chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pain in extremity
Clinical narrative: Body aches; very sore arm; felt bad; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Pfizer Covid 19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on Jan2021 at a single dose for covid-19 immunization. Medical history included covid-19 this summer (2020). The patient's concomitant medications were not reported. The patient reported that she got the vaccine last week (Jan2021) and the post op was not very pleasant [pending clarification]. She said that she did not have a fever, but she did have body aches and a very sore arm in Jan2021. The reporter mentioned that she heard that after the second vaccine you can develop high fever and she is hearing that you can from other people. The patient further mentioned that she took the first dose of vaccine and then felt bad afterwards (Jan2021) so she wanted to know more information about the second vaccine for safety purposes. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hangover, Headache, Pain, Pyrexia
Clinical narrative: A bad hangover; Body aches; headache; low grade fever; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, headache and low grade fever. The patient felt like the day after vaccine was a bad hangover. The events took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood creatinine normal, Blood fibrinogen increased, Blood lactic acid, Blood sodium decreased
Clinical narrative: A bad hangover; Body aches; headache; low grade fever; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, headache and low grade fever. The patient felt like the day after vaccine was a bad hangover. The events took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Cardiac arrest, Death, Diarrhoea, Fibrin D dimer increased
Clinical narrative: A bad hangover; Body aches; headache; low grade fever; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, headache and low grade fever. The patient felt like the day after vaccine was a bad hangover. The events took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, Myocarditis, Oropharyngeal pain, Platelet count decreased, Pyrexia
Clinical narrative: A bad hangover; Body aches; headache; low grade fever; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, headache and low grade fever. The patient felt like the day after vaccine was a bad hangover. The events took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive, Serum ferritin increased, Transaminases, Troponin increased, White blood cell count increased
Clinical narrative: A bad hangover; Body aches; headache; low grade fever; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, headache and low grade fever. The patient felt like the day after vaccine was a bad hangover. The events took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient just had 46 sore arms and that was it. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Malaise, Rhinorrhoea
Clinical narrative: Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Sneezing
Clinical narrative: Coughing/cough has worsened; Tiredness; Sinus congestion; Runny nose; Dizzy; Didn't feel well; Sneezing; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 09Jan2021 (11:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at a clinic (not a military facility). Medical history included ongoing rhinosinusitis from 2019; ongoing allergy multiple; bronchitis from Mar2020; upper respiratory tract infection from Mar2020; sleep apnea; bipolar depression; and post-traumatic stress disorder (PTSD). There were no concomitant medications. On 09Jan2021 (06:00), the patient had sinus congestion and runny nose. On 09Jan2021, the patient was dizzy. On 10Jan2021, the patient was coughing, and then cough was reported to have worsened; and had tiredness. In Jan2021, the patient did not feel well; and was sneezing. The patient had used a nose rinse with an alcohol rub, and took and Epsom salt bath, and had some soup as treatment for the sinus congestion and runny nose. The patient had two COVID-19 virus tests on unspecified dates, and both were labeled as inconclusive. The outcome of the events was not recovered for 'sinus congestion', 'runny nose' and 'cough/cough has worsened'; and was unknown for 'dizzy', 'tiredness', 'did not feel well' and 'sneezing'.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Immediate leg cramping after shot was given and following 24 hours; This is a spontaneous report from non-contactable consumer  representative. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced immediate leg cramping after shot was given and following 24 hours on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Urine analysis
Clinical narrative: Blood in urine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on left arm on 12Jan2021 10:00 at a single dose for Covid-19 immunization. The patient's medical history was not reported. The 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 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan (reported as "losortan") and rosuvastatin calcium (CRESTOR). The patient experienced blood in urine on 12Jan2021 10:00. The event was not treated and reported as non-serious. The outcome of the event was not recovered. The patient received vaccine on workplace clinic.  Information on the batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Stuffy and Runny Nose; Stuffy and Runny Nose; Severe Tiredness; Sore Throat that comes and goes; mild head fogginess; This is a spontaneous report from a contactable Other HCP. A 19-year-old male patient received the first dose of BNT162B2 (lot number: EJ1686), via an unspecified route of administration on 10Jan2021 11:15 at single dose in the right arm for COVID-19 immunization. Medical history included hyperhidrosis and anxiety. Concomitant medication included clonidine, gabapentin, citalopram and lorazepam. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies; and had influenza vaccine inact split 4v (AFLURIA QUAD) (Lot number: P100275860) on 24Dec2020 at single dose for immunization. On 11Jan2021 06:00, the patient experienced stuffy and runny nose, severe tiredness, sore throat that comes and goes and mild head fogginess. No treatment received for all the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included rRT-PCR Deep Nasal Swab - Both Nostrils: pending results on 09Jan2021 and pending results on 11Jan2021. The outcome of the events was not recovered.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Stuffy and Runny Nose; Stuffy and Runny Nose; Severe Tiredness; Sore Throat that comes and goes; mild head fogginess; This is a spontaneous report from a contactable Other HCP. A 19-year-old male patient received the first dose of BNT162B2 (lot number: EJ1686), via an unspecified route of administration on 10Jan2021 11:15 at single dose in the right arm for COVID-19 immunization. Medical history included hyperhidrosis and anxiety. Concomitant medication included clonidine, gabapentin, citalopram and lorazepam. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies; and had influenza vaccine inact split 4v (AFLURIA QUAD) (Lot number: P100275860) on 24Dec2020 at single dose for immunization. On 11Jan2021 06:00, the patient experienced stuffy and runny nose, severe tiredness, sore throat that comes and goes and mild head fogginess. No treatment received for all the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included rRT-PCR Deep Nasal Swab - Both Nostrils: pending results on 09Jan2021 and pending results on 11Jan2021. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Headache, Heart rate
Clinical narrative: flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscle and joint pains; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received the second dose of bnt162b2, intramuscular in the left arm, from 12Jan2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at vaccination. Medical history included GERD (gastroesophageal reflux disease) and barrett's esophagus. Historical Vaccine included 1st dose of BNT162B2 on 24Dec2020 via intramuscular in the right arm for COVID-19 immunization. Concomitant medications included melatonin, pantoprazole sodium sesquihydrate (PROTONIX), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS), and algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 13Jan2021 03:00, the patient felt like she had a flu; her HR was higher than normal, felt like she had a fever, felt weak, developed a dry cough, headache; and muscle and joint pains. The outcome of events was recovered. The patient did not receive any treatment for the events.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza, Myalgia, Pyrexia
Clinical narrative: flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscle and joint pains; This is a spontaneous report from a contactable nurse.  A 27-year-old female patient received the second dose of bnt162b2, intramuscular in the left arm, from 12Jan2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at vaccination. Medical history included GERD (gastroesophageal reflux disease) and barrett's esophagus. Historical Vaccine included 1st dose of BNT162B2 on 24Dec2020 via intramuscular in the right arm for COVID-19 immunization. Concomitant medications included melatonin, pantoprazole sodium sesquihydrate (PROTONIX), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS), and algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 13Jan2021 03:00, the patient felt like she had a flu; her HR was higher than normal, felt like she had a fever, felt weak, developed a dry cough, headache; and muscle and joint pains. The outcome of events was recovered. The patient did not receive any treatment for the events.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Pounding headache; Chills; body aches; fever of 100.2; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, and losartan potassium (LOSARTIN). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the left arm on 18Dec2020 14:30 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 09Jan2021 02:30, the patient experienced pounding headache. On Jan2021, 18-40 hours after vaccination, the patient experienced chills, body aches, and fever of 100.2. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen lymph nodes above clavicle; Redness over those lymph nodes; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 22-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on her left arm on 11Jan2021 at 07:45, at a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Concomitant medications included doxycycline and vitamin D3. The patient received her first dose of BNT162B2, lot number: EL0140 on 20Dec2020 at 02:30 PM. The patient experienced swollen lymph nodes above clavicle, redness over those lymph nodes, redness, pain, warmth, and swelling at injection site on 11Jan2021 at 18:30. There was no treatment received for the adverse events. The outcome of the events was recovering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Swollen lymph nodes above clavicle; Redness over those lymph nodes; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; Redness, pain, warmth, and swelling at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 22-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on her left arm on 11Jan2021 at 07:45, at a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Concomitant medications included doxycycline and vitamin D3. The patient received her first dose of BNT162B2, lot number: EL0140 on 20Dec2020 at 02:30 PM. The patient experienced swollen lymph nodes above clavicle, redness over those lymph nodes, redness, pain, warmth, and swelling at injection site on 11Jan2021 at 18:30. There was no treatment received for the adverse events. The outcome of the events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Smear test, Swelling face
Clinical narrative: left side of face swelling, especially left eye area and around left side of mouth; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number: EKG9231, expiration date: not reported), via an unspecified route of administration, on 12Jan2021 10:00 AM on left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at a hospital. She 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. Medical history included gerd (Gastroesophageal reflux disease) and allergy to grapefruit. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: Elo 140, expiration date: not reported), via an unspecified route of administration, on 23Dec2020 09:00 AM on left arm for COVID-19 immunization. The patient experienced left side of face swelling, especially left eye area and around left side of mouth, on 13Jan2021 11:00 PM. Since the vaccination, the patient has been tested for COVID-19: Nasal swab on 01Oct2020 (as reported) with negative result. The treatment received for the adverse event was Otc (over-the-counter) Benadryl. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: arthritis pain has been gone for 2 days; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for an COVID-19 immunization. Medical history included osteoarthritis. The patient's concomitant medications were not reported. Patient took the 1 dose of BNT162B2 on 19Dec2020. Patient had no side effects with the first injection but she had a few with the second. Patien had something happen that was very unexpected. She had osteoarthritis and her arthritis pain has been gone for 2 days now on Jan2021.  No follow-up attempts are needed. Information about lot/batch number could not be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: sore arm at the injection site; chills; subjective fever; fatigue; headache; This is a spontaneous report from a contactable physician (reporting for himself). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 12Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included migraine, rosacea and overweight (not obese) from an unknown date and unknown if ongoing. Concomitant medication included doxycycline, magnesium, sulfamethoxazole, trimethoprim (BACTRIM) and Vitamin D. The patient was 59 years old when vaccinated with first dose of BNT162B2 (lot number: EL0140), intramuscular in left arm on 22Dec2020 11:00 at single for COVID-19 immunization and experienced a sore arm at the injection site. The facility where the most recent COVID-19 vaccine was administered was in the nursing home/senior living facility. 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. For the first 24 hours, the patient simply had a sore arm at the injection site on 13Jan2021 09:00, similar to what he had with the first vaccination. Then for the next 12 hours had chills, subjective fever, fatigue, and headache on 13Jan2021 that did not respond simply to ibuprofen. The outcome of the events was recovered on unspecified date. The patient took ibuprofen, triptan as treatment for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. 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. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit  that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. 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. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit  that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: swollen lymph nodes in right armpit that were tender; swollen lymph nodes in right armpit that were tender; Body ache; Had low grade temp fever 99-99.5; Terrible headache; Fatigue/ tiredness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; Sore arm at injection site with warmth, swelling and redness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 29Dec2020 12:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. 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. Concomitant medication included levothyroxine sodium (SYNTHROID). On 30Dec2020, approximately 12 hour started with body ache; from 18 hours to 30 hours, patient had low grade temp fever 99-99.5 (I usually run 97.50), body ache, terrible headache, fatigue, tiredness- slept all but 3 hours throughout day, sore arm at injection site with warmth, swelling and redness. On day 3-4, the patient had swollen lymph nodes in right armpit  that were tender. By day 5, the patient felt back to baseline. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Hypersomnia
Clinical narrative: Violent chills; Temp up to 102.6; Body and joint aches; Joint aches; Slept x 24 hours due to headache; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL 3246, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at 12:30 PM at a single dose for COVID-19 in a public health clinic/facility.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK 5730, unknown expiration) via an unspecified route of administration in left arm on 22Dec2020 at 12:30 PM for COVID-19. Medical history reported as none.  The patient's concomitant medications were not reported.  The patient previously took thimerosal and experienced allergies. By midnight of 12Jan2021, the patient experienced violent chills, temp up to 102.6, body and joint aches, and she slept x 24 hours due to headache. She started to feel better on 13Jan2021 at 8:00 PM, and 100% better on 14Jan2021 at 07:15 AM.  The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 14Jan2021 at 07:15 AM. The events were assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Violent chills; Temp up to 102.6; Body and joint aches; Joint aches; Slept x 24 hours due to headache; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL 3246, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at 12:30 PM at a single dose for COVID-19 in a public health clinic/facility.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK 5730, unknown expiration) via an unspecified route of administration in left arm on 22Dec2020 at 12:30 PM for COVID-19. Medical history reported as none.  The patient's concomitant medications were not reported.  The patient previously took thimerosal and experienced allergies. By midnight of 12Jan2021, the patient experienced violent chills, temp up to 102.6, body and joint aches, and she slept x 24 hours due to headache. She started to feel better on 13Jan2021 at 8:00 PM, and 100% better on 14Jan2021 at 07:15 AM.  The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 14Jan2021 at 07:15 AM. The events were assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea, Vaccination site pain
Clinical narrative: Fatigue; Injection site pain; Runny nose; Cold-like symptoms; This is a spontaneous report from a contactable physician (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 11Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient previously took codeine and amoxicillin and experienced allergy. The patient received multivitamins within 2 weeks of vaccination. On 12Jan2021, the patient experienced fatigue, injection site pain, runny nose and cold-like symptoms. The patient took OTC (over the counter) cold medication as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, Intramuscular on 21Dec2020 06:00 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient had no Allergies to medications, food, or other products. Concomitant medication included atorvastatin. The patient had sore arm after the fist dose of BNT162B2 on unknown date. No treatment was received for the event. 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 had not been tested for COVID-19. The outcome of the event was resolved.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injection site.; This is a spontaneous report from a non- contactable consumer. A 54-years-old male patient started to receive bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 13Jan2021 08:45 at single dose (lot_number=EK9231 / 4130121) on left arm for covid-19 immunisation. Medical history included heart surgery, penicillin allergy, heart failure. Patient received other medications within 2 weeks of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm soreness at injection site on 13Jan2021 18:00. No treatment received for the event. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 2-3 days; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID-19 Vaccine, lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for 2-3 days. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate increased, SARS-CoV-2 test negative
Clinical narrative: Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication.  The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's fiance) reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization on an unspecified date. It was reported that the patient got her second dose today (11Jan2021); however, she experienced a severe abdominal pain on an unspecified date. Outcome of event was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive with the covid-19 after getting the first dose; tested positive with the covid-19 after getting the first dose; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer sponsored program, Pfizer First Connect. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced cough, runny nose and tested positive with the covid-19 after getting the first dose of the covid-19 in Jan2021. He asked if he should still get the second dose three weeks after the first one.  Information on the lot/batch number was requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown.  The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative.     Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown.  The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative.     Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever; sore arm; This is a spontaneous report from a contactable consumer from Pfizer-sponsored Program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever and a sore arm. The patient outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.