chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heavy menstrual bleeding, Hypotension, Pyrexia
Clinical narrative: blood pressure was super low (BP: 83/56); period started and it was the worst flow she have ever had/ lost over a cup of blood in 5 mins; extremely tired; mild to severe fever; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:30 (Lot Number: EN6203), at the age of 39-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included asthma, hypotension, allergies. The patient is not pregnant at the time of vaccination.  The patient did not have COVID-19 prior vaccination. Concomitant medications included fludrocortisone; diphenhydramine hydrochloride (BENADRYL); salbutamol (VENTOLIN); ergocalciferol (VIT D), all were taken for unspecified indication, start and stop date were not reported.  On 02Mar2021, the patient was extremely tired for the first 48 hours; the patient also had a mild to severe fever for 5 days. On 05Mar2021 1:00PM, the patient's period started and it was the worst flow she have ever had. The patient lost over a cup of blood in 5 mins, and had to change 4 pads within 1 half hour period. Thankfully after 2 hours of this. It stopped to a "normal" heavy flow; where I changed pads every 3-6 hrs. The next day, the patient was fine, but her blood pressure was super low (BP: 83/56). The patient reported this to her primary care physician. The patient was not tested for COVID-19 post vaccination. The outcome of the events extremely tired was recovered on 04Mar2021; the event 'mild to severe fever' was recovered on 07Mar2021; the event ' period started and it was the worst flow she have ever had/ lost over a cup of blood in 5 mins ' was recovered; the other event was unknown. Treatment was received for the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a spontaneous report from contactable nurses. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at 38 years old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included methotrexate; fluticasone propionate (FLONASE ALLERGY RELIEF); VITAMIN D (reported as VITAMIN D-400) taken for an unspecified indication, and an unspecified multivitamin capsule. The patient previously took tofacitinib citrate (XELJANZ) and was on hold for about one month due to eye infection from which she took antibiotics. The patient stated she received her first COVID vaccine before restarting tofacitinib citrate. She is currently having a rheumatoid arthritis flare up in Mar2021. The physician (MD) is aware. The outcome of the event was not resolved.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relation, the assosciation between BNT162B2 vaccine and rheumatoid arthritis flare up cannot be completely ruled out.The impact of this report on 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 committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears/low-frequency sound; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ringing in ears/low-frequency sound/ Low grade hum on an unspecified date. The patient received the shot (Unspecified Medication) on Thursday afternoon. And starting Friday evening had started with a ringing in ear and it's a low grade hum and it's ringing on ever since and had it before and I got the Pfizer shot. The patient talked to doctor she had no answer, she had suggested that maybe call and report it as possible side effect. She hasn't heard of anything. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Severe Allergic Reactions; hives; swollen face; swollen eyes; difficulty in breathing; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe allergic reactions immediately after the administration of 1st dose of Pfizer/BioNTech Covid-19 vaccine which resulted in more than 24-hour hospitalization with symptoms of  hives, swollen face, swollen eyes and difficulty in breathing, all on an unknown date. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Feeling hot, Flushing, Hypoaesthesia oral
Clinical narrative: difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; shaky; really thirsty suddenly; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 39-years-old) at as a single dose for COVID-19 immunization. Medical history included allergic to Compazine and allergic to dogs, both from unspecified dates and unspecified if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (medications received within 2 weeks of the vaccination) included vitamins NOS and ibuprofen, occasional, both taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Apr2021 the patient experienced, difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the events and included Benadryl, Prednisone and an Epipen was prescribed but was not used. The clinical outcomes of the events difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly were all recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Thirst, Tremor
Clinical narrative: difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; shaky; really thirsty suddenly; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 39-years-old) at as a single dose for COVID-19 immunization. Medical history included allergic to Compazine and allergic to dogs, both from unspecified dates and unspecified if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (medications received within 2 weeks of the vaccination) included vitamins NOS and ibuprofen, occasional, both taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Apr2021 the patient experienced, difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the events and included Benadryl, Prednisone and an Epipen was prescribed but was not used. The clinical outcomes of the events difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly were all recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Disturbance in attention, Fatigue, Feeling cold, Headache
Clinical narrative: Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Photosensitivity reaction, Suicidal ideation
Clinical narrative: Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Body temperature increased, Cutaneous vasculitis, Dyspepsia
Clinical narrative: Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation.  Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Fatigue, Feeling abnormal, Fibromyalgia, Headache
Clinical narrative: Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation.  Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Multiple sclerosis relapse, Muscle spasticity, Rash, Rheumatoid arthritis
Clinical narrative: Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation.  Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss, Tremor
Clinical narrative: Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation.  Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Tinnitus
Clinical narrative: deafness; Tinnitus; ear pressure; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0105) via an unspecified route of administration into the right arm on 05Apr2021 15:45 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimoto's disease, hypothyroidism and asthma. Patient was not pregnant. Concomitant medications included simvastatin (SIMVASTATIN), quetiapine (QUETIAPINE), magnesium (MAGNESIUM), acetylsalicylic acid (ASPIRIN (E.C.))and bepotastine besilate (POTAS). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534) into the right arm on 16Mar2021 01:00 PM (at the age of 57-years-old) for COVID-19 immunization. On 06Apr2021, patient experienced deafness, tinnitus and ear pressure. The patient did not receive treatment for the events reported. Outcome of events recovered on Apr2021.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: tightening of the chest; This is a spontaneous report from a contactable consumer.  This consumer reported similar event for two patients. This is the second of two reports. This case is serious. The other case is non-serious.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "tightening of the chest" and went to the hospital for it. The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021392718 Same reporter/drug and AE for different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid after receiving the first shot; Tested positive for covid after receiving the first shot; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not pregnant. The patient was tested positive for COVID after receiving the first shot on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Diarrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diarrhea; she tested positive for Covid-19; she tested positive for Covid-19 with fever; This is a spontaneous report received from a contactable nurse (patient herself). A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number/Expiration date: EK5730/Unknown) via an unspecified route of administration in the left arm on 19Dec2020 and second dose (lot number/expiration date: EL1283/Apr2021) via an unspecified route of administration in the left arm on 07Jan2021 at 18:00 (at the age of 42-year-old) as a single dose for COVID-19 immunization at Hospital. Medical history included ongoing Ulcerative colitis from 1997. Patient prior vaccination included flu shot, had a little neuropathy from the flu shot the last couple of times that she received it and the last flu shot was in 2018. Concomitant medications included adalimumab (HUMIRA) at an unspecified dose once weekly from 2008 still ongoing for Ulcerative colitis and was taking immunosuppressants to treat and rabeprazole sodium (ACIPHEX) at a dose of 20 mg once daily (reported as probably 4 years ago) still ongoing for reflux. Patient was a non-smoker. Patient reported that she works in health care and has a daughter with special needs, and she wanted to protect herself so that she did not become a vector for her daughter, and she was definitely symptomatic for Covid-19 and reported that she ran a fever, her highest temperature was 102.6 and stated that she thinks that it's been coming down considerably every day. On 08Apr2021, patient temperature was 100. On 08Apr2021, patient had COVID-19 PCR test and tested positive after receiving both doses of vaccine. It was unknown that patient had SARS-CoV2 antibodies at diagnosis. On 09Apr2021, her temperature was 99. The patient did not require supplemental oxygen or mechanical ventilation and patient did not have multiorgan failure, respiratory, cardiovascular, vascular, renal, neurological, hematological, dermatological symptoms but had gastrointestinal/hepatic symptoms of diarrhea issues but she has been having ulcerative colitis issues and she would not say that the diarrhea issues started when she got sick. The patient did not receive any additional therapies or initiation of a new medication or other treatment or procedure for Covid-19. The outcome of the event she tested positive for Covid-19 was recovering and for diarrhea was unknown.; Sender's Comments: The contributory role of the suspect product to reported events is possible.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have tested positive in less than four months of full vaccination; have tested positive in less than four months of full vaccination with symptoms; This is a spontaneous report received from a contactable other HCP (patient) via patient assistance. A patient of an unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in Dec2020 as single dose for COVID-19 immunization. On 7Apr2021, patient had tested positive in less than four months of full vaccination and currently experiencing chills, loss of taste and extremely severe headache. Outcome for the events were unknown.  Information of batch details/Lot number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: There was blood in the stool and coming alongside the stool; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 08Apr2021 at 18:15 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not pregnant. The patient has no known allergies. Facility type vaccine was health clinic/facility. No other vaccine in four weeks. Concomitant medications included escitalopram oxalate (LEXAPRO), clarithromycin (CLARITIN) and melatonin; all taken for an unspecified indication, start and stop date were not reported. The patient experienced there was blood in the stool and coming alongside the stool on 09Apr2021 at 23:00 with outcome of not recovered. No treatment was received for the event. No Covid prior to vaccination and not Covid tested post vaccination.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cholecystitis, Discomfort, Gallbladder oedema
Clinical narrative: swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper right abdomen; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EN6208) as SINGLE DOSE, 48 years old. Medical history included none from an unknown date. The patient's concomitant medications were not reported. No known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. No other vaccine in four weeks. There were no other medications in two weeks. On unspecified date after first dose patient suddenly experienced very sharp pain in her upper right abdomen. Patient went to hospital. They could not pinpoint anything. The doctor believes it is a swollen/inflamed gallbladder. The pain lessened due to the new diet. I still have pain and discomfort. Scheduled for a gallbladder scan. Treatment includes change to low fat diet. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events were reported as not recovered. The second dose was administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Haemorrhage, Menstrual disorder
Clinical narrative: bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn't received treatment for the events. The clinical outcome of the events not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Headache, Lethargy, Nausea, Nervousness
Clinical narrative: Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body Ache (Moderate); Trembling / Shaky Feeling (Occasional - Moderate); Light Fever; Nausea (Severe); severe headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 08Apr2021 at 12:00 PM (at the age of 29-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 1:00 PM as single dose for COVID-19 immunization. There was no list of any other medications the patient received within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.There were no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 10:00 AM, the patient experienced moderate lethargy, moderate body ache, severe nausea, severe dehydration, occasional - moderate trembling / shaky feeling, light fever and severe headache. The events were considered serious due to medically significant. The patient was admitted to emergency room and Intravenous treatment was administered for the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Dehydration (Severe); Trembling / Shaky Feeling (Occasional - Moderate); Lethargy (Moderate); Body Ache (Moderate); Trembling / Shaky Feeling (Occasional - Moderate); Light Fever; Nausea (Severe); severe headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 08Apr2021 at 12:00 PM (at the age of 29-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 17Mar2021 at 1:00 PM as single dose for COVID-19 immunization. There was no list of any other medications the patient received within 2 weeks of vaccination.The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.There were no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 10:00 AM, the patient experienced moderate lethargy, moderate body ache, severe nausea, severe dehydration, occasional - moderate trembling / shaky feeling, light fever and severe headache. The events were considered serious due to medically significant. The patient was admitted to emergency room and Intravenous treatment was administered for the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid the 18Feb2021 a day before his second vaccine.; Tested positive for Covid the 18Feb2021 a day before his second vaccine.; This is a spontaneous report from a contactable consumer (patients wife). This consumer (reporter's husband) reported for an unspecified age male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date: unknown) via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter husband got his first shot of vaccine on 30Jan2021 and patient underwent lab test and procedure which included Covid-19 test which result was tested positive for Covid on 18Feb2021 a day before his second vaccine. Patient went to hospital for IV of Bamlanivimab. The outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392105 same reporter/drug different patient/AE
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid the 18Feb2021 a day before his second vaccine.; Tested positive for Covid the 18Feb2021 a day before his second vaccine.; This is a spontaneous report from a contactable consumer (patients wife). This consumer (reporter's husband) reported for an unspecified age male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date: unknown) via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter husband got his first shot of vaccine on 30Jan2021 and patient underwent lab test and procedure which included Covid-19 test which result was tested positive for Covid on 18Feb2021 a day before his second vaccine. Patient went to hospital for IV of Bamlanivimab. The outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392105 same reporter/drug different patient/AE
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Sepsis
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender 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 in Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got their first shot in January and was then hospitalized with sepsis. Did not come out of the hospital for 35 days. Dates of hospitalization not specified. The patient also experienced arm hurt on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on currently known drug safety profile, the reported event sepsis more likely represented intercurrent illness, but not related to BNT162B2. 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 RAs, Ethics Committees, and investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Vaccination site pain
Clinical narrative: Shaking chills; Arm pain at the injection site; Ill; This is a spontaneous report from a contactable physician (Patient). A male patient of an unknown age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date unknown) via unspecified route of administration, on 15Mar2021 at 12:00 at single dose for COVID-19 immunization. The patient had severe COVID in April 2020. Concomitant medication was not reported. After receiving the dose 1 of the Pfizer COVID-19 vaccine on 15Mar2021 at 12 noon on that day, twelve hours later the patient developed arm pain at the injection site followed by shaking chills from 2 am to 5 am. The patient was ill for 48 hours then recovered. The patient stated that he felt like when he had COVID. Event took place after use of product. The outcome of the event pain at the injection was unknown. The patient recovered from the events shaking chills and ill in 2021.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection, Sarcoidosis
Clinical narrative: Maybe it was sarcoidosis; Could be infection, but she is unsure; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. On unspecified dates the patient experienced maybe it was sarcoidosis and could be infection, but she is unsure. The patient called to ask if there had been any reports of post vaccination autoimmune disorders or sarcoidosis developing. She reported that she received both doses of the COVID-19 vaccine and that she was "experiencing some unusual symptoms" that could be infection, but she was unsure. She stated that maybe it was sarcoidosis, but it was not diagnosed by a physician yet. The patient called to see if anything was reported regarding this. The clinical outcome of maybe it was sarcoidosis and could be infection, but she is unsure were both unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of infection and sarcoidosis  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive with moderate symptoms within my 90 day vaccination period; Covid positive with moderate symptoms within my 90 day vaccination period; This is a spontaneous report from a contactable other health care professional (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiration dates were not reported), first dose on 18Dec2020 18:00 and second dose on 08Jan2021, both via unspecified routes of administration, in Left arm (at the age of 32-years-old) at single doses for COVID-19 immunization at a hospital. Medical history included clotting disorder. Patient had no known allergies. Concomitant medication included unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not pregnant, was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. The patient tested positive for COVID with moderate symptoms within 90-day vaccination period on 04Apr2021. Her family was also positive for COVID hence wanted to know if it was due to constant exposure. The patient underwent lab tests and procedures which included Nasal Swab/ PCR COVID test: positive on 07Apr2021. No treatment was given for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: He had a stroke; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Apr2021 (lot number and expiration date were not reported) as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunization. The patient had the second Pfizer dose on unspecified date and the next day he had a stroke. The patient's wife was very concerned because she was reading other symptoms faced from the Pfizer product. The patient's wife wanted to know if anybody else faced a stroke after having the Pfizer shot. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Right eye, subconjunctival hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09Apr2021 11:00 (Lot Number: EP7533) as single dose (at the age of 66-years-old) for covid-19 immunisation. Medical history included high cholesterol, cataract surgery. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included atorvastatin (LIPITOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Left arm (Lot number: EN6206) on 17Mar2021 02:45 PM (at the age of 66-years-old) for COVID-19 immunization. The patient experienced right eye, subconjunctival hemorrhage on 11Apr2021 at 12:00. No treatment was required. Patient was recovering from the event.