chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Feeling abnormal, Hyperhidrosis
Clinical narrative: AH had vaccine administered at employee health, observed 15 minutes, came back to work, approximately 50 min to 1 hr later, she started having shortness of breath, said she "felt off", and became diaphoretic.   Symptoms included: Tachycardia, hypotension, shortness of breath, diaphoresis, throat pain, chest heaviness, and rigors  We started an IV, gave 25mg IV Benadryl, started 3L 02 via mask and monitored.  Symptoms began improving after benadryl and 02 administration within 3-5 minutes.  We monitored the patient for 2 hours.  Symptoms completely resolved and patient back to baseline within 1.5 hours.  Patient was sent home with instructions to take benadryl and pepcid  in the afternoon.  No further episodes after the patient went home.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Oropharyngeal pain, Tachycardia
Clinical narrative: AH had vaccine administered at employee health, observed 15 minutes, came back to work, approximately 50 min to 1 hr later, she started having shortness of breath, said she "felt off", and became diaphoretic.   Symptoms included: Tachycardia, hypotension, shortness of breath, diaphoresis, throat pain, chest heaviness, and rigors  We started an IV, gave 25mg IV Benadryl, started 3L 02 via mask and monitored.  Symptoms began improving after benadryl and 02 administration within 3-5 minutes.  We monitored the patient for 2 hours.  Symptoms completely resolved and patient back to baseline within 1.5 hours.  Patient was sent home with instructions to take benadryl and pepcid  in the afternoon.  No further episodes after the patient went home.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Eye swelling; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), on 28Dec2020 10:30AM (vaccine location: Left arm) via unknown route of administration at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Eye swelling where Allergen filler was placed 7 weeks prior to the event on 30Dec2020 07:00AM. Patient did not receive any treatment. Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. The outcome of the event was not recovered. This case was assessed non-serious by reporter. The event did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; I have not received the vaccine intramuscularly; I have not received the vaccine intramuscularly; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid-19 Vaccine the day before reporting (29Dec2020) from work. She has not received the vaccine intramuscularly; the needle was a half inch. She thought she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm (onset date: 29Dec2020). Patient asked if the vaccine can be administered by an alternative route other than intramuscular. She wanted to know if she should restart the vaccination series as she received the first dose of Covid-19 vaccine by the wrong route. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product use issue, Vaccination site erythema, Vaccination site mass
Clinical narrative: She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; She though she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm; I have not received the vaccine intramuscularly; I have not received the vaccine intramuscularly; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Covid-19 Vaccine the day before reporting (29Dec2020) from work. She has not received the vaccine intramuscularly; the needle was a half inch. She thought she received the vaccine either intradermally or subcutaneously, because she noticed a red bump on her arm (onset date: 29Dec2020). Patient asked if the vaccine can be administered by an alternative route other than intramuscular. She wanted to know if she should restart the vaccination series as she received the first dose of Covid-19 vaccine by the wrong route. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left supraclavicular lymph adenopathy; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) intramuscular on 16Dec2020 14:00 (02:00 PM) at a single dose on the left arm as COVID-19 vaccine. The patient had no medical history/concurrent conditions and no known allergies to medications, food, or other products. Concomitant medication included paracetamol (TYLENOL) (received within 2 weeks of vaccination). The patient had an adverse event (AE) left supraclavicular lymph adenopathy on 23Dec2020 which resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the AE included antibiotics. It 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 pregnant at the time of vaccination. She did not receive other vaccines within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The outcome of the event was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypersensitivity, Laryngeal oedema, Nasoendoscopy
Clinical narrative: mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic response; This is a spontaneous report from a contactable physician.  A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 23Dec2020 12:30 at single dose for COVID-19 immunisation.  Medical history included allergies to medications, food, or other products: Penicillin.  There were no concomitant medications.  The patient previously took benzoyl peroxide and experienced allergies.  The patient experienced stated that on 23Dec2020 12:31, "I am an ENT surgeon. I received the first dose of the vaccine at 12:30pm. Within 1-2 minutes I started to feel difficulty swallowing (globus). I reported this to the nurse and she offered me ginger ale. My symptoms worsened and then stabilized after 10 minutes. I went upstairs and got the residents to perform a fiberoptic nasoendoscopy and this demonstrated mild supraglottic swelling of my aryepiglottic folds. I choose not to receive treatment as I did not want to dampen my allergic response and as an ENT surgeon manage airways on a daily basis. I stayed at the hospital for a further 6 hours and continued to work. My symptoms resolved after 9 hours". The outcome of the events was recovered on 23Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event laryngeal oedema cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: mild supraglottic swelling of my aryepiglottic folds; feel difficulty swallowing (globus); allergic response; This is a spontaneous report from a contactable physician.  A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 23Dec2020 12:30 at single dose for COVID-19 immunisation.  Medical history included allergies to medications, food, or other products: Penicillin.  There were no concomitant medications.  The patient previously took benzoyl peroxide and experienced allergies.  The patient experienced stated that on 23Dec2020 12:31, "I am an ENT surgeon. I received the first dose of the vaccine at 12:30pm. Within 1-2 minutes I started to feel difficulty swallowing (globus). I reported this to the nurse and she offered me ginger ale. My symptoms worsened and then stabilized after 10 minutes. I went upstairs and got the residents to perform a fiberoptic nasoendoscopy and this demonstrated mild supraglottic swelling of my aryepiglottic folds. I choose not to receive treatment as I did not want to dampen my allergic response and as an ENT surgeon manage airways on a daily basis. I stayed at the hospital for a further 6 hours and continued to work. My symptoms resolved after 9 hours". The outcome of the events was recovered on 23Dec2020.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event laryngeal oedema cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever (102 F); Chills; Tired; Muscle aches; Some upset stomach the night of the vaccination (12 hours after administration); Headache; This is spontaneous report from a contactable other-HCP (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: unknown) intramuscularly on 30Dec2020 12:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin (reported as ammoxicillin) and experienced drug allergy. The patient experienced fever (102 F) and chills on 31Dec2020 12:00, muscle aches and some upset stomach the night of the vaccination and headache (12 hours after administration), tired the day after (31Dec2020 12:00). No treatment received for the adverse events. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 31Dec2020.  Information on lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (102 F); Chills; Tired; Muscle aches; Some upset stomach the night of the vaccination (12 hours after administration); Headache; This is spontaneous report from a contactable other-HCP (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: unknown) intramuscularly on 30Dec2020 12:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin (reported as ammoxicillin) and experienced drug allergy. The patient experienced fever (102 F) and chills on 31Dec2020 12:00, muscle aches and some upset stomach the night of the vaccination and headache (12 hours after administration), tired the day after (31Dec2020 12:00). No treatment received for the adverse events. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 31Dec2020.  Information on lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Dizziness, Hypertension, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Face went numb; light headed; Tongue started to go numb and feel swollen; Tongue started to go numb and feel swollen; Slight temp of 99.3; blood pressure was high; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL1284), via an unspecified route of administration on right arm on 28Dec2020 19:45 at single dose for covid-19 immunisation. Medical history included asthma, migraine, and juvenile heart murmur. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and Birth control. No other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination, no known allergies, no allergies to medications, food, or other products. The patient experienced Face went numb and felt light headed 5-10 minutes after vaccine. Tongue started to go numb and feel swollen about 15 minutes after vaccine. Slight temp of 99.3 and blood pressure was high at 159/95. Seen in the emergency room. Events onset date all reported as 28Dec2020 20:00. Therapeutic measures were taken as a result included Prednisone, benadryl, and pepcid. Outcome of events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Face went numb; light headed; Tongue started to go numb and feel swollen; Tongue started to go numb and feel swollen; Slight temp of 99.3; blood pressure was high; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL1284), via an unspecified route of administration on right arm on 28Dec2020 19:45 at single dose for covid-19 immunisation. Medical history included asthma, migraine, and juvenile heart murmur. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and Birth control. No other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination, no known allergies, no allergies to medications, food, or other products. The patient experienced Face went numb and felt light headed 5-10 minutes after vaccine. Tongue started to go numb and feel swollen about 15 minutes after vaccine. Slight temp of 99.3 and blood pressure was high at 159/95. Seen in the emergency room. Events onset date all reported as 28Dec2020 20:00. Therapeutic measures were taken as a result included Prednisone, benadryl, and pepcid. Outcome of events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Swollen tongue
Clinical narrative: Face went numb; light headed; Tongue started to go numb and feel swollen; Tongue started to go numb and feel swollen; Slight temp of 99.3; blood pressure was high; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL1284), via an unspecified route of administration on right arm on 28Dec2020 19:45 at single dose for covid-19 immunisation. Medical history included asthma, migraine, and juvenile heart murmur. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and Birth control. No other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination, no known allergies, no allergies to medications, food, or other products. The patient experienced Face went numb and felt light headed 5-10 minutes after vaccine. Tongue started to go numb and feel swollen about 15 minutes after vaccine. Slight temp of 99.3 and blood pressure was high at 159/95. Seen in the emergency room. Events onset date all reported as 28Dec2020 20:00. Therapeutic measures were taken as a result included Prednisone, benadryl, and pepcid. Outcome of events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Night sweats
Clinical narrative: vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Burning anterior thigh pain on left 13hrs after injection; Burning hand pain on right; right hand was warm to touch relative to left; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 34-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:00 PM (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included hypertension (HTN), polymyositis, and psoriasis. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included olmesartan medoxomil (BENICAR), methotrexate, prednisone, vitamin C, and vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 08:40 PM, 40 minutes after injection, the patient experienced burning hand pain on right, and the right hand was warm to touch relative to left. On 29Dec2020 at 09:00 AM, 13hrs after injection, the patient experienced burning anterior thigh pain on left. Treatment for the events included physical therapy nerve glides: for burning hand pain on right, and the right hand was warm to touch relative to left included Median Nerve Glides, with a frequency of once a day which improved 99% in 24hrs; and treatment for the event burning anterior thigh pain on left included Femoral Nerve Glides, with a frequency of 2-5 times a day which improved 85% in 3 days. The patient was recovering from the events burning hand pain on right, the right hand was warm to touch relative to left, and burning anterior thigh pain on left. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Flushing, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: numbness in his right hand and foot, and numbness in his left foot; This is a spontaneous report from a contactable pharmacist (patient).  A 33-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Dec2020 at 33-years-old at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: numbness in his right hand and foot, and numbness in his left foot (left foot-opposite injection site) (non-serious). The clinical course was reported as follows: The patient was a pharmacist who received his first COVID-19 vaccine on 24Dec2020. The patient reported numbness in his right hand and foot.  The patient also had numbness in his left foot that had resolved.  The patient had numbness in his right hand and foot; which was "persistent but occasional."  The patient while reporting the adverse event (AE), was also looking for additional information regarding the duration and/or resolution of numbness that was reported by one vaccine recipient in the clinical trial. The clinical outcome of the event was not recovered; also reported as "persistent but occasional" for numbness in his right hand and foot and numbness in his left foot had resolved.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in his right hand and foot, and numbness in his left foot; This is a spontaneous report from a contactable pharmacist (patient).  A 33-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Dec2020 at 33-years-old at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: numbness in his right hand and foot, and numbness in his left foot (left foot-opposite injection site) (non-serious). The clinical course was reported as follows: The patient was a pharmacist who received his first COVID-19 vaccine on 24Dec2020. The patient reported numbness in his right hand and foot.  The patient also had numbness in his left foot that had resolved.  The patient had numbness in his right hand and foot; which was "persistent but occasional."  The patient while reporting the adverse event (AE), was also looking for additional information regarding the duration and/or resolution of numbness that was reported by one vaccine recipient in the clinical trial. The clinical outcome of the event was not recovered; also reported as "persistent but occasional" for numbness in his right hand and foot and numbness in his left foot had resolved.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; hives; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unspecified route on 30Dec2020 (at the age of 34 years-old) as a single dose (dose 1) for COVID-19 vaccination. Medical history included metabolic syndrome, tachycardia, interstitial cystitis, anxiety, depression, gastroesophageal reflux (GERD), migraines, polycystic ovarian syndrome (PCOS) and allergy to chocolate, vitamin E and cefaclor (CECLOR). The patient was not pregnant at the time of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications included dulaglutide (TRULICITY), metformin, dexlansoprazole (DEXILANT), lamotrigine (LAMICTAL), nitrofurantoin (MACRODANTIN), prazosin, vilazodone hydrochloride (VIBRYD), cefixime (FLEXERIL), ergocalciferol (DRISDOL), topiramate (TOPAMAX) and sumatriptan succinate (IMITREX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 09:30 PM, the patient experienced rash and hives. The report was reported as non-serious. The adverse events rash and hives resulted in physician office visit, emergency room/department or urgent care. The patient was treated for the rash and hives with diphenhydramine (BENADRYL) and prednisone. The clinical outcome of rash and hives was unknown. Since the vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Flushing, Livedo reticularis, Palpitations
Clinical narrative: within 5 minutes after injection had palpitations, flushing , tachycardia of 124 and BP of 154/106.  Skin rash of erythema and mottling, no urticaria, feeling of impending doom, burning in chest. given Benadryl and symptoms resolved after 30-40 minutes
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Tachycardia
Clinical narrative: within 5 minutes after injection had palpitations, flushing , tachycardia of 124 and BP of 154/106.  Skin rash of erythema and mottling, no urticaria, feeling of impending doom, burning in chest. given Benadryl and symptoms resolved after 30-40 minutes
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Nausea
Clinical narrative: dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye pain, Eye swelling, Night sweats, Periorbital swelling
Clinical narrative: I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen and red (only my eyelids); they were still red and painful; My eyes were slightly puffy the next morning but nothing alarming; Night sweats that were worst the night of the vaccination; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 29Dec2020 17:00 at single dose in the left arm for COVID-19 immunization. Medical history included none. No known allergies. No other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC). Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient experienced night sweats that were worst the night of the vaccination. Her eyes were slightly puffy the next morning (30Dec2020) but nothing alarming, however, Thursday morning (31Dec2020 06:00) she woke up with her eyes ever swollen and red (only her eyelids). Thursday evening she'd been able to get the swelling down but they were still red and painful (after diphenhydramine hydrochloride (BENADRYL)). The events were non-serious. Employer and provider of vaccine had no protocol in place and said to treat it like any other reaction and go to ER if it worsened. The events were not resolved.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Cardiovascular evaluation, Electrocardiogram, Electrocardiogram ambulatory, Full blood count
Clinical narrative: Patient describes tachycardia starting on day 4 following the vaccination.  Required emergency room visit along with primary care and cardiology evaluation.  Currently undergoing holter monitor study.  As of 1/6/2021 patient clinical status improving.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Physical examination, Tachycardia, Thyroxine
Clinical narrative: Patient describes tachycardia starting on day 4 following the vaccination.  Required emergency room visit along with primary care and cardiology evaluation.  Currently undergoing holter monitor study.  As of 1/6/2021 patient clinical status improving.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Chills, Heart rate, Laboratory test
Clinical narrative: Patient describes tachycardia starting on day 4 following the vaccination.  Required emergency room visit along with primary care and cardiology evaluation.  Currently undergoing holter monitor study.  As of 1/6/2021 patient clinical status improving.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Sinus tachycardia, Tachycardia, Thyroxine
Clinical narrative: Patient describes tachycardia starting on day 4 following the vaccination.  Required emergency room visit along with primary care and cardiology evaluation.  Currently undergoing holter monitor study.  As of 1/6/2021 patient clinical status improving.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: 1 hour from the time of administration, my throat began to tighten/narrow and became numb - no loss of airway. Administered self Benadryl for 24 hours following. Symptoms relieved within 24 hours.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: 1 hour from the time of administration, my throat began to tighten/narrow and became numb - no loss of airway. Administered self Benadryl for 24 hours following. Symptoms relieved within 24 hours.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain, SARS-CoV-2 test negative
Clinical narrative: Fatigue; Bad headaches; body/stomach aches; body/stomach aches; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 17Dec2020 09:30 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020, the patient got the 1st dose of the vaccine in the hospital. On 28Dec2020 11:00, the patient went home from work due to bad headaches followed by body/stomach aches, and fatigue. On 01Jan2021 finally feeling a little better. Fatigue and aches have subsided, but headache still around. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab on 29Dec2020, 30Dec2020, and 31Dec2020 and the result were all negative. The outcome of the event headache as not recovered while recovering for the other events.  Information about lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Fatigue; Bad headaches; body/stomach aches; body/stomach aches; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 17Dec2020 09:30 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020, the patient got the 1st dose of the vaccine in the hospital. On 28Dec2020 11:00, the patient went home from work due to bad headaches followed by body/stomach aches, and fatigue. On 01Jan2021 finally feeling a little better. Fatigue and aches have subsided, but headache still around. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab on 29Dec2020, 30Dec2020, and 31Dec2020 and the result were all negative. The outcome of the event headache as not recovered while recovering for the other events.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Full blood count, Hypertension, Laboratory test
Clinical narrative: dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. 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.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. 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.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Dizziness, Flushing, Pyrexia
Clinical narrative: dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. 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.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: Headache, Nausea
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache, Nausea
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Sensation of foreign body, Throat tightness
Clinical narrative: Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel throat tightness -upper pharynx/larynx region - like something was stuck or like I swallowed something - no difficulty breathing, just constant throat clearing like something was stuck on both sides of my upper pharynx/larynx region.  I was monitored by EMS and given 50 mg IM Benadryl. After 30 - 40 min. symptoms cleared.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Throat clearing, Throat tightness
Clinical narrative: Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel throat tightness -upper pharynx/larynx region - like something was stuck or like I swallowed something - no difficulty breathing, just constant throat clearing like something was stuck on both sides of my upper pharynx/larynx region.  I was monitored by EMS and given 50 mg IM Benadryl. After 30 - 40 min. symptoms cleared.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: I had my vaccine at 910am 12/30/2020.  I was sitting in the chair and one of the people walking around checking on people asked me how I was doing . I told her I was feeling a little foggy. She gave me a bottle of water and kept checking on me every few mins. At around 935 she took me into the back with the medics to get my vitals. They hooked me up to their defib machine for my vitals. My BP was 190/111. They did it manually and it was 180/110. I was starting a headache. By the time I left my BP was 165/99.  I then went to work. At lunchtime my BP was 148/99. I still had a headache for the rest of the day
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: I had my vaccine at 910am 12/30/2020.  I was sitting in the chair and one of the people walking around checking on people asked me how I was doing . I told her I was feeling a little foggy. She gave me a bottle of water and kept checking on me every few mins. At around 935 she took me into the back with the medics to get my vitals. They hooked me up to their defib machine for my vitals. My BP was 190/111. They did it manually and it was 180/110. I was starting a headache. By the time I left my BP was 165/99.  I then went to work. At lunchtime my BP was 148/99. I still had a headache for the rest of the day