chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller states the patient had COVID-19 in Jul2022; Caller states the patient had COVID-19 in Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group, Program ID.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown), on 07Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 11Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Meningitis b vaccine (Lot Number/ Expiry Date: Unknown, Route, Anatomical Location: Unknown, No. of Previous Doses: Unknown), for Immunization; Meningitis vaccines, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Caller states the patient had COVID-19 in Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive.  Clinical information: Patient received Dose 4 Bivalent vaccine on 27Oct2022. Treatment: None.  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 available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine dose number=3/Moderna/vaccine dose number=4/Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9266), in right arm and on 09Mar2021 as dose 2, single (Lot number: EN6206) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Lot number: 062E21A), in right arm, on 12Jun2022 as dose 4 (booster), single (Lot number: 038A22A), in right arm and on 21Sep2022 as dose 5 (booster), single (Lot number: AS7162B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FIORICET. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Aspirin, reaction(s): "Known allergies: aspirin"; Vancomycin, reaction(s): "Known allergies: vancomycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Oct2021, outcome "unknown", described as "vaccine dose number=3/Moderna/vaccine dose number=4/Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 69.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6204), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8737), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 05Aug2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: May2017; MALARONE, start date: 30Sep2022, stop date: 13Oct2022. 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: (unspecified date) Positive, notes: COVID 19 Treatment; (19Oct2022) Positive, notes: tested positive on the 6th day after completing the full course of Paxlovid with a faint T line; (24Oct2022) Positive, notes: I am now on day 5 of positive testing; (18Oct2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient took Paxlovid for the full 5 day course. I then tested negative for COVID using an at home antigen test. Patient tested positive on the 6th day after completing the full course of Paxlovid with a faint T line. Patient now on day 5 of positive testing with no fever but having nasal congestion and an occasional dry cough and some fatigue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I am almost positive at this point; I did had Covid on 01Jan2022; I am almost positive at this point; I did had Covid on 01Jan2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6207) and on 19Apr2021 as dose 2, single (Lot number: EW0171) at the age of 40 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) all with onset 01Jan2022, outcome "unknown" and all described as "I am almost positive at this point; I did had Covid on 01Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: I am almost positive at this point. Clinical course: She had Pfizer vaccine on 22Mar2021 and then had second dose on 19Apr2021 and she reported that was almost positive at this point and she did have Covid on 01Jan2022 that was why she didn't get the booster.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID-19) and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Diabetes mellitus, Hypertension
Clinical narrative: diabetes; She was very sick for three and a half weeks afterward; sleep apnea; high cholesterol; high blood pressure; 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 65-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. Vaccination history included: Flu vaccine (she got sick with the flu shot); Pneumonia shots (She has gotten pneumonia shots and has been fine with those, no side effects or anything.).  The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick for three and a half weeks afterward"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high.  Clinical course: Patient first received the Pfizer BioNTech Covid 19 vaccine when it first came out, she believes in December, when it initially came out about 2 years ago but was unsure if it was a purple or gray cap formulation. She was very sick for three and a half weeks afterward.No one gets sick for three and a half weeks like she did. She never got another Covid 19 vaccine even though she would like to.She mentioned that about 20-25 years ago, she got sick with the flu shot, and was sick for 7-8 days after getting the flu shot, everyone else only gets sick for a few days. She had probably gotten a tetanus shot. The caller has not gotten any Pfizer Covid 19 vaccines since the first one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Sleep apnoea syndrome
Clinical narrative: diabetes; She was very sick for three and a half weeks afterward; sleep apnea; high cholesterol; high blood pressure; 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 65-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. Vaccination history included: Flu vaccine (she got sick with the flu shot); Pneumonia shots (She has gotten pneumonia shots and has been fine with those, no side effects or anything.).  The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick for three and a half weeks afterward"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high.  Clinical course: Patient first received the Pfizer BioNTech Covid 19 vaccine when it first came out, she believes in December, when it initially came out about 2 years ago but was unsure if it was a purple or gray cap formulation. She was very sick for three and a half weeks afterward.No one gets sick for three and a half weeks like she did. She never got another Covid 19 vaccine even though she would like to.She mentioned that about 20-25 years ago, she got sick with the flu shot, and was sick for 7-8 days after getting the flu shot, everyone else only gets sick for a few days. She had probably gotten a tetanus shot. The caller has not gotten any Pfizer Covid 19 vaccines since the first one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyshidrotic eczema, Feeling abnormal, Hand dermatitis, Pain, Pruritus
Clinical narrative: Severe eczema on my hands; have fully developed Dishydrotic Eczema; have been absolutely miserable; the never ending itching/fissures on my hands; the never ending itching/fissures on my hands; I have just started to begin injections every 2 weeks to help with the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 at 12:00 as dose 2, single (Lot number: FE3592) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FE3183, Prev dose lot unknown: False, Prev dose administration date: 20Aug2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 20Aug2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "I have just started to begin injections every 2 weeks to help with the pain"; HAND DERMATITIS (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "Severe eczema on my hands"; FEELING ABNORMAL (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have been absolutely miserable"; DYSHIDROTIC ECZEMA (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have fully developed Dishydrotic Eczema"; PRURITUS (non-serious), SKIN FISSURES (non-serious) all with onset 20Sep2021 at 12:00, outcome "not recovered" and all described as "the never ending itching/fissures on my hands". The events "severe eczema on my hands", "have fully developed dishydrotic eczema", "have been absolutely miserable", "the never ending itching/fissures on my hands" and "i have just started to begin injections every 2 weeks to help with the pain" required physician office visit. Therapeutic measures were taken as a result of hand dermatitis, dyshidrotic eczema, feeling abnormal, pruritus, skin fissures, pain.  Additional information: No covid prior and post vaccination and known allergies was penicillin. No vaccine in four week and other medication in two weeks.Clobetasol, Triamcinolone, Opzelura, Dupixent used as treatment drug. He used every possible steroid and cream available. He had been absolutely miserable since getting these vaccines and he have been living a nightmare with the never ending itching/fissures on my hands. He had just started to begin injections every 2 weeks to help with the pain, fissures and itching on my hands.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Skin fissures
Clinical narrative: Severe eczema on my hands; have fully developed Dishydrotic Eczema; have been absolutely miserable; the never ending itching/fissures on my hands; the never ending itching/fissures on my hands; I have just started to begin injections every 2 weeks to help with the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 at 12:00 as dose 2, single (Lot number: FE3592) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FE3183, Prev dose lot unknown: False, Prev dose administration date: 20Aug2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 20Aug2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "I have just started to begin injections every 2 weeks to help with the pain"; HAND DERMATITIS (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "Severe eczema on my hands"; FEELING ABNORMAL (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have been absolutely miserable"; DYSHIDROTIC ECZEMA (non-serious) with onset 20Sep2021 at 12:00, outcome "not recovered", described as "have fully developed Dishydrotic Eczema"; PRURITUS (non-serious), SKIN FISSURES (non-serious) all with onset 20Sep2021 at 12:00, outcome "not recovered" and all described as "the never ending itching/fissures on my hands". The events "severe eczema on my hands", "have fully developed dishydrotic eczema", "have been absolutely miserable", "the never ending itching/fissures on my hands" and "i have just started to begin injections every 2 weeks to help with the pain" required physician office visit. Therapeutic measures were taken as a result of hand dermatitis, dyshidrotic eczema, feeling abnormal, pruritus, skin fissures, pain.  Additional information: No covid prior and post vaccination and known allergies was penicillin. No vaccine in four week and other medication in two weeks.Clobetasol, Triamcinolone, Opzelura, Dupixent used as treatment drug. He used every possible steroid and cream available. He had been absolutely miserable since getting these vaccines and he have been living a nightmare with the never ending itching/fissures on my hands. He had just started to begin injections every 2 weeks to help with the pain, fissures and itching on my hands.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:00 as dose 1, single (Lot number: ER6206), in right arm, on 27Mar2021 at 13:00 as dose 2, single (Lot number: ER8730), in right arm, on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: PH8028), in left arm and on 12Aug2022 at 13:00 as dose 4 (booster), single (Lot number: FP1780) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Menieres Disease." (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE, start date: 01May2017; LORATADINE, start date: 01May2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Oct2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (16Oct2022) Positive, notes: Tested positive; (22Oct2022) Negative, notes: tested negative; (28Oct2022) Positive, notes: Took another Covid test and it was definitely positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. On 17Oct2022 the patient received Paxlovid covid-19 treatment and it was stopped on 21Oct2022. Clinical course: Patient had no known allergies. Other medication in 2 weeks product: Colace, start date: 26Sep2022 and Metamucil, start date: 10Oct2022.
Age: 66.0
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EK8982), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asmaa undifferentiated connective tissue disease" (unspecified if ongoing), notes: undifferentiated connective tissue disease; "sick sinus syndrome" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; AZELASTINE; FLUTICASONE. Past drug history included: Hydroxychloroquine, reaction(s): "Known allergies: hydroxychloroquine", notes: Known allergies: hydroxychloroquine. The following information was reported: DRUG INEFFECTIVE (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: (24Oct2022) Negative, notes: tested negative Days 6 and 8; (28Oct2022) Positive, notes: positive on Day 10; (26Oct2022) Negative, notes: tested negative Days 6 and 8. Therapeutic measures from 19Oct2022 to 24Oct2022 were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) from 15Oct2022 to 19Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Pancreatic carcinoma stage IV
Clinical narrative: pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after; arthritis; joint pain; This is a spontaneous report received from contactable reporter(s) (Physician).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), 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 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: PANCREATIC CARCINOMA STAGE IV (death, medically significant), outcome "fatal", described as "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after"; ARTHRITIS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". The events "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after" required emergency room visit. It was unknown if therapeutic measures were taken as a result of pancreatic carcinoma stage iv. The patient date of death was unknown. Reported cause of death: "pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after". It was not reported if an autopsy was performed.  Clinical course: Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if COVID Prior vaccination and if COVID tested post vaccination. Patient in remission from pancreatic cancer. Decided to get Pfizer Bio-N-Tech Covid-19 vaccine series. Immediately after second dose, she experienced arthritis and severe joint pain. 4 months after getting second dose, she was diagnosed with stage 4 cancer and passed away shortly after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pancreatic carcinoma stage  IV  and the suspect product BNT162B2cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: pancreatic cancer/ diagnosed with stage 4 cancer and passed away shortly after
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: feeling chills; aches all over; 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 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 28Oct2022, outcome "unknown", described as "aches all over"; CHILLS (non-serious) with onset 28Oct2022, outcome "unknown", described as "feeling chills".  Additional information: Caller took the Pfizer-BioNTech COVID-19 Vaccine, booster dose, yesterday. Today she woke up feeling chills and aches all over. She wanted to know if the vaccine could give her COVID or these might be just side effects. She described that she did not feel this with other doses.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post-menopausal menstrual bleeding; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 13:15 as dose number unknown (booster), single (Lot number: GH9694) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 26Oct2022, outcome "recovering", described as "post-menopausal menstrual bleeding". Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  Clinical course: It was reported that patient received More than 3 doses. Facility type vaccine Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and did not test positive covid post vaccination .  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 5 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 19Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 27Oct2022, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of pyrexia.  Additional information: Report is about COVID vaccine. Dose received: More than 3. Patient received other vaccine in four weeks (flu). No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain and swelling at site of injection; pain and swelling at site of injection; body pain; headache; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 28Oct2022, outcome "not recovered", described as "body pain"; HEADACHE (non-serious) with onset 28Oct2022, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Oct2022, outcome "not recovered" and all described as "pain and swelling at site of injection"; NASAL CONGESTION (non-serious) with onset 28Oct2022, outcome "not recovered", described as "stuffy nose". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, pain, headache, nasal congestion.  Additional information: She received Pfizer Bivalent Booster on 28Oct2022 in the evening. After few hours of vaccination, she had pain and swelling at site of injection. Later at night she started having body pain, headache and stuffy nose. All events are ongoing. Patient did not had Covid prior to vaccination. Patient was not tested covid post vaccination. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Tinnitus
Clinical narrative: Developed tinnitus in both ears 12 hours after vaccine; Other vaccine same date product: Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 21Oct2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Sulfa antibiotics allergy" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: CHOLESTYRAMINE. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. Vaccination history included: Pfizer (Prev dose dose number=3, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration time=14:00 PM, Prev dose vaccine location=Left arm), administration date: Sep2021, when the patient was 51 years old, for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 21Oct2022, outcome "unknown", described as "Other vaccine same date product: Flu"; TINNITUS (non-serious) with onset 22Oct2022 at 09:00, outcome "not recovered", described as "Developed tinnitus in both ears 12 hours after vaccine". Therapeutic measures were not taken as a result of tinnitus.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Seriousness criteria was reported as no.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. The patient's concomitant medications were not reported (Other medication in 2 weeks reported as unknown). Patient had no known allergies. Reaction allergy for relevant past drug history (as reported). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 11Oct2022 to 15Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Overdose
Clinical narrative: A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day; A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day; nonstop headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Lot number: GJ6665, Expiration Date: May2023) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), OVERDOSE (non-serious) all with onset Oct2022, outcome "unknown" and all described as "A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day"; HEADACHE (non-serious) with onset Oct2022, outcome "not recovered", described as "nonstop headache".  Additional information: NDC number of Pfizer COVID Booster was 59267-0304-02. The caller had no reference as the staff on duty at time of reporting was not there. This Pharmacist called regarding Pfizer COVID Booster, adult gray cap bivalent multidose vial formulation. A pharmacist at reporter's store administered 2 doses of the product to the patient on the same day. The patient was reporting nonstop headache for the last 48 hours. The patient did not want to take any over the counter products for the nonstop headache like Tylenol or Ibuprofen. She called to ask how long they should expect the nonstop headache to last; how long to wait to go to the doctor; and what the patient could take for the nonstop headache. She was reading any studies to see if it was known how long headaches should last and kind of got the idea it was about a week, a person could have on and off headaches.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 15:30 as dose 5 (booster), single (Lot number: gh9693) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2020, stop date: 20Oct2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 21Oct2022 to 25Oct2022.   Clinical Course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Night sweats
Clinical narrative: Night sweats; Just over sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 26Jul2021 as dose 1, single (Lot number: EW0164) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history included: "Protein allergy" (unspecified if ongoing); "Had COVID twice" (unspecified if ongoing), notes: Had COVID twice; "Allergy symptoms" (ongoing). Concomitant medication(s) included: PREDNISONE taken for hypersensitivity; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]; SINGULAIR; EPINEPHRINE.  The following information was reported: HYPERAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Just over sensitivity"; NIGHT SWEATS (non-serious) with onset 2021, outcome "unknown".  Additional information: This report was not related to a study or programme. Investigations reported as no. NDC number of COVID-19 vaccine was unknown. Consumer confirmed the name of the product as Pfizer COVID-19 vaccine. Consumer was informed about the role of Pfizer Drug Safety department and to contact Pfizer Medical Information department for the questions. Consumer was provided with the number as option 3 and was provided timings as 8am- 9pm from Monday to Friday. After the COVID-19 vaccine, the patient got her second shot and then the first one gave her night sweats and just over sensitivity and then she was about to get the second one which she did indeed received. Consumer stated, "I got my short this year. I think I was 25. The second shot was 2 days after I turned, oh my shot was last year. My final shot was 17Aug2021 having the health issues last year and then everything else." Consumer stated, she has received dose 2 on 17Aug2021 (Lot number: FC2181, Expiry date not provided). Consumer stated, "I have had to start about four different new medications due to this. 3 of them were allergy meds and one of them was switch on testosterone and right now, we started 3 different allergy mediations, we started an Epipen on reserve and now on Prednisone. I have got Prednisone 10mg tablets for the next 5 days to try and get my allergy symptoms down, 180mg tablet of Allegra daily but we might have to change it to twice a day. I have Singulair 10mg tablet every night, Epipens as needed, Epinephrine 0.3mg injections as needed. I have an Albuterol inhaler and Flovent inhaler." (Intent: Treatment). They were trying treatment to, they were injecting in her allergy slowly and trying to get her allergy down that they never would have had to do prior to this. Consumer stated, "She received the vaccine after the pandemic. She was not hospitalized for COVID based on literally 0.5 temperature. She had COVID twice and then she got vaccinated. But she has not had COVID since she was vaccinated though." The patient did not have any prior vaccination within 4 weeks of getting the Pfizer vaccine. She could not get the booster either.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing), notes: celiac; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Patient did not receive other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Interstitial lung disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; FLOVENT; PROAIR [FLUTICASONE PROPIONATE]; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: To update of slide#1 reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, SARS-CoV-2 test
Clinical narrative: Alopecia areata; Hair still falling out.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema, allergies, now non-manifest." (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: beta lactam antibiotics" (unspecified if ongoing), notes: known allergies: beta lactam antibiotics; "allergies, now non-manifest" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid-19 vaccine (Dose: 03 , Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 01, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ALOPECIA AREATA (non-serious) with onset 10May2022, outcome "not recovered"; ALOPECIA (non-serious) with onset 10May2022, outcome "not recovered", described as "Hair still falling out.". The events "alopecia areata" and "hair still falling out." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: The most recent COVID-19 vaccine was administered at Workplace clinic. Alopecia areata commenced (first noticed) approximately 4-5 weeks later, now increased to large areas of back and sides of scalp. Hair still falling out. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Vitamin C, vitamin D. Events were treated with Acupuncture. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with negative nasal swab result.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: 649702), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing), notes: known allergies: statins. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti-viral treatment for COVID-19 with Paxlovid from 18Oct2022 to 23Oct2022.  No follow-up attempts are possible. No further information is expected.