chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 1 Moderna; Dose Number: 2 Moderna; Dose Number: 3 Pfizer / BioNTech; 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 male patient received bnt162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: F12593) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 18Feb2021 as dose 2, single (Lot number: 011M20A), in left arm, on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, on 03Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm and on 05Jun2023 as dose 6 (booster), single (Lot number: A571858), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ADD" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2019, stop date: 07Sep2023; ROSUVASTATIN, start date: 01Jan2019, stop date: 07Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2021, outcome "unknown", described as "Dose Number: 1 Moderna; Dose Number: 2 Moderna; Dose Number: 3 Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from  12Sep2023 to 16Sep2023.
Age: 67.0
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 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Lot number: FM7553), 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 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 Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 13Sep2023 to 18Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307996 same patient, different drug and different event.;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02May2023 as dose 6 (booster), single (Lot number: 010H22A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 007M20A), on 15Mar2021 as dose 2, single (Lot number: 003A21A), on 27Oct2021 as dose 3 (booster), single (Lot number: 026D21A) and on 01Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 17Sep2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308228 Same patient, different drug and different event;
Age: 37.0
Sex: M
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 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 Sep2023, 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 had received the treatment of COVID-19 as Paxlovid on 10Sep2023 to 14Sep2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307909 same patient, different drug/event;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 18Apr2021 at 11:00 as dose 1, single (Lot number: EW0164), in right arm and on 08May2021 at 11:00 as dose 2, single (Lot number: EW0176) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2022 at 11:00 as dose 3 (booster), single (Lot number: 022J121A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Grave's disease" (unspecified if ongoing); "Allergic to morphine" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE, start date: 01Jan2017. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jan2022 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 08Sep2023 to 13Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307986 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  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 compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), on 23Mar2021 at 11:30 as dose 2, single (Lot number: EP7534), in right arm, on 08Oct2021 at 13:15 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 28May2022 at 13:15 as dose 4 (booster), single (Lot number: FN2908) at the age of 61 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: "CLL - leukemia" (unspecified if ongoing); "malignant melanoma" (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 09Sep2023 at 21:00, outcome "not recovered" 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: From 11Sep2023 to 16Sep2023 patient Paxlovid as treatment of COVID-19. The patient had fever, headaches, body aches, nausea, lung congestion heavy, intense fatigue, light sensitivity, sneezing, coughing, brain fog.
Age: 29.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 29 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 11Jul2018. The following information was reported: 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: (08Sep2023) Positive; (09Sep2023) Positive; (10Sep2023) Positive; (11Sep2023) Positive, notes: it got noticeably lighter every day; (12Sep2023) Positive, notes: it got noticeably lighter every day; (13Sep2023) Positive, notes: it got noticeably lighter every day; (14Sep2023) Positive, notes: it got noticeably lighter every day; (15Sep2023) Positive, notes: it got noticeably lighter every day; (16Sep2023) Positive, notes: it was very dark again; (17Sep2023) Positive; (18Sep2023) Positive; (19Sep2023) Positive; (20Sep2023) Positive; (21Sep2023) Positive. Patient tested herself with an antigen test every day. It was positive every day from 08Sep to 21Sep, but between 11Sep and 15Sep it got noticeably lighter every day. On 16Sep it was very dark again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Sep2023 to 12Sep2023.   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: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jun2023 (as reported) as dose 4 (booster), single (Lot number: 038A22A), 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 included: "HIV" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraine medications" (unspecified if ongoing), notes: Known allergies: Migraine medications, e.g. maxalt, tetanus anti-toxin. Concomitant medication(s) included: ATORVASTATIN, stop date: 12Sep2023. Past drug history included: Maxalt for Migraine, reaction(s): "Allergies: maxalt"; Tetanus anti-toxin, reaction(s): "Allergies: tetanus anti-toxin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Jun2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included: Paxlovid.
Age: 62.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Feb2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Sep2023 to 12Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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) all with onset 19Sep2023, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 102.3; SARS-CoV-2 test: (19Sep2023) Positive. Clinical courses: The patient's temperature was 102.3, he had fever. Patient working from home, isolating.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307925 same reporter/drug/AE, different patients;
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 06Aug2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CFIDS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "COPD" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "severe sleep apnea" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Choline, reaction(s): "Allergy"; Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Se2023 to 16Sep2023.  Clinical course: Patient got COVID from her Caregiver and was exposed to it on 07Sep2023 (as reported) before this new and 5th vaccination was made available to her on 12Sep2023! So, instead of being proactive and making this latest vaccination available sooner, now they are getting sick and having to be reactive! Called (Withheld) three times to be checked out and to ER.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Gastrointestinal pain, Pain assessment
Clinical narrative: He has 9-10 level pain, feels like his GI tract will explode; feels like his GI tract will explode/ Gastrointestinal discomfort; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (COMIRNATY), 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: GASTROINTESTINAL PAIN (medically significant), outcome "unknown", described as "He has 9-10 level pain, feels like his GI tract will explode"; ABDOMINAL DISCOMFORT (medically significant), outcome "unknown", described as "feels like his GI tract will explode/ Gastrointestinal discomfort". The patient underwent the following laboratory tests and procedures: Pain assessment: 9-10 level pain. Clinical course: He had 2 shots and 2 boosters. He had 9-10 level pain, felt like his GI tract will explode.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid/sinus for 2 weeks, tested positive; diagnosed with Covid/sinus for 2 weeks, tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 21-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "diagnosed with Covid/sinus for 2 weeks, tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2023) Positive. Clinical course: Caller (Patient/daughter's mother) reporting that entire family took Covid vaccine. Caller and her 2 adult daughters, started to have people around them get Covid. Jul2023, they all panicked, took the vaccines. Tuesday, this week, all of them got Covid. They live in separate households. Diagnosed with Covid: Daughters had sinus for 2 weeks, they both tested positive. This was all Tuesday, 19Sep2023. Daughters are twins, both doing all normal activities. They were isolating themselves, according to CDC. Caller and her 2 daughters took their booster in Jul2023. Does not have daughters card.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307925 same reporter/drug/AE, different patients;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid/sinus for 2 weeks, tested positive; diagnosed with Covid/sinus for 2 weeks, tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 21-year-old female patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "diagnosed with Covid/sinus for 2 weeks, tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2023) Positive. Additional information: Caller (Patient/daughter's mother) reporting that entire family took Covid vaccine. Caller and her 2 adult daughters, started to have people around them get Covid. Jul2023, they all panicked, took the vaccines. Tuesday, this week, all of them got Covid. They live in separate households. Diagnosed with Covid: Daughters had sinus for 2 weeks, they both tested positive. This was all Tuesday, 19Sep2023. Daughters are twins, both doing all normal activities. They were isolating themselves, according to CDC. Caller and her 2 daughters took their booster in Jul2023. Does not have daughters card.   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-202300307925 same reporter/drug/AE, different patients;
Age: 32.0
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 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single and on 12May2023 as dose 5 (booster), single at the age of 32 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included: Paxlovid from 12Sep2023 to 16Sep2023.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0162), on 29Apr2021 as dose 2, single (Lot number: EW0167) and on 13May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing); "spinal cord injury" (unspecified if ongoing); "mild 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) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-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 included: "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 24Sep2023. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatmentof COVID-19; Treatmentof COVID-19; Moderna Dose Number 3 / Pfizer / BioNTech Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Lot number: fk9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: 007M20A), in left arm, on 02Mar2021 as dose 2, single (Lot number: 025A21A), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 432F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Apr2022, outcome "unknown", described as "Moderna Dose Number 3 / Pfizer / BioNTech Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatmentof COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
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 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 73 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: en9581), in left arm, on 20Feb2021 as dose 2, single (Lot number: en6203), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: fc3184), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Chrome, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 22Sep2023 to 24Sep2023.
Age: 46.0
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; Moderna Dose Number: 2; 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 (PFIZER-BIONTECH COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: Fg3s27) at the age of 46 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 046a21a), in left arm and on 18Apr2021 as dose 2, single (Lot number: 041b21a), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 19Dec2022 as dose number unknown, single (Lot number: As7166b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "polyarteritis nodosa (in remission)" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Klonopin, reaction(s): "Known alleries: Klonopin"; Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Nov2021, outcome "unknown", described as "Moderna Dose Number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2023) negative; (24Sep2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Sep2023 to 20Sep2023.
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 49-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: "hypothyroidism" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies"; Bactrim, reaction(s): "Known allergies". 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 which included COVID 19 treatment from 16Sep2023 to 20Sep2023.  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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, 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 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, from 12Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Known allergies: Penicillin" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Sep2023 to 20Sep2023.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; METFORMIN; TRAZODONE. Past drug history included: Metronidazole, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Clinical course: Symptoms were resolving and COVID antigen test was negative on Day 9. Then COVID symptoms returned on Day 10 and COVID antigen test was positive. Resting and symptomatic on day 14 still with positive antigen test and COVID symptoms. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 13Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; 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), in Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 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). 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 "unknown" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Sep2023 to 20Sep2023.  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: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 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 included: "Cancer" (unspecified if ongoing); "splenectomy" (unspecified if ongoing); "removed gall bladder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Thimerosal, reaction(s): "Allergies: Thimerosal". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 17Sep2023 to 21Sep2023 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19 treatment: Paxlovid; Covid-19 treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Sep2023 to 20Sep2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, 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 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 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 had no relevant medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid from 15Sep2023 to 19Sep2023 as treatment.  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: RSV
Symptoms: Device defective, Syringe issue
Clinical narrative: It looks like we had one syringe over here that is broken; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A female patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Lot number: HF5016, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "It looks like we had one syringe over here that is broken". Additional information: It was reported that they had one syringe that was broken, and they were hoping to get a replacement because it was a broken syringe. This never reached the patient because they saw that the tip was broken. They could not even twist a needle on to it because it's broken. It was 1 syringe, so 1 milliliter. It's just a defective syringe so that's the reason why they never got to give it to the patient. They had to use a different syringe for her. The sample of the product was available to be returned, if requested.  Investigation results included: Reportability Determination: After further review the Reportability Determination statement was not correct in the original assessment. This is Medical Device Related. Reportability Determination: This complaint for the tip was broken. We could not even twist a needle on to it because it's broken for ABRYSVO sfdpo 5x0.5ml gvl+syr is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for rest of world (ROW) since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected.   The reporter considered "it looks like we had one syringe over here that is broken" not related to pf-06928316. Causality for "it looks like we had one syringe over here that is broken" was determined associated to device constituent of pf-06928316 (malfunction).  Follow-up (12Sep2023): This is a spontaneous follow-up report received from the product quality group. Updated information includes: investigation results.; Sender's Comments: A possible contributory role of the device constituent cannot be excluded for the reported event based the information available
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: MYASTHENIA GRAVIS (medically significant), outcome "unknown". Patient just got diagnosed with myasthenia gravis from having Covid shots. Reporter would like to know how concerned should they be about taking more Covid shots.  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.