chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Felt intoxicated; Severe whole body pain; Chills; Headache; Unable to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Lot number: ew0153) as dose 1, single and (Lot number: ew0176) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SAVELLA; LEXAPRO; PROPANOLOL [PROPRANOLOL]; JUNEL. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Felt intoxicated"; PAIN (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Severe whole body pain"; CHILLS (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Headache"; INSOMNIA (non-serious) with onset 17Dec2021 21:00, outcome "not recovered", described as "Unable to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pain, chills, headache, insomnia. The patient had not taken other vaccine in 4 weeks. The patient received dose 3 (Lot number: fd0809) on 18Dec2021 12:00 pm.  No follow-up attempts possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol abnormal, Hyperaesthesia, Immunisation, Lymphadenopathy, Mass
Clinical narrative: Swelling at arm pit; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Fj8757), administered in arm left, administration date 14Dec2021 08:00 at the age of 51 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Ew0161, Prev dose lot unknown=False, Prev dose administrationdate=14Apr2021, Prev dose administration_time=01:00 PM , Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 14Apr2021, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Er8730, Prev dose lot unknown=False, Prev dose administration date=25Mar2021, Prev dose administration time=01:00 , Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 25Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 15Dec2021 12:00, outcome "not recovered", described as "Swelling at arm pit"; MASS (non-serious), LYMPHADENOPATHY (non-serious), HYPERAESTHESIA (non-serious), PAIN (non-serious) all with onset 15Dec2021 12:00, outcome "not recovered" and all described as "lump swollen at collar bone, hurts to touch". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of peripheral swelling, mass, lymphadenopathy, hyperaesthesia, pain. The patient was not diagnosed with covid-19 prior and after vaccination.  Follow-Up (30DEC2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling at arm pit; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; lump swollen at collar bone, hurts to touch; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Fj8757), administered in arm left, administration date 14Dec2021 08:00 at the age of 51 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Ew0161, Prev dose lot unknown=False, Prev dose administrationdate=14Apr2021, Prev dose administration_time=01:00 PM , Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 14Apr2021, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfzer, Prev dose brand unknown=False, Prev dose lot number=Er8730, Prev dose lot unknown=False, Prev dose administration date=25Mar2021, Prev dose administration time=01:00 , Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 25Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 08:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 15Dec2021 12:00, outcome "not recovered", described as "Swelling at arm pit"; MASS (non-serious), LYMPHADENOPATHY (non-serious), HYPERAESTHESIA (non-serious), PAIN (non-serious) all with onset 15Dec2021 12:00, outcome "not recovered" and all described as "lump swollen at collar bone, hurts to touch". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of peripheral swelling, mass, lymphadenopathy, hyperaesthesia, pain. The patient was not diagnosed with covid-19 prior and after vaccination.  Follow-Up (30DEC2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Booster; Headaches; right arm pain at vaccination site; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 61 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. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, lot unknown reason=Unable to locate or read the details), administration date: 26Mar2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "covid test date: 16Aug2021 / covid test result: Positive", "covid test date: 16Aug2021 / covid test result: Positive"; Bnt162b2 (Dose: 1, lot unknown reason=Unable to locate or read the details), for Covid-19 immunization, reaction(s): "covid test date: 16Aug2021 / covid test result: Positive", "covid test date: 16Aug2021 / covid test result: Positive". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "Headaches"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "recovering", described as "right arm pain at vaccination site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site pain with  Ibuprofen.  Additional information: Patient did not receive other vaccine in four weeks. prior vaccination, the patient had tested with Covid-19 and post vaccination tested for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823145 same reporter and patient, different AE
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Booster; achy; coughing; fever; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (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 Number: 2, Batch/Lot No: Unknown), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization; Flu shot, for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "achy"; COUGH (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "coughing"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "fever"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "very tired"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "headache"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "nausea". It was unknown if therapeutic measures were taken as a result of pain, cough, pyrexia, fatigue, headache, nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Booster; achy; coughing; fever; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (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 Number: 2, Batch/Lot No: Unknown), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization; Flu shot, for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "achy"; COUGH (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "coughing"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "fever"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "very tired"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "headache"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "nausea". It was unknown if therapeutic measures were taken as a result of pain, cough, pyrexia, fatigue, headache, nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Booster; coughing; fever; achy; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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: Covid19 vaccine (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "recovered", described as "Booster"; COUGH (non-serious), outcome "recovered", described as "coughing"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "achy"; FATIGUE (non-serious), outcome "recovered", described as "very tired"; HEADACHE (non-serious), outcome "recovered", described as "headache"; NAUSEA (non-serious), outcome "recovered", described as "nausea".  Additional Information: The patient had no other vaccine in four weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Booster; coughing; fever; achy; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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: Covid19 vaccine (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "recovered", described as "Booster"; COUGH (non-serious), outcome "recovered", described as "coughing"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "achy"; FATIGUE (non-serious), outcome "recovered", described as "very tired"; HEADACHE (non-serious), outcome "recovered", described as "headache"; NAUSEA (non-serious), outcome "recovered", described as "nausea".  Additional Information: The patient had no other vaccine in four weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Pyrexia
Clinical narrative: Fever 103.6; chills; headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Oct2021 18:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (ongoing). Concomitant medication(s) included: PREDNISONE; FLUDROCORTISONE; FEXOFENADINE. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrum". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Location of injection: Arm Left , Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 50 years old, for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Location of injection: Arm Left , Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Oct2021 18:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "Fever 103.6"; CHILLS (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "chills"; HEADACHE (non-serious) with onset 07Oct2021 08:30, outcome "recovered" (08Oct2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was with Tylenol, increased prednisone dose in accordance with sick day rules for Addison's disease. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine was received in four weeks. The patient did not have Covid prior vaccination. The patient was not tested  for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Immunisation, SARS-CoV-2 test
Clinical narrative: loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then; 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 17Nov2021 08:30 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HYPOTHYROID" (unspecified if ongoing), notes: HYPOTHYROID; "PCOS" (unspecified if ongoing), notes: PCOS; "Allery to Penicillan" (unspecified if ongoing). Concomitant medication(s) included: WILD YAMS; MACA [LEPIDIUM MEYENII]; SOYA LECITHIN. Past drug history included: Amoxicillian, reaction(s): "Amoxicillin: Drug Allergy", notes: AMOXICILLIAN; Doxycycline, reaction(s): "Doxycycline: Drug allergy"; Cephalosphorins, reaction(s): "Cephalosphorins: Drug allergy", notes: Cephalosphorins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 25Feb2021, when the patient was 30 years old, for Covid-19 immunization, reaction(s): "Loss of smell"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 29Jan2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 08:30, outcome "unknown", described as "Dose Number:3"; ANOSMIA (non-serious), outcome "not recovered", described as "loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia.  Additional information : It was reported that patient had loss of smell after 2nd shot and was consistent issues since that second series, never recovered prior enhanced smell since then. No prolonged hospitalization, No Congenital anomaly/birth defect, No Disabling/Incapacitating and was not Life threatening. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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 been tested for COVID-19. Treatment received for the adverse event was nasal spray.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: COVID vaccine booster; fever; Arm pain; fatigue; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 17 year-old 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. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID vaccine booster"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; VOMITING (non-serious), outcome "unknown", described as "vomiting".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Lymphadenopathy, Pain, Swelling
Clinical narrative: booster; lymph nodes swelling under the armpit where the shot was given.; painful; swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from License Party. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Oct2021 (Lot number: 3203080) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 29Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Oct2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lymph nodes swelling under the armpit where the shot was given."; PAIN (non-serious) with onset 2021, outcome "unknown", described as "painful"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen."  Additional Information: Regulatory authority notified was unknown. No report of exposure during pregnancy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Immunisation
Clinical narrative: Booster; headache; lower back pain on right side of body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (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. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "lower back pain on right side of body".  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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; booster shot of the Pfizer COVID vaccination; This is a spontaneous report received from a contactable consumer (patient's wife) from medical information team.  A 53-year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 16:20 (Batch/Lot number: unknown) at the age of 53 years as dose 3, (booster) single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed maybe 10 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "tested positive for Covid"; IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "his booster shot of the Pfizer COVID vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) positive. Additional information: The patient started coughing after the vaccine and tested positive for Covid on 17Dec2021 with an at home antigen test. The patient wanted to know if Pfizer had information on individuals who have tested positive after the booster dose with an antigen test. The reporter clarified that with the first Pfizer COVID vaccination, the patient had a fever, body aches, chills, all that for a couple days. This time, with the booster, the patient had all the same things the second day. On 16Dec2021, the patient felt pretty good, but on 17Dec2021, he was coughing a little bit and tested at work. The test came back positive, and he did not know if it was right.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pruritus, Urticaria
Clinical narrative: Dose 1 and dose 2 Moderna, Dose 3 Pfizer; Dose 1 and dose 2 Moderna, Dose 3 Pfizer; Booster; Hives and itching and its started on my hands and my cheek;; Hives and itching and its started on my hands and my cheek; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:00 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: CHLORTHALIDONE taken for hypertension; AMLODIPINE; ASPIRIN (E.C.); PREMARIN; VITAMIN D 2000; AMPHETAMINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for immunization; Moderna covid-19 vaccine (Dose 2). The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 11Nov2021, outcome "unknown" and all described as "Dose 1 and dose 2 Moderna, Dose 3 Pfizer"; IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant) with onset Nov2021, outcome "unknown", described as "Hives and itching and its started on my hands and my cheek;"; PRURITUS (medically significant) with onset Nov2021, outcome "unknown", described as "Hives and itching and its started on my hands and my cheek". Therapeutic measures were taken as a result of urticaria, pruritus including diphenhydramine (BENADRYL).  Course of the event. "I started getting the hives and itching and its started on my hands and my cheek and I was very uncomfortable for about three days and I started calling, I called my doctor and she said that it was probably a reaction to the shot and she told me take Anti- histamine around the clock for 2 weeks and not to stop"   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Tooth infection, Toothache
Clinical narrative: had a toothache on his right upper molar; The doctor was thinking it was an infection of some sort; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: He has been tested for asthma he is called a slight asthmatic.; "chronic cough" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT taken for cough (ongoing). Vaccination history included: Shingles vaccine (a good year or year and a half ago), for Shingles. The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "had a toothache on his right upper molar"; TOOTH INFECTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "The doctor was thinking it was an infection of some sort". The events "had a toothache on his right upper molar" and "the doctor was thinking it was an infection of some sort" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, tooth infection.  Additional information: Patient stated that it was the right upper molar. It was tooth number 2 to be exact. He went to the dentist thinking it was a dentist problem. That tooth had been root canaled, prior to vaccine, so there was not much left of that tooth. The dentist sent caller to the root canal people. Caller took antibiotics and it went away after 10 days of antibiotic. The doctor was thinking it was an infection of some sort. It resolved.  When he went to the dentist they said nothing except go to the endodontist which is the root canal people.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccinated with Pfizer Covid 19 vaccine and tested positive for Covid infection; vaccinated with Pfizer Covid 19 vaccine and tested positive for Covid infection; 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 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccinated with Pfizer Covid 19 vaccine and tested positive for Covid infection".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He caught Covid; He caught Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He caught Covid".  Clinical course: He caught Covid while in withheld - posted that he was sick with it 4 days ago at the time of report submission, that he would stop posting videos for a bit, but that thankfully symptoms are mild so far. Pretty sure he was vaccinated but do not know with what vaccine or when. Probably late 20s / early 30s.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: booster dose last Thursday; sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "chills", "headache", "nausea", "fever"; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose last Thursday"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm".  Additional information: The patient has received both doses of the Pfizer COVID-19 vaccine as well as the booster dose last Thursday and she has not felt any of the symptoms like she did after receiving the first two doses. She stated after the Second dose in Apr she "really got hit with it" She stated she had chills, fever, nausea, headache and she was wondering why she has not had much of a reaction this time other than a sore arm. The patient was asking about the booster increasing the antibody levels by 50-fold. She stated she was told to multiply 50 by whatever her level was. She has spoken to people who have had the booster and their antibodies went up to 30%. She has also spoken with her dentist and his level was 800 and after he received the booster, he waited a month and got his antibodies test, and it went o 20,000 or 30,0000. The patient was advised to speak to her Healthcare professional.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Immunisation, Vaccination site urticaria
Clinical narrative: The caller was tired and she took a nap; hives on the arm that the got the vaccine; The hives are burning now; Pfizer booster vaccine; Got a headache a few hours after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 14:30 (Lot number: FE3594, Expiration Date: 11Jan2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Verbatim: Hypothyroidism; "Depression" (unspecified if ongoing), notes: Verbatim: Depression. Concomitant medication(s) included: ZOLOFT; SYNTHROID. Vaccination history included: Bnt162b2 (First Dose, lot ER2613, AE(s) following prior vaccinations: None), administration date: 19Mar2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "None"; Bnt162b2 (Second Dose, lot EW0158, AE(s) following prior vaccinations: None), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 Immunization, reaction(s): "None". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 14:30, outcome "unknown", described as "Pfizer booster vaccine"; FATIGUE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "The caller was tired and she took a nap"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (20Dec2021), described as "Got a headache a few hours after the booster"; VACCINATION SITE URTICARIA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "hives on the arm that the got the vaccine"; BURNING SENSATION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "The hives are burning now".  Additional Information: Additional vaccine administered on same date was reported as none. Prior vaccination within 4 weeks was reported as none. Family history relevant to adverse event and relevant tests was reported as none. The caller was tired and had the hives. The caller clarifies that her headache was through yesterday night but it was gone today. tired, hives on the arm that the got the vaccine was reported as worsened. The events did not cause Physician Office or Emergency Room visit.   No follow-up attempts are needed. No further information is expected.~
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Immunisation
Clinical narrative: I took the booster shot now; booster shot brought up the creatinine number 25% again; This is a spontaneous report received from a non-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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), for COVID-19 Immunization, reaction(s): "the creatinine level of the Kidney number got increased by 25% got worse". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I took the booster shot now"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "booster shot brought up the creatinine number 25% again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that, I took the Pfizer shot first and second shot and after the second shot the creatinine level of the Kidney number got increased by 25% got worse and then it got better after a month or two. I got a question for you. Is this one of the side effects because I am trying to find out is this one of the side effects. Booster shot brought up the creatinine number 25% again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Left arm sore within 12 hours of each dose; Headache; exhaustion; felt nauseated; shortness of breath; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 14:00 (Lot number: FF2S89) at the age of 48 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each dose.), administration date: 23Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each, dose.), administration date: 02Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 14:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Left arm sore within 12 hours of each dose"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "exhaustion"; NAUSEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "felt nauseated"; DYSPNOEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "shortness of breath". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue, nausea, dyspnoea.  Additional information: No other vaccine in four weeks. Left arm sore within 12 hours of each dose. Experienced Headache and exhaustion, felt nauseated, shortness of breath. The  patient not tested COVID prior vaccination and tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm sore within 12 hours of each dose; Headache; exhaustion; felt nauseated; shortness of breath; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 14:00 (Lot number: FF2S89) at the age of 48 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each dose.), administration date: 23Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ENS318, Location of injection: Arm Left, Route of Administration: Intramuscular, Left arm sore within 12 hours of each, dose.), administration date: 02Mar2021, for Covid-19 Immunization, reaction(s): "Left arm sore". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 14:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Left arm sore within 12 hours of each dose"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "exhaustion"; NAUSEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "felt nauseated"; DYSPNOEA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "shortness of breath". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue, nausea, dyspnoea.  Additional information: No other vaccine in four weeks. Left arm sore within 12 hours of each dose. Experienced Headache and exhaustion, felt nauseated, shortness of breath. The  patient not tested COVID prior vaccination and tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Nausea; Headache; Chills; Tiredness; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 (Lot number: FL3197) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Route of Administration: Unspecified), administration date: 03Feb2021, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3247; Route of Administration: Unspecified), administration date: 24Feb2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Dose number: 3"; NAUSEA (non-serious) with onset 23Dec2021 at 01:30, outcome "recovered" (23Dec2021), described as "Nausea"; HEADACHE (non-serious) with onset 23Dec2021 at 01:30, outcome "recovered" (23Dec2021), described as "Headache"; CHILLS (non-serious) with onset 23Dec2021 at 01:30, outcome "recovered" (23Dec2021), described as "Chills"; FATIGUE (non-serious) with onset 23Dec2021 at 01:30, outcome "recovered" (23Dec2021), described as "Tiredness". Therapeutic measures were taken as a result of nausea, headache, chills and fatigue.  Additional Information: Treatment for the events included IBUPROFEN. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The bride had covid; The bride had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The bride had covid". Clinical course: There was a super spreader event at a wedding that I think had 800 people. The bride had covid and did not know.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Seizure, Speech disorder, Thinking abnormal
Clinical narrative: couldn't think and progress my speech and thoughts; had a few seizures; couldn't think and progress my speech and thoughts; couldn't think and progress my speech and thoughts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Dec2021 14:45 (Lot number: FL3197) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MENTAL IMPAIRMENT (non-serious), SPEECH DISORDER (non-serious), THINKING ABNORMAL (non-serious) all with onset 22Dec2021 07:00, outcome "recovered with sequelae" and all described as "couldn't think and progress my speech and thoughts"; SEIZURE (non-serious) with onset 22Dec2021 07:00, outcome "recovered with sequelae", described as "had a few seizures". Therapeutic measures were not taken as a result of mental impairment, seizure, speech disorder, thinking abnormal. The patient had no covid prior vaccination, covid tested post vaccination and known allergies.