chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, SARS-CoV-2 test
Clinical narrative: Feeling weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 13Jan2021 (14:45) at single dose for Covid-19 immunization. The patient's medical history included anxiety and known allergy to Grapefruit. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced feeling weak on 16Jan2021 (23:00). There was no treatment received for the adverse event. The patient has been tested for COVID-19 post vaccination on 16Jan2021with Unknown result. The outcome of event was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Feeling hot, Musculoskeletal stiffness
Clinical narrative: pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pulse abnormal
Clinical narrative: pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Breast pain, Chest pain, Dizziness
Clinical narrative: pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Flushing, Hepatic enzyme increased, Immediate post-injection reaction
Clinical narrative: pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mammogram, Neck pain, Palpitations, Panic reaction, Troponin
Clinical narrative: pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3.  It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown.   No follow-up attempts are possible, No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis, Malaise, Nervousness
Clinical narrative: blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk; Blood pressure (BP) 146/88; feeling hot and tingly on neck and all the way down to her legs; her throat feeling hot and tingly; her throat feeling hot and tingly; Heart rate (HR)-140- 150; not feeling well; Got a rush of feeling very warm and shaky; Got a rush of feeling very warm and shaky; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; This is a spontaneous report from a contactable pharmacist. A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Dec2020 09:45 AM at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Events onset date was 24Dec2020. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. Heart rate (HR)-140- 150, Blood pressure (BP) 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Medical response called. Continued to monitor and talk with patient until response team arrived. Patient transferred to Emergency room (ED). The outcome of event Feeling of warmth and tingly was not recovered. The outcome of Blotchy rash was recovering. The outcome of Blood pressure (BP) 146/88 was recovered on 24Dec2020. The outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported events were likely related to the first dose of bnt162b2 (Pfizer-BioNTech COVID-19) due to plausible temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Paraesthesia, Pharyngeal paraesthesia, Rash, Rash macular
Clinical narrative: blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk; Blood pressure (BP) 146/88; feeling hot and tingly on neck and all the way down to her legs; her throat feeling hot and tingly; her throat feeling hot and tingly; Heart rate (HR)-140- 150; not feeling well; Got a rush of feeling very warm and shaky; Got a rush of feeling very warm and shaky; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; This is a spontaneous report from a contactable pharmacist. A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Dec2020 09:45 AM at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Events onset date was 24Dec2020. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. Heart rate (HR)-140- 150, Blood pressure (BP) 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Medical response called. Continued to monitor and talk with patient until response team arrived. Patient transferred to Emergency room (ED). The outcome of event Feeling of warmth and tingly was not recovered. The outcome of Blotchy rash was recovering. The outcome of Blood pressure (BP) 146/88 was recovered on 24Dec2020. The outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported events were likely related to the first dose of bnt162b2 (Pfizer-BioNTech COVID-19) due to plausible temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk; Blood pressure (BP) 146/88; feeling hot and tingly on neck and all the way down to her legs; her throat feeling hot and tingly; her throat feeling hot and tingly; Heart rate (HR)-140- 150; not feeling well; Got a rush of feeling very warm and shaky; Got a rush of feeling very warm and shaky; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; This is a spontaneous report from a contactable pharmacist. A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Dec2020 09:45 AM at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Events onset date was 24Dec2020. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. Heart rate (HR)-140- 150, Blood pressure (BP) 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Medical response called. Continued to monitor and talk with patient until response team arrived. Patient transferred to Emergency room (ED). The outcome of event Feeling of warmth and tingly was not recovered. The outcome of Blotchy rash was recovering. The outcome of Blood pressure (BP) 146/88 was recovered on 24Dec2020. The outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported events were likely related to the first dose of bnt162b2 (Pfizer-BioNTech COVID-19) due to plausible temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health care professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), intramuscular (left arm) second dose on 14Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included Diabetes and PKD.  The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686) via Intramuscular left arm first dose on 22Dec2020 08:00 AM for covid-19 immunisation. On 16Jan2021 08:00, the patient experienced headache and Vertigo. The patient did not received treatment for the events.  The outcome of the events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Exercise lack of
Clinical narrative: Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, intramuscular on 09Jan2021 16:45 at single dose on left arm for COVID-19 immunization. The patient is not pregnant and has no medical history, no known allergies and no prior vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). The patient experienced joint aching and feeling of weakness in forearms, fingers, left hip and toes; not actively exercising on 13Jan2021 at 14:00. The patient had no treatment received. The outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included history of seafood allergy during the childhood and allergic reaction to shampoo, conditioner and skincares. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021 (reported as around a week after the second shot), the patient experienced rash. The patient took an antihistamine as treatment for the event.  Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Increased upper airway secretion, Pharyngeal paraesthesia
Clinical narrative: Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; Within 5-10 minutes injection, tingling back of throat and increased mucus that lasted less than a minute; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140, expiry date: unknown), intramuscular on 23Dec2020 18:00 at single dose (left arm) for COVID-19 immunization. Medical history included hypertension and allergies to medications, food, or other products: Shellfish, phenergan, possibly sulfa. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin, amlodipine, fluticasone propionate (FLONASE); medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient, within 5-10 minutes injection, had tingling back of throat and increased mucus that lasted less than a minute on 23Dec2020 18:15. The outcome of the events was recovered on an unspecified date. Treatment was not received for the adverse event. Patient received second dose of bnt162b2 (lot number El3248) intramuscular on 14Jan2021 17:00 (vaccine location: Left arm). Events were reported as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: redness on her arm that extended to her elbow and up to her ear; She stated that she has a lot allergies; stated that they were like hives and it was a little raised/bumps below her ear and below her jaw line now; said that her arm was itching by the time she got to her car; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3246; expiry date: unknown) intramuscular injection in the left arm, on 15Jan2021 at 10:20, for COVID-19 prophylaxis. Medical history included diabetic (type 2, insulin controlled, sugars are controlled, diagnosed about 1.5 years ago), allergies to Bee stings (needs EpiPen (hornets, yellow jackets) and a trip to the hospital) and anaphylactic allergy to tomatoes. Patient has no concomitant medications. The patient previously received flu vaccine that is allergen free. She said that she had a reaction to the regular flu vaccine about 10 years ago. She went to The ER and had severe hives, but no breathing issues, just a localized hive reaction. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient has no previous immunization with the Pfizer vaccine. The patient stated that she had her first dose of the Covid-19 vaccine today 15Jan2021. She said that about a half hour to 45 minutes after receiving the injection she had real redness on her arm that went down to her elbow and up to her ear and stated that they were like hives and it was a little raised. She said that she has bumps below her ear and below her jaw line now. She stated that she has a lot of allergies. She treated her symptoms with Benadryl. She also took Benadryl as a premed prior to getting the vaccination. She said that she called her allergist and sent her pictures of what was happening, and her allergist told her to take another Benadryl and to lay down and relax. She was a little worked up. The redness is not as red, but it is still warm, and it is still "raise" a tiny bit.  The area on her arm is now about the size of a CD and doesn't extend to the elbow anymore. She said that she got the injection at 1020 and had to wait until 40minutes. Her arm was itching by the time she got to her car and she put an ice pack on it that she keeps for emergencies in her car. She took her second dose of Benadryl at 1300. She said that she probably slept until 1530 and noticed it was looking a little bit better. She was told that people have reactions like these, and it was not a big deal and she notified her doctor and occupational health. Outcome of the event redness was recovering, while for the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Somnolence
Clinical narrative: his stomach swelled a little; a little more sleepy than before; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's wife was checking her app and found the news about 22 people have died after receiving the vaccine. She is very concerned because her husband got the vaccine. He has finished the second one. She didn't see in him any symptoms besides his stomach swelled a little and he is a little more sleepy than before. She needs to know if this vaccine is killing people. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Approximately 72 hrs after administration developed axillary lymphadenopathy; This is a spontaneous report from a contactable consumer (patient himself). A 61-year-old male patient received his second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administrationin the left leg on 14Jan2021 16:00 at SINGLE DOSE for Covid-19 immunisation. He received the vaccine in a hospital. Medical history included multiple seasonal environmental allergies. He received his first dose of bnt162b2 on 24Dec2020 12:00 in the left arm. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (ADVIL), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) and acetylsalicylic acid (BABY ASPIRIN). Approximately 72hrs after administration (17Jan2021 23:00), he developed an axillary lymphadenopathy (non-serious). Since the vaccination, he had not been tested for COVID-19. No treatment given. The outcome of event was not recovered.    Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 14Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. In Jan2021 over the weekend, patient had fever and chills and took Tylenol and seems to be fine now. The patient asked will she get the same reaction to her second dose? Will she be ok after the symptoms pass? The outcome of the events was recovered.  Information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: severe headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (left arm) on 16Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) on 26Dec2020 for Covid-19 immunization. The patient's medical history included sleep apnea and increased blood pressure (managed); no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, dizziness, nausea on 16Jan2021. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Feeling hot, Musculoskeletal chest pain, Vision blurred, Visual impairment
Clinical narrative: Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown.   The information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypophagia, Pyrexia, Tremor
Clinical narrative: strong shaking; teeth chattering; temperature went up to 101; consumed very little food in 48 hours; This is a spontaneous report from a contactable other-HCP, the patient.  A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3249), via an unspecified route of administration on 16Jan2021 at 08:45 (at the age of 63-years-old) as a single dose, in the left arm for COVID-19 immunization. The patient has no relevant medical history, no known allergies and no prior vaccine reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included ibuprofen at an unknown dose, for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jan2021 at 10:45, the patient experienced strong shaking, teeth chattering. On 16Jan2021 the patient experienced fever up to 101 and on an unknown date in Jan2021 the patient experienced consuming very little food.  The patient did not receive therapeutic interventions for the events. The patient described the clinical course as follows: two hours after vaccine administration the patient experienced strong shaking and teeth chattering as would be normal for influenza or Noro Virus per patient. The patient's temperature went up to 101 and the patient was in bed with fever for 40 hours, the patient consumed very little food in 48 hours, and maintained fluid intake. The patient reported he had no nausea, no diarrhea. The patient stated it was unpleasant to the point of not being to do anything but lay in bed. Then, at about 40-48 hours temp was gone, and the patient felt very close to normal and the patient resumed eating. The clinical outcomes of the strong shaking, teeth chattering, temp went up to 101 and consumed little food were recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccination site pain, Vaccination site rash
Clinical narrative: I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; I developed a painful burning rash below the injection site; It appears my skin is beginning to peel as well. It remains painful to touch; This is a spontaneous report from a contactable consumer, the patient.  A 44-year-old non-pregnant female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), via an unspecified route of administration in the left arm on 15Jan2021 at 2:30 PM (at the age of 44-year-old) as a single dose for COVID-19 immunization.  Medical history included  unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), intramuscular, left arm  on 29Dec2020 for COVID-19 immunization. On 17Jan2021, approximately 48 hours after, the patient developed a painful burning rash below the injection site. It appears her skin is beginning to peel as well, it remains painful to touch. Treatment with over the counter (OTC) medicine was taken as a result of patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch. The clinical outcome of the events patient developed a painful burning rash below the injection site, it appears her skin is beginning to peel as well, it remains painful to touch was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: slightly light headed for over an hour; This is a spontaneous report from a contactable healthcare professional (patient herself). A 59-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (left arm), on 30Dec2020 12:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included estradiol; loratadine; paracetamol (TYLENOL); fish oil and; calcium. The patient previously took tetracycline, amoxicillin, sulfamethoxazole and trimethoprim (BACTRIM) and, erythromycin and experienced allergies to all these drugs. Immediately after receiving the first dose, the patient was slightly light headed for over an hour on 30Dec2020 12:00 PM. No treatment was received for the adverse event. The patient recovered from the event on 30Dec2020. The patient had no other vaccine in four weeks and had no Covid prior to vaccination. The patient had a Covid-19 nasal swab Covid-test post vaccination on 05Jan2021 with results of negative, on 11Jan2021 with results of negative and, on 18Jan2021 with results pending.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he thought he was having a vertigo attack; super sick on the 8th after his second dose; Fever; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 07Jan2021 at single dose on the left arm for COVID-19 immunization. Medical history included vertigo from Aug2019. There were no concomitant medications. The patient received the vaccine through the facility where he works (not a military facility). Patient received his first dose on 17Dec2020 (lot number: EL0140). Patient said that the symptoms started Monday, he was super sick Friday after first dose. Patient clarified to super sick on 08Jan2021 after his second dose. On 08Jan2021 after his second dose, patient had a fever of unknown temperature which he slept through it. He was tired the whole day on Monday (11Jan2021) and really dizzy and had chills from then to now, which is not stopping, he means the dizziness is not better, the chills come and go. He clarifies that he did take Tylenol to treat the fever and the next day he had no fever. He says that the dizzy, he still has it. Patient took 500mg once by mouth of the Tylenol. Patient stated that he also has a history of vertigo, so he thought he was having a vertigo attack, but he took his medicine and it did not help him. Patient stated that these were not serious for him, he just feels dizzy and lightheaded. He has no loss of balance. The patient reported that he had both doses of the COVID vaccine on the left arm. Patient had the second dose on 07Jan2021, and until now he has been dizzy, it started 3 days ago (11Jan2021), he has had chills and then after he was warm all of a sudden, he was concerned. Patient has had no new medications or other vaccinations recently. He last saw his doctor six months ago and he plans to see her tomorrow (15Jan2021). The events were assessed as non-serious by the reporter. Outcome of the event dizzy/dizziness vertigo attack, and chills was not recovered (ongoing), for fever was recovered on 09Jan2021 while for other events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vertigo
Clinical narrative: tired; dizzy/dizziness/lightheaded; chills; he is warm all of a sudden; a history of vertigo, so he thought he was having a vertigo attack; super sick on the 8th after his second dose; Fever; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 07Jan2021 at single dose on the left arm for COVID-19 immunization. Medical history included vertigo from Aug2019. There were no concomitant medications. The patient received the vaccine through the facility where he works (not a military facility). Patient received his first dose on 17Dec2020 (lot number: EL0140). Patient said that the symptoms started Monday, he was super sick Friday after first dose. Patient clarified to super sick on 08Jan2021 after his second dose. On 08Jan2021 after his second dose, patient had a fever of unknown temperature which he slept through it. He was tired the whole day on Monday (11Jan2021) and really dizzy and had chills from then to now, which is not stopping, he means the dizziness is not better, the chills come and go. He clarifies that he did take Tylenol to treat the fever and the next day he had no fever. He says that the dizzy, he still has it. Patient took 500mg once by mouth of the Tylenol. Patient stated that he also has a history of vertigo, so he thought he was having a vertigo attack, but he took his medicine and it did not help him. Patient stated that these were not serious for him, he just feels dizzy and lightheaded. He has no loss of balance. The patient reported that he had both doses of the COVID vaccine on the left arm. Patient had the second dose on 07Jan2021, and until now he has been dizzy, it started 3 days ago (11Jan2021), he has had chills and then after he was warm all of a sudden, he was concerned. Patient has had no new medications or other vaccinations recently. He last saw his doctor six months ago and he plans to see her tomorrow (15Jan2021). The events were assessed as non-serious by the reporter. Outcome of the event dizzy/dizziness vertigo attack, and chills was not recovered (ongoing), for fever was recovered on 09Jan2021 while for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Neck pain, Paraesthesia
Clinical narrative: pain and a dull ache on the same place on her neck; fleeting facial pain/pain and a dull ache on the same place on her face/pain is consistent in her face and it is a sensation of a dull ache; tingling on the right side of her face; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sales representative. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration at the left arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Jan2021, the patient noticed fleeting facial pain and tingling on the right side of her face. She awoke in the middle of the night on 13Jan2021 with pain and a dull ache on the same place on her face and neck. Today, on 15Jan2021, the pain was consistent in her face and it is a sensation of a dull ache. The outcome of the event fleeting facial pain/pain and a dull ache on the same place on her face/pain is consistent in her face and it is a sensation of a dull ache was not recovered while the outcome of the events tingling on the right side of her face and pain and a dull ache on the same place on her neck was unknown.  Information on the batch/lot number has been requested.