chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 30-year-old male patient received BNT162B2 9 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left, administration date 22Jun2021 (Lot number: ew0181) as dose 2, single (at the age of 30 years old) and intramuscular, administered in arm left, administration date 01Jun2021 (Lot number: ew0185) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 20Nov2021, outcome "not recovered" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Nov2021) negative, notes: Nasal Swab; (20Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough Covid infection; breakthrough Covid infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193).  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "recovered" (2021) and all described as "breakthrough Covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Clinical course: the patient received her second Pfizer shot about three weeks before returning to high school for her sophomore year. Around the beginning of October, she experienced a breakthrough Covid infection. Contact tracing could find nobody she had been around with a positive test. Everyone was fully masked in the schools here, so it was a mystery where she picked it up. She had mild symptoms and quarantined in her bedroom for 10 days. She was fine now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; He tested positive for COVID today.; This is a spontaneous report received from contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient was 44-year-old at the time of vaccination. The patient had no relevant medical history. There were no concomitant medications. It was reported that the patient tested positive for COVID on 22Nov2021. The outcome of event was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Haemorrhage, Peripheral swelling, Rash, Skin fissures
Clinical narrative: The skin on my hands had cracked and were bleeding; rash; feet were swollen; The skin on my hands had cracked; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date on 13Nov2021 15:00 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 2), administration date: Apr2021, for COVID-19 immunisation, reaction(s): "rash"; Bnt162b2 (dose 1), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: HAEMORRHAGE (medically significant) with onset 15Nov2021, outcome "unknown", described as "The skin on my hands had cracked and were bleeding"; RASH (non-serious) with onset 15Nov2021, outcome "unknown", described as "rash"; PERIPHERAL SWELLING (non-serious) with onset 15Nov2021, outcome "unknown", described as "feet were swollen"; SKIN FISSURES (non-serious) with onset 15Nov2021, outcome "unknown", described as "The skin on my hands had cracked". The patient stated, "I had my booster shot at 3pm on Saturday, 13Nov2021. Monday, 15Nov2021 I woke up with a more sever rash. The skin on my hands had cracked and were bleeding. My feet were swollen." The patient underwent the following laboratory tests and procedures: biopsy: having a reaction to a medication, notes: having a reaction to a medication.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Eye disorder, Memory impairment, Transient ischaemic attack
Clinical narrative: TIA; his memory became affected; confused; he words were jumble up on the TV and when reading the newspaper; This is a spontaneous report received from a contactable consumer from Medical information team.  A 73 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "his memory became affected"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused"; EYE DISORDER (non-serious), outcome "unknown", described as "he words were jumble up on the TV and when reading the newspaper". The patient had a TIA but he felt a little confused after his second Pfizer Covid Vaccination (purple label) and by the next day he told her the words were jumble up on the TV and when reading the newspaper. The patient got his first Pfizer COVID-19 vaccination and everything was fine. The patient felt confused as he was going in the drive thru to get his second dose. When the patient took the vaccine, by the time he was home he told the caller that when he was looking at words on the TV the letters were jumbled. This lasted for several days, 2-3 days or whatever. Long term the patient's memory had been effected. The patient has never had a problem with his memory or remembering names or anything prior to this. Did the patient have a TIA? The patient never reported this event to Pfizer because it was ambiguous as to if this was caused by the product or not. This event could have been a TIA, the patient is 73 years old. The patient has never had one before with this kind of effect. The patient continues to have memory problems but the thing with the letters is okay. The letters looked jumbled up if the patient was trying to read something.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Immunisation
Clinical narrative: difficulty breathing which requires inhaler; dose received: 3; cough which makes sleeping difficult; cough which makes sleeping difficult; some congestion; swollen glands; extreme fatigue; fever; chills; muscle aches; still not well, three days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "various foods" (unspecified if ongoing); "molds" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; VITAMIN D NOS; MELOXICAM. Past drug history included: Aspirin, reaction(s): "Drug allergy"; Thimerosal, reaction(s): "Drug allergy"; Prednisone, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Right Arm, Vaccine Administration Time: 03:15 PM), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Right Arm, Vaccine Administration Time: 09:30 AM), administration date: 27Feb2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "difficulty breathing which requires inhaler"; IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "dose received: 3"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "cough which makes sleeping difficult"; NASAL CONGESTION (non-serious) with onset 20Nov2021, outcome "not recovered", described as "some congestion"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "not recovered", described as "swollen glands"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "extreme fatigue"; PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "muscle aches"; MALAISE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "still not well, three days later". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, cough, nasal congestion, lymphadenopathy, fatigue, pyrexia, chills, myalgia, malaise, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Malaise, Myalgia, Nasal congestion
Clinical narrative: difficulty breathing which requires inhaler; dose received: 3; cough which makes sleeping difficult; cough which makes sleeping difficult; some congestion; swollen glands; extreme fatigue; fever; chills; muscle aches; still not well, three days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "various foods" (unspecified if ongoing); "molds" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; VITAMIN D NOS; MELOXICAM. Past drug history included: Aspirin, reaction(s): "Drug allergy"; Thimerosal, reaction(s): "Drug allergy"; Prednisone, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Right Arm, Vaccine Administration Time: 03:15 PM), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Right Arm, Vaccine Administration Time: 09:30 AM), administration date: 27Feb2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "difficulty breathing which requires inhaler"; IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "dose received: 3"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "cough which makes sleeping difficult"; NASAL CONGESTION (non-serious) with onset 20Nov2021, outcome "not recovered", described as "some congestion"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "not recovered", described as "swollen glands"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "extreme fatigue"; PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "muscle aches"; MALAISE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "still not well, three days later". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, cough, nasal congestion, lymphadenopathy, fatigue, pyrexia, chills, myalgia, malaise, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: difficulty breathing which requires inhaler; dose received: 3; cough which makes sleeping difficult; cough which makes sleeping difficult; some congestion; swollen glands; extreme fatigue; fever; chills; muscle aches; still not well, three days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "various foods" (unspecified if ongoing); "molds" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; VITAMIN D NOS; MELOXICAM. Past drug history included: Aspirin, reaction(s): "Drug allergy"; Thimerosal, reaction(s): "Drug allergy"; Prednisone, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Right Arm, Vaccine Administration Time: 03:15 PM), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Right Arm, Vaccine Administration Time: 09:30 AM), administration date: 27Feb2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "difficulty breathing which requires inhaler"; IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "dose received: 3"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "cough which makes sleeping difficult"; NASAL CONGESTION (non-serious) with onset 20Nov2021, outcome "not recovered", described as "some congestion"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "not recovered", described as "swollen glands"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "extreme fatigue"; PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "muscle aches"; MALAISE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "still not well, three days later". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, cough, nasal congestion, lymphadenopathy, fatigue, pyrexia, chills, myalgia, malaise, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: had an anaphylaxis problem 6 weeks after 2nd covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had an anaphylaxis problem 6 weeks after 2nd covid shot".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Jan2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and administration date 02Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yellowtail or yellow fin tuna" (unspecified if ongoing), notes: Yellowtail or yellow fin tuna. The patient's concomitant medications were not reported. No covid prior vaccination; Tested for covid post vaccination. It was unknown if patient received any other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 19Nov2021, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Adverse event: Breakthrough case. Tested positive for Covid on 20Nov2021. Symptoms started on 19Nov2021 included body aches, headache, fatigue, myalgia, and loss of appetite, mild sore throat, runny nose for half day and occasional sneezing. The treatment reported as Yes, and it includes Advil.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Dizziness, Feeling cold, Malaise
Clinical narrative: pneumonia; shaking, describes as felt cold; not feeling well; restless leg; cold temperature of 94 degrees Fahrenheit; Dizziness after booster; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), administered in arm left, administration date 19Nov2021 10:00 (Lot number: FJ1620) at the age of 67 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "elective oral surgery", start date: Mar2020 (unspecified if ongoing), notes: Caller explains that she had elective oral surgery in Mar2020 and was not able to eat because of the surgery and could not keep up her nutrition without her original teeth. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First vaccine: , Date: 08Mar2021, NDC/expiration: unknown, Lot: EN6199, Site: Caller thinks right arm), administration date: 08Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Second vaccine: , Date: 29Mar2021, NDC/expiration: unknown, Lot: EN6707 or  could be 6202, handwritten , Site: left arm), administration date: 29Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "she was tired". The patient reported that the first vaccine she had no problem, and the second vaccine, she was tired. She further stated that after the third Covid vaccine, she had a reaction. She thinks maybe not having good nutrition was a precursor. She had the booster vaccine on 10am last Friday (19Nov2021). She stated she was shaking, describes as felt cold and not feeling well on 19Nov2021. She added that it came in waves and felt like severe restless leg. She was wondering if she was having a seizure, but subsided. She also had a cold temperature of 94 degrees Fahrenheit.  She added that she felt like she had pneumonia, and describes as having trouble breathing, heavy coughing and sinus dripping. She added that she had dizziness. The onset of events was on 19Nov2021. The outcome of events felt cold, not feeling well, and restless leg was recovered on 20Nov2021; outcome of other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Restless legs syndrome
Clinical narrative: pneumonia; shaking, describes as felt cold; not feeling well; restless leg; cold temperature of 94 degrees Fahrenheit; Dizziness after booster; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), administered in arm left, administration date 19Nov2021 10:00 (Lot number: FJ1620) at the age of 67 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "elective oral surgery", start date: Mar2020 (unspecified if ongoing), notes: Caller explains that she had elective oral surgery in Mar2020 and was not able to eat because of the surgery and could not keep up her nutrition without her original teeth. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First vaccine: , Date: 08Mar2021, NDC/expiration: unknown, Lot: EN6199, Site: Caller thinks right arm), administration date: 08Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Second vaccine: , Date: 29Mar2021, NDC/expiration: unknown, Lot: EN6707 or  could be 6202, handwritten , Site: left arm), administration date: 29Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "she was tired". The patient reported that the first vaccine she had no problem, and the second vaccine, she was tired. She further stated that after the third Covid vaccine, she had a reaction. She thinks maybe not having good nutrition was a precursor. She had the booster vaccine on 10am last Friday (19Nov2021). She stated she was shaking, describes as felt cold and not feeling well on 19Nov2021. She added that it came in waves and felt like severe restless leg. She was wondering if she was having a seizure, but subsided. She also had a cold temperature of 94 degrees Fahrenheit.  She added that she felt like she had pneumonia, and describes as having trouble breathing, heavy coughing and sinus dripping. She added that she had dizziness. The onset of events was on 19Nov2021. The outcome of events felt cold, not feeling well, and restless leg was recovered on 20Nov2021; outcome of other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: itching and burning throughout body; itching and burning throughout body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "itching and burning throughout body". Therapeutic measures were taken as a result of burning sensation, pruritus.  Additional information: After the first dose the patient immediately experienced itching and burning throughout body. The reporter stated that she was currently taking a 6-day regimen of steroids which will end on 11Nov2021 (reported as Thursday). She was scheduled for her second dose on 29Nov2021 (Monday). She wanted to know if the potency of the second dose the same as the first dose or is it different. There was no product quality complaint (PQC) present.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: But she did have "crusting" of her lips that was "kind of annoying"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISCOMFORT (non-serious), outcome "recovered" (2021), described as "But she did have "crusting" of her lips that was "kind of annoying"".  Additional Information: It was reported that, the reporter was calling about the Pfizer booster shot. She was supposed to get the booster on 27Oct2021. Her last Pfizer vaccine was on the 24Mar2021, which according to her is about a 6-month period. She got struck by a car (she also referred to it as a terrible accident) and ended up in the withheld emergency room instead of the withheld hospital to get her booster shot. She ended up getting a fractured left elbow which she had to get surgery on 08Nov2021. She also has a weakened right leg that she had annoyance from "to do with the sacrum area". She says she said getting evaluated and probably won't get to a doctor until Feb because they're so busy. She doesn't know if she should get the booster shot at this time and yet she felt like she was overdue for it but she felt like she has plenty going on with these other things. She mentioned she did not really have any bad side effects from the other two Pfizer shots. But she did have "crusting" (the word was hard to understand and I had the caller repeat it which did not clarify much) of her lips that was "kind of annoying". When asked to spell the word she said before, she did not spell it and she said "but it went away, I did not report it because it went away, it wasn't so terrible you know". She adds she has to go to physical therapy and then she has to go to another doctor to be evaluated for her right leg which is weaker than before. She mentions she will not be in crowds and she doesn't have family so she'll be alone for holiday. Caller wanted to know if the booster shot is the same as the initial Pfizer shot, is it the same strength/ingredients. Caller wanted to know if she can take the booster right now with everything going on in her life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Breathing problems- sent to hospital a few times; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 10:00 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No covid prior vaccination. No covid tested post vaccination. There were no concomitant medications (No other vaccine in four weeks, no other medications in two weeks). Vaccination history included: Bnt162b2 (Dose 1, in left arm), administration date and time: 24Apr2021 10:00 AM, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (hospitalization, life threatening) with onset 16May2021 12:00, outcome "not recovered", described as "Breathing problems- sent to hospital a few times". The patient was hospitalized for dyspnoea (hospitalization duration: 1 day(s)). The event "breathing problems- sent to hospital a few times" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of dyspnoea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid/ lost our sense of taste and smell/ cough; got covid/ lost our sense of taste and smell/ cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2021, outcome "unknown" and all described as "got covid/ lost our sense of taste and smell/ cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Oct2021) positive. Clinical course: After having 2 vaccines, patient got Covid. On 18Oct, he got tested and on 19Oct2021, he tested positive. His symptoms were bad including a cough. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: tongue is numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "received the Pfizer booster shot on Friday"; HYPOAESTHESIA ORAL (non-serious) with onset 19Nov2021, outcome "unknown", described as "tongue is numb".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Cerebrovascular accident, Speech disorder
Clinical narrative: stroke like symptoms lasting 30-60 seconds; garbled speech x 2 episodes approx 5 hours apart.; significant ataxic gait; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 21Mar2021 (Lot number: ER2613) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). The patient did not have COVID prior to vaccination. The patient did not receive any other vaccines within 4 weeks of the COVID vaccine. There were no concomitant medications. Past drug history included: Dilantin, reaction(s): "known allergies: Dilantin"; Lamictal, reaction(s): "known allergies: Lamictal". Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 27Feb2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "stroke like symptoms lasting 30-60 seconds"; SPEECH DISORDER (medically significant) with onset 22Mar2021, outcome "recovered", described as "garbled speech x 2 episodes approx 5 hours apart."; ATAXIA (medically significant) with onset 22Mar2021, outcome "recovered", described as "significant ataxic gait". Therapeutic measures were not taken as a result of cerebrovascular accident, speech disorder, ataxia. The patient was not COVID tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity, Product preparation error
Clinical narrative: Received booster dose of vaccine mixed with the wrong diluent, sterile water was used as diluent instead of sodium chloride; Received booster dose of vaccine mixed with the wrong diluent, sterile water was used as diluent instead of sodium chloride; Had a sore arm and was exhausted for a couple of days.; Had a sore arm and was exhausted for a couple of days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "Received booster dose of vaccine mixed with the wrong diluent, sterile water was used as diluent instead of sodium chloride"; FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Had a sore arm and was exhausted for a couple of days.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647371 same drug/event different patient
Sex: M
Vaccine: COVID19
Symptoms: Hemiparesis, Multiple sclerosis relapse, Ophthalmoplegia, Optic neuritis
Clinical narrative: MS exacerbation; hemiparesis; optic neuritis; intranuclear opthalmoplegia; This is a spontaneous report received from contactable reporter(s) (Other healthcare professional). Other Case identifier(s): LRN4462471.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "MS exacerbation"; HEMIPARESIS (medically significant), outcome "unknown", described as "hemiparesis"; OPTIC NEURITIS (medically significant), outcome "unknown", described as "optic neuritis"; OPHTHALMOPLEGIA (medically significant), outcome "unknown", described as "intranuclear opthalmoplegia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chest X-ray, Drug ineffective, Suspected COVID-19
Clinical narrative: Bronchitis; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4163705-00 (AbbVie).  A 79 years-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Sep2021, outcome "recovered" (2021) and all described as "COVID-19"; BRONCHITIS (non-serious) with onset 15Nov2021, outcome "recovered" (2021), described as "Bronchitis". The patient underwent the following laboratory tests and procedures: chest x-ray: (15Nov2021) unknown results; (15Nov2021) unknown results, notes: Lung X-ray. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID- 19 and BRONCHITIS FROM COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter considered "covid-19" and "bronchitis" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19 and bronchitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test, Thunderclap headache
Clinical narrative: had an episode of HTN 160/110; Thunderclap headache; This is a spontaneous report received from contactable reporter(s) (nurse and Other HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 (Lot number: EN6202) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Controlled HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "MS" (unspecified if ongoing); "known_allergies: Beta Blockers" (unspecified if ongoing), notes: Name of Drug as Reported: Beta blockers; "known_allergies: Adhesive tape" (unspecified if ongoing), notes: Name of Drug as Reported: Adhesive tape. Concomitant medication(s) included: oral MONTELUKAST [MONTELUKAST SODIUM] 10mg tablet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The following information was reported: HYPERTENSION (medically significant) with onset 20Mar2021, outcome "recovered with sequelae", described as "had an episode of HTN 160/110"; THUNDERCLAP HEADACHE (non-serious) with onset 20Mar2021, outcome "recovered with sequelae", described as "Thunderclap headache". The events "had an episode of htn 160/110" and "thunderclap headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (20Mar2021) 160/110; (unspecified date) 150/100; sars-cov-2 test: (17Apr2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of hypertension, thunderclap headache, as the patient was started on cozaar.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and underlying medical history of hypertension, the event "episode of htn 160/110" is not related to the suspect product BNT162B2. The event occurred 21 days after the vaccination. This case will be re-assessed should additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohns disease aggravated;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4163864-00 (Abbvie).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf pen for crohn's disease. Relevant medical history included: "Moderate To Severe pediatric Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohns disease aggravated". The event of non-serious Crohn's disease getting worse versus better with Humira (Adalimumab). The action taken for adalimumab was unknown.  The reporter's causality for the event Crohn's disease getting worse versus better with HUMIRA(ADALIMUMAB) was no reasonable possibility while for Crohns disease aggravated was not reported.  The reporter's causality for the event Crohns disease aggravated with Pfizer Biontech Covid-19 Vaccine was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Crohns disease . The case will be reassessed once new information is 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.] retained for this spontaneous serious HCP report .
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: just a little pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "recovered", described as "just a little pain".  Additional information: The patient stated that the first shot did not cause the type of pain, just a little pain but it went away after 2 to 3 days. The patient stated that she was wondering if there was any way she could get a smaller shot. She stated that she would be willing to complete a report but she was having trouble hearing with the connection. She agreed to be transferred back to complete the report after she spoke with Medical Information when she had a better connection.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flared; COVID-19 vaccine allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4162810-00 (AbbVie).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset 2021, outcome "not recovered", described as "Psoriatic arthritis flared"; ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "COVID-19 vaccine allergy". The action taken for adalimumab was unknown. Clinical course: DOSE 2 of BNT162B2 was administered intramuscularly on 16Aug2021 (lot: FC3180) for COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Kidney infection
Clinical narrative: Felt like a kidney infection; Back pain; Booster; This is a spontaneous report from a contactable consumer. A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), administration date 28Sep2021 (lot number: FF8839) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included blood pressure abnormal (ongoing). Concomitant medications included atenolol taken for blood pressure abnormal, start date: Sep2020 (ongoing). Vaccination history included BNT162B2, dose 1, single and dose 2, single administered on unspecified dates (lot number: unknown) for COVID-19 immunization. The following information was reported: On 04Oct2021 (6 days after the vaccination), the patient experienced back pain. It felt like a kidney infection. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.