chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: read around the site and more swollen; fever of 101 or less; chills; injection site pain; Headache; body aches; nausea; read around the site and more swollen; administration date 15Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), intramuscular in the left arm on 15Jan2021 16:00 at single dose for COVID-19 immunisation.  Medical history included ulcerative colitis, depression, and incomplete lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. 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 vedolizumab (ENTYVIO), and fluoxetine hydrochloride (PROZAC). The patient previously took first dose of bnt162b2 (lot number: EK9231, expiry date not reported), intramuscular in the right arm on 29Dec2020 at 12:00 PM at single dose for COVID-19 immunisation. The patient verbalized, "The day after the second vaccine I had a fever of 101 or less, chills, injection site pain, headache, body aches especially in my lower back and neck ,and some nausea. I took Tylenol which helped with the fever, but the headache continued that day. On the second to hear from vaccine I continued to have a fever and chills with some body aches but improving. On the second day I noticed the injection site was not only painful but read around the site and more swollen. Currently it is Tuesday and I no longer have a fever but continue to have injection site pain, redness, swelling. I have an appointment to follow up with my doctor for any further recommendations." Clinical outcome of fever was recovered on an unspecified date; for pyrexia, chills, and body aches was resolving; while for the other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lethargy, Nausea
Clinical narrative: Fever; chills; nausea; headache; overall lethargy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El1284), via an unspecified route of administration on 18Jan2021 09:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose on 30Dec2020 06:45 AM (lot number Eh9899) at left arm for covid-19 immunization. The age of first dose was also 59 years old. Patient is not pregnant. The facility type vaccine was hospital. Medical history included Sulfa allergy from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, nausea, headache, overall lethargy on 18Jan2021 09:00 PM. Patient didn't receive treatment for the adverse events. The outcome of events was recovering.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; nausea; headache; overall lethargy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El1284), via an unspecified route of administration on 18Jan2021 09:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose on 30Dec2020 06:45 AM (lot number Eh9899) at left arm for covid-19 immunization. The age of first dose was also 59 years old. Patient is not pregnant. The facility type vaccine was hospital. Medical history included Sulfa allergy from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, nausea, headache, overall lethargy on 18Jan2021 09:00 PM. Patient didn't receive treatment for the adverse events. The outcome of events was recovering.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body pain; This is a spontaneous report from a non-contactable consumer (relation with patient was other). A 31-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient had Covid prior vaccination. The patient experienced fever and body pain on unspecified dates. It was unknown if patient had Covid tested post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Nausea, Tachycardia
Clinical narrative: Nausea; Tachycardia (heart rate 140-160); This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246), intramuscular at the left arm on 07Jan2021 03:45 at a single dose for COVID-19 immunization. The patient medical history includes Known allergies: Iodine. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously received bnt162b2, 1st dose Intramuscularly at the left arm on 18Dec2020 01:00 AM, lot number EK5730. On 07Jan2021 at 4 AM the patient experienced nausea, palpation, tachycardia (heart rate 140-160). The events resulted in: Emergency room/department or urgent care. Treatment received for the adverse events was unknown. The vaccine was administered in a hospital. 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 recovered on an unspecified date in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Fever of 100.2; Swollen lymph nodes; Threw up; This is a spontaneous report from a contactable nurse, the patient. This male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 15Jan2021 for COVID-19 vaccination. Relevant medical history was unknown. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Jan2021, the patient had a headache, muscle pain, chills, joint pain, fever of 100.2, swollen lymph nodes and threwup. The outcome of the events headache, muscle pain, chills, joint pain, fever of 100.2, swollen lymph nodes and threw up was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Fever of 100.2; Swollen lymph nodes; Threw up; This is a spontaneous report from a contactable nurse, the patient. This male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 15Jan2021 for COVID-19 vaccination. Relevant medical history was unknown. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Jan2021, the patient had a headache, muscle pain, chills, joint pain, fever of 100.2, swollen lymph nodes and threwup. The outcome of the events headache, muscle pain, chills, joint pain, fever of 100.2, swollen lymph nodes and threw up was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event following immunisation, Ill-defined disorder
Clinical narrative: it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus; it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus; This is a spontaneous report from a contactable consumer reported for friend's father. A male patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had COVID-19, and also had a severe reaction to the first shot. That was like 10 times worse than Covid itself. He had pretty rough time with it and it was worse for him after her received the COVID-19 Vaccine shot than having the COVID-19 Virus. Outcome of the events was unknown.    Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Conjunctivitis in right eye; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (24Dec), at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced conjunctivitis in right eye on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for 3 days; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the second of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the doctor himself was sick for 3 days on an unspecified date. The doctor looked like he was completely recovered, the doctor made it sound like it was a while back. Outcome of the event was reported as unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046013 same reporter/ product, different patient / event
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Condition aggravated, Dizziness
Clinical narrative: she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249),  dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient  barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Weight increased
Clinical narrative: she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249),  dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient  barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: felt really hot; Tired; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt really hot and tired on an unspecified date after getting his second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: came down with COVID in a week of vaccination; came down with COVID in a week of vaccination; This is spontaneous report from a contactable physician. This physician reported similar events for four patients. This is the 1st of four reports.   A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   Information on batch/lot number has been requested.; 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 (a week in this case). However, a causal relationship between event "came down with COVID in a week of vaccination" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded,Linked Report(s) : US-PFIZER INC-2021064978 same reporter/drug/event, different paitent;US-PFIZER INC-2021064979 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different paitent;US-PFIZER INC-2021072675 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: they all came down with COVID in a week; they all came down with COVID in a week; This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 2nd of 4 reports. An elderly patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, an unknown date as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; 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 (a week in this case). However, a causal relationship between event "came down with COVID in a week of vaccination" (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021064977 as same reporter/drug/AE/different patients.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had arm soreness; This is a spontaneous report from a contactable Consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. His shot was administered correctly and he had arm soreness on 18Jan2021. The outcome of the event was unknown. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: got her first dose yesterday on her left arm and after that stated she felt hurt on the left arm; felt like vomiting; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A 69-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 18Jan2021 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 got her first dose yesterday on her left arm and after that stated she felt hurt on the left arm and felt like vomiting. It was reported that she took 2 tabs of Tylenol that were 500mg each. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; headache; myalgias; This is a spontaneous report from a contactable physician. A 64-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included mechanical valve, atrial fibrillation. No known allergies. There was concomitant medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 1-3 (13Jan2021), the patient had arm pain, headache, myalgias, then day 4 felt better and on day 5-7 (17Jan2021) developed tingling and severe burning in her legs and arms, that gradually improved to only included tingling in the feet at this date 7 day after injection. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid after receiving the first shot; got covid after receiving the first shot; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is second of two reports.   A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got COVID after receiving the first shot on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046083 same reporter/drug/event, different patient
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; tingling on outside of left arm where he had the shot that progresses to his pinky finger which is most numb; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELQ142), via an unspecified route of administration on 12Jan2021 at single dose at left arm for covid-19 immunisation. Medical history and concomitant medications were none. Patient experienced tingling outside of left arm where he had the shot, progresses to pinky finger which was most numb. Stated thumb and pinky finger that it was not there. Stated when woke up had numbness tingling feeling that had never gone away. Above symptoms started on 16Jan2021. No treatment was received for the events. Outcome of the events was not resolved. The second dose was due on 02Feb2021.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 22-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included prior Covid. Concomitant medications included ethinylestradiol/etonogestrel (NUVARING) and cetirizine hydrochloride (ZYRTEC). The patient had no known allergies. Historical vaccine included BNT162B2 on 28Dec2020 in left arm, dose number 1. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. On 19Jan2021 at 03:00, the patient experienced fever (100.5), body aches, chills, headache, and fatigue. No treatment was provided for the events fever, body aches, chills, headache, and fatigue. The outcome of the events fever, body aches, chills, headache, and fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; Fever (100.5), body aches, chills, headache, fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 18Jan2021 (at the age of 22-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included prior Covid. Concomitant medications included ethinylestradiol/etonogestrel (NUVARING) and cetirizine hydrochloride (ZYRTEC). The patient had no known allergies. Historical vaccine included BNT162B2 on 28Dec2020 in left arm, dose number 1. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. On 19Jan2021 at 03:00, the patient experienced fever (100.5), body aches, chills, headache, and fatigue. No treatment was provided for the events fever, body aches, chills, headache, and fatigue. The outcome of the events fever, body aches, chills, headache, and fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: stomach upset; Lightheaded; This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249) intramuscularly into the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included allergies to dairy and nuts. There were no concomitant medications. The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140) intramuscularly into the left arm on 21Dec2020 at a single dose for covid-19 immunization. The patient experienced stomach upset and was lightheaded on 12Jan2021. The patient did not receive treatment for the events reported. Patient was not pregnant. Outcome of the events recovered on an unspecified date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Body Chills; body aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261, expiration date unspecified), via an unspecified route of administration on 16Jan2021 08:30 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19, prior vaccination. The patient was not pregnant. Concomitant medications were not reported. Patient had other medications in two weeks. The patient previously took codeine (reported as codine) and experienced allergies. On an unspecified date, the patient experienced body chills, body aches and nausea. There were no treatment for the events. There were no other vaccine in four weeks and patient was not Covid tested post vaccination. Outcome of events was recovered in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: very sore in their arm; felt off; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is second of three reports. This consumer reported for sister of her boyfriend. A 68 (units unknown) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 18Jan2021 as a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was very sore in their arm and felt off; in Jan2021. The events were reported as non-serious. The clinical outcome of very sore in their arm and everyone felt off was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021069652 Same reporter/products/events, different patients;US-PFIZER INC-2021069654 Same reporter/products/events, different patients
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: very sore in the arm; Felt off; This is a spontaneous report from a contactable consumer reporting for her brother in law. This consumer reported similar events for 3 patients. This is 1 of 3 reports. A 69 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unspecified date in Jan2021, the patient was very sore in the arm and felt off. The outcome of the events very sore in the arm and felt off was unknown. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021069653 Same reporter/products/events, different patients;US-PFIZER INC-2021069652 Same reporter/products/events, different patients
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy
Clinical narrative: swollen lymph node in the left arm pit; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 15Jan2021 at a single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medication included desogestrel, ethinylestradiol (KARIVA) in Sep2020 for birth control. There was no history of all previous immunization with the Pfizer vaccine. The patient had no prior vaccination within four weeks. On 17Jan2021, the patient experienced swollen lymph node in the left arm pit which became really noticeable. She reported she feels like she looks deformed due to the swollen lymph node. She had bloodwork drawn about 1.5 weeks ago (Jan2021) but has not received the results from that yet. The event did not require emergency room or physician office visit. The patient was not hospitalized. Outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling; redness; itching; if touched it was hot like sunburned and could see like ring around where injection site; bruise; received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine,, lot number EL3248, via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced swelling, redness and itching. On the 3rd day it started going back to normal. just had a bruise like a small bruise for several days up until and last night which would have been a week after and it swelled up, it was very red and if she touched it, it was hot almost like a sunburned and you could see like a perfect ring around where the injection site was. The clinical outcome of the events was not reported,
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Headache, Myalgia, Pain
Clinical narrative: bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not  anything she can clock by time, it goes and comes back, only lasts a very short time,  it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered.  Information about lot/batch has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitivity to weather change
Clinical narrative: bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not  anything she can clock by time, it goes and comes back, only lasts a very short time,  it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered.  Information about lot/batch has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: stated that she woke up and her left foot was swollen; This is a spontaneous report from a contactable consumer, the patient. A 86-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot # EL3248), via an unspecified route of administration in the right  arm on 19Jan2021 'at about 9:30 AM' as a single dose for COVID-19 vaccination. Medical history included hip arthroplasty in 2012, blood cholesterol abnormal and blood pressure abnormal.  The patient's concomitant medications were not reported.  No other vaccines were given within 4 weeks. On 20Jan2021 the patient experienced that she woke up and her left foot was swollen. Consumer stated  I got a vaccine yesterday and I am not feeling bad or anything.  I just took a shower and my left foot is swollen. She inquired if vaccine caused that and wanted to know if she needed to go and get the second shot on 09Feb.  No treatment was  given for the event. The clinical outcome of the event left foot swollen was not recovered.                Consumer stated, I got a vaccine yesterday and I am not feeling bad or anything I just took a shower and my left foot is swollen. I just want to see if vaccine caused that. I just want to see if vaccine made my feet swell. I took a COVID-19 Shot (COVID-19 Vaccine) yesterday and today my left foot is swollen. I just want to know if that could have come from the vaccine." When probed if it was the Pfizer COVID Vaccine, Consumer stated, "I took one shot yesterday.  Consumer was provided with the number of Pfizer Medical Information. Product details (LOT# and expiration date): Consumer stated, I don't have vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: rash on both arms at the site of the nicotine patch; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (lot number: EL3249) first dose on 19Jan2021 10:00 o left arm at single dose for want to be safe. Co-suspect product included nicotine transdermal system patch (lot number: 50430, expiration date: Mar2023) at 21mg; apply to the skin daily from Dec2020 (since 12Dec2020 or 15Dec2020)and ongoing for help stop smoking. Medical history included surgery on her neck in Dec2020 and states everything was fine and Diabetes. This surgery predates treatment with the vaccine. Family Medical History was none. Concomitant medication included ongoing insulin human, insulin human injection, isophane (HUMULIN 70/30) for Diabetes taking for over 10 years. The patient previously received Flu shot on 10Dec2021 (age 79-year-old female) for immunization. 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. She just got the vaccine today (19Jan2021). Everything went fine. The shot didn't hurt. The process went really smooth. She just wants to get rid of this virus. She waited the time period there and then went home. When she was changing clothes after she got home, she noticed a rash. She had been wearing a nicotine patch. On both arms, in both places where she had worn the patch on her arms there is a rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 19Jan2021 at 10:00AM in the left arm. She noticed a couple of hours later a rash at the location of where she had previously worn the nicotine patch on both arms. She has been on the patch for a month and has not had any rash before. Adds she is supposed to use alternate arms and change daily. The rash is where she used it the last time. She did wash those places this morning before she had the shot so she thinks there shouldn't be any residue. She just changed it to a new location and there is no rash at the new location of the patch yet. Adds there is no pain or itching, just a rash. She is scheduled 09Feb2021 for the second dose. Mentions she was not sure if she should report but she didn't want another elderly person to get the rash and be scared. She imagines that Pfizer already tested the vaccine with tobacco. Event did not require a visit to physician or ER. The outcome of the event was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Influenza like illness, Pyrexia
Clinical narrative: weak; beginning of flu; coughing little on Sunday and it was worst on Monday (18Jan2021); shoulder was sore and painful; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and his wife). This is the 1st of two reports.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (reported as "shot left shoulder") on 18Jan2021 07:00 at single dose for Covid-19 immunization. The patient's medical history included cough (Sunday) 17Jan2021. There were no concomitant medications. The patient reported that yesterday morning (18Jan2021) he had first vaccine shot, then last night and this morning that he had fever during the night. The patient stated that this morning (19Jan2021) he was weak and anxious. He further stated that he is better now. He does not know if it is related to the vaccine. He added that he went to take a Covid test (unspecified date) and will receive the results in three days. He stated that he does not think that he has Covid. The patient added that his temperature was normal when he saw the doctor at 10:00 this morning (19Jan2021). He took two Tylenol every four hours. The last time that he took some was at 2:00-3:00 this morning. He recovered but not totally at this time. He further stated that because of Covid in the air was because he said that he was anxious. He stated he recovered from being anxious at noon today, completely and with lasting effects. He also stated that he was weak and had to lay down on 19Jan2021. His wife gave him a cold towel and he was better and had breakfast. He added that he was coughing little on Sunday and it was worst on Monday (18Jan2021). He added that his shoulder was sore and painful on 18Jan2021 and that this morning it is almost okay. He stated that he still have pain when he moves his shoulder. He put an ice on his shoulder. The doctor checked lungs and thinks that he may have the beginning of the flu (19Jan2021). The outcome of event beginning of flu was not recovered; outcome of event cough was unknown; while the outcome of other events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021064803 same reporter and product, similar event, different patients
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: weak; beginning of flu; coughing little on Sunday and it was worst on Monday (18Jan2021); shoulder was sore and painful; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and his wife). This is the 1st of two reports.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (reported as "shot left shoulder") on 18Jan2021 07:00 at single dose for Covid-19 immunization. The patient's medical history included cough (Sunday) 17Jan2021. There were no concomitant medications. The patient reported that yesterday morning (18Jan2021) he had first vaccine shot, then last night and this morning that he had fever during the night. The patient stated that this morning (19Jan2021) he was weak and anxious. He further stated that he is better now. He does not know if it is related to the vaccine. He added that he went to take a Covid test (unspecified date) and will receive the results in three days. He stated that he does not think that he has Covid. The patient added that his temperature was normal when he saw the doctor at 10:00 this morning (19Jan2021). He took two Tylenol every four hours. The last time that he took some was at 2:00-3:00 this morning. He recovered but not totally at this time. He further stated that because of Covid in the air was because he said that he was anxious. He stated he recovered from being anxious at noon today, completely and with lasting effects. He also stated that he was weak and had to lay down on 19Jan2021. His wife gave him a cold towel and he was better and had breakfast. He added that he was coughing little on Sunday and it was worst on Monday (18Jan2021). He added that his shoulder was sore and painful on 18Jan2021 and that this morning it is almost okay. He stated that he still have pain when he moves his shoulder. He put an ice on his shoulder. The doctor checked lungs and thinks that he may have the beginning of the flu (19Jan2021). The outcome of event beginning of flu was not recovered; outcome of event cough was unknown; while the outcome of other events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021064803 same reporter and product, similar event, different patients