chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest heaviness; This is a spontaneous report from a contactable pharmacist. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration on 08Jan2021 at a single dose, for covid-19 immunization. Medical history included allergies from shellfish-derived products. The patient's concomitant medications were not reported.  The patient experienced chest heaviness on 08Jan2021. Patient was transported to ER for evaluation. Upon re-evaluation in ER, patient felt back to baseline and was discharged. The outcome of event was recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Gastrointestinal pain, Hyperhidrosis, Metabolic function test, Muscle fatigue
Clinical narrative: Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy  and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None.  Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown.    Information about lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Pyrexia, Tremor
Clinical narrative: Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy  and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None.  Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: pain in the thigh muscle; terrible pain in her leg and in her thigh/arm was feeling a little sore/ache in arm; a lot of pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Jan2021 to Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient stated that she got the Pfizer Vaccine on Tuesday and she have now a terrible pain in her leg and in her thigh, pain in the thigh muscle, it is very, very painful. She had a little ache in arm, nothing terrible. She also stated that She felt fine except her arm was feeling a little sore. Last night, she got terrific pain in her thigh muscle and she is in a lot of pain. Outcome of the events was unknown.   Information on lot/batch number has been requested..
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: Transient global amnesia; This is a spontaneous report from a contactable physician.  A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142, expiration date not reported), intramuscular on the left arm, from 07Jan2021 at 09:00 at a single dose for Covid-19 immunization.  Medical history included low back pain, benign prostatic hyperplasia, impaired fasting glucose.  Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and tamsulosin. 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. On 07Jan2021, the patient experienced transient global amnesia. Started about 4-5 hours after vaccination and lasted 12 hours. There was no treatment received for the event. Outcome of the event was recovered on 07Jan2021. The reporter assessed the event as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dyspnoea, Flushing, Palpitations, Tremor
Clinical narrative: It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Flushing, Panic attack, Tachycardia, Vertigo
Clinical narrative: Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization.  The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. 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. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered.  The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching on torso and neck; Rash and itching on torso and neck; This is a spontaneous report from a contactable physician who reported for herself, a 53-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm, on 12Jan2021 at 09:15 at the age of 53 years, at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant. Concomitant medications included ospemifene (OSPHENA), vitamins and ibuprofen (ADVIL). Patient had no other vaccines in four weeks. The patient previously took and had known allergies to Gentamycin Opath Drops and hydroxychloroquine. The patient received the first dose of BNT162B2 with lot number: EJ1685 at the age of 53 years, in the left arm on 21Dec2020 at 07:00 PM for COVID-19 immunization. The patient experienced rash and itching on torso and neck 48 hours after injection on 14Jan2021 at 20:00. Therapeutic measures taken as a result of rash and itching on torso and neck included Benadryl. The outcome of the events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Dizziness, Headache
Clinical narrative: blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia, Vision blurred
Clinical narrative: blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Laboratory test
Clinical narrative: Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash
Clinical narrative: Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Headache; fatigue; joint pain; left supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable physician.  A 30-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on an unspecified date at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced Headache, fatigue, joint pain, and left supraclavicular lymphadenopathy on an unspecified date.  The outcome of events was recovering. Therapeutic measures were taken as a result of headache and joint pain included OTC pain relievers.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: she had an allergic reaction to the Prevnar 13; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. Caller wanted to know if the Covid vaccine had similar components as the Prevnar 13 vaccine. Caller stated that she had an allergic reaction to the Prevnar 13 vaccine in the past and had to go to the hospital to receive a shot. The outcome of the event was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling on injection site for the first pfizer covid vaccine, it was red; swelling on injection site for the first pfizer covid vaccine, it was red; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received 1st dose of BNT162B2 (lot# EH9899), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications was not reported. On an unspecified date, she did experience swelling on injection site for the first pfizer covid vaccine, it was red. They had her draw a circle around it and monitor that it did not expand out of the circle.  It did not and went down on its own. The outcome of events was recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Pyrexia
Clinical narrative: fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"/she did not feel good; Chills; This is a spontaneous report from a contactable nurse.  A 44-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) intramuscular on 14Jan2021 single dose for COVID-19 immunisation. Vaccine location was deltoid left. No other vaccine was received in four weeks.  The patient medical history was not reported. Historical vaccine included first dose of BNT162B2 (Lot: EL1284) received on 28Dec2020 around 7pm, intramuscular injection right deltoid. There were no concomitant medications. The patient experienced fever (she woke up with a fever of 101.3 at 6am), pretty intense 'joint pain, felt like it was on fire' on 14Jan2021; with the first dose of the covid vaccine she had really bad hip pain about 24 hours after (as reported) and it lasted about 12 hours but she could still walk and move, it was just annoying. The patient was ''like death today"/ she did not feel good' on 14Jan2021, chills on 14Jan2021. Her temperature has improved and it is around 99. The outcome of fever and chills was recovering, of 'pretty intense joint pain, felt like it was on fire' was recovered on 15Jan2021, of she feels 'like death today'/ she did not feel good and hip pain was unknown.; Sender's Comments: A possible contributory effect of suspect BNT12B2 on reported fever cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: Rash under the skin that is itchy; Rash under the skin that is itchy; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route of administration on the left arm on 29Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetic, and metal and copper allergies. Concomitant medication included unspecified regular medications. No other vaccines were administered on the same date. No vaccinations were received four weeks prior. On 10Jan2021 23:00, the patient reported that she broke out in a rash under her skin that was so itchy. She noticed the rash around 11PM and had been taking Benadryl around the clock. She can still see the rash on her skin, it was not raised or bumpy, but it itches like crazy. She clarified the rash was located on both of her arms, trunk, chest, back, and neck. She believed the COVID-19 vaccine was related to the rash that was itchy that she was having. She cannot think of anything she has done differently to cause this itching. It started Sunday and at the time of reporting, it was Thursday and she still had it. She stated she was trying to go to the doctor to be looked at, but no one called her back. She has been taking Benadryl around the clock from the beginning of when it was needed. It seemed like the Benadryl has not phased her at all as she was wide awake. The next dose was scheduled for Monday 18Jan2021 and she did not know if she wanted to get the second dose of the vaccine. The vaccine was given at a hospital, not military facility. The adverse events did not require a visit to the emergency room or to the physician's office. The patient underwent lab tests and procedures which included rapid COVID test: negative on 13Jan2021. Outcome of the events was recovering. The events were reported as non-serious and related to the suspect drug.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Musculoskeletal discomfort
Clinical narrative: crawling on her hands and knees as well; horrific neck issue; This is a spontaneous report from a contactable physician (Specialty: Obstetrics & Gynecology). This physician reported for a patient (Reporter's friend) that: A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization.  Medical history included minor lower back issues from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization with no adverse events. The patient has a horrific neck issue in Jan2021. She got the second dose of the Pfizer COVID19 vaccine on Friday and over the weekend in Jan2021 she was crawling on her hands and knees as well. The outcome of the events was unknown  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid + since receiving the first dose; Covid + since receiving the first dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included near end of life (patient was transitioned to hospice). The patient's concomitant medications were not reported. Per second (2nd) vaccination clinic on 12Jan2021, it was reported the one resident was transitioned to hospice (and is near end of life) and also reported was COVID positive (+) since receiving the first dose on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID positive (+)  based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Swelling
Clinical narrative: Swelling behind left ear. Mastoiditis ruled out by CT; This is a spontaneous report from a contactable consumer, the patient.  A 55-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  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. Since the vaccination, the patient had not been tested for COVID-19.  The patient previously took tetracycline hcl (MANUFACTURER UNKNOWN) and thimerosal (MANUFACTURER UNKNOWN); both on unknown dates for unknown indications and experienced drug allergy.  On 12Jan2021 at 06:00, the patient experienced swelling behind left ear. The event required a visit to the emergency room and physician's office.  A computed tomogram in Jan2021 ruled out mastoiditis.  The patient was started on antibiotics to see if the swelling would resolve. The clinical outcome of the swelling behind the left ear was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from contactable nurse. This Nurse reported same events for six patients. This report is for 1st of six reports.  A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035080 same reporter/drug/event, different patient;US-PFIZER INC-2021035079 same reporter/drug/event, different patient;US-PFIZER INC-2021035081 same reporter/drug/event, different patient;US-PFIZER INC-2021035082 same reporter/drug/event, different patient;US-PFIZER INC-2021035083 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is a spontaneous report from a contactable nurse. This nurse reported same events for six patients. This is the second of six reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 22Dec2020 at a single dose in the nursing home for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted covid after receiving the 1st vaccine dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 4th of 6 reports.   An unknown age and gender patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: contracted covid after receiving the 1st dose and were still symptomatic; contracted covid after receiving the 1st dose and were still symptomatic; This is spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 6 patients. This is the sixth of six reports. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 22Dec2020 at single dose in the nursing home for COVID-19 immunization. Medical history and concomitant drugs were not reported. On an unspecified date, patient contracted covid after receiving the 1st dose and were still symptomatic and was unable to receive their 2nd dose on 12Jan2021. Outcome of events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, 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.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Recent COVID + diagnosis/Covid exposure; Recent COVID + diagnosis/Covid exposure; This is a spontaneous report from two contactable nurses via a Pfizer sales representative.  This author reported similar events for 4 patients. This is 1st of 4 reports.  A patient of unspecified age and gender receive 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had been vaccinated with a 1st dose and had to defer to 02Feb2021 due to recent COVID + diagnosis/COVID exposure. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021035087 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035086 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035085 the same reporter, product and adverse events in different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: COVID + diagnosis/Covid exposure; COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported same events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/Covid exposure. Lab test included positive covid test. The outcome of events was unknown.  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.,Linked Report(s) : US-PFIZER INC-2021035084 the same reporter, product and adverse events in different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: recent COVID + diagnosis/Covid exposure; recent COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported similar events for 4 patients. This is the third of four reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Reporter stated 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/COVID exposure. Event took place after use of product. Covid test was positive. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, 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.,Linked Report(s) : US-PFIZER INC-2021035084 the same reporter, product and adverse events in different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Recent COVID + diagnosis/Covid exposure; Recent COVID + diagnosis/Covid exposure; This is a spontaneous report from contactable nurses. This nurse reported same events for 4 patients. This is 4th of 4 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that 4 employees that had been vaccinated with a 1st dose had to defer to 02Feb2021 due to recent COVID + diagnosis/Covid exposure. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021035084 same reporter, product and adverse events in different patients
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: extreme fatigue; fever 5+ days; headache; diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283), intramuscular (left arm), on 10Jan2021 13:00, at single dose, for covid-19 immunization. Medical history included allergies: sulfa, venom. Concomitant medications included omeprazole (OMEPRAZEN); duloxetine; cefixime (FLEXERIL); promethazine (PHENERGAN) and; gabapentin. The patient previously took gentamicin and experienced allergies. The patient experienced extreme fatigue, fever 5+ days, headache, diarrhea all on 10Jan2021 at 18:00. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unspecified treatment for these events. The patient had no other vaccines administered in four weeks and had no Covid prior vaccination. The patient had a rapid Covid test post vaccination via nasal swab on 15Jan2021 with result of negative. The outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Headache, Pyrexia
Clinical narrative: Dizziness; headaches; chills while body is on fire/temperatures ranging from 10.5-102.8; This is a spontaneous report from a contactable healthcare professional, the patient.  A 33-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Jan2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included aplastic anaemia, gastroparesis, and migraine with aura.  The patient did not have any allergies to medications, food, or other products. There were no concomitant medications.  The patient previously received the first dose of BNT162B2 on 28Dec2020 at 14:00 (at the age of 33-years-old) in the right arm for COVID-19 immunization.  The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first dose). On 15Jan2021 at 17:00, the patient experienced dizziness, headaches, chills while body was on fire/temperatures ranging from 10.5 (as reported) to 102.8 even with the use of acetaminophen (TYLENOL) or ibuprofen (MOTRIN).  The patient did not receive any treatment for the dizziness or headaches.  The clinical outcomes of the dizziness, headaches, and chills while body was on fire/temperatures ranging from "10.5-102.8" were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site swelling, Injection site warmth
Clinical narrative: Dizziness; headaches; chills while body is on fire/temperatures ranging from 10.5-102.8; This is a spontaneous report from a contactable healthcare professional, the patient.  A 33-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Jan2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included aplastic anaemia, gastroparesis, and migraine with aura.  The patient did not have any allergies to medications, food, or other products. There were no concomitant medications.  The patient previously received the first dose of BNT162B2 on 28Dec2020 at 14:00 (at the age of 33-years-old) in the right arm for COVID-19 immunization.  The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first dose). On 15Jan2021 at 17:00, the patient experienced dizziness, headaches, chills while body was on fire/temperatures ranging from 10.5 (as reported) to 102.8 even with the use of acetaminophen (TYLENOL) or ibuprofen (MOTRIN).  The patient did not receive any treatment for the dizziness or headaches.  The clinical outcomes of the dizziness, headaches, and chills while body was on fire/temperatures ranging from "10.5-102.8" were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Dizziness; headaches; chills while body is on fire/temperatures ranging from 10.5-102.8; This is a spontaneous report from a contactable healthcare professional, the patient.  A 33-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15Jan2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included aplastic anaemia, gastroparesis, and migraine with aura.  The patient did not have any allergies to medications, food, or other products. There were no concomitant medications.  The patient previously received the first dose of BNT162B2 on 28Dec2020 at 14:00 (at the age of 33-years-old) in the right arm for COVID-19 immunization.  The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first dose). On 15Jan2021 at 17:00, the patient experienced dizziness, headaches, chills while body was on fire/temperatures ranging from 10.5 (as reported) to 102.8 even with the use of acetaminophen (TYLENOL) or ibuprofen (MOTRIN).  The patient did not receive any treatment for the dizziness or headaches.  The clinical outcomes of the dizziness, headaches, and chills while body was on fire/temperatures ranging from "10.5-102.8" were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Night sweats, Pain in jaw
Clinical narrative: Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.