chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Nausea
Clinical narrative: Booster; Nausea; Sleeplessness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:00 (Lot number: FH8027) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "SLE" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 19Nov2021; METHOTREXATE; FOLIC ACID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09May2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Dose number:1 02May2021 Dose number:2 09May2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 37 years old, for COVID-19 immunization, reaction(s): "Dose number:1 02May2021 Dose number:2 09May2021". The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:00, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 26Nov2021 01:00, outcome "not recovered", described as "Nausea"; INSOMNIA (non-serious) with onset 26Nov2021 01:00, outcome "not recovered", described as "Sleeplessness". Therapeutic measures were not taken as a result of nausea, insomnia.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for virus after having two dose of Pfizer; tested positive for virus after having two dose of Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 2021, outcome "unknown" and all described as "tested positive for virus after having two dose of Pfizer". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) negative.  Additional Information: Consumer asked that why would be tested positive for virus after having two dose of Pfizer and after that booster and was tested positive. Consumer further stated what the patient was saying that had a hard time understanding patient name and all the patient just wanted to report if would know what was going with the Pfizer booster that was all the patient wanted to say and the patient was not expecting to be positive, that it was did not have anything more to say. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pelvic floor muscle weakness, Urinary tract infection
Clinical narrative: I developed a UTI a urinary tract infection; my pelvic floor is weakening; 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 number: 1, I ended up catching COVID on Aug 30th even though I was fully vaccinated), for COVID-19 immunization, reaction(s): "COVID", "ended up catching COVID".  The following information was reported: PELVIC FLOOR MUSCLE WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "my pelvic floor is weakening"; URINARY TRACT INFECTION (non-serious) with onset 11Nov2021, outcome "unknown", described as "I developed a UTI a urinary tract infection". Therapeutic measures were taken as a result of pelvic floor muscle weakness.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Colitis, Heart rate, Laboratory test, Tachycardia
Clinical narrative: I have been having fast heart rate, Tachycardia; mild colitis; I am worried because of my health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: 301358A) at the age of 21 years 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. Lot/batch Number: FC3184), administration date: 10Sep2021, when the patient was 21 years old, for COVID-19 immunization; Flu shot (She got a Flu shot every year but she has not got the flu vaccine yet this year). The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "I have been having fast heart rate, Tachycardia"; COLITIS (non-serious), outcome "unknown", described as "mild colitis"; ANXIETY (non-serious), outcome "unknown", described as "I am worried because of my health". The events "i have been having fast heart rate, tachycardia", "mild colitis" and "i am worried because of my health" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia. The clinical course of events was as follows: Patient got the Second vaccine (clarified as COVID 19 vaccine) of the Pfizer on 1Oct221 and she had to go to the hospital (further not clarified) last Tuesday because she has been having fast heart rate, tachycardia and she took (word not clear) had mild colitis had to get to the hospital because they were still worried about it. She had a doctor appointment next day but it had been happening (further clarification unknown) ever since the second dose of the Pfizer vaccine. Patient got a Flu shot every year but she has not got the flu vaccine yet this year. Patient stated she was healthy about 2 years ago she was promoted and she had to go through medical processing to get hired which was very hard to get. They get a physical health assessment every year annually. She had not any other medical conditions, this has never happened until about a couple of days after the 2nd dose. Patient did not know about lab test, they ran a bunch of test and all they put in her the documentation was that it was reaction to the vaccine tachycardia. She was going to see the cardiologist in Dec. Patient queried how long does tachycardia take to go away on its own. Patient added she was worried because of her health. Patient queried in order to get her ER bill paid for.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Seizure
Clinical narrative: seizure; Grand mal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LUPI21-04196 (Reference).  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Her sister's seizures were dormant for a while" (ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "seizure"; GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "Grand mal". Event description: The reporter said that her sister's seizures were dormant for a While, but she experienced a lot of seizures when she took Pfizer's vaccine in Sep2021. After taking the 1st shot the patient experienced 13 episodes of back to back seizures, like Grand mal, She said that the patient got 1st shot of Pfizer's vaccine but now she cannot get the 2nd shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Lot number: FK5618) at the age of 5 years 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: COVID-19 (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Covid infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19. Additional information: Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. AE resulted in: None of the above. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Immunisation
Clinical narrative: third dose; erectile dysfunction; 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 (005570). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 11Nov2021 (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), for Covid-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 11Nov2021, outcome "unknown", described as "third dose"; ERECTILE DYSFUNCTION (medically significant) with onset 11Nov2021, outcome "not recovered", described as "erectile dysfunction". The clinical course: On 11Nov2021, Patient was vaccinated with the third dose of your Pfizer vaccine against Covid 19 and from that same day he have suffered from erectile dysfunction. He would like to know if this effect lasts long because he have almost completed three weeks and patient have not had an erection again and that already has him very worried because something like this had never happened to him and patient had erections without any problem every day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: all the systems of her body began to collapse'; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adolescent female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (medically significant), outcome "unknown", described as "all the systems of her body began to collapse'". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of consciousness, Syncope
Clinical narrative: Fainting; Blacking out; Booster; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:00 (Lot number: FD0809) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25Feb2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK4176, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 04Feb2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Nov2021 12:00, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 28Nov2021 06:00, outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant) with onset 28Nov2021 06:00, outcome "unknown", described as "Blacking out". The events "fainting" and "blacking out" were evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test, Menstrual disorder
Clinical narrative: miscarriage; have had long and inconsistent cycles since vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 37 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jun2021 14:00 (Lot number: EW0168) at the age of 37 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Date of last menstrual period: 18May2021. The patient was 4 weeks pregnant at the time of exposure to bnt162b2. The patient was 4 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. The patient had no covid vaccine within 4 weeks and has not been tested post vaccination. Concomitant medication(s) included: ESCITALOPRAM; ZYRTEC. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Erythromycin, reaction(s): "Known allergies: Erythromycin"; Fluorescein, reaction(s): "Known allergies: Fluorescein". Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 27May2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "Exposure during pregnancy (Patient last menstrual period date :18May2021)". The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 19Jun2021, outcome "recovered with sequelae" (2021), described as "miscarriage"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "have had long and inconsistent cycles since vaccination". The event "miscarriage" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown, notes: confirmed that no hcg levels remained. Therapeutic measure Rhogam injection was taken as a result of abortion spontaneous (loss of pregnancy).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101691653 same patient, different dose, different event;US-PFIZER INC-202101691654 same patient, different drug, different event
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: Headache; Lots off Allergic reaction; Heart beat high; Dry cough; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Nov2021 20:15 (Lot number: FH8030) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 2, Batch/Lot No: Lot er 8730. Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM.), administration date: 25Mar2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 1, Batch/Lot No: Lot Ewo 161. Location of injection: Arm Left. Vaccine Administration Time: 06:15 PM.), administration date: 14Apr2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Dose Number 3"; HEADACHE (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Headache"; HYPERSENSITIVITY (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Lots off Allergic reaction"; HEART RATE INCREASED (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Heart beat high"; COUGH (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Dry cough". The patient was hospitalized for immunisation, headache, hypersensitivity, heart rate increased, cough (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: heart rate: (26Nov2021) high; sars-cov-2 test: (29Nov2021) negative, notes: Nasal Swab. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination was Nasal Swab, Covid test name post vaccination was Rapid Taste. Therapeutic measures were not taken as a result of headache, hypersensitivity, heart rate increased, cough.  Follow-up (02Dec2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test
Clinical narrative: Headache; Lots off Allergic reaction; Heart beat high; Dry cough; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Nov2021 20:15 (Lot number: FH8030) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Prior to vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 2, Batch/Lot No: Lot er 8730. Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM.), administration date: 25Mar2021, when the patient was 30 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose brand=Pfizer, Dose Number: 1, Batch/Lot No: Lot Ewo 161. Location of injection: Arm Left. Vaccine Administration Time: 06:15 PM.), administration date: 14Apr2021, when the patient was 30 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "Dose Number 3"; HEADACHE (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Headache"; HYPERSENSITIVITY (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Lots off Allergic reaction"; HEART RATE INCREASED (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Heart beat high"; COUGH (hospitalization) with onset 26Nov2021 15:15, outcome "not recovered", described as "Dry cough". The patient was hospitalized for immunisation, headache, hypersensitivity, heart rate increased, cough (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: heart rate: (26Nov2021) high; sars-cov-2 test: (29Nov2021) negative, notes: Nasal Swab. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination was Nasal Swab, Covid test name post vaccination was Rapid Taste. Therapeutic measures were not taken as a result of headache, hypersensitivity, heart rate increased, cough.  Follow-up (02Dec2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I am getting the rash and hives; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: ER8729) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Apr2021, when the patient was 39 years old, for covid-19 immunisation, reaction(s): "RASH", "URTICARIA". The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "I am getting the rash and hives"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash". The event "i am getting the rash and hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria. No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: did a test for COVID which was positive; 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. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (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: COVID-19 (non-serious) with onset Nov2021, outcome "unknown", described as "did a test for COVID which was positive". The event "did a test for covid which was positive" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient got COVID a week after first dose. The caller got his first COVID 19 vaccine (Pfizer covid 19 vaccine confirmed), and got sick a week later. He is calling to report that. He didn't get sick after the vaccine. He got the vaccine, and the following week he started getting a head cold that moved into his chest. He was away from home when he was sick so when he got back, he went to the doctor. The doctor check him out and did a test for COVID which was positive. He has went through his quarantine. As of tomorrow , he is okay to go to work. Caller received his first dose of the vaccine on 09Nov2021 and is due to receive his second dose on 30Nov2021. He is calling to ask a question. Now that he has had COVID how long does he need to wait to get his Pfizer COVID second dose? It turned out someone at his job had COVID, and he didn't find out until a couple of days after ward.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: break through case of covid; break through case of covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02059112.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "break through case of covid". Clinical course: Employee reported that her friend took immunosuppressants (specific product unknown). Employee reported that she was unsure of the brand name of the Covid vaccine that her friend received.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immunisation, Pain
Clinical narrative: coronavirus booster; soreness; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (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. Past drug history included: Xeljanz xr, start date: 27Jul2021, stop date: 2021, for Rheumatoid Arthritis, notes: oral, Strength: 11MG, dose: 11mg, daily. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "coronavirus booster"; PAIN (medically significant), outcome "unknown", described as "soreness"; COUGH (medically significant), outcome "unknown", described as "cough". 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 reported events and the suspect drug BNT162B2 cannot be excluded. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: The patient tested positive for covid; The patient tested positive for covid; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 39 year-old male patient (reporter's brother in law) received bnt162b2 (BNT162B2), administered in arm, administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, 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 Nov2021, outcome "unknown" and all described as "The patient tested positive for covid"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. Clinical course: He was calling because he was pissed off because he got Covid from his brother in law who was vaccinated with our vaccine. His brother in law got sick so was not working and transmitted it to the caller and he was mad. Caller stated we have a product issue. His wife was out of work and his kids are out of school. Caller confirmed it was his brother in law who got the Pfizer Covid-19 Vaccine. He was calling to find out what we are going to do to help him out. People were trusting the vaccine and it's not working. The company has to take some kind of responsibility. The caller said it's not safe and effective. Caller explained the patient got sick last Wednesday; that's when he got tested for covid. He also got the results then too later that evening. The patient tested positive for covid. Caller stated he talked to the patient a few times. This was the only person outside of his family he was in contact with. The patient used the Abbott Test. Patient got the first dose Jun2021 or Jul2021. Patient got the second dose in Aug2021. Caller mentioned he did not know why we call it a vaccine. If get a vaccine it should be effective. How was it called a vaccine, that was like false advertisement. It should be more like "therapeutic."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Investigation, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; develop shortness of breath; chest pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 11:30 (Lot number: EW0196) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM; LEXAPRO; SPIRONOLACTONE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 28Oct2021, outcome "recovering", described as "POTS"; FATIGUE (disability) with onset 18Jul2021 08:00, outcome "recovering", described as "fatigue"; DYSPNOEA (disability) with onset 20Jul2021, outcome "recovering", described as "develop shortness of breath"; CHEST PAIN (disability) with onset 20Jul2021, outcome "recovering", described as "chest pain". The events "pots", "fatigue", "develop shortness of breath" and "chest pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (28Oct2021) pots; sars-cov-2 test: (21Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, fatigue, dyspnoea, chest pain included: propanolol and physical therapy. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After many visits with different specialists patient was diagnosed with POTS on 28Oct. Never had any problems like this until got the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: POTS; develop shortness of breath; chest pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 11:30 (Lot number: EW0196) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM; LEXAPRO; SPIRONOLACTONE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 28Oct2021, outcome "recovering", described as "POTS"; FATIGUE (disability) with onset 18Jul2021 08:00, outcome "recovering", described as "fatigue"; DYSPNOEA (disability) with onset 20Jul2021, outcome "recovering", described as "develop shortness of breath"; CHEST PAIN (disability) with onset 20Jul2021, outcome "recovering", described as "chest pain". The events "pots", "fatigue", "develop shortness of breath" and "chest pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (28Oct2021) pots; sars-cov-2 test: (21Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, fatigue, dyspnoea, chest pain included: propanolol and physical therapy. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After many visits with different specialists patient was diagnosed with POTS on 28Oct. Never had any problems like this until got the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Loss of consciousness, Seizure, Terminal insomnia
Clinical narrative: passed out; Felt like I was about to have a seizure (am epileptic); Woke up at about 3a; vomited 2x; diarrhea; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:30 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing); "Allergies: Eggs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; IPRATROPIUM BROMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 24May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO172, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 03May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 28Nov2021 12:30, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "passed out"; SEIZURE (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "Felt like I was about to have a seizure (am epileptic)"; TERMINAL INSOMNIA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "Woke up at about 3a"; VOMITING (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "vomited 2x"; DIARRHOEA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of loss of consciousness, seizure, terminal insomnia, vomiting, diarrhoea. Clinical course: On 29Nov2021, Patient was vaccinated with the third dose of Pfizer vaccine against COVID-19. AE were not Required visit to emergency room visit and physician office visit. This report was considered as serious and the events did not result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. 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. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: passed out; Felt like I was about to have a seizure (am epileptic); Woke up at about 3a; vomited 2x; diarrhea; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:30 (Lot number: FJ8762) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing); "Allergies: Eggs" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; IPRATROPIUM BROMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 24May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO172, Location of injection: Arm Left, Vaccine Administration Time: 14:00 PM), administration date: 03May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 28Nov2021 12:30, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "passed out"; SEIZURE (medically significant) with onset 29Nov2021 03:00, outcome "recovering", described as "Felt like I was about to have a seizure (am epileptic)"; TERMINAL INSOMNIA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "Woke up at about 3a"; VOMITING (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "vomited 2x"; DIARRHOEA (non-serious) with onset 29Nov2021 03:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of loss of consciousness, seizure, terminal insomnia, vomiting, diarrhoea. Clinical course: On 29Nov2021, Patient was vaccinated with the third dose of Pfizer vaccine against COVID-19. AE were not Required visit to emergency room visit and physician office visit. This report was considered as serious and the events did not result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. 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. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy rectum, Biopsy small intestine, Body temperature, C-reactive protein, Clostridium test
Clinical narrative: Ulcerative colitis flare-ups following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s): (removed). Case description/methods: A 36-year-old female with past medical history of ulcerative colitis, autoimmune pancreatitis presented with intermittent lower abdominal pain and diarrhea for 2 weeks with fever for 1 day. Her last flare-up was 3 years ago before she was put on Tofacitinib. She never required hospitalization. Her symptoms started the second day after she received the second dose of Pfizer COVID-19 vaccine. She had daily 5-10 times of non-bloody diarrhea and abdominal cramps. Her symptoms subsided after 7 days of initial onset. On day 11, she started to have daily up to 15 times bloody bowel movements, along with nausea, vomiting, unable to maintain oral intake. Day 17 after vaccination, patient went to ED after fever of 100.5F. On presentation, she is afebrile, WBC 11.9, CRP 61.8, calprotectin 1840, Clostridioides difficile negative, GI Panel negative. CT showed severe colitis involving the left colon from splenic flexure to rectum. Colonoscopy showed erythematous, granular, hemorrhagic, and ulcerated mucosa in the entire examined colon. Terminal ileum, cecum, ascending, transverse, descending, sigmoid and rectum biopsies were negative for CMV, showed chronic active colitis. Patient received intravenous Methylprednisolone, then transited to oral Prednisone taper and resumed her Tofacitinib. Her symptoms gradually improved.  Discussion(s): To our best knowledge, no report has shown the association of mRNA vaccine and UC flare-up. In general, non-live vaccines are safe for UC patients regardless of immunosuppressants usage. Live vaccines are also contraindicated Tofacitinib users like our patient. In the Pfizer COVID- 19 vaccine trial, patients on immunosuppressive therapy were excluded. Given the temporal relationship between the vaccine and her flare-up in the setting of long-term remission history, we are concerned that the stress induced by the mRNA vaccine may increase the risk of flare-up. More studies need to be done to evaluate the safety profile of mRNA vaccine for UC patients on immunosuppressants.  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, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Computerised tomogram, Faecal calprotectin, Gastrointestinal pathogen panel
Clinical narrative: Ulcerative colitis flare-ups following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s): (removed). Case description/methods: A 36-year-old female with past medical history of ulcerative colitis, autoimmune pancreatitis presented with intermittent lower abdominal pain and diarrhea for 2 weeks with fever for 1 day. Her last flare-up was 3 years ago before she was put on Tofacitinib. She never required hospitalization. Her symptoms started the second day after she received the second dose of Pfizer COVID-19 vaccine. She had daily 5-10 times of non-bloody diarrhea and abdominal cramps. Her symptoms subsided after 7 days of initial onset. On day 11, she started to have daily up to 15 times bloody bowel movements, along with nausea, vomiting, unable to maintain oral intake. Day 17 after vaccination, patient went to ED after fever of 100.5F. On presentation, she is afebrile, WBC 11.9, CRP 61.8, calprotectin 1840, Clostridioides difficile negative, GI Panel negative. CT showed severe colitis involving the left colon from splenic flexure to rectum. Colonoscopy showed erythematous, granular, hemorrhagic, and ulcerated mucosa in the entire examined colon. Terminal ileum, cecum, ascending, transverse, descending, sigmoid and rectum biopsies were negative for CMV, showed chronic active colitis. Patient received intravenous Methylprednisolone, then transited to oral Prednisone taper and resumed her Tofacitinib. Her symptoms gradually improved.  Discussion(s): To our best knowledge, no report has shown the association of mRNA vaccine and UC flare-up. In general, non-live vaccines are safe for UC patients regardless of immunosuppressants usage. Live vaccines are also contraindicated Tofacitinib users like our patient. In the Pfizer COVID- 19 vaccine trial, patients on immunosuppressive therapy were excluded. Given the temporal relationship between the vaccine and her flare-up in the setting of long-term remission history, we are concerned that the stress induced by the mRNA vaccine may increase the risk of flare-up. More studies need to be done to evaluate the safety profile of mRNA vaccine for UC patients on immunosuppressants.  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, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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