chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Heart rate
Clinical narrative: joint pain; tiredness; headache; muscle pain in my joints; musculoskeletal pain; I felt a little bit feverish and warm/I had a slight fever; a slight heaviness on my chest; needed to take a nap, more than normal; really not feeling well; feeling very achy; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (reported as '30', unknown unit), received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her shot on Friday morning (08Jan2021) and felt no pain at all, at the injection site, it didn't hurt at all in my left deltoid muscle. She felt great afterwards after the whole day. Then about the 2nd-3rd day on after she felt she had a little bit of joint pain on Jan2021. On the 3rd day patient felt a little bit of tiredness, headache, muscle pain in my joints as well musculoskeletal pain. She felt a little bit feverish and warm. She normally run 97 and I'm usually cold, but I was definitely a lot warmer and a slight heaviness on my chest on the 4th day feeling she needed to take a nap, more than normal. She have a stethoscope, heard her lungs and heart which was normal and clear and vitals were normal. She wasn't having a reaction or anything. Patient took Tylenol and Ibuprofen as well and that helped. Patient was fine. It only lasted about 4-5 hours that she was really not feeling well and needed to sleep and take a nap. She was just feeling very achy and headachy and body achy and after she woke up and had a slight fever, sweating if off and then felt fine. She had no other symptoms and her arm felt fine where she got the injection site. All events happened on Jan2021. Outcome of the events was recovered on an unspecified date in Jan2021.  Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Malaise, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: joint pain; tiredness; headache; muscle pain in my joints; musculoskeletal pain; I felt a little bit feverish and warm/I had a slight fever; a slight heaviness on my chest; needed to take a nap, more than normal; really not feeling well; feeling very achy; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (reported as '30', unknown unit), received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her shot on Friday morning (08Jan2021) and felt no pain at all, at the injection site, it didn't hurt at all in my left deltoid muscle. She felt great afterwards after the whole day. Then about the 2nd-3rd day on after she felt she had a little bit of joint pain on Jan2021. On the 3rd day patient felt a little bit of tiredness, headache, muscle pain in my joints as well musculoskeletal pain. She felt a little bit feverish and warm. She normally run 97 and I'm usually cold, but I was definitely a lot warmer and a slight heaviness on my chest on the 4th day feeling she needed to take a nap, more than normal. She have a stethoscope, heard her lungs and heart which was normal and clear and vitals were normal. She wasn't having a reaction or anything. Patient took Tylenol and Ibuprofen as well and that helped. Patient was fine. It only lasted about 4-5 hours that she was really not feeling well and needed to sleep and take a nap. She was just feeling very achy and headachy and body achy and after she woke up and had a slight fever, sweating if off and then felt fine. She had no other symptoms and her arm felt fine where she got the injection site. All events happened on Jan2021. Outcome of the events was recovered on an unspecified date in Jan2021.  Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: joint pain; tiredness; headache; muscle pain in my joints; musculoskeletal pain; I felt a little bit feverish and warm/I had a slight fever; a slight heaviness on my chest; needed to take a nap, more than normal; really not feeling well; feeling very achy; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (reported as '30', unknown unit), received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her shot on Friday morning (08Jan2021) and felt no pain at all, at the injection site, it didn't hurt at all in my left deltoid muscle. She felt great afterwards after the whole day. Then about the 2nd-3rd day on after she felt she had a little bit of joint pain on Jan2021. On the 3rd day patient felt a little bit of tiredness, headache, muscle pain in my joints as well musculoskeletal pain. She felt a little bit feverish and warm. She normally run 97 and I'm usually cold, but I was definitely a lot warmer and a slight heaviness on my chest on the 4th day feeling she needed to take a nap, more than normal. She have a stethoscope, heard her lungs and heart which was normal and clear and vitals were normal. She wasn't having a reaction or anything. Patient took Tylenol and Ibuprofen as well and that helped. Patient was fine. It only lasted about 4-5 hours that she was really not feeling well and needed to sleep and take a nap. She was just feeling very achy and headachy and body achy and after she woke up and had a slight fever, sweating if off and then felt fine. She had no other symptoms and her arm felt fine where she got the injection site. All events happened on Jan2021. Outcome of the events was recovered on an unspecified date in Jan2021.  Information about Lot/Batch has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Fever up to 101; severe body aches; severe chills; nausea; fatigue; headache; BNT162B2 1st dose: 23Dec2020/BNT162B2 2nd dose: 09Jan2021 14:45; This is a spontaneous report from a non-contactable nurse reported that a 25-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231; expiry date: not known) on 09Jan2021 14:45 and first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK5730; expiry date: not known) on 23Dec2020, both intramuscular in the right arm at single dose for COVID-19 immunization, administered in hospital. The patient's medical history was not reported. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) (medication received in two weeks). The patient had no COVID prior to vaccination. The patient experienced fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache on 10Jan2021. No treatment was received for these reported events. The patient underwent lab tests and procedures which included nasal swab (COVID test) on 14Nov2020: negative. The outcome of the events fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache was recovering.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever up to 101; severe body aches; severe chills; nausea; fatigue; headache; BNT162B2 1st dose: 23Dec2020/BNT162B2 2nd dose: 09Jan2021 14:45; This is a spontaneous report from a non-contactable nurse reported that a 25-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231; expiry date: not known) on 09Jan2021 14:45 and first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK5730; expiry date: not known) on 23Dec2020, both intramuscular in the right arm at single dose for COVID-19 immunization, administered in hospital. The patient's medical history was not reported. Concomitant medication included ethinylestradiol, norgestrel (CRYSELLE) (medication received in two weeks). The patient had no COVID prior to vaccination. The patient experienced fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache on 10Jan2021. No treatment was received for these reported events. The patient underwent lab tests and procedures which included nasal swab (COVID test) on 14Nov2020: negative. The outcome of the events fever up to 101, severe body aches, severe chills, nausea, fatigue, and headache was recovering.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Very sleepy 4 hours after second dose; This is a spontaneous report from a contactable healthcare professional (patient herself). A 60-year-old female patient received the second dose of bnt162b2 (lot number: Ek9231), intramuscularly on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient was not pregnant. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (lot number: Ek5730) intramuscularly on the right arm on 22Dec2020 at 08:00 AM. On 11Jan2021 14:00, the patient became very sleepy four hours after second dose. The patient was recovering from the event. No treatment was given in response to very sleepy 4 hours after second dose.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient received the first dose then tested positive for the COVID-19 virus, on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive. The patient outcome of the event was unknown.    The information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and suspected LOE  due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: Lymphadenopathy
Clinical narrative: her lymph nodes are swelling after the administration of the second dose of the Pfizer's COVID-19 vaccine.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date to a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that her lymph nodes are swelling after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information regarding Lot/Batch/Expiry date could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: hiccups; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single fdose for COVID-19 immunization. The patient 's medical history and concomitant medications were not reported. The patient experienced hiccups on 10Jan2021 after eating dinner that lasted until he went to sleep, over an hour. Patient was wondering if this is a known side effect of the vaccine and/or Covid.  The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Throat irritation, Weight
Clinical narrative: he felt "very hot" ("felt like a heatlash"); itchy ("sandpapery") throat; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received first dose of bnt162b2 (BNT162B2; lot number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunisation/ work. The patient has no medical history and concomitant medications. On 23Dec2020, the patient reported right after the first shot he had to wait 15 minutes for reaction-based purposes. Once he got to his car, the patient felt really really hot, and his throat started to itch described as was "sandpapery". It wasn't horrible. It was not like anaphylactic. The patient took 2 antihistamine tablets (Benadryl), and it went away. He has had no AE since. The outcome of the events was recovered on 23Dec2020.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Painful respiration
Clinical narrative: Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spontaneous report from a contactable consumer (reporting for a patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 12:00 at a single dose for COVID-19 immunization. There was no other medical history, had no known allergies. Concomitant medications were not reported. The patient did not have COVID and did not receive other vaccine in four weeks prior to vaccination; did not have other medication within two weeks and was not pregnant at the time of vaccination. On 08Jan2021, the patient experienced occasional chills and mild chest pain with deep breath. No treatment was given for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Fever; chills; lethargy; body aches; headache that kicked in 12 hours; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 not diagnosed with COVID-19 prior to and post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 09Jan2021, the patient experienced fever, chills, lethargy, body aches, and headache that kicked in 12 hours after the vaccination and lasted for 24 hours. Clinical outcome of the events was recovered on an unspecified date.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1282 and expiration date not provided), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus.  The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included metformin, lisinopril, and aspirin (ACETYLSALICYLIC ACID). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 11Jan2021 14:00, the patient experienced pain and numbness in arm of injection. Treatment was not provided in response to the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a contactable physician (patient). This 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiry date unknown, vaccine location: left arm), intramuscular on 05Jan2021 08:00 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient has no known allergies. Concomitant medication included valsartan and loratadine (other medications in two weeks include valsartan and loratadine). The patient took the first dose of bnt162b2 on 16Dec2020 01:00 PM (lot number: EH9899) intramuscular, vaccine location: left arm. The patient experienced severe right tibialis anterior muscle cramp on 06Jan2021 12:00 PM, 30 hours after second injection (as reported) with onset of low level fever. The fever resolved within 2 hours. Muscle cramping persisted for 30 hours with complete resolution. No treatment was received. Outcome of the event low level fever was recovered on 06Jan2021 14:00 and of the event muscle severe right tibialis anterior muscle cramp was recovered on 07Jan2021 18:00. The patient had no COVID prior to vaccination. The patient was not tested for COVID post-vaccination. The patient had no other vaccine in four weeks.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Malaise, Neurological examination normal, Paraesthesia, Polyneuropathy
Clinical narrative: fever and malaise 1st couple of days after her COVID vaccine.; fever and malaise 1st couple of days after her COVID vaccine.; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; This is a spontaneous report from a contactable Physician reporting for herself. A female patient of an unspecified age received 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 from Feb2020. The patient's concomitant medications were not reported. The patient reported fever and malaise 1st couple of days after her COVID vaccine. On day 3-10, she experienced 'paresthesia, felt like polyneuropathy in her hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'. Has since resolved completely. She has seen a neurologist who performed a general physical exam and it appeared normal. Also, she notified or asked Nursing occupational health. She had a history of COVID last Feb2020. She was asking if there are any recommendation if she should get the 2nd dose of the COVID vaccine. The events had resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event polyneuropathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: Pyrexia
Clinical narrative: fever and malaise 1st couple of days after her COVID vaccine.; fever and malaise 1st couple of days after her COVID vaccine.; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; This is a spontaneous report from a contactable Physician reporting for herself. A female patient of an unspecified age received 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 from Feb2020. The patient's concomitant medications were not reported. The patient reported fever and malaise 1st couple of days after her COVID vaccine. On day 3-10, she experienced 'paresthesia, felt like polyneuropathy in her hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'. Has since resolved completely. She has seen a neurologist who performed a general physical exam and it appeared normal. Also, she notified or asked Nursing occupational health. She had a history of COVID last Feb2020. She was asking if there are any recommendation if she should get the 2nd dose of the COVID vaccine. The events had resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event polyneuropathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: yeast infection; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 36-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL0140; expiry date: not known), intramuscular on 18Dec2020 and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246; expiry date: not known), via an unspecified route of administration on 08Jan2021, both in the right arm at single dose for COVID-19 immunization, administered in hospital. There was no medical history. No known allergies. The patient is not pregnant. Concomitant medications included ibuprofen (ADVIL), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), and valaciclovir hydrochloride (VALACYCLOVIR) (medications received in two weeks). The patient had no COVID prior vaccination and not tested post vaccination. The patient experienced yeast infection on 19Dec2020. This event got by the patient for both doses. No treatment received for this event. The outcome of the event was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Night sweats, Paraesthesia, Pyrexia
Clinical narrative: lightheaded; tingling in her fingers; feverish but my temperature was ok; night sweats; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had COVID vaccine and experienced a couple of side effects two days after getting the vaccine which lasted 3 days. On an unspecified date, she was lightheaded and had this random tingling in her fingers. She also felt feverish but her temperature was ok but she was also feeling like she was having night sweats. She got a first dose of the vaccine at 2pm on Wednesday, then she woke up on Friday morning and felt, everything was like subtle, and did not feel like she had to stay at home. She could go to work, was just how she felt. Sometimes it felt like it was just in her head but then by 5 or 6 days later, that Monday or Tuesday morning she woke up and everything was gone and back to normal. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash macular, Rash pruritic
Clinical narrative: has an itchy rash on her legs; has lots of red dots on the bottom part of her legs that's really itchy; is going crazy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date  at a single dose for COVID-19 immunization.  The patient's medical history included kind of itchy before the first Pfizer COVID vaccine. Concomitant medications were not reported. On an unspecified date, the patient experienced an itchy rash on her legs. The patient received the Pfizer COVID  vaccine and was not sure if this issue was related with it, but had lots of red dots on the bottom part of her legs The patient reported she was going crazy and that it was really itchy. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 13:00 at a single dose for COVID-19 immunization at a Public Health Department. The patient's medical history and concomitant medications were not reported. The patient experienced insomnia on 10Jan2021 01:00 with outcome of not recovered. No treatment was given for the event. Patient is not pregnant. The patient was not diagnosed of COVID prior vaccination and has not tested for COVID post vaccination.  Information about Lot/Batch number is requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever; Chills; Total body aching; Nausea; Headache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 08Jan2021 (07:45) at single dose for Covid-19 immunization. Medical history included kidney reflux as child, gallbladder removal at 18, and known allergies: rubber allergies, lactose intolerant, and seasonal allergies. Concomitant medications included ascorbic acid (VITAMIN C) and Multivitamins (ritual women 2 a day). The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 (06:00 AM) via an unspecified route (left arm) 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 08Jan2021 (21:00), patient experienced chills, total body aching, nausea, headache, tiredness; and fever for about 24 hours starting about 18 hours after received the vaccine on 09Jan2021 (01:45). It was reported that it was hard to keep the fever down with just Tylenol, the patient needed to take ibuprofen. There was no treatment received for the other adverse event. The outcome of events was recovered with lasting effects (unspecified date). The patient has not been tested for COVID-19 since the vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Total body aching; Nausea; Headache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 08Jan2021 (07:45) at single dose for Covid-19 immunization. Medical history included kidney reflux as child, gallbladder removal at 18, and known allergies: rubber allergies, lactose intolerant, and seasonal allergies. Concomitant medications included ascorbic acid (VITAMIN C) and Multivitamins (ritual women 2 a day). The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 (06:00 AM) via an unspecified route (left arm) 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 08Jan2021 (21:00), patient experienced chills, total body aching, nausea, headache, tiredness; and fever for about 24 hours starting about 18 hours after received the vaccine on 09Jan2021 (01:45). It was reported that it was hard to keep the fever down with just Tylenol, the patient needed to take ibuprofen. There was no treatment received for the other adverse event. The outcome of events was recovered with lasting effects (unspecified date). The patient has not been tested for COVID-19 since the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Hyperacusis, Influenza like illness
Clinical narrative: Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some sensitivity to sound and light; having some sensitivity to sound and light; I'm suspecting this may be triggering a migraine; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL1283, expiry date not reported), via an unspecified route of administration on 09Jan2021 07:00 at a single dose on the left arm for COVID 19 immunization. Medical history included GERD (gastrooesophageal reflux disease), migraines, and indoor allergies. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. Concomitant medication included mometasone furoate (FLONASE), taken within two week prior to vaccination. The patient previously took codeine and was allergic to it; and flu vaccine and experienced intolerance and short term dizziness. Patient had first dose of Pfizer COVID 19 bnt162b2 as COVID 19 immunization on 19Dec2020 at 07:30 AM, intramuscularly on the left arm. No other vaccines were taken in the four weeks. Patient received second Pfizer dose on Saturday (09Jan2021) at approximately 7:00am. Consistent with prior history of dizziness following flu vaccines, patient started to develop mild dizziness and mild brain fog mid afternoon (reported as 09Jan2021 11:30). Flu-like symptoms and headache started around 8:00pm and resolved around 6:00pm on Sunday (the following day; 10Jan2021). Mild nausea also experienced Sunday morning (10Jan2021). Unfortunately, patient was still experiencing dizziness and brain fog that comes and goes and was worse midafternoon. Patient was having some sensitivity to sound and light, and suspecting this may be triggering a migraine since 09Jan2021 11:30. As treatment to the reported events patient received Aleve. The patient was not tested for COVID post vaccination. The patient recovered from flu-like symptoms and headache on 10Jan2021 18:00. The patient had not recovered from mild dizziness, mild brain fog, mild nausea, some sensitivity to sound and light and migraine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Photophobia
Clinical narrative: Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some sensitivity to sound and light; having some sensitivity to sound and light; I'm suspecting this may be triggering a migraine; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL1283, expiry date not reported), via an unspecified route of administration on 09Jan2021 07:00 at a single dose on the left arm for COVID 19 immunization. Medical history included GERD (gastrooesophageal reflux disease), migraines, and indoor allergies. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. Concomitant medication included mometasone furoate (FLONASE), taken within two week prior to vaccination. The patient previously took codeine and was allergic to it; and flu vaccine and experienced intolerance and short term dizziness. Patient had first dose of Pfizer COVID 19 bnt162b2 as COVID 19 immunization on 19Dec2020 at 07:30 AM, intramuscularly on the left arm. No other vaccines were taken in the four weeks. Patient received second Pfizer dose on Saturday (09Jan2021) at approximately 7:00am. Consistent with prior history of dizziness following flu vaccines, patient started to develop mild dizziness and mild brain fog mid afternoon (reported as 09Jan2021 11:30). Flu-like symptoms and headache started around 8:00pm and resolved around 6:00pm on Sunday (the following day; 10Jan2021). Mild nausea also experienced Sunday morning (10Jan2021). Unfortunately, patient was still experiencing dizziness and brain fog that comes and goes and was worse midafternoon. Patient was having some sensitivity to sound and light, and suspecting this may be triggering a migraine since 09Jan2021 11:30. As treatment to the reported events patient received Aleve. The patient was not tested for COVID post vaccination. The patient recovered from flu-like symptoms and headache on 10Jan2021 18:00. The patient had not recovered from mild dizziness, mild brain fog, mild nausea, some sensitivity to sound and light and migraine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Body temperature, Fatigue, Headache
Clinical narrative: strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdominal pain; general weakness; unquenchable thirst; very bad headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 10Jan2021 10:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he did not experience any symptoms yesterday (unspecified date) and a few hours ago, he started to experience severe arm pain, fever with of 102 [units unspecified], abdominal pain, general weakness, unquenchable thirst, very bad headache, tiredness and strong pulsating heartbeat. The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia, Thirst
Clinical narrative: strong pulsating heartbeat; severe arm pain; fever with temperature of 102 [units unspecified]; abdominal pain; general weakness; unquenchable thirst; very bad headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 10Jan2021 10:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he did not experience any symptoms yesterday (unspecified date) and a few hours ago, he started to experience severe arm pain, fever with of 102 [units unspecified], abdominal pain, general weakness, unquenchable thirst, very bad headache, tiredness and strong pulsating heartbeat. The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Panic attack, Paraesthesia, Sleep disorder
Clinical narrative: treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tingly; My arms were very numb and tingly; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown lot number), via an unspecified route of administration in left arm on 30Dec2020 at 09:30 at a single dose for COVID-19 immunization.  Medical history included prior history of panic attacks, HPV, and known allergies to pets and pollen.  Concomitant medications included naproxen sodium (ALEVE), cyclobenzaprine, and aspirin. The patient was vaccinated in a hospital on 30Dec2020 at 09:30. The early morning of 06Jan2021 at 03:15 AM, the patient woke up with very alarming symptoms.  She woke up very suddenly and was having difficulty getting thoughts together, her arms were very numb and tingly. She has had panic attacks before, and this did not feel like anything she had experienced. The events resulted in emergency room (ER)/department or urgent care visit. In ER, the patient treated as panic attack, no testing done. The patient was treated for the events. The patient did not have COVID prior to vaccination and the patient was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tingly; My arms were very numb and tingly; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown lot number), via an unspecified route of administration in left arm on 30Dec2020 at 09:30 at a single dose for COVID-19 immunization.  Medical history included prior history of panic attacks, HPV, and known allergies to pets and pollen.  Concomitant medications included naproxen sodium (ALEVE), cyclobenzaprine, and aspirin. The patient was vaccinated in a hospital on 30Dec2020 at 09:30. The early morning of 06Jan2021 at 03:15 AM, the patient woke up with very alarming symptoms.  She woke up very suddenly and was having difficulty getting thoughts together, her arms were very numb and tingly. She has had panic attacks before, and this did not feel like anything she had experienced. The events resulted in emergency room (ER)/department or urgent care visit. In ER, the patient treated as panic attack, no testing done. The patient was treated for the events. The patient did not have COVID prior to vaccination and the patient was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure diastolic, Blood pressure diastolic increased, Hypervigilance, Initial insomnia
Clinical narrative: Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's; feeling heart beat in chest; Minor anxious feeling; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no: EK9231, expiry date: unknown), via unspecified route of administration on left arm on 05Jan2021 08:15 at a single dose (1st dose) for Covid-19 immunization.  The patient received the vaccine in a hospital. There were no other vaccine administered in the last four weeks. The patient's medical history included penicillin allergies, seasonal asthma, and increased cholesterol. Concomitant medications included Fish oil, D3, Vitamin C, Bilberry, Chromium. On 05Jan2021 20:15, patient experienced increased level of alertness, difficulty falling asleep, increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's feeling heart beat in chest and minor anxious feeling. There was no treatment given for all reported adverse events. It was unknwon if patient had COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of all events was recovering.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Increased level of alertness; Difficulty falling asleep; Increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's; feeling heart beat in chest; Minor anxious feeling; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no: EK9231, expiry date: unknown), via unspecified route of administration on left arm on 05Jan2021 08:15 at a single dose (1st dose) for Covid-19 immunization.  The patient received the vaccine in a hospital. There were no other vaccine administered in the last four weeks. The patient's medical history included penicillin allergies, seasonal asthma, and increased cholesterol. Concomitant medications included Fish oil, D3, Vitamin C, Bilberry, Chromium. On 05Jan2021 20:15, patient experienced increased level of alertness, difficulty falling asleep, increased diastolic blood pressure(high 80's/low 90's) which is usually in 70's feeling heart beat in chest and minor anxious feeling. There was no treatment given for all reported adverse events. It was unknwon if patient had COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of all events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Headache, Muscle spasms
Clinical narrative: Headache; muscle cramps; chills; diarrhea; chest pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm on 10Jan2021 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included irritable bowel syndrome (IBS), endometriosis, chronic headaches, birth control, and sulfonamide allergy (reported as known allergy to Sulfa). The patient had no Covid prior vaccination. Concomitant medications included montelukast and unspecified medication for birth control. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1685) in the left arm on 20Dec2020 17:30 at a single dose for COVID-19 immunization. The patient was tested for Covid post vaccination of the first dose and had negative nasal swab on 01Jan2021. The patient did not receive any other vaccine in four weeks. The patient experienced headache, muscle cramps, chills, diarrhea, and chest pain on 11Jan2021. No treatment was received for the reported events. The outcome of the events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; muscle cramps; chills; diarrhea; chest pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL1284), via an unspecified route of administration in the left arm on 10Jan2021 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included irritable bowel syndrome (IBS), endometriosis, chronic headaches, birth control, and sulfonamide allergy (reported as known allergy to Sulfa). The patient had no Covid prior vaccination. Concomitant medications included montelukast and unspecified medication for birth control. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1685) in the left arm on 20Dec2020 17:30 at a single dose for COVID-19 immunization. The patient was tested for Covid post vaccination of the first dose and had negative nasal swab on 01Jan2021. The patient did not receive any other vaccine in four weeks. The patient experienced headache, muscle cramps, chills, diarrhea, and chest pain on 11Jan2021. No treatment was received for the reported events. The outcome of the events was not recovered.