chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Cannot even talk; Chills; Nausea; Headache; Fatigue; I can't do anything I am just "lying" on bed; miserable; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no allergies. The patient reported they couldn't spend on the phone long; they experienced a lot of side effects from their vaccination on "Monday." They reported being vaccinated, first vaccination on "Monday." Tuesday the patient started getting chills and nausea and headache and fatigue and was still in bed. The reporter also stood up and then had a headache and was nauseous; further reporting they had been doing that for 3 days. The reporter inquired when the side effects would stop, further reporting feeling miserable and that they couldn't do anything, just lying on bed, cannot even talk. The clinical outcomes of chills, nausea, headache, fatigue, cannot talk, I can't do anything I am just lying on bed, and miserable were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Speech disorder
Clinical narrative: Cannot even talk; Chills; Nausea; Headache; Fatigue; I can't do anything I am just "lying" on bed; miserable; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no allergies. The patient reported they couldn't spend on the phone long; they experienced a lot of side effects from their vaccination on "Monday." They reported being vaccinated, first vaccination on "Monday." Tuesday the patient started getting chills and nausea and headache and fatigue and was still in bed. The reporter also stood up and then had a headache and was nauseous; further reporting they had been doing that for 3 days. The reporter inquired when the side effects would stop, further reporting feeling miserable and that they couldn't do anything, just lying on bed, cannot even talk. The clinical outcomes of chills, nausea, headache, fatigue, cannot talk, I can't do anything I am just lying on bed, and miserable were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity, Pharyngeal swelling, Upper respiratory tract congestion
Clinical narrative: I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestion:a feeling of thickness and swelling.; higher temp; arm ache; This is a spontaneous report from a contactable consumer for herself. A 79-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 30Jan2021 14:30 (Lot number: EL9264) via an unspecified route of administration in the right arm at single dose for COVID-19 Immunization. The patient's medical history included cholesterol but not high. The patient had no known allergies to medications, food, or other products. The patients concomitant medication included rosuvastatin at 5mg, aspirin (acetylsalicylic acid) at 81mg. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The dose was received at 2:25pm. The dose was received on adverse event start date: 30Jan2021 at 2:25pm. patient waited the 15 minutes waiting period & went home. 95 minutes after (30Jan2021 16:00 PM) the injection she experienced throat congestion: a feeling of thickness and swelling. The symptoms lasted 35 minutes. Other reactions were normal: higher temp & arm ache. There was no treatment received for the adverse events. The outcome of the events was recovered on 30Jan2021 16:35.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at the site of injection. Not major or debilitating, but noticeable; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date: unknown.), via an unspecified route of administration on the left arm at the age of 34 years old on 04Feb2021 at 15:00 at a single dose for covid-19 immunisation. Patient is not pregnant. Medical history included allergies with sulfa drugs and acne. Concomitant medication included spironolactone for acne. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced arm soreness at the site of injection; not major or debilitating, but noticeable on 04Feb2021 at 16:00. No treatment was received in response to the event. The patient assessed the event as non-serious. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare professional (consumer) reported that a 57-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. On an unspecified date after the second shot, the patient ran a fever and had body aches and chills, which took 2 days to recover. It was unknown if the patient received treatment in response to the event. The patient recovered from the events on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Fever; feels lousy; This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 26Jan2021 at 18:10 (at the age of 75 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included 3 cardiac stents on an unknown date. Concomitant medication was not provided. On 27Jan2021 at 15:00, the patient experienced fever all day. The patient's highest body temperature was on 27Jan2021 at 101.9 F and on 28Jan2021, the temperature was 101.4 F. On 27Jan2021 (time unspecified), the patient stated that she feels lousy. The outcome of the events fever and feels lousy was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Diarrhoea, Feeling abnormal, Feeling hot
Clinical narrative: tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient.  A 66-years-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261),   via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old)  as a single dose for covid-19 immunisation .  Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas).  The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks.  On 27Jan2021 The patient reported she was sick last night,  tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was  No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever  was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pyrexia
Clinical narrative: tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient.  A 66-years-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261),   via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old)  as a single dose for covid-19 immunisation .  Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas).  The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks.  On 27Jan2021 The patient reported she was sick last night,  tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was  No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever  was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes/lymph nodes are swollen on both sides; pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231), via an unspecified route of administration in the left arm on 27Jan2021 at 10:10 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 28Jan2021 at 07:00, the patient experienced swollen lymph nodes. The patient stated that the lymph nodes were swollen on both sides (or so he thought, as he couldn't see the uvula at all). The patient stated, "it looks about the same right now", but the pain (onset: Jan2021) has decreased. The patient stated he had taken several COVID-19 tests prior to the vaccination, on unspecified dates, all negative. The last test, a nasal swab was on Jan2021 with negative results. The clinical outcome of "swollen lymph nodes/lymph nodes are swollen on both sides" and pain was resolving.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after the vaccine; tested positive for Covid after the vaccine; This is a spontaneous report from a contactable consumer reported for her husband. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine and then he tested positive for Covid after the vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for the Covid virus on 02Feb; tested positive for the Covid virus on February 2nd.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is 2nd of 3 reports. A 77-year-old patient of unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Pharmacy technician, calling on behalf of three patients who tested positive after receiving the first dose of the Covid vaccine, asked when they can get the second dose of the Covid vaccine. They received their first dose on 16Jan2021 and tested positive for the Covid virus on 02Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138460 same drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Tinnitus, Vaccination site pain
Clinical narrative: Mild soreness at injection site; Myalgia; Tinnitus; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (also reported as day 30 following dose 1) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 29Dec2020 (at the age of 79 years old) at a single dose in the left arm for covid-19 immunization and experienced neurosensory deafness in Rt ear./ total hearing loss in right ear; arm soreness; headache; myalgia; tiredness/episodic fatigue; mild cold intolerance; frontal headache (sinus like); stuffiness/Nasal congestion; postnasal drip and tinnitus in Right Ear. On unspecified date, the patient experienced mild soreness at injection site, myalgia 3/10 on day 1 and tinnitus (bilaterally, left more than right) on day 3 which was persisting but no hearing loss. The patient is scheduled to have an appointment with ENT on 18Feb2021 and will also have antibodies checked. Outcome of the event tinnitus was not recovered while outcome of all the other events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller got her first shot last Saturday, then she woke up today with fever and chills (2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes (left side of neck, under arm, left chest); Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL 3247, expiry: unknown), via an unspecified route of administration in the left arm on 27Jan2021 12:45 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included endometriosis, vertigo, pure hypercholesterolemia and allergies to sulfa, orange citrus and almonds. The patient has no covid prior to vaccination. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), rosuvastatin calcium (CRESTOR), magnesium, ethinylestradiol, norgestimate (SPRINTEC) and multivitamin. The patient had no other vaccine in four weeks. The patient had PCR test via nasal swab on 04Feb2021 which was negative. The patient experienced dry mouth on 27Jan2021at 13:00 and swollen lymph nodes in the left side of neck, under arm, and left chest on 31Jan2021 at 13:00. The events were not treated. The event dry mouth recovered with sequelae on 31Jan2021 while swollen lymph nodes recovered with sequelae on 07Feb2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Hallucination, Headache
Clinical narrative: felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM,  99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; aches; fever; chills; This is a spontaneous report from a non-contactable consumer (Patient). An adult male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Not available/provided to reporter at the time of report completion), via unknown route of administration on left arm on 10Feb2021 at 17:00 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jan2021 on left arm for COVID-19 immunisation. On 11Feb2021 at 12:00 PM, the patient experienced sore arm, fever, chills, aches. The patient assessed the events as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient not recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal spasm
Clinical narrative: severe prolonged cricopharyngeal spasm; This is a spontaneous report from a contactable physician (patient)  A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 09Feb2021 at single dose for covid-19 immunisation at hospital. Medical history included rheumatoid arthritis, allergy to penicillin, asthma vaccine, pollen, cats, sea food and latex. Concomitant medication included methotrexate (unknown manufacturer) and methylprednisolone (unknown manufacturer). The patient experienced severe prolonged cricopharyngeal spasm on 09Feb2021 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was performed due to the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe prolonged cricopharyngeal spasm and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site inflammation, Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; worse sore arm; This is a spontaneous report from a contactable consumer (patient's father). A 21-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 07Jan2021 at 15:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 17Dec2020 for COVID-19 immunization and experienced arm was kind of sore and she was pretty tired, for which no admission to the hospital was involved and the patient did not receive any treatment. The patient's medical history was not reported. There were no concomitant medications. There were no other products taken together with the vaccine. The patient experienced worse sore arm on 07Jan2021 at 20:00 and experienced fatigue the next day on 08Jan2021 at 08:00. The adverse events (AEs) did not require any visit to an emergency room or a physician office. The patient did not receive any treatment for the events. The patient recovered from the event "worse sore arm" on an unspecified date, while the outcome of the event "fatigue" was unknown.  Information on the batch/lot number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Blood glucose increased
Clinical narrative: really high blood sugar, some mornings over 300 mg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date in Feb2021 (a week ago) as a single dose for COVID-19 vaccination. Medical history included ongoing diabetic from an unknown date. Concomitant medications were not reported (reported she takes 'sugar medicine' for diabetes). In Feb2021, since receiving the vaccine, the patient experienced sugar levels have been high, the first 3 or 4 days they were really high, some mornings they were over 300mg. The patient underwent lab tests which included sugar levels which showed over 300mg on an unknown date. The patient was treated for the blood sugar high with taking half of her sugar medicine. The clinical outcome of the event blood sugar increased was recovering reported as the levels were lowering a little.     The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symtoms; chill; sligh headache; a little tired; This is a spontaneous report from a contactable other hcp (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9810), via an unspecified route of administration on 08Feb2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient experienced flu like symtoms, chill, sligh headache, temp at 97.8 and a little tired on 12Feb2021 09:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was unknown. The events were reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tenderness, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: lady who injected the patient was a little upset since it bleed a little after being injected; bruise on her arm/Injection site bruising; she felt a little light headedness; little nauseated; Slight 'tenderness'; This is a spontaneous report from a contactable consumer (female). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry not reported), as second dose via an unspecified route of administration on the arm on 11Feb2021 at single dose for covid-19 immunization. Medical history included slow clotting problem (when she was little/was never diagnose with a disorder) and first vaccination (she did not have any bruise). The patient's concomitant medications were not reported. It was reported that the patient had the second dose of the Pfizer COVID-19 vaccine yesterday (11Feb2021). The lady who injected the patient was a little upset since it bleed a little after being injected. The patient stated, "You are very good that did not hurt. She said not that good. You are bleeding. You should not be bleeding but I do not even know she said you should not be bleeding but she said and then she kept patting my arm on the spot that it was, where she injected me and she said yeah that is right where I should inject you". The patient said that she was fine and was not concerned with the AEs but she wanted to know if the vaccine was still effective even though she bled. She also said that she developed a pretty big bruise on her arm/injection site bruising. The patient was injected in the deltoid muscle. She said when she removed the band aid there was only little blood transferred there. The patient said that her doctor when she was little told her that she has a slow clotting problem but was never diagnose with a disorder. The patient said that she felt a little light headedness or a little nauseated after being injected. The patient's concerns were not to the bruising, did not concern her at all. Her main concern was to make sure that she did not have symptoms and she wondered afterwards, the patient ended consoling her. The lady was concerned that may be the patient was on blood thinners. The patient said that she was not on blood thinners. The patient had a slight 'tenderness' never really caused her a problem. Just breathe a little bit easier and when she got home and took off the Band-Aid there was really hardly any blood there but she had the first vaccination she did not have any bruise. The patient have a huge bruise on her arm this time and that was okay. The patient bruise equally too. But she just wanted to make sure that since they really did not have symptoms that the vaccine was really injected into the area where it was going to be affected for her. The patient assessed the case as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Musculoskeletal stiffness, Paranasal sinus hypersecretion
Clinical narrative: Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of "itching on right side of arm near elbow, middle part of stomach and neck", "feeling dizzy and faint like", tired, sinuses started to drain, "feet felt stiff and bone in right leg felt strange" and "itching on the right shoulder (where she had the vaccine)" was resolving.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of "itching on right side of arm near elbow, middle part of stomach and neck", "feeling dizzy and faint like", tired, sinuses started to drain, "feet felt stiff and bone in right leg felt strange" and "itching on the right shoulder (where she had the vaccine)" was resolving.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hyperhidrosis, Pyrexia
Clinical narrative: Fever / He was at a feverish point; his body was warm and getting warmer and warmer; sweating; Chills; This is a spontaneous report from a contactable consumer reporting for himself. This 75 years old male consumer received the first single dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9261) on 28Jan2021 at 09:50, in left arm, for COVID-19 immunisation. The patient was a veteran; gave him the COVID vaccine. Medical history included malaria (and another unspecified condition during, they used "IVs to bring him back" and he even had a spinal tap, he was also in "a coma, on his way out to the next" and they said he was shaking like a leaf on the tree), skin problems (he had already been under the (government organization) care of malaria and skin problems), prostate problems, back problems since the war, he was still in a back brace for his back problems (he had been wearing it since the 60's), major spinal surgery in Mar2019 where his L1 and L5 were taken out (he lost a lot of fluid as a result of this surgery). Since they took his L1-L5, he had no real body control of his lower extremities and due to this he was awarded money from the (government organization). The patient received an unspecified influenza vaccine in the past, on an unknown date, for immunization. Concomitant medications were not reported. On 12Feb2021 at 03:30 AM, the patient experienced fever, he described his body was warm and getting warmer and warmer and was sweating. He was at a feverish point, his sheets he was sweating and wet from his back to feet. He also had chills. He got up thinking this reaction was from the COVID vaccine, he had an drink in his fridge and took powdered acetylsalicylic acid (ASPIRIN) and then he laid there and let his body go through the changes. He knew that his body can recover from heat. He went to sleep, woke up and had no more chills; he was sweating, but it was gone, his body was normal, he was under the covers. It was like how his normal body just took it like penicillin, it did the same thing. The events resolved on 12Feb2021 at 07:00 AM. His second vaccine dose was schedule on 18Feb2021 at 9:50 AM.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: a nursing student took out the needle and watered down vaccine came out with blood (not typical); a nursing student took out the needle and watered down vaccine came out with blood (not typical); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called regarding an incident that took place yesterday (11Feb2021) at the vaccine center. The patient asked about a loss of vaccine when an injection causes bleeding. He went to a hospital and a nursing student took out the needle and the vaccine came watering down with blood which was not typical. He was asking what should be done on this case, if there were any cases like this, how much vaccine came out, and if it required re-vaccination. It was given intramuscularly, but however when the needle was removed, a little geyser of blood came out of the hole. That's where the question lies, he asked if he needs to be concerned. The only person who would have that information would be Pfizer or CDC. His physician was not educated regarding this. He was asking about the loss of vaccine when there's bleeding and what to do. He was a journalist and thought it would be better if a scientist who can answer and give an answer more directly would speak to him. He already has part of this written up and will publish this. He wanted more information regarding this. He believes more people have experienced this and there was more information available for this. The outcome of the events was unknown.   Information on the lot/batch number has been requested.