chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Rash, Rash erythematous
Clinical narrative: red spots on inside of lips and cheeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 5 (booster), single (Lot number: HF9275) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; FAMOTIDIN; FISH OIL; CLARITINE; PAXIL [PAROXETINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 2, SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE), reaction(s): "Covid-19 immunization". The following information was reported: ECZEMA (non-serious) with onset 25Sep2023, outcome "recovering", described as "red spots on inside of lips and cheeks". The events "red spots on inside of lips and cheeks" required physician office visit. It was unknown if therapeutic measures were taken as a result of eczema.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema
Clinical narrative: red spots on inside of lips and cheeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 5 (booster), single (Lot number: HF9275) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; FAMOTIDIN; FISH OIL; CLARITINE; PAXIL [PAROXETINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 2, SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 3 (BOOSTER) SINGLE), reaction(s): "Covid-19 immunization"; Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE), reaction(s): "Covid-19 immunization". The following information was reported: ECZEMA (non-serious) with onset 25Sep2023, outcome "recovering", described as "red spots on inside of lips and cheeks". The events "red spots on inside of lips and cheeks" required physician office visit. It was unknown if therapeutic measures were taken as a result of eczema.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was losing her voice; malaise/not feeling well; injection site pain; Muscle ache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 15:00 as dose 6 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 immunization; Bnt162b2 (Dose4 (Booster)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 (Booster) ), administration date: Oct2022, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 20Sep2023, outcome "not recovered"; MYALGIA (non-serious) with onset 20Sep2023, outcome "recovering", described as "Muscle ache"; VACCINATION SITE PAIN (non-serious) with onset 20Sep2023, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 20Sep2023, outcome "recovering", described as "malaise/not feeling well"; APHONIA (non-serious) with onset 22Sep2023, outcome "unknown", described as "she was losing her voice". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller (patient is his wife) mentioned that a family member who received a Pfizer Covid vaccine is not feeling well and got worse the next day. His wife and he got the Pfizer COVID-19 vaccine on Wednesday (20Sep2023). Caregiver on the line calling about his wife got Covid-19 Vaccine and she experienced symptoms, malaise, injection site pain, and the next day got worse. So she had chills something like the flu. She got this vaccine on Wednesday. Yesterday evening they test themselves for Covid, caller was negative, but wife was positive for covid after getting the vaccine. Patient had total previous 5 doses Pfizer Covid Vaccines. The last one given was the Bivalent Vaccine in Oct 2022.   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: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Fatigue, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: she was losing her voice; malaise/not feeling well; injection site pain; Muscle ache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 15:00 as dose 6 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 immunization; Bnt162b2 (Dose4 (Booster)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 (Booster) ), administration date: Oct2022, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 20Sep2023, outcome "not recovered"; MYALGIA (non-serious) with onset 20Sep2023, outcome "recovering", described as "Muscle ache"; VACCINATION SITE PAIN (non-serious) with onset 20Sep2023, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 20Sep2023, outcome "recovering", described as "malaise/not feeling well"; APHONIA (non-serious) with onset 22Sep2023, outcome "unknown", described as "she was losing her voice". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller (patient is his wife) mentioned that a family member who received a Pfizer Covid vaccine is not feeling well and got worse the next day. His wife and he got the Pfizer COVID-19 vaccine on Wednesday (20Sep2023). Caregiver on the line calling about his wife got Covid-19 Vaccine and she experienced symptoms, malaise, injection site pain, and the next day got worse. So she had chills something like the flu. She got this vaccine on Wednesday. Yesterday evening they test themselves for Covid, caller was negative, but wife was positive for covid after getting the vaccine. Patient had total previous 5 doses Pfizer Covid Vaccines. The last one given was the Bivalent Vaccine in Oct 2022.   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: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she was losing her voice; malaise/not feeling well; injection site pain; Muscle ache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 15:00 as dose 6 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster)), for COVID-19 immunization; Bnt162b2 (Dose4 (Booster)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 (Booster) ), administration date: Oct2022, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 20Sep2023, outcome "not recovered"; MYALGIA (non-serious) with onset 20Sep2023, outcome "recovering", described as "Muscle ache"; VACCINATION SITE PAIN (non-serious) with onset 20Sep2023, outcome "recovering", described as "injection site pain"; MALAISE (non-serious) with onset 20Sep2023, outcome "recovering", described as "malaise/not feeling well"; APHONIA (non-serious) with onset 22Sep2023, outcome "unknown", described as "she was losing her voice". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller (patient is his wife) mentioned that a family member who received a Pfizer Covid vaccine is not feeling well and got worse the next day. His wife and he got the Pfizer COVID-19 vaccine on Wednesday (20Sep2023). Caregiver on the line calling about his wife got Covid-19 Vaccine and she experienced symptoms, malaise, injection site pain, and the next day got worse. So she had chills something like the flu. She got this vaccine on Wednesday. Yesterday evening they test themselves for Covid, caller was negative, but wife was positive for covid after getting the vaccine. Patient had total previous 5 doses Pfizer Covid Vaccines. The last one given was the Bivalent Vaccine in Oct 2022.   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: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Patient uncooperative
Clinical narrative: No further adverse event; Medical assistant reported while administering VARIVAX dose, the patient moved and did not receive a full dose; This spontaneous report was received from a registered medical assistant and refers to a 4 years and 7 months old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (dose, lot #, expiration date and route were not reported). While administering of the vaccine, the patient moved and did not receive a full dose (incorrect dose administered).  No further adverse event and nor product quality complain were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP reported that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: X007358, Expiration: 9/; HCP reported that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: X007358, Expiration: 9/; Information has been received from a health care professional, referring to a 1 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X007358, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided); and with an sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, lot number reported as "W034712", expiration date: 19-JUL-2025 (strength, lot #, route of administration, and indication were not provided). No adverse effects were reported.  The vaccine had a temperature excursion of 13.2 Fahrenheit (F) during 5 minutes. It was confirmed that no previous temperature excursions occurred.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other AE; Caller reported an AE for MMRII. The caller said the product was administered on 7/13/2023 after the labeled expiration date. Confirmed with caller no other AE occurred. Confirmed no temperature excursion occurred prior to administration. AE letter s; This spontaneous report has been received from an office manager, concerning to a 12-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-JUL-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, dose number, route of administration, anatomical location were not provided) (lot#: U011993, expiration date: 15-APR-2023) (albumin status: rHA) (expired product administered). No other adverse event occurred and there was no temperature excursion prior to the administration. No further information was provided.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     Concurrent medical conditions included Pollen allergy, Dust allergy and Sulfonamide allergy (Sulfa allergy).    On 21-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. The patient's last menstrual period was on 22-Aug-2023 and the estimated date of delivery was 28-May-2024. On 21-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The patient received mRNA-1273.815 (SPIKEVAX 2023-2024) beginning around the  fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    No Concomitant medications were reported.  EDC was reported as early June or late May 2024. This was her 2nd pregnancy. 1st baby was born on XX-Nov-2021. She was scheduled to have her 1st prenatal checkup in October. She had normal pregnancy so far. Her immunization details were: 1st dose on 22-Apr-2021, lot number 002C21A. 2nd dose on 20-May-2021, lot number 017C21A. 3rd dose on 18-Nov-2021, lot number FH8027.  No treatment medications were reported.; Reporter's Comments: This is a spontaneous case concerning a pregnant (4 weeks of gestation period) 30-year-old female patient, with no relevant medical history, who experienced exposure during pregnancy with no adverse events associated. A dose of SPIKEVAX 2023-2024 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Live birth, No adverse event
Clinical narrative: No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    No Concomitant and treatment medication reported.  Patient was 9 weeks pregnant and did receive the vaccine on 23-Sep-2023. Patient had not any problems and had no adverse event. Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received a dose of mRNA-1273.815 (SPIKEVAX 2023-2024). The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that the patient was 9 weeks pregnant and received the vaccine. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Choking, Cough, Throat irritation
Clinical narrative: choke; Throat sounds scratchy when talking; cough; This spontaneous case was reported by a patient and describes the occurrence of CHOKING (choke) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 50 microgram. On an unknown date, the patient experienced CHOKING (choke) (seriousness criterion medically significant), THROAT IRRITATION (Throat sounds scratchy when talking) and COUGH (cough). At the time of the report, CHOKING (choke), THROAT IRRITATION (Throat sounds scratchy when talking) and COUGH (cough) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company comment: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the serious (medically significant) unexpected event of choking among other non-serious events. A dose of mRNA-1273 Bivalent vaccine was administered on an unknown date. Temporal association cannot be assessed due to lack of information on vaccination date and onset date of the event. The patient reported that her throat sounded scratchy when talking and caused to cough/choke. At the time of the latest report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent vaccine is not affected by this report.
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: large rash under her breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received pf-06928316 (ABRYSVO), on 21Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "large rash under her breast". The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Feeling abnormal, Feeling hot, Malaise, Pyrexia
Clinical narrative: Not feeling well/feeling bad; fever of 103.5/started out last night at 100.8/101.5, this morning it was a 103.5/he's burning up/feeling very warm last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received pf-06928316 (ABRYSVO), on 21Sep2023 at 22:30 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 21Sep2023, outcome "unknown", described as "Not feeling well/feeling bad"; PYREXIA (non-serious) with onset 21Sep2023, outcome "unknown", described as "fever of 103.5/started out last night at 100.8/101.5, this morning it was a 103.5/he's burning up/feeling very warm last night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, pyrexia.  Additional information: Reporter's husband is currently in the bed. She said that he received the Abrysvo at 10:30 yesterday started feeling bad and started feeling very warm last night. His temperature was 100.8 and then about an hour later his temperature was 101.8. He had a terrible night last night and this morning and his temperature was 103.5. He had a terrible night and was treated with Tylenol last night.   The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she gave it much higher than had vaccine administered before, usually get it in muscle in arm, little bit high up in shoulder but not that high, was painful when she did it, not hurting too much now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HG4629) at the age of 50 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Sep2023, outcome "unknown", described as "she gave it much higher than had vaccine administered before, usually get it in muscle in arm, little bit high up in shoulder but not that high, was painful when she did it, not hurting too much now".  Additional information: The patient reports that she gave it much higher than he had a vaccine administered before, usually you get it in the muscle in the arm, little bit high up in the shoulder but not that high, was painful when he did it, not hurting too much now. He just want to make sure she got a good dose of the vaccine. Patient was calling about the Pfizer covid vaccine he said it was the new bivalent one, he went in today and the lady that did the injection told him there was an air bubble in the vaccine and she was trying to flick ended up squeezing the plunger and said you could hear the air coming out seem did not usual to him. He also was concerned the lady injected really high in his shoulder / is it effective in this case, wants to know about the air bubble." The air bubble wouldn't impact how much fluid was in there, because some of the fluid might not come in there.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Dizziness. Started about 1 hour after the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 23Sep2023 at 16:15 as dose 1, single (Lot number: WAG36183) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DIZZINESS (non-serious) with onset 23Sep2023 at 17:30, outcome "not recovered", described as "Dizziness. Started about 1 hour after the vaccine.". It was unknown if therapeutic measures were taken as a result of dizziness.  Additional information: The patient had no other vaccine in four weeks. The patient did not have Covid prior to the vaccination, was not tested for Covid post-vaccination, and has no known allergies.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID; They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID; 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 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "They prescribe patient that medication (Clarified as Paxlovid) because patient had COVID ". The patient had COVID before and was worse than now because patient had a shot (clarified as Pfizer COIVD-19 Shot). Patient was reading the side effects that's very bad that medication and patient was scared to take Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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: RSV
Symptoms: Asthenia, Dyspnoea, Headache, Muscle disorder, Pain
Clinical narrative: Could not breathe very well; trouble breathing; Bad headaches; Really bad muscle; Muscle very sick; lack of energy; super achy; Quite achiness in fingers; hurts a lot; Very sore arms for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Could not breathe very well; trouble breathing"; HEADACHE (non-serious), outcome "unknown", described as "Bad headaches"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "Really bad muscle; Muscle very sick"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Quite achiness in fingers; hurts a lot"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Very sore arms for 5 days"; ASTHENIA (non-serious), outcome "unknown", described as "lack of energy"; PAIN (non-serious), outcome "unknown", described as "super achy". Additional information: Consumer stated, "I have concern that just had a terrible reaction, I could not breathe very well, super achy, super bad headaches, fingers hurt a lot really bad muscle, I have for 5 days. you know some tough reaction from the vaccine, they are some of the reactions with the vaccine." When paraphrased the concern: Consumer stated, "Muscle very sick, quite achiness in fingers hurts a lot, trouble breathing, and it would not away from 5 days. Terrible Headaches, trouble aching, trouble in breathing, very sore arms for 5 days and lack of energy."  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: RSV
Symptoms: Pain in extremity
Clinical narrative: Could not breathe very well; trouble breathing; Bad headaches; Really bad muscle; Muscle very sick; lack of energy; super achy; Quite achiness in fingers; hurts a lot; Very sore arms for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Could not breathe very well; trouble breathing"; HEADACHE (non-serious), outcome "unknown", described as "Bad headaches"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "Really bad muscle; Muscle very sick"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Quite achiness in fingers; hurts a lot"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Very sore arms for 5 days"; ASTHENIA (non-serious), outcome "unknown", described as "lack of energy"; PAIN (non-serious), outcome "unknown", described as "super achy". Additional information: Consumer stated, "I have concern that just had a terrible reaction, I could not breathe very well, super achy, super bad headaches, fingers hurt a lot really bad muscle, I have for 5 days. you know some tough reaction from the vaccine, they are some of the reactions with the vaccine." When paraphrased the concern: Consumer stated, "Muscle very sick, quite achiness in fingers hurts a lot, trouble breathing, and it would not away from 5 days. Terrible Headaches, trouble aching, trouble in breathing, very sore arms for 5 days and lack of energy."  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.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2 NOS), on 03Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: The patient received treatment with Paxlovid (Lot number: GJ5686) from 10Sep2023 to 14Sep2023 for COVID-19. Patient had no known allergies.  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: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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 included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: Reporter stated that there were people having adverse reactions to the covid shots but only 2-3 days later they were feeling better but it was all over the news that after 2-3 days most people had a reaction; has no further details to provide for any other patient other than his niece and has no specific patient details, dates of their covid vaccines, lots, expiry dates or dates of administration to provide. His niece had a reaction and she was actually a nurse too and she was took her vaccine and actually caught covid and it was not a severe case of covid and states he thinks she had covid before she had the Pfizer covid vaccine but she was sick for 2-3 days and took her shot and it was a really bad reaction 2-3 days later but the reaction she had is unknown by the caller but he does know she was pretty sick for a couple of days. He does not have any other details for his niece or her dates of administration of the Pfizer covid vaccine or lots, expiry dates or NDC numbers but she did get real sick.     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: Sjogren's syndrome
Clinical narrative: Person reported Sjogren's syndrome symptoms starting after taking the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, administration date=03Jan2022 (as reported), ), for Covid-19 immunization. The following information was reported: SJOGREN'S SYNDROME (medically significant), outcome "recovering", described as "Person reported Sjogren's syndrome symptoms starting after taking the vaccine.". The event "person reported sjogren's syndrome symptoms starting after taking the vaccine." required physician office visit. It was unknown if therapeutic measures were taken as a result of sjogren's syndrome.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, FLUC4
Symptoms: Bell's palsy
Clinical narrative: bells palsy; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:45 as dose 5, single (Lot number: HG4628) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing). The patient had no known allergies. The patient didn't have covid prior vaccination and was not tested post vaccination. Concomitant medication(s) included: METFORMIN; SYNJARDY; TRULICITY. The patient didn't receive other vaccine in four weeks. Vaccination history included: moderna covid-19 vaccine (Dose 4, single, Batch/Lot No: as7146b), administration date: 21Sep2022, when the patient was 56-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 23Sep2023 at 18:30, outcome "not recovered", described as "bells palsy". The event "bells palsy" required physician office visit. Therapeutic measures were taken as a result of bell's palsy. On 24Sep2022, physician was notified, started on predisone 60 and Valacyclovir.; Sender's Comments: Based on the information available, a possible contributory role of the suspect drug for the reported event Bell's palsy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: she gets a cough every time she gets a Covid shot or vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), in 2022 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: COUGH (non-serious) with onset 2022, outcome "unknown", described as "she gets a cough every time she gets a Covid shot or vaccine".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 66 years and on 21Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 66 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0151) at the age of 64 years, on 07May2021 as dose 2, single (Lot number: EW0162) at the age of 64 years and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 051C21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Moderna Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08Sep2023 to 12Sep2023. Patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Acoustic Neuroma (Cause of Left-Ear Deafness)" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: since 14; "Colon Cancer (Resection with Chemotherapy)" (unspecified if ongoing); "Heart Ablation" (unspecified if ongoing); "Heart Stenting" (unspecified if ongoing); "Left-Sided Neuropathy" (unspecified if ongoing); "Weakness from Chemotherapy" (unspecified if ongoing); "Weakness from Chemotherapy" (unspecified if ongoing); "Acoustic Neuroma (Cause of Left-Ear Deafness)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: home; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: The patient was feeling weak, foggy, and disoriented. He took a home Covid-19 test, which was positive. They called the doctor and they ordered Paxlovid for him. The patent started treatment with Paxlovid (oral) on 10Sep2023 for COVID-19 and discontinued on 11Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Dysgeusia, Inappropriate schedule of product administration, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Neuropathy in both feet; Loss of smell and taste; Loss of smell and taste; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Sep2021 as dose 2, single (Lot number: 30145ba) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; LAMOTRIGINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: fc3180, Location of injection: Arm Left), administration date: 11Aug2021, when the patient was 48-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The patient had no known allergy.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ANOSMIA (disability), DYSGEUSIA (disability) all with onset Feb2022, outcome "recovering" and all described as "Loss of smell and taste"; NEUROPATHY PERIPHERAL (disability, medically significant) with onset Feb2022, outcome "recovering", described as "Neuropathy in both feet". The events "neuropathy in both feet" and "loss of smell and taste" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. Therapeutic measures were taken as a result of neuropathy peripheral, anosmia, dysgeusia. Laser therapy for neuropathy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310745 same patient, different dose number, different event;
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Neuropathy in both feet; Loss of smell and taste; Loss of smell and taste; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Sep2021 as dose 2, single (Lot number: 30145ba) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; LAMOTRIGINE; DEXTROAMPHETAMINE [DEXAMFETAMINE]. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: fc3180, Location of injection: Arm Left), administration date: 11Aug2021, when the patient was 48-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The patient had no known allergy.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; ANOSMIA (disability), DYSGEUSIA (disability) all with onset Feb2022, outcome "recovering" and all described as "Loss of smell and taste"; NEUROPATHY PERIPHERAL (disability, medically significant) with onset Feb2022, outcome "recovering", described as "Neuropathy in both feet". The events "neuropathy in both feet" and "loss of smell and taste" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive. Therapeutic measures were taken as a result of neuropathy peripheral, anosmia, dysgeusia. Laser therapy for neuropathy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310745 same patient, different dose number, different event;
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Dysgeusia, Inappropriate schedule of product administration, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Lot number: FC3180), in left arm and on 28Sep2021 as dose 2, single (Lot number: 30145ba) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jun2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309383 same patient, different dose number, different event;
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Lot number: FC3180), in left arm and on 28Sep2021 as dose 2, single (Lot number: 30145ba) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive; (Jun2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309383 same patient, different dose number, different event;