chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Polymerase chain reaction, Pyrexia
Clinical narrative: fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:45 AM (at the age of 52 years old) as a single dose on left arm for COVID-19 immunisation. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 26Dec2020 (lot number: EL1284) on right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C) and Zinc. The patient did receive other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 05:30 PM, the patient experienced severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea. No treatment was received. The outcome of the events severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 05Jan2021 at 13:30, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes, arthritis, vitamin D, bones, gums, eye, joint pain lubrication, hair and nail growth and strength, control sugar, atrial fibrillation (Afib), heart, supplement, cholesterol, liver clean, and gastro problem. The patient's concomitant medications included apixaban (ELIQUIS) for Afib from 2019 (a year and three-fourths), metoprolol for heart from 2019 (a year and three-fourths), metformin hydrochloride (METFORMIN ER) for diabetes, berberine to control sugar, biotin from 2011 (for 10 years) for hair and nail growth and strength, Silybum marianum (MILK THISTLE) to make liver clean (two or three years), hyaluronic acid for joint pain lubrication, niacinamide for diabetes, chondroitin sulfate/ glucosamine sulfate (GLUCOSAMINE CHONDROITIN) for bones, Monascus purpureus (RED YEAST RICE) for cholesterol, colecalciferol (VITAMIN D3; UPC Number: 3373900373, Lot Number: 3162111, and Expiration Date: Jun2024) for vitamin D, probiotics for gastro problem, betacarotene for eye, ubidecarenone (COENZYME Q10) for gums, calcium/ magnesium (CALCIUM MAGNESIUM) for bones, and unspecified multivitamins as supplement and OSTEOPHASE for arthritis; all were ongoing. The patient her first dose of COVID-19 vaccine dose on 05Jan2021. The patient had experienced diarrhea ever since 09Jan2021 and is still continuing until today. The patient experienced a sudden onset of diarrhea and it has continued on and off since then; it is persisting or worse. She has seen a gastroenterologist, but they don't have any answers, sent stool cultures in Jan2021 but no results yet. The patient was asking if this is a documented adverse event. The patient is scheduled on 26Jan2021 for the second dose. With this experience, the patient was asking what to do with the second dose- if she should get the second shot. The patient had not recovered from the event.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling, Pruritus, Swelling face
Clinical narrative: right side of her face was swollen and was itching; eyes swollen/puffy; puffy underneath eyes/ like bags; swelling of right side of face/ right side of her face was swollen; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date: 30Apr2021) intramuscular on the right arm on 15Jan2021 at 30 ug, single for COVID-19 prophylaxis. Medical history included high cholesterol, high blood pressure, cancer survivor and allergic to walnuts. Concomitant medication included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) for supplementation therapy, HCTZ for high blood pressure, vitamins nos (MULTIVITAMIN [VITAMINS NOS]) for supplementation therapy, rosuvastatin for high cholesterol. The patient received 1st dose of vaccine on Friday and on 17Jan2021 evening, experienced the following: "swelling of right side of face, eyes swollen/puffy." She spoke with HCP office and was told to take Benadryl and Tylenol. She took the medication and the "swelling went down". She said she woke up this morning and had "puffy underneath eyes", "like bags", and "slight facial swelling." The patient ate at an Indian restaurant on 17Jan2021 at about 6:30-7:00pm and was unsure if her reaction was to the vaccine or food, since the food she ate could have been cooked with nut oil. She said that her eyes were still puffy and her face was still a little swollen. She went to see her doctor today 19Jan2021 and he was trying to figure out what could have caused this on his end. The patient said that the right side of her face was swollen and was itching. The left side did not appear to be swollen at all. Outcome of the event pruritus facial was unknown while recovering for the other events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Diarrhea; Chills; Fever of 101.8; muscle pain; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), intramuscular on 18Jan2021 00:45 at a single dose for COVID-19 immunisation. The patient's medical history included endometriosis and sulfa antibiotics allergy. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at the age of 27 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Jan2021 03:45, the patient experienced diarrhea, chills, fever of 101.8 and muscle pain. No treatment was received for these adverse events. Outcome of the events diarrhea, chills, fever of 101.8 and muscle pain was not recovered. The events diarrhea, chills, fever of 101.8 and muscle pain were considered non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Duration of diarrhea following first dose of vaccine on 16Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient called and asked about duration of diarrhea following first dose of vaccine on 16Jan2021.  Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=PFZ39), via an unspecified route of administration in left arm on 14Jan2021 19:00 at first single dose for covid-19 immunisation. Medical history included obesity, depression, hypothyroidism.  Other medications the patient received within 2 weeks of vaccination included: levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took demerol and experienced drug hypersensitivity. The patient experienced tinnitus on 14Jan2021 20:00 with outcome of not recovered. Since about an hour after receiving the vaccine, the patient's ears had been ringing. She had never experienced this before. It's noticeable but did not interfere with daily activities. Event was considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neuralgia
Clinical narrative: Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL8982) via an unspecified route of administration on arm right on 15Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included occipital and trigeminal neuralgia, C5-C6 cervical cage, temporomandibular joint syndrome (TMJD), cerebrospinal graft. Known allergy: shellfish, walnuts, mustard, sweet potato. Concomitant medication included gabapentin, acetaminophen. The patient previously took penicillin B, phenergan and chloral hydrate (PHENERGAN), Codeine and linalool, all experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Jan2021 06:00, the patient woke up with a bad headache that triggered a neuralgia attack. It persisted for 24hrs. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Heart rate, Heart rate increased, Pain
Clinical narrative: racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lip swelling, SARS-CoV-2 antibody test negative, Swelling face
Clinical narrative: Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever and chills; fever and chills; This is a spontaneous report from a non-contactable consumer (husband).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Husband reported that his wife received vaccine yesterday (18Jan2021) and developed fever and chills in Jan2021. Can she use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine? Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Nausea, Off label use, Product use issue, Vomiting
Clinical narrative: Excessive vomiting for 24 hours; Excessive nausea for 24 hours; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; patient was pregnant at the time of the Covid-19 immunization; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported information for mother. This is maternal report. A 30-year-old pregnant female patient receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. Medical history included had COVID prior vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient received her vaccination in a nursing home/senior living facility. The patient was pregnant at the time of the Covid-19 immunization. The patient reported experiencing excessive nausea and vomiting for 24 hours (unspecified date). The patient received treatment for the adverse events which included over the counter medications. The patient was not COVID tested post vaccination. The outcome of the events nausea and vomiting was recovering while the outcome of the other events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Head ache; Body and joint pain; Body and joint pain; Sore throat; This is a spontaneous report from a contactable Other HCP reporting for self. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), intramuscular on 12Jan2021 11:00 at single dose for COVID-19 immunization.  Medical history included pineapple allergy. Patient received first dose of bnt162b2 on 22Dec2020. There were no concomitant medications. The patient experienced Fever, Head ache, body and Joint pain, Sore throat on 13Jan2021 03:00. Outcome of events was recovered.   No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Getting dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female non-pregnant patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 19Jan2021 13:00 at right arm, at single dose for covid-19 immunization.  Medical history included Asthma, allergies, diabetic, high BP, hypothyroidism and Known allergies: Penicillin and Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Other medications in two weeks. Within 5 minutes of receiving her first dose of the vaccine the patient started getting dizzy and lightheaded at 19Jan2021 13:15 (as reported). Lasted 10 minutes then it gradually went away. No treatment was received. The outcome of the event was recovered on 19Jan2021 13:25. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: woke with her right arm feeling like it was on fire and prickly; woke with her right arm feeling like it was on fire and prickly/it hurt really bad/hands hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch#/Lot#: EK9231) on right arm at single dose on 13Jan2021 for COVID-19 immunisation. Her right arm had a history of going to sleep. Her arm had been going to sleep for less than a year. She thought she may have a pinched nerve. There was no concomitant medication or investigation assessment. Patient got first covid shot a week ago and she didn't know if this was a side effect or not. She got this shot in her right arm. Last night she woke up an 3am and her right arm had gone to sleep but felt like it was on fire and prickly and hurt really bad on 19Jan2021 at 03:00. She got up and shook it and couldn't get it to go away. She was sitting up over an hour and it did lessen somewhat but then started back up. She was scheduled to get her second shot and decided she would get it in her other arm. Patient stated her hands hurt and she was unsure of how long she could stay on the phone. Reporter seriousness for woke with her right arm hurting really bad was unspecified. The outcome of event was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Bad taste in mouth; numbness and tingling on right side of face; numbness and tingling on right side of face; swollen area near jaw line; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (pregnant: No) received first dose of bnt162b2, via an unspecified route of administration in right arm on 19Jan2021 11:00 at single dose for covid-19 immunization. Medical history included cardiac patient, iodine allergy from an unknown date and unknown if ongoing. Concomitant medication included prednisone, clopidogrel bisulfate (PLAVIX), lisinopril. The patient experienced bad taste in mouth, numbness and tingling on right side of face, swollen area near jaw line on 19Jan2021 with outcome of recovering. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No other vaccine in four weeks. No treatment received. No COVID prior vaccination. No COVID tested post vaccination.  Information about Lot/Batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruises on hands; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL0140) on 26Dec2020 10:00 in the left arm. The patient is not pregnant. The patient received no other vaccine in four weeks and had no other medications in two weeks. The patient had bruises on hands on 17Jan2021 with outcome of unknown. No treatment was received. The patient had no COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Laryngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: congestion; sore throat; cough; laryngitis; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via an unspecified route of administration on 13Jan2021 11:45 AM at single dose on the left arm for COVID-19 immunization.  Patient is not pregnant. Medical history included COVID prior vaccination (reported as "If Covid prior vaccination: Yes"). No other medical history reported. No known allergies. There were no other vaccines in four weeks and two weeks. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) on  23Dec2020 11:45 AM on the left arm. Facility type vaccine is hospital. The patient experienced upper respiratory symptoms (congestion/sore throat/cough), laryngitis on 16Jan2021 20:00 (08:00 PM). Events resulted in doctor or other healthcare professional office/clinic visit. Patient took prednisone as treatment for the events. Outcome of the events was recovering. Patient was not tested for COVID-19 since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient receive the COVID-19 vaccine in 30Dec2020 and on 05Jan2021 he tested positive for COVID-19. He got the first dose of the vaccine on 30Dec2020 and was COVID-19 positive on 01Jan2021 and then tested negative on 08Jan2021. He was supposed to take the second dose on 19Jan2021, if he had COVID-19, he wanted to know if he needs to get the second dose or skip it. The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Off label use, Pain
Clinical narrative: Chest pain; Joint pain; Headache; Low grade fever; Body aches; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; This is a spontaneous report from a contactable nurse (patient). A 34-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Jan2021 19:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin (reported as PCN), azithromycin (reported as Z-Pack), hydrocodone bitartrate, paracetamol (NORCO). The patient's concomitant medications was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first of BNT162B2 on 26Dec2020 04:00 PM at right arm for covid-19 immunization.  The patient experienced chest pain, joint pain, headache, low grade fever, body aches on 19Jan2021 10:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia
Clinical narrative: Chest pain; Joint pain; Headache; Low grade fever; Body aches; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; This is a spontaneous report from a contactable nurse (patient). A 34-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Jan2021 19:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin (reported as PCN), azithromycin (reported as Z-Pack), hydrocodone bitartrate, paracetamol (NORCO). The patient's concomitant medications was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first of BNT162B2 on 26Dec2020 04:00 PM at right arm for covid-19 immunization.  The patient experienced chest pain, joint pain, headache, low grade fever, body aches on 19Jan2021 10:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: notice pain in left ring finger/By 6pm very painful; loss of range of motion; ring finger swollen; This is a spontaneous report from a contactable nurse. A 24-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included allergy to penicillin and gluten intolerance. Concomitant medication included ethinylestradiol, norgestimate (TRI-PREVIFEM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 (first dose). It was reported that the patient received the vaccine in left arm, a few hours later began to notice pain in left ring finger. By 6pm very painful and loss of range of motion, ring finger swollen; all on 19Jan2021 13:30. No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Headache, Nausea
Clinical narrative: very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dissociation, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose bnt162b2 (BNT162B2 reported as Pfizer- Biontech COVID-19 Vaccine; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration right arm on 19Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included diabetes and high blood pressure, although both are mostly kept at bay with diet and exercise. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHET SALTS XR), trazodone, metformin and lisinopril. There was no other vaccine in the last four weeks. The patient received her vaccine in a school or health clinic. The patient reported that on about 30 minutes (19Jan2021 03:00 PM) later, he got home. He felt a little tired and maybe just out of it. It's now 2.5 hours later and he is very spaced out. He mentioned that she's feeling disconnected a bit but mostly just out of it. She was not dizzy but like a bit drunk. No treatment received for the adverse events. The patient did not have Covid tested post vaccination. The outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion, Fatigue, Pain, Pain in extremity
Clinical narrative: soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization.  Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine.  The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours.  Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious.  Information on lot number/batch number was requested.  Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Skin discolouration
Clinical narrative: soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization.  Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine.  The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours.  Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious.  Information on lot number/batch number was requested.  Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Two people got covid after receiving the first shot; Two people got covid after receiving the first shot; This is a spontaneous report received from a non-contactable consumer. This consumer reported similar events for 2 patients. This is the first of two reports.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that two people got Covid after receiving the first shot. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065167 same reporter/drug/ae, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: she tested positive for covid after first dose; she tested positive for covid after first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after first dose in Jan2021 with outcome of unknown. Second dose scheduled for Saturday. She was in quarantine for two weeks. She would like to know if she should get second dose or not. The patient underwent lab tests and procedures which included covid 19 test: positive in Jan2021. Serious: No.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration 19Jan2021 at 14:30 date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021 at 18:15, the patient experienced vomiting and nausea and she started to feel better on the same day at 20:15. The clinical outcome of the event vomiting and nausea was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; nauseous/nauseated; This is a spontaneous report from a contactable consumer.  An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, on 13Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history included COPD (chronic obstructive pulmonary disease) and diabetes and cancer surgery. The patient has unspecified concomitant medications ("she takes many"). The patient experienced being nauseous/nauseated when she got up this morning (25Jan2021). And her arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site. The patient underwent unspecified lab tests and procedures on Dec2020, results were also unknown. Patient took Tylenol as treatment to the events. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on 18Jan2021 13:00, at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via a unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient experienced soreness in the arm, body aches, very tired on 19Jan2021 12:00AM. Therapeutic measures were taken as a result of all events includes Tylenol Every 6 Hours. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: dizziness; extreme fatigue/fatigue; Sore arm at injection site; dull headache; This is a spontaneous report from a contactable Other-HCP reporting for self. A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), intramuscular on 14Jan2021 08:30 at single dose for COVID-19 immunization.  Medical history was not reported. There were no concomitant medications.  The patient experienced on 14Jan2021 09:00 Sore arm at injection site, dull headache day of injection, 2 days later extreme fatigue. 4 days later dizziness and fatigue that lasted 2 days. Outcome of events was recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a contactable Other HCP reporting for self. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 18Jan2021 09:30 at single dose for COVID-19 immunization. Patient received first dose of bnt162b2 on 31Dec2020. Medical history included Fatty liver and vertigo.  The patient's concomitant medications were not reported.  Patient had allergies medications. The patient experienced Injection site pain, headaches, muscle pain, chills, fever on 18Jan2021 16:00. Outcome of events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Headache, Myalgia, Vaccination site pain
Clinical narrative: Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient).  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination.  No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.