chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme tiredness/reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), intramuscular on the left arm on 06Jan2021 14:50 at SINGLE DOSE for COVID-19 immunization (also reported as preventative) at the hospital. Medical history was not reported. There were no concomitant medications. It was reported that the patient had tetanus shot around 21Dec2020 or 22Dec2020. The patient also had prior vaccinations which included first pneumonia shot was fine. During the second pneumonia shot, the patient had extreme swelling on left arm and could not lift her arm. She was off work several days due to the pain. It was part of a two shot series for those over 65 years old. She had the COVID-19 vaccine yesterday (06Jan2021). The patient had extreme tiredness that started a that night of 06Jan2021 and was really ongoing at the time of the report. She does not want to fall asleep while driving home as she was at work. She has an appointment for the second dose on an unknown date. It was mentioned that the extreme tiredness was reported as worsened (not recovered).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 101.7/ fever was at 101.5; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 previously took 1st dose of BNT162B2. The patient received second COVID shot on Wednesday (06Jan2021). On 06Jan2021, had a fever of 101.7. This morning (08Jan2021) fever was at 101.5. Patient was advised by his HCP to call and report side effects. Outcome of the event was unknown.   Information about lot/batch number is requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body height, Body height decreased, Body temperature, Chest pain
Clinical narrative: he was 6 feet but had shrunk a little; fever of 100.9; chills; pain around pacemaker in chest; lower back pain; had a sore arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: 3L3246) on right arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included 3 heart attacks in the past and pacemaker from an unspecified date. Concomitant medications were not reported. The patient had a reaction to the Covid vaccine he received on 05Jan2021, stated he had a sore arm the next day 06Jan2021 that had resolved. Stated last night on 07Jan2021, he had a fever of 100.9 and chills and mild pain around pacemaker area in his chest and lower back pain. Stated he treated the fever and chills and pain with Tylenol and stated it had improved. The patient stated he was 6 feet but had shrunk a little on an unspecified date. The outcome of the event had a sore arm was recovered on 07Jan2021, for the event he was 6 feet but had shrunk a little was unknown, while other events were recovering.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: he was 6 feet but had shrunk a little; fever of 100.9; chills; pain around pacemaker in chest; lower back pain; had a sore arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: 3L3246) on right arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included 3 heart attacks in the past and pacemaker from an unspecified date. Concomitant medications were not reported. The patient had a reaction to the Covid vaccine he received on 05Jan2021, stated he had a sore arm the next day 06Jan2021 that had resolved. Stated last night on 07Jan2021, he had a fever of 100.9 and chills and mild pain around pacemaker area in his chest and lower back pain. Stated he treated the fever and chills and pain with Tylenol and stated it had improved. The patient stated he was 6 feet but had shrunk a little on an unspecified date. The outcome of the event had a sore arm was recovered on 07Jan2021, for the event he was 6 feet but had shrunk a little was unknown, while other events were recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 20:00 at a single dose for COVID-19 immunization. Medical history included HTN and pericarditis. Concomitant medication included valsartan, spironolactone, amlodipine, desvenlafaxine succinate (PRISTIQ) and ascorbic acid (C 1000). The patient experienced flushed on 08Jan2021 at 19:00. No treatment was received for the adverse 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 has not been tested for COVID-19. There were no known allergies. No allergies to medications, food, or other products. Outcome of the event was not recovered.   Information about batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: A little bruising where the shot was given; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route of administration at left arm on 02Jan2021 4:00 PM at single dose for COVID-19 immunization. Medical history included allergic to is red meat and environmental allergies. No concomitant medication. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the pfizer suspect was none. Prior Vaccinations (within 4 weeks) was None. AE following prior vaccinations was no. Patient has a question. She got her COVID shot on Saturday. She has not had no side effects or anything like that. She has a little bruising where the shot was given. Patient asked if that was normal. It is just a little bruise where the injection was given. It isn't that big of a bruise. It is just where the shot was injected. She didn't notice it until the second day. She received the vaccine on 02Jan2021 and noticed the bruise on 03Jan2021.  She wasn't too worried about it and she read the literature. It said if there was anything to call because that is how it will determine. Event was not required a visit to Emergency Room or Physician Office. It didn't hurt it is just a small bruise. Relevant Tests was none. No Investigation Assessment. Patient was not recovered from the event.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Tiredness; Little headache; Muscle and body pain; Muscle and body pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The day prior to the report on 07Jan2021, the patient got side effects of tiredness, little headache, fever, muscle and body pain. He stated that tiredness began in early morning. He was scheduled to receive second dose on 23Jan2021. He asked a nurse to give him something for a headache the day prior to the report. Since 07Jan2021, he was feeling better. Clarified he cannot confirm the name of medication he was given. He was still feeling body pain. At the time of the report, he asked if he needed to go to the clinic. Didn't know if he needed to wait. Clarified he was asking for medication and if he could go to the hospital to ask for medication. The outcome of the event body pain was not recovered, for the event tiredness and little headache was recovering, while other events were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her arm is beginning to itch; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 06Jan2021 07:30 via intramuscular at left arm at single dose for some other people who have had COVID and she didn't want to take any chances (because of her age and knowing she works in the medical field). Medical history and concomitant medication were none. The caller states she works in healthcare, clarifies she is a medical assistant. She is calling in regard to Pfizer's COVID-19 Vaccine. She received her first dose on Wednesday and she was having no side effects until last night. Her arm started getting hot in the area where the injection was. Her arm began to get warm, red, and was swelling (07Jan2021 21:00). She took a couple of paracetamol (TYLENOL, lot number: SHA101, expiration date: Jun2024 at 500mg) and put an icepack on it. However, this morning, her arm is still the same. Caller wanted to know if she can still continue to take paracetamol and use the icepacks and just give it some time or what. She knows the redness, swelling, warmth are some side effects but she wanted to just follow-up to see if she can continue to take the paracetamol. Caller verifies she received her first vaccine on 06Jan2021. Last night, 07Jan2021, around 9 pm, she started to get the warmth, redness, and swelling. She states her arm looks the same as it did last night. However, her arm is beginning to itch (08Jan2021). It wasn't itching last night. She explains the vaccine was available to her. She took it because of her age and knowing she works in the medical field, she is around a lot of young people and patients, and also for her family and friends. She knows some other people who have had COVID and she didn't want to take any chances.  None of additional vaccines administered on same date of the Pfizer Suspect. Event was not required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was none. Patient was not recovered from the events.
Sex: F
Vaccine: PNC13
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain, Peripheral swelling
Clinical narrative: pain; extreme swelling on left arm and could not lift her arm; extreme swelling on left arm and could not lift her arm; Second pneumonia shot/part of a two shot series; This is a spontaneous report from a contactable consumer. A 66-year-old female patient started to receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: EE8493), via an unspecified route of administration on an unspecified date at a single dose for second pneumonia immunisation. Medical history included was reported as none. There were no concomitant medications. It was reported that the second pneumonia shot caused extreme swelling on left arm to the patient and she could not lift her arm, she was off work several days due to the pain, she does not know the name and does not have lot, NDC, or expiration date. Stated the first pneumonia shot was fine. It was part of a two-shot series for those over 65 years old. The outcome of the events was unknown.  No follow-up attempts are needed. Information on lot/batch cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contactable Other HCP reporting for herself. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number K9231), intramuscular, in left arm, on 06Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 52 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and did not receive concomitant medications. She had no known allergies to medications, food, or other products. On the first and second day the patient experienced high fever, chills, shivering, body ache; headache the third day with chills. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The events were resolving.    No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on left arm on 15Dec2020 at single dose for covid-19 immunization, administered at hospital. Medical history included idiopathic epilepsy. The patient's concomitant medications were not reported. With first dose, the patient experienced soreness in his arm with no other symptoms on an unspecified date. The outcome of the reported event soreness in his arm was unknown. On 06Jan2021 10:45, the patient received second dose of vaccine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Vaccination site pain
Clinical narrative: says in her arm where her shot was given is sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on right arm on 18Dec2020 10:00 at single dose for covid-19 prevention. Medical history included ongoing arthritis probably since ten years ago (2011), ongoing osteoporosis at least since five years ago, maybe longer, and ongoing Barrett's esophagus probably since five years ago (2016). Family included ongoing high cholesterol diagnosed probably 20 years ago (2001), her whole family has it and was managed or lowered with medication. There were no concomitant medications. The patient said in her arm where her shot was given was sore on an unspecified date. The first time she got the injection in her right arm, but the second time her right was still hurting. The outcome of the event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Night sweats, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a contactable other hcp. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left hand on 30Dec2020 14:15 at a single dose for COVID-19 immunization. Vaccination occurred in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C), colecalciferol (VITAMIN D), and zinc (ZINC). The patient was feverish, lightheaded, had tingling in fingers and had night sweats on 01Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test-nasal swab with a negative result on 04Jan2021.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Nausea; General malaise; This is a spontaneous report from a contactable pharmacist who reported for himself. A 59-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included hypertension and type 2 diabetic, both from unspecified dates and unspecified if ongoing. Concomitant medications included metoprolol taken for hypertension and metformin taken for type 2 diabetic. The patient experienced "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise", all on unspecified dates. The reporter stated that he "was calling about the side effects of the COVID-19 vaccination. What I had, of course, the injection site pain, tiredness, headache, chills, nausea, just the general feeling of malaise. I slept at 10 O'clock and its 3 O'clock in the morning now, I just woke up I lay down at 6 O'clock so I sleep for about 8-9 hours." (as reported). The patient stated that he self-medicated with Acetaminophen prior to the vaccination and again 7 hours later and that he took Zofran for nausea. The patient further stated "the injection site pain that (Incomplete sentence). The nurse gave the injection very high to the deltoid muscle and have pushed it very quickly, like I never have experienced the injection itself, having pain upon injection. I have given thousands of Flu shots never so high of deltoid muscle and nowhere had I ever pushed the same." (as reported). The patient was informed about the Pfizer Medical information department and he was also encouraged to visit the website (website name) for additional information. The clinical outcomes of the events "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise" were all unknown. The reporter believed that there was a reasonable possibility (method of assessment: global introspection) that the events were all related to the suspect product BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Nausea; General malaise; This is a spontaneous report from a contactable pharmacist who reported for himself. A 59-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EK5730) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included hypertension and type 2 diabetic, both from unspecified dates and unspecified if ongoing. Concomitant medications included metoprolol taken for hypertension and metformin taken for type 2 diabetic. The patient experienced "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise", all on unspecified dates. The reporter stated that he "was calling about the side effects of the COVID-19 vaccination. What I had, of course, the injection site pain, tiredness, headache, chills, nausea, just the general feeling of malaise. I slept at 10 O'clock and its 3 O'clock in the morning now, I just woke up I lay down at 6 O'clock so I sleep for about 8-9 hours." (as reported). The patient stated that he self-medicated with Acetaminophen prior to the vaccination and again 7 hours later and that he took Zofran for nausea. The patient further stated "the injection site pain that (Incomplete sentence). The nurse gave the injection very high to the deltoid muscle and have pushed it very quickly, like I never have experienced the injection itself, having pain upon injection. I have given thousands of Flu shots never so high of deltoid muscle and nowhere had I ever pushed the same." (as reported). The patient was informed about the Pfizer Medical information department and he was also encouraged to visit the website (website name) for additional information. The clinical outcomes of the events "injection site pain", "tiredness", "headache", "chills", "nausea" and "general malaise" were all unknown. The reporter believed that there was a reasonable possibility (method of assessment: global introspection) that the events were all related to the suspect product BNT162B2.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: after receiving the 1st dose of the COVID-19 vaccine,it was about 9 hours later before her right shoulder hurt; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in her right deltoid on 18Dec2020 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. It was reported that the patient received her first COVID-19 vaccine dose, the person who administered the shot used a 3-finger width distance from her right shoulder bone when administering the COVID-19 vaccine into her right deltoid muscle. She said after receiving the first dose of the COVID-19 vaccine, it was about 9 hours later before her right shoulder hurt. The outcome of the event was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: mild nausea; severe dizziness; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored Program. A female patient (reporter's niece) of an unspecified age (reported as 27, unit unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included vertigo. Concomitant medications were not reported. On 07Jan2021, the patient experienced mild nausea and severe dizziness. Dizziness got so severe that she couldn't get out of bed last night so she had to pee in a cup. Clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Within 5 minutes, writer noted person itching arms, legs, & back. Itching continued for approx. 48 hours. It did not get worse and no additional symptoms developed. Vitals stable.; This is a spontaneous report from a contactable nurse. A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), intramuscularly in the right arm on 29Dec2020 14:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  On 29Dec2020, within 5 mins, it was noted the patient had itching arms, legs, & back. Itching continued for approximately 48 hours. It did not get worse and no additional symptoms developed. Vitals were stable. Treatment for the event included benadryl 25mg given per MD with extended monitoring for 2 full hours. The outcome of the event was recovered. It was unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine was administered in a hospital.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low grade fever of 100 F; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female received bnt162b2 (lot: EK9231), intramuscular in the left arm on 30Dec2020 14:30 at a single dose for covid-19 immunization. The patient's medical history included migraine, seizure (resolved x2years) from an unknown date and unknown if ongoing , and allergy to penicillin. There were no concomitant medications. On 30Dec2020 20:00, the patient experienced left arm soreness for 24 hours and low grade fever of 100 f. The outcome of the event was recovered on an unknown date. No treatment was given to the patient for the event. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and has not been tested post vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; Severe body aches; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in the right arm on 04Jan2021 17:30 at a single dose for COVID-19 immunization at the hospital. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe body aches and fatigue on 06Jan2021 04:00 (also reported as about 36 hours after injection). Treated at home with rest, increased fluids, and Ibuprofen 800mg. The patient fully recovered at 72 hours post-vaccine. Outcome of the events was recovered in Jan2021. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: sores in my mouth; This is a spontaneous report from a contactable physician. A 58-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient experienced sores in mouth on 08Jan2021 with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: face got itchy; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced face got itchy. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: within 2 to 3 hours started with lot of fever, haven't been able to take it off; still sick; sever body aches; flu like symptoms; This is a spontaneous report from a contactable nurse. This nurse reported information for two patients. This is the second of the two reports.    A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Jan2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported as follows " within 2 to 3 hours started with lot of fever, haven't been able to take it off ", "still sick ", " sever body aches ", "flu like symptoms", all on 02Jan2021.  Details were as follows: The reactions occurred immediately after the vaccination. Patient received the vaccine on a Saturday and immediately within 2 to 3 hours. The patient indicated that two reacted immediately like that and haven't been able to get any better.  The outcomes of events were unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015659 Same reporter/drug/ event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Eyelid ptosis
Clinical narrative: Left eye swollen, and droopy.; Left eye swollen, and droopy.; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 02L20A), via an unspecified route of administration on her left arm on 26Dec2020 at 17:30 at a single dose for immunization. Medical history included penicillin (PCN) allergy. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included phentermine which was received within 2 weeks of vaccination. The patient experienced left eye swollen, and droopy on 08Jan2021 at 04:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Throbbing at the injection site; muscle aches over whole body; This is a spontaneous report from a non-contactable other healthcare professional. A 37-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular at the right arm on 07Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, alcohol, salicylates. The patient's concomitant medications were not reported. The patient was not pregnant when she received the vaccination. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. On 07Jan2021 at 10pm, the patient experienced throbbing at the injection site and muscle aches over whole body. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient not pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number unknown, via an unspecified route of administration on 08Jan2021 h 11: 00 at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive other concomitant medications within 2 weeks of vaccination. On 08Jan2021 patient experienced an extreme hot sensation and dizziness lasted a minute (within seconds I felt an extreme hot sensation and dizziness, as reported). No treatment administered for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from both events on 08Jan2021.  Information on the Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger  joints; pain in arm down to her finger joints; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ES1685, via an unspecified route of administration in the left arm, from 08Jan2021 12:45 at a single dose, for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), dairy intolerance and perfume sensitivity. The patient's concomitant medications were not reported. On 08Jan2021 13:15, a half hour after the vaccination, the patient experienced that her left arm was tingling, a numb feeling all the way to fingers; it lasted about one hour after it came on, but now she have pain in arm down to her finger joints. The outcome of events was reported as recovered with sequelae. No treatment was received/given due to the events.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain
Clinical narrative: joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp.  A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm,  from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine), 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 reporter was asking if the patient can take rizatriptan since he experienced migraine on an unspecified date after taking his first dose of the COVID vaccine. The outcome of the event was unknown.   Information on the lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in  hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization.  The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse.  A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in  hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization.  The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Neck pain
Clinical narrative: Chills; neck/back ache; neck/back ache; headache; This is a spontaneous report from a contactable pharmacist who reported for herself. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Jan2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. It was reported that the patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate and zinc oxide (PRENATAL VITAMINS), ascorbic acid (VITAMIN C) and vitamin D3, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 01:00, the patient experienced chills, neck/back ache and headache. It was reported that the events were non-serious and did not require hospitalization. The patient received treatment for the events which included acetaminophen. The clinical outcomes of the events chills, neck/back ache and headache were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A male patient of an unspecified age (reported as age: 65, unit: unknown) received BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine), 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. It was reported that the patient had fever, chills and fatigue, on an unspecified date, the day after the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient herself). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant. 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 medications included buspirone hydrochloride (BUSPAR), escitalopram oxalate (LEXAPRO), and trazodone. The patient experienced diarrhea on 06Jan2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: Malaise; body aches; Chills; This is a spontaneous report from non-contactable consumer. A 33-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiration date was not provided), via an unspecified route of administration second dose on 07Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 07Jan2021, hours after second dose the patient experienced malaise, body aches, and chills with an outcome of recovering.  No treatment received for the adverse events. Facility where the most recent COVID-19 vaccine was administered at Hospital. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Unknown  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: headache; Body chills came on 10-12 hrs after vaccine.; nausea; fever; This is a spontaneous report from a non-contactable nurse. A 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were note reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included RA -rheumatoid arthritis. Concomitant medication included prednisone (PREDNISONE), fish oil (FISH OIL), flaxseed oil [linum usitatissimum seed oil] (FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL]), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]). The patient previously received the first dose of bnt162b2 on 17Dec2020. On 07Jan2021, the patient experienced Body chills came on 10-12 hrs after vaccine, followed by nausea, fever, headache.The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was assessed as non serious. No treatment involved for the events.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nightmare, Vaccination site pain, Vaccination site warmth
Clinical narrative: Headache; pain/warmth at injection site; pain/warmth at injection site; nightmares; This is a spontaneous report from a non-contactable other health care professional. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: lot number: EL0142), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE at right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took amoxicillin and Aspirin; and experienced allergies. On 07Jan2021, the patient experienced headache, pain/warmth at injection site, and nightmares. The outcome of the events was recovered. The patient took some ibuprofen as treatment.     No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer vaccine for the COVID-19 on 29Dec2020. She reported that it was hard for her to swallow on an unspecified date. It was not when she was eating or drinking, just sitting down. She was having trouble swallowing on an unspecified date. It felt like something in her throat swelled. She was having trouble swallowing. She works as a lab assistant. As for the treatment, she said that she has a doctor appointment on Monday (unspecified date). She had been taking diphenhydramine hcl (BENADRYL) as treatment. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Migraine, Myalgia
Clinical narrative: Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer (emergency department technician like a clinical assistant). A 22-year-old female patient received her first injection of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EK9231) intramuscularly at a single dose on 17Dec2020 for Covid-19 immunization. The patient had a medical history of migraine. Concomitant medications included cyproheptadine for migraine and multivitamins. The patient experienced dizziness and palpitations initially and then little bit later on the day she had tingling in her face and legs and she had myalgia, nausea and headache and fatigue. The symptoms lasted for 2 days. The patient medicated with Benadryl and Famotidine. Outcome of the events was unknown. The patient had her second vaccine injection on 06Jan2021.