chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; Patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant medication information was provided. It was reported that a technician gave 0.25 ml of the Bivalent booster to patient. No treatment drug was reported. This case contains information for the 4th of 5 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654611, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654608 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654611:Patient 5 US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose, Vaccination site irritation, Wrong technique in product usage process
Clinical narrative: Had a little bit of arm irritation; Bivalent booster dose that leaked onto his arm during administration; Not sure how much of the vaccine he has received; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE IRRITATION (Had a little bit of arm irritation), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (Had a little bit of arm irritation). At the time of the report, VACCINATION SITE IRRITATION (Had a little bit of arm irritation), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received) outcome was unknown.            On 10-Feb-2021, patient received first dose of Moderna COVID-19 vaccine (lot number 025420A, Intramuscular) On 10-Mar-2021, patient received second dose of Moderna COVID-19 vaccine (lot number 002A2PA) On 4-Nov-2021, patient received booster dose of Moderna COVID-19 vaccine (lot number 076C21A) The most recent dose was a bivalent booster dose that leaked onto patient's arm during administration. Patient was not sure how much of the vaccine patient has received. Patient has had a little bit of arm irritation after receiving those injections, and took the flu shot the same time as the most recent dose.  No additional doses, medications, or treatments have been administered up to that point.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syringe issue, Wrong technique in product usage process
Clinical narrative: Had a little bit of arm irritation; Bivalent booster dose that leaked onto his arm during administration; Not sure how much of the vaccine he has received; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE IRRITATION (Had a little bit of arm irritation), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (Had a little bit of arm irritation). At the time of the report, VACCINATION SITE IRRITATION (Had a little bit of arm irritation), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Bivalent booster dose that leaked onto his arm during administration) and UNDERDOSE (Not sure how much of the vaccine he has received) outcome was unknown.            On 10-Feb-2021, patient received first dose of Moderna COVID-19 vaccine (lot number 025420A, Intramuscular) On 10-Mar-2021, patient received second dose of Moderna COVID-19 vaccine (lot number 002A2PA) On 4-Nov-2021, patient received booster dose of Moderna COVID-19 vaccine (lot number 076C21A) The most recent dose was a bivalent booster dose that leaked onto patient's arm during administration. Patient was not sure how much of the vaccine patient has received. Patient has had a little bit of arm irritation after receiving those injections, and took the flu shot the same time as the most recent dose.  No additional doses, medications, or treatments have been administered up to that point.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: no adverse events; adult patient received the monovalent Moderna booster dose instead of a bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (adult patient received the monovalent Moderna booster dose instead of a bivalent booster) and NO ADVERSE EVENT (no adverse events) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (adult patient received the monovalent Moderna booster dose instead of a bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse events). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (adult patient received the monovalent Moderna booster dose instead of a bivalent booster) and NO ADVERSE EVENT (no adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse events) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (adult patient received the monovalent Moderna booster dose instead of a bivalent booster).    No concomitant information provided No treatment information provided
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Possible administration of booster dose to a 12 year old patient; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Possible administration of booster dose to a 12 year old patient).    No concomitant medications were reported.   Pharmacist reported that, a mother was asking hypothetically what would happen if a 12-year-old receives a booster dose of the Moderna COVID-19 vaccine. Upon further probing, HCP states that the mother had not said anything else and was just asking a hypothetical question.  No treatment details were reported.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurt; Felt tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were provided. The patient had received Moderna COVID-19 vaccine on 01-Apr-2022 after a 3 dose series of the pfizer vaccine. Patient went to receive their updated booster dose last Wednesday (28-Sep-2022) and received a monovalent vaccine at that appointment. After the dose in April patient had felt tired and her arm hurt. Patient had experienced the same symptoms after her dose last week. Patient's vaccination provider had encouraged her to wait at least 2 months before receiving a dose of the bivalent booster. Patient had not taken any medications or treatments for her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2022-654637 (E2B Linked Report). This case was linked to MOD-2022-654632 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654637:Husband Case (Influenza, Cough, Pyrexia, Fatigue, Headache)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Gave a Moderna monovalent COVID vaccine (NDC  80777-0273-98) on day 38 of it being put in the refrigerator, so 8 days after the BUD; Product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna monovalent COVID vaccine (NDC  80777-0273-98) on day 38 of it being put in the refrigerator, so 8 days after the BUD), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a Moderna monovalent COVID vaccine (NDC  80777-0273-98) on day 38 of it being put in the refrigerator, so 8 days after the BUD), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna monovalent COVID vaccine (NDC  80777-0273-98) on day 38 of it being put in the refrigerator, so 8 days after the BUD), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Gave a Moderna monovalent COVID vaccine (NDC  80777-0273-98) on day 38 of it being put in the refrigerator, so 8 days after the BUD) and PRODUCT STORAGE ERROR (Product storage error).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 36.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Burning sensation, Fatigue, Pain, Vaccination site pain, Vaccination site urticaria
Clinical narrative: Noticed the vaccine seemed to burn; Pain at the injection site; Experienced a little fatigue; Large welt developed about the size of a baseball at the injection site; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Noticed the vaccine seemed to burn). At the time of the report, PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Experienced a little fatigue) outcome was unknown and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) had resolved.            No concomitant product reported by reporter. Patient noticed that the vaccine seemed to burn more than the previous doses. No treatment medication reported by reporter.
Age: 36.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Fatigue, Injection site pain, Pruritus, Urticaria
Clinical narrative: Noticed the vaccine seemed to burn; Pain at the injection site; Experienced a little fatigue; Large welt developed about the size of a baseball at the injection site; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Noticed the vaccine seemed to burn). At the time of the report, PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Experienced a little fatigue) outcome was unknown and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) had resolved.            No concomitant product reported by reporter. Patient noticed that the vaccine seemed to burn more than the previous doses. No treatment medication reported by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise
Clinical narrative: Had high blood pressure; Didn't feel well; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Had high blood pressure) and MALAISE (Didn't feel well) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Controlled by medication) and Drug allergy (Toradol).    On 29-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced HYPERTENSION (Had high blood pressure) and MALAISE (Didn't feel well). At the time of the report, HYPERTENSION (Had high blood pressure) had not resolved and MALAISE (Didn't feel well) outcome was unknown.            Concomitant medications included unspecified medication for high blood pressure. Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On 09-Feb-2021, patient administered 1st dose of Moderna (Lot number: 039K20A). On 09-Mar-2021, patient administered 2nd dose of Moderna (Lot number: 030A21A). On 29-Oct-2021, patient administered 1st booster dose of Moderna (Lot number: 011F21A). On 07-Apr-2022, patient administered 2nd booster dose of Moderna (Lot number: 084J21A). On 29-Sep-2022, patient took the fifth booster, but patient didn't have fever or chills. Patient didn't feel well though. Then patient had high blood pressure, which made her go to her doctor's office, but theydidn't know anything. Patient had office visit on 03-Oct-2022. The patient did not experienced a similar event in the past. The doctor just upped patient's medication on 03-Oct-2022.   This case was linked to MOD-2022-654748 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: Cold symptoms; feeling of generally unwell; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (Cold symptoms), MALAISE (feeling of generally unwell), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (an allergic reaction). At the time of the report, ALLERGY TO VACCINE (an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Oral pain, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; Mouth sores; The patient had Covid-19 for a year after taking the mRNA Moderna COVID-19 vaccine.; The individual got diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), ORAL PAIN (Mouth sores), COVID-19 (The patient had Covid-19 for a year after taking the mRNA Moderna COVID-19 vaccine.) and DIARRHOEA (The individual got diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding), ORAL PAIN (Mouth sores), COVID-19 (The patient had Covid-19 for a year after taking the mRNA Moderna COVID-19 vaccine.) and DIARRHOEA (The individual got diarrhea). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding), ORAL PAIN (Mouth sores), COVID-19 (The patient had Covid-19 for a year after taking the mRNA Moderna COVID-19 vaccine.) and DIARRHOEA (The individual got diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.   COVID-19 gave terrible symptoms to patient as inside the body where the mucus forms, it peeled the mucus out of the body. It lasted for a very long time.  No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Fever lasting 48hrs; tiredness; full body aches (most intense at injection site); full body aches (most intense at injection site); headaches; chills; sweating; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:15 as dose 1, single (Lot number: GJ6742) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: Sulpha Antibiotics" (unspecified if ongoing). Concomitant medication(s) included: TRUMENBA taken for immunisation, on 09Sep2022 as dose number unknown, single; INFLUENZA taken for immunisation, on 09Sep2022 as dose number unknown,  single.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 29Sep2021, outcome "unknown", described as "Wrong vaccine administered"; PYREXIA (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "Fever lasting 48hrs"; CHILLS (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering"; PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 29Sep2022 at 14:45, outcome "recovering" and all described as "full body aches (most intense at injection site)"; HEADACHE (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "headaches"; HYPERHIDROSIS (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "sweating"; FATIGUE (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, fatigue, pain, vaccination site pain, headache, chills, hyperhidrosis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Wrong product administered
Clinical narrative: Fever lasting 48hrs; tiredness; full body aches (most intense at injection site); full body aches (most intense at injection site); headaches; chills; sweating; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:15 as dose 1, single (Lot number: GJ6742) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: Sulpha Antibiotics" (unspecified if ongoing). Concomitant medication(s) included: TRUMENBA taken for immunisation, on 09Sep2022 as dose number unknown, single; INFLUENZA taken for immunisation, on 09Sep2022 as dose number unknown,  single.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 29Sep2021, outcome "unknown", described as "Wrong vaccine administered"; PYREXIA (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "Fever lasting 48hrs"; CHILLS (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering"; PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 29Sep2022 at 14:45, outcome "recovering" and all described as "full body aches (most intense at injection site)"; HEADACHE (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "headaches"; HYPERHIDROSIS (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "sweating"; FATIGUE (non-serious) with onset 29Sep2022 at 14:45, outcome "recovering", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, fatigue, pain, vaccination site pain, headache, chills, hyperhidrosis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Gait disturbance, Movement disorder, Tremor
Clinical narrative: whole body shaking; limping; his right arm doesn't swing anymore though it works good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 2 (booster), single (Lot number: 33030BD) at the age of 68 years, in the right arm for COVID-19 immunisation. The patient's relevant medical history included: "heart surgery", start date: 2001 (unspecified if ongoing), notes: He had been busted open and they fixed his heart for a while which he had for 22 years. The patient took concomitant medications. Vaccination history included: Janssen COVID-19 vaccine (dose 1, single), administration date: 17Mar2021, when the patient was 67-year-old, for COVID-19 immunisation. The following information was reported: TREMOR (hospitalization) with onset 26Dec2021, outcome "recovered", described as "whole body shaking"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "limping"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "his right arm doesn't swing anymore though it works good". The patient was hospitalized for tremor (start date: 26Dec2021, discharge date: 29Dec2021, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: brain CT scan: Unknown results.  Clinical course details: Consumer said he got one before and the day after it put him in the hospital with his whole body shaking. He was in the hospital three days then they finally started pulling stuff out of him. Caller doesn't clarify this statement. They haven't helped anymore, he is not shaking, he is limping and his right arm doesn't swing anymore though it works good, it doesn't swing anymore when he walks. It was his second one, he had one almost a year ago, with one given as two shots at one time, which he was fine after that. Then he got this thing here, the Pfizer vaccine. He wants to know what to do, his doctor even done a check on his brain right side. His shaking is gone and he can hold his right hand out and it will shake and rock back and forth. His right leg limps a lot when he walks. He limps and has to go up steps one at a time, he can't put one down then one on the next, he has to pull himself up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient got infected with COVID/once was about Dec2021; the patient got infected with COVID/once was about Dec2021; This is a spontaneous report received from a contactable reporter (other HCP) from Medical Information Team. A male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose number unknown, single (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) and COVID-19 (medically significant) with onset Dec2021, outcome "unknown" and described as "the patient got infected with COVID/once was about Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) positive. Clinical course: The patient got infected with COVID; he has been exposed to COVID and he got very sick once was about Dec2021.   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 known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201198081 same patient/product/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Disease progression
Clinical narrative: Potential progression of condition after taking her original shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 46-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. Past drug history included: Xeljanz. The following information was reported: DISEASE PROGRESSION (non-serious), described as "Potential progression of condition after taking her original shot".   Additional information: The patient wanted to take the booster shot and wanted to know if she should stop taking Xeljanz. The patient is planning to get her (Pfizer COVID19) bivalent booster next week. The patient mentioned getting an original shot when she was not on Xeljanz. Potential progression of condition after taking her original shot (could not confirm which shot the patient was referring to).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuropathy peripheral, Wrong product administered
Clinical narrative: Muscle ache and neuropathy in my hands and lower leg; Muscle ache and neuropathy in my hands and lower leg; wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 15:30 as dose 1, single (Lot number: GH9703) at the age of 68 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "SVT" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 15:30, outcome "unknown", described as "wrong vaccine administered"; NEUROPATHY PERIPHERAL (medically significant) with onset 30Sep2022 at 23:45, outcome "recovering", MYALGIA (non-serious) with onset 30Sep2022 at 23:45, outcome "recovering" and all described as "Muscle ache and neuropathy in my hands and lower leg". Therapeutic measures were not taken as a result of neuropathy peripheral, myalgia.  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: Orthostatic hypotension
Clinical narrative: Orthostatic hypotension; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ORTHOSTATIC HYPOTENSION (non-serious) with onset 30Sep2022 at 06:00, outcome "not recovered". Therapeutic measures were not taken as a result of orthostatic hypotension.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: All 4 doses were administered to both of them, and got covid after that; All 4 doses were administered to both of them, and got covid after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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 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 "All 4 doses were administered to both of them, and got covid after that". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got covid after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- answered by consumers husband who said that he was not able to swallow the pill as it was too big, he did not chew it, his wife was taking the medication (PAXLOVID), she did not experienced any symptoms. All 4 doses were administered to both of them, and got covid after that.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200075122 same reporter/drug/event, different patient;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right 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. The following information was reported: HEADACHE (non-serious) with onset 21Sep2022, outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Therapeutic measures were taken as a result of headache, pain in extremity.  Additional Information: Patient mentioned that she received the vaccine on the 21st of September and she mentioned that she had a headache as well arm pain. Patient added that the headache did not run away and she is calling to have that reported. Patient stated that she had her bivalent shot, her booster on 21Sep and she had a headache since 21Sep, and it was terrible headache. Anatomical site, Reporter stated,  It was in her right arm. Treatment: Reporter stated, she have been taking Advil and Tylenol. Other Conditions: No; Other Products: 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: U
Vaccine: COVID19
Symptoms: Foetal death
Clinical narrative: fetal demise; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Prev dose product is COVID 19, brand unknown is True, brand name unknown is COVID19 Vaccine, Is bivalent was False, lot unknown was True, lot unknown reason was Not available/provided to reporter at the time of report completion, dose number was 2.), for Covid-19 Immunization; Covid-19 vaccine (Prev dose product was COVID 19, brand unknown was True, brand name unknown was COVID19 Vaccine, bivalent is False, lot unknown was True, lot unknown reason was Unable to locate or read the details, dose number is 1.), for Covid-19 Immunization. The following information was reported: FOETAL DEATH (death, medically significant), outcome "fatal", described as "fetal demise". The event "fetal demise" required physician office visit and emergency room visit. The patient date of death was unknown. Reported cause of death: "fetal demise". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Given the limited information in narrative, and for the purpose of submission the company considerers, casual association between the event fetal demise and suspected vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s) : PFIZER INC-202201198744 EDP Case-Same vaccine, different patient/event; Reported Cause(s) of Death: fetal demise.
Age: 65.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, 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 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 "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.  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: 52.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 08Apr2021 as dose 2, single (Lot number: EW0153), in right arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE, stop date: 21Sep2022; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; positive, notes: Recurrence if Covid symptoms, positive test results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Anti viral medication received by patient due to the event was Paxlovid, from 21Sep2022 to 26Sep2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP7534, fill lot EP7532, and the formulated drug product lot EP7528; lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071; lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148; and lot FJ9943, fill lot FJ9942 and the bulk formulated drug product FJ9940. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; 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 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01Oct2022, outcome "unknown". Additional information: The patient had the Pfizer booster (anatomical site was reported as "Left") on 01Oct2022 and had been feeling dizziness. It started a few hours after that and now it is the next day too. The patient asked if it was a common side effect. The dizziness did not occur within the first hour after getting the vaccine. The patient hasn't received treatment yet.  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.