chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; budesonide, formoterol fumarate (SYMBICORT), (Batch/Lot number: unknown). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Heart" (unspecified if ongoing); "Irregular Heartbeat" (unspecified if ongoing); "known allergies: Iodine in CT scan dye" (unspecified if ongoing), notes: known allergies: Iodine in CT scan dye. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ASPIRINE 325 MG; GABAPENTIN; LOSARTAN; METOPROLOL TARTRATE; NORTRIPTYLINE. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin", notes: known allergies: Levaquin; Doxycycline, reaction(s): "known allergies: Doxycycline", notes: known allergies: Doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (05Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Aug2022 to 05Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 12Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 30 years, in right arm for covid-19 immunisation. 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. Covid was tested post vaccination. Facility type vaccine was workplace clinic. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Sep2022 at 02:00, outcome "unknown", COVID-19 (medically significant) with onset 11Sep2022 at 02:00, outcome "unknown" and all described as "Tested positive for COVID after having vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive, notes: At 02:00 AM, Tested positive for COVID after having vaccine. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed; had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed; 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 41-year-old 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Consumer's mother mentioned her daughter also will be getting Epipen after getting vaccinated and she finds it hard to swallow Paxlovid. Unable to offer warm transfer to program during the call. E-transmitting to program.  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: Hypersensitivity
Clinical narrative: allergic reaction with the Pfizer BioNTech Covid-19 vaccine; 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 41-year-old 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction with the Pfizer BioNTech Covid-19 vaccine".  Additional information: Consumer's mother wanted to know if Paxlovid can be crushed. Consumer's mother mentioned in passing that her daughter had an allergic reaction with the Pfizer BioNTech Covid-19 vaccine and asked if Paxlovid can be crushed. Her daughter also will be getting Epipen after getting vaccinated and she finds it hard to swallow Paxlovid. Caller asked if there are alternatives aside from Paxlovid tablets. Caller asked when Paxlovid is prescribed (if her husband is diabetic and had covid symptoms, can he take Paxlovid)  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: Positive for SARS COVID 2; Positive for SARS COVID 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL1283), on 06Feb2021 as dose 2, single (Lot number: EN5318), on 04Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for SARS COVID 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive for SARS COVID 2; Weight: 185-190, notes: Weight: 185-190. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reporter stated that she was listening to an online channel talking about the immunization is not for b4 and b5 and she got the last booster 22May not even 6 months so it indicates the past boosters there are break through cases.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vascular graft
Clinical narrative: triple bypass surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 68 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing); "Blood thinner" (ongoing); "Coronary bypass surgery" (unspecified if ongoing), notes: . Concomitant medication(s) included: LIPITOR taken for coronary artery bypass (ongoing); CLOPIDOGREL taken for coagulopathy, start date: 15Feb2022 (ongoing); METOPROLOL taken for blood pressure measurement, start date: 15Feb2022 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6205, Exp: Unknown, Dose and Route: Unknown), administration date: 09Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (DOSE 2, SINGLE, Lot: EN6202, Exp: Unknown, Dose and Route: Unknown), administration date: 01Apr2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: VASCULAR GRAFT (medically significant) with onset 07Feb2022, outcome "unknown", described as "triple bypass surgery". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Positive.  Clinical course: Additional vaccines administered on same date of the Pfizer Suspect was reported as with one of the vaccines he might have gotten his flu shot also, but he was not sure. He knows he has had his flu shot. Prior vaccinations were reported as none.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right 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: "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; VENLAFAXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; Blood pressure measurement: High; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 31Aug2022 to 04Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: ew0171), in left arm, on 18May2021 as dose 2, single (Lot number: ew0173), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: 33036BD), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (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: Negative, notes: Tested on day 4 night, negative; Positive, notes: Tested on day 6 night, positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 05Sep2022 to 10Sep2022. Patient did not receive other medication in 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 71-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6198), on 01Apr2021 as dose 2, single (Lot number: er8737), on 13Oct2021 as dose 3 (booster), single (Lot number: fh8020) and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrilation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after having tested negative two days in a row; Positive, notes: Tested positive after having tested negative two days in a row; Negative, notes: Tested positive after having tested negative two days in a row; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had Paxlovid for COVID 19 Treatment from 31Aug2022 to 04Sep2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; 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 male patient received BNT162b2 (BNT162B2), 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 was not reported. Concomitant medication(s) included: LOSARTAN; VERAPAMIL; DOXAZOSIN; JANUVIA; METFORMIN; GLIMEPIRIDE; LEVOTHYROXINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he's tested positive for COVID 19. Clinical information: Consumer states that he was been fully vaccinated with Pfizer COVID 19 vaccine, the primary series and 2 booster doses, and he was tested positive for COVID 19. He also takes Losartan, Verapamil, Doxazosin, Januvia, Metformin, Glimepiride, and Levothyroxine. Patient took his first dose of Paxlovid about 1/2 hour ago and asking can he take next dose in 12 hours and how he should take. 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN [METFORMIN HYDROCHLORIDE]; METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant), 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, notes: COVID 19 Treatment; (10Sep2022) Negative, notes: I had a positive test today after testing negative (and having no symptoms) Saturday 10Sep22; (11Sep2022) Positive, notes: I had a positive test today after testing negative (and having no symptoms) Saturday 10Sep22. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid anti-viral COVID 19 treatment.Treatment start date was 02Sep2022 and stop date was 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
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) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive; (09Sep2022) Positive, notes: Rebound COVID, sxm restarted on 09Sep2022 and positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Aug2022 to 03Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Slightly elevated cholesterol levels" (unspecified if ongoing), notes: Slightly elevated cholesterol levels, controlled by , Atorvastatin. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: 02Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment of COVID-19 from 31Aug2022 to 05Sep2022.  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: Arthralgia, Bone pain, Pain in extremity
Clinical narrative: pain in my shoulder and it goes down my arm; pain in my bone; pain in my shoulder and it goes down my arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-022934 (MODERNA).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1st dose, Manufacturer: Pfizer, Lot number: unknown, Dose: full, Date administered: Sep2021), administration date: Sep2021, for Covid-19 immunization, reaction(s): "pain in my shoulder", "pain in my bone", "pain in my shoulder & it goes down my arm". The following information was reported: BONE PAIN (non-serious) with onset 09Sep2022, outcome "not recovered", described as "pain in my bone"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 09Sep2022, outcome "not recovered" and all described as "pain in my shoulder and it goes down my arm".  Additional information: Dose Number: 2nd dose. Manufacturer: Unclear "I don't know what they gave me". Concomitant: There is no concomitant list.. 2nd dose in Nov2021 (unsure if Moderna or Pfizer). Patient started having pain in patient's shoulder & it goes down patient's arm. It's like pain in patient's bone. Patient was afraid it might go into patient's back. Rambling speech. Arguing with grandson, while on call with this agent. Says Experian called to notify that someone attempted to make a purchase in name. Also says daughter became payee & they said they were going to put away in an insane asylum. Events did not meet seriousness criteria like Life Threatening, Disabling/Incapacitating, Intervention/Medically Important, Congenital Anomaly/Birth Defect, Death, Hospitalization Required, Hospitalization Prolonged and Other. Product Complaint: There is no product complaint associated with this case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Body temperature increased, Dizziness, Headache, Mobility decreased
Clinical narrative: Fever over 101F; severe headache; muscle pain throughout body; dizziness; swelling under left armpit; making raising left arm difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asperger syndrome" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "known allergies Ceclor"; Tegretol, reaction(s): "known allergies tegretol". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "Fever over 101F"; DIZZINESS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering"; MOBILITY DECREASED (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "making raising left arm difficult"; MYALGIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "muscle pain throughout body"; HEADACHE (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "severe headache"; AXILLARY MASS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "swelling under left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, dizziness, axillary mass, mobility decreased.  Additional information: Fever over 101F, severe headache, muscle pain throughout body, dizziness, swelling under left armpit making raising left arm difficult. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever over 101F; severe headache; muscle pain throughout body; dizziness; swelling under left armpit; making raising left arm difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asperger syndrome" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "known allergies Ceclor"; Tegretol, reaction(s): "known allergies tegretol". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "Fever over 101F"; DIZZINESS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering"; MOBILITY DECREASED (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "making raising left arm difficult"; MYALGIA (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "muscle pain throughout body"; HEADACHE (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "severe headache"; AXILLARY MASS (non-serious) with onset 10Sep2022 at 19:00, outcome "recovering", described as "swelling under left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, myalgia, dizziness, axillary mass, mobility decreased.  Additional information: Fever over 101F, severe headache, muscle pain throughout body, dizziness, swelling under left armpit making raising left arm difficult. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I didn't feel very good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't feel very good". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Context: The patient stated that she wanted to try to see if she can report what she thought was a side effect from the Pfizer COVID-19 vaccine but she also was wondering if this was something that other people have reported. So she received, she had to get the vaccine for work. The patient's employer required it, so she got 2 doses of the vaccine and then she also required a booster. After the first dose, she did not have any problems, but she did not feel very good which she was informed to be expected.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 at 09:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulosis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3302, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Feb2021, when the patient was 77-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 21Sep2021, outcome "recovered", described as "The morning following day of second shot and again morning following the day of third shot, I passed out. This happened 12 plus hours after the shot, so was not a reaction from fear of the shot". Therapeutic measures were not taken as a result of loss of consciousness. Clinical course: The patient did not received any other vaccine within four weeks. The patient not had COVID Prior vaccination and not tested COVID post vaccination. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201157480 same reporter/patient/AE, different drug dose.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: big red mark on my arm, like a big red circle/I had a big red patch on me; 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), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I take high blood pressure medication" (unspecified if ongoing), notes: further clarification unknown. The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "big red mark on my arm, like a big red circle/I had a big red patch on me".  Additional information: The patient had a big red mark on arm, like a big red circle (described as covid arm or booster arm).   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: Gait disturbance, Loss of personal independence in daily activities, Ophthalmological examination, Pain, Visual impairment
Clinical narrative: intense pain; She can barely walk; eye sight has diminished; she has not driven or worked in over 17 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30-year-old 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: GAIT DISTURBANCE (disability) with onset Apr2020, outcome "unknown", described as "She can barely walk"; VISUAL IMPAIRMENT (disability) with onset Apr2020, outcome "unknown", described as "eye sight has diminished"; PAIN (disability) with onset Apr2020, outcome "unknown", described as "intense pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset Apr2020, outcome "unknown", described as "she has not driven or worked in over 17 months". The patient underwent the following laboratory tests and procedures: Ophthalmological examination: Diminished, notes: Her eye sight has diminished.  Clinical course: Father of a female patient reported that, my 30 year old daughter is about 95% disabled. She is in intense pain, even on pain meds. She can barely walk and has seen dozens of specialist. None of the specialist have been helpful. This all started in Apr2020. This all started within hours of getting the 2 shot of the Pfizer vaccine. (2 shot protocol). She needs relief. Her eye sight has diminished and she has not driven or worked in over 17 months. Caller later stated that patient has no future.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8732), in right arm, on 15Apr2021 as dose 2, single (Lot number: EW0164), in right arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 30Apr2022 at 13:30 as dose 4 (booster), single (Lot number: FP4554) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive, notes: I completed the Paxlovid medication on the evening of 10Sep. The following morning, I took a COVID Test and it registered positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Patient completed the Paxlovid medication on the evening of 10Sep. The following morning, Patient took a COVID Test and it registered positive. The other medication in 2 weeks (05Sep2022- 06Sp2022) are Vitamin D, Vitamin C, Vitamin B12, Osteo BiFlex, Ferrous Sulfate, Theraflu Cold and Flu.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Sjogren's syndrome
Clinical narrative: she has "Sjogren's" Syndrome; Caller mentioned she has an autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to other ingredients like dairy" (unspecified if ongoing), notes: allergy to other ingredients like dairy; "allergy to other ingredients like dairy or citrus" (unspecified if ongoing), notes: allergy to other ingredients like dairy or citrus. 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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "she has "Sjogren's" Syndrome"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Caller mentioned she has an autoimmune disease".  Clinical course: Patient stated that she had the original and booster last Nov and was waiting for the new vaccine to come out. She asked was it true that the original booster would be discontinued, for the "original booster" and the vaccine for the two shots (primary), was it the same vaccine and was asking how long the protection would last. Reporter mentioned she could not find anywhere online the full list of ingredients of the bivalent vaccine and was really could not find that distinctively online. Reporter asked for her allergy. Reporter stated: she could not take the Moderna because it had citric in it and could not take flu or pneumonia shots because of allergy to other ingredients like dairy or citrus. She was thrilled when Pfizer's did not have any of that. Reporter mentioned she had an autoimmune disease, and that her doctor advised against getting flu, shingles, and pneumonia shots. Reporter stated she had Sjogren's Syndrome, explained that her immune system was barely functioning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; mild muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 16 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 Immunization; Covid-19 vaccine (Dose 2), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, manufacturer Unknown), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Sep2022, outcome "recovered"; MYALGIA (non-serious) with onset 11Sep2022, outcome "recovered", described as "mild muscle aches". Therapeutic measures were not taken as a result of fatigue, myalgia. Additional information: Patient had no other vaccine in four weeks and no other medications in two weeks. Patient had no COVID prior vaccination and not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient) received  (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8731), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: VERTIGO (non-serious) with onset 25Apr2021, outcome "recovered", described as "Vertigo. First vaccine was a sever case 11 days later". The event "vertigo. first vaccine was a sever case 11 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperaesthesia, Musculoskeletal stiffness, Myalgia, Night sweats
Clinical narrative: skin sensitive to touch (like with fever); low grade fever; muscle aches; night sweats; dizziness; stiffness in neck and left side of body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; PYREXIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "low grade fever"; MYALGIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "muscle aches"; NIGHT SWEATS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; HYPERAESTHESIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "skin sensitive to touch (like with fever)"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "stiffness in neck and left side of body". Therapeutic measures were not taken as a result of hyperaesthesia, pyrexia, myalgia, night sweats, dizziness, musculoskeletal stiffness.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: skin sensitive to touch (like with fever); low grade fever; muscle aches; night sweats; dizziness; stiffness in neck and left side of body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; PYREXIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "low grade fever"; MYALGIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "muscle aches"; NIGHT SWEATS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; HYPERAESTHESIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "skin sensitive to touch (like with fever)"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "stiffness in neck and left side of body". Therapeutic measures were not taken as a result of hyperaesthesia, pyrexia, myalgia, night sweats, dizziness, musculoskeletal stiffness.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inner ear disorder, Palpitations, Peripheral swelling, Tinnitus
Clinical narrative: heart palpitations; clouded ears; ringing in the ears; swollen feet; brain fog; weight gain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 1, single (Lot number: 33036BD) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Feb2022, outcome "not recovered", described as "brain fog"; INNER EAR DISORDER (non-serious) with onset 17Feb2022, outcome "not recovered", described as "clouded ears"; PALPITATIONS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "heart palpitations"; TINNITUS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "ringing in the ears"; PERIPHERAL SWELLING (non-serious) with onset 17Feb2022, outcome "not recovered", described as "swollen feet"; WEIGHT INCREASED (non-serious) with onset 17Feb2022, outcome "not recovered", described as "weight gain". The events "heart palpitations", "clouded ears", "ringing in the ears", "swollen feet", "brain fog" and "weight gain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, inner ear disorder, tinnitus, peripheral swelling, feeling abnormal, weight increased.  Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received the first dose on 16Feb2022 and second dose on 16Mar2022 but after both doses she experienced clouded ears, ringing in the ears, heart palpitations, swollen feet, brain fog and weight gain. Still till this day in Sep2022 experiencing clouded ears where its hard for her to hear at times and periodically heart palpitations, brain fog, and increase weight gain. The events required Doctor or other healthcare professional office/clinic visit. The patient had covid prior vaccination. The patient was not covid tested post vaccination. The patient had no/none known allergies and no other medical history.   No follow-up attempts are possible. No further information is expected