chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Feeling abnormal, Hallucination
Clinical narrative: I was hallucinating; Fever; Chills; Headache; Abdominal pain; Nausea; I was weak; Couldn't get to sleep; life miserable; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old patient of an unspecified gender received bnt162b2 (Batch/Lot Number: EW0175), Solution for injection, via an unspecified route of administration (dose 2), administered in arm right on 27Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing depression. Concomitant medication included fluoxetine hydrochloride (PROZAC) Oral, at 40 mg, daily for depression. In Apr2021, patient suffered from fever, chills, headache, abdominal pain and nausea. Patient stated 'worst part of it was I could not get to sleep because I thought that if I sleep through it I will get through the symptoms of vaccine. I expected some problems but not as many as I had. When I tried to go to sleep I could not sleep. I was awake for 24 hours no matter how hard I tried to go to sleep. I had taken Aleve for the pain (treatment). Nothing worked. After 24 hours I eventually was able to fall asleep. When I woke up I was weak and I was hallucinating in Apr2021 but the fever is gone and now I just feel weak and frankly I am a little angry. I had a severe reaction to this vaccine second dose and I had it within 12 hours of the injection and it really made my life miserable for 24 hours at least. I was just in misery I was not just uncomfortable I was in misery and I am really upset with it and if I had known that I was going to be this sick I never would have given myself opportunity of having 2nd shot and my concern after having 2nd shot is what's gonna happen to me down the road. I am now afraid that you cannot put this kind of medicine under my arm without having serious problems happening down the road'. The outcome of the event fever is recovered in Apr2021 and outcome of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Pyrexia
Clinical narrative: I was hallucinating; Fever; Chills; Headache; Abdominal pain; Nausea; I was weak; Couldn't get to sleep; life miserable; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old patient of an unspecified gender received bnt162b2 (Batch/Lot Number: EW0175), Solution for injection, via an unspecified route of administration (dose 2), administered in arm right on 27Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing depression. Concomitant medication included fluoxetine hydrochloride (PROZAC) Oral, at 40 mg, daily for depression. In Apr2021, patient suffered from fever, chills, headache, abdominal pain and nausea. Patient stated 'worst part of it was I could not get to sleep because I thought that if I sleep through it I will get through the symptoms of vaccine. I expected some problems but not as many as I had. When I tried to go to sleep I could not sleep. I was awake for 24 hours no matter how hard I tried to go to sleep. I had taken Aleve for the pain (treatment). Nothing worked. After 24 hours I eventually was able to fall asleep. When I woke up I was weak and I was hallucinating in Apr2021 but the fever is gone and now I just feel weak and frankly I am a little angry. I had a severe reaction to this vaccine second dose and I had it within 12 hours of the injection and it really made my life miserable for 24 hours at least. I was just in misery I was not just uncomfortable I was in misery and I am really upset with it and if I had known that I was going to be this sick I never would have given myself opportunity of having 2nd shot and my concern after having 2nd shot is what's gonna happen to me down the road. I am now afraid that you cannot put this kind of medicine under my arm without having serious problems happening down the road'. The outcome of the event fever is recovered in Apr2021 and outcome of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Head discomfort, Limb injury, Malaise
Clinical narrative: I had a seizure and I have never had a seizure in all my life; It was like my lungs are about to collapse and especially my left lung; Difficulty in breathing; Dizziness; Have been bothered with my hand; Have been terrible ever since I had my shot; My first symptom was like in my head, it was like sinus pressure; My first symptom was like in my head, it was like sinus pressure; This is a spontaneous report from a contactable consumer. A 65-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, had been having difficulty in breathing, dizziness, bothered with hand and have been terrible ever since had the shot, had never felt like this before. These symptoms started like about two weeks after taking the first one and first symptom was like in my head, it was like sinus pressure and everything but now, it has gone. And it just kept going on for about two weeks. Then on March the 11th, the patient went to doctor and told him about how the feeling was, and they gave a shot, a steroid shot (Unspecified Medication) as he was having difficulty breathing, like lungs are about to collapse and especially left lung and then, was okay for a day or so and two days after. The patient had a seizure and never had a seizure in all life of 65 years. The patient had to go to the hospital. The patient does not feel well. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pneumothorax, Seizure
Clinical narrative: I had a seizure and I have never had a seizure in all my life; It was like my lungs are about to collapse and especially my left lung; Difficulty in breathing; Dizziness; Have been bothered with my hand; Have been terrible ever since I had my shot; My first symptom was like in my head, it was like sinus pressure; My first symptom was like in my head, it was like sinus pressure; This is a spontaneous report from a contactable consumer. A 65-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, had been having difficulty in breathing, dizziness, bothered with hand and have been terrible ever since had the shot, had never felt like this before. These symptoms started like about two weeks after taking the first one and first symptom was like in my head, it was like sinus pressure and everything but now, it has gone. And it just kept going on for about two weeks. Then on March the 11th, the patient went to doctor and told him about how the feeling was, and they gave a shot, a steroid shot (Unspecified Medication) as he was having difficulty breathing, like lungs are about to collapse and especially left lung and then, was okay for a day or so and two days after. The patient had a seizure and never had a seizure in all life of 65 years. The patient had to go to the hospital. The patient does not feel well. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: My wife is having side effects that have to do with the formation of blood clots in the reproductive system.; This is a spontaneous report from a contactable consumer (consumer's wife). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration Date were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter has been reporting on COVID. His wife and he has been vaccinated. His wife was having side effects that have to do with the formation of blood clots in the reproductive system. Consulted in different forums in two countries there are many women reporting the same. The outcome of event was unknown on an unspecified date.  Information on lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021; Nasal swab Positive; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) (at the age of 86 years old) as single dose for COVID-19 immunization. Medical history included gastro-intestinal problem. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was admitted to the emergency room on 31Mar2021 the morning after receiving the vaccine. The patient was hospitalized for two days. It was unknown if treatment was given. This event (Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021) resulted in emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event) and patient died. The patient died on 07Apr2021. The patient's nasal swab was positive on 31Mar2021. The outcome of the event nasal swab was positive was unknown. It was not reported if an autopsy was performed.  Information on batch/lot number has been requested.; Reported Cause(s) of Death: Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 01May2021 10:30 (at the age of 59-years-old) as a single dose for covid-19 immunization. The vaccine was administered at the Pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The next day morning on 02May2021 05:00, the patient experienced chest pain. The event was considered as life-threatening. It was unknown if the patient received treatment for the event. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Paralysis, SARS-CoV-2 test
Clinical narrative: had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events  resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Haemorrhage, Headache, Hypersensitivity
Clinical narrative: he was in the hospital for 10 days he said he almost died; he blisters that he had were bleeding; getting blisters on his face and then it went to his neck and went to his head then to his arm; headache; fever; chill; allergic reaction to the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had with the first dose of the COVID vaccine on 26Mar2021. He after the first dose he started getting blisters on his face and then it went to his neck and went to his head then to his arm on an unspecified date in 2021. He was in the hospital for 10 days he said he almost died. He had the headache, fever, chill the blisters that he had were bleeding on an unspecified date in 2021. He said something about a medical report due to a biopsy and he wanted to know the next step and said that he needed a certificate that he has an allergic reaction to the vaccine, because of travelling because his doctor told him that he shouldn't receive his second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience, Pyrexia
Clinical narrative: he was in the hospital for 10 days he said he almost died; he blisters that he had were bleeding; getting blisters on his face and then it went to his neck and went to his head then to his arm; headache; fever; chill; allergic reaction to the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had with the first dose of the COVID vaccine on 26Mar2021. He after the first dose he started getting blisters on his face and then it went to his neck and went to his head then to his arm on an unspecified date in 2021. He was in the hospital for 10 days he said he almost died. He had the headache, fever, chill the blisters that he had were bleeding on an unspecified date in 2021. He said something about a medical report due to a biopsy and he wanted to know the next step and said that he needed a certificate that he has an allergic reaction to the vaccine, because of travelling because his doctor told him that he shouldn't receive his second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Infarction, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: blood clots in left lung which turned into an infarction; blood clots in left lung which turned into an infarction; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration, administered on the left arm on 15Jan2021 (at the age of 40-year-old) at a single dose for COVID-19 immunisation. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had blood clots in left lung which turned into an infarction on 22Feb2021. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events which included blood thinners and anti-inflammatory meds. COVID test post vaccination on 03Mar2021 Nasal Swab: Negative. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely fo rBNT162B2 since there is no plausible mechanism implicating the subject drug to the events. The case will be reassessed should additional information become available. 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: Condition aggravated, Immune system disorder, Lupus-like syndrome, Sjogren's syndrome
Clinical narrative: symptoms of lupus; sjogrens syndrome; immune system goes wacko; The vaccine woke/caused a disease to flare that was already in her; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient received first dose of BNT162B2 on Feb2021 (lot Number: en6201, expiration date: 30Jun2021) and second dose on Mar2021 (lot Number: en6199, expiration date: 30Jun2021): both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had side effects to the first and second dose but not as bad to the first. The vaccine woke/caused a disease to flare that was already in her. She had symptoms of lupus and sjogrens syndrome and right after the vaccine she got it. Patient got the shot and her immune system went wacko. She had been monitored for rheumatoid factor. There was no other causation for her experience. Reporter thought the reaction was due to her condition and not the vaccine. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID on 12Feb2021; Got COVID on 12Feb2021; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program. A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunisation. Medical history included neoplasm malignant with some radiotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Feb2021, patient experienced got COVID. On 21Feb2021 'bam' infusion was given as treatment. On 12Feb2021, patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of got COVID on 12Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot on the cerebellum that caused a stroke; Blood  clot on the cerebellum that caused a stroke; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167), first dose via an unspecified route of administration, administered in Arm Left on 30Apr2021 11:30 (at 29 years old,(not pregnant), single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included an unspecified vitamin.  The patient previously took ibuprofen and experienced Ibuprofen drug allergy. On 02May2021 08:30, patient experienced a Blood clot on the cerebellum that caused a stroke. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in visit to Emergency room/department or urgent care. Treatment received for the adverse event was Blood clot meds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (02May2021), negative for swab test. Events caused 3 days of hospitalization.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's daughter). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) first dose on 28Feb2021 and second dose on 21Mar2021 (both at the age of 73-years-old) via unspecified routes of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation after the first and second dose, both occurred two days after injection (on 02Mar2021 and 23Mar2021, respectively). The event lasted for approximately 12 hours with each episode. Outcome of the event was recovered in Mar2021.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Alcohol use, Suicidal ideation
Clinical narrative: "combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide; "combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide; This is a spontaneous report from a contactable consumer (patient's brother). A 35-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 13Apr2021 (Tuesday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Apr2021 (Wednesday) night, after "combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide. The patient was placed in a 72 hour psychiatric hold. The patient was "being monitored and medicated" and that there is no other follow-up to report. The outcome of the events was unknown at the reporting time.   Follow up attempts are needed; information about batch/lot number can be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Joint injury, Muscle strain, Soft tissue injury
Clinical narrative: DVT symptoms occurred after first dose and was undiagnosed; soft tissue injury; muscle pull and ankle strain; muscle pull and ankle strain; This is a spontaneous report from a contactable nurse. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm on 23Feb2021 at 13:30 (Batch/Lot Number: EN6200) at a single dose for COVID-19 immunization. Medical history included a family history of diabetes - his mother had diabetes. The patient's concomitant medications were not reported. DVT symptoms occurred in Feb2021 after the first dose and was undiagnosed. He treated it as soft tissue injury and thought it was a muscle pull and ankle strain. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose 01apr2021 and was scheduled for her second 22Apr2021, but before she got her second dose, on 14Apr2021, she tested positive for COVID. The outcome of the event was unknown.   Information on Batch number/Lot number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: received his second dose of the vaccine and then died; got very ill; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had unspecified underlying health issues. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced COVID-19. The reporter's mom's cousin who was in his late 70s/ early 80s, had some underlying health issues. He received his second dose of the vaccine, got very ill, and died. Reporter was unsure if he received Pfizer vaccine or different brand. The outcome of got very ill was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: received his second dose of the vaccine and then died
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, CD4 lymphocytes decreased, Conjunctivitis, Deafness neurosensory, Haematuria
Clinical narrative: worsening renal failure/kidney function continued to decline; gross hematuria; follicular conjunctivitis; a low CD3/CD4 count (CD4 91, CD347, CD8 258); a low CD3/CD4 count (CD4 91, CD347, CD8 258); The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; pustular rash on his chin forehead, chest and back; nauseous; diffuse myalgia; vomited; suprapubic pain; This is a spontaneous report from a contactable other healthcare professional.   A 20-year-old male patient first dose of received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 19Apr2021, at the age of 20-years old, (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. It was reported that the patient was in his usual state of good health until 19Apr2021, when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. On 20Apr2021, he woke up the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. On21Apr2021, he began to experience gross hematuria and presented to the Emergency department. On the medicine floor he was initially found to have worsening renal failure, follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. His kidney function continued to decline and hemodialysis was begun on 27Apr2021. His kidney function continued to decline on hemodialysis, becoming so he was transferred to the MICU for CRRT. The patient was hospitalized for 12 days due to the events, the events were also  assessed as life-threathening. The patient been tested for COVID-19 post vaccination with unknown result. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Rash pustular, Renal failure, SARS-CoV-2 test
Clinical narrative: worsening renal failure/kidney function continued to decline; gross hematuria; follicular conjunctivitis; a low CD3/CD4 count (CD4 91, CD347, CD8 258); a low CD3/CD4 count (CD4 91, CD347, CD8 258); The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; pustular rash on his chin forehead, chest and back; nauseous; diffuse myalgia; vomited; suprapubic pain; This is a spontaneous report from a contactable other healthcare professional.   A 20-year-old male patient first dose of received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 19Apr2021, at the age of 20-years old, (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. It was reported that the patient was in his usual state of good health until 19Apr2021, when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. On 20Apr2021, he woke up the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. On21Apr2021, he began to experience gross hematuria and presented to the Emergency department. On the medicine floor he was initially found to have worsening renal failure, follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. His kidney function continued to decline and hemodialysis was begun on 27Apr2021. His kidney function continued to decline on hemodialysis, becoming so he was transferred to the MICU for CRRT. The patient was hospitalized for 12 days due to the events, the events were also  assessed as life-threathening. The patient been tested for COVID-19 post vaccination with unknown result. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Suprapubic pain, T-lymphocyte count decreased, Tinnitus, Vomiting
Clinical narrative: worsening renal failure/kidney function continued to decline; gross hematuria; follicular conjunctivitis; a low CD3/CD4 count (CD4 91, CD347, CD8 258); a low CD3/CD4 count (CD4 91, CD347, CD8 258); The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; pustular rash on his chin forehead, chest and back; nauseous; diffuse myalgia; vomited; suprapubic pain; This is a spontaneous report from a contactable other healthcare professional.   A 20-year-old male patient first dose of received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 19Apr2021, at the age of 20-years old, (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. It was reported that the patient was in his usual state of good health until 19Apr2021, when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. On 20Apr2021, he woke up the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. On21Apr2021, he began to experience gross hematuria and presented to the Emergency department. On the medicine floor he was initially found to have worsening renal failure, follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. His kidney function continued to decline and hemodialysis was begun on 27Apr2021. His kidney function continued to decline on hemodialysis, becoming so he was transferred to the MICU for CRRT. The patient was hospitalized for 12 days due to the events, the events were also  assessed as life-threathening. The patient been tested for COVID-19 post vaccination with unknown result. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got infected with covid and died yesterday; Looks like the vaccine may not be as effective with the new variants.; This is a spontaneous report from a non-contactable consumer. A male patient (infectious disease doctor) received two doses of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on unknown dates . The patient travelled and got infected with covid and died yesterday (02May2021). The reporter stated that it looked like the vaccine might not be as effective with the new variants. After two Pfizer vaccines shots , this doctor travelled to see his parents and succumbed to the new variant. Outcome of the event was fatal.  No follow up attempts are possible; Information about Lot and batch number could not be obtained. No further information is expected.; Reported Cause(s) of Death: got infected with covid and died yesterday.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS) and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a publication. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer