chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Arm pain; Nausea; lightheadedness; This is a spontaneous report from a contactable healthcare professional (patient).  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm in Jan2021 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypothyroidism. It was reported that the patient had allergies with sulfa and trimethoprim / sulfamethoxazole (BACTRIM). Concomitant medications included levothyroxine sodium (SYNTHYROID), ergocalciferol (VIT D), levocetirizine dihydrochloride (XYZAL).  It was stated that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. In Jan2021, the patient experienced arm pain after 10 hours of getting the vaccine. It was also reported that nausea and lightheadedness the following day. No treatment received for the adverse events. The patient recovered from the events in Jan2021 (reported as feeling passed after 2hrs)  Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills/Shivering; Muscle Aches and Soreness; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 06Jan2021 08:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took bupropion hydrochloride (WELLBUTRIN) and clindamycin, both experienced drug allergy, previously received 1st dose of BNT162B2 in right arm in Dec2020 at 08:45 AM for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever, chills, shivering, muscle aches and soreness, fatigue on 06Jan2021 22:00. No treatment received for events. The outcome of events was recovering. The case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had bot been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crying, Emotional disorder, Headache
Clinical narrative: Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231), via an unspecified route of administration on 05Jan2021 at 12:45 at single dose in right arm for covid-19 immunization. Medical history included acute lymphoblastic leukemia at age 11, remission for 14 years. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. The patient experienced headache, unexplainable crying/emotional, awful right shoulder pain; all on 05Jan2021 at 15:30. All events were reported as non-serious. 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, and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: swelling of the lymph nodes; fever; right arm injection site pain; aches and pains; chills; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 53-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 04Jan2021 at 13:00 at single dose in right shoulder for covid-19 prophylaxis. There were no medical history or concomitant medications. The patient experienced fever, right arm injection site pain, aches and pains, and chills on 05Jan2021, swelling of the lymph nodes on 06Jan2021. Event details: On 05Jan2021 in the morning, he started having a fever and chills. He stated that he noticed the injection site pain on the 05Jan2021 and stated that it only hurt at time of reporting if he pushed on it. He stated it did not hurt when he moved his arm around. The patient stated that he noticed the aches and pains on the 05Jan2021 in the morning and it stuck with him throughout the day and was over by the time he went to bed on 05Jan2021. Wednesday 06Jan2021, toward the early morning around 0300 under his arm hurt and the lymph node under his arm was swollen about the size of a baseball. The patient said that his fever was currently 99.5 in Jan2021. The outcome of events fever and swelling of the lymph nodes was not resolved, outcome of right arm injection site pain, aches and pains was resolved in Jan2021, outcome of event chills was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: swelling of the lymph nodes; fever; right arm injection site pain; aches and pains; chills; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 53-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 04Jan2021 at 13:00 at single dose in right shoulder for covid-19 prophylaxis. There were no medical history or concomitant medications. The patient experienced fever, right arm injection site pain, aches and pains, and chills on 05Jan2021, swelling of the lymph nodes on 06Jan2021. Event details: On 05Jan2021 in the morning, he started having a fever and chills. He stated that he noticed the injection site pain on the 05Jan2021 and stated that it only hurt at time of reporting if he pushed on it. He stated it did not hurt when he moved his arm around. The patient stated that he noticed the aches and pains on the 05Jan2021 in the morning and it stuck with him throughout the day and was over by the time he went to bed on 05Jan2021. Wednesday 06Jan2021, toward the early morning around 0300 under his arm hurt and the lymph node under his arm was swollen about the size of a baseball. The patient said that his fever was currently 99.5 in Jan2021. The outcome of events fever and swelling of the lymph nodes was not resolved, outcome of right arm injection site pain, aches and pains was resolved in Jan2021, outcome of event chills was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Headache, Nasal congestion
Clinical narrative: Temperature was 101.2F/100.5 degrees Fahrenheit; Felt fatigue; Congestion; Headache; felt warm; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), second dose via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization (direct patient care). The patient previously took first dose of bnt162b2 via an unspecified route of administration on 16Dec2020 at a single dose in the right deltoid for COVID-19 immunization and she had no side effects to. There were no medical history or concomitant medications. On 07Jan2021, the patient experienced temperature was 101.2 degrees Fahrenheit, felt fatigue, congestion and headache. She woke up this morning an felt warm, which was why she took her temperature. She also took paracetamol (TYLENOL) last night prior to bed but clarifies that she had no side effects last night from the COVID Vaccine. They all started this morning. Treatment included after she checked her temperature, she took 1000 mg of paracetamol. She rechecked her temperature 1.5 hours later and it was 100.5 degrees Fahrenheit. The paracetamol also helped her headache improve. The outcome of event temperature was 101.2F and headache and felt warm was recovering, outcome of events not recovered.   Relatedness of product to reactions temperature of 101.2 degrees Fahrenheit, fatigue, Congestion, Headache was assessed related by Primary Source Reporter. Events temperature of 101.2 degrees Fahrenheit and congestion were assessed related to COVID vaccine.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature was 101.2F/100.5 degrees Fahrenheit; Felt fatigue; Congestion; Headache; felt warm; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), second dose via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization (direct patient care). The patient previously took first dose of bnt162b2 via an unspecified route of administration on 16Dec2020 at a single dose in the right deltoid for COVID-19 immunization and she had no side effects to. There were no medical history or concomitant medications. On 07Jan2021, the patient experienced temperature was 101.2 degrees Fahrenheit, felt fatigue, congestion and headache. She woke up this morning an felt warm, which was why she took her temperature. She also took paracetamol (TYLENOL) last night prior to bed but clarifies that she had no side effects last night from the COVID Vaccine. They all started this morning. Treatment included after she checked her temperature, she took 1000 mg of paracetamol. She rechecked her temperature 1.5 hours later and it was 100.5 degrees Fahrenheit. The paracetamol also helped her headache improve. The outcome of event temperature was 101.2F and headache and felt warm was recovering, outcome of events not recovered.   Relatedness of product to reactions temperature of 101.2 degrees Fahrenheit, fatigue, Congestion, Headache was assessed related by Primary Source Reporter. Events temperature of 101.2 degrees Fahrenheit and congestion were assessed related to COVID vaccine.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was 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 mentioned that she was still having side effects. She got the vaccine a week ago, on Saturday (unspecified date), and she was still having side effects. She wanted to know how long the side effects are going to last for "like what's the longest you have seen." It was clarified that she had the vaccine 9-10 days ago (unspecified date) and she had a headache ever since that doesn't go away. She asked is she should  still get the second dose if she was still having symptoms of the 1st dose. She added that she read that the side effects usually last a couple of days, but hers has not gone away. She queried how will she get rid of the of the headache and if everyone's symptoms eventually go away in the study; and if she will have this headache permanently. The outcome headache was not recovered.  Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip oedema
Clinical narrative: Lower lip edema/Only edema in lower lip; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK5730, via an unspecified route of administration in the left arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history included Graves' disease with hypothyroidism and epilepsy; and had dermal filler 2 months ago (in 2020) in both top and bottom lip. Concomitant medication included levothyroxine. The patient was not pregnant. The patient previously took aspirin bayer and experienced drug hypersensitivity. The patient was not diagnosed with covid prior vaccination nor was she tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lower lip edema and mentioned that she had dermal filler 2 months ago in both top and bottom lip. Only edema in lower lip. Have image if needed. No changes in medications, no changes in soap, skin care or makeup. The event occurred on 07Jan2021 at 05:00 AM with outcome of not recovered. The event was reported as non-serious. Therapeutic measures were taken as a result of lower lip edema/only edema in lower lip which included famotidine and CLARITIN.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm, on 06Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included chronic migraine and allergies to medications, food, or other products including penicillin. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) for birth control. The patient previously took piroxicam and experienced allergy. The patient was not pregnant. The patient was not diagnosed with covid-19 prior to vaccination nor was she tested for Covid-19 since vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5 on 07Jan2021, 10:00 AM, with outcome of not recovered. The events were reported as non-serious with no treatment received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Depression, Dizziness, Fatigue
Clinical narrative: Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Sinus pain, Vision blurred
Clinical narrative: seeing kind of blurry; flu like side effects; sinus aches; This is a spontaneous report from a contactable consumer (patient himself). A 52-year-old male patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 05Jan2021 in left arm at single dose for prevent getting COVID-19. There were no medical history and concomitant medications. Consumer said he took the COVID-19 vaccine yesterday for where he worked, and had flu like side effects and would like to make sure they are normal. Caller clarified that he got the vaccine on Tuesday, 05Jan2021. He said that the side effects were his body and head hurts. He said that the side effects started yesterday, like the flu, he had body and sinus aches, and was like coughing a little bit with a low fever last night that went away. He said that this morning (06Jan2021) he woke up the same way, then went outside and he was seeing kind of blurry, but not much. He said he came inside and sit down, and was ok again, he felt like he had a big flu in his head. Caller said that he took a picture of the vaccine card, where they kind of wrote on it and it said Pfizer EL0140. Caller said that yesterday and today he woke up the same, so no change to events, he just took over the counter pills for sinus, he didn't want to drink nothing. No further information was provided about the over the counter pills for sinus. Caller said he had no new medications and received no other vaccines when he got the COVID-19 vaccine. Caller said for his fever his wife put her hand on him and said he was kind of hot, but it was nothing big. Temperature was not taken. Outcome of events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Muscle twitching
Clinical narrative: 101.1 Fever; chills; body aches; headache; Eye twitching; Fatigue; This is a spontaneous report from a contactable nurse (patient). An adult non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 06Jan2021 10:45 at single dose for covid-19 immunization in hospital. Medical history included were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient previously took first dose of bnt162b2 on 16Dec2020 05:00 PM via intramuscular in left arm for covid-19 immunization. The patient experienced 101.1 fever, chills, body aches, headache, eye twitching, fatigue on 06Jan2021 16:00. The events were non-serious. The events did not result in emergency room or physician visit. There was no treatment for the events. The outcome of the events was resolving.     Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 101.1 Fever; chills; body aches; headache; Eye twitching; Fatigue; This is a spontaneous report from a contactable nurse (patient). An adult non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 06Jan2021 10:45 at single dose for covid-19 immunization in hospital. Medical history included were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no allergies to medications, food, or other products. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient previously took first dose of bnt162b2 on 16Dec2020 05:00 PM via intramuscular in left arm for covid-19 immunization. The patient experienced 101.1 fever, chills, body aches, headache, eye twitching, fatigue on 06Jan2021 16:00. The events were non-serious. The events did not result in emergency room or physician visit. There was no treatment for the events. The outcome of the events was resolving.     Information on the Lot/Batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: received the second dose in less than 21 days from  the first dose; cervical lymphadenopathy; Swelling at location of undereye cosmetic fillers; This is a spontaneous report from a contactable Physician (reporting for herself). A 37-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), intramuscular on right arm, on 04Jan2021 (lot no: EL1283) 17:00 at a single dose for COVID-19 immunization.  Medical history included prolactinoma an patient had infertility. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ascorbic acid;betacarotene;cupric oxide;manganese sulfate;selenium;tocopheryl acetate;ubidecarenone;zinc oxide]), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ascorbic acid;betacarotene;calcium sulfate;colecalciferol;cyanocobalamin;ferrous fumarate;folic acid;nicotinamide;pyridoxine hydrochloride;retinol acetate;riboflavin;thiamine mononitrate;tocopheryl acetate;zinc oxide]), levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D [colecalciferol]).; all on unspecified dates (reported as taken within 2 weeks of vaccination) for unspecified indications.  The patient had her 1st dose on right arm (lot no: EJ1685, expiry: unknown) of COVID-19 Vaccine on 16Dec2020. She received the second dose in less than 21 days from  the first dose. On 06Jan2021, patient experienced swelling at location of undereye cosmetic fillers, right worse than left with mild associated right cervical lymphadenopathy. Patient was given fexofenadine (ALLEGRA) and improvement was seen.  Outcome of the events lymphadenopathy cervical and eye swelling recovering. The female was not pregnant. Patient has no COVID prior vaccination. The most recent COVID-19 vaccine was admistered at the hospital and patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: episode of tachycardia; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced an episode of tachycardia 5 minutes after getting the COVID vaccine. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: axillary lymph node swelling/neck lymph node is swollen; This is a spontaneous report from a contactable physician. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at the left arm from an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported hat the patient had axillary lymph node swelling. It was stated that the patient's neck lymph node is also swollen. This was the patient's first injection and clarified that it was given in her left arm. The outcome of the event was unknown.  Information on the lot number/batch number was requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; she tested positive for COVID-19 after receiving the first dose of the Pfizer-Biontech COVID-19 vaccine.; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) intramuscular in left arm on 26Dec2020 14:30 at a single dose for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The physician received her first dose of the COVID vaccine on 26Dec2020 and on 02Jan2021, tested positive for COVID. She actually tested negative 2 days before testing positive (26Dec2020). The outcome of the event was recovered on an unknown date. According to the physician, the event was unrelated to the vaccine as her nanny and her son was also tested positive.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccinated in her arm then was feeling well but had sore arm; This is a spontaneous report from a contactable nurse (reporting for herself). A 19-year-old female patient to received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 22:45 (lot number: EL1284) and first dose on 17Dec2020 15:30 (lot number: EK5730); via intramuscular in left arm at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was vaccinated in her arm then was feeling well but had sore arm on 19Dec2020, comparable to the flu vaccine. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on unspecified date. No treatment was given to the patient for the event. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: Joint pain in both shoulders and knees; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 and first dose on 19Dec2020 08:00 (lot number: EH9899) in left arm; both via at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Dec2020 10:00, the patient experienced flu like symptoms and joint pain in both shoulders and knees that continued until second shot on 07Jan2021 that eventually subsided. The outcome of the events was recovered with lasting effects on unspecified date. No treatment given to the patient for the events. 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, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare professional reporting for a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0142), intramuscular on 04Jan2021 15:30 in left arm at single dose for COVID-19 immunization. Medical history included COVID-19, type 1 diabetes and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included insulin.  The patient experienced fatigue, headache and body aches on 05Jan2021 10:00. No treatment was given to the patient for the events. 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 recovering. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: her arm just feels like she bumped into a door; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer-Biontech COVID-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was lucky enough to get the vaccine last night and her arm just feels like she bumped into a door. She mentioned that assuming this vaccine is similar to the flu, she inquired are the symptoms less if you contract covid after getting the vaccine. She inquired as well if it is "consider putting in the fact sheet how long after getting before being protected". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable Registered Nurse (patient) via a Pfizer sponsored program IBCC (Inbound Call Center for HCPs).  A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID on an unspecified date with outcome of unknown. The patient just received the COVID vaccine, and also tested positive for COVID. The patient underwent lab tests and procedures which included COVID test: positive. Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: This patient experience left sided numbness (felt like left arm and left leg was heavy); This patient experience left sided numbness (felt like left arm and left leg was heavy); This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 07Jan2021 11:00 at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in a nursing home/senior living facility. This patient experience left sided numbness (felt like left arm and left leg was heavy) on 07Jan2021 11:00 AM. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care visit. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: upper right lip swelling; hive on forearm above elbow on left arm; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. The patient's medical history included type 2 diabetes. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included metformin and glucosamine. 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 had not been tested for COVID-19 since the vaccination. On 06Jan2021 17:00, the patient experienced hive on forearm above elbow on left arm then on 07Jan2021, the patient experienced upper right lip swelling. No treatment was received for the adverse events. Outcome of the events was unknown. The events were considered non-serious by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills; Tiredness; generalized body aches; fever 101.4; This is a spontaneous report from a contactable Nurse (patient). A 30-year-old non-pregnant patient female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1686),intramuscular at Right arm on 06Jan2021 08:15 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included covid-19 prior vaccination. Concomitant medication included levothyroxine and multivitamin. The patient experienced tiredness, generalized body aches, chills, fever 101.4 on 06Jan2021 20:00. No treatment received.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 28Dec2020, the patient experienced arm sore and tired a couple of days. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient). A 32-years-old female patient received BNT162B2(Lot number: EK9231) , intramuscular on 06Jan2021 08:15 at 32 years old at Arm Right at single dose for COVID-19 immunization.  Medical history included migraine, Allergies to Latex.  Concomitant medications included asa, ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (Multi Vit). The patient experienced fever 101, fatigue, nausea, migraine on 06Jan2021 19:00.  There was no treatment received for the adverse events. 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 underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 06Jan2021. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1 intramuscularly on 07Jan2021 11:00 at a single dose on the right arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The patient received the vaccine at a nursing home/senior living facility. No medications were received within 2 weeks of vaccination and no other vaccines were received within 4 weeks prior vaccination. The patient experienced chest pain on 07Jan2021 12:00. The went to the emergency room/sought urgent care for the event. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of the event was unknown. The event was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate elevated; This is a spontaneous report from a contactable pharmacist. A 37-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1 intramuscularly on 07Jan2021 12:00 at a single dose on the right arm for COVID-19 immunization. The vaccine was administered at a nursing home/senior living facility. There was no relevant medical history. The patient had no concomitant medications. No other vaccines were received within 4 weeks prior vaccination and no medications were taken within 2 weeks of vaccination. The patient experienced heart rate elevated on 07Jan2021 12:00. The patient went to the emergency room/sought urgent care for the event. No treatment was received for the event. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm from at 00:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included depression and anxiety. Concomitant medication included bupropion, vortioxetine hydrobromide (TRINTELLIX). The patient experienced tiredness, severe headache, nausea, vomiting at 08:00 AM on 06Jan2021. It lasted about 36 hours total. The events were reported as non-serious. The patient did not receive any treatment from the events. 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 events was recovered on 07Jan2021.  Information on the Lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Injection site pain; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899), via Intramuscular on 06Jan2021 08:00 at single dose in the left arm for COVID-19 immunisation. Medical history included Asthma. Concomitant medications were not reported. On 06Jan2021, the patient experienced fever, injection site pain, tiredness, chills, feeling unwell. The patient did not receive any treatment. Outcome of events was recovered on Jan2021.   No follow up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Fatigue; first dose of BNT162B2 on 17Dec2020 then second dose on 05Jan2021; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on 05Jan2021 at 13:00 (second dose) on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not also receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. On  05Jan2021 at 14:00, the patient experienced fatigue. The patient was given Tylenol as treatment for fatigue. The outcome of the event fatigue was recovered with sequel on an unspecified date in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Intensive care, SARS-CoV-2 test positive
Clinical narrative: has COVID now and was pretty ill and in their ICU, positive COVID-19 test; has COVID now and was pretty ill and in their ICU, positive COVID-19 test; This is a spontaneous report from a contactable pharmacist.  A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient developed positive COVID-19 test with symptoms on unknown date. The clinical course was as follows: the patient received the first dose of the vaccine 2 weeks ago and has COVID now and was pretty ill and in their ICU. Laboratory data included: SARS-CoV-2 test (unknown date): positive. The pharmacist was wondering if the participants in the trials received their second dose if they tested positive before the second dose and if there is any data on when to give the second dose of the vaccine for patients that test positive before the second dose. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Swollen tongue
Clinical narrative: Anaphylactic reaction; Tongue was swelling; Difficulty breathing; This is a spontaneous report from a contactable Pharmacist.   A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at SINGLE DOSE for COVID-19 immunization. The patient experienced "Tongue was swelling, Difficulty breathing, and an Anaphylactic reaction".No other details provided. The outcome of the events was unknown  Information on lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of Anaphylactic reactions presented as Tongue swelling/Difficulty breathing and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine.  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: Body temperature, Fatigue, Headache, Malaise, Neck pain
Clinical narrative: fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination.  Information on Lot/batch number has been requested.