chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Nausea
Clinical narrative: muscle aches; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer reporting for self.  A 29-years-old female patient received Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 28Dec2020 12:15 (at age 29 years old), as a single dose in left arm; and Dose 2, Lot# EL3247, via an unspecified route of administration on 20Jan2021 10:15 (at age 29 years old) as a single dose, left arm for COVID-19 immunization.  The patient was not pregnant at the time of vaccination. Medical history included generalised anxiety disorder, obsessive-compulsive disorder, asthma, and food allergy (citrus, berries, tropical fruits, ascorbic acid, dill, crab, tree nuts, peanuts).  The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), alprazolam (XANAX), diphenhydramine hydrochloride (BENADRYL), and ibuprofen.  The patient did not receive any other vaccines in the 4 weeks prior to COVID vaccination. On unspecified dates after both first and second doses, she had muscle aches, joint pain, chills, and nausea. There was no hospitalization or treatment received for the events. The events were reported as non-serious. The patient was recovering from  muscle aches, joint pain, chills, and nausea. Since the vaccination, the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: I received the first vaccine and donated blood 17 days later but I showed no antibodies.; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine and donated blood 17 days later but showed no antibodies. The patient was interested in knowing if blood should show antibodies 17 days after 1st vaccine. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:15 AM at single dose in left arm for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at workplace clinic. Patient age at vaccination is 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 06:15 PM, at single dose in right arm. Medical history included high blood pressure and high cholesterol. The patient has no allergies to medications, food, or other products/known allergies. The patient received unspecified concomitant medications. On 20Jan2021 on 01:00 PM the patient experienced a headache after second dose, it started about 24 hours after the 2nd dose. Still have it on day 2, but is not severe. Using generic Tylenol to treat it. The event was reported as non serious. The event was resolving. Prior to vaccination the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has been tested for COVID-19 SR008138-Salivary, SARS-COV-2 COVID-19 test on 14Jan2021 with negative result.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: fatigue; slight headache; nausea; sore arm (left); swollen lymph nodes -left arm; This is a spontaneous report from a contactable consumer.  A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at arm left on 30Dec2020 at single dose for COVID-19 immunization.  On 20Jan2021, the patient experienced fatigue, slight headache, nausea, sore arm (left) and swollen lymph nodes (left arm). The patient outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain
Clinical narrative: Headache; Body aches; Diarrhea; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (brand: Pfizer), lot/batch no. and expiration date not provided, intramuscular on 20Jan2021 at a single dose for COVID-19 immunization. Medical history included diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified vaccine/s. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a nursing home/senior living facility. The patient was not pregnant at the time of vaccination. The patient experienced headache, body aches, diarrhea on 20Jan2021. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: heavy tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021, at 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After vaccine the patient had no fever but feels really tired, 'heavy tired'. Has taken two aspirins for symptoms. The outcome of the event was unknown.  The information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nausea
Clinical narrative: Nausea; Chills; Headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on left arm on 19Jan2021 14:15 at single dose for covid-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol, lisinopril, estradiol, sertraline and tramadol hydrochloride (TRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, chills, headache, cough, all on 19Jan2021. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen neck glands; scattered itching; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 12Jan2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation.  Medical history included end-stage renal failure and bipolar and the patient had known allergies to penicillin, sulfa, fish, shellfish, broccoli, and cauliflower. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medication included apixaban (ELIQUIS) from an unknown date at an unknown dose for an unknown indication.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  On 12Jan2021 at 01:15 (as reported) the patient experienced severe injection site pain and swelling, swollen neck glands, scattered itching, and dizziness. The patient was treated for the arm pain with paracetamol (TYLENOL). The clinical outcome of the severe injection site pain and swelling, swollen neck glands, scattered itching, dizziness was recovered on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Moderate soreness at injection site lasting 24 hours; Moderate fatigue; This is a spontaneous report from a non-contactable consumer (patient)  A 35-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) Lot# EH9899 on 19Jan2021 18:00 at SINGLE DOSE for Covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported. No Covid prior vaccination. Facility where the most recent COVID-19 vaccine was hospital.  The patient experienced moderate soreness at injection site lasting 24 hours on Jan2021, moderate fatigue (12-24 hrs post injection) on Jan2021. The patient had not been tested for COVID post vaccination . Outcome of the events was unknown.  No follow-up attempts are possible.No further infromation expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vomiting
Clinical narrative: Fever 103.6F with chills; Fever 103.6F with chills; Vomiting; This is a spontaneous report from a contactable other healthcare professional reporting for a patient.  A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 19Jan2021 at 11:15 (at the age of 71 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included hypertension, seizures, hypothyroid, and attention deficit disorder all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication names were not reported, but it was reported that she used other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination,  The vaccine was given at a Nursing Home/Senior Living Facility. On 20Jan2021 at 12:00AM, the patient experienced fever 103.6F with chills, and vomiting. The patient received treatment of Tylenol 1gm once only for fever and chills. The clinical outcome of fever 103.6F with chills, and vomiting was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: believes it has a little fever; Got the first shot, there was a little soreness; Redness at the injection site for about 4-5 days; The rash is back/ Injection site rash is getting bigger; little itchy/ Itchy with a lump in it; Itchy with a lump in it; Little swollen at the injections site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) intramuscular on the left arm from 07Jan2021 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported that she got the first shot and noticed redness at the injection site for about 4-5 days in Jan2021 and then it went away. Reported that 2-3 days ago she noticed that the rash was back or the redness at the injection site was back and itchy with a lump in it. She reported that the spot was 2 inches in diameter then went to 3 inches, so it was enlarged. She was asking "should I put something on it?" and "the next shot is on the 28th, should I get it?". She got the first shot on 07Jan2021, there was a little soreness. It took it from then until Monday for the redness to go away at the injection site and it did go away but then last night she was putting on lotion and she looked on the arm there it was back again there was a 2 inch red circle and it looks like it has little rash type thing in it and it was itchy. She had a redness and it looked little swollen at the injections site (Jan2021). She noticed the injection site rash was getting bigger, referring to the little rash around the site, and it was a little itchy and she believed it has a little fever. Added it was 2 inches and now it was 3 inches. Outcome of the events vaccination site pain and vaccination site warmth was unknown, while not recovered for the other events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: believes it has a little fever; Got the first shot, there was a little soreness; Redness at the injection site for about 4-5 days; The rash is back/ Injection site rash is getting bigger; little itchy/ Itchy with a lump in it; Itchy with a lump in it; Little swollen at the injections site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) intramuscular on the left arm from 07Jan2021 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported that she got the first shot and noticed redness at the injection site for about 4-5 days in Jan2021 and then it went away. Reported that 2-3 days ago she noticed that the rash was back or the redness at the injection site was back and itchy with a lump in it. She reported that the spot was 2 inches in diameter then went to 3 inches, so it was enlarged. She was asking "should I put something on it?" and "the next shot is on the 28th, should I get it?". She got the first shot on 07Jan2021, there was a little soreness. It took it from then until Monday for the redness to go away at the injection site and it did go away but then last night she was putting on lotion and she looked on the arm there it was back again there was a 2 inch red circle and it looks like it has little rash type thing in it and it was itchy. She had a redness and it looked little swollen at the injections site (Jan2021). She noticed the injection site rash was getting bigger, referring to the little rash around the site, and it was a little itchy and she believed it has a little fever. Added it was 2 inches and now it was 3 inches. Outcome of the events vaccination site pain and vaccination site warmth was unknown, while not recovered for the other events.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). This 78-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the higher dose flu vaccine on an unspecified date for an unspecified indication and they got sick. The patient developed severe diarrhea and some vomiting on an unspecified date in Jan2021. The patient reported they still had diarrhea; further reporting that they read that the second dose caused more problem and consequently the reporter was considering not taking that dose. The patient reported they were sensitive to vaccine so they can only take the lower dose flu vaccine. The patient reported the one time they had the higher dose flu vaccine they got sick. The reporter's son wanted the reporter to take the second dose of the COVID vaccine but the patient fears they may land in the hospital if they do. The clinical outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 infection on 11Jan2021 with outcome of unknown. The reported wanted to know how long the patient should wait before receiving the second dose.  Information on the lot/batch number has been requested.; 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 Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness in left arm; Body chills; low grade fever; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left on 20Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history was none.  The patient's concomitant medications were not reported. On 21Jan2021 at 03:00, the patient experienced stiffness in left arm, body chills and low-grade fever. The patient outcome of the events was not recovered.  The information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: no side effects except a sore arm and I feel great; This is a spontaneous report from a contactable consumer. This 68-years-old elderly consumer (patient) of unknown gender received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown), via an unspecified route of administration on unknown date at single dose for an COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated she experienced "no side effects except a sore arm and I feel great" on unknown date. The outcome of event "no side effects except a sore arm and I feel great" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: She got tested with the COVID saliva test on 09Jan2021 and tested positive; She got tested with the COVID saliva test on 09Jan2021 and tested positive; headache; not feeling well; fell super run down; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) via an unspecified route of administration at single dose arm left on 06Jan2021 16:45 for covid-19 immunisation. Medical history included allergy induced asthma, neoplasm malignant since 2011 (reported as 10 years ago), ongoing white blood cell count decreased. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for allergy induced asthma, cetirizine hydrochloride (ZYRTEC) for allergy. No other vaccine was received in four weeks.  Patient had headache on 09Jan2021, not feeling well on 09Jan2021, fell super run down on 09Jan2021. The patient got tested with the covid saliva test on 09Jan2021 and was positive. Patient just wanted to know if she can go forward to 2nd dose. The outcome of headache was not recovered, of fell super run down was recovering, of the other events was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: I am very tired; have been sleeping both day and night since I had my Covid-19 injection; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1293), via an unspecified route of administration, in the left arm on 19Jan2021 at 18:00 PM (at the age of 78-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included oxycodone, gabapentin, morniflumate (FLOMAX), acetylsalicylic acid (ASPIRIN ), and  metaxalone. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has known allergies to morphine. On 20Jan2021 at 05:00 AM, the patient experienced being tired.  The patient reported "I am very tired, I have been sleeping both day and night since I had my Covid-19 injection". The patient did not receive treatment for the events. The clinical outcome of the events tired and I have been sleeping both day and night since I had my Covid-19 injection was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3246), via an unspecified route of administration in the left arm on 20Jan2021 at 11:45 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none.  The patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 20Jan2021 at 23:30 (the evening after receiving the first dose), the patient experienced an itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet. The patient was treated for the events with 1 tablet of expired diphenhydramine (BENADRYL), one to one and a half hours after which the symptoms started to improve and by 02:00 the patient was able to get some sleep. Since the vaccination, the patient was not tested for COVID. The clinical outcome of "itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet" was resolved on 21Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable Consumer (patient).  A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive to covid-19 in Jan2021 (last week) with outcome of unknown. The patient wanted to know when he should receive the second dose.   No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minimal soreness at site; This is a spontaneous report from a contactable consumer (patient).  This 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via an unknown route of administration, on 20Jan2021 at 10:30 at a single dose on the left arrm for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After vaccination, the patient had minimal soreness at site. Second shot was scheduled on 04Mar2021. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: swelling of tongue; swelling of the throat; This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the covid vaccine. It was unknown if the patient was diagnosed with covid 19 prior to vaccine. It was unknown if the patient tested for covid 19 since the vaccination. On unspecified date, the patient experienced swelling of tongue and swelling of the throat. The events were assessed as non-serious. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Swelling face, Urticaria
Clinical narrative: swelling on his face; hives all over his body; dose 1 administration date: 22Dec2020, dose 2 administration date: 14Jan2021; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. An adult male patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot and expiry date: not reported), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Allergies to medications, food, or other products was unknown. The patient previously received the first dose of BNT162B2 on 22Dec2020 for COVID-19 immunization. On 18Jan2021, it was reported that the patient experienced swelling on his face and hives all over his body. The patient also received the first dose on 22Dec2020 and the second dose on 14Jan2021. Treatment received was reported as unknown. The outcome of the events swelling on his face and hives all over his body was recovering. The reporter assessed the event as non-serious. The events did not result in death, life threatening condition, prolonged hospitalization, disability or congenital anomaly or birth defect. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and if the patient was tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue 5 days later I am still having extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot and expiry were not available), via an unspecified route of administration in the right arm on 16Jan2021 at 10:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included asthma and high cholesterol. No allergies to medications, food, or other products. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT), atorvastatin calcium (ARVASTATIN) and azelastine which were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue 5 days later (on 21Jan2021 at 12:00). The patient stated, "I am still having extreme fatigue." The event was considered non-serious as it did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the event was recovering. No treatment was received for the adverse event.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red and swollen arm; red and swollen arm; This is a spontaneous report from a contactable consumer.  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced red and swollen arm on 20Jan2021. The outcome was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; exposed to Covid positive patient; This is a spontaneous report from a contactable nurse (patient).  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was exposed to Covid positive patient on 15Jan2021. She tested positive for Covid 19 the following Monday 18Jan2021. The patient wanted to know if now that she was positive, she should still proceed with the second dose in February. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; 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 Drug ineffective and COVID-19 cannot be totally excluded. Occupational exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: daily headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 via an unspecified route of administration in the left arm on 13Jan2021 19:45 (07:45 PM) at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included levothyroxine (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced daily headache on 14Jan2021. Treatment for the event was not received. The event was non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: got soreness in the arm; This is a spontaneous report from a contactable consumer (patient):  A male patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after vaccination patient got soreness in the arm. He asked if Tylenol or aspirin could relax the pain. At the time of the reporting event outcome was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Needle issue, Syringe issue, Underdose, Vaccination site discharge
Clinical narrative: Covid-19 vaccine was not fully administered to the arm of the patient; in the course of administering vaccine, there was a drippage in the needle or leakage of a few drops when the needle was extracted from the injection site; 1 syringe has a leakage; in the course of administering vaccine, there was a drippage in the needle or leakage of a few drops when the needle was extracted from the injection site; This is a spontaneous report. A contactable other healthcare professional (hcp) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that they operate a vaccine clinic, and 1 syringe has a leakage, and asked for the reason why the whole dosage didn't go through the patient. He was calling to see if there were guidelines on how to handle that situation. The scenario was where in the course of administering vaccine, there was a drippage in the needle or leakage of a few drops when the needle was extracted from the injection site. Reporter was asking if there's guidelines on how to handle with that situation. The Covid-19 vaccine was not fully administered to the arm of the patient. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Mild injection site soreness; more tired than usual which extended into the following day; This is a spontaneous report from a contactable consumer (patient's parent). A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 12Jan2021 11:00 to 12Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported.  Concomitant medication included etonogestrel (NEXPLANON). On 12Jan2021, the patient had mild injection site soreness and 3-4 hours after receiving the vaccination and noted being more tired than usual which extended into the following day. The events were assessed as non-serious as per the reporter. The patient did not received any treatment for the events. The patient is not pregnant at the time of the report. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Taste disorder
Clinical narrative: headache; bad taste; loss of energy; This is a spontaneous report from a Pfizer-sponsored program Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after the first dose of the vaccine caller experienced headache, bad taste, and loss of energy. The caller also mentioned that he would like to set up an appointment for his second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Chills; light headedness; shortness of breath; headache; This is a spontaneous report from a non-contactable consumer reporting for a patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination.  Medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced chills, light headedness, shortness of breath, and headache. The clinical outcome of chills, light headedness, shortness of breath, and headache was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; headache; extreme fatigue; chills; This is a spontaneous report from a non-contactable other HCP communicated to a Pfizer colleague.   A female patient of unspecified age, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. The patient experienced extreme fatigue and chills after first dose of vaccine. Additional relevant medical history concomitant medications were not reported. On an unspecified date After the second dose, she experienced a headache for 3 days, extreme fatigue, chills and fever. She said she felt like she got every side effect after the second dose. Really knocked her off her feet" (as reported). It was reported that she was doing fine now. At the time of the reporting the patient recovered from the events on an unspecified date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A   5-decade-old female patient (late 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 'approx' 30Dec2020 as a single dose,  for COVID-19 vaccination.  The patient medical history includes ongoing rheumatoid arthritis, ongoing blot clots (previously hospitalized for treatment of blood clots ). Concomitant medication included adalimumab (HUMIRA) and on 'blood thinners for prevention of blood clots'.  On Dec2020, the patient experienced pain at injection site (kind of dull pain, very similar to a tetanus shot). 'Just the first day, took some Tylenol so I could sleep and woke up next day feeling fine.' Therapeutic measures were taken as a result of pain at injection site included Tylenol. The clinical outcome of pain at injection site was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: pain at injection site; mild headache; some fatigue; This is a spontaneous report from a non-contactable Consumer via social medica site. This female Consumer (patient) of unknown age reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown), via an unspecified route of administration on 19Jan2021 at single dose for an COVID-19 immunisation. The patient medical history included rheumatoid arthritis, on blood thinners for prevention of blood clots (she has been previously hospitalized for treatment of blood clots). Historical vaccine included first dose of BNT162B2 on approximately 30Dec2020 and experienced pain at injection site (kind of dull pain, very similar to a tetanus shot) on first day of vaccination and took some Tylenol so patient could sleep and woke up next day feeling fine. Concomitant medication included adalimumab (HUMIRA). On 19Jan2021, the patient received her second dose of BNT162B2 and experienced the same kind of pain at injection site, mild headache, some fatigue. The patient took Tylenol again and stated that she was still able to do her normal daily household activities (laundry, tidying up, plying w/ dogs, vacuuming, and making sure (son) actually does his school work). Therapeutic measures were taken as a result of events pain at injection site, mild headache, some fatigue included Tylenol.  No follow-up attempts are possible. Information regarding Lot/Batch No. cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058015 Same patient, different dose
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt fatigued; This is a spontaneous report from a non-contactable consumer (wife of the patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 09:30 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Medical history included allergy and anxiety. Past drug history included allergy to VICODIN. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Concomitant medications included unspecified drugs for allergy and anxiety. The patient said to the consumer just at the time of report that he felt fatigued the morning after his second shot on 14Jan2021 at 06:00. The patient was not treated for the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Myalgia, SARS-CoV-2 test
Clinical narrative: bilateral sharp leg muscle pain; difficulty to move around; severe fatigue; This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for herself   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 04Jan2021  at single dose via an unspecified route of administration  for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included ibuprofen 1 dose of over the counter Ibuprofen a day prior to vaccination. On an unspecified date in Jan2021 after the 1st dose patient experienced bilateral sharp leg muscle pain causing difficulty to move around and severe fatigue. The events lasted daily for more than 1 week. Treatment received included Tylenol. It was informed that 2nd dose should be administered the week of 25Jan2021. The patient recovered from the events on an unspecified date.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Polymerase chain reaction
Clinical narrative: Sudden onset of Hypertension with out history; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 11Jan2021 07:15 for Covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included allergy to beer. The patient was not pregnant. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications patient received within 2 weeks of vaccination. The patient experienced sudden onset of hypertension (without history) on 12Jan2021 06:00. Event required doctor or other healthcare professional office/clinic visit. The event was considered as non-serious by the reporter. Treatment received for the adverse event included oral lisinopril 10 mg. Nasal swab (PCR) on 18Jan2021 was negative. The patient had not recovered from sudden onset of hypertension at the time of reporting.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: chills; sweating; dizziness; headache; head rash; general tiredness/bad lethargy/ more tired; muscle aches; Nausea/ sick to her stomach; Vomiting/ throwing up; sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient was having side effects like vomiting, sore throat, sweating, dizziness, head rash, general tiredness, muscle aches, and nausea, the patient was wondering if she can go to the hospital. She got her vaccine on 15Jan2021 and had a tiny reaction right away that went away in 20 minutes; sweating, dizziness and a headache. After that she felt a little more tired than usual, but it has progressed more and more everyday; she has been more and more tired. On 22Jan2021 she had some chills, and was feeling a little worse and worse, then yesterday she had a headache and a little bit of a sore throat. Stated that she went home from work yesterday and went right to bed at 2pm because she was so tired. Today, she woke up again really tired but went in to work, and then this after she got so sick to her stomach and started throwing up. Now, she can't keep anything down. Stated that she just kept feeling worse and worse. "Is this Covid? Or is it from the vaccine?" It was starting to scare her. It felt like she almost has food poisoning at this point, but with really bad lethargy, a headache, and really bad chills. Outcome of the events sweating and dizziness was recovered on 15Jan2021, while unknown for the other events.   Information on the lot/batch number has been requested.