chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "bronchitis" (unspecified if ongoing), notes: thinks the girlfriend got bronchitis from her family. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious), outcome "unknown".  Additional information: It was reported that the caller's brother and his girlfriend received the Pfizer covid vaccine omicron. Caller stated the girlfriend thinks she got bronchitis from the vaccine. Caller was requested an email saying that bronchitis was not a side effect of the vaccine. Caller declined to be transferred over because she stated that bronchitis was not a side effect and thinks the girlfriend got bronchitis from her family. Caller stated she did not want to make a report. Caller stated she was thrilled she got the omicron vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Blood creatinine, Blood test, Glomerular filtration rate, Renal failure
Clinical narrative: stage 1 kidney failure; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2, on 03Dec2021 at 17:00 as dose 1, single (Lot number: FH8C28) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Patient didn't received other vaccine in four weeks and other medications in two weeks. Patient had no COVID prior vaccination and no COVID tested post vaccination.   The following information was reported: RENAL FAILURE (disability) with onset 01Mar2022, outcome "recovering", described as "stage 1 kidney failure". The event "stage 1 kidney failure" required physician office visit. Patient was diagnosed as stage 1 kidney failure per Creatinine, EGFR and anion gap levels measured via blood test. Prior to vaccine, kidney levels had been normal throughout life. Therapeutic measures were not taken as a result of renal failure.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: A little headache; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "A little headache", "Achy"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "A little headache", "Achy"; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "A little headache", "Achy". The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "A little headache"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Achy".  Additional information: He was calling on behalf of his wife who had the 5 COVID-19 vaccines. The first 4 times she had minor reactions and the last time she had the Bivalent booster, he had a very negative reaction and woke up the next morning with some memory loss and he was wondering if that's anything. He was calling on behalf of his wife who had the 5 COVID-19 vaccines. The first 4 times she had minor reactions and the last time she had the Bivalent booster, he had a very negative reaction and woke up the next morning with some memory loss and he is wondering if that's anything that we've had reported on in previous cases. That we've been had reported on in previous cases. Reporter stated his wife had the 4th Pfizer shot mid July and received the bivalent booster on 03Nov2022. Reporter stated she only was a achy and had a little headache after the previous vaccines. Reporter stated after the 5th vaccine she was a little groggy and experienced some of the same things from the previous vaccines. Reporter stated in the middle of the night, around 2:30 AM to 3 AM, she was shivering and shaking and almost convulsing. Reporter stated she woke up at 8 AM and was warm because she had put clothes on and went back to sleep and slept until noon, which is 4 hours longer than her normal schedule. Reporter stated she had no recollection of getting the booster, experienced memory loss describing it as early onset Alzheimer's. Reporter stated she knew who her husband was but did not remember that her daughter is getting married or that her mother had passed away. Reporter stated his wife went to the ER and had an MRI, CT scan, blood work and urine and nothing was wrong. Reporter stated by 12 AM she was starting to come back and at 2 AM she had her memory back and now has minor lapses but is pretty much back to herself. Reporter stated she was diagnosed with global transient anemia due to the violent reaction that she had to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: A little headache; A achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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, reaction(s): "A little headache", "A achy"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "A little headache", "A achy". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "A little headache"; PAIN (non-serious), outcome "unknown", described as "A achy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: a little headache; a achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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, reaction(s): "A little headache", "a achy". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "a little headache"; PAIN (non-serious), outcome "unknown", described as "a achy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: a little headache; a achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "a little headache"; PAIN (non-serious), outcome "unknown", described as "a achy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: No other medication in 2 weeks. Paxlovid Treatment start date on 29Oct2022 and stop date on 02Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing), notes: Heart failure with reduced ejection fraction; "Reduced ejection fraction" (unspecified if ongoing), notes: Heart failure with reduced ejection fraction; "Chronic kidney disease" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Peripheral artery disease" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures included Anti-viral details: Product: COVID-19 Treatment, treatment started on 05Nov2022 and stopped on 06Nov2022 via oral route, Indication: Treatment of COVID-19. The device date was on 09Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective and COVID-19 cannot be ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing), notes: Other medical history: SVT; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 01May2014; ATORVASTATIN, start date: 01Sep2020, stop date: 27Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Treatment Drug (PAXLOVID), from 28Oct2022 to 01Nov2022 for covid-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 26Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 041L20A), in left arm and on 08Feb2021 as dose 2, single (Lot number: 0271n20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing); "Von Willowbrande type 2A bleeding disorder" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "feral cat bite" (unspecified if ongoing), notes: just took 5 rabies vaccines and immuglobin for a sick, feral cat bite. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Feb2022; PROGESTERONE, start date: 01Feb2022; ESTRADIOL, start date: 01Oct2021. Past drug history included: Known allergies: cipro, reaction(s): "Known allergies: cipro"; Known allergies: keflex, reaction(s): "Known allergies: keflex"; Known allergies: amoxicillin, reaction(s): "Known allergies: amoxicillin". Vaccination history included: Rabies vaccines (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for IMMUNIZATION; Immuglobin (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for IMMUNIZATION; Just took 5 rabies vaccines (just took 5 rabies vaccines and immuglobin for a sick, feral cat bite.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took other medication in two weeks.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; 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 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9702, Expiration Date: 30Jul2023) for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot (flu shot every year), for Immunisation; Pneumonia shot (pneumonia shot), for Immunisation.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing), notes: Name of Drug as Reported: Sulfa, Reaction: Allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies reported. patient received vaccine, received other medication in 2 weeks it was Biktarvy.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Pain
Clinical narrative: intense pain bone and joint; intense pain bone and joint; severe pain; 10/ 10 pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 18May2021 as dose 2, single (Lot number: EW0168) at the age of 42 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Surgery" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION oral taken for attention deficit hyperactivity disorder (ongoing); GUAIFENESIN oral taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown, Anatomical location: Arm), administration date: 27Apr2021, when the patient was 42-year-old, for COVID-19 immunisation, reaction(s): "a little tired". The following information was reported: BONE PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 18May2021, outcome "recovered" and all described as "intense pain bone and joint"; PAIN (non-serious) with onset 18May2021, outcome "recovered", described as "severe pain; 10/ 10 pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bone pain, arthralgia, pain.  Additional information: The patient did not undergo any specific relevant test for thromboembolic events with thrombocytopenia. Second and third doses of vaccine were followed by the most intense pain. It feel like the patients bones were being crushed by a machine, 10/10 pain. Particularly in the joints (hips, elbows). If the patient had not had medication left over from a past surgery, would have gone to the ER. It also was not particularly effective, since caught covid 3 times, but that was probably not relevant. No apparent lasting effects once pain subsided.; Sender's Comments: Linked Report(s) : 202201236731 Same patient/ vaccine, different dose/AE;US-PFIZER INC-202201236731 Same patient/ vaccine, different dose/AE;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0170), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "OCD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: SYNTHROID; BUPROPION; PRISTIQ; VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794032 same patient/drug/event, different time period;
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (04Nov2022) Negative; (06Nov2022) Positive; (09Nov2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient felt better and tested negative 2 days after ending Paxlovid treatment. Started having fever 4 days after ending treatment and tested positive on the 4th day. He was at the 7th day after treatment now, He had a 102-degree fever, headache, extreme nasal congestion, aches. It felt like he had the flu and testing positive for covid again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had mild covid; had mild covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had mild covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She reported that she took the Paxlovid medication in August because she had mild covid. Began taking Paxlovid on 12Aug2022 and stopped taking it 5 days. The patient administered covid vaccines way back and had two. She declined to provide dates of her Pfizer Covid vaccines or lots. She had covid on 09Aug was her first symptom till now so it is 4 months since she had covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete unknown manufacturer), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown".  Clinical information: What reporter only want to know was for the teenagers when they get the booster shot, the fatigue, how long that usually last if they are fatigued. Can it last a month or two or it was just a few days. Product details, Pharmacy details and other details could not be probed as reporter was unwilling to complete the report. 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.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent (mother).  A 31-year-old male patient received BNT162b2 on 26Jan2021 as dose 2, single (Lot number: EJ1686, Expiration Date: Mar2021) at the age of 31 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial bigeminy" (unspecified if ongoing), notes: Atrial bigeminy diagnosed at three years old. Cardiologists and neurologist said his heart was fine and this was nothing contributing. He was always healthy when covid hit. Patient did not have family history relevant to adverse events. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EK9321 or EK4321, thinks it is EK9321, Expiration: Apr2021), administration date: 05Jan2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: SEIZURE (medically significant) with onset Mar2021, outcome "not recovered", described as "seizures". He did not remember the month exactly but thought the seizures started in Mar2021. In Jul2021 was when they became monthly and Oct2021 was when the seizures increased to more frequently than monthly. The event "seizures" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of seizure. They put him on one medication for seizures called Lacosamide and then he was still having seizures so they added an additional medication, Lamotrigine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283002 Same patient, similar event, different dose (dose 3);
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 at 11:00 as dose 1, single (Lot number: EL1283), in right arm, on 08Feb2021 at 15:00 as dose 2, single (Lot number: EL9265), in right arm and on 30Sep2021 at 17:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 19:00 as dose 4 (booster), single (Lot number: AR71448) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022 at 19:00, outcome "unknown", described as "Moderna Dose Number: 4; Pfizer Dose Number: 3, 2, 1"; COVID-19 (medically significant) with onset 10Nov2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: difficulty moving arm; Pain; 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 74-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Nov2022, outcome "recovering"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Nov2022, outcome "recovering", described as "difficulty moving arm". Therapeutic measures were not taken as a result of joint range of motion decreased, pain. Additional information: 11 days prior to this report (on 31Oct2022) he got a shot of Prevnar 20, he has had difficulty moving his arm up to the present and cannot left his arm up and is in pain. He wanted to know what the remedy would be. Pain and difficulty moving arm started the following day. Treatment: declines any.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A female patient in her 60's received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension - not certain of medications. The patient's concomitant medications were not reported. Vaccination history included: Ppsv23, for Immunization; Pcv13, for Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylaxis". The event "anaphylaxis" required emergency room visit. Clinical details: The patient was in early 60's. Patient ended up in ER with anaphylaxis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect PREVNAR 20 may have contributed to the onset of reported event anaphylaxis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19-2
Symptoms: Basedow's disease, Blood thyroid stimulating hormone, Thyroid stimulating immunoglobulin, Thyroxine free
Clinical narrative: Graves' disease; This is a Regulatory Authority report.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: BASEDOW'S DISEASE (medically significant), 5 days after the suspect product(s) administration, outcome "unknown", described as "Graves' disease". Clinical course: patient developed hyperthyroid symptoms 5 days after receiving a 3rd booster dose of P?zer mRNA SARS-CoV- 2 (P?zer) vaccination. Labs a week later the vaccine: TSH 0.01 u[IU]/mL (0.4 - 5.0 u[IU]/mL), free T4 (FT4) 3.1 ng/dL (0.6 - 1.2 ng/dL), Thyroid-Stimulating Immunoglobulin (TSI) 3.2 (<1.3), consistent with diagnosis of graves' disease. None of the patient had a personal or family history of thyroid disease. Therapeutic measures were taken as a result of basedow's disease. She responded well to methimazole 20 mg daily.  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 known the information available the Causal relation between the event BASEDOW'S DISEASE and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201287741 Same article/ drug and different patient;US-PFIZER INC-202201287742 Same article/ drug and different patient;US-PFIZER INC-202201287890 Same article/ drug and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: swollen lymph nodes; didn't feel good; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete but manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; MALAISE (non-serious), outcome "unknown", described as "didn't feel good".  Additional information: On 25Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at a booster dose for COVID-19 immunization. It was reported the patient had a reaction to the Pfizer booster. The individual reported that she had swollen lymph nodes that lasted for a little while, but it was not severe and also reported that she didn't feel good but that was normal with a booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: felt like she just had a fever; very nauseous; sick for 10 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) 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. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "felt like she just had a fever"; NAUSEA (non-serious), outcome "unknown", described as "very nauseous"; ILLNESS (non-serious), outcome "unknown", described as "sick for 10 days".  Additional information: On 25Oct2022, it was reported that a patient started treatment on Apr2021 with Pfizer BioNTech COVID-19 Vaccine at dose 2 for COVID-19 immunization and got very sick for 10 days. The patient was very nauseous and felt like she just had a fever. The patient also had a booster on Aug2021 which was really bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Slight headache; Sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Woman experienced slight headache and sore arm the day after receiving the Pfizer COVID vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; nauseous; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown", described as "nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive, notes: She now has tested positive for COVID rebound . Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: sick; pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown". The events "sick" and "pain" required emergency room visit.  Additional Information: Event: She received the Pfizer shot two days later, she got sick had pain went to the ER.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 13 year-old-male experienced bad headache the day after receiving the Pfizer COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "13 year-old-male experienced bad headache the day after receiving the Pfizer COVID vaccine".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: 09-year-old female patient experienced sore arm the day after receiving the COVID vaccine (booster); This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 9-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "09-year-old female patient experienced sore arm the day after receiving the COVID vaccine (booster)".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: reports getting COVID after vaccine;  reports getting COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "DR reports getting COVID after vaccine".  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (160849). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of pruritus.  Additional information: It was also reported that there was a inbound call from patient stating, since receiving the Pfizer covid 19 vaccine he had been experiencing itching but this medication (Eucrisa) was very useful.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.