chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Systemic lupus erythematosus, Urethral haemorrhage
Clinical narrative: Lupus got worse; Lot of bleeding from her womb and rectum; Lot of bleeding from her womb and rectum; COVID positive; Dizzy; Strong reaction; Can't get out of bed; A spontaneous report was received from a consumer who was also a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Lupus got worse, lot of bleeding from her womb and rectum,COVID positive, dizzy, strong reaction and can't get out of bed.  The patient's medical history included lupus. Concomitant medications included prednisone, enoxaparin, folic acid and pain killers.  On 12 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, 15 days later, patient had a "strong reaction" and went to the hospital where patient got diagnosed with COVID. Patient says patient cannot even stand, felt dizzy and had to lay in bed all day. The patient had lupus, which worsened after vaccination. She had a lot of bleeding from womb and rectum.  Patient said she won't get the second dose because it will kill patient. Treatment for the event included tylenol but symptoms did not get better.  The mRNA-1273 was withdrawn in response to the events  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the event -tested positive has been provided at this time.  Further information has been requested. However, based on the mechanism of action of mRNA-1273, the event- COVID-19 is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath, she was gasping for air, her oxygen level was really low; Affect her lungs, her heart and esophagus; Tightness on the chest; Fatigue; Chills; Headache; Stomach pain; A spontaneous report received from a Consumer concerning, a female patient of unspecified age who received first dose of the Moderna (mRNA-1273) and experienced tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain.  The patient's medical history included cancer survivor, heart attack, numerous surgeries, asthma and CPAP machine. Patient's concomitant included albuterol, aspirin, buspirone, covitol, B12 injections once a month, cyclobenzaprine, levoxacin, Vit D, ezetimibe, fexofenadine, Advil, levothyroxine, Nasonex, Montelukast, niacin, Xolair injection once a month, oxybutynin, prosol, potassium chloride, primidone, raloxifene, Ramipril, tiotropium bromide, tramadol, zinc and pepsin.  On 30 Dec 2020 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J204) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient stated she received her first dose of the Moderna COVID19 on 30 Dec 2020 and she experienced tightness on the chest immediately. The next day 31 Dec 2020 she felt worse, so she went to the ER and she was told that it was a reaction to the vaccine. Then, 01 Jan 2021 she went to urgent care because she was feeling worse and they gave her prednisone. Patient stated she then went to the pulmonologist and a few days later, she was admitted to the hospital. She said it affected her lungs, her heart and esophagus. She stated that the symptoms are still ongoing, she was still having issues.   Treatment received was prednisone and breathing treatment was oxygen steroids.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain was not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pneumomediastinum
Clinical narrative: Shortness of breath, she was gasping for air, her oxygen level was really low; Affect her lungs, her heart and esophagus; Tightness on the chest; Fatigue; Chills; Headache; Stomach pain; A spontaneous report received from a Consumer concerning, a female patient of unspecified age who received first dose of the Moderna (mRNA-1273) and experienced tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain.  The patient's medical history included cancer survivor, heart attack, numerous surgeries, asthma and CPAP machine. Patient's concomitant included albuterol, aspirin, buspirone, covitol, B12 injections once a month, cyclobenzaprine, levoxacin, Vit D, ezetimibe, fexofenadine, Advil, levothyroxine, Nasonex, Montelukast, niacin, Xolair injection once a month, oxybutynin, prosol, potassium chloride, primidone, raloxifene, Ramipril, tiotropium bromide, tramadol, zinc and pepsin.  On 30 Dec 2020 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J204) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient stated she received her first dose of the Moderna COVID19 on 30 Dec 2020 and she experienced tightness on the chest immediately. The next day 31 Dec 2020 she felt worse, so she went to the ER and she was told that it was a reaction to the vaccine. Then, 01 Jan 2021 she went to urgent care because she was feeling worse and they gave her prednisone. Patient stated she then went to the pulmonologist and a few days later, she was admitted to the hospital. She said it affected her lungs, her heart and esophagus. She stated that the symptoms are still ongoing, she was still having issues.   Treatment received was prednisone and breathing treatment was oxygen steroids.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events tightness in chest, affected lungs, heart and esophagus, shortness of breath, fatigue, chills, headache and stomach pain was not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cranial nerve paralysis
Clinical narrative: Right six cranial nerve palsy; A spontaneous report was received from a consumer  concerning a 73-year-old, female patient, who developed right six cranial nerve palsy/facial paralysis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  In January 2021 (date not specified), approximately 2 weeks prior to the onset of symptoms, the patient received the first dose of two planned doses mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed right six cranial nerve palsy. She consulted a physician and a CTR (not further specified) and magnetic resonance imaging were scheduled. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event, right six cranial nerve palsy, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: immediately after getting the vaccine he started with like a post nasal drip cough, now he was not sick before or anything like that; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid.  A contactable consumer (patient's wife) reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included drug hypersensitivity (reported as allergic to penicillin and all Cephalosporins), anaphylactic shock (reported as anaphylactic shock reaction to these medications), cerebrovascular accident (reported as strokes since age 35), paralysis (paralyzed on his right side), cardiac operation (open heart surgery), endarterectomy (had 3 Endarterectomy on his neck which none of them taken), and drug hypersensitivity (allergic to penicillin and all sulphur form drugs). Concomitant medications were not reported. The patient immediately after getting the vaccine started with like a post nasal drip cough on an unspecified date, now he was not sick before or anything like that. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Swelling face, Vaccination site pain
Clinical narrative: After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Chills, Ear pain
Clinical narrative: Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes.  The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00  pain in left ear on 28Jan2021 19:00 and  The patient underwent lab tests and procedures which included body temperature: 97.3 on  Temperature under the tongue was 97.3 and outcome of the events was unknown   Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal temperature; This is a spontaneous report from a contactable physician for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) on 11Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. Patient's medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient previously had erythromycin and had allergies. Concomitant medication included Lipitor (Atorvastatin calcium). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 16Dec2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient did not have any other vaccine within four weeks. The patient did not receive COVID-19 vaccine prior to vaccination. The patient experienced chills, fatigue/severe fatigue, subjective cold, myalgias, felt feverish and but always below normal temperature in Jan2021. The patient was underwent COVID-19 (Nasal Swab) on 18Jan2021 which was negative. The patient didn't receive treatment. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal temperature; This is a spontaneous report from a contactable physician for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) on 11Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. Patient's medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient previously had erythromycin and had allergies. Concomitant medication included Lipitor (Atorvastatin calcium). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 16Dec2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient did not have any other vaccine within four weeks. The patient did not receive COVID-19 vaccine prior to vaccination. The patient experienced chills, fatigue/severe fatigue, subjective cold, myalgias, felt feverish and but always below normal temperature in Jan2021. The patient was underwent COVID-19 (Nasal Swab) on 18Jan2021 which was negative. The patient didn't receive treatment. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Bone pain, Hypertension, Malaise, SARS-CoV-2 test
Clinical narrative: Exacerbation of previously controlled hypertension with blood pressure spiking to 200/100; Had skeletal chest pain; doing well until Covid vaccine; This is a spontaneous report from contactable physicians (one of which was the patient).  A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration at the right arm on 22Jan2021 08:30 at single dose for COVID-19 immunization. Vaccination was done in a TN. Medical history included CABG Post op RT CABG (coronary artery bypass; doing well until Covid vaccine) from 11May2020 and hypertension. Concomitant medication included metoprolol succinate (TOPROL), ubidecarenone (COQ10), losartan and Hybrid. There was no other vaccine receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took atorvastatin (LIPITOR) and experienced allergies: Lipitor.  The patient experienced exacerbation of previously controlled hypertension with blood pressure spiking to 200/100 on 26Jan2021, went to local ER, BP 180/100 there on 26Jan2021. He had skeletal chest pain which began 25Jan2021 22:00. He stated post op right cabg from 11may2020, doing well until covid vaccine on 22Jan2021. Treatment IV Hydralazine received. The events were considered non-serious by the reporter. On 26Feb2021, it was reported that the patient provided information to another physician regarding the reported adverse events with the use of BNT162B2. The physician did not consider the Pfizer product had a causal effect to the adverse events. Lab data also included Covid test (rapid nasal swab) on 26Jan2021 was negative. The outcome of the events was not recovered.  Follow-up (26Feb2021): New information received from a contactable physician in response to HCP letter sent includes: reporter details (added a physician as a reporter), causality assessment and clinical course details.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT62B2 to the events hypertension aggravated, skeletal pain and unwell cannot be excluded. The fluctuation of underlying hypertension may be major cofounder.  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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site discomfort, Vaccination site haemorrhage
Clinical narrative: arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do.  Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL3302, via an unspecified route of administration in left arm on 05Feb2021 10:15 at a single dose for covid-19 immunization in a military base at age 47 years old. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on 05Feb2021 10:15. The event was reported as non-serious. No treatment was received from the adverse event. The patient recovered from the event on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: 2 of the doctors did not convert with antibody test which was performed about 10-18 days after the 2nd Pfizer vaccine dose; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), both via an unspecified route of administration on unspecified dates and at single dose for COVID-19 immunisation. The patient received the product in the hospital. The patient's medical history and concomitant medications were not reported. The physician reported that several doctors have received both vaccines and 2 of the doctors "did not convert with antibody test." HCP stated the test was performed "about 10-18 days after the 2nd Pfizer vaccine dose." The patient underwent lab tests and procedures which included COVID-19 antibody test: did not convert with antibody test on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171614 same drug/reporter/event, different patients
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021/ 03Feb2021 of a runny nose/ covid19 test (06Feb2021)/ it came back positive, this morning (08Feb2021); first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021/ 03Feb2021 of a runny nose/ covid19 test (06Feb2021)/ it came back positive, this morning (08Feb2021); This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program.  A 71-year-old male patient (also age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262, expiry date: May2021), intramuscular on 22Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Pfizer-Biontech Covid19 vaccine on 22Jan2021 and due his second COVID shot tomorrow (09Feb2021). The wife started feeling ill 26Jan2021 and she thought just had sinus infection but she went Sunday 31Jan2021 and had a swab test done and she got swabbed then Monday (results 01Feb2021) she found out she was positive for COVID. The patient took a rapid test that same Monday (01Feb2021) and the rapid test was negative. He reports Covid symptoms on 03Feb2021 of a runny nose-no fever, chills, or diarrhea. He went for a second saliva-based covid19 test (06Feb2021: confirmed by the patient), and it came back positive, this morning (08Feb2021). It was added that the patient had not showed any symptoms through all that time until 03Feb2021 he had a runny nose for one afternoon and that was it and so with the second vaccine on the 09Feb2021 and him being exposed he thought he would get a test Saturday (06Feb2021), he had a saliva test and he got the results today that unfortunately were positive but he still hasn't showed any symptoms other than a runny nose for one afternoon. he has not had  fever or none of the flu like symptoms. He is asking for some information he is hoping for anyway. The patient asked if he should go ahead to get the second shot. and he's looking for guidance on getting his second vaccine dose, tomorrow, or not? What is the recommended interval? What if he waits 4 weeks? He is wondering what to do about 2nd dose, as he is concerned with the timeline. The outcome of the events was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Hyperhidrosis, Pyrexia
Clinical narrative: Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Injection site warmth, Myalgia
Clinical narrative: Chills; Muscle pain; Fatigue; Flu like symptoms; Arm swollen size of a baseball and radiating heat at site.; Arm swollen size of a baseball and radiating heat at site.; This is a spontaneous report from a Non-contactable consumer. A adult female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. the patient's medical history included covid-19 (If covid prior vaccination: Yes).  She was vaccinated on a Monday. Tuesday, the patient experienced chills, muscle pain, fatigue, flu like symptoms. Friday she experienced arm swollen size of a baseball and radiating heat at site.  This Adverse event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment. The outcome of the events was recovered.  No follow-up attempts are possible. Information about batch/Lot number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Chills; Muscle pain; Fatigue; Flu like symptoms; Arm swollen size of a baseball and radiating heat at site.; Arm swollen size of a baseball and radiating heat at site.; This is a spontaneous report from a Non-contactable consumer. A adult female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. the patient's medical history included covid-19 (If covid prior vaccination: Yes).  She was vaccinated on a Monday. Tuesday, the patient experienced chills, muscle pain, fatigue, flu like symptoms. Friday she experienced arm swollen size of a baseball and radiating heat at site.  This Adverse event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment. The outcome of the events was recovered.  No follow-up attempts are possible. Information about batch/Lot number can not be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging
Clinical narrative: Knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the patient, reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL8982, first dose) solution for injection intramuscular on 27Jan2021 (at the age of 70-years-old) at single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient experienced knee pain after the first vaccine in 2021 and her orthopedic doctor recommended an oral steroid for 6 days. The patient had a knee procedure (unrelated to vaccine) and was prescribed methylprednisolone to address the pain. MRI on an unknown date with unknown results. The outcome of the event knee pain was unknown.  The consumer stated that the knee pain was unrelated to COVID vaccine.; Sender's Comments: The event Arthralgia is most likely related to an intercurrent or underlying condition which may not be related to the suspected drug BNT162B2.  Knee procedure may provide an explanation for the event.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got Covid virus; she got Covid virus; This is a spontaneous report from a Pfizer-sponsored program via a contactable Nurse reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient reported that she already got the first dose of her COVID Vaccine and after that she got COVID virus on an unspecified date. Patient lab data included she got COVID virus on an unspecified date. She wanted to know if she should continue to get her 2nd dose or what she should do. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasal congestion, SARS-CoV-2 test
Clinical narrative: she got Covid virus; she got Covid virus; This is a spontaneous report from a Pfizer-sponsored program via a contactable Nurse reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient reported that she already got the first dose of her COVID Vaccine and after that she got COVID virus on an unspecified date. Patient lab data included she got COVID virus on an unspecified date. She wanted to know if she should continue to get her 2nd dose or what she should do. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar went up; This is a spontaneous report from a contactable consumer (patient) via medical information team and a Pfizer-sponsored program . A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown) via an unspecified route of administration on 11Feb2021 at single dose to prevent COVID-19 virus. Medical history included that he was legally blind and he did not drive; his oncologist told him to take the Pfizer COVID-19 Vaccine because he has Leukemia, to prevent the COVID-19 virus that has been going around; this consumer was a type II diabetic and he took his blood sugar every morning. The patient's concomitant medications were not reported.  He had an injection of BNT16B2 on 11Feb2021 afternoon and his blood sugar spike up on 12Feb2021. The outcome of event was unknown.  Information on batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as pneumonia vaccine), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date, without any other problems. The outcome of event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia universalis, SARS-CoV-2 test
Clinical narrative: Alopecia universalis; This is a spontaneous report from a contactable physician. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route of administration on 20Dec2020 (at the age of 51 years-old) as a single dose for COVID-19 vaccination.  Medical history included erectile dysfunction and GERD. The patient had no known allergies. The patient's concomitant medications were not reported.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination on an unknown date and the COVID test result was negative. On 21Dec2020 the patient experienced alopecia universalis- onset after 1st shot, mild. The event alopecia universalis resulted in a physician office visit. The patient was treated for the alopecia universalis with Minoxidil, allegra, prednisone started on 08Feb2021. The clinical outcome of the alopecia universalis was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nasal congestion, Nasopharyngitis, Throat irritation
Clinical narrative: Head cold; Diarrhea; developed a kind of allergies like a scratchy throat; Congested; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unspecified route of administration on 25Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient's medical history included 'thyroid' from an unspecified date and unknown if ongoing. Concomitant medications were not reported. On an unknown date, reported as all of the sudden, the patient experienced a kind of allergy like a scratchy throat and then I was congested, a bad head cold (started last week) and from last night I started to have diarrhea. The clinical outcome of head cold, diarrhea, scratchy throat and congested was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Heart rate, Investigation, Laboratory test, Ultrasound scan
Clinical narrative: Miscarriage; This is a Spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report. A 39-year-old female consumer reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9269), via an unspecified route of administration at left arm on 04Feb2021 14:00 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. No other vaccine in four weeks. Concomitant medications included (in two weeks) Prenatal vitamin, colecalciferol (VITAMIN D), folic acid (FOLATE) and sertraline hydrochloride (ZOLOFT 25mg). The patient's last menstrual date was 14Dec2020 and the delivery date was on 17Sep2021 (Gestational period: 8, as reported). An OB exam on 03Feb2021 showed healthy baby at 7w5d- heartbeat detected 152bpm; no abnormalities identified via ultrasound, Labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb2021. AE resulted in Emergency room/department or urgent care, congenital anomaly (as reported). No treatment was administered. No COVID prior vaccination. Patient not COVID tested post vaccination. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225027 fetus case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chills, Dizziness, Feeling hot, Investigation
Clinical narrative: syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Syncope, Throat irritation, Vaccination site pain
Clinical narrative: syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Chest X-ray, Computerised tomogram thorax, Cough
Clinical narrative: COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).   A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.