chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: Sore arm in injection area; headache; dizzy feeling; extreme chills all night; body aches; fast heart beat; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 21Jan2021 07:30 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no concomitant medications. The patient previously took flexeril [cefixime] and experienced allergies. The patient had no other vaccine in four weeks. On 21Jan2021 17:30 (10 hours after injection), the patient experienced headache, dizzy feeling, extreme chills all night, body aches, fast heart beat. On 21Jan2021 18:00, the patient experienced sore arm in injection area. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events headache, dizzy feeling, extreme chills all night, body aches, fast heart beat, sore arm in injection area was recovering.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Sore arm in injection area; headache; dizzy feeling; extreme chills all night; body aches; fast heart beat; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 21Jan2021 07:30 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital. The patient's medical history was not reported. The patient has no concomitant medications. The patient previously took flexeril [cefixime] and experienced allergies. The patient had no other vaccine in four weeks. On 21Jan2021 17:30 (10 hours after injection), the patient experienced headache, dizzy feeling, extreme chills all night, body aches, fast heart beat. On 21Jan2021 18:00, the patient experienced sore arm in injection area. The patient was not covid tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events headache, dizzy feeling, extreme chills all night, body aches, fast heart beat, sore arm in injection area was recovering.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Ultrasound scan, Viral test negative
Clinical narrative: Intense pain to R foot within 12 hours; This is a spontaneous report from a contactable other HCP (patient). A 62-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), via an unspecified route of administration on 29Dec2020 10:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension, type 2 diabetes mellitus, cerebrovascular accident, Penicillin allergy.  The patient experienced intense pain to R foot within 12 hours on 30Dec2020 01:30 with outcome of recovered with sequelae. Treatment received for the adverse event included: MRI, Ultrasound, Interventional radiology. The patient was hospitalized for intense pain to R foot within 12 hours for 9 days.  The patient underwent lab tests and procedures which included Interventional radiology, magnetic resonance imaging, Nasal Swab test: negative, ultrasound scan.; Sender's Comments: The 62-year-old male patient had medical history included hypertension, type 2 diabetes mellitus and cerebrovascular accident.  The reported intense pain to R foot was more likely due to intercurrent condition/disease, and less likely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information, including MRI and Ultrasound findings and Interventional radiology details, become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: I feel fine today, but sure felt like i had the flu; This is a spontaneous report from a contactable nurse. A 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9261), intramuscular on the left arm on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included allergy to bee sting from an unknown date and unknown if ongoing and arthritis from an unknown date and unknown if ongoing. There were no concomitant medications. The patient stated, "I feel fine today, but sure felt like i had the flu" on Jan2021. The outcome of the event was recovered on Jan2021.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: a fever of 101.5F; chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 21Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer vaccine yesterday (21Jan2021) and was scheduled for her second dose a month (4 weeks) after. The patient seemed to be fine yesterday (21Jan2021); however, today (22Jan2021), she started to have chills and a fever of 101.5F. She didn't feel bad, but she thought the chills maybe went away, but she had a fever now. She is asking for recommendations on what to do. The patient was all alone and new to the area and only can access Urgent Care as her healthcare professional (HCP). Today (21Jan2021) at 2PM, she took paracetamol (TYLENOL) and didn't have chills anymore. The outcome of event fever was unknown, outcome of event chills was recovered on an unspecified date in Jan2021.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: she developed a pretty strong pain in her right ear cartilage; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: right arm) on 19Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient stated that she had the vaccine in the right arm and about a day and a half later she developed a pretty strong pain in her right ear cartilage. Patient mentioned that it started at 4:30 yesterday (21Jan2021). It was really pretty strong and this morning (22Jan2021) it was about 80% better. Patient asked if this is a side effect that people reported. After verbal response was provided, patient asked if this was just a coincidence. Outcome of the event was recovering.  Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, SARS-CoV-2 test positive
Clinical narrative: tested positive with COVID PCR tests; tested positive with COVID PCR tests; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient (pharmacist colleague) received the first does of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EJ1685, Expiration Date: Mar2021), via an unspecified route of administration at site of left arm at 11:45 on 27Dec2020 at single dose for covid-19 immunization. Medical history included was none. There were no concomitant medications. There were no other vaccinations given recently, or no new medications. The patient experienced tested positive with COVID PCR tests on 28Dec2020 (also reported 24 hours - 48 hours after getting the vaccine). Clinical: After the first dose of vaccination, the patient had no symptoms, she had been routinely screened prior and was negative, then tested positive 24 hours after receiving vaccination on 29Dec2020. they did another one on 29Dec2020 and on 30Dec2020 that were negative. Event was assessed as non-serious since patient had no symptoms. After the second dose, the patient did not test positive, and after the second one they did a little study. The patient underwent another lab tests and procedures which included CT value: 24 on 28Dec2020.; Sender's Comments: Based on the current available information, Drug ineffective and COVID-19 PCR test positive are unlikely related to BNT162B2 vaccine.  The event occurred two day after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Dizziness, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: cellulitis in arm; Dizzy head; sore; a few lymph nodes reacted; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient was pregnant. The patient received the first dose of BNT162B2 (lot number: EL0140) on 28Dec2020 for covid-19 immunization. On an unknown date in Jan2021, the patient experienced Dizzy head and sore. Then injection site swelling and was hot to the touch and a few lymph nodes reacted. Two days of 102+ fever, diagnosis of cellulitis in arm. Antibiotics received for cellulitis. Adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone.  The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Malaise, Myalgia, Nausea
Clinical narrative: Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone.  The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Renal pain, SARS-CoV-2 test
Clinical narrative: Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone.  The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: cl3249) intramuscularly at left arm on 22Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included hypothyroid, asthma, seasonal allergies and known allergies: bee stings. The patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. The patient experienced adverse events included headache, flush, diaphoretic, stiff neck; with start date on 22Jan2021 at 12:00 PM. Treatment ibuprofen received for events. The outcome of events was resolving. No covid prior vaccination and no covid tested post vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a non-contactable consumer (patient himself). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EC0142), via an unspecified route of administration, on 20Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EC1284) on 30Dec2020 for covid-19 immunization at 38-years-old. The patient experienced having a fever on 21Jan2021, the day following dose 2 vaccination. No treatment was received for the event. The patient recovered from the event on Jan2021. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 10 days ago I developed the virus; 10 days ago I developed the virus; 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, solution for injection, lot number and expiration date were unknown), 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. The patient reported that he had the first Pfizer COVID vaccine dose and he was scheduled to get the 2nd dose on 25Jan2021. He reported that 10 days ago (12Jan2021) he developed the virus. The patient asked if he should wait longer to get his 2nd dose. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: diminished use of my left thumb in picking pills off counter and tying my shoelaces; tingly feeling in my left palm and thumb; discomfort/ache in my left hand; aching in my left hand, wave like impact/ pain (not ache) in my left mid finger; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 17Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included High cholesterol and bypass surgery. Concomitant medications included metoprolol, famotidine, ezetimibe, and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had his first COVID vaccine shot on 17Jan2021 16:00. On 17Jan2021 22:00, the patient had an onset of aching in his left hand, wave like impact. The ache became more intense, and then receded, then more intense, then receded, etc. That night, 18Jan2021, he woke up at 03:30 with a pain (not ache) in my left mid finger. Then 30 min later, it receded and he fell back asleep. On Monday, 18Jan2021, he woke up with discomfort/ache in his left hand. It disappeared by mid afternoon of 18Jan2021. On Tuesday, 19Jan2021 02:00, he woke up with pain in his mid finger left hand which again receded and he went back to sleep. On Thursday, 21Jan2021, he noted a diminished use of his left thumb in picking pills off counter and tying his shoelaces. He can replicate the tingly feeling in his left palm and thumb by inverting his hands and stretching them away from him. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given in response to the events. The outcome of the events pain in extremity was recovered on 19Jan2021 and limb discomfort was recovered on 18Jan2021 while the outcome of the rest of the events was not recovered. The patient has not been tested for COVID post vaccination.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vomiting
Clinical narrative: profuse vomiting, no nausea/had a huge episode of vomiting; felt really tired/felt tired; sleeping; This is a spontaneous report from a contactable nurse. A 76-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3302, expiration date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11:00 at single dose on left arm for gain immunity against Covid-19. Medical history included stroke from 2017.  There were no concomitant medications. Caller was reporting on her husband. He received the first dose of the Covid-19 vaccine yesterday (21Jan2021). He felt tired today (22Jan2021). 24 hours after he received the vaccine, he had a huge episode of vomiting. He was not nauseated and didn't even feel sick. He ate this morning as usual. All of a sudden he vomited. He still did not feel nauseated. He was tired on 22Jan2021 and was sleeping in Jan2021. Reporter had not measured his temperature but said he did not have a fever. He hadn't vomited in years. Outcome of the events was unknown. This case was reported as non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Pruritus, Urticaria
Clinical narrative: welts/ she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; welts/she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; Itching; This is a spontaneous report from a contactable consumer. a 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021, NDC number: 5926710001) on 14Jan2021 at right arm at single dose for covid-19 immunization. Medical history included Welts. Concomitant medication was not reported. Caller is a Pharmacy Tech and a patient had the first dose of the Covid 19 vaccine and had itching (15Jan2021) and whelps (17Jan2021). She would like to know if these are normal side effects and if the patient can get the 2nd dose. Pharmacy Technician is calling about the Covid Vaccine. It was administered to a patient and the patient experienced an AE. Pharmacy Technician clarifies that she is calling on behalf of the patient. She started itching a little on Friday 15Jan2021, then Sunday she started getting welts that were the size of pencil erasers to a dime. She would take Benadryl and when she took it, she was fine for 24 hours. Then welts every day, in different areas, she had the welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs. The added that she has had welts before in the past but she was not sure what caused them in the past. Reporter does not know if the itching and welts are still ongoing or when it stopped. The Patient did state that Itching went away with Benadryl however reporter does not know when or if that is still the case. Not sure when it stopped. Patient didn't provide end dates or if the adverse events ended. The Patient did not list any allergies. When queried if the patient had any positive covid or antibody test prior to the vaccine, caller states that all of the patients that they vaccinated, they ask them if they had any positive test within 90 days, all stated no, if they state, they do not give the vaccine and make then wait. Caller asks if there is any information about if these side effects are normal, as well as if the patient is still able to receive the second dose. the last outcome of the events was unknown. It was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased, Hypoaesthesia oral, Pain in extremity
Clinical narrative: increased heart rate; palpitations; numbness around the mouth; arm is hot and sore; arm is hot and sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 77 with unknown units) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient reported that after her second dose of the Pfizer COVID 19 vaccine on 21Jan2021, she had increased heart rate, palpitations and numbness around the mouth, arm was hot and sore (Jan2021). The patient stated she had water with her, and the symptoms went away. The outcome of the events was recovered in Jan2021.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: increased heart rate; palpitations; numbness around the mouth; arm is hot and sore; arm is hot and sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 77 with unknown units) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient reported that after her second dose of the Pfizer COVID 19 vaccine on 21Jan2021, she had increased heart rate, palpitations and numbness around the mouth, arm was hot and sore (Jan2021). The patient stated she had water with her, and the symptoms went away. The outcome of the events was recovered in Jan2021.  Information on lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: mild numbness on her throat; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3426) at single dose on 08Jan2021 via an unknown route at left arm for Covid-19 immunization, which was recommended for her age. Medical history included ongoing cervical spinal stenosis for 5 or more years (no investigation assessment, no relevant tests), high cholesterol, high blood pressure, heart beat. Concomitant drugs included ongoing amlodipine besilate 5 mg twice daily for high blood pressure, ongoing atorvastatin 10mg daily for high cholesterol, ongoing hydrochlorothiazide 12.5 mg daily for high blood pressure, ongoing losartan 10 mg daily for blood pressure, ongoing metoprolol tartrate 25 mg twice daily for heart beat. Patient had been taking atorvastatin, hydrochlorothiazide, amlodipine besilate for a long time. Patient had been taking losartan for 10-11 years.  Patient had been taking metoprolol tartrate for 4-5 years. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. She experienced having mild numbness on her throat on 08Jan2021 that lasted for an hour and a half. The event clinical course was as follows: After waiting 15 minutes she was ok and was cleared to go. On the way to her car she felt numbness in her throat. It was mild and lasted for an hour and a half and then it cleared on its own. No Emergency Room or Physician Office visit required due to the event. She was scheduled to get the 2nd dose of the COVID-19 vaccine on 29Jan2021. She wanted recommendations on whether she should take the second dose of the vaccine. She was concerned if that would be a problem with getting the second shot. She was asking if this could happen again.  Outcome of the event was resolved on 08Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site reaction
Clinical narrative: had diarrhea badly, 6-7 bowel movements a day; injection site stiffness; 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, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported, "I received my first dose on Thursday 14Jan2021 and then the next morning I had diarrhea badly, 6-7 bowel movements a day, and injection site stiffness. Should I get the second dose?" Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Therapeutic response unexpected
Clinical narrative: Since receiving the vaccine it "went down on its own and its staying down".; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization.  Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. The patient has diabetes and typically her "sugar runs high" but since receiving the vaccine, within a few days of having the shot, sugar went down all on its own, and its staying down. The patient wanted to document her experience as a positive effect to the vaccine, as she has not made any other lifestyle changes. The outcome of the event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: having stomach issues; This is a spontaneous report from a contactable consumer (patient). This 79-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history and concomitant medications were unknown. The patient explained that the hospital gave her a document presenting an interval varying between "17-24 or 28 days" for the second dose of the COVID-19 vaccine. She stated that her appointment for the second dose was 17 days after the first dose, and asked if this timing was "legitimate". The patient had first dose of covax, inquiring on the change of having second dose after 17days instead of 21 days. The patient had to hang up, stated she was having stomach issues, was not able to transfer. Outcome of the event was unknown.    Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Investigation
Clinical narrative: fast heartbeat; This is a spontaneous report from a contactable consumer reporting for self. This 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at left upper arm at single dose for COVID-19 immunisation.  Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medications included lisopnphill (as reported, spelling as provided by caller- as close as he can get) started it 3 years ago (in 2018) for blood pressure; pravastatin started about 3 years ago (in 2018) for cholesterol. On 07Jan2021, patient experienced a fast heartbeat for about a minute when was going to lay down to go to sleep. He had not had the other symptoms like dizziness or chills, and did not experience a rash, dizziness, or swelling all over face, that had not happened.  He saw his primary guy 3 days after and all his counts were good, his blood pressure and everything, etc. so they didn't suspect anything at this time. He will go ahead with the second shot. He had an exam with his private doctor on 12Jan2021, and everything was fine. The outcome of event was recovered on 07Jan2021.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Headache; Horizontal red line of swelling at the injection site; Horizontal red line of swelling at the injection site; Nausea; Circular rash on the shoulder; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 20Jan2021 (12:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included high blood pressure (HBP); atrial fibrillation (atrial fib.); sleep apnea; heart disease; contrast dye allergy; and mold allergy. Concomitant medications included losartan, carvedilol (COREG) and piroxicam (MAXIDENE). On 22Jan2021 (08:00), the patient had headache; horizonal red line of swelling at the injection site; nausea; and circular rash on the shoulder. The patient did not receive any treatment for all the reported events. The outcome of the events, 'headache', 'horizonal red line of swelling at the injection site', 'nausea' and 'circular rash on the shoulder', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 19/it was a swab in her nostrils; tested positive for covid 19/it was a swab in her nostrils; This is a spontaneous report from a contactable consumer reporting for self. This 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 06Jan2021 around 14:30-14:45 at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No prior vaccinations within 4 weeks and no AEs follow prior vaccinations. Family medical history included diabetes. The patient received 1st dose of vaccine on 06Jan2021, tested positive for COVID 19 on 19Jan2021. Unable to provide which COVID test she received. Stated she was tested at (Pharmacy) and it was a swab in her nostrils. She was scheduled for 2nd dose on 27Jan2021 at 15:45 and asking if she can/should get the 2nd dose. The outcome of event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable other health care professional reported for self. A female of an unknown age received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 06Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. The patient received 1st dose of Covid vaccine on 06Jan2021 and then tested positive for Covid on an unknown date in Jan2021. She was wondering what she should do about the 2nd dose.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; her arm was sore yesterday but better today/her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing 'sometimes her hip and leg would hurt prior to getting the vaccine'.  There were no concomitant medications. Caller received the covid shot on Wednesday, 20Jan2021, her arm was sore yesterday (21Jan2021) but better today (22Jan2021). Caller reports worsening hip and leg pain on 22Jan2021 because sometimes her hip and leg would hurt prior to getting the vaccine. Caller would like to know if it's okay to have taken Tylenol for her symptoms after taking the covid vaccine. Response: The interim ACIP guidelines note that, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot;  If you are a patient, you should discuss this with your healthcare provider. Caller would like to know how long the symptoms from the covid vaccine would last. Calling about the Pfizer COVID vaccine she took it on Wednesday (20Jan2021), the Pfizer Biontech, and yesterday (21Jan2021) her arm was sore all day, which is probably to be expected, but today (22Jan2021), she has, her hips and legs feel real achy, she has achiness in her hips and legs, it was asked if that is normal. it was asked if it is a side effect from the shot. Her arm is not like it was yesterday (21Jan2021) if the achiness was a side effect, she thought she may have had it yesterday (21Jan2021), but she didn't, just today (22Jan2021). The outcome her arm was sore yesterday but better today/her arm was sore was recovering. The outcome of other events was not recovered.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia oral
Clinical narrative: tingling around the mouth area and lips; her mouth or lips were moving in a way that she had no control over/It was just a feeling she was having; This is a spontaneous report from a contactable consumer (patient).  A 91-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL3247, via an unspecified route of administration on 19Jan2021 18:00 at single dose at left shoulder for covid-19 immunisation.  Medical history included osteoporosis from Aug2020, rash on her legs from Aug2020, (lower leg below the knee, she was using a steroid but she had stopped as she was told not to use it too often by her doctor and just use Vaseline to keep the skin moist. She was asked if she had used any steroids but she hadn't used it in the past week and maybe only once in the previous week but couldn't be certain it wasn't in the last 10 days. She resisted the urge to use Mometasone 0.01 as it damaged the skin.); allergies to Sulfa a few years before. The patient reported her daughter who died at 41 years old of breast cancer. There were no concomitant medications. There was no additional vaccines administered on same date of BNT162B2 and no prior vaccinations within 4 weeks.The patient previously took brimonidine tartrate/timolol maleate (COMBIGAN) a few years before and experienced allergies, the eye drops didn't her any good at all and was told not to use it anymore. She previously received flu shot most every year and never had a problem. She stated that evening on 19Jan2021 she felt fine and then the next morning on 20Jan2021 she experienced tingling around the mouth area and lips. Almost as though her mouth or lips were moving in a way that she had no control over. She looked in the mirror and saw no evidence of it moving but could feel it moving. It was just a feeling she was having. The feeling was about the same. The first 2 days was on just the right side but she has had now had 2 occasions where it was on the left side. This was not constant, just occasionally during the day. She wanted to know if this was a known side effect and will it go away. She wanted to know if she should receive the second dose of the vaccine considering these side effects.The outcome of the events was not resolved.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: pain and swelling in arm pit of left arm; pain and swelling in arm pit of left arm; This is a spontaneous report from a contactable Non-healthcare Professional. This Non-healthcare Professional reported that a 44-years-old female patient received bnt162b2 (BNT162B2;  brand=Pfizer COVID; lot number=EL3302) second dose, via an unspecified route of administration at Left arm on 20Jan2021 11:30 AM at SINGLE DOSE for covid-19 immunisation.  Medical history included lymphocytic colitis from an unknown date and unknown if ongoing, diagnosed with covid-19 prior to vaccination. No Allergies to medications, food, or other products. Historical vaccine included received first dose of Pfizer COVID 19 vaccine (lot number=EL3246) on 30Dec2020 at left arm for covid-19 immunization. Concomitant medication included budesonide and OTC vitamins.  The patient experienced pain and swelling in arm pit of left arm on 22Jan2021 08:00 AM with outcome of recovering. No treatment received. The events reported as non-serious.The patient was not pregnant and not Pregnant at the time of vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: nervous; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This (age: 78 units: unspecified) female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she got first dose of the Covid vaccine by Pfizer today (22Jan2021) and they gave her next appointment about 4 weeks later. She stated she was nervous (22Jan2021), so did not see that its 4 weeks apart instead of 3 weeks apart until she got home. She was scheduled to get the 2nd dose of the Covid vaccine 4 weeks from date of 1st dose instead of 3 weeks and patient was wondering if this was ok. Outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2  cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: general body aches; and general body aches, described as similar to flu symptoms; headache; This is a spontaneous report from a contactable consumer reporting for a patient. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced headache that lasted about a day and a half and general body aches, described as similar to flu symptoms. Outcome of the events was resolved. This case was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Headache
Clinical narrative: Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.