chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Impaired driving ability
Clinical narrative: headache; chills; dizziness; Fatigue; unable to drive; This is a spontaneous report from a contactable consumer (daughter).   A 46-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Mar2021 11:30 am (Batch/Lot Number: EN6199) as single dose at the age of 46-year-old for COVID-19 immunisation, administered at School/Student Health clinic.   Medical history included ongoing diabetes mellitus, ongoing obesity. Family medical history included: asthma, diabetes, blood pressure. The patient's concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 14Feb2021 16:45 (Batch/Lot Number: EN5318) as single dose at the age of 46-year-old for COVID-19 immunisation and experienced chills, fatigue, headaches, dizziness and unable to drive on 14Feb2021 until the second day and recovered on 16Feb2021.  No prior Vaccinations. The patient experienced headache, chills, dizziness, fatigue, and unable to drive on 08Mar2021, all with outcome of recovered on 09Mar2021. No treatment received for the events. The patient underwent lab tests and procedures which included x-ray: knee cup bad shape on Mar2021 Being evaluated for knee surgery.   The course of events was as follows: Both times day after the shot was administered the body felt chills, Fatigue, headaches, dizziness unable to drive until the second day. No symptoms were present 2 days after the shot was administered.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: headache; chills; dizziness; Fatigue; unable to drive; This is a spontaneous report from a contactable consumer (daughter).   A 46-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Mar2021 11:30 am (Batch/Lot Number: EN6199) as single dose at the age of 46-year-old for COVID-19 immunisation, administered at School/Student Health clinic.   Medical history included ongoing diabetes mellitus, ongoing obesity. Family medical history included: asthma, diabetes, blood pressure. The patient's concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 14Feb2021 16:45 (Batch/Lot Number: EN5318) as single dose at the age of 46-year-old for COVID-19 immunisation and experienced chills, fatigue, headaches, dizziness and unable to drive on 14Feb2021 until the second day and recovered on 16Feb2021.  No prior Vaccinations. The patient experienced headache, chills, dizziness, fatigue, and unable to drive on 08Mar2021, all with outcome of recovered on 09Mar2021. No treatment received for the events. The patient underwent lab tests and procedures which included x-ray: knee cup bad shape on Mar2021 Being evaluated for knee surgery.   The course of events was as follows: Both times day after the shot was administered the body felt chills, Fatigue, headaches, dizziness unable to drive until the second day. No symptoms were present 2 days after the shot was administered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cognitive disorder, Dyspnoea, Dysstasia
Clinical narrative: muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Headache, Hyperhidrosis, Influenza
Clinical narrative: muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Spotting/bleeding two weeks into the first shot; This is a spontaneous report from a contactable consumer.   A 26-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Right Arm on 22Apr2021 17:00 (Lot Number: En0172) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19 On 08May2021, patient experienced spotting/bleeding two weeks into the first shot. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown. No treatment was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Asthenia, Blood pressure measurement, Cardiac disorder
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Hyperhidrosis, Hypersensitivity
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Inflammation, Loss of consciousness, Malaise, Myocarditis
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myositis, Nausea, Pyrexia, Seizure, Tremor
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vital signs measurement
Clinical narrative: feelings of throat closing 10 minutes after vaccine; This is a spontaneous report from a contactable physician and consumer via Medical Information. A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly on 13May2021 (Batch/Lot Number: EW0179) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the public health department. The patient's medical history was not reported. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. 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. The patient was not pregnant at the time of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feelings of throat closing 10 minutes after vaccine on 13May2021 at 11:45. The adverse event (AE) did result in a doctor or other healthcare professional office/clinic visit. It was further reported that the throat felt like it was closing 5-10 minutes after administration and they got medical advise 30 minutes after the shot. All vitals were normal and no other symptoms. Diphenhydramine (BENADRYL) was administered. Symptoms resolved within 2 hours. The patient recovered from the event on 13May2021.; Sender's Comments: Based on chronological connection to the vaccine and known the potential for severe allergic reactions after vaccination, a causal relationship between event "throat felt like it was closing 5-10 minutes after administration" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Musculoskeletal stiffness, Neck pain, Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica; had a fever of 100; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; Severe morning stiffness; ESR (sedate) was 52 mm/hr; C reactive Protein 32.3; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 06:00 (Batch/Lot Number: Unknown) as 2ND DOSE, single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; tamsulosin hydrochloride (FLOMAX) taken for an unspecified indication, start and stop date were not reported; lisinopril dihydrate (PRINIVIL) taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 (as reported), the patient had a fever of 100 after the second shot for one day and then he felt fine. About 6-7 day (on 03Apr2021, as reported), he started having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck. On 03Apr2021 (as reported) he experienced severe morning stiffness to where he couldn't even put on socks. He went to the doctor and had blood test drawn on 03Apr2021 with the results: "ESR (sedate)" was 52 mm/hr C reactive Protein was 32.3; he was diagnosed with Polymyalgia Rheumatica on 03Apr2021 (as reported). He was put on Prednisone (15mg) and within a few days he felt much better, but his doctor said he has to be on this from 6months to a year. The outcome of event "had a fever of 100" was recovered on 04Apr2021; Outcome of all other events was reported as recovering. It was reported that the patient receive treatment for all events.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Polymyalgia Rheumatica; had a fever of 100; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck.; Severe morning stiffness; ESR (sedate) was 52 mm/hr; C reactive Protein 32.3; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 06:00 (Batch/Lot Number: Unknown) as 2ND DOSE, single for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; tamsulosin hydrochloride (FLOMAX) taken for an unspecified indication, start and stop date were not reported; lisinopril dihydrate (PRINIVIL) taken for an unspecified indication, start and stop date were not reported. On 03Apr2021 (as reported), the patient had a fever of 100 after the second shot for one day and then he felt fine. About 6-7 day (on 03Apr2021, as reported), he started having pain in the hip area then down his legs to calves. It spread to the shoulders then neck and finally to neck. On 03Apr2021 (as reported) he experienced severe morning stiffness to where he couldn't even put on socks. He went to the doctor and had blood test drawn on 03Apr2021 with the results: "ESR (sedate)" was 52 mm/hr C reactive Protein was 32.3; he was diagnosed with Polymyalgia Rheumatica on 03Apr2021 (as reported). He was put on Prednisone (15mg) and within a few days he felt much better, but his doctor said he has to be on this from 6months to a year. The outcome of event "had a fever of 100" was recovered on 04Apr2021; Outcome of all other events was reported as recovering. It was reported that the patient receive treatment for all events.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a Pfizer sponsored program support from a non- contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore throat (oropharyngeal pain) (non-serious) on an unspecified date with outcome of unknown. The patient had the first dose of the Pfizer Covid 19 Vaccine last April 23 and she was scheduled to get the second dose on May 14. However, she has a sore throat. She wants to know if she can still get the second dose of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: coughing; face went numb as well as her tongue and hands for two and half days; face went numb as well as her tongue and hands for two and half days; maybe she had an allergic reaction to the first one; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events for two patients. This is one for two reports.  A 49-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04May2021 (Batch/Lot Number: EW0171) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that for the first 15 minutes she was fine but aafter like 25 minutes, her face went numb as well as her tongue and hands for two and half days. She was "feeling like death for two days and a half ." Because she needed to work that day, she took fexofenadine (ALLEGRA 180 mg) because "it's for allergies" and massaged her face, tongue and hands. After that, she felt okay. Her daughter, aged 18 had the same vaccine, and had the same exact reaction but received it at the+3  hospital. Her sister received Pfizer Covid 19 vaccine but in  its a 90 day interval between doses. Her doctor told her maybe she had an allergic reaction to the first one and wasn't sure if she should get the second dose. She was told to call Pfizer to see what they recommend. Primary care told her to call Pfizer to make sure if she is supposed to take the second one or if she needed to choose a different kind like Moderna or maybe Johnson and Johnson because of the side effect. Patient also stated "after my shot, I had horrible coughing. I am coughing for like 2 weeks but I don't know if it is related with my vaccine or not. I am going to hospital tonight to check." Outcome of the event coughing was unknown, and of remaining events was recovered on an unspecified date.  Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling of body temperature change, Headache, Pain
Clinical narrative: body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Apr2021 08:00 (Batch/Lot Number: EW0171) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, body aches, chills, goes from being cold and hot, headache and dizziness. Reporter clarifies that after the first dose of the covid vaccine, patient had all of the same symptoms but he did not pass out. Patient never felt 100 percent after receiving the first dose of the covid vaccine. All of the same symptoms after the first dose began the night patient received the first dose of the covid vaccine, 20 Apr 2021. The outcome of the event goes from being cold and hot was unknown while not recovered for the other events.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Body height, Fatigue
Clinical narrative: neck not sleeping well; neck not sleeping well; body pain; he can't even lift his arms up due to the pain; arthritis; severe fatigue / very fatigued / now if he walks a mile thats a long walk for him, he's very tired; achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy; sleeping from 12 to 16 hours a day; had no energy; very lethargic; muscles and joints started to ache like crazy; This is a spontaneous report from a contactable consumer. This patient reported similar events for 5 patients. This is the 2nd of 5 reports.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 27Jan2021 (lot number: EK4176) as single dose, and second dose via an unspecified route of administration, administered in left arm on 18Feb2021 (lot number: EL3247) as single dose for COVID-19 immunisation. Medical history included open heart surgery, cholesterol, and blood pressure. Concomitant medications included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), atorvastatin for cholesterol, amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) for blood pressure, and acetylsalicylic acid (ASPIRIN 81). Vaccine was not administered in a facility. The patient experienced he can't even lift his arms up due to the pain on an unspecified date, severe fatigue / very fatigued / now if he walks a mile that's a long walk for him, he's very tired on Apr2021, achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy on Apr2021, neck not sleeping well on an unspecified date, body pain, sleeping from 12 to 16 hours a day on Apr2021, had no energy on Apr2021, very lethargic on Apr2021, arthritis on May2021. The patient underwent lab tests and procedures which included height: 183 cm on an unspecified date, X-rays (spinal x-ray): arthritis on May2021, weight: 89.81 kg on an unspecified date, X-rays (X-ray limb): arthritis on May2021. Therapeutic measures were taken as a result of arthritis. The outcome of the events fatigue and asthenia was recovering; the outcome of the events arthralgia and myalgia was not recovered; and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Musculoskeletal discomfort, Myalgia, Pain
Clinical narrative: neck not sleeping well; neck not sleeping well; body pain; he can't even lift his arms up due to the pain; arthritis; severe fatigue / very fatigued / now if he walks a mile thats a long walk for him, he's very tired; achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy; sleeping from 12 to 16 hours a day; had no energy; very lethargic; muscles and joints started to ache like crazy; This is a spontaneous report from a contactable consumer. This patient reported similar events for 5 patients. This is the 2nd of 5 reports.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 27Jan2021 (lot number: EK4176) as single dose, and second dose via an unspecified route of administration, administered in left arm on 18Feb2021 (lot number: EL3247) as single dose for COVID-19 immunisation. Medical history included open heart surgery, cholesterol, and blood pressure. Concomitant medications included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), atorvastatin for cholesterol, amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) for blood pressure, and acetylsalicylic acid (ASPIRIN 81). Vaccine was not administered in a facility. The patient experienced he can't even lift his arms up due to the pain on an unspecified date, severe fatigue / very fatigued / now if he walks a mile that's a long walk for him, he's very tired on Apr2021, achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy on Apr2021, neck not sleeping well on an unspecified date, body pain, sleeping from 12 to 16 hours a day on Apr2021, had no energy on Apr2021, very lethargic on Apr2021, arthritis on May2021. The patient underwent lab tests and procedures which included height: 183 cm on an unspecified date, X-rays (spinal x-ray): arthritis on May2021, weight: 89.81 kg on an unspecified date, X-rays (X-ray limb): arthritis on May2021. Therapeutic measures were taken as a result of arthritis. The outcome of the events fatigue and asthenia was recovering; the outcome of the events arthralgia and myalgia was not recovered; and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Spinal X-ray, Weight, X-ray limb
Clinical narrative: neck not sleeping well; neck not sleeping well; body pain; he can't even lift his arms up due to the pain; arthritis; severe fatigue / very fatigued / now if he walks a mile thats a long walk for him, he's very tired; achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy; sleeping from 12 to 16 hours a day; had no energy; very lethargic; muscles and joints started to ache like crazy; This is a spontaneous report from a contactable consumer. This patient reported similar events for 5 patients. This is the 2nd of 5 reports.  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 27Jan2021 (lot number: EK4176) as single dose, and second dose via an unspecified route of administration, administered in left arm on 18Feb2021 (lot number: EL3247) as single dose for COVID-19 immunisation. Medical history included open heart surgery, cholesterol, and blood pressure. Concomitant medications included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), atorvastatin for cholesterol, amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) for blood pressure, and acetylsalicylic acid (ASPIRIN 81). Vaccine was not administered in a facility. The patient experienced he can't even lift his arms up due to the pain on an unspecified date, severe fatigue / very fatigued / now if he walks a mile that's a long walk for him, he's very tired on Apr2021, achy shoulder / pain in his shoulders /muscles and joints started to ache like crazy on Apr2021, neck not sleeping well on an unspecified date, body pain, sleeping from 12 to 16 hours a day on Apr2021, had no energy on Apr2021, very lethargic on Apr2021, arthritis on May2021. The patient underwent lab tests and procedures which included height: 183 cm on an unspecified date, X-rays (spinal x-ray): arthritis on May2021, weight: 89.81 kg on an unspecified date, X-rays (X-ray limb): arthritis on May2021. Therapeutic measures were taken as a result of arthritis. The outcome of the events fatigue and asthenia was recovering; the outcome of the events arthralgia and myalgia was not recovered; and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: he can't even lift his arms up due to the pain; severe fatigue; achy shoulder; neck not sleeping well; neck not sleeping well; body pain; The patient got sick from the virus.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is the fourth of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date the patient experienced severe fatigue, achy shoulder, neck not sleeping well and body pain. Patient cannot even lift his arms up due to the pain. The patient got sick from the virus. The outcome of the events reported was unknown.   Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality sleep, Viral infection
Clinical narrative: he can't even lift his arms up due to the pain; severe fatigue; achy shoulder; neck not sleeping well; neck not sleeping well; body pain; The patient got sick from the virus.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is the fourth of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date the patient experienced severe fatigue, achy shoulder, neck not sleeping well and body pain. Patient cannot even lift his arms up due to the pain. The patient got sick from the virus. The outcome of the events reported was unknown.   Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients.