chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; 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 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 at 11:00 as dose 1, single (Lot number: EN6206), in right arm, on 03Apr2021 at 11:00 as dose 2, single (Lot number: ER8734), in right arm and on 24Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Nov2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) positive, notes: Test positive for covid on 17Nov2022; (21Nov2022) Negative, notes: test negative on 21Nov2022; (26Nov2022) positive, notes: repeat the test 26Nov morning getting a positive; (29Nov2022) positive, notes: Today is 29Nov still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Per clinical course, patient tested positive for covid on 17Nov2022 and started paxlovid lowdose (renal patient) on 18Nov2022 then tested negative on 21Nov2022. Last day of treatment was on 22Nov2022. Symptoms came back on 25Nov night: runny & stuffy nose, fatigue, sore throat and repeated the test on 26Nov morning and getting a positive. Today was 29Nov and still testing positive with fatigue and headache.
Sex: U
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Immune system disorder
Clinical narrative: got ALS after the vaccine; damaged immune system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "got ALS after the vaccine"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "damaged immune system ". It was reported that the patient got the same (ALS and damaged immune system) after the vaccine.  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-202201341349 Same reporter, drug and event; different patient.;US-PFIZER INC-PV202200114181 Same reporter, drug and event; different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days"; Bnt162b2 (DOSE 3, BOOSTER (SINGLE)), for COVID-19 immunization. The following information was reported: DYSMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "received the second booster in October; experiencing similar side effects that my menstrual cycle is again delayed with just very painful cramps because I haven't started yet, but it's delayed".    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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO, start date: 01Sep2022; LEVOTHYROXINE, start date: 01Sep2022. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 19Nov2022 to 24Nov2022.  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: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever; fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL1284) for covid-19 immunisation. The patient's relevant medical history included: "I have had ammenorhea (absent menstrual cycle) for 6 years", start date: 2015 (ongoing), notes: had ammenorhea (absent menstrual cycle) for 6 years. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".   Additional information: Patient had no known allergies or other medical history. Patient did not have covid prior vaccination. With the first dose, patient had fever, fatigue, and a sore arm. Patient did not have other vaccine in four weeks. Other medications in two weeks included Birth control pills. Patient was tested (nasal swab test) positive for covid post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341882 same patient and drug, different dose/different event separated in time;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Body aches; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Batch/Lot No: Unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 29Nov2022, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset 29Nov2022, outcome "not recovered", described as "Headache ". Therapeutic measures were taken as a result of headache, pain.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 29Nov2022 at 15:15 as dose 5 (booster), single (Lot number: GJ5342) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 07Nov2022 as dose 1, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EN6205; Anatomical location: Arm Right; Administration Time: 12:00 PM), administration date: 09Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot No: ER8727; Anatomical location: Arm Left; Administration Time: 12:00 PM), administration date: 31Jul2021, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: 330308D; Anatomical location: Arm Left; Administration Time: 12:00 PM), administration date: 02Dec2021, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot No: FJ4991; Anatomical location: Arm Left; Administration Time: 03:45 PM), administration date: 12Jul2022, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "Very dizzy"; VERTIGO (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "horrible vertigo"; BALANCE DISORDER (non-serious) with onset 29Nov2022 at 16:00, outcome "not recovered", described as "unsteady". Therapeutic measures were taken as a result of vertigo, dizziness, balance disorder.  Additional information: Within 1 hours of vaccination the patient started suffering from horrible vertigo. Never experienced anything like this. The patient was wondering if had been drugged with some sort of narcotic. Almost 24 hours later still had it. Very dizzy and unsteady. The patient had no adverse reactions to previous COVID vaccinations. The patient didn't experienced covid prior vaccination. The patient was not tested for covid post vaccination. The Other medical history was reported as none (as reported).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Musculoskeletal discomfort, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "left knee replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 11May2022, outcome "unknown", described as "all of sudden patient arm was like it had no feeling"; PAIN (non-serious) with onset 11May2022, outcome "unknown", described as "could not control it almost, it was very, not in pain, not pain but throbbing pain but it was like pin sticking all in"; SENSORY LOSS (non-serious) with onset 11May2022, outcome "recovered", described as "my arm it was like it had no feeling"; ARTHRALGIA (non-serious) with onset May2022, outcome "not recovered", described as "elbow was still painful"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "I have feeling in my arm, yes. But it is just painful"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset 2022, outcome "unknown", described as "hip hurts and patient cannot sleep on that side over there"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "my shoulder still bothers me"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2022, outcome "unknown", described as "patient cannot straighten it out but staying on it to straighten it all the time and cannot straighten it out and it was straight at that time".  The patient was not neglecting the fact that, had left knee replacement. But the patient does not see why that should have anything to do with last booster shot. The first 3 did not bothered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Sensory loss, Sleep disorder due to a general medical condition
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "left knee replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 11May2022, outcome "unknown", described as "all of sudden patient arm was like it had no feeling"; PAIN (non-serious) with onset 11May2022, outcome "unknown", described as "could not control it almost, it was very, not in pain, not pain but throbbing pain but it was like pin sticking all in"; SENSORY LOSS (non-serious) with onset 11May2022, outcome "recovered", described as "my arm it was like it had no feeling"; ARTHRALGIA (non-serious) with onset May2022, outcome "not recovered", described as "elbow was still painful"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "I have feeling in my arm, yes. But it is just painful"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset 2022, outcome "unknown", described as "hip hurts and patient cannot sleep on that side over there"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "my shoulder still bothers me"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2022, outcome "unknown", described as "patient cannot straighten it out but staying on it to straighten it all the time and cannot straighten it out and it was straight at that time".  The patient was not neglecting the fact that, had left knee replacement. But the patient does not see why that should have anything to do with last booster shot. The first 3 did not bothered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 47 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: "Asthma" (unspecified if ongoing); "Shellfish" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Started Paxlovid on 17Nov2022 until 21Nov2022.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Positron emission tomogram, Ultrasound abdomen
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 59-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EW0162) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1,  Unknown, Lot: EN6204, Expiration: Unknown, Dose given: Unknown, Time given: Unknown, Anatomical location: Left arm), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Series or bunch of swollen lymph nodes popped up after the second vaccine/find another option instead of having walnuts in his arms and neck". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had received the 3 covid vaccines, over the past 1.5 years. He had a series or a whole bunch of swollen lymph nodes which popped up at the 2nd vaccine." He has been tested and had a PET scan that revealed no cancer but he still had a multitude of swollen nodes, and he believed they were linked to the vaccine. He was looking for a solution.He was looking for treatment options. He noted that the doctors "were scratching their head at this point and did not know what to do other than cut him open and pull lymph nodes out" which he did not think it was a good alternative.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest pain, Interchange of vaccine products, Malaise
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: 2012 (ongoing), notes: high blood pressure diagnosed 10 years ago. Concomitant medication(s) included: LISINOPRIL taken for hypertension, blood pressure abnormal;     All of her previous COVID 19 vaccines have been four shots Moderna and she got the Pfizer COVID19 booster because the pharmacy did not have the Moderna booster available and said it was ok to mix them; the last booster dose of Moderna was in May and she had no side effects at all to the Moderna vaccines she received; also had a flu shot on 07Nov2022, she does not know the name of it or the manufacturer or lot, expiry date or to provide but it was at the doctor's office. Her last booster dose was in May, and it was Moderna. She had no side effects to the Moderna vaccines. She had a flu shot 10Oct2022. Her patient card has no expiry date or for the Pfizer COVID booster dose. Had no treatment for the reported events. She had a dentist's appointment she was scared to took and she did not want to put any more chemicals in her body because she does not feel well and was cancelling her dentist's appointment due to not feeling well. No investigation and conditions were reported. These events do not require a visit to Emergency room. It was reported that the case was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: still contracting Covid 19 virus/ tested positive; still contracting Covid 19 virus/ tested positive; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 "still contracting Covid 19 virus/ tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She tested positive on Tuesday morning and took 3 tests to confirm;  Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.  Additional information: Main symptom reported was scratchy/sore throat. States it is a light case.   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: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: vision loss; 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 female patient 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization; Bnt162b2 (Dose: 3), for Covid-19 immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "vision loss".  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "Supplement" (unspecified if ongoing); "Compromised immune system" (unspecified if ongoing); "APL leukemia", start date: 05Mar2020, stop date: 26Nov2020; "cancerous tumor" (unspecified if ongoing). The patient's family history included: "Parkinson's disease" (unspecified if ongoing), notes: father; "Brain stem stroke" (unspecified if ongoing), notes: mother; "Glioblastoma" (unspecified if ongoing), notes: sister. Concomitant medication(s) included: APIXABAN taken for atrial fibrillation, start date: 2018 (ongoing); METOPROLOL taken for atrial fibrillation, start date: 2018 (ongoing); CALCIUM & VITAMIN D3 taken for supplementation therapy, start date: 2018 (ongoing). Past drug history included: Cipro, reaction(s): "Nausea"; Bupropion, reaction(s): "Nausea". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, 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 available information, a lack of efficacy (vaccination failure and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke and is now unable to take care of himself after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), described as "had a stroke and is now unable to take care of himself after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative Colitis flare ups due to covid vaccination; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4166223.  A 39-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 01Jan2021, outcome "not recovered", described as "Ulcerative Colitis flare ups due to covid vaccination".  The reporter's causality for the event(s) of Ulcerative Colitis flare ups due to covid vaccination with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Regulatory Authority opinion was that the causality for the event(s) of Ulcerative Colitis flare ups due to covid vaccination with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported event colitis ulcerative .Case will be reviewed further on receipt of FU information . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (Unknown).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Additional information: What makes the Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines? I don't know much about the other vaccines except that Johnson & Johnsons wasn't good and my mom develop blood clots after reviewing hers. She used Pfizer I believe.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had covid a few months ago; Had covid a few months ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid a few months ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was a little sore after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 33-year-old female 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was a little sore after the first shot".  Additional information: The patient was relieved get first [Pfizer] Covid vaccine. The patient was worried about possible side effects and watched short film which mentioned the most common side effects and the fear/concern came back to the patient. The patient's arm was little sore after the first shot.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: I got the [Pfizer] vaccine and then I got Covid; I got the [Pfizer] vaccine and then I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the [Pfizer] vaccine and then I got Covid".  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: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Felt weird/ Felt bad; Headache; Pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt weird/ Felt bad"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in my arm".  Additional information: Patient felt weird because the shots made her have a headache and pain in her arm for over 2 days. All she did was sleep and felt bad.  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: Head discomfort, Muscle disorder, Pain
Clinical narrative: affected the muscles; affected the muscles and the overall body more than the head or the brain; affected the muscles and the overall body more than the head or the brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: I had very bad long covid. The patient's concomitant medications were not reported. The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "affected the muscles"; HEAD DISCOMFORT (non-serious), PAIN (non-serious), outcome "unknown" and all described as "affected the muscles and the overall body more than the head or the brain".  Additional information: It was the only safe vaccine for patient. She had very bad long covid and Pfizer basically saved her. The fact that it affected the muscles and the overall body more than the head or the brain. She really couldn't take moderna.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUX, UNK, UNK
Symptoms: Bone pain, Diarrhoea, Fatigue, Nausea, Off label use
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; treprostinil sodium (REMODULIN), first regimen since 26Sep2022 (ongoing) (Batch/Lot number: unknown), second regimen since 2022 (ongoing) (Lot number: 2102128, Expiration Date: 31May2023) at 0.014 ug/kg, subcutaneous and third regimen since 2022 (ongoing) (Lot number: 2102233, Expiration Date: 31Oct2023) at 0.026 ug/kg, subcutaneous for pulmonary arterial hypertension; gabapentin (GABAPENTIN), (Batch/Lot number: unknown) for bone pain. The patient's relevant medical history included: "primary pulmonary arterial hypertension." (ongoing); "Bone pain" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovering", described as "Tired"; NAUSEA (non-serious), DIARRHOEA (non-serious), BONE PAIN (non-serious) all with onset 2022, outcome "recovering" and all described as "With each Remodulin dose titration has nausea, diarrhea and severe bone pain"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Nov2022, outcome "unknown" and all described as "On 12Nov2022 (Saturday), the patient got his COVID and Flu vaccine". The action taken for treprostinil sodium was dosage increased; for gabapentin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUX, UNK, UNK
Symptoms: Product use issue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; treprostinil sodium (REMODULIN), first regimen since 26Sep2022 (ongoing) (Batch/Lot number: unknown), second regimen since 2022 (ongoing) (Lot number: 2102128, Expiration Date: 31May2023) at 0.014 ug/kg, subcutaneous and third regimen since 2022 (ongoing) (Lot number: 2102233, Expiration Date: 31Oct2023) at 0.026 ug/kg, subcutaneous for pulmonary arterial hypertension; gabapentin (GABAPENTIN), (Batch/Lot number: unknown) for bone pain. The patient's relevant medical history included: "primary pulmonary arterial hypertension." (ongoing); "Bone pain" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovering", described as "Tired"; NAUSEA (non-serious), DIARRHOEA (non-serious), BONE PAIN (non-serious) all with onset 2022, outcome "recovering" and all described as "With each Remodulin dose titration has nausea, diarrhea and severe bone pain"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 12Nov2022, outcome "unknown" and all described as "On 12Nov2022 (Saturday), the patient got his COVID and Flu vaccine". The action taken for treprostinil sodium was dosage increased; for gabapentin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Interchange of vaccine products, Myalgia, Vaccination site erythema
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 26-year-old female patient 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 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for Covid-19 immunization; Bnt162b2 (Dose-2), for Covid-19 immunization; Moderna (Dose-3), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; HEADACHE (non-serious), outcome "recovered"; CHILLS (non-serious), outcome "recovered"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "a red, swollen, itchy, and warm injection site (commonly known as COVID arm)".  Additional information: Patient experienced negative side effects following the fourth COVID booster vaccine (bi-valent). These side effects included muscle aches, headache, and chills for one day, as well as a red, swollen, itchy, and warm injection site (commonly known as COVID arm) for approximately three days. Optional Information: Patient has previously received the initial two Pfizer shots, a Moderna booster, and now this bivalent Pfizer booster. Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms. Patient has no comorbidities and was currently not taking any medication.  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: COVID19-2
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 26-year-old female patient 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 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for Covid-19 immunization; Bnt162b2 (Dose-2), for Covid-19 immunization; Moderna (Dose-3), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; HEADACHE (non-serious), outcome "recovered"; CHILLS (non-serious), outcome "recovered"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "a red, swollen, itchy, and warm injection site (commonly known as COVID arm)".  Additional information: Patient experienced negative side effects following the fourth COVID booster vaccine (bi-valent). These side effects included muscle aches, headache, and chills for one day, as well as a red, swollen, itchy, and warm injection site (commonly known as COVID arm) for approximately three days. Optional Information: Patient has previously received the initial two Pfizer shots, a Moderna booster, and now this bivalent Pfizer booster. Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms. Patient has no comorbidities and was currently not taking any medication.  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: COVID19
Symptoms: Adverse event following immunisation, Brief resolved unexplained event
Clinical narrative: My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine; My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (life threatening), ADVERSE EVENT FOLLOWING IMMUNISATION (life threatening), outcome "unknown" and all described as "My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu and still have it; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced still got the flu and still have it while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious still got the flu and still have it (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu and still have it).  At time of reporting, the outcome was Unknown for the event still got the flu and still have it.
Sex: U
Vaccine: FLUX
Symptoms: Gait disturbance
Clinical narrative: trouble walking; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced trouble walking while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Influenza immunisation.  On an unknown date the patient developed a non-serious trouble walking (gait disturbance) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (trouble walking).  At time of reporting, the outcome was Unknown for the event trouble walking.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I said it got my shot and got the flu; Initial information received on 25-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i said it got my shot and got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown at this time via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious i said it got my shot and got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I said it got my shot and got the flu).  At time of reporting, the outcome was Unknown for the event i said it got my shot and got the flu.