chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pyrexia
Clinical narrative: I develop a temperature of 102; Headache; I am sick/I am really not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Jun2023 as dose number unknown, 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. The following information was reported: HEADACHE (non-serious) with onset 14Jun2023, outcome "unknown"; PYREXIA (non-serious) with onset 14Jun2023, outcome "unknown", described as "I develop a temperature of 102"; MALAISE (non-serious) with onset Jun2023, outcome "unknown", described as "I am sick/I am really not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, malaise. Additional information: Consumer stated, "I took Pfizer BioNTech yesterday and last night I develop the temperature of 102 (degree) and I have a headache so I am calling find out do I need to go to the hospital or just take Tylenol or something?" Consumer stated, "Yes, I have a temperature and a headache, so I don't know I should go in to the hospital or should I just take some Tylenol because the information, it said if we have one of these side effects call, so that is why I am calling." As for lot, Consumer stated, "Well this person pen writing is trouble it looks, I cannot read this. It looks like 0253270. I am not even sure if that is, they have troubled penmanship. All of them it just looks like scribbled, it appears to be 0253270, I am reading it but I am not sure if that is the one. I got the vaccine yesterday 14Jun2023 (Further date and month could not be appropriately clarified) and then it has my patient number, my date of birth, it has no expiration." Consumer stated, "The LOT# that I just read to you, Pfizer BioNTech and it is a 2 and then the other number appear to be 0213270, I am not sure if that is correct because I am unable to read the penmanship." As for treatment, Consumer stated, "No, I called the number for the information. I do not take medicine."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart problems caused by Pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems caused by Pfizer vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: Loss of voice after Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: EN6199), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Anatomical Site of injection: Arm , Batch/Lot number: EN6198), administration date: 01Mar2021, for Covid-19 Immunization, reaction(s): "Loss of voice after Pfizer shots". The following information was reported: APHONIA (non-serious), outcome "not recovered", described as "Loss of voice after Pfizer shots". The event "loss of voice after pfizer shots" required physician office visit. Therapeutic measures were taken as a result of aphonia.  Additional information: It was reported that there was loss of voice and went to (withheld) 1st time. Botox with no positive results. Reportedly, loss of voice after Pfizer shots went to a Clinic and another clinic 12 times (presented as reported). No positive results. Never Pfizer again. Prior Vaccinations reported as Manufacturer Moderna Batch/Lot number was 1394.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300224001 same reporter/patient/AE, different dose;US-PFIZER INC-202300144501 same reporter/patient/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult 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: ILLNESS (non-serious), outcome "unknown", described as "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An adult 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: ILLNESS (non-serious), outcome "unknown", described as "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.".  Additional information: "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Gene mutation, Pain, Presyncope
Clinical narrative: molecular structure altered after receiving the vaccine to a third helix DNA instead of a two helix/ gave him a third helix in his DNA in his chromosomes/ third helix in his DNA in his chromosomes; felt he was to pass out too; chest is squeezing; body aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENE MUTATION (non-serious), outcome "unknown", described as "molecular structure altered after receiving the vaccine to a third helix DNA instead of a two helix/ gave him a third helix in his DNA in his chromosomes/ third helix in his DNA in his chromosomes"; PRESYNCOPE (non-serious), outcome "unknown", described as "felt he was to pass out too"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest is squeezing"; PAIN (non-serious), outcome "unknown", described as "body aching".  Additional Information: The reporter asked for the side effects of the vaccine. The reporter asked if the Pfizer COVID 19 vaccine mRNA alters the DNA, because the molecular structure of his was altered after receiving the vaccine to a third helix DNA instead of a two helix. Further wanted to know the chemical composition of the Covid-19 Vaccines; also wanted to know if Pfizer employees have also taken the Pfizer Covid-19 Vaccine. The reporter stated that it was killing a lot of people and did not understand why he had to take it, why it was mandated, even though  is not FDA approved, is not safe to give out into children, women adults, seniors, it's crazy times in this world, we are at the end of times. Stated that he has only 5-10 years of living and he will be dead by 2030 because of the vaccine, it gave so many adverse effects. Reporter mentioned that mentioned that he understands the mRNA changes the molecular structure of the DNA which gave him a "third helix in his DNA" in his chromosomes. He mentioned he felt he was to pass out too and had really bad symptoms for a few weeks, he still has weird symptoms, chest is squeezing, body aching and that he cannot explain it. Reporter also added that COVID was made and that Pfizer is giving the vaccine to depopulate to 880 million by 2030.  He reiterated that the vaccine altered his DNA and that he is not the same person he was before, because it gave him a third helix, and that now he does not have a gender anymore, no male nor female and stated the most common side effect of the vaccine is "passing out" and that Pfizer was trying to hide it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 at 15:30 as dose 8 (booster), single (Lot number: FL0447) at the age of 67 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), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown) and as dose 7 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date: 09Jun2023, Treatment stop date: 13Jun2023); Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225278 Same patient/product, different dose/events;US-PFIZER INC-202300225108 Same patient, different drug/AE.;
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 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: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient took Paxlovid for treatment of COVID-19 from 03Jun2023 to 07Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225098 Same reporter/patient, different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Near death experience
Clinical narrative: Passed out; She almost died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Passed out"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "She almost died". Clinical course: Reporter stated that his grandma passed out a few months ago and she almost died, right before that, the day before she took the vaccine, he thought it might have been adverse effect. Caller mentioned his grandma was the first to pass out.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225285 same reporter/drug, different patient/event;US-PFIZER INC-202300225284 same reporter/drug, different patient/event;US-PFIZER INC-202300225069 same reporter/drug, different patient/event;
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out". Clinical course: Caller also added his mum's friend also passed out, so it could not be related to their genes because "millions of Americans are dying from the vaccine."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225285 same reporter/vaccine, different patient/event;US-PFIZER INC-202300225283 same reporter/vaccine, different patient/event;US-PFIZER INC-202300225069 same reporter/vaccine, different patient/event;
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2022 as dose 3 (booster), single (Lot number: FP7135) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (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 "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took paxlovid from 09Jun2023 to 15Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225165 Same patient, different drug/Event;
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Body mass index, Cerebrovascular accident, Heart rate, Heart rate increased
Clinical narrative: minor strokes; Increased heart rate; Stopped absorbing iron; Stopped producing blood; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 1, single (Lot number: EP7543) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Surgery at 14" (not ongoing), notes: Surgery at 14, otherwise perfectly healthy. Normal BMI former college athlete.; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. There were no concomitant medications. The following information was reported: HEART RATE INCREASED (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Increased heart rate"; IRON DEFICIENCY (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Stopped absorbing iron"; BLOOD DISORDER (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Stopped producing blood"; CEREBROVASCULAR ACCIDENT (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "minor strokes". The patient was hospitalized for heart rate increased, iron deficiency, blood disorder (hospitalization duration: 4 day(s)). The events "minor strokes", "increased heart rate", "stopped absorbing iron" and "stopped producing blood" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) Normal; Heart rate: (07Apr2021) Increased; SARS-CoV-2 test: (unspecified date) Positive, notes: Took 20 different ones; post vaccination. Therapeutic measures were taken as a result of cerebrovascular accident, heart rate increased, iron deficiency, blood disorder. Clinical course: Patient had no known allergies. AE treatment: Blood transfusions, iron infusions for life  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Iron deficiency, SARS-CoV-2 test
Clinical narrative: minor strokes; Increased heart rate; Stopped absorbing iron; Stopped producing blood; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 1, single (Lot number: EP7543) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Surgery at 14" (not ongoing), notes: Surgery at 14, otherwise perfectly healthy. Normal BMI former college athlete.; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. There were no concomitant medications. The following information was reported: HEART RATE INCREASED (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Increased heart rate"; IRON DEFICIENCY (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Stopped absorbing iron"; BLOOD DISORDER (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "Stopped producing blood"; CEREBROVASCULAR ACCIDENT (hospitalization, life threatening) with onset 07Apr2021 at 12:00, outcome "recovered with sequelae", described as "minor strokes". The patient was hospitalized for heart rate increased, iron deficiency, blood disorder (hospitalization duration: 4 day(s)). The events "minor strokes", "increased heart rate", "stopped absorbing iron" and "stopped producing blood" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) Normal; Heart rate: (07Apr2021) Increased; SARS-CoV-2 test: (unspecified date) Positive, notes: Took 20 different ones; post vaccination. Therapeutic measures were taken as a result of cerebrovascular accident, heart rate increased, iron deficiency, blood disorder. Clinical course: Patient had no known allergies. AE treatment: Blood transfusions, iron infusions for life  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 09Jun2023 to 15Jun2023. No other medication in 2weeks.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300226102 Same patient, different drug/ events;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Diagnosed on Tuesday positive Covid with home test; Diagnosed on Tuesday positive Covid with home test; Moderna Covid booster on 20Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3248), on 05Feb2021 as dose 2, single (Lot number: EL964), on 09Oct2021 as dose 3 (booster), single (Lot number: 301258A) and on 05May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Dec2022 as dose 5 (booster), single (Lot number: 023422A) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "knee pain" (unspecified if ongoing); "sciatic, mostly left side sciatic" (unspecified if ongoing); "hysterectomy" (not ongoing), notes: complete hysterectomy in the 1990's.; "gallbladder removed" (not ongoing), notes: gallbladder removed in the 1990's; "appendix removed" (not ongoing), notes: appendix removed in the 1990's. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); OXYCODONE taken for arthralgia, sciatica (ongoing); FLU VACCINE VII taken for influenza immunisation as dose number unknown, single; SHINGRIX taken for varicella immunisation as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for pneumococcal immunisation as dose number unknown, single as dose number unknown, single. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Dec2022, outcome "unknown", described as "Moderna Covid booster on 20Dec2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Diagnosed on Tuesday positive Covid with home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller mentioned last week she was diagnosed with Covid even though she got all the shots and boosters. The Covid was not a lot of mucous, it was a runny nose and cough. She had all Pfizer Shots and last booster and flu and shingle and both pneumonia vaccines. Shouldn't had taken it. It made her worse. Going through changes in her body that she didn't have before Covid. Doesn't like how she felt. Diagnosed on Tuesday positive Covid with home test started Paxlovid on Friday thinks it was 02Jun2023 or possibly 26May2023.  Didn't have covid this last week or last.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225043 Same patient, different drug/ events;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Jul2022 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Jul2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 28Aug2021 as dose 5 (booster), single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "hypothyroid" (ongoing), notes: on treatment for hypothyroid; "GERD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 04Jun2023 to 08Jun2023. No Other medication in 2 weeks. No Known allergies.  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-202300225109 Same patient, different drug/ events;US-PFIZER INC-202300226199 Same Reporter/Patient/Drug, Different Vaccine Dose;US-PFIZER INC-202300226198 Same Reporter/Patient/Drug, Different Vaccine Dose;
Age: 37.0
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 non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date: 07Jun2023, Treatment stop date: 11Jun2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the sub product , BNT162B2 vaccine, cannot be excluded for suspected LOE.  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-202300226209 same patients, different drugs and events;
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 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: ILLNESS (non-serious), outcome "unknown", described as "sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Neurological symptom
Clinical narrative: Patient had a "stroke like" reaction; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Patient had a "stroke like" reaction". Clinical course: The customer reported that the patient received a dose of Prevnar "any" years ago (date unknown), and the patient had a "stroke like" reaction to Prevnar. The customer said the patient is needing to undergo surgery soon and need a dose of pneumonia vaccine. Type of surgery unknown by reporter.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event "stroke like reaction" with PREVNAR 13 can not be fully excluded.  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.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Cardiac disorder, Skin disorder
Clinical narrative: a skin disorder; I am also having heart anxiety problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 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: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "a skin disorder"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I am also having heart anxiety problems". The events "a skin disorder" and "i am also having heart anxiety problems" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient now had a skin disorder that was a mystery to four doctors: urgent care, dermatologist (including a biopsy), autoimmune specialist, primary care physician, and patient was being referred to a hematologist. The patient was also having heart anxiety problems.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Periorbital swelling
Clinical narrative: acquired an extreme allergic reaction with red puffiness around my eyes; acquired an extreme allergic reaction with red puffiness around my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 HYPERSENSITIVITY (non-serious), PERIORBITAL SWELLING (non-serious), outcome "unknown" and all described as "acquired an extreme allergic reaction with red puffiness around my eyes".  Additional information: the patient had acquired an extreme allergic reaction with red puffiness around eyes after receiving the Pfizer vaccine series and 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: Linked Report(s) : US-PFIZER INC-202300223992 same patient/reporter; different dose/AE;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: the pain in my shoulder and upper arms never went away; the pain in my shoulder and upper arms never went away; can't hardly raise my arms up specially my right arm that I got 2 or 3 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "the pain in my shoulder and upper arms never went away"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "not recovered", described as "can't hardly raise my arms up specially my right arm that I got 2 or 3 shots".  Additional information: Ever since the patient got Covid shots the pain in shoulder and upper arms never went away. Now after a few years it got even worse. The patient used to do 50-100 push ups a day. Patient can't hardly raise arms up specially right arm that got 2 or 3 shots. Patient cannot handle this pain any more after 2 and half years. The patient was a strong healthy person and seldom like to go to a doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Hey Pfizer, you can stuff your newest money making Covid medication up your ass along with your ineffective and mislabeled vaccine; Hey Pfizer, you can stuff your newest money making Covid medication up your ass along with your ineffective and mislabeled vaccine; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Hey Pfizer, you can stuff your newest money making Covid medication up your ass along with your ineffective and mislabeled vaccine".  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: Anaphylactic reaction
Clinical narrative: anaphylaxis reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction".  Clinical course: It was reported that the outcome of the event as unknown and considered that the event was caused by the suspect product. The patients age was reported in the group of 50-99 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult 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: ILLNESS (non-serious), outcome "unknown", described as "I got 3 shots but never went for the booster. Made me sick each time. Don't feel like being sick.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Laboratory test, Loss of consciousness, Musculoskeletal disorder
Clinical narrative: passed out; Violent pains in stomach; lost all use in limbs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD-2023-729228 (Moderna).  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "passed out"; ABDOMINAL PAIN UPPER (hospitalization), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "Violent pains in stomach"; MUSCULOSKELETAL DISORDER (hospitalization), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "lost all use in limbs". The patient underwent the following laboratory tests and procedures: tests: unknown result. Clinical course: Reporter was looking for advice on safety of the latest covid spring vaccine, as he was unable to get any information from the local doctors. At present time, they were both unsure whether or not to have the vaccine. He and his wife were in mid to late seventies, When she had the fifth (Pfizer vaccine), 2 weeks later she had violent pains in stomach, lost all use in her limbs and passed out, then finished up in Hospital for a day having tests. When she had the sixth (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), 2 weeks later, she got Oedema in her ankles and feet, together with her immune system attacking her hands arms and shoulders, which was put down to Rheumatoid Arthritis. The above situations seems too co-insidential. Reporter at that time put the information on the "yellow card system" His wife was also in part remission after having chemotherapy for T cell lymphoma and also took methatrexate for the arthritis.  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, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; Suffering from long COVID for the past 10 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000637 (Novavax).  A female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown), on 11Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 09Jan2022 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: POST-ACUTE COVID-19 SYNDROME (non-serious) with onset 18Aug2022, outcome "unknown", described as "Suffering from long COVID for the past 10 months"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical course: Not doing really well at all.  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: Fear, Middle insomnia, Tremor, Weight, Weight increased
Clinical narrative: gained weight; Shaking; Fear of COVID; wakes up at night; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained weight"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; FEAR (non-serious), outcome "unknown", described as "Fear of COVID"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "wakes up at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Withheld called in asking for more information about boosters for COVID-19 and would like to know the strength of the vaccines as he was concerned if he had taken enough shots of it to be immune to the virus. He said that he gained weight and wakes up at night shaking due to the fear of COVID.  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: Fear
Clinical narrative: scared; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). 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: FEAR (non-serious), outcome "unknown", described as "scared".  Additional information: Caller is asking for the chemical composition of the Pfizer COVID-19 vaccine, saying the vaccine that is killing everybody, caller and her grandmother recently received the vaccine. They are scared with the vaccine than they are with COVID. They called recently and were yelled at like mental patients. They don't understand why they need to get the vaccine to get a job. Asking are they the only one who gets all these complications.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Near death experience
Clinical narrative: Her grand mother passed out and almost died; Her grand mother passed out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  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 included: "Heart complications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Her grand mother passed out and almost died"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Her grand mother passed out". Clinical Course: Caller stated that her grandmother recently received the vaccine passed out and almost died. Her grandmother had heart complication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300108185 same reporter and drug, different patient and event;