chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sleep disorder, Vaccination site pain
Clinical narrative: soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm.  About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache.  She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Erythema, Full blood count
Clinical narrative: chest pressure; his psoriasis scars were red; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date not reported), intramuscular in the left arm on 08Jan2021 10:30 at a single dose for COVID 19 immunization. Medical history included Type 2 DM (diabetes mellitus), HTN (hypertension), and psoriasis. The patient had no covid prior to vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA) at 60 mg, amlodipine besilate (NORVASC) at 5mg, losartan at 100 mg, glipizide at 5mg, fenofibrate, hydrocodone bitartrate, paracetamol (NORCO) at 7.5 mg, as needed; and methotrexate weekly (unsure of dose); all reported as medication within two weeks of vaccination. The patient previously took phenylpropanolamine and sulfamethoxazole, trimethoprim (SEPTRA), and experienced rash from both of these drugs. The patient received first dose of bnt162b2 (lot number: EK5730, expiry date not reported) intramuscularly on 18Dec2020 as COVID 19 immunization. The patient did not receive any other vaccine in four weeks. The vaccinations were given in the hospital. Patient was vaccinated at 10:30 on 08Jan2021and observed for 15 minutes. Patient came back and reported shortly after leaving he developed chest pressure and noticed his psoriasis scars were red. He was transported to ED (emergency department) (2 min). ER workup on 08Jan2021 included CBC within nl (normal) limits and EKG that showed no abnormal findings. Plan was to observe and discharge pt. Plan was to observe and discharge patient. The patient did not receive treatment in response to the events reported. The events resulted in emergency room/department or urgent care. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient was not tested for COVID post vaccination. The outcome of the events chest pressure and psoriasis scars were red was recovered in Jan2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; Fever after 14 hours; arm  pain; This is a spontaneous report from a contactable other healthcare professional (patient).  A 25-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, intramuscularly on 08JAN2021 10:00 AM (at the age of 25-years-old) as a single dose in the left arm  for COVID-19 immunization.  Medical history included allergies to penicillin. Concomitant medication included birth control. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccinations were received in 4 weeks. On 09Jan2021 01:00, the patient experienced fever after 14 hours, and arm pain. The patient took acetaminophen (TYLENOL) every 4-6hours. No temperature was taken. The patient experienced headache on 10Jan2021. The fever, arm pain and headache did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  Outcome of the events fever, arm pain and headache were recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gastrointestinal pain, Headache, Nausea, Paraesthesia
Clinical narrative: severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot very sore arm; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EH9899, expiry date not reported), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN), CKD (Chronic kidney disease), and had known allergies to bee stings. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior vaccination. Unspecified concomitant medications (reported as "lots") were taken within two weeks of vaccination. The patient previously took ibuprofen and experienced allergies. The vaccination was administered in the hospital. The patient experienced from the first shot, very sore arm on an unspecified date. Arm still sore at 60 hours. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the event reported. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event sore arm was reported as recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, SARS-CoV-2 test positive
Clinical narrative: tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Severe headache lasting 2-3 days; fever; chills; light-headedness; Fatigue; This is a spontaneous report from a contactable health care professional, the patient.  A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 23Dec2020 at 08:00 AM (at the age of 26-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 17:00 PM, the patient experienced severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. The patient did not receive any treatment for the severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache lasting 2-3 days, fever, chills, light-headedness, and fatigue was recovered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Faeces soft, Fatigue, Muscle spasms, Myalgia
Clinical narrative: soft bowel movements for two days; rigors; Profound Fatigue For 36 Hours and Milder Fatigue Thereafter; Myalgias; Cramps; This is a spontaneous report from a contactable physician (patient himself). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el0142; expiry date: unknown) intramuscular (right arm), on 06Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Medical history included increased cholesterol; allergies to penicillin; and COVID-19 that started on an unspecified date (prior COVID-19 vaccination) to an unspecified date (ongoing: no). Concomitant medication included rosuvastatin calcium (CRESTOR). The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 06:00, the patient experienced myalgias and cramps. The next morning (08Jan2021), the patient experienced rigors. 26 hours post vaccination, he experienced profound fatigue for 36 hours which became milder fatigue thereafter. On an unspecified date, the patient experienced soft bowel movements for 2 days. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharochalasis
Clinical narrative: Swelling of upper left eyelid without redness, heat, or pain consistent with blepharochalasis; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 16Dec2020, 12:00PM for the first dose (lot number: EH9899) and on 06Jan2021, 12:00PM for the second dose (lot number: EH1284), both in the left arm at a single dose for COVID-19 immunization. The patient's medical history included beta thalassaemia trait and BPH (benign prostatic hyperplasia), both from an unknown date. The patient had no known allergies. Concomitant medications included tadalafil, fluticasone propionate (FLONASE), ketotifen (ZADITOR), and fexofenadine hydrochloride (ALLEGRA); these medications were also received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021, 08:00AM, the patient experienced swelling of upper left eyelid without redness, heat, or pain; onset was in morning after 2nd dose and c/w (consistent with) blepharochalasis. There was no evidence of hordeolum or conjunctivitis. Four days after dose, there was no change in swelling which is not responding to Allegra or Tobradex eye drops. There is short-lived relief with cold compresses. Tobradex was suggested in curbside consult with an ophthalmologist colleague. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event at the time of last observation was not recovered. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiry date not reported), intramuscular in the right arm on 04Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included norethisterone (CAMILA). The patient previously took erythromycin and experienced allergies. On 10Jan2021 at 2:00, the patient experienced bilateral armpit lymph node pain and bilateral groin lymph node pain 7 days after vaccine. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo, Vomiting
Clinical narrative: Nausea; vomiting; dizziness with vertigo; dizziness with vertigo; headache; fever; severe body aches in lower back; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), via intramuscular on 07Jan2021 11:45 at single dose in left arm for covid-19 immunization. Medical history included asthma, hospitalized with pertussis related bronchiolitis/hypoxia in Apr2020. The patient's concomitant medications received within 2 weeks of vaccination included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products included erythromycin and pancuronium bromide (PAVULON). The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via intramuscular on 17Dec2020 17:00 at single dose in right arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, vomiting, dizziness with vertigo, headache, fever, severe body aches in lower back and fatigue from 36 to 50 hours post vaccination on 09Jan2021. The patient did not receive any treatments. The outcome of the events was recovered in Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body aches; fever; chills; headache; This is a spontaneous report from a contactable other health professional (patient).  A 35-year-old female patient (no pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: El1283) via an unspecified route of administration on the left arm on 08Jan2021 02:00 PM at single dose for COVID-19 immunisation.  Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on the left arm on 18Dec2020 03:45 PM at single dose for COVID-19 immunisation.  Medical history included known allergy to Bactrum and ciprofloxacin hydrochloride monohydrate (CIPRO). The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lisdexamfetamine mesilate (VYVANSE). No other vaccine in four weeks. On 09Jan2021 at 04:00 AM, patient experienced body aches, fever, chills, headache. Nasal swab covid test post vaccination on 28Dec2020 was negative. No treatment received for the events. The outcome of events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Electrocardiogram, Heart rate, Laboratory test
Clinical narrative: Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. 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 patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Tachycardia
Clinical narrative: Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. 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 patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Condition aggravated, Focal dyscognitive seizures, Hypotonia, Muscular weakness
Clinical narrative: partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Syncope
Clinical narrative: partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors.  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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature rupture of membranes
Clinical narrative: spontaneous rupture of membranes at 36-0 weeks; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is the maternal report. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) on 18Dec2020 and 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cold sores, no active cold sore at time of labor. On an unspecified date, it was reported that a healthy 29-year-old G1P0 with good prenatal care and no pregnancy complications who had spontaneous rupture of membranes at 36-0 weeks, one day after her second Pfizer CoVid vaccine (09Jan2021). She felt well after her vaccine and had no symptoms today. The mother reported she became pregnant while taking BNT162B2. The patient takes prenatal vitamins. The mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Feb2021. Therapeutic measures were taken as a result of premature rupture of membranes. The outcome of the event was recovering.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of spontaneous rupture of membranes due to temporal relationship.  However, the reported event may possibly represent intercurrent medical condition in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Frequent bowel movements, Headache, Malaise
Clinical narrative: Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Dysphagia, Dyspnoea, Sensation of foreign body, Somnolence
Clinical narrative: Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: significant swelling to lymph nodes under armpit of injection side (L arm); This is a spontaneous report from a contactable consumer.  A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 09Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at a hospital.  Medical history included asthma, food allergy with peanuts and pine nuts. No known medication allergy. The concomitant medications included albuterol and unspecified multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at the left arm on 19Dec2020 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient was not pregnant. On 10Jan2021 16:00, the patient noted significant swelling to lymph nodes under armpit of injection side, swelling in the left armpit lymph nodes began approximately 32 hours after injection. Swelling measuring approximately size of a ping pong ball. At time of this reporting (approximately 40 hours post-injection) lymph node swelling still persists, with no change in size. The patient did not receive any treatment for the events. The patient has not recovered from the events.   No follow-up attempts are needed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient.  A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The  patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Lymphadenopathy; This is a spontaneous report from a contactable healthcare professional who reported for herself, a 40-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: el0142) at the hospital, intramuscular in the left arm on 06Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included "COVID prior vaccination Yes" on an unspecified date. The patient was not pregnant at the time of reporting. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 with lot number: EK7530 at age 40 years, via intramuscular route in the left arm, on 16Dec2020 at 12:00 PM, Nasal Swab test result was positive on 28Dec2020. The patient experienced lymphadenopathy on 07Jan2021 at 19:00. The event was considered as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; Patient was tested for Covid post vaccination/ Covid test on 28Dec2020 and resulted positive; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK7530) solution for injection, intramuscular on left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. It was reported that patient was tested for Covid post vaccination. Nasal swab for Covid test was done on 28Dec2020 and resulted positive. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.