chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: felt cold like; achy; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 16Feb2021 (lot number: EL9264, expiration date: 31May2021) (age at vaccination 75-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included shoulder surgery on an unknown date and physical therapy included cortisone shot. The patient concomitant medications were not reported as none. The patient had felt cold like and achy on 17Feb2021. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Emotional distress
Clinical narrative: Little bit distressed; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable female consumer (patient) reported that: 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration on 01Feb2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included lymphoma from an unknown date and unknown if ongoing. Consumer stated, I am in remission from lymphoma. Stage 2 lymphoma remission and I am finished with chemo. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient reported that she received her first Pfizer vaccine dose on 01Feb2021 and was scheduled to receive her second dose 3 weeks later on 22Feb2021. Patient reported that today she received a "surprise phone call" and was told that she was scheduled to receive her second dose today (16 days after her first) because there was no appointment on 22Feb. Patient reported that she is very concerned and scared. She reported that she tried to speak with a supervisor, but they wouldn't let her, she was provided a number for the company coordinating the vaccine clinic, but the number was not a working number. And asks, what is the efficacy if I get the vaccine today. Patient reported that she is calling because she wanted Pfizer's recommendation, and "Pfizer would be liable if something happens if I go and they recommended it. Patient was little bit distressed on an unspecified date. Patient was not performed any lab test in past 2 weeks. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date Lab work: I get blood work on a regular basis and everything was normal. No therapeutic measures were taken as a result of the event. The outcome of the event was reported as unknown.   No follow up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal stenosis
Clinical narrative: acute spinal stenosis; This is a spontaneous report from a contactable other hcp. An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 06Feb2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included prednisone acetate (PREDNISONE [PRED-NISONE ACETATE]) taken for an unspecified indication, start and stop date were not reported; cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute spinal stenosis on an unspecified date. Clinical course was reported as she has a question regarding the use of Prednisone with the COVID19 Vaccine. Her husband has been diagnosed with acute spinal stenosis. Before he was diagnosed with this, he was on Prednisone regimen. He also has gotten Cortisone injection in the hip too. He took the first dose of prednisone. He starts high and lowers it for 6 days. On the second day is when he got the COVID vaccine. her husband's first dose of Prednisone was on Friday and then on Saturday he got the vaccine. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of acute spinal stenosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable other-HCP (patient himself). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9263, Age at Vaccination: 67 years), via an unspecified route of administration, administered in Arm Left on 01Feb2021 12:00 as dose 1, single for COVID-19 immunisation at Hospital. The patient medical history was not reported. Other medications were taken in two weeks. No other vaccine in four weeks. It was reported that, he was not tested with COVID post vaccination and if diagnosed with COVID prior vaccination was unknown. He had no known allergies. On 11Feb2021 08:00, the patient experienced he had a runny nose. It wasn't heavy, but still a runny nose. Friday, he woke up and the runny nose was gone, but he had chest congestion. It was like 3/10. Sunday it seemed weird the chest congestion and it lasted till Monday. The first symptoms popped up 10 days after first shot. He was calling to ask if he is ok to get the shot as planned next Friday given his symptoms? The seriousness of the events was non-serious. No therapeutic measures were taken for the events. The outcome of the events runny nose and chest congestion was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: her cold is much worse; runny nose/ nose is running; headache/her head started to hurt; her cold is much worse; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included cold from 16Feb2021 to an unknown date. Caller reported that her and her husband received first dose of vaccine yesterday. patient would like to know if it is okay for her to take Tylenol or acetaminophen. She was coming down with a cold and has had a runny nose, and headache since AM. She was taking OTC Claritin because she thought it was allergies and enquired if she can take any medication over the counter since she had a cold. It started actually yesterday she started to feel like she had a cold but she didn't feel that bad so she thought she should be able to get the vaccine still, but today her cold is much worse. After vaccine she had been coming down with a cold and her nose is running and now she has a headache and she wanted to know can she take any over the counter meds for a headache. She has just been blowing her nose so much she has a headache she wonders if there is any reason not to take Acetaminophen. It was just a head ache from blowing her nose so much from a cold, her head started to hurt. She had a headache that started today and was ongoing at this time but is about about the same as when it started. She was basically healthy. She doesn't take medications only vitamins. Therapeutic measures were taken as a result of her cold is much worse, runny nose/ nose is running. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Eye pain, Feeling abnormal, Gait disturbance, Illness
Clinical narrative: she couldn't walk because she ached all over; she couldn't walk because she ached all over; Her neck hurt; Her eyes hurt; She couldn't stand up; She thought she was dying; She got sick; She felt rubbery; This is a spontaneous report from a contactable consumer(patient). An unspecified age female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Feb2021 at 09:00 as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Feb2021, the patient felt rubbery. On 16Feb2021, the patient experienced couldn't walk because she ached all over, Her neck hurt, Her eyes hurt, couldn't stand up, thought she was dying, got sick. It was reported that Caller received her 2nd dose of the Pfizer covid vaccine on Monday at 9:00 AM. She got sick and was aching all over. Her eyes and neck hurt to the point that she could not walk or stand up. Caller states her grandson had to help her get to bed. She 'felt rubbery'. She went to (hospital name_ and got her second shot. The next day she couldn't walk because she ached all over. Her neck hurt. Her eyes hurt. She couldn't stand up. She thought she was dying.  What can she do to straighten it out? She had no trouble with the first shot. Caller clarified shot as COVID19 Vaccine. She called her family doctor and the doctor said she needed to call #. Caller dialed # and the gal that she talked to said that she need to call #. Caller states she doesn't want to go to the hospital. Is there anything she can get to take? Her doctor said she wouldn't touch it.  She wants to talk to someone. She feels a little better today. Will it take a while to get out of her? Caller declined to do a report. She got the second shot on Monday, 15Feb2021, in the morning at 9AM. Tuesday was when she got sick. She ached all over. Description of complaint: She got her second shot. The next day she couldn't walk because she ached all over. Her neck hurt. Her eyes hurt. She couldn't stand up. She thought she was dying. She had no trouble with the first shot. Caller clarified shot as COVID19 Vaccine. Her doctor said she wouldn't touch it. Will it take a while to get out of her? Caller declined to do a report. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Thanatophobia
Clinical narrative: she couldn't walk because she ached all over; she couldn't walk because she ached all over; Her neck hurt; Her eyes hurt; She couldn't stand up; She thought she was dying; She got sick; She felt rubbery; This is a spontaneous report from a contactable consumer(patient). An unspecified age female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Feb2021 at 09:00 as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Feb2021, the patient felt rubbery. On 16Feb2021, the patient experienced couldn't walk because she ached all over, Her neck hurt, Her eyes hurt, couldn't stand up, thought she was dying, got sick. It was reported that Caller received her 2nd dose of the Pfizer covid vaccine on Monday at 9:00 AM. She got sick and was aching all over. Her eyes and neck hurt to the point that she could not walk or stand up. Caller states her grandson had to help her get to bed. She 'felt rubbery'. She went to (hospital name_ and got her second shot. The next day she couldn't walk because she ached all over. Her neck hurt. Her eyes hurt. She couldn't stand up. She thought she was dying.  What can she do to straighten it out? She had no trouble with the first shot. Caller clarified shot as COVID19 Vaccine. She called her family doctor and the doctor said she needed to call #. Caller dialed # and the gal that she talked to said that she need to call #. Caller states she doesn't want to go to the hospital. Is there anything she can get to take? Her doctor said she wouldn't touch it.  She wants to talk to someone. She feels a little better today. Will it take a while to get out of her? Caller declined to do a report. She got the second shot on Monday, 15Feb2021, in the morning at 9AM. Tuesday was when she got sick. She ached all over. Description of complaint: She got her second shot. The next day she couldn't walk because she ached all over. Her neck hurt. Her eyes hurt. She couldn't stand up. She thought she was dying. She had no trouble with the first shot. Caller clarified shot as COVID19 Vaccine. Her doctor said she wouldn't touch it. Will it take a while to get out of her? Caller declined to do a report. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Migraine, Tinnitus
Clinical narrative: Ringing in ears worsened; Migraine Worsened; This is a spontaneous report from a contactable consumer or other non-healthcare profession (patient reported for herself). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 13:35 (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing, tinnitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, spinal fusion surgery from Oct2020 to an unknown date. Investigation Assessment was reported as yes. There were no concomitant medications. On 12Feb2021, the patient experienced ringing in ears worsened, migraine worsened. Can the COVID vaccine make tinnitus worse and how long will the symptoms last. Caller reported that she received her first dose of the covid vaccine on Thursday, on 11Feb2021 and then started to experience worsening ringing in her ears and a migraine. She asked if this was normal and if the vaccine can make tinnitus worse and how long the symptoms will last. Caller was a consumer, asking, are the first and second dose the same and do you have to get the second vaccine for it to work. She was calling about the Covid Vaccine, she was having really bad ringing in the ears and migraines, she noticed it got worse after she got the vaccine. She got the first dose on 11Feb2021 Thursday and noticed that it was worse since she got the vaccine. Caller clarifies that her First dose was on 11Feb2021 Thursday and she got the vaccine at like 1:35PM, she explains that she has always had ringing in the ears, but it got worse on Friday 12Feb2021. She also explains that she has always had migraines, however that also worsened along the same time. Caller stated that the ringing was really loud right now. Caller stated that the Expiry was not written on her card, but when she had a conversation with the nurse, she thinks she said it was good for 6 months. The hearing test was maybe in Sep2020 or around that, she was recently fitted with a hearing aid. Caller apologizes for speaking over this call handler, stating that if she does not continue to talk, she loses her train of thought. The patient underwent lab tests and procedures which included acoustic stimulation tests: fitted with a hearing aid on an unspecified date in Sep2020. No product quality complaint was reported. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to device use error, Fatigue
Clinical narrative: she noticed the lot number  written on the immunization card is the same for the first and second dose.; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-years-old female patient received Pfizer-Biontech Covid-19 Vaccine, dose 2 (Lot Number: EL1283 expiry date was unknown) via an unspecified route of administration at arm right on 16Feb2021 (at the age of 81-years-old) as a single dose for covid-19 immunisation. Medical history included chemotherapy from an unknown date and unknown if ongoing. Januvia [sitagliptin phosphate] for diabetes mellitus. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Time the Vaccination Was Given: Not provided. Historical vaccine COVID-19 Vaccine, (Lot Number: EL1283, Expiry Date: Unknown) via intramuscular route of administration arm left of date on 25Jan2021 as a single dose for Covid-19 immunisation. Reported she received her second COVID-19 Vaccine shot yesterday (16Feb2021). She said there was something that concerned her. She said the COVID-19 Vaccine immunization card that was given to her listed the same exact Pfizer Lot Number for her first and second COVID-19 Vaccine shot (circumstance or information capable of leading to device use error). She said it struck her funny that she would have the same exact Pfizer COVID-19 Vaccine Lot Number administered to her 3 weeks apart. She said she didn't know if there was anything she should be concerned about. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported the only reaction she had, if it was even a reaction, was that she found herself to be very tired yesterday after receiving her second COVID-19 Vaccine shot. She said she just went to bed. Treatment: Reported she just went to bed. Patient Weight: unfortunately, 200 lbs., as provided by the reporter. Reported she was on chemotherapy in the past and has been on diabetes medicine for a while. She said about 6 months ago her doctor put her on Janu via because she went from being borderline diabetic to over the line. She said her doctor said if she loses weight, she may not need to take any medication. No further details provided. Outcome of the events was not recovered.    No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids
Clinical narrative: he developed a bad hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, The patient on developed a bad haemorrhoid. Reportedly, the patient received his first dose of the Pfizer COVID vaccine three weeks ago from the time of reporting. The patient was scheduled to receive his second dose. The patient developed a bad haemorrhoid and his physician prescribed hydrocortisone topical cream. The patient states that he read somewhere that oral cortisone may have an effect on the efficacy of the vaccine. The patient would like to know whether topical hydrocortisone will have an effect on the efficacy of the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Somnolence
Clinical narrative: she said she has been really sick; I am so sleepy, I sleep all the time; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced she said she has been really sick; I am so sleepy, I sleep all the time. Patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 09Feb2021. Since then, she said she has been really sick. Patient wants to know what would happen if she does not receive the 2nd dose, and if the vaccine would still be effective if she only receives 1 dose. Patient stated, May I ask you a question if I have. Patient got the vaccine on the 9th on February (not clarified) and I have been really sick since then. Patient was wondering what happens if I don't get the second shot. Patient stated, If I don't fall asleep, I am so sleepy, I sleep all the time. LOT: Patient stated, I don't know. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: vertigo; headache; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261, Expiry date: unknown, at the age of 66 years old), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 09:30 as dose 1, single for covid-19 immunization. Medical history included peripheral neuropathy, hypertension and high blood cholesterol. Concomitant medication(s) included hydrochlorothiazide, losartan potassium, gabapentin, and simvastatin. The patient previously took neosporin topical and experienced drug hypersensitivity and reported allergy to adhesives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Gabapentin300; Losartan-HCTZ100-25; Simvastatin10 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced exactly 7 days after the vaccination, woke up with vertigo/headache on 13Feb2021 07:00 which lasted 24 hrs. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Advil or Tylenol or any pain types of medications might affect its effectiveness; I was going down the sore arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; meloxicam (MELOXICAM), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK UNK, as needed (took one dose on Tuesday and one dose on Wednesday morning) for back pain. Medical history included thyroid, ongoing osteoarthritis (Caller mentioned that she has osteoarthritis in which she usually takes a cortisone shot in her spine to alleviate symptoms), back issues. Concomitant medication(s) included atorvastatin and thyroid medications (unspecified). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as dose 1, single for covid-19 immunisation. Caller mentioned that she got the 2nd dose of the vaccine yesterday (unspecified date). She had been looking at news websites and tv and they say that one should not take Tylenol or Ibuprofen or any pain types of medications before getting the vaccine because it might affect its effectiveness. Caller mentioned that she has osteoarthritis in which she usually takes a cortisone shot in her spine to alleviate symptoms. She was told by her doctor to hold off on the Cortisone for 2 weeks after receiving the 2nd shot in order to not affect her immune system. She was prescribed Meloxicam in order to address her back pain. She mentioned that she took one dose on Tuesday and one dose on Wednesday morning because of back pain before receiving the shot yesterday. She was asking if that will affect the vaccine and if that should affect her response, how will she determine that the vaccine was effective for her. She further stated that she has back issues and she does not take these drugs every single day, only when it really gets bad. Yesterday and this morning, she took one dose each day of Meloxicam. She stated she did not take it just to anticipate that she was going down the sore arm. She took it basically because she had a back issue. And the reason she took it (Meloxicam) because it was not hard on her stomach as taking Advil. Seriousness of the events was reported as non-serious. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenitis, Malaise, Myalgia
Clinical narrative: malaise; About 24 hours p second dose- left axilla became tender and swollen.; Body aches started 9hrs after second dose; muscle aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 19Jan2021 at 09:00 AM (age at vaccination was 43-years-old) as dose 2, single for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included reflux and paroxysmal a fib; both from an unknown date and unknown if ongoing. Known allergy to some adhesives. The patient's concomitant medications were not reported. No other vaccines administered within four weeks. No other medications the patient received within 2 weeks of vaccination. The patient previously took bnt162b2 (Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 at 12:00 PM as dose 1, single for covid-19 immunisation; zithromax and factive, both for an unspecified indication and experienced allergies. On 19Jan2021 at 06:00 PM, 9 hours after second dose, the patient experienced body aches. On the same day, within 12 hours, she had chills, rigors, fatigue and aches which later resolved within 36 hours on an unspecified date in 2021. On 20Jan2021, about 24 hours after second dose, the patient's left axilla became tender and swollen. Since the second injection, she had continued epiodes of fatigue, muscle aches, and chills. They tend to be cyclic and occur after any physical exertion. The cycle of fatigue and malaise last 4-5 days after exertion then slowly wane. This has been happening for the last 4 weeks. The events resulted in visit to doctor or other healthcare professional office/clinic visit. On 17Feb2021, the patient underwent rapid PCR covid test post vaccination with covid test type nasal swab: negative. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Therapeutic measures were taken as a result of the events. Treatment included Prednisone 20 mg orally twice daily for five days starting from 10Feb2021. The outcome of the events body ache was unknown; events chills, rigors, fatigue, aches was recovered on an unspecified date in 2021; and other events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: malaise; About 24 hours p second dose- left axilla became tender and swollen.; Body aches started 9hrs after second dose; muscle aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 19Jan2021 at 09:00 AM (age at vaccination was 43-years-old) as dose 2, single for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included reflux and paroxysmal a fib; both from an unknown date and unknown if ongoing. Known allergy to some adhesives. The patient's concomitant medications were not reported. No other vaccines administered within four weeks. No other medications the patient received within 2 weeks of vaccination. The patient previously took bnt162b2 (Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 at 12:00 PM as dose 1, single for covid-19 immunisation; zithromax and factive, both for an unspecified indication and experienced allergies. On 19Jan2021 at 06:00 PM, 9 hours after second dose, the patient experienced body aches. On the same day, within 12 hours, she had chills, rigors, fatigue and aches which later resolved within 36 hours on an unspecified date in 2021. On 20Jan2021, about 24 hours after second dose, the patient's left axilla became tender and swollen. Since the second injection, she had continued epiodes of fatigue, muscle aches, and chills. They tend to be cyclic and occur after any physical exertion. The cycle of fatigue and malaise last 4-5 days after exertion then slowly wane. This has been happening for the last 4 weeks. The events resulted in visit to doctor or other healthcare professional office/clinic visit. On 17Feb2021, the patient underwent rapid PCR covid test post vaccination with covid test type nasal swab: negative. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Therapeutic measures were taken as a result of the events. Treatment included Prednisone 20 mg orally twice daily for five days starting from 10Feb2021. The outcome of the events body ache was unknown; events chills, rigors, fatigue, aches was recovered on an unspecified date in 2021; and other events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after injection; This is a spontaneous report from a non-contactable consumer or other non health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm after injection on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on the left side of the neck. (Left shoulder injection site); This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (non- pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201) via an unspecified route of administration on 13Feb2021 (at the age of 30-year-old) as dose number unknown, single for COVID-19 immunisation at hospital. Medical history included known allergies to penicillin. No covid prior vaccination. Not tested for covid post vaccination. Concomitant medications were not reported. In Feb2021, the patient experienced swollen lymph node on the left side of the neck (Left shoulder injection site). The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anxiety just after the day of receiving the second dose of covid-19 vaccination. The patient believed the anxiety was due to vaccine as she never suffered from anxiety before the vaccine. It was unknown if therapeutic measures were taken for the events. It was unknown if patient received any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. It was unknown if patient tested positive for covid-19 prior to vaccination and unknown if tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: all over body aches; headache; generally feeling unwell; all over body aches; headache; generally feeling unwell; all over body aches; headache; generally feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 35-years-old (non-pregnant) female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 16Feb2021 13:30 as DOSE 2, SINGLE for covid-19 immunization (age at vaccination 35 years). The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL 3247), via an unspecified route of administration, administered in Arm Right on 26Jan2021 14:00 as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced all over body aches, headache and generally feeling unwell on 17Feb2021 11:00. Patient did not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: Body is feeling chilly; transient headaches; This is a spontaneous report from a contactable consumer (Patient). A 24-years-old non-pregnant-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9267) via an unspecified route of administration in left arm on 17Feb2021 at 17:30 (at the age of 24-years-old) as dose 2, single for COVID-19 immunization. Medical history included eating disorder and known allergies included Asparagus. Patient received multivitamins in two weeks. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within four weeks. Patient did not have covid prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 24Jan2021 at 15:30 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. The patient experienced body was feeling chilly, transient headaches on Feb2021. Still had been going on 5 days after patient received the vaccine, which was why patient a little bit worried right now. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 18Feb2021. Patient did not receive any treatment for the events. Outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: red in area in the injection site; arm has been noticeably swollen; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the second dose of the covid vaccine and since then, the wife had been having red in area in the injection site that resolved yesterday of about 6x4 inches and her arm had been noticeably swollen. He said that they have a little card but lost it about what to do in cases like this and so they called to know what they should be doing. The outcome of the event red in area in the injection site was resolved on unspecified date and her arm had been noticeably swollen was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache
Clinical narrative: Severe headache; Elevated temperature 100.0; This is a spontaneous case from a Patient. A 69-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration, administered in Arm Left on 17Feb2021 15:00 (at the age of 69-years-old) as dose number unknown, single for covid-19 immunisation. The patient Medical history included type 2 diabetes mellitus, hypertension, asthma, and Drug hypersensitivity. Concomitant medications included Metformin, Lisinopril, VITAMIN B12, and Multivitamin all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Feb2021, 02:00 the patient experienced severe headache and elevated temperature 100.0. No treatment was received in response to the adverse events. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extremely sore arm at the site of injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 46-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3247, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 10:15 AM (at a age of 46-year-old)  as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EL3247, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 28Jan2021 as dose 1 single, for COVID-19 immunisation. patient medical history and concomitant medications were not reported. The patient had no known allergies. Patient was not positive for COVID-19 prior to vaccination and not tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks prior to the COVID vaccine. On 19Feb2021 at 07:00 AM the patient experienced extremely sore arm at the site of injection. The patient did not receive any treatment for adverse events. The outcome of the event was not recovered.   Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Horrible neck pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 70- years-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 01Feb2021 at 10:45 (age at the time of vaccination was 69 years) as dose number unknown, single for covid-19 immunisation. Medical history included lupus from an unknown date and unknown if ongoing and known allergies were reported as no. Concomitant medications included azathioprine sodium (IMURAN) taken, isosorbide mononitrate (IMDUR), hydroxychloroquine sulfate (PLAQUENIL), levothyroxine sodium and estradiol all taken for an unspecified indication, start and stop date were not reported. The patient did not have covid prior vaccination. On 15Feb2021, the patient experienced horrible neck pain. Therapeutic measures were taken as a result of horrible neck pain which included treatment with Pain meds. The patient was not covid tested post vaccination. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Sinus disorder
Clinical narrative: sinus problem; migraine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 27Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included laxatives. On an unspecified date, the patient experienced sinus problem and migraine. Caller stated that the patient had received the first dose of the bnt162b2 vaccine on 27Jan2021. The second dose was re-scheduled for tomorrow (day after reporting). Caller had some unresolved underlying conditions. Caller was having some digestive issues since last Sunday. It was not accompanied by fever. She was feeling better on the day of reporting. She believed this was the effect of the candy she ate. She also took some laxatives which lead to her having diarrhea. She mentioned she hadn't had diarrhea for years. She had a sinus problem and a migraine post vaccination. Caller wanted to know if she was eligible to receive the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Tired; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 at 14:15(at the age of 59-year-old) as dose number unknown,single for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included insulin detemir (LEVEMIR), insulin aspart (NOVOLOG) taken for an unspecified indication. Patient had no known allergies. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination. On 19Feb2021 at 10:00 the patient experienced headache, chills, tired. Reporter stated that the events was not severe but has continued to escalate as day is going on. Patient not received treatment for the events. Since the vaccination the Patient had not been diagnosed with COVID-19. Outcome of the events was unknown.  Information about lot/Batch number has been requested.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: minor muscle/arm soreness; minor muscle/arm soreness; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 10Feb2021, the patient experienced minor muscle/arm soreness (pain in extremity, myalgia). Additional information included, patient reported that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 09Feb2021. She had minor muscle/arm soreness the day after the first dose. Her second dose is scheduled 3 weeks after first dose on 02Mar2021. She was supposed to have surgery (mastectomy due to breast cancer diagnosis; this diagnosis was prior to receipt of vaccine) this past week but due to weather in her area, it got pushed back to 03Mar2021. Her surgeon has recommended that no vaccination within a week of surgery so she is trying to determine which one to push back, either the second dose or the surgery. She planned to discuss this further with her physician. Consumer asked if there are any allowable deviations for timing of second dose. Is it effective if given later than the 3 weeks. She disconnected so no further contact information or details could be collected. Outcome of the events was unknown.  No Follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.