chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance
Clinical narrative: Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Condition aggravated, Dementia, Gait disturbance, Gait inability
Clinical narrative: Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise, Neuropathy peripheral, Walking aid user
Clinical narrative: Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; headache; This is a spontaneous report from a contactable consumer.  A 65-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation .  Medical history included migraine.  The patient's concomitant medications were not reported.  The patient experienced nausea, headache on 19Jan2021. The outcome of events was unknown.    Information on Lot/Batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Candida infection, Laboratory test normal, SARS-CoV-2 test positive
Clinical narrative: thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Vaccination site pain
Clinical narrative: a loss of smell; some minor pain in the arm in the injection; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on arm on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first injection of Pfizer COVID-19 vaccine on 06Jan2021. He experienced some minor pain in the arm in the injection on unspecified date in Jan2021. About two days after the injection on 08Jan2021, he experienced a loss of smell. He reported that the loss of smell has gradually come back and is not as bad now. The outcome of the event a loss of smell was recovering while unknown for the other event.  Information on the Lot/Batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Lethargy, Malaise
Clinical narrative: Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence, Vomiting
Clinical narrative: Felt like had the flu; Lethargic; Nauseated/ Nausea; overall unwell feeling, she did not feel well at all; she slept constantly/sleeping; Tiredness; did not eat; felt like throwing up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELI283) via an unspecified route of administration on the left arm on 15Jan2021 10:15 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She mentioned she felt nauseated on 15Jan2021. She woke on 16Jan2021 and felt like she had the flu. From Friday until Sunday like until 12:45 she slept constantly. She experienced tiredness. She did not eat. She was just sleeping and felt like throwing up (Jan2021). She started the feel the nausea the same day she got the vaccine. She blew it off thinking it was nothing. However, the next morning she felt like she had the flu. She was feeling lethargic. The nausea went away yesterday afternoon. On 19Jan2021 was the first day she felt like herself. She felt like she had the flu soon as she woke up. She had this overall unwell feeling, she did not feel well at all in Jan2021. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to the emergency room and physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events nauseated/ nausea and felt like had the flu on 18Jan2021; lethargic on 19Jan2021. Outcome of the other events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Tongue discomfort
Clinical narrative: back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of her mouth felt like they were burning; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 11Jan2021 10:30 AM at a single dose as COVID vaccine in a hospital. The patient had no medical history. She had no known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular in the right arm on 21Dec2020 at 11:00 AM as COVID vaccine. It was reported that on 12Jan2021-13Jan2021, the patient noticed the back of her tongue and roof of her mouth felt like they were burning, similar to eating too much pineapple. It was persistent and had not lessened. Treatment was not received for the events. She had no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 swollen lymph nodes occipital and posterior left neck; This is a spontaneous report from a non-contactable Other Health Professional. A 61-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via intramuscular on 07Jan2021 at 16:45 at single dose on left arm for covid-19 immunisation. Medical history was none. Historical vaccine included 1st dose of bnt162b2 (lot number: EH9899) received on 18Dec2020 at 10:00 am via Intramuscular on left arm for COVID-19 immunisation. The patient's concomitant medications were not reported.  The patient experienced 2 swollen lymph nodes occipital and posterior left neck on 15Jan2021 with outcome of recovering. Therapeutic measures were taken as a result of 2 swollen lymph nodes occipital and posterior left neck.  No follow-up attempts are possible. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Skin disorder
Clinical narrative: bumps that were flesh/skin tone, not red, on her hands/she developed bumps on her palms and fingers; bumps on her palms and fingers; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 08Jan2021 at single dose for COVID-19 immunisation (to prevent COVID). Medical history and concomitant medication were none. patient received vaccine on 08Jan2021 and 9 days later (17Jan2021) developed "bumps that were flesh/skin tone, not red, on her hands", she asked if this has been associated with the product. Patient sked if there have been any reports of coxsackievirus (Hand-foot-mouth disease) with the vaccine. It was also reported she says got the first vaccine 08Jan and 9 days later she developed bumps on her palms and fingers, it happened this Sunday. She doesn't know if it might be work related she works with cleaning supplies and wearing gloves in the hospital but she did get the vaccine so she is wondering if that is a side effect that anyone else has called about. She clarifies the bumps are not red they are skin color, they are only red if she scratches them. When they started out she only had about 3 now she has about 20. Patient was not recovered from the events. It was a non-serious report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: felt a strong pain in the chest; injection site was color purple; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 14Jan2021 to 14Jan2021 as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient stated that 2 days after the administration, the injection site was color red, swollen and with pain; 3 days after the administration the injection site was color purple; and 4 days after the administration she felt a strong pain in the chest. The outcome of the events was unknown.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the vaccine on 29Dec2020 and tested positive for COVID on 11Jan2021. Patient was scheduled for her second dose this week and stated she is trying to figure out what to do. Patient asked if there are side effects if she get is earlier that the suggested 90 days. Patient also asked if there is a recommendation on what to do if it ended up running out of the vaccine before she gets her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test with result of positive on 11Jan2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a contactable health care professional (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on 13Jan2021 at 07:00 PM on the left arm at a single dose for COVID-19 immunization.  Medical history included hypothyroidism and allergies to eggs both from an unknown date and unknown if ongoing.  Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not have COVID-19 prior to vaccination. It was reported that on 14Jan2021 at 07:00 AM, 12 hours after the vaccine, the patient experienced dizziness, aches, fever, sniffles and pain at injection site.  The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive any treatment for the events. The patient has not been tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Has some injection site pain/ Pain injection site; Body Aches; Pain in the opposite shoulder/the pain in the right Shoulder; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3248) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 69-years-old) as a single dose for COVID-19 vaccination. Medical history included rotator cuff surgery (1.5 years ago, moving the shoulder around freely time to time and then it flares up time to time) and positive Covid test on 17Mar2020. There were no concomitant medications. On 18Jan2021, the patient experienced has some injection site pain/pain injection site and body aches. In Jan2021, the patient experienced pain in the opposite shoulder/the pain in the right shoulder. The outcome of the events injection site pain and body aches was recovering. The outcome of the event shoulder pain was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye discharge, Eye swelling, Headache, Hyperhidrosis
Clinical narrative: Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut with some clear discharge; Half of the right side of her face was swelling and being numb; Half of the right side of her face was swelling and being numb; On and off chills; Sweating; Headache; Fever; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 31Dec2020 at 09:30, at a single dose, for COVID-19 immunization. The patient's medical history included enlarged thyroid (normal for her), painful menstruations, allergies to cats, dogs, and dust, seasonal allergies, and birth control. The patient's concomitant medication included ethinylestradiol/ norethisterone acetate (JUNEL) as birth control. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 06:15 AM, the patient woke up from sleep with her left eye being swollen almost shut with some clear discharge and half of the right side of her face was swelling and being numb. This persisted for about 3 days with on and off chills, sweating, headache, and a fever on 12Jan2021 (06:15). The symptoms completely dissipated on 22Jan2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the events. The patient got a COVID-19 test on 13Jan2021 just to be safe which came back as negative. The patient recovered from the events on 22Jan2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pyrexia, SARS-CoV-2 test, Swelling face
Clinical narrative: Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut with some clear discharge; Half of the right side of her face was swelling and being numb; Half of the right side of her face was swelling and being numb; On and off chills; Sweating; Headache; Fever; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 31Dec2020 at 09:30, at a single dose, for COVID-19 immunization. The patient's medical history included enlarged thyroid (normal for her), painful menstruations, allergies to cats, dogs, and dust, seasonal allergies, and birth control. The patient's concomitant medication included ethinylestradiol/ norethisterone acetate (JUNEL) as birth control. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 06:15 AM, the patient woke up from sleep with her left eye being swollen almost shut with some clear discharge and half of the right side of her face was swelling and being numb. This persisted for about 3 days with on and off chills, sweating, headache, and a fever on 12Jan2021 (06:15). The symptoms completely dissipated on 22Jan2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the events. The patient got a COVID-19 test on 13Jan2021 just to be safe which came back as negative. The patient recovered from the events on 22Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: sore arm; joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pai; body aches all over; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140, expiration date was not reported), intramuscular in left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included headaches of an unknown origin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant. She did no receive any other vaccine four weeks prior covid vaccine. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies. The patient reported adverse events for the first shot: Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain; and body aches all over for the next 2 days. The events' onset was on 18Dec2020 at 07:00 PM. Outcome recovered for events 'Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain' was recovered in Dec2020, while body aches all over was recovered on 20Dec2020.No treatment received for the events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Tiredness; chills; fever; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: True, lot unknown reason: not available/provided to reporter at the time of report completion) intramuscularly at right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history included known allergies: penicillin. Other medical history was reported as none. No other vaccine in four weeks. Other concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer) intramuscularly at right arm on 28Dec2020 at 01:00 PM at a single dose for COVID-19 immunization. Facility type vaccine was at Hospital. The patient was not pregnant. The patient experienced adverse events included tiredness, chills, fever; with start date on 19Jan2021 at 04:30 AM. No treatment received for events. The outcome of events was resolving. No COVID prior vaccination and no COVID tested post vaccination.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Prolonged fever (102); shaking chills; body aches; headache; nausea; lightheadedness; fatigue; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231, on 18Jan2021 11:30 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant medication included Prenatal vitamins. The patient previously had allergies to Spironolactone. The patient previously received first dose of BNT162B2 lot number EK5730 on 28Dec2020 11:30 AM in left arm at the age of 39-year-old. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Prolonged fever (102), shaking chills, body aches, headache, nausea, lightheadedness, fatigue on 18Jan2021 21:00. Treatment received for all events included Tylenol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Prolonged fever (102); shaking chills; body aches; headache; nausea; lightheadedness; fatigue; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231, on 18Jan2021 11:30 at single dose in left arm for covid-19 immunization. Medical history was not reported. Concomitant medication included Prenatal vitamins. The patient previously had allergies to Spironolactone. The patient previously received first dose of BNT162B2 lot number EK5730 on 28Dec2020 11:30 AM in left arm at the age of 39-year-old. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Prolonged fever (102), shaking chills, body aches, headache, nausea, lightheadedness, fatigue on 18Jan2021 21:00. Treatment received for all events included Tylenol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolving.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Influenza like illness, Musculoskeletal discomfort
Clinical narrative: dizziness; His head felt like it was too heavy; threw up; flu like symptoms; discomfort in his neck; nausea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (lot number: EL3249, expiration date: May2021) first dose on 13Jan2021 15:10 to 15: 20 intramuscular injection in right arm at single dose for covid-19 immunization. Medical history included Type II diabetes mellitus, High cholesterol and Blood pressure, all diagnosed about 15 years ago and ongoing. Concomitant medications included insulin glargine (LANTUS) for diabetes, insulin aspart (NOVOLOG) for diabetes, metformin for diabetes, lisinopril for High cholesterol and pravastatin to control blood pressure, all ongoing. None History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was None. He is supposed to get second dose on 04Feb2021. He sat for 15 minutes after getting the shot and he had no reaction. About an hour or two into his shift for work he started having nausea, tiredness, and his neck was killing him, like something was on his neck, a discomfort in his neck. He worked through his shift. He was going through discomfort flu-like symptoms through Friday (15Jan2021). He thought he was ok as of Sunday. He went to work yesterday and his shift started at 6am, he was ok and then through breakfast, the room started to spin and he was experiencing dizzy spells (18Jan2021), nausea and his neck was extremely uncomfortable. His head felt like it was too heavy. He went to his supervisor to ask to go to the back and he threw up once and then he threw up again. He had to leave work around 12-12:30. He was told to go home. He is to go back to work tomorrow. He is hoping that he feels better tomorrow. Treatment: He took Tylenol. He took a lift home and he stayed in bed all day yesterday. His wife gave him some soup last night. He is not experiencing tiredness, nausea, discomfort in his neck as of now since he is laying down and not on his feet. He feels ok and he is not really experiencing anything of the events mentioned right now since he is laying down and trying to rest. Events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: dizziness; His head felt like it was too heavy; threw up; flu like symptoms; discomfort in his neck; nausea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (lot number: EL3249, expiration date: May2021) first dose on 13Jan2021 15:10 to 15: 20 intramuscular injection in right arm at single dose for covid-19 immunization. Medical history included Type II diabetes mellitus, High cholesterol and Blood pressure, all diagnosed about 15 years ago and ongoing. Concomitant medications included insulin glargine (LANTUS) for diabetes, insulin aspart (NOVOLOG) for diabetes, metformin for diabetes, lisinopril for High cholesterol and pravastatin to control blood pressure, all ongoing. None History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was None. He is supposed to get second dose on 04Feb2021. He sat for 15 minutes after getting the shot and he had no reaction. About an hour or two into his shift for work he started having nausea, tiredness, and his neck was killing him, like something was on his neck, a discomfort in his neck. He worked through his shift. He was going through discomfort flu-like symptoms through Friday (15Jan2021). He thought he was ok as of Sunday. He went to work yesterday and his shift started at 6am, he was ok and then through breakfast, the room started to spin and he was experiencing dizzy spells (18Jan2021), nausea and his neck was extremely uncomfortable. His head felt like it was too heavy. He went to his supervisor to ask to go to the back and he threw up once and then he threw up again. He had to leave work around 12-12:30. He was told to go home. He is to go back to work tomorrow. He is hoping that he feels better tomorrow. Treatment: He took Tylenol. He took a lift home and he stayed in bed all day yesterday. His wife gave him some soup last night. He is not experiencing tiredness, nausea, discomfort in his neck as of now since he is laying down and not on his feet. He feels ok and he is not really experiencing anything of the events mentioned right now since he is laying down and trying to rest. Events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: Chills; Upset stomach; Severe headache; 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) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history included SARS-Cov-2 in Mar2020. Concomitant medications were not reported. The patient was experiencing chills, upset stomach and severe headache on unspecified dates. She took extra strength Tylenol. She asked if she should receive second dose and about efficacy without second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Middle insomnia, Vaccination site pain
Clinical narrative: Tenderness at injection sight, severe enough to awaken during the night; Tenderness at injection sight, severe enough to awaken during the night; The day after the injection, I broke out in sweats to the point that my shirt was wet; This is a spontaneous report from a non-contactable nurse reported for herself. A currently 50-year-old (reported age at vaccination was 50) female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for covid-19 immunization in Hospital. Medical history was not reported. Patient is not pregnant at the time of vaccination. Not allergies to medications, food, or other products. Concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of bnt162b2 on 22Dec2020 via Intramuscular at left arm at single dose for covid-19 immunization. Patient experienced tenderness at injection sight, severe enough to awaken during the night (12Jan2021); relieved with ibuprofen. Lasted about one week. The day after the injection, patient broke out in sweats to the point that my shirt was wet. This occurred multiple times but resolved about 24 hours post injection. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. treatment received for the events included OTC med. Patient was recovered from the events tenderness at injection sight, severe enough to awaken during the night in Jan2021 and recovered from sweats on 13Jan2021. It was non-serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Faeces discoloured, Gastrointestinal sounds abnormal, Nausea
Clinical narrative: explosive diarrhea that was liquid and green in color; explosive diarrhea that was liquid and green in color; feeling "queasiness"/queasy abdomen; loose bowel movement; a queasy abdomen right now, kind of gurgling; This is a spontaneous report from a contactable consumer (patient) and nurse. A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140, expiration date 31Mar2021), intramuscularly at site of left arm on 18Jan2021 09:30 AM at single dose for prevent COVID. The patient medical history was not reported. There were no concomitant medications. The patient previously received flu shot in Oct2020 for immunization (she had the flu shot last year but it was not within 4 weeks, it was in the fall time around Oct2020). The patient experienced a loose bowel movement later in the day on 18Jan2021 (after the vaccine dose) and reported that on 19Jan2021 she was having explosive diarrhea that was liquid and green in color. Also reported feeling queasiness. She known about the reported side effects of the clinical trials. She asked if she could get a colonoscopy next day and she was referred to her hcp. She just had a queasy abdomen right now, kind of gurgling in Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. The outcome of event bowel movement irregularity was recovered in Jan2021, the outcome of events explosive diarrhea and greenish stool was recovered on 19Jan2021, the outcome of rest events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Chills; Body aches; A fever that has went up to 101F (also reported as 100.3); Sore throat; This is a spontaneous report from a contactable consumer (patient's husband). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 18Jan2021 at 08:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included ongoing blood pressure high, allergies, and pollen/cedar allergy. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 31Dec2020 for COVID-19 immunization .The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The husband called to report that his family got their second dose of the Covid-19 vaccine yesterday (18Jan2021). He and his daughter were okay, but his wife (patient) experienced chills, body aches, a fever that has went up to 101F (also reported as 100.3), and sore throat on 18Jan2021 at 19:00. The husband would like to know if these were normal side effects and how long should they last. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Furuncle
Clinical narrative: developed two boils after getting the first dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left upper arm on 29Dec2020 at 12:00 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient developed two boils after getting the first dose of the COVID-19 vaccine (non-serious) on 29Dec2020. The patient said she had received her first dose of the COVID-19 Vaccine on 29Dec2020 at 12:00 in her left upper arm. The patient said she had developed boils since she received the COVID-19 vaccine. The patient said that she had never had boils, and now she had two boils. Therapeutic measures were taken as a result of the boils, which included antibiotics. The clinical outcome of the event was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minor soreness at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at arm left on 17Jan2021 at 01:30 PM at a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered at doctor's office/urgent care. The patient experienced adverse event minor soreness at injection site on 17Jan2021 at 12:30 PM. The event was reported as non-serious. No treatment received for adverse event. The outcome of event was resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: increased heart rate; breathing difficulty; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2(lot number=EK5730), via an unspecified route of administration on 15Jan2021 13:45 at single dose, left arm for covid-19 immunization. Medical history included partial obstruction in coronary artery, arthritis, allergies to pregabalin (LYRICA), levofloxacin (LEVAQUIN). Concomitant medication included cortisone. The patient experienced increased heart rate and breathing difficulty on 15Jan2021 13:45 with outcome of recovered in Jan2021. The events were non-serious. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report from a contactable consumer (reporting for his wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting on 18Jan2021. The reporter mentioned that he and his wife (patient) received the vaccine yesterday (18Jan2021). His wife has experienced vomiting since last night, earlier this morning, and 20 minutes before the call. He was asking if this was a normal side effect and for any recommendations on what they should do. His wife has been vomiting since getting the COVID-19 vaccine. He said he was trying to see if vomiting is one of the side effects of the COVID-19 vaccine. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit.  The outcome of the events was recovering.