chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: vaccine given after expiration date due to temperature change in storage; vaccine given after expiration date due to temperature change in storage; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine given after expiration date due to temperature change in storage) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine given after expiration date due to temperature change in storage).    Concomitant medication was not provided.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AEs or PQC reported; VARIVAX was administered on 8/14/2023 and MMR II was administered on 9/5/2023.; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), lot #W031815 (expiration date not reported, but upon internal validation established as 05-OCT-2024), and then on 05-SEP-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot #W034592 (expiration date not reported, but upon internal validation established as 10-MAY-2024) (Inappropriate schedule of product administration), both administered for prophylaxis (strength, dose, frequency and route of administration were not provided for both). No other information was provided. No additional adverse events (AEs) or product quality complaints (PQC) were reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gallbladder removal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2023) positive, notes: bright red positive. Therapeutic measures Paxlovid was taken as a result of drug ineffective, covid-19. Additional information: The patient has no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: After first shot, 2 days after, started causing him severe neck pain and shoulder pain; After first shot, 2 days after, started causing him severe neck pain and shoulder pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "After first shot, 2 days after, started causing him severe neck pain and shoulder pain".  Additional information: Last shot he has taken, was last year, second shot, didn't remember what month. After first shot, 2 days after, started causing him severe neck pain and shoulder pain. Can not do any exercising at all because of this pain. It has injured his lifestyle. Looking for monetary compensation.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID; COVID; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing); "General Anxiety Disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone"; Hydrocodone, reaction(s): "known allergies: Hydrocodone". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06May2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Aug2023, outcome "recovered" (02Sep2023) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2023) Positive; (02Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Aug2023 to 01Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300294586 same patient, different drug;
Age: 48.0
Sex: F
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 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Mar2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 27Aug2023 to 01Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295290 same reporter/patient, different product/event;
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: rash; 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 71-year-old female patient received pf-06928316 (ABRYSVO), on 02Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 02Sep2023, outcome "unknown". Additional information included: She received Abrysvo last Saturday and suddenly started experiencing a rash. It was the first time that she ever had a vaccine reaction. She would like to report a possible reaction to the RSV vaccine, Abrysvo. She mentioned she was wondering what sort of components are in it besides the antigen itself or any preservatives or carriers that she should know about so that she will know what to do about future vaccines. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain on her arm/arm throbbing; pain in the muscle from her neck to her finger tips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "Pain on her arm/arm throbbing"; MYALGIA (non-serious) with onset 2023, outcome "not recovered", described as "pain in the muscle from her neck to her finger tips". Therapeutic measures were taken as a result of pain in extremity, myalgia. Clinical course: She took the vaccine on 30Aug2023, wanted to know if she should go to the emergency room and what can she do about the arm pain. Took pain pills. This was hurting too bad.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: The after taste after taking COVID is like rust; 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 patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "The after taste after taking COVID is like rust".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: COVID and Shot has left an awful taste in my mouth; 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, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "COVID and Shot has left an awful taste in my mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 14 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 17May2021 as dose 1, single (Lot number: EW0179), on 21Jun2021 as dose 2, single (Lot number: EW0191) and on 31May2022 as dose 3 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 29Aug2023 to 03Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295414 same patient, different drug and different AE.;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: Dose Number: 6/Pfizer / BioNTech: Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31May2023 at 15:00 as dose 6 (booster), single (Lot number: AS7185B), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31May2023 at 15:00, outcome "not recovered", described as "Moderna: Dose Number: 6/Pfizer / BioNTech: Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 29Aug2023 to 04Sep2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 52 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zoloft, reaction(s): "Known allergy: Zoloft". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid from start 30Aug2023 to 03Sep2023 as treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295333 same patient, different drug/event;
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm 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 10Sep2022, outcome "not recovered", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2023) Negative, notes: tested negative until 07Sep; (06Sep2023) Negative, notes: tested negative until 07Sep; (07Sep2023) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Aug2023 to 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
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 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose number unknown, single (Lot number: 0810234) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 27Aug2023 to 31Aug2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative, notes: negative tests. Therapeutic measures included Paxlovid from 29Aug2023 to 03Sep2023 were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), on 03Nov2021 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Rebound 4 days after 1st negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient was treated with Paxlovid and had rebound 4 days after 1st negative test.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE, start date: 07Feb2018; PAROXETINE HCL, start date: 01Jul1997; VALACYCLOVIR HCL, start date: 01Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 25Aug2023 to 29Aug2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: high fever; Felt pretty bad for a couple of days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), 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: PYREXIA (non-serious), outcome "unknown", described as "high fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt pretty bad for a couple of days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Deep vein thrombosis, Diplopia, Fatigue, SARS-CoV-2 test
Clinical narrative: Deep Vein Thrombosis; Chronic Fatigue for months; Diplopia; Aneurysm in Ascending Aorta; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Not Available, Location of injection: Arm Left), administration date: 23Jan2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: AORTIC ANEURYSM (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Aneurysm in Ascending Aorta"; FATIGUE (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Chronic Fatigue for months"; DEEP VEIN THROMBOSIS (disability, medically significant, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae"; DIPLOPIA (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae". The events "deep vein thrombosis", "chronic fatigue for months", "diplopia" and "aneurysm in ascending aorta" required physician office visit. Therapeutic measures were taken as a result of deep vein thrombosis, fatigue, diplopia, aortic aneurysm. Treatment received included referral to Ultrasound/PCP, Put on Eliquis. Covid test type on 23Dec2021 (Nasal Swab) on 23Dec2021: negative.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events AORTIC ANEURYSM, FATIGUE,DEEP VEIN THROMBOSIS, DIPLOPIA  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300296256 Same patient, same events, different dose;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Deep Vein Thrombosis; Chronic Fatigue for months; Diplopia; Aneurysm in Ascending Aorta; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Not Available, Location of injection: Arm Left), administration date: 23Jan2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: AORTIC ANEURYSM (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Aneurysm in Ascending Aorta"; FATIGUE (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Chronic Fatigue for months"; DEEP VEIN THROMBOSIS (disability, medically significant, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae"; DIPLOPIA (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae". The events "deep vein thrombosis", "chronic fatigue for months", "diplopia" and "aneurysm in ascending aorta" required physician office visit. Therapeutic measures were taken as a result of deep vein thrombosis, fatigue, diplopia, aortic aneurysm. Treatment received included referral to Ultrasound/PCP, Put on Eliquis. Covid test type on 23Dec2021 (Nasal Swab) on 23Dec2021: negative.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events AORTIC ANEURYSM, FATIGUE,DEEP VEIN THROMBOSIS, DIPLOPIA  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300296256 Same patient, same events, different dose;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose: 1, 2, 3; Moderna, Dose: 4, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL2747), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Sep2022 as dose 4 (booster), single (Lot number: AS7163B), in left arm and on 23May2023 as dose 5 (booster), single (Lot number: AS7180B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ongoing valley fever infection (onset Aug2022)", start date: Aug2022 (unspecified if ongoing), notes: ongoing valley fever infection (onset Aug2022). The patient's concomitant medications were not reported. The patient did not received other medication in 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose: 1, 2, 3; Moderna, Dose: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: I am strongly positive; (03Sep2023) Negative, notes: tested negative on day 5; (08Sep2023) Positive, notes: strongly positive. Therapeutic measures were taken as a result of Treatment of COVID-19 included Paxlovid from 30Aug2023 to 03Sep2023.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Lot number: FF2589), in right arm and on 04Apr2022 as dose 2, single (Lot number: F55683) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2023) Negative; (08Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used from 29Aug2023 to 03Sep2023 as treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296334 Same reporter/patient/drug, different AE/different dose.;
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 56 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FL3197), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bacitracin, reaction(s): "known allergies: Bacitracin"; Neomycin, reaction(s): "known allergies: neomycin"; Possibly belladonna (atropine), reaction(s): "known allergies: possibly belladonna (atropine)"; Possibly belladonna (atropine), reaction(s): "known allergies: possibly belladonna (atropine)". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: RSV
Symptoms: COVID-19
Clinical narrative: came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73-year-old male patient received pf-06928316 (ABRYSVO), on 01Sep2023 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: COVID-19 (non-serious), outcome "unknown", described as "came down with Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller stated immediately after getting the vaccine, her husband came down with Covid and was now on Paxlovid. Caller stated she did not think getting Covid has anything to do with getting the vaccine, as they were at a racetrack.   The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: COVID-19 represents an intercurrent viral infection caused by SARS COV-2 unrelated to ABRYSVO use.,Linked Report(s) : US-PFIZER INC-202300296329 same reporter/product/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID; all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID; 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 71-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: G49703), in right arm and on 18Jun2023 as dose 6 (booster), single (Lot number: GK9276), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ5668), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes Type 2" (unspecified if ongoing), notes: Other medical history: diabetes Type 2. The patient's concomitant medications were not reported. Past drug history included: Jardiance, reaction(s): "Known Allergies: Jardiance", notes: Known Allergies: Jardiance. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: have had all vaccines and boosters for Covid. We had Covid in July; have had all vaccines and boosters for Covid. We had Covid in July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "have had all vaccines and boosters for Covid. We had Covid in July". Clinical course: Patient's wife and him have had all vaccines and boosters for Covid. They had Covid in Jul and patient had concern that how long they could wait to get new boosters vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151917 Same event, vaccine and different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had all vaccines and boosters for Covid. We had Covid in July; had all vaccines and boosters for Covid. We had Covid in July; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "had all vaccines and boosters for Covid. We had Covid in July". Clinical course: Patient had have all vaccines and boosters for Covid and had Covid in July.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT16B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151904 Same event, same vaccine different patient;
Sex: U
Vaccine: RSV
Symptoms: COVID-19
Clinical narrative: COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received pf-06928316 (ABRYSVO), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID 19".  The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she already got COVID; she already got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she already got COVID". Clinical Course: Reporter's wife is doctor she, she got all, she had the required, by the hospital that she works at, to get the vaccine, she got all Pfizer, and she got all 3 but she already got COVID.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered QUADRACEL to a 16-year-old patient with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA270585.  This case involves a 16 years old female patient to whom administered diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine [Quadracel] to a 16-year-old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2023, the 16 year old female patient received a unknown dose of suspect diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine Suspension for injection (Frequency: once, Strength: standard, expiry date: 14-Apr-2025 and lot: 07632BB) via intramuscular route in the left deltoid as Immunization and (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.