chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; 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 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 16:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 50 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: "known allergies: penicillin" (unspecified if ongoing); "known allergies: all melons" (unspecified if ongoing); "known allergies: bananas" (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 "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergy. 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 including Paxlovid from 14Mar2023.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin op, reaction(s): "known allergies: Erythromycin OP". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine product varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2  to the reported event drug ineffective and COVID-19 cannot be ruled out. The ongoing pandemic with high community virus transmission is assessed as a confounding factor.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: With the first vaccine I only experienced significant muscle pain in the left arm where the injection was given.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "polyarthralgia" (unspecified if ongoing); "hypertension" (unspecified if ongoing), notes: experiencing medication resistant hypertension later on as well. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: MYALGIA (medically significant), outcome "unknown", described as "With the first vaccine I only experienced significant muscle pain in the left arm where the injection was given". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2021) Positive, notes: Blood test covid test name post vaccination: Unknown. No other vaccine in four weeks. With the first vaccine I only experienced significant muscle pain in the left arm where the injection was given. Without any history of RA or OA, I have continued to have severe polyarthralgia to this day, with my joints popping and cracking in addition to the pain. I also began experiencing medication resistant hypertension later on as well. No covid prior vaccination. No known allergies.  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 available information, a possible contributory role of subject product, BNT162B2 vaccine,  cannot be excluded for the reported event of myalgia, based on temporal relationship and the known product safety profile. There is limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.  ,Linked Report(s) : US-PFIZER INC-202300133156 Same product, patient, different AEs, different dose;US-PFIZER INC-202300135597 Same product, patient and different event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 47-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), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" (22Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Diagnosed Covid, notes: home test; (22Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Diagnosed with home test on 15Mar2023, symptoms started the night of 14Mar2023. The patient received Paxlovid for COVID-19 treatment from 16Mar2023 to 20Mar2023. Symptoms improved and resolved.   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: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Body temperature, Headache, Migraine, Muscle spasms, Nausea
Clinical narrative: Pain/Swelling at injection site and in gland of armpit; Pain/Swelling at injection site and in gland of armpit; severe headache; migraine; Severe nausea; Muscle spasms in legs; Fever of 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2023 as dose 2, single (Lot number: FP7136) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 24Mar2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Ancef, reaction(s): "Drug allergy: Ancef". Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: FP7136, Location of injection: Arm Left), administration date: 02Mar2023, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Fever of 103"; MUSCLE SPASMS (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Muscle spasms in legs"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 25Mar2023, outcome "not recovered" and all described as "Pain/Swelling at injection site and in gland of armpit"; NAUSEA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Severe nausea"; MIGRAINE (non-serious) with onset 25Mar2023, outcome "not recovered"; HEADACHE (non-serious) with onset 25Mar2023, outcome "not recovered", described as "severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, headache, migraine, nausea, muscle spasms, pyrexia.  Additional information: Patient did not received other vaccine in four weeks. Patient did not had covid prior vaccination. Patient had received other medications in two weeks.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain/Swelling at injection site and in gland of armpit; Pain/Swelling at injection site and in gland of armpit; severe headache; migraine; Severe nausea; Muscle spasms in legs; Fever of 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2023 as dose 2, single (Lot number: FP7136) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 24Mar2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Ancef, reaction(s): "Drug allergy: Ancef". Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: FP7136, Location of injection: Arm Left), administration date: 02Mar2023, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Fever of 103"; MUSCLE SPASMS (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Muscle spasms in legs"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 25Mar2023, outcome "not recovered" and all described as "Pain/Swelling at injection site and in gland of armpit"; NAUSEA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Severe nausea"; MIGRAINE (non-serious) with onset 25Mar2023, outcome "not recovered"; HEADACHE (non-serious) with onset 25Mar2023, outcome "not recovered", described as "severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, headache, migraine, nausea, muscle spasms, pyrexia.  Additional information: Patient did not received other vaccine in four weeks. Patient did not had covid prior vaccination. Patient had received other medications in two weeks.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: 6H9694) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Clindamycin, reaction: "known allergies: Clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
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 42-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), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: ringing in my ears; it's getting increasingly harder for me to hear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "ringing in my ears"; HYPOACUSIS (non-serious), outcome "not recovered", described as "it's getting increasingly harder for me to hear".  Additional information: patient had received 2 doses and a booster of your Covid 19 vaccination. Unfortunately, immediately after his first dose he started experiencing ringing in his ears. He spoke with his physician and allergist, and they had no answers. He had been lived with this ringing for 2 years now and he wanted to know if there was anything you can do for him to help him get it to stop? He was an actor, and it was getting increasingly harder for him to hear his cues on set.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision even in Daytime/ Vision was blurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/ Lot number unknown), for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 14Oct2021, outcome "not recovered", described as "Blurred vision even in Daytime/ Vision was blurred".  Additional Information: It was reported that after taking the second Pfizer COVID-19 vaccine, the patient woke up the next morning and his vision was blurred for about 5-10 minutes. It happened every morning and even in day time, patient experienced blurred vision. The patient enquired if he will lose his vision and also enquired if these symptoms were common.  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-202300134304 Same patient, same reporter, same product, different dose, different events;
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 13Apr2021 as dose 2, single (Lot number: EW0161), in right arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FYGG43), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was being treated with paxlovid from 18Mar2023 to 22Mar2023 for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300133332 same patient, different drug/event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: Flare of auto immune-AS; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 49 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Patient was not a smoker/former smoker" (unspecified if ongoing); "Heart Disease: SVT" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing); "Immunosuppressive disorder/Immunocompromised" (unspecified if ongoing), notes: Medication Cimzia positive Imuran; "Autoimmune conditions -AS-uveitis-HLA- B27" (unspecified if ongoing); "Autoimmune conditions -AS-uveitis-HLA- B27" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; IMURAN [AZATHIOPRINE SODIUM] taken for immunodeficiency, ankylosing spondylitis, uveitis; CIMZIA taken for immunodeficiency, ankylosing spondylitis, uveitis; PROTONIX [OMEPRAZOLE]; TOPROL XL. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot number: EK9231, Route: Intramuscular), administration date: 11Feb2021, for COVID-19 immunisation; BNT162b2 (Dose 2, Single, Batch/Lot number: EN6206, Route: Intramuscular), administration date: 04Mar2021, for COVID-19 immunisation; BNT162b2 (Dose 3 (Booster), Single, Batch/Lot number: FC3181, Route: Intramuscular), administration date: 25Aug2021, for COVID-19 immunisation; BNT162b2 (Dose 4 (Booster), Single, Batch/Lot number: FJ6369, Route: Intramuscular), administration date: 05Apr2022, for COVID-19 immunisation. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "Flare of auto immune-AS".; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event spondylitis ankylosing aggravated  is related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300081585 Same patient, same product, different event (LOE);
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Pancreatic enzymes, Pancreatic failure, Positron emission tomogram
Clinical narrative: Diagnosed with Exocrine Pancreatic Insufficiency; Hemoglobin started going down like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EW0186) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with Exocrine Pancreatic Insufficiency"; HAEMOGLOBIN DECREASED (non-serious), 3 months after the suspect product(s) administration, outcome "unknown", described as "Hemoglobin started going down like crazy". The patient underwent the following laboratory tests and procedures: Haemoglobin: going down, notes: hemoglobin started going down; Positron emission tomogram: Diagnosed with Exocrine Pancreatic Insufficiency, notes: Had to pay to get a PET scan that wasn't covered. They were looking for endocrine tumors; Pancreatic enzymes: Pancreas stopped producing enzymes. Clinical course: Patient had to take pancreatic enzymes now for the rest of his life. Everything started 2-3 months after receiving the Pfizer COVID-19 Vaccines.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46-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 (Batch/Lot number: unknown) at the age of 46 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicllin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL, start date: 01Dec2022; LISINOPRIL; METFORMIN ER; and multivitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (17Mar2023) and all described as "Treatment of COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 17Mar2023. After completing Paxlovid on 17March, the patient tested negative for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Eyelid disorder, Vision blurred
Clinical narrative: Blurred vision; The left eyelid uncontrollably jumps unexpectedly and continue from then until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 13Oct2021, for COVID-19 immunisation, reaction(s): "Blurred vision even in Daytime/ Vision was blurred"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VISION BLURRED (non-serious) with onset Jun2022, outcome "unknown", described as "Blurred vision"; EYELID DISORDER (non-serious) with onset Jun2022, outcome "not recovered", described as "The left eyelid uncontrollably jumps unexpectedly and continue from then until now".  Additional information: Inquiry: After the booster shot on 24Jun2022 and the morning after he started to experience even longer periods of blurred vision along with another symptom. The left eyelid uncontrollably jumps unexpectedly and continue from then until now. medical inquiry was forwarded.  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-202300133428 same patient/drug, different dose/event;
Age: 37.0
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) 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), 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: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Mental illness" (unspecified if ongoing). The patient had no known allergy. 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 including Paxlovid from 18Mar2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 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), outcome "unknown" and all described as "positive for COVID". 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. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300057980 same reporter product event, different patient;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Patient had no past drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2021, outcome "unknown" and all described as "Positive for COVID-19". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2021) Positive, notes: Blood test.  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 available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300132926 Same product, patient and different event;US-PFIZER INC-202300133156 Same product, patient and different event;
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: PRURITUS (non-serious), outcome "unknown", described as "itching". The event "itching" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy uterus, Platelet factor 4, Postmenopausal haemorrhage, Vitreous floaters
Clinical narrative: I have been having menstrual spotting three times since 2021; Floaters in my right eye started after 2nd vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 at 08:00 as dose 2, single (Lot number: EN6205) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus", start date: 1974 (ongoing); "High blood pressure", start date: 1999 (ongoing), notes: High blood pressure. The patient's family history included: "Diabetes", start date: 2018 (ongoing), notes: Diabetes (Aunt/Uncle). Concomitant medication(s) included: VALSARTAN oral taken for hypertension (ongoing); JENTADUETO taken for diabetes mellitus (ongoing); HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE] taken for lupus-like syndrome (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 08:30 AM, Anatomical Site of Injection: Right Arm, Route of administration: Intramuscular, Batch /Lot Number: EM9810), administration date: 21Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 2021, outcome "unknown", described as "Floaters in my right eye started after 2nd vaccine"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "I have been having menstrual spotting three times since 2021". The patient underwent the following laboratory tests and procedures: Biopsy uterus: (2021) Negative; Platelet factor 4: (unspecified date) Always ran low, notes: Test: Antibody test to platelet factor IV: Always ran low.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024719 same patient, vaccine, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had a rebound; had a rebound; This is a spontaneous report received from a contactable reporter (Consumer), Program ID: (RA). The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had a rebound".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Off label use
Clinical narrative: therapy with Pfizer COVID Booster for Rheumatoid arthritis; Chills; Not feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s):  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history included: "Aneurysm in heart" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "clogged artery" (unspecified if ongoing); "Smoker" (unspecified if ongoing); "Thyroid issues" (ongoing); "Cholesterol issues" (ongoing); "Trouble breathing" (ongoing); "cough" (ongoing); "Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR HFA; AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "therapy with Pfizer COVID Booster for Rheumatoid arthritis"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Not feel well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient got Covid after the 1st dose; Patient got Covid after the 1st dose; 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), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Virus " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient got Covid after the 1st dose".  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: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Nurse).  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (ongoing); "Drug allergies: Penicillin" (unspecified if ongoing), notes: Drug allergies: Penicillin. Concomitant medication(s) included: SERTRALINE taken for depression (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: positive rapid test; (Feb2023) Negative, notes: negative rapid testing; (Feb2023) Positive, notes: positive for 7 more days. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to a power outage. The highest temperature reached 59.4 F and the total excursion lasted 59 hours and 10 minutes with no reported adverse event; a patient received IPOL, with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA046769.  This case involves a patient of unknown age and gender and it was reported that temperature excursion due to a power outage; the highest temperature reached 59.4 f and the total excursion lasted 59 hours and 10 minutes and the patient received ipv (vero) [IPOL], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, temperature excursion due to a power outage, the highest temperature reached 59.4 f and the total excursion lasted 59 hours and 10 minutes with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received an unknown dose of ipv (vero) [IPOL] suspension for injection (batch/lot number, expiry date, strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (poor quality product administered) (latency: 1 day).  It was reported "A temperature excursion due to a power outage. The highest temperature reached 59.4 F and the total excursion lasted 59 hours and 10 minutes. However, the products were removed from the fridge and left at room temperature after they discovered the temperature excursion so the products have now been out of range for over 72 hours. No previous temperature excursions to report. None of the products have been administered post excursion. None of the products are supported by the extended stability information post excursion.  She is asking if she should complete the paperwork since no patient was involved during the temperature excursion, but a letter preceeding it says that aside from the temperature excursion, she had been involved with a patient that received ACTHIB and IPOL, but no patient were vaccinated."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 24-Mar-2023: Event added. Corresponding fields updated; text amended accordingly.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA096953.  This case involves a 3 months old male patient and reporter reported that an expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 20-Mar-2023, caller reported that 0.5 ml (milliliter) (1x) (once) of an expired HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ649AAA, expiry date: 05-Mar-2023) (Strength: standard) via intramuscular route in the thigh NOS for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: 1 same day).   No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of an expired product,with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 1 years old male patient and reporter reported administration of an expired HIB (PRP/T) Vaccine [ACT-HIB] ,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received 0.5 ml Total (1X) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot NUMBER: UJ49AAA; Expiry date: 05-Mar-2023) (Frequency- once) (Strength-standard)  (with an unknown strength) via unknown route in unknown administration site for Immunization.  On 22-Mar-2023, reporter reported administration of an expired HIB (PRP/T) Vaccine, with no reported adverse event (expired product administered) (Latency: same day).  It was reported, This situation is reported as a medication error due to the administration of an expired product.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient states having sudden blurry vision
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-