chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal discomfort, Rash, SARS-CoV-2 test
Clinical narrative: On day 14, after my second shot I starting getting a rash; some discomfort on my lower back; Went to an urgent care, where they diagnosed me with shingles.; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:00 (Batch/Lot Number: EN6208) as DOSE 2, single for covid-19 immunisation (at the age of 36-year-old). The patient medical history and concomitant medications was not reported. The patient had not experienced covid prior vaccination. The patient had tested covid post vaccination on 31Mar2021 and result was negative. Covid test type post vaccination was Nasal Swab. On 29Mar2021 the patient experienced event described as "on day 14, after my second shot I starting getting a rash, some discomfort on my lower back, went to an urgent care, where they diagnosed me with shingles". Therapeutic measures were taken as a result of the events. The outcome for all the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Brain natriuretic peptide, Electrocardiogram, Full blood count, Laboratory test
Clinical narrative: Myocardial infarction (open heart surgery required); Shoulder pain; Local injection discomfort, pain for couple of days; This is a spontaneous report from a contactable physician (patient).   A 73-year-old patient of an unspecified gender (weight: 86.18 kg, height: 176.5 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6700) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 01Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9265) at single dose, for COVID-19 immunisation. After first dose, on an unspecified date, in Feb2021, the patient experienced shoulder pain. On an unspecified date, in 2021, the patient experienced myocardial infarction (open heart surgery required) and shoulder pain described as "patient had no fever just local injection discomfort, pain for couple of days, shoulder pain". The patient underwent lab tests and procedures on an unspecified date, which included multiphasic blood chemistry, brain natriuretic peptide (BNP), electrocardiogram (EKG) full blood count (CBC), and pulmonary function test: all with an unknown results. Clinical outcome of the adverse events was unknown at time of this report. Then, the patient received the third dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. 301458A) on 23Sep2021, at single dose, for COVID-19 immunisation.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to reported event of Myocardial infarction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101274881 Same patient and drug, different event separated in time;US-PFIZER INC-202101275260 Same patient and drug, different event separated in time
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Pulmonary function test, Vaccination site pain
Clinical narrative: Myocardial infarction (open heart surgery required); Shoulder pain; Local injection discomfort, pain for couple of days; This is a spontaneous report from a contactable physician (patient).   A 73-year-old patient of an unspecified gender (weight: 86.18 kg, height: 176.5 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6700) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 01Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9265) at single dose, for COVID-19 immunisation. After first dose, on an unspecified date, in Feb2021, the patient experienced shoulder pain. On an unspecified date, in 2021, the patient experienced myocardial infarction (open heart surgery required) and shoulder pain described as "patient had no fever just local injection discomfort, pain for couple of days, shoulder pain". The patient underwent lab tests and procedures on an unspecified date, which included multiphasic blood chemistry, brain natriuretic peptide (BNP), electrocardiogram (EKG) full blood count (CBC), and pulmonary function test: all with an unknown results. Clinical outcome of the adverse events was unknown at time of this report. Then, the patient received the third dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. 301458A) on 23Sep2021, at single dose, for COVID-19 immunisation.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to reported event of Myocardial infarction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202101274881 Same patient and drug, different event separated in time;US-PFIZER INC-202101275260 Same patient and drug, different event separated in time
Sex: U
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, Arthritis reactive, Blood creatine phosphokinase, Blood uric acid
Clinical narrative: Reactive arthritis ANA positive; Knee pain worsened; with swelling bilateral (b/l) lower extremity (LE); Lower extremity edema; Body aches; Positive for urinary tract infection (UTI); This is a spontaneous report from a contactable physician. A 21-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26May2021 at 10:22am, intramuscular in right arm (Lot: EW0178) for Covid-19 immunization and experienced knee pain and left knee pain with effusion. There were no concomitant medications. After the second dose, on 05Jul2021, knee pain worsened with swelling bilateral (B/L) lower extremity (LE), lower extremity edema, and body aches. Patient had reactive arthritis ANA positive on 12Jul2021. The events resulted in emergency room visit and physician office visit. Following with rheumatologist and sports medication (med), patient was currently under treatment with prednisone (pred-conservatively) and sulfasalazine. Lab tests on 05Jul2021, Complete blood count (CBC) with differential: Within normal limits, Comprehensive metabolic panel (CMP): Within normal limits, Covid-19 test: negative, Right lower extremity (RLE) Emergency Medicine Bedside Ultrasound (EMBU): Negative for deep vein thrombosis (DVT), Urine analysis (UA) complaint of (cx): Positive for urinary tract infection (UTI). On 10Jul2021, Cyclic citrullinated peptide (CCP IgG), Creatine Phosphokinase (CKP), C3/C4, Sedimentation rate, Urine analysis (UA) complaint of (cx): results were not reported. On 12Jul2021, Uric Acid, C-Reactive protein (CRP), Complete blood count (CBC) with differential, Lyme, Comprehensive metabolic panel (CMP), Sedimentation rate, Rheumatoid factor (RF): results were not reported. On 06Aug2021, Gonorrhea and Chlamydia screening test (GC/CT): result was not reported. Outcome of urinary tract infection was unknown. Outcome of the other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, Investigation, Oedema peripheral, Pain, Red blood cell sedimentation rate
Clinical narrative: Reactive arthritis ANA positive; Knee pain worsened; with swelling bilateral (b/l) lower extremity (LE); Lower extremity edema; Body aches; Positive for urinary tract infection (UTI); This is a spontaneous report from a contactable physician. A 21-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26May2021 at 10:22am, intramuscular in right arm (Lot: EW0178) for Covid-19 immunization and experienced knee pain and left knee pain with effusion. There were no concomitant medications. After the second dose, on 05Jul2021, knee pain worsened with swelling bilateral (B/L) lower extremity (LE), lower extremity edema, and body aches. Patient had reactive arthritis ANA positive on 12Jul2021. The events resulted in emergency room visit and physician office visit. Following with rheumatologist and sports medication (med), patient was currently under treatment with prednisone (pred-conservatively) and sulfasalazine. Lab tests on 05Jul2021, Complete blood count (CBC) with differential: Within normal limits, Comprehensive metabolic panel (CMP): Within normal limits, Covid-19 test: negative, Right lower extremity (RLE) Emergency Medicine Bedside Ultrasound (EMBU): Negative for deep vein thrombosis (DVT), Urine analysis (UA) complaint of (cx): Positive for urinary tract infection (UTI). On 10Jul2021, Cyclic citrullinated peptide (CCP IgG), Creatine Phosphokinase (CKP), C3/C4, Sedimentation rate, Urine analysis (UA) complaint of (cx): results were not reported. On 12Jul2021, Uric Acid, C-Reactive protein (CRP), Complete blood count (CBC) with differential, Lyme, Comprehensive metabolic panel (CMP), Sedimentation rate, Rheumatoid factor (RF): results were not reported. On 06Aug2021, Gonorrhea and Chlamydia screening test (GC/CT): result was not reported. Outcome of urinary tract infection was unknown. Outcome of the other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid factor, Swelling, Urinary tract infection
Clinical narrative: Reactive arthritis ANA positive; Knee pain worsened; with swelling bilateral (b/l) lower extremity (LE); Lower extremity edema; Body aches; Positive for urinary tract infection (UTI); This is a spontaneous report from a contactable physician. A 21-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26May2021 at 10:22am, intramuscular in right arm (Lot: EW0178) for Covid-19 immunization and experienced knee pain and left knee pain with effusion. There were no concomitant medications. After the second dose, on 05Jul2021, knee pain worsened with swelling bilateral (B/L) lower extremity (LE), lower extremity edema, and body aches. Patient had reactive arthritis ANA positive on 12Jul2021. The events resulted in emergency room visit and physician office visit. Following with rheumatologist and sports medication (med), patient was currently under treatment with prednisone (pred-conservatively) and sulfasalazine. Lab tests on 05Jul2021, Complete blood count (CBC) with differential: Within normal limits, Comprehensive metabolic panel (CMP): Within normal limits, Covid-19 test: negative, Right lower extremity (RLE) Emergency Medicine Bedside Ultrasound (EMBU): Negative for deep vein thrombosis (DVT), Urine analysis (UA) complaint of (cx): Positive for urinary tract infection (UTI). On 10Jul2021, Cyclic citrullinated peptide (CCP IgG), Creatine Phosphokinase (CKP), C3/C4, Sedimentation rate, Urine analysis (UA) complaint of (cx): results were not reported. On 12Jul2021, Uric Acid, C-Reactive protein (CRP), Complete blood count (CBC) with differential, Lyme, Comprehensive metabolic panel (CMP), Sedimentation rate, Rheumatoid factor (RF): results were not reported. On 06Aug2021, Gonorrhea and Chlamydia screening test (GC/CT): result was not reported. Outcome of urinary tract infection was unknown. Outcome of the other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: I got the vaccine on my left arm and the back of my left knee, it''s slightly swollen; my leg is hurt; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that patient just (2021) got first dose of Pfizer Vaccine and the patient was having a side effect where leg was 'hurt' (incomplete word), left leg (incomplete sentence). The patient got the vaccine on left arm and left leg, 'it's hurting' and the back of left knee, it's slightly swollen. The patient wanted to know if that was something like a blood clot. Outcome of events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness to Right side of face, right hand; severe pain upper right back and under arm; severe pain upper right back and under arm; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old non-pregnant female patient (not pregnant at time of vaccination) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in arm right on 07Oct2021 (age at the time of vaccination 51 years) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypothyroidism, high blood pressure, obesity, migraines and psoriasis. The patient previously took penicillin, Levaquin, Omnicef and Fluticasone and experienced drug allergy. The patient had Mango allergy and Pistachio allergy. The patient previously took flu vaccine (other vaccine 4 weeks) via an unspecified route of administration in right arm on 28Sep2021. The patient historical vaccine included received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in right arm on 01Apr2021 (age at the time of vaccination 51 years) as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in right arm on 11Mar2021 (age at the time of vaccination 51 years) as dose 1, single for COVID-19 immunization. No COVID prior vaccination and no COVID tested post vaccination. On 07Oct2021 17:00, the patient experienced numbness to right side of face and severe pain upper right back and under arm. No treatment received for the events. The seriousness of the events was non-serious. The outcome of the events was recovering.   No Follow-up attempts are possible. Information about lot/batch number cannot be Obtained.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Ages 8 and 10, both went to receive the flu vaccine but instead inadvertently received 0.3mL doses of the Pfizer BioNTech Covid 19 vaccine; Inappropriate age at vaccine administration; Right leg pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's mother). This is the first of two reports:  A 10-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FE3590), via an unspecified route of administration, administered in left arm on 05Oct2021 as dose 1, 0.3ml single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 05Oct2021, the patient inadvertently received 0.3ml dose of the Pfizer biontech covid-19 vaccine instead of flu vaccine. Following vaccination, on an unspecified date in Oct2021, the patient had experienced right leg pain. The reporter stated that she thought the patient was fine, but she did not know what had happened inside or when side effects would happen and queried about the risks of the vaccine and any other possible information she could get regarding that situation. The reporter stated that, it was human error, and she was trying to figure out what to be done because the paediatrician and nobody knew how to handle that, and the paediatrician had not encountered that for the patient age group and nobody knew the dosing or if they need 2nd dose. The reporter stated that they were still seeing if the patient had side effects. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: caller has a friend who developed myocarditis after the vaccination; This is a spontaneous report received from a contactable Consumer or other non-health professional (patient's friend) via Pfizer.  A male patient of an unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that caller has a friend (patient), knows the patient personally. On an Unspecified date, patient developed myocarditis after the vaccination with Pfizer covid vaccine, who was a golfer and cannot play golf. As per understand by patient friend myocarditis shortens life and have major structural damage done to the heart. Investigation Assessment was not provided. Outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: I had massive menstrual hemmohaging and large blood clots for 11 days.; I had massive menstrual hemmohaging and large blood clots for 11 days.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left in Sep2021 at 04:45 PM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 55 years old. Medical history was none. There were no concomitant medications. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took ceclor and experienced allergies to ceclor. The patient reported that she had massive menstrual hemmohaging and large blood clots for 11 days on 15Sep2021. This started 7 days after getting the first shot dose. The events resulted in physician office visit. The events were serious per life threatening. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered with sequelae in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Encephalitis, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: West Nile Virus; slept all the time; ran 99 fever and tired; ran 99 fever and tired; encephalitis; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 3 via an unspecified route of administration, administered in arm left on 20Sep2021 01:30 PM (at the age of 84 years old, Lot Number: FC3183) as dose 3 (booster), single for covid-19 immunisation. Medical history included cll, bovine heart valve. The patient's concomitant medications were not reported. The patient previously took Dose 1 of BNT162B2 in arm left 0.3ML on 04Feb2021 (lot number EN9581); Dose 2 of BNT162B2 in Arm Left 0.3ML on 23Feb2021 (lot number EN6202) and ran a slight fever on 17Sep2021 after coming from gym. The patient previously received unspecified drug and experienced allergy. On 21Sep2021 08:30 patient ran 99 fever and tired. On 22Sep2021 fever a bit higher and slept all the time. Went to emergency and admitted. Could not find any bacteria infection. Week of 27Sep2021 found he had West Nile Virus. Went on ventilator and hospitalized for 2 weeks. Now inpatient PT have encephalitis. Doctors wonder if vaccine accelerated the virus.. The patient was hospitalized for all events from Sep2021 to Oct2021. Duration of Hospitalization: 16 days. Hospitalization Prolonged. The patient underwent lab tests and procedures which included body temperature: 99 on 21Sep2021, sars-cov-2 test: negative. Therapeutic measures were taken as a result of all events. No other vaccines within 4 weeks prior to the Covid vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Everything imaginable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, West Nile virus test positive
Clinical narrative: West Nile Virus; slept all the time; ran 99 fever and tired; ran 99 fever and tired; encephalitis; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 3 via an unspecified route of administration, administered in arm left on 20Sep2021 01:30 PM (at the age of 84 years old, Lot Number: FC3183) as dose 3 (booster), single for covid-19 immunisation. Medical history included cll, bovine heart valve. The patient's concomitant medications were not reported. The patient previously took Dose 1 of BNT162B2 in arm left 0.3ML on 04Feb2021 (lot number EN9581); Dose 2 of BNT162B2 in Arm Left 0.3ML on 23Feb2021 (lot number EN6202) and ran a slight fever on 17Sep2021 after coming from gym. The patient previously received unspecified drug and experienced allergy. On 21Sep2021 08:30 patient ran 99 fever and tired. On 22Sep2021 fever a bit higher and slept all the time. Went to emergency and admitted. Could not find any bacteria infection. Week of 27Sep2021 found he had West Nile Virus. Went on ventilator and hospitalized for 2 weeks. Now inpatient PT have encephalitis. Doctors wonder if vaccine accelerated the virus.. The patient was hospitalized for all events from Sep2021 to Oct2021. Duration of Hospitalization: 16 days. Hospitalization Prolonged. The patient underwent lab tests and procedures which included body temperature: 99 on 21Sep2021, sars-cov-2 test: negative. Therapeutic measures were taken as a result of all events. No other vaccines within 4 weeks prior to the Covid vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Everything imaginable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dysphagia, Eating disorder, Fatigue
Clinical narrative: My wife is suffering now, she is not eating, she is not drinking; Very fatigued; Had no energy; Had no appetite; Couldn't even drink water and all day she just had a few sips of water; Have been sleeping most of the day; My wife is suffering now, she is not eating, she is not drinking; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 08Oct2021 at 15:00 as dose 3 (booster), single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 09Oct2021, after third dose the patient experienced Swallowing difficult, Fatigue, Energy decreased, Appetite lost, Loss of personal independence in daily activities, Sleepy, and Eating disorder. The patient took the COVID-19 Pfizer booster shot at 3 pm on 08Oct2021. Everything worked out, they went to bed, but in the morning reporter was very fatigued, had no energy, had no appetite, couldn't even drink water and all day she just had a few sips of water, have been sleeping most of the day, and has been very fatigued. So reporter was very concerned when this will pass. The patient had not yet recovered from all events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Somnolence
Clinical narrative: My wife is suffering now, she is not eating, she is not drinking; Very fatigued; Had no energy; Had no appetite; Couldn't even drink water and all day she just had a few sips of water; Have been sleeping most of the day; My wife is suffering now, she is not eating, she is not drinking; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 08Oct2021 at 15:00 as dose 3 (booster), single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 09Oct2021, after third dose the patient experienced Swallowing difficult, Fatigue, Energy decreased, Appetite lost, Loss of personal independence in daily activities, Sleepy, and Eating disorder. The patient took the COVID-19 Pfizer booster shot at 3 pm on 08Oct2021. Everything worked out, they went to bed, but in the morning reporter was very fatigued, had no energy, had no appetite, couldn't even drink water and all day she just had a few sips of water, have been sleeping most of the day, and has been very fatigued. So reporter was very concerned when this will pass. The patient had not yet recovered from all events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Eye disorder, Feeling abnormal
Clinical narrative: Related to a condition called Bell''s Palsy, and I also understand it could be slight paralysis on the side of the face; I started feeling little weird; Something started happening with my eye, my right eye, it wasn''t, it felt like it wasn''t closing; My left eye I was having problems with that; This is a spontaneous report from a non-contactable consumer, the patient.  A patient of unspecified age and gender received an unknown dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient suddenly  started feeling little weird on an unknown date and left eye, the patient was having problems with that on an unknown date and the patient understood this was related to a condition called Bell's Palsy, and also understood it could be slight paralysis on the side of the face related to a condition called bell''s palsy on an unknown date. The outcome of all th events was unknown.  No follow up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Myocardial infarction, Near death experience, Off label use, Peripheral swelling
Clinical narrative: I almost died here, when I took the booster shot; I almost have a heart attack in my heart; my arms still swelled up; Booster; Off label use; This is a spontaneous case received from a non- contactable consumer (patient). A patient of unspecified age and gender received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number not reported), via an unspecified route of administration on an unknown date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that his arms still swelled up, he almost died here, when he took the booster shot and he almost had a heart attack in his heart on an unspecified date. The outcome of the event arms still swelled up was not resolved and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Brain hypoxia, Cerebral thrombosis, Cognitive disorder, Feeling abnormal
Clinical narrative: blood clots in her brain; Auto immune; Diagnosed with lack of oxygen to her brain; Brain fog; Cognitive issues; This is a spontaneous report from a contactable consumer (patient's grandson) from a Pfizer Sponsored Program. An 80-years-old female patient (reporter's grandmother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 80-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date reporter stated, grandma had blood clots in her brain, had brain fog, and was diagnosed with lack of oxygen to her brain. The patient also had auto immune and was having cognitive issues. The patient was 80 and was perfectly healthy and then this happened months after the two doses of the Pfizer Covid vaccine. The patient underwent lab tests and procedures which included lack of oxygen: lack of oxygen (Diagnosed with lack of oxygen to her brain). The outcome of event was unknown.    Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: blood clots in her brain; Auto immune; Diagnosed with lack of oxygen to her brain; Brain fog; Cognitive issues; This is a spontaneous report from a contactable consumer (patient's grandson) from a Pfizer Sponsored Program. An 80-years-old female patient (reporter's grandmother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 80-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date reporter stated, grandma had blood clots in her brain, had brain fog, and was diagnosed with lack of oxygen to her brain. The patient also had auto immune and was having cognitive issues. The patient was 80 and was perfectly healthy and then this happened months after the two doses of the Pfizer Covid vaccine. The patient underwent lab tests and procedures which included lack of oxygen: lack of oxygen (Diagnosed with lack of oxygen to her brain). The outcome of event was unknown.    Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Off label use
Clinical narrative: Developed Shingles on lt side of back and lt breast; Off label use; Booster dose; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 71-year-old non-pregnant female patient received third dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: FC3184) via an unspecified route of administration, administered in Arm Left on 28Sep2021 17:00(at the age of 71 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included high blood pressure, Shingles (in early 20's; received Zostavax in 1999 at age 50) both from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (DEXCEL), losartan potassium both taken for an unspecified indication, start and stop date were not reported. The Historical vaccines included BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:30AM as DOSE 1, SINGLE and dose 2 BNT162B2 (BNT162B2, Solution for injection) via an unspecified route of administration, administered in Arm Left on 20Feb2021 09:30AM as DOSE 2, SINGLE (at the age of) for Covid-19 immunization. Zostavax from 1999 for shingles (at the age of 50). Patient previously took Ampicillin and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced developed shingles on lt side of back and lt breast on 30Sep2021 17:00. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a 39 year old woman who got blood clots from the vaccine and died; This is a spontaneous report from a contactable consumer or other non hcp received from a Regulatory Authority. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection; Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient who got blood clots from the vaccine and died. It was reported that patient had no history that got blood clots after receiving the Pfizer Covid vaccine and died. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: a 39 year old woman who got blood clots from the vaccine and died
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Disturbance in attention, Feeling abnormal, Feeling hot, Heart rate
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Nervousness, Pain, Paraesthesia oral, Pyrexia
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Screaming, Suspected COVID-19
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac disorder, Disturbance in attention, Dyspnoea, Feeling hot
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected