chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; Shivers; Nausea; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary series of Immunization completed, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Shivers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain, chills, nausea, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in two weeks: Unknown. The patient experienced a rebound case of covid after taking Paxlovid. The rebound case was worse in severity than her original case of Covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 33.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 29Aug2022 to 03Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Pain
Clinical narrative: clotted blood which were not typical to my period cycle; Severe period cramps; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 17:00 as dose 4 (booster), single (Lot number: Oh9694) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Got COVID", start date: Apr2022 (unspecified if ongoing), notes: Got COVID in April 2022. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Sep2022 at 03:00, outcome "recovering", described as "Body aches"; DYSMENORRHOEA (non-serious) with onset 11Sep2022 at 03:00, outcome "recovering", described as "Severe period cramps"; MENSTRUAL DISORDER (non-serious) with onset 11Sep2022 at 03:00, outcome "recovering", described as "clotted blood which were not typical to my period cycle". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, pain.  Additional information: I had my period 5 days after my vaccine. I had severe period cramps, body aches, and clotted blood which were not typical to my period cycle. The patient had COVID prior vaccination. Not tested for COVID post vaccination. There were no known allergies. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: I had flu shot with COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiovascular disease" (unspecified if ongoing), notes: cardiovascular disease. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received Paxlovid as an antiviral treatment from 03Sep2022 to 07Sep2022. Patient had no known allergies. This case assessed as non-serious by the reporter.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug interaction NOS" (unspecified if ongoing), notes: Other medical history: No, Known allergies: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral drug PAXLOVID was taken from 26AUG2022  for the treatment of COVID-19. I got rebound COVID on day 6, 04Sep2022 and still can't get a negative test I have a viral load still on 09Sep2022 of 24  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use
Clinical narrative: achy muscles; Off-label use; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 3; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 4; manufacturer unknown), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (non-serious) with onset 07Sep2022 at 19:00, outcome "unknown", described as "Off-label use"; MYALGIA (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "achy muscles". Therapeutic measures were not taken as a result of myalgia.  Additional information: Patient reported day 1 of achy muscles, feeling of needing to have diarrhea most of day but didn't occur. Day 2 patient felt 75% better, a lot less muscle ache. By end of day 2, 48 hours after shot, back to normal. She had no reaction to previous 4 shots but this new bivalent one did, although mild and lasted approximately 48 hours.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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 was not reported. Concomitant medication(s) included: TAMOXIFEN, start date: 02Feb2022. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment Brand was Paxlovid. Treatment start date was 06Sep2022. Indication was Treatment of COVID-19. Patient received other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: All over body ache day after vaccination; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose : 03, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose : 02, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose : 01, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 09Sep2022, outcome "recovering", described as "All over body ache day after vaccination". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: Product: COVID 19, brand; Pfizer BioNTech Omicron Booster.Since the vaccination, the patient had not been tested for COVID-19. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine; and unknown Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: EL9269), on 21Feb2021 as dose 2, single (Lot number: EL9269), on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 18May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Limited Scleroderma" (unspecified if ongoing), notes: Limited Scleroderma; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: days after negative test 1 week after completion of treatment I tested positive; (Sep2022) Negative, notes: Tested negative 3 days after Paxlovid completed. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore left arm; Chills; fatigue; 99.1 temp briefly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:30 as dose 4 (booster), single (Lot number: FG9694) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering", described as "99.1 temp briefly"; CHILLS (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering", described as "Sore left arm"; FATIGUE (non-serious) with onset 10Sep2022 at 14:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, chills, fatigue, pyrexia. Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. AE treatment: Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Ear pain, Headache
Clinical narrative: 2 days later my left shoulder and clavicle became so sore I could not move my left arm; 2 days later my left shoulder and clavicle became so sore I could not move my left arm; Slight swelling at shoulder and clavicle.; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; At first, nothing but a sore arm.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Sjogrens" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB; "Other medical history: HPB" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB. Concomitant medications included: HYDROCHLOROTHIAZIDE; VENLAFAXINE HCL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2022 at 01:00, outcome "recovering", described as "At first, nothing but a sore arm."; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "2 days later my left shoulder and clavicle became so sore I could not move my left arm"; JOINT SWELLING (non-serious) with onset 12Sep2022, outcome "recovering", described as "Slight swelling at shoulder and clavicle."; NECK PAIN (non-serious), EAR PAIN (non-serious), HEADACHE (non-serious), BACK PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "The pain seemed to spread into my neck, ear and head, followed by severe low back pain". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, bone pain, joint swelling, neck pain, ear pain, headache, back pain.  Additional information: at first, the patient had nothing but sore arm. 2 days later, her left shoulder and clavicle became so sore that she could not move her left arm. The pain spread to her neck, ear, and head, followed by severe low back pain. She had slight swelling at her shoulder and clavicle. She had no other vaccine within four weeks of vaccination. She had no COVID prior to vaccination. She did not tested for COVID after vaccination. She had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Neck pain, Pain in extremity
Clinical narrative: 2 days later my left shoulder and clavicle became so sore I could not move my left arm; 2 days later my left shoulder and clavicle became so sore I could not move my left arm; Slight swelling at shoulder and clavicle.; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; The pain seemed to spread into my neck, ear and head, followed by severe low back pain; At first, nothing but a sore arm.; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Sjogrens" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB; "Other medical history: HPB" (unspecified if ongoing), notes: Other medical history: Sjogren's, HPB. Concomitant medications included: HYDROCHLOROTHIAZIDE; VENLAFAXINE HCL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Sep2022 at 01:00, outcome "recovering", described as "At first, nothing but a sore arm."; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "2 days later my left shoulder and clavicle became so sore I could not move my left arm"; JOINT SWELLING (non-serious) with onset 12Sep2022, outcome "recovering", described as "Slight swelling at shoulder and clavicle."; NECK PAIN (non-serious), EAR PAIN (non-serious), HEADACHE (non-serious), BACK PAIN (non-serious) all with onset 12Sep2022, outcome "recovering" and all described as "The pain seemed to spread into my neck, ear and head, followed by severe low back pain". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, bone pain, joint swelling, neck pain, ear pain, headache, back pain.  Additional information: at first, the patient had nothing but sore arm. 2 days later, her left shoulder and clavicle became so sore that she could not move her left arm. The pain spread to her neck, ear, and head, followed by severe low back pain. She had slight swelling at her shoulder and clavicle. She had no other vaccine within four weeks of vaccination. She had no COVID prior to vaccination. She did not tested for COVID after vaccination. She had no known allergies.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Lot number: 30336BD) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient'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 2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Yes. The patient previously receive a COVID-19 Vaccine. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1 and 2: Pfizer, Dose 3 and 4: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 14Apr2021 as dose 2, single (Lot number: ER8735) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 037C21A), in left arm and on 03Mar2022 as dose 4 (booster), single (Lot number: 066h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: DULERA, start date: Jan2015; SINGULAIR, start date: Jan2010; RABEPRAZOLE, start date: Jan2010; ZYRTEC ALLERGY, start date: Jan2010. Past drug history included: Naproxen, reaction(s): "Known allergies: naproxen", notes: Known allergies: naproxen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and 2: Pfizer, Dose 3 and 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Rebound with worse symptoms 4 days after completion of Plaxovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 01Sep2022 to 05Sep2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH Covid-19 Vaccine lot ER8732, ER8735 was investigated. The investigation included a review of packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot ER8732, lot ER8735 fill lot EP8684 and fill lot EP8687 and bulk formulation lot EP8571 and lot EP8574. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.   A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2021 as dose 3 (booster), single (Lot number: FL 3197) at the age of 49 years, in left arm for covid-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 07Jan2021 as dose 1, single (Lot number: 025L20a) and on 01Feb2021 as dose 2, single (Lot number: 043L20a) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Dec2021, outcome "unknown", described as "vaccine brand other Moderna"; 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: (unspecified date) Positive, notes: Treatment of COVID-19; (06Sep2022) Negative; (09Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient did not received any other medication in 2 weeks. I completed 5-day course of Paxlovid, tested negative on 06Sep2022. Symptoms recur 08Sep2022 and tested positive again 09Sep2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded. Given the nature of the event of interchange of vaccine products, role of suspect product BNT162b2 cannot be assessed for it.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Vaccination site swelling
Clinical narrative: The site of the shot seem little bit swollen and stiff; The site of the shot seem little bit swollen and stiff; I had difficulty sleeping; 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 BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset Sep2022, outcome "unknown", described as "I had difficulty sleeping"; VACCINATION SITE SWELLING (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset Sep2022, outcome "unknown" and all described as "The site of the shot seem little bit swollen and stiff".  Additional information: The patient stated that they had flu shot given at the same point; side effects could have been from anything. The patient reported that they got the new vaccine yesterday which was Bivalent booster shot (Suspect captured as per verbatim), she mention that they experienced some side effect and they want to know if they can take Advil or aspirin. When they got the first shot including the boosters, they were told not to take Advil or aspirin. The patient forgot for how many days afterwards. So they don't want to do anything to screw up the efficacy of the vaccine. The patient stated that there was nothing that would need to use the, take the Advil for. The site of the shot seem little bit swollen and stiff and patient had difficulty sleeping but none of that was critical, to and for patient those are reasonable side effect. The patient also have to add come to think of it. Patient had flu shot (Further clarification unknown, hence captured as Unspecified flu shot) given at the same point. So the side effects could have been from anything. It could be from either of those things. The patient stated that the question was very simple, just want to know whether can take Advil and if can't how were it and were Aspirin if can't how long that goes on to work it's simple. Patient got all the information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (Sep2022) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received vaccine and other medications in 2 weeks. Patient had COVID 19 Treatment with Paxlovid (Lot number :1910754A) for which treatment started was on 02Sep2022 and stopped on 06Sep2022. The patient had received other medications with in 2 weeks which included Lozarton started on 01Aug2022 and stopped on 10Sep2022. Tested negative 1 day after the fifth/final day of taking Paxlovid. Most symptoms were gone. The third day after finishing the Paxlovid had runny nose and mild cough - became stuffy nose overnight and the next day, which is now. The patient had no known allergies. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date : 10Sep2022.
Age: 54.0
Sex: M
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) (Physician) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 54 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes, HTN, hyperlipidemia; "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing).  The patient had no known allergies. Concomitant medication(s) included: FARXIGA; ROSUVASTATIN; IRBESARTAN; OZEMPIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (04Sep2022) positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 03Sep2022 to 07Sep2022 and the patient had rebound positive test on 04Sep2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation, prophylaxis. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: He also has COPD diagnosed around the same time as her 5-10 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (2022) and all described as "Contracted COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter was asking her husband took Paxlovid, could he get the new booster. She had a consumer on the line regarding Pfizer COVID 19 vaccine adult formulation and unsure if purple or grey cap. Received doses 1, 2 and a booster and then contracted COVID in May2022. She did mention that her husband received the vaccine as well and then agent inadvertently disconnected before providing any additional details about husband. She stated they did not have any adverse reactions to the booster. Withheld said that people that took the Pfizer vaccines and contracted COVID afterwards was the reason she transferred her. Her husband also contracted COVID first and then she got it. He also received 3 doses of the Pfizer COVID vaccine. This report was to capture information for her husband. She said her husband took Paxlovid. His PCP (primary care physician) actually prescribed Paxlovid. He did very well with it. She did not have an address, phone or email for his primary care physician. Her husband received his first and second dose at the same time she did, but received his booster in Aug2021. She did not have his card to provide lot and expiration for any of them. He took Paxlovid and was better in 3-4 days. He did not have an ER or physician's office visit. He did not administered any other vaccine prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201151180 same reporter/drug/event, different pt.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2020 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Sep2010; LOSARTAN, start date: 01Sep2010; ESTRADIOL, start date: 01Sep2010.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Conclusion: This report was about covid treatment. The patient has received vaccine. The patient has received other medication in 2 weeks. Anti-viral details included Product=COVID 19 Treatment, brand=Paxlovid, on 30Aug2022 and treatment stopped on 03Sep2022 (Lot number=Unknown) for Treatment of COVID-19. Adverse event: Rebound headache sore throat aches chills nasal/sinus congestion cough on 08Sep2022 (Outcome: Not recovered, If treatment AE: No). Other medical history included Hypertension.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 13:45 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 at 13:00 as dose 2, single (Lot number: EN6206), in right arm and on 17Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW0179) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2022 at 10:30 as dose 4 (booster), single (Lot number: 045L21A), in left arm and on 29Jul2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2weeks. Anti-viral details for COVID 19 Treatment included Paxlovid, treatment start date: 01Sep2022 and treatment stop date: 05Sep2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2021 as dose 3 (booster), single (Lot number: 007c21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Intersticial lung disease" (unspecified if ongoing). Concomitant medication(s) included: REPATHA, start date: 01Jan2016; PRILOSEC [OMEPRAZOLE], start date: 01May2019; EFFEXOR, start date: 01Feb2008; SYNTHROID, start date: 01Jan1974; DILTIAZEM, start date: 01Nov2019; LOSARTAN, start date: 01Jan2018; DIFLUCAN, start date: 01Jun2021. Past drug history included: Known allergies: neglect ciprofloxacin, reaction(s): "Known allergies: Neglect ciprofloxacin". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks reported as yes. Anti viral details reported as Product COVID 19 Treatment, bran was Paxlovid, treatment start date reported as 03Sep2022, treatment stop date reported as 07Sep2022. Adverse event start date was 11Sep2022, adverse event start time was 01:00 PM. The patient recovered was recovering, the treatment ae reported as no.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken; I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: 30Jun2021), on 15Mar2021 as dose 2, single (Lot number: EN6207, Expiration Date: 31Jul2021) and on 01Dec2021 as dose 3 (booster), single (Lot number: 32030DD, Expiration Date: 28Feb2022) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Pulmonary embolism" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Cancer" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Sep2022, outcome "unknown" and all described as "I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken". The event "i was diagnosed with covid; three (pfizer covid-19 vaccine) that i have taken" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) Result: unknown, notes: I just went for MRI because I had cancer; SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: The patient was diagnosed with COVID, Monday and symptoms started Sunday so, doctor gave Paxlovid, and on Tuesday patient started the dosage. Patient had pulmonary embolism and had several blood clots so; patient was on blood thinners.  No follow-up attempts are possible. No further information is expected.