chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter was asking how long they should wait before they can give the Spikevax to patient who had Covid in Sep2023. HCP stated that patient had previous Moderna Covid-19 vaccines.  No treatment medications were reported.  This case referred to Patient 4 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748266:Patient 1 out of 4
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-748924, US-MODERNATX, INC.-MOD-2023-748925, US-MODERNATX, INC.-MOD-2023-748928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748924:Patient 2 out of 4 US-MODERNATX, INC.-MOD-2023-748925:Patient 3 out of 4 US-MODERNATX, INC.-MOD-2023-748928:Patient 4 out of 4
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Eosinophil count, Eosinophil count decreased, Haematocrit, Haematocrit decreased
Clinical narrative: His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7); His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4); He states that his hemoglobin and hematocrit levels are also low; He states that his hemoglobin and hematocrit levels are also low; This spontaneous case was reported by a patient and describes the occurrence of MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Monocyte count (last year was 9 (normal value 6-12)) in 2022 and Eosinophil count (last year is 1.0 (normal value 1-5)) in 2022.    On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low). At the time of the report, MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Colonoscopy: No polyps seen. In 2023, Eosinophil count (2-4): 1.0, Decreased. In 2023, Haematocrit: Low. In 2023, Haemoglobin: Low. In 2023, Monocyte count (3-7): 11.7, Increased.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Reporter was a semi-retired pharmacist and asked if Spikevax affects the monocyte and eosinophils count. He got the Spikevax vaccine and had his annual checkup on 02Nov2023. He stated that his hemoglobin and hematocrit levels were also low which may mean that he may have cancer as he lost a brother to colon cancer.  Treatment information was not reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Monocyte count, Monocyte count increased
Clinical narrative: His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7); His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4); He states that his hemoglobin and hematocrit levels are also low; He states that his hemoglobin and hematocrit levels are also low; This spontaneous case was reported by a patient and describes the occurrence of MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Monocyte count (last year was 9 (normal value 6-12)) in 2022 and Eosinophil count (last year is 1.0 (normal value 1-5)) in 2022.    On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low). At the time of the report, MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Colonoscopy: No polyps seen. In 2023, Eosinophil count (2-4): 1.0, Decreased. In 2023, Haematocrit: Low. In 2023, Haemoglobin: Low. In 2023, Monocyte count (3-7): 11.7, Increased.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Reporter was a semi-retired pharmacist and asked if Spikevax affects the monocyte and eosinophils count. He got the Spikevax vaccine and had his annual checkup on 02Nov2023. He stated that his hemoglobin and hematocrit levels were also low which may mean that he may have cancer as he lost a brother to colon cancer.  Treatment information was not reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever/ low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever/ low grade fever) in a 56-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First Monovalent Booster dose) on 21-Oct-2021 and Pfizer (Monovalent Booster dose) on 08-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 04-Nov-2023 at 11:30 AM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever/ low grade fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL, PIPERYLONE MALEATE (THERAFLU [CAFFEINE;CODEINE PHOSPHATE;PARACETAMOL;PIPERYLONE MALEATE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever/ low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2023, Body temperature: 100 F.         Concomitant medication not reported.   On Sunday 05 NOV 2023 he started having a low-grade Fever 100 F. He took some Ibuprofen and Theraflu. The fever goes away, he sleeps and waking up the fever was back. He drunk a lot of water. His fever not gone over 100 Fahrenheit. He has been having a low-grade fever on and off.   First Primary Moderna monovalent dose on 07 Feb 2021 with unknown with lot number and expiry date.  2nd Primary Moderna monovalent dose on 5 Mar 2021 with unknown with lot number and expiry date. Dose 5 Moderna Bivalent Booster on 23 Aug 2023 (Lot number AS7643E and Expiry Date with unknown). Dose 6 of Spikevax by Moderna on 04 Nov 2023 (Lot number AU3834B and Expiry Date with unknown).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity
Clinical narrative: Arm was also very sore; body aches; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was also very sore), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) in a 32-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Nov-2023, the patient experienced PAIN IN EXTREMITY (Arm was also very sore), PAIN (body aches), CHILLS (chills) and NAUSEA (nausea). On 08-Nov-2023, PAIN (body aches), CHILLS (chills) and NAUSEA (nausea) had resolved. On 09-Nov-2023, PAIN IN EXTREMITY (Arm was also very sore) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's nausea started about 10 hours after vaccination, followed by chills and body aches that lasted for about a day. The patient's arm was also very sore for 2 days.  No treatment medications were reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No adverse event; HBP called to report an LPN administered expired PNEUMOVAX 23 to a patient.; This spontaneous report has been received from an office manager referring to an approximately 47-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-NOV-2023, the patient was vaccinated with 1 dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot number W007035 which was verified to be a valid lot number, with an expiry date of 20-OCT-2023, (exact dose, vaccination scheme, frequency, indication, route of administration and anatomical site of injection were not reported) (expired product administered).
Sex: U
Vaccine: RSV
Symptoms: Device malfunction
Clinical narrative: Malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0167, Expiration Date: Feb2025), Device Lot Number: F831, Device Expiration Date: 01Aug2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece".  The reporter considered "malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist reporter called about about 2 bottles of Abrysvo vaccine malfunctioned and wanted to replace them. Reporter confirmed both bottles had the same lot details for all the components (the carton, vial adapter, antigen vial, and diluent syringe). The pharmacist clarified that the malfunction as the part that when screwon the adapter the syringe popped out of this piece (occurred for both bottles). The reporter stated that Abrysvo bottles that malfunctioned was not administered to any patient. Reporter got a third one out to use and that one worked.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pruritus, Rhinorrhoea, Sinus congestion, Skin haemorrhage
Clinical narrative: intense coughing; later much mucus and congested sinuses with later much yellow discharging along with mucus; later much mucus and congested sinuses with later much yellow discharging along with mucus; blood under skin when skin is itchy( a normal condition); blood under skin when skin is itchy( a normal condition); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 18:00 as dose 1, single (Lot number: HU4664) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CHF" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Weeds" (unspecified if ongoing), notes: known allergies: weeds-itching. Concomitant medication(s) included: SYNTHYROID; ELIQUIS; METOPROLOL; PANTOPRAZOLE; GLI. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: PRURITUS (non-serious), SKIN HAEMORRHAGE (non-serious) all with onset 17Oct2023 at 12:00, outcome "not recovered" and all described as "blood under skin when skin is itchy( a normal condition)"; COUGH (non-serious) with onset 17Oct2023 at 12:00, outcome "not recovered", described as "intense coughing"; SINUS CONGESTION (non-serious), RHINORRHOEA (non-serious) all with onset 17Oct2023 at 12:00, outcome "not recovered" and all described as "later much mucus and congested sinuses with later much yellow discharging along with mucus". The events "intense coughing", "later much mucus and congested sinuses with later much yellow discharging along with mucus" and "blood under skin when skin is itchy( a normal condition)" required emergency room visit. It was unknown if therapeutic measures were taken as a result of cough, sinus congestion, rhinorrhoea, pruritus, skin haemorrhage.  Additional information: Patient didn't receive any other vaccine in four weeks. Prior vaccination, patient was not diagnosed with COVID-19. Post vaccination, patient was not tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Memory impairment, Mental disorder, Somnolence
Clinical narrative: Knocked him out; when someone was talking to him about something he could not remember what they were talking about; wiped him out mentally/These vaccines are messing with his head so bad; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Knocked him out"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about"; MENTAL DISORDER (non-serious), outcome "unknown", described as "wiped him out mentally/These vaccines are messing with his head so bad"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "takes away his ability to concentrate"; SOMNOLENCE (non-serious), outcome "unknown", described as "He will need to sleep it off over the weekend".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4 of his doses have had exact same thing. He will need to sleep it off over the weekend.  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-202300355612 same reporter/patient/drug/AEs and different dose;
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Face is swollen; specially under my throat part it looks like I got two faces; Face is swollen; specially under my throat part it looks like I got two faces; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), PHARYNGEAL SWELLING (non-serious) all with onset Nov2023, outcome "unknown" and all described as "Face is swollen; specially under my throat part it looks like I got two faces".  Additional information : Patient had the covid shot the previous day that was Comirnaty and just noticed because patient was looking in the mirror trying to do hair, that patient's face was swelled, specially under throat part it look like patient got two faces  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Made me sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Made me sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling of body temperature change
Clinical narrative: laid around for 2 days; hot and cold chills; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 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 moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation; Fluvaccin (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 2023, outcome "unknown", described as "Shortness of breath"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2023, outcome "unknown", described as "hot and cold chills"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "laid around for 2 days".  Additional information: Reporter was asked if she would like to complete a safety report on behalf of her mother when reporter stated her mother had the Pfizer Vaccine also and her mother experienced hot and cold chills, had shortness of breath and laid around for 2 days and that was it. She added her mother took over her appointment and got that Pfizer vaccine as the caller was buying her prescriptions and the caller said go head of her for the vaccine. The reporter and her mom got the shot so they did not get covid as they are up in their age and have been doing Moderna constantly but they were out of the Moderna that day so they got the Pfizer.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356607 same reporter/drug, different patient/AE;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little sore arm/soreness in her right arm; 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 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: 20 years ago. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal. Vaccination history included: Comirnaty (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: Jun2023, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Nov2023, outcome "recovered" (02Nov2023), described as "Little sore arm/soreness in her right arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Patient would like to know if Pfizer manufactured smaller pill size of Paxlovid. Patient received the Pfizer COVID-19 vaccine the other day and reported that she received all Pfizer vaccines. She did not have COVID but would like to know if she got the infection and she had to take the medication Paxlovid, she might not be able to take it. She stated that her entire life she had difficulty in swallowing medications. Her pharmacist showed her the pill size of Paxlovid. There was no way that she would be able to swallow that pill. Patient stated that no, did not have any problems with covid, she had masks, she had no covid problems. That was out covid booster, the updated covid booster that she had two days ago at the pharmacy, she had no problems with any other Pfizer Covid shot. Her concern was only, if she came down with covid at some point of time she could not swallow the pills that she had seen. She did not have any problems with any of shots, she had received the original shots, she received the other 2 boosters. She also received the shot in June and she had to tell that she did not have any problem with any of the Pfizer shot. She had no side effects or issue after it. She was fine afterwards except a little soreness in her arm.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain
Clinical narrative: Arthritis; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Lot number: HG2282) at the age of 64 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "Heart attack" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2 (Dose 4), for COVID-19 immunization; Bnt162b2 (Dose 5), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered"; ARTHRITIS (non-serious) with onset 06Oct2023, outcome "not recovered". The events "arthritis" and "pain" required physician office visit. Additional information: patient had six Pfizer shots since the pandemic, and she had been fine after all of them, except for this last one, patient now have Arthritis okay and it came on exactly on the 10th day after she had gotten a shot and she was talking, she had been in pain for 28 days. Patient went to the doctor on Monday but she had been in pain for. Patient did not have Arthritis before. Patient had the Flu (Unspecified flu shot) and the RSV (Unspecified RSV vaccine) two or three weeks prior.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist).  A 27-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 02Nov2023, outcome "recovered" (Nov2023). Therapeutic measures were not taken as a result of fatigue.  Additional information: No COVID prior vaccination. No COVID tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Headache
Clinical narrative: Severe joint pain; burning sensation; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Severe joint pain"; BURNING SENSATION (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". The events "severe joint pain", "burning sensation" and "headache" required physician office visit.  Additional information: The Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if  the patient been tested for COVID-19 since the vaccination. It was unknown if the patient had any known allergies. It was unknown if patient had any other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Illness, Malaise
Clinical narrative: Warmness; I am not feeling that great; I'll sweat; I feel kind of cruddy; I feel little feverish/fever will break through in the night; little achy; I am sick for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2019 (unspecified if ongoing); "Covid", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "I feel little feverish/fever will break through in the night"; PAIN (non-serious), outcome "unknown", described as "little achy"; ILLNESS (non-serious), outcome "recovered", described as "I am sick for 2 days"; FEELING HOT (non-serious), outcome "recovered", described as "Warmness"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling that great"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "I'll sweat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel kind of cruddy".  Additional information: Patient took the original 2 Pfizer shot when it first came out, then she took two of the boosters back about a year and a half ago. She didn't take one last year but she took another booster this year (Pfizer Covid-19 booster shot) So, the total she have had 5 shots. she wanted to know if it was common or uncommon, that meant, she got almost like 12 to 14 hours after the shot, she felt little feverish, little achy, if all those little things were normal. Reporter stated, If anyone knew if it was normal or anybody else were reported anything like that because she had the same reactions for like two days and then the warmness or fever will break through in the night and she was sweat and then she was normal again. She wanted to know if that was a reaction to the shot or it was just if it worked with some people. She felt kind of cruddy but she was not feeling that great but she guessed so." Just board it out the last time and within 48 hours, it finally like she broke fever in it but she was back to normal. So, she guesses it was giving her a hint, if she take any four of them.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357098 same patient, different dose/AE;US-PFIZER INC-202300356952 same reporter, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Warmness; I am not feeling that great; I'll sweat; I feel kind of cruddy; I feel little feverish/fever will break through in the night; little achy; I am sick for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: 2019 (unspecified if ongoing); "Covid", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "I feel little feverish/fever will break through in the night"; PAIN (non-serious), outcome "unknown", described as "little achy"; ILLNESS (non-serious), outcome "recovered", described as "I am sick for 2 days"; FEELING HOT (non-serious), outcome "recovered", described as "Warmness"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling that great"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "I'll sweat"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel kind of cruddy".  Additional information: Patient took the original 2 Pfizer shot when it first came out, then she took two of the boosters back about a year and a half ago. She didn't take one last year but she took another booster this year (Pfizer Covid-19 booster shot) So, the total she have had 5 shots. she wanted to know if it was common or uncommon, that meant, she got almost like 12 to 14 hours after the shot, she felt little feverish, little achy, if all those little things were normal. Reporter stated, If anyone knew if it was normal or anybody else were reported anything like that because she had the same reactions for like two days and then the warmness or fever will break through in the night and she was sweat and then she was normal again. She wanted to know if that was a reaction to the shot or it was just if it worked with some people. She felt kind of cruddy but she was not feeling that great but she guessed so." Just board it out the last time and within 48 hours, it finally like she broke fever in it but she was back to normal. So, she guesses it was giving her a hint, if she take any four of them.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357098 same patient, different dose/AE;US-PFIZER INC-202300356952 same reporter, different patient/AE;
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fall, Pain, Peripheral swelling, Swelling
Clinical narrative: Arm swelling; dizziness; pain swelling to same side of body; pain swelling to same side of body; fell as a result of symptoms; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 67-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for immunisation. The patient's relevant medical history included: "Remission breast ca" (unspecified if ongoing), notes: Remission breast ca; "HTN" (unspecified if ongoing); "known allergies: Pcn" (unspecified if ongoing), notes: known allergies: Pcn. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023), described as "Arm swelling"; DIZZINESS (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023); FALL (non-serious) with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023), described as "fell as a result of symptoms"; PAIN (non-serious), SWELLING (non-serious) all with onset 25Oct2023 at 18:00, outcome "recovered" (26Oct2023) and all described as "pain swelling to same side of body". Therapeutic measures were not taken as a result of peripheral swelling, dizziness, pain, swelling, fall. Additional information: vaccine location Deltoid provided. There was no other vaccine on same date and in four weeks.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pruritus
Clinical narrative: Itching on the arm; It just feels a little stiff; Itching on the arm; It just feels a little stiff; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old patient received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; tafamidis (VYNDAMAX), (ongoing). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "Itching on the arm; It just feels a little stiff". The action taken for tafamidis was dosage not changed.  Additional information: A patient on the line was taking the medication Vyndamax and reported an itching just on top of the arm. It might have been an injection (COVID Vaccine) that the patient took about four weeks ago for a COVID (Manufacturer name not clarified, hence tab left unchecked). It was just itching in arm and just felt a little stiff or something. The patient just wanted to make sure, the pill the patient was taking Vyndamax was an Amyloid. Further probing could not be done as the consumer was unwilling to file a safety report. Thus, product details and pharmacy details were unknown. Hence, limited information is available over the call.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue
Clinical narrative: Feeling very down, like very tired.; Feeling very down, like very tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious), FATIGUE (non-serious) all with onset 03Nov2023 at 18:00, outcome "unknown" and all described as "Feeling very down, like very tired.".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: She had horrible intense itching to the booster for 6 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (ongoing), notes: Caller states she is immunocompromised and has an autoimmune disease; "autoimmune disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation, reaction(s): "No adverse event". The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "She had horrible intense itching to the booster for 6 weeks.". The event "she had horrible intense itching to the booster for 6 weeks." required physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: Caller stated she was immunocompromised and had an autoimmune disease. She had a reaction a year and a half ago to the Pfizer BioNTech Covid 19 vaccine booster. She had horrible intense itching to the booster for 6 weeks. She stated it was internal from the inside out and she took 10 antihistamines a day. She had no reaction to the primary series. "It wasn't every time." She had boosters and the primary series and she was fine. She had doctor and immunologist. She had asked for a referral to a dermatologist.  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-202300357094 Same patient/product, different dose/events;US-PFIZER INC-202300357093 Same patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: broke out into a rash on the trunk of her body and arms that was also itching as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation, reaction(s): "no adverse event"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation, reaction(s): "She had horrible intense itching to the booster for 6 weeks". The following information was reported: RASH PRURITIC (non-serious), outcome "not recovered", described as "broke out into a rash on the trunk of her body and arms that was also itching as well". The events "broke out into a rash on the trunk of her body and arms that was also itching as well" required physician office visit.  Additional information: Reporter stated she was immunocompromised and had an autoimmune disease. She had a reaction a year and a half ago to the Pfizer Biontech Covid 19 vaccine booster. She had horrible intense itching to the booster for 6 weeks. She stated it was internal from the inside out and she took 10 antihistamines a day. She had no reaction to the primary series. She received the Comirnaty 2023/2024 vaccine in the beginning of Oct and broke out into a rash on the trunk of her body and arms that was also itching as well. She still had it. Patient asked if anyone reported having a rash with this product. She had doctor and immunologist. She asked for a referral to a dermatologist.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357094 Same patient/product, different dose/events;US-PFIZER INC-202300357092 Same patient/product, different dose/events;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain
Clinical narrative: Muscle spasms in upper back/Two weeks later middle neck pain and spasms; One week later, pain moved up toward lower neck. Two weeks later middle neck pain and spasms. Three weeks later the pain has been upper neck and base of skull; Feels like throbbing dull pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, on 15Sep2023 as dose 1, single. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: er8734, Anatomical location: Right arm), administration date: 30Mar2021, for COVID-19 Immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: ew0162, Anatomical location: Right arm), administration date: 20Apr2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: fe3590, Anatomical location: Left arm), administration date: 07Oct2021, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: fm9992, Anatomical location: Left arm), administration date: 21Apr2022, for COVID-19 immunisation; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/lot number: gh9693, Anatomical location: Left arm), administration date: 20Sep2022, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered", described as "Feels like throbbing dull pain"; NECK PAIN (non-serious) with onset 2023, outcome "not recovered", described as "One week later, pain moved up toward lower neck. Two weeks later middle neck pain and spasms. Three weeks later the pain has been upper neck and base of skull"; MUSCLE SPASMS (non-serious) with onset 14Oct2023, outcome "not recovered", described as "Muscle spasms in upper back/Two weeks later middle neck pain and spasms". The events "muscle spasms in upper back/two weeks later middle neck pain and spasms", "one week later, pain moved up toward lower neck. two weeks later middle neck pain and spasms. three weeks later the pain has been upper neck and base of skull" and "feels like throbbing dull pain" required physician office visit. Therapeutic measures were not taken as a result of muscle spasms, neck pain, pain.  Additional information: Patient was administered with Sanofi Pasteur Flu for Influenza immunisation within 4 weeks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.