chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: increased liver enzymes and white count; increased liver enzymes and white count; They didn't rule out Covid illness; They didn't rule out Covid illness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (Age at vaccination: 67-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. About 3 weeks after her dose she ended up being transported by ambulance (for the first time in her life) to the hospital. She reported increased liver enzymes and white count. They didn't rule out Covid illness. Caller has an opportunity to receive her second dose this Saturday, but doesn't know if she should? After returning from hold and providing information to caller, she indicated she would forgo a second dose. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt a little sore after the 1st dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported a female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date after dose 1 of BNT162B2 the patient experienced her arm felt a little sore. The outcome of her arm felt a little sore was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, SARS-CoV-2 test, Troponin, Troponin increased
Clinical narrative: Acute chest pain; Elevated troponin 16; This is spontaneous report received from a contactable Healthcare professional. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 08Apr2021 13:15 (Batch/Lot Number: EW0151) (at 17-year-old) as first dose, single in arm left for COVID-19 immunisation. Other unspecified Pfizer vaccine was received via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW0170) as second dose, single in arm. Medical history included ongoing hospitalization (Vaccine received during existing hospitalization). The patient's other concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Other medications received within 2 weeks of vaccination was reported as unknown. On 02May2021 04:00 AM, the patient experienced acute chest pain and elevated troponin 16, he was admitted to hospital. It's reported AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization). Prior to vaccination, the patient was not diagnosed with COVID-19. On 02May2021, PCR Nasal Swab was performed and showed negative. Ketorolac tromethamine (TORADOL) and ibuprofen (MOTRIN) were received as treatment. Duration of hospitalization was 4 (discharged on 06May2021). The outcome of the event was resolved in May2021.; Sender's Comments: Based on the strong temporal relation, the association between chest pan, troponin increased and vaccine administration cannot be completely ruled out with the information available. 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.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Erythema nodosum
Clinical narrative: acute appendicitis; Erythema nodosum/ atypical erythema nodosum; This is a spontaneous report received from a contactable physician. An approximately 40-year-old (reported as middle-aged, 40 something year old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunisation at an unknown age. The patient medical history and concomitant medications were not reported. The patient experienced acute appendicitis in Apr2021 with outcome of recovered on an unspecified date in 2021, erythema nodosum/ atypical erythema nodosum in Apr2021 with outcome of recovered with sequelae on an unspecified date in 2021.  Clinical course: Caller was inquiring for their middle-aged, 40 something year old, female patient who received her 1st dose of the vaccine on 08Apr2021. About 24-48 hours she developed Erythema nodosum in Apr2021. About 2 weeks later, she developed acute appendicitis in Apr2021. They mentioned that the symptoms might have already been resolved but the erythema nodosum might have some remnants. They know that there have been reports of appendicitis and would like to know during which dose it specifically occurred and whether or not the patients received the 2nd dose. They would also know for any reports of erythema nodosum. Dermatology resident calling regarding the Pfizer COVID 19 vaccine. Reported he has a patient who developed atypical erythema nodosum. He was calling to report this event and would like to confirm if the patient should take dose two. Stated he was in the middle of a clinic and can't answer questions right now; he would like immediate transfer to ask his question. Seriousness not provided.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported appendicitis 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.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Pericardial effusion, Pericarditis
Clinical narrative: 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); This is a spontaneous report from a contactable Physician (patient). A 47-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 20Jan2021 (lot number: EL3302) at 19:00 at single dose for COVID-19 immunization. The relevant medical history included CSF leak (Cerebrospinal fluid leakage) from an MVA, depression, asthma, reglan allergy and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL) and temazepam (TEMAZE). The patient experienced 2 weeks post second vaccine (as reported) with pericarditis (classic positional chest pain and pericardial effusion) on 30Jan2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prednisone, colchicine, aspirin and anakinra, received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pericardial Effusion, pericarditis, Chest Pain and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); This is a spontaneous report from a contactable Physician (patient). A 47-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 20Jan2021 (lot number: EL3302) at 19:00 at single dose for COVID-19 immunization. The relevant medical history included CSF leak (Cerebrospinal fluid leakage) from an MVA, depression, asthma, reglan allergy and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL) and temazepam (TEMAZE). The patient experienced 2 weeks post second vaccine (as reported) with pericarditis (classic positional chest pain and pericardial effusion) on 30Jan2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prednisone, colchicine, aspirin and anakinra, received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pericardial Effusion, pericarditis, Chest Pain and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Ultrasound uterus
Clinical narrative: Miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the mother report.  A 35-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 35-year-old administered in arm left on 18Apr2021 09:15 (Lot Number: EW0164) at singe dose, dose 1 via an unspecified route of administration at the age of 35-year-old administered in arm left on 28Mar2021 15:00 (Lot Number: Er8732) at single dose for covid-19 immunisation. The patient medical history was not reported. There was no Covid prior vaccination. Concomitant medications included estradiol (ESTRACE), progesterone. There was no other vaccine in four weeks. On 23Apr2021, 14:00, the patient experienced miscarriage - baby stopped growing 5 days after shot, confirmed with ultrasounds on 26Apr2021 and 06May2021. The event resulted in doctor or other healthcare professional office/clinic visit. Last menstrual date was 10Mar2021. There was no Covid test post vaccination. There was no treatment for event. The outcome of event was recovering.; Sender's Comments: Linked Report(s) : PFIZER INC-2021512724 baby case
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolus; This is a spontaneous report from a contactable physician.  A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 13Apr2021 (at the age of 72-year-old) (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Relevant medical history included coronary artery disease (CAD), diastolic congestive heart failure, obstructive sleep apnoea (OSA), morbid obesity and hyperlipidaemia. The patient's concomitant medications were not reported. On an unspecified, the patient experienced pulmonary embolus. The event required Emergency Room/department or urgent care visit and the patient was hospitalized for 2 days. Corrective treatments taken as a result of the event included anticoagulation. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported pulmonary embolism  and the use of BNT162B2 cannot be fully excluded.  The patient's underlying condition may also contribute to the risk for the reported event. As there is limited information available to further assess the case, the case will be assessed further upon receipt of new information.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose, Blood pressure measurement, Body temperature, Dizziness
Clinical narrative: Passed out for 1 minute; Near syncope; Felt dizzy; Epigastric pain x3 days w/N/V; This is a spontaneous report from a non-contactable Pharmacist. A 57 years old  female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) intramuscular at single dose for COVID-19 immunisation on 24Mar2021. Relevant history included Pancreatitis, Abdominal cancer and Colostomy. Prior to vaccination, the patient was diagnosed with COVID-19. Relevant concomitant drug was unknown.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had near syncope in parking lot after COVID vaccine on 24Mar2021. When walked out of hospital entrance, she felt dizzy, sat down, and passed out for 1 minute, she was met by code team and brought to ED. The patient reported epigastric pain  for 3 days w/ N/V. Relevant lab tests included POC BG: 111;  A&Ox1 VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.  The adverse events resulted in emergency room/department or urgent care. Treatment therapy included ondansetron and morphine injections. The outcome of events was resolved .  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported loss of consciousness  and the use of BNT162B2 cannot be fully excluded.  As there is limited information available to further assess the case, the case will be assessed further upon receipt of new information.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Loss of consciousness, Oxygen saturation, Presyncope, Respiratory rate
Clinical narrative: Passed out for 1 minute; Near syncope; Felt dizzy; Epigastric pain x3 days w/N/V; This is a spontaneous report from a non-contactable Pharmacist. A 57 years old  female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) intramuscular at single dose for COVID-19 immunisation on 24Mar2021. Relevant history included Pancreatitis, Abdominal cancer and Colostomy. Prior to vaccination, the patient was diagnosed with COVID-19. Relevant concomitant drug was unknown.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had near syncope in parking lot after COVID vaccine on 24Mar2021. When walked out of hospital entrance, she felt dizzy, sat down, and passed out for 1 minute, she was met by code team and brought to ED. The patient reported epigastric pain  for 3 days w/ N/V. Relevant lab tests included POC BG: 111;  A&Ox1 VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.  The adverse events resulted in emergency room/department or urgent care. Treatment therapy included ondansetron and morphine injections. The outcome of events was resolved .  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported loss of consciousness  and the use of BNT162B2 cannot be fully excluded.  As there is limited information available to further assess the case, the case will be assessed further upon receipt of new information.  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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling hot, Heart rate
Clinical narrative: Dizziness; Don't feel well; Mild lightheadedness; BP still elevated/ BP 152/82/ BP repeated 148/85; Feeling warm surge to body; This is a spontaneous report from a non-contactable pharmacist.  A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the right arm on 03Mar2021 (Batch/Lot Number: EN6199) as 2ND DOSE, SINGLE (at the age of 69 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included fist dose of BNT162B2 on 10Feb2021 intramuscular (at the age of 69 years old) in the right arm (lot number: EL9262) for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced blood pressure (bp) still elevated/ bp 152/82/ bp repeated 148/85 on 03Mar2021 at 11:05 with outcome of unknown, feeling warm surge to body on 03Mar2021 at 11:05 with outcome of unknown, mild lightheadedness on 03Mar2021 at 11:22 with outcome of unknown, dizziness on 03Mar2021 at 11:39 with outcome of unknown, and don't feel well on 03Mar2021 at 11:39 with outcome of unknown. Details were reported as follows: 11:05: Patient complained of feeling warm surge to body; vital signs: BP 152/82, heart rate (HR) 67, respiratory rate (RR) 16, 100% RA 11:19: BP repeated 148/85, HR 54-64, RR 16 1120: drank 3 bottles of water, feeling better 11:22: Patient ambulate in hallway w/ mild light headedness 11:39: BP repeated sitting 140/90, RR 16, HR 61, standing BP 158/102, HR 59, associated lightheadedness/ dizziness. Patient reported "I don't feel well". It was recommended patient be seen in emergency department. 11:57: Now complained of lightheadedness, BP still elevated. Patient transferred to emergency department for further evaluation and work up. No medications given in emergency department. Treatment was not received for any of the events.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from limited information at the time of reporting, the causal association of reported event BP increased in relation to suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be totally 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Respiratory rate
Clinical narrative: Dizziness; Don't feel well; Mild lightheadedness; BP still elevated/ BP 152/82/ BP repeated 148/85; Feeling warm surge to body; This is a spontaneous report from a non-contactable pharmacist.  A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the right arm on 03Mar2021 (Batch/Lot Number: EN6199) as 2ND DOSE, SINGLE (at the age of 69 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included fist dose of BNT162B2 on 10Feb2021 intramuscular (at the age of 69 years old) in the right arm (lot number: EL9262) for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced blood pressure (bp) still elevated/ bp 152/82/ bp repeated 148/85 on 03Mar2021 at 11:05 with outcome of unknown, feeling warm surge to body on 03Mar2021 at 11:05 with outcome of unknown, mild lightheadedness on 03Mar2021 at 11:22 with outcome of unknown, dizziness on 03Mar2021 at 11:39 with outcome of unknown, and don't feel well on 03Mar2021 at 11:39 with outcome of unknown. Details were reported as follows: 11:05: Patient complained of feeling warm surge to body; vital signs: BP 152/82, heart rate (HR) 67, respiratory rate (RR) 16, 100% RA 11:19: BP repeated 148/85, HR 54-64, RR 16 1120: drank 3 bottles of water, feeling better 11:22: Patient ambulate in hallway w/ mild light headedness 11:39: BP repeated sitting 140/90, RR 16, HR 61, standing BP 158/102, HR 59, associated lightheadedness/ dizziness. Patient reported "I don't feel well". It was recommended patient be seen in emergency department. 11:57: Now complained of lightheadedness, BP still elevated. Patient transferred to emergency department for further evaluation and work up. No medications given in emergency department. Treatment was not received for any of the events.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from limited information at the time of reporting, the causal association of reported event BP increased in relation to suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be totally 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Circumstance or information capable of leading to medication error, Coeliac disease, Pain in extremity
Clinical narrative: positive blood test for celiac disease; Reporter added they basically said to redo all the shots.; sore arm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on 26Mar2021. She had a positive blood test for celiac disease 4 days after first dose on 30Mar2021. The reporter was seeing a GI specialist for issues she was having, and the doctor thought it was unrelated. Patient received the first dose of the Pfizer Covid-19 vaccine on 26Mar2021 in a clinic that was shut down due to poor safety and storage issues, after investigation the health Department sent her an e-mail (13Apr2021) stating that she should revaccinate regardless of receiving one or both doses of the vaccine. It was based on an investigation the department of health did. The reporter added they basically said to redo all the shots. She was notified of this on 13Apr2021 and is technically scheduled for her third dose tomorrow. The outcome of event celiac disease was unknown, sore arm was recovered on 28Mar2021.; Sender's Comments: -Based on the limited information in the case report , A possible causal relationship between event Celiac disease 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.
Sex: U
Vaccine: COVID19
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (fetus's mother). This consumer reported information for both mother and fetus. This is the fetus report. A patient (fetus) mother (35-years-old ) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 09:15 (Batch/Lot Number: EW0164) at the age of 35-years-old as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 15:00 (Batch/Lot Number: Er8732) at the age of 35-years-old as single dose for covid-19 immunisation. Route of the administration for fetus was provided as Transplacental. The patient's mother medical history was not reported. The patient's mother's concomitant medication included estradiol (ESTRACE) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The baby experienced maternal exposure during pregnancy, first trimester from 28Mar2021 15:00. On 23Apr2021, 14:00, the mother experienced miscarriage, the baby stopped growing 5 days after shot 23Apr2021 14:00, confirmed with ultrasounds 26Apr2021 and 06May2021, the event resulted in doctor or other healthcare professional office/clinic visit, there was no treatment for event. Mother's Last menstrual date was 10Mar2021. The outcome of the events was fatal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509131 mother case; Reported Cause(s) of Death: Baby stopped growing 5 days after shot, confirmed with ultrasounds on 4/26 and 5/6; Maternal exposure during pregnancy, first trimester
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pharyngeal swelling, Pyrexia, Thinking abnormal
Clinical narrative: Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Blood pressure got totally out of control, it just spiked; had like a fever; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; got a very bad headache; nausea; chills; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0162 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Apr2021 09:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. Medical history included blood pressure, patient had anaphylaxis to other drugs in the past, the medication was an ace inhibitor caller took years ago when trying to help blood pressure. Family Medical History provided as "no". Concomitant medications included losartan for blood pressure (patient had been on this medication for years); and progesterone (began taking this medication probably last summer). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153 and expiration date not provided), via an unspecified route of administration, in left arm, on 05Apr2021 13:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. The patient got a very bad headache from 26Apr2021 (about an hour after received second vaccine); nausea from 26Apr2021; chills from 26Apr2021; brain fog from 26Apr2021; fatigue from 26Apr2021; throat was swollen, started having anaphylaxis from 28Apr2021 (in the evening) to 02May2021 (it had eased up enough and patient could swallow); blood pressure got totally out of control, it just spiked from 28Apr2021, patient was still having trouble getting it back down. Patient had to double up on blood pressure medication. Patient stated it was persisting a little bit. Patient's blood pressure was going way higher than what it would normally. Patient only took 25mg of losartan. Patient's blood pressure usually never went over 125. Injection site turned red, swollen, "angry", itching and had like a fever from 28Apr2021. On 26Apr2021, patient got a very bad headache, nausea, chills and fatigue. Patient was expecting all of this. Patient was sick on 26Apr2021 and 27Apr2021 and had to stay in bed, clarified she was sick with headache, chills and fatigue. On 28Apr2021 (Wednesday), patient's throat was swollen, started having anaphylaxis. The outcome of the events "headache, nausea, chills, brain fog" was recovered on 27Apr2021; of "fatigue" was recovering; of "throat was swollen, started having anaphylaxis" was recovered on 02May2021; of "blood pressure got totally out of control, it just spiked" was not recovered; of "injection site turned red, swollen, angry, itching and had like a fever" was recovered on 03May2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Blood pressure got totally out of control, it just spiked; had like a fever; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; got a very bad headache; nausea; chills; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0162 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Apr2021 09:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. Medical history included blood pressure, patient had anaphylaxis to other drugs in the past, the medication was an ace inhibitor caller took years ago when trying to help blood pressure. Family Medical History provided as "no". Concomitant medications included losartan for blood pressure (patient had been on this medication for years); and progesterone (began taking this medication probably last summer). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153 and expiration date not provided), via an unspecified route of administration, in left arm, on 05Apr2021 13:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. The patient got a very bad headache from 26Apr2021 (about an hour after received second vaccine); nausea from 26Apr2021; chills from 26Apr2021; brain fog from 26Apr2021; fatigue from 26Apr2021; throat was swollen, started having anaphylaxis from 28Apr2021 (in the evening) to 02May2021 (it had eased up enough and patient could swallow); blood pressure got totally out of control, it just spiked from 28Apr2021, patient was still having trouble getting it back down. Patient had to double up on blood pressure medication. Patient stated it was persisting a little bit. Patient's blood pressure was going way higher than what it would normally. Patient only took 25mg of losartan. Patient's blood pressure usually never went over 125. Injection site turned red, swollen, "angry", itching and had like a fever from 28Apr2021. On 26Apr2021, patient got a very bad headache, nausea, chills and fatigue. Patient was expecting all of this. Patient was sick on 26Apr2021 and 27Apr2021 and had to stay in bed, clarified she was sick with headache, chills and fatigue. On 28Apr2021 (Wednesday), patient's throat was swollen, started having anaphylaxis. The outcome of the events "headache, nausea, chills, brain fog" was recovered on 27Apr2021; of "fatigue" was recovering; of "throat was swollen, started having anaphylaxis" was recovered on 02May2021; of "blood pressure got totally out of control, it just spiked" was not recovered; of "injection site turned red, swollen, angry, itching and had like a fever" was recovered on 03May2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, Pneumonia, SARS-CoV-2 test
Clinical narrative: She was tested positive with corona virus; she ended up in the hospital and had pneumonia for 7 days.; 2nd dose is supposedly on 21Apr but she missed; 2nd dose is supposedly on 21Apr but she missed; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Mar2021 as 1 st dose single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose of bnt162b2 last 21Mar2021 and second dose was supposedly on 21Apr21 but she missed it because 3 days later (24Mar2021) after her first dose she got sick (chills) and tested positive for the virus on 31Mar2021, she ended up in the hospital and had pneumonia for 7 days. Second dose was supposedly on 21Apr2021 but she missed. On 24Mar2021, the patient had a contact with someone with covid and on 31Mar2021 she was tested positive with corona virus. The patient added that she was experiencing pains and was hospitalized for 7 days. The patient went to her doctor, told her she could already get her second dose. However, a clinic told her she should wait for 90 days after hospitalization before she could get her second dose. Asked if she really needed to wait for 90 days until she could get her second dose, she wanted to reschedule her second dose but did not know who to contact. The patient asked if this was true and if she will start all over again. The patient also asked where she could get her second dose. The patient got out of the hospital on 19Apr2021. The patient received unspecified treatment for pneumonia and pain. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coronavirus infection, Pneumonia, SARS-CoV-2 test
Clinical narrative: She was tested positive with corona virus; she ended up in the hospital and had pneumonia for 7 days.; 2nd dose is supposedly on 21Apr but she missed; 2nd dose is supposedly on 21Apr but she missed; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Mar2021 as 1 st dose single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose of bnt162b2 last 21Mar2021 and second dose was supposedly on 21Apr21 but she missed it because 3 days later (24Mar2021) after her first dose she got sick (chills) and tested positive for the virus on 31Mar2021, she ended up in the hospital and had pneumonia for 7 days. Second dose was supposedly on 21Apr2021 but she missed. On 24Mar2021, the patient had a contact with someone with covid and on 31Mar2021 she was tested positive with corona virus. The patient added that she was experiencing pains and was hospitalized for 7 days. The patient went to her doctor, told her she could already get her second dose. However, a clinic told her she should wait for 90 days after hospitalization before she could get her second dose. Asked if she really needed to wait for 90 days until she could get her second dose, she wanted to reschedule her second dose but did not know who to contact. The patient asked if this was true and if she will start all over again. The patient also asked where she could get her second dose. The patient got out of the hospital on 19Apr2021. The patient received unspecified treatment for pneumonia and pain. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Off label use, Pneumonia, SARS-CoV-2 test
Clinical narrative: Double pneumonia; patient had the corona virus and tested positive; 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), dose 1 via an unspecified route of administration on 21Mar2021 (Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient got sick three days later and evidently didn't know that the patient was sick before getting the shot and that was corona virus and didn't know at that time. On 31Mar2021, patient had the corona virus and tested positive. On 11Apr2021, patient went to the hospital and was in there for 7 days(as reported) and had double pneumonia. Patient was scheduled to get the second shot on 21Apr2021 which didn't happen because the patient was in the hospital. Patient didn't get the second shot yet. The outcome of the events was unknown.   Information for lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Coronavirus infection, Pneumonia, SARS-CoV-2 test
Clinical narrative: Double pneumonia; patient had the corona virus and tested positive; 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), dose 1 via an unspecified route of administration on 21Mar2021 (Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient got sick three days later and evidently didn't know that the patient was sick before getting the shot and that was corona virus and didn't know at that time. On 31Mar2021, patient had the corona virus and tested positive. On 11Apr2021, patient went to the hospital and was in there for 7 days(as reported) and had double pneumonia. Patient was scheduled to get the second shot on 21Apr2021 which didn't happen because the patient was in the hospital. Patient didn't get the second shot yet. The outcome of the events was unknown.   Information for lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Contusion, Nausea, Thrombosis, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 05May2021 as a single dose for COVID-19 immunization. Medical history included lupus, high blood pressure and severe pancreatitis wherein she had surgery all on unknown dates and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported some adverse effects after the first dose of the Pfizer COVID-19 vaccine. The patient reported stomach pain and nausea from an unknown date and fears it may be a blood clot and wants to know if these are common side effects. The patient reported having stomach pain on an unspecified date and she doesn't know if it is normal. At first she thought it was because she was so nauseous, but the nausea went away. Then she thought maybe it was like a bowel thing and she was going to have issues like diarrhea, but that was not the case. The pain is pretty bad. She is wondering if that can be a side effect. She is just wondering if she should follow up with a doctor or go to the hospital, because it hurts pretty bad in 3 different sections of her stomach. Her stomach feels like her arm felt when she got the shot. It feels like she had bruising, not exactly stabbing but it is pretty painful and she is kind of concerned. She doesn't know if her doctor would have information on the vaccine for what to do, and they would probably send her to the hospital. She hopes it's not something serious. She is worried something went wrong. Her entire family got the same shot and were fine. The pain is just like where her pancreas and gallbladder are. Since she had severe pancreatitis last summer, and it hurts where she had surgery. She wants to know if it is related to the shot or something else. The outcome of the event nausea/so nauseous was recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested. Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported blood clot 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.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Laboratory test, Neuropathy peripheral
Clinical narrative: Idiopathic peripheral neuropathy; This is a spontaneous report from Pfizer sponsored program Pfizer Rx pathways. A contactable consumer (patient) reported that a 67-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported), at UNKNOWN, SINGLE for immunization.  The patient's medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. 2 weeks later in Apr2021, patient developed idiopathic peripheral neuropathy. Patient was wondering if there is any data or anecdotal incidents of people having this reaction after a combination of the 2 vaccinations fairly close together. The patient underwent lab tests and procedures in 2021 which included vitamin levels were checked with a blood test and are all normal. The outcome of event was unknown.  Information related lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lyme disease
Clinical narrative: Lyme Disease; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Lyme disease in May2021. The nurse reported that the patient was due for 2nd dose 07May2021. However, he was diagnosed with Lyme Disease on 07May2021 and vaccination provider refused to give 2nd dose of the Pfizer Bio-NTech COVID 19 Vaccine. Nurse was requesting safety information for administration of 2nd dose after this diagnosis. Patient's lab test done in May2021 came back positive for Lyme disease. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.