The patient had very, very minor reactions to the 1st and 2nd doses. The patient''s wife stated that on 20Aug2021, within a day from having the 3rd single dose, her husband who was 100% well, developed pneumonia, for which he was hospitalized on 21Aug2021, and then went to the A-Fibrillation (as reported). She thought this was directly related to the booster shot. The reporter had no information regarding the treatment received due to pneumonia. The patient had not recovered from pneumonia at the time of the reporting, while the outcome of atrial fibrillation was not provided. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1681904 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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? 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: COVID test; Test Result: Positive
CDC Split Type: USPFIZER INC202101094630

Write-up: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported for 5 patients. This report refers to the male (other guest''s husband) she was at dinner with. A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Aug2021, after vaccination, the patient was tested positive for COVID. This consumer reported stated she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn''t wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn''t. She clarified she still has immunity obviously, and she doesn''t want to get another shot. The consumer clarifies the female person who was coughing her brains but was wearing a mask and was sitting across from the reporting consumer. This person''s husband had COVID and didn''t know it but was cured. His symptoms resolved in 2 days but was shedding the virus apparently. She clarifies this person''s husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Apparently, the male that had COVID that week was still shedding the virus because the other male guest at the dinner was in the hospital for 2 weeks. The reporting consumer confirms they all three people at the dinner with her tested positive for COVID. The patient had recovered from the event on unknown date in 2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1681922 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Contusion, Fibromyalgia, Fluid retention, Pain, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101098029

Write-up: every joint on her body has been hurting/joint issues and her fingers also hurt; hurt pretty bad; hurt pretty bad/injection site that hurt pretty bad; fibromyalgia; retaining water; she also had a bruise on that same arm; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 50-years-old). The patient Medical history, family history and concomitant medications were none. It was reported that, patient still needs to get the 2nd shot of the Comirnaty vaccine but she was concerned if she should get it because the 1st shot hurt pretty bad and every joint on her body has been hurting for the last week and a half and was reported as worsened. As per caller, she clarified that it was the arm where she got the injection site that hurt pretty bad later afternoon. She added that she felt the injection go in and then she screamed because it hurt. She felt that for 2 and a half to 3 days and she also had a bruise on that same arm which was her left arm. Those symptoms went away and now she has body joint issues and her fingers also hurt. Caller received her 1st dose on 06Aug2021 and was set to receive the 2nd one this Friday. She was told that the 1st shot would not bother her and would only feel the side effects after the 2nd shot. She called to know if these are normal side effects of the vaccine because she was nervous to get the 2nd shot. She mentioned that she would be calling her doctor after the call as well. She stated that she felt comfortable knowing that these are normal side effects. She was nervous on day 6 it hurt pretty bad, she had pain when it happen and two and a half to three days later it hurt and bruising. For about a week and a half now every joint in her body hurts. Her husband said it did not hurt him. She hated needles, and she talked to her daughter and she said she also had pain in her joints. Hurt pretty bad: The pain stopped where she got the injection. It went away. The patient experienced hurt pretty bad/injection site that hurt pretty bad on 06Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt on 09Aug2021, she also had a bruise on that same arm, fibromyalgia and retaining water on an unspecified date in Aug2021. Her mother has fibromyalgia and she was thinking that was what she has. She was double checking with us and the doctor before the second shot. The patient did not receive any treatment. The patient not required to visit emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no relevant tests performed. Outcome of the events hurt pretty bad/injection site that hurt pretty bad was recovered on 09Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt was not recovered and unknown for other events.


VAERS ID: 1681927 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Cardiac flutter, Chest discomfort, Chest pain, Erythema, Feeling hot, Hyperhidrosis, Insomnia, Joint range of motion decreased, Neck pain, Pain in extremity, Peripheral swelling, Rhinorrhoea, Vaccination site erythema, Vaccination site pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 INC202101098402

Write-up: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there''s a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn''t lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn''t feel like a fever and hadn''t taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there''s not always pain that''s associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that''s the one she had this reaction with. Her arm was swollen, couldn''t lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1681945 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3180 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Headache, Illness, Loss of consciousness, Nausea, Pain, Pallor, Palpitations, Somnolence, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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), 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: USPFIZER INC202101099795

Write-up: almost passed out after vaccination/Still feels like he has to pass out; sick; throw uppy/feeling like he has to throw up but he can''t/feeling like have to vomit; He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night; wakes up feels nauseous; achy; he feels this bad; heart racing; headachy; he is pale; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FC 3180) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jul2021 for Covid-19 Immunisation and experienced got really sick, heart racing, feeling like have to vomit, nauseous and headache. And He spent 3 to 4 days in nursing quarters, sleeping. After the second dose got even sicker. heart racing, feeling like have to vomit, she is concerned that he is having an adverse event. After his 2nd dose he is still sick, almost passed out after vaccination, the pharmacist thought they would have to call an ambulance, but did not call the ambulance. "He is sleeping, napping during the day 4 to 6 hours, sleeps 9 hours at night, wakes up feels nauseous, achy and headachy and throw uppy, not just being teenage lazy, feeling like he has to throw up but he can''t he is pale and still aches. Still feels like he has to pass out, he asks to sleep with us, because he feels this bad.She called the Doctor "can''t get us in until Thursday. The nurse said he probably had covid when he got his vaccine. They want to test his white, red blood cell hemoglobin and something else and another covid test. "Call back 24Aug2021 at 2:54PM - Left voice mail with telephone number and extension due to call disconnected while on hold.Outcome of achy was not recovered, of others was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202100909916 same pt, different dose/event


VAERS ID: 1681952 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test positive
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Covid-19; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101102522

Write-up: Typical signs of infection, individual tested positive for Covid with a rapid test.; Typical signs of infection, individual tested positive for Covid with a rapid test; Breakthrough infection 4 months after second dose.; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination was yes. On an unspecified date in Aug2021, breakthrough infection 4 months after second dose. Typical signs of infection, individual tested positive for Covid with a rapid test. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with REGEN-COV. The patient underwent lab tests and procedures which included sars-cov-2 test positive (nasal swab): positive on an unspecified date in Aug2021. The outcome of events was recovering. Information on the lot/batch number has been requested.


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