chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia
Clinical narrative: fever; his body is cold; This is a spontaneous report from a contactable consumer (patient himself). A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry date: not reported), via an unspecified route of administration on 08May2021 (48-year-old at vaccination) as Dose 2, Single for COVID-19 immunization. There was no relevant medical history reported. The patient's concomitant medication included paracetamol (TYLENOL) (patient had taken it for fever).The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0164, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient experienced fever on 10May2021 and was ongoing at time of report and he though this may go away tomorrow. On an unspecified date in 2021 his body was cold. The reporter wanted to know if the fever experienced was normal or associated with vaccine. The patient confirmed he took Tylenol today for the fever as he was experiencing after the vaccine. No investigation assessment was reported. The outcome of the event fever was not recovered and unknown for other event.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Pain, Pain in extremity
Clinical narrative: Sudden leg pain below tailbone; Joints really hurt; Pain around 17:30; Was sick day after vaccination, then ok most of day; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04May2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 05May2021, the patient was sick day after vaccination, then ok most of day. On 06May2021 at 17:30, the patient experienced sudden leg pain below tailbone, joints really hurt and had pain. The clinical outcome of the events sudden leg pain below tailbone, joints really hurt and was sick day after vaccination, then ok most of day and pain around 17:30 was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Pruritus, Rash
Clinical narrative: rash; itching; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, and Expiration date: 06May2021), via an unspecified route of administration, administered in left arm on 06May2021 (after 09:00, in the morning because she went in early) at the age of 67-year-old as dose 2, single for COVID-19 immunization. The patient medical history included ongoing type 2 diabetes, ongoing high blood pressure, and rheumatoid arthritis from 2008 and ongoing. The patient stated that it had been years, she could not remember when she was diagnosed with type 2 diabetes and high blood pressure. The patient had no family medical history relevant to adverse events. Concomitant medication included METHOTREXATE SODIUM taken for rheumatoid arthritis (took it last Friday and she had not taken her dosage, her doctor told her to not take it after, to wait a week). No additional vaccines administered on same date of the Pfizer suspect. No additional investigation assessment. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EWD or 0, EW0169, and Expiration date: 03Aug2021), via an unspecified route of administration, administered in left arm on 15Apr2021 (after 12:00 PM) (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient stated, she had a rash. She got the vaccination on Thursday (06May2021), the rash came last night on 09May2021. The patient stated the rash was still there, it was a little better on 09May2021, the patient additionally experienced itching. The patient reported, it was not itching as it was last night. The patient underwent lab tests and procedures which included mammogram and result was unknown on an unspecified date in Mar2021 unknown. The patient verified she received the Pfizer COVID vaccine. The patient stated she took Pfizer COVID vaccine so she would not get COVID because she had underlying conditions. The events were not resulted in emergency room or physician office visit. The patient wanted to know that should she visit the emergency room. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Body aches; This is a spontaneous report from a contactable consumer (patient). Via medical information team reported that:  A 52 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 28Mar2021 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that not related to a study or programme. No other Products, investigation Assessment, emergency Room and Physician office. On an unspecified date, the patient experienced flu like symptoms, fever, body aches. The outcome of the events was recovered.  Follow up#1(PRD10May2021): This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that:  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on an unknown date (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever, chills, body aches, headache and fatigue. The clinical outcome of the events fever, chills, body aches, headache and fatigue were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: rashes; headache; dizziness/lightheadedness; chills; muscle ache; joint ache; diarrhea; unexplained tiredness/worsened; fell asleep; feel miserable; unexplained migraines; itching terrible rash on his arms; This is a spontaneous report from a contactable consumer, the patient.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0182), via an unspecified route of administration, administered in arm right on 06May2021 09:30 as dose 2, single (at the age of 63-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 1, single for covid-19 immunization. The patient got the second injection on 06May2021 and that night he started having unexplained migraines and then itching terrible rash on his arms. The patient experienced unexplained tiredness, dizziness/lightheadedness, chills, muscle aches, joint aches and diarrhea. Patient's tiredness was so bad for 3 or 4 days where he almost fell asleep on the freeway several times. The patient did not understand what was going on and he was tried to wrap his brain around what could cause this because it was completely abnormal for him. The patient normally could drive 3 or 4 hours on 6 hours of sleep and back without a problem, but his tiredness was so bad he had been drunk 4 double shot espresso just to try to get back. The patient had 8 hours of sleep last night and he had a headache and was so tired like he was a grandma. The patient could not explain what was going on, but he put an anti-topical itching cream on and for his headaches he did not take anything for that well might be a couple of ibuprofen but that did not work. The patient stated in the morning it started off slow but by the end of day he wants get out of his body. The patient stated it was so frustrated and he tried to rule out everything that could have changed in his situation and then it came down to this vaccine. The patient stated he was tried to resist the itching, but his arm itched so much that he drew blood. The patient stated that there were sporadic intensities. The patient felt miserable. The patient did not visit emergency room and physician office. The patient stated he was prediabetic and monitors his blood sugar very closely though. The outcome of the events dizziness, chills, myalgia, arthralgia, diarrhoea, somnolence, feeling abnormal, migraine and rash pruritic was unknown while outcome of other events was not recovered.  Information on Lot/Batch number was available. No further information was expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Migraine, Myalgia, Rash
Clinical narrative: rashes; headache; dizziness/lightheadedness; chills; muscle ache; joint ache; diarrhea; unexplained tiredness/worsened; fell asleep; feel miserable; unexplained migraines; itching terrible rash on his arms; This is a spontaneous report from a contactable consumer, the patient.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0182), via an unspecified route of administration, administered in arm right on 06May2021 09:30 as dose 2, single (at the age of 63-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 1, single for covid-19 immunization. The patient got the second injection on 06May2021 and that night he started having unexplained migraines and then itching terrible rash on his arms. The patient experienced unexplained tiredness, dizziness/lightheadedness, chills, muscle aches, joint aches and diarrhea. Patient's tiredness was so bad for 3 or 4 days where he almost fell asleep on the freeway several times. The patient did not understand what was going on and he was tried to wrap his brain around what could cause this because it was completely abnormal for him. The patient normally could drive 3 or 4 hours on 6 hours of sleep and back without a problem, but his tiredness was so bad he had been drunk 4 double shot espresso just to try to get back. The patient had 8 hours of sleep last night and he had a headache and was so tired like he was a grandma. The patient could not explain what was going on, but he put an anti-topical itching cream on and for his headaches he did not take anything for that well might be a couple of ibuprofen but that did not work. The patient stated in the morning it started off slow but by the end of day he wants get out of his body. The patient stated it was so frustrated and he tried to rule out everything that could have changed in his situation and then it came down to this vaccine. The patient stated he was tried to resist the itching, but his arm itched so much that he drew blood. The patient stated that there were sporadic intensities. The patient felt miserable. The patient did not visit emergency room and physician office. The patient stated he was prediabetic and monitors his blood sugar very closely though. The outcome of the events dizziness, chills, myalgia, arthralgia, diarrhoea, somnolence, feeling abnormal, migraine and rash pruritic was unknown while outcome of other events was not recovered.  Information on Lot/Batch number was available. No further information was expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Somnolence
Clinical narrative: rashes; headache; dizziness/lightheadedness; chills; muscle ache; joint ache; diarrhea; unexplained tiredness/worsened; fell asleep; feel miserable; unexplained migraines; itching terrible rash on his arms; This is a spontaneous report from a contactable consumer, the patient.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0182), via an unspecified route of administration, administered in arm right on 06May2021 09:30 as dose 2, single (at the age of 63-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 as dose 1, single for covid-19 immunization. The patient got the second injection on 06May2021 and that night he started having unexplained migraines and then itching terrible rash on his arms. The patient experienced unexplained tiredness, dizziness/lightheadedness, chills, muscle aches, joint aches and diarrhea. Patient's tiredness was so bad for 3 or 4 days where he almost fell asleep on the freeway several times. The patient did not understand what was going on and he was tried to wrap his brain around what could cause this because it was completely abnormal for him. The patient normally could drive 3 or 4 hours on 6 hours of sleep and back without a problem, but his tiredness was so bad he had been drunk 4 double shot espresso just to try to get back. The patient had 8 hours of sleep last night and he had a headache and was so tired like he was a grandma. The patient could not explain what was going on, but he put an anti-topical itching cream on and for his headaches he did not take anything for that well might be a couple of ibuprofen but that did not work. The patient stated in the morning it started off slow but by the end of day he wants get out of his body. The patient stated it was so frustrated and he tried to rule out everything that could have changed in his situation and then it came down to this vaccine. The patient stated he was tried to resist the itching, but his arm itched so much that he drew blood. The patient stated that there were sporadic intensities. The patient felt miserable. The patient did not visit emergency room and physician office. The patient stated he was prediabetic and monitors his blood sugar very closely though. The outcome of the events dizziness, chills, myalgia, arthralgia, diarrhoea, somnolence, feeling abnormal, migraine and rash pruritic was unknown while outcome of other events was not recovered.  Information on Lot/Batch number was available. No further information was expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; Pressure in the head; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E200173) via an unspecified route of administration in the left arm on 01May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 04May2021 at 06:30, the patient experienced vertigo and pressure in the head. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 04May2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events vertigo and pressure in the head were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin disorder, Swelling
Clinical narrative: swelling of the lymph nodes; right armpit swelling, though, that was spreading out; her skin under her right armpit is "falling out" from under her right arm like a fat woman's; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0175, NDC number/Expiry Date: Unknown), via an unspecified route of administration, administered in right arm on 06May2021 17:00 at the of 53 years old as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included had Covid-19 from 2020 to 2020 (Had COVID-19 infection back in October-November). The patient asked if she needed to get the second COVID-19 Vaccine dose since she had the COVID-19 Virus in 2020. Family Medical History Relevant to AE(s) not provided. Concomitant medications were not reported. The patient did not receive any other vaccines on same Date of the Pfizer Suspect. The patient did not receive any other vaccine in 4 weeks prior to Vaccinations. On 07May2021 the patient experienced swelling of the lymph nodes, right armpit swelling, though, that was spreading out, and her skin under her right armpit was falling out from under her right arm like a fat woman. It was reported that, the patient stated she had swelling of her lymph nodes. The patient stated she had the COVID-19 virus in Oct2020 or Nov2020. The transferring agent stated the patient asked if she needed to get the second COVID-19 Vaccine dose since she had the COVID-19 Virus in 2020. The transferring agent stated she shared some information about the COVID-19 Vaccine with the caller. Reviewed and clarified the transferring agent's report details with the caller. Clarified she had swelling in her right armpit lymph nodes that she noticed on Friday morning (07May2021). For treatment reported she was taking Ibuprofen and icing her right armpit. She said she was taking 3-200mg Ibuprofen tablets since her right armpit lymph node swelling started. She said she didn't take any Ibuprofen today, though. She said she was at work, and did not have the Ibuprofen 200mg tablet NDC, Lot, and Expiration Date. Reported the swelling in her armpit right lymph nodes improved. She said she now had right armpit swelling, though, that was spreading out. She said her right armpit swelling did not look pleasant. She said her skin under her right armpit is falling out from under her right arm like a fat woman's. She said the difference in size between her right armpit and her left armpit was obvious. The adverse events did not result in Emergency Room nor Physician Office visit. She only called Pfizer to see if she should not take the second COVID-19 Vaccine. The patient did not undergo any relevant test. The patient received treatment for the adverse events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Fatigue, Productive cough, Respiratory tract congestion
Clinical narrative: had a severe amount of cough but I have had some amount of phlegm; chest area starting to feel bit more congested ; I could feel that there is abnormal sensation that has been there and it's kind of lingering; chest area starting to feel bit more congested ; I could feel that there is abnormal sensation that has been there and it's kind of lingering; little tired; my voice started to change/hoarseness in my voice; This is a spontaneous report from a contactable consumer reported for himself that. A 38-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182) via an unspecified route of administration on 05May2021 (Age at Vaccination 38-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 07May2021 the patient experienced my voice started to change, chest area starting to feel bit more congested, I could feel that there is abnormal sensation that has been there, and it's kind of lingering and little tired. On unspecified date had a severe amount of cough but I have had some amount of phlegm. It was reported that Consumer stated, Okay, so this was interesting, and I had a feeling that this was normal. So, I got my first Covid shot and then the second Covid shot. The second Covid Pfizer vaccine I got it on Wednesday evening. I didn't see anything abnormal on Thursday but Friday morning onwards like my voice started to change and I have it, like had a severe amount of cough, but I have had some amount of phlegm and slowly but surely I did feel that my chest area is starting to feel little bit more congested but it's not like severe as in severe difficulty breathing but I could feel that there is abnormal sensation that has been there and it's kind of lingering and I have been a little tired. Consumer stated, I spoke to other person a bit ago, I got my 2nd Vaccine shot this Wednesday the 5th in the evening and the 1st day was fine ever since Friday morning, I have had symptoms of like my voice has changed, I have had a hoarseness in my voice like it was perfectly fine on Thursday and I have had some I wouldn't call it severe breathing difficulty but I had like some I would say some slight heaviness on my chest area, It's kind a like something was there. I have been more tired for the last Friday for sure. So, I thought like, I'm not sure about but my wife had the same vaccine the same day, she's fine. So, I wanted to check with you, if you've heard of this thing or what was that you suggest at this point. When probed for treatment, consumer stated, I just took Advil primarily. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: when he urinated there was pure red/ bleeding in the urine; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration in left arm on 20Mar2021 (between 9 and 10 in the morning) (at the age of 81-years-old) as dose 1, single for COVID-19 immunization. Medical history Crohn's colitis since an unknown date diagnosed around 20 years ago, or 25 years ago patient added that it all happened when he quit smoking, lung cancer non small cell, on an unknown date in Jun2018, diabetes. Concomitant medication included insulin LANTUS 10-16 units a night for brittle diabetic type 1, insulin aspart NOVOLOG (has been on since 1994 or 1995), MESALAMINE (has been on for 15 years, 4 pills a day. He takes it for Crohns), patient takes other medications, and just vitamins. Patient also had the other vaccine (unspecified) for shingles but that was a couple years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not have any AEs. On an unknown date, the patient experienced bleeding in the urine. He mentioned that it first occurred 24 hours after his 1st dose. He mentioned that it looked like pure blood/ pure red. It lasted for an hour or hour and a half in the morning. Patient added it was not light red, it was dark red. It was about the same color when he cut his hand the last time. He mentioned that he was going in for more testing with his doctors. He was asking if there have been reports of this event associated with the vaccine. Patient confirmed that the pure red stopped after that, and then came back after the second vaccine. Patient had an MRI the other day and they said his urinary tract was normal, they found nothing. He does not know if it has anything to do with the Pfizer vaccine or not. He searched and can not find anything. The adverse event resulted in physician office visit. On an unknown date, the patient underwent lab tests and procedures which included CAT scan Normal and MRI Normal. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Musculoskeletal chest pain
Clinical narrative: severe pain in the right side of his chest down to his ribcage; pain with from his right side and his rib cage that goes to his back; having a quite severe, he had pain in his ribs; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A male patient (reporter's fiancée) of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe pain in the right side of his chest down to his ribcage, pain with from his right side and his rib cage that goes to his back, having a quite severe, he had pain in his ribs. The outcome of event was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Myalgia
Clinical narrative: dizziness; muscle pain; joint pain; fever; no appetite; His feet feel like they are weak; This is a spontaneous report from contactable consumer (patient). A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Apr2021 (age at vaccination: 34 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 10 days ago. Until now, he was still experiencing fever, dizziness, muscle pain, and joint pain on 01May2021. His fever started the second or third day after he had the vaccine. It went away 2 days ago 08May2021. He didn't know if he's recovered completely, he was not measuring it all of the time. Sometimes he felt a little bit warm, but he doesn't know. He didn't measure. He felt better but now again his side effects came up. He wanted to know if it was normal that the reaction happened more than 2 days. The patient wanted to know if he should go to a doctor, and if he should still receive the 2nd dose. The patient had no appetite all the time and he was not hungry (2 days after he had the vaccine), dizziness (started probably 2 days after the first vaccination and he had 2 days where he was fine and now it started again), and his feet feel like they were weak and when he was walking he felt this dizziness and like his feet are a little bit weak on 01May2021. This was not report related to a study or programme. Right now he didn't know if it was too late or if he should go to the doctor. He had a fever for probably 7 days, a low fever. The patient asked if this happens and if it will just go away in a few days. Then he will wait to see the doctor. Outcome of the event fever was recovered on 08May2021 and for all other events, it was not recovered.  No follow-up attempts are needed; information about lot/batch number can-not be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizziness; muscle pain; joint pain; fever; no appetite; His feet feel like they are weak; This is a spontaneous report from contactable consumer (patient). A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Apr2021 (age at vaccination: 34 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 10 days ago. Until now, he was still experiencing fever, dizziness, muscle pain, and joint pain on 01May2021. His fever started the second or third day after he had the vaccine. It went away 2 days ago 08May2021. He didn't know if he's recovered completely, he was not measuring it all of the time. Sometimes he felt a little bit warm, but he doesn't know. He didn't measure. He felt better but now again his side effects came up. He wanted to know if it was normal that the reaction happened more than 2 days. The patient wanted to know if he should go to a doctor, and if he should still receive the 2nd dose. The patient had no appetite all the time and he was not hungry (2 days after he had the vaccine), dizziness (started probably 2 days after the first vaccination and he had 2 days where he was fine and now it started again), and his feet feel like they were weak and when he was walking he felt this dizziness and like his feet are a little bit weak on 01May2021. This was not report related to a study or programme. Right now he didn't know if it was too late or if he should go to the doctor. He had a fever for probably 7 days, a low fever. The patient asked if this happens and if it will just go away in a few days. Then he will wait to see the doctor. Outcome of the event fever was recovered on 08May2021 and for all other events, it was not recovered.  No follow-up attempts are needed; information about lot/batch number can-not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Rash, Urticaria
Clinical narrative: they woke up with chills and body aches; After the second one there is a rash; they woke up with chills and body aches; has a rash on his side that described as hives; This is a spontaneous report received from a contactable consumer (patient's wife).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient received Pfizer covid 19 vaccine dose. The patient didn't experience any adverse reaction after first dose. The patient's concomitant medications were not reported. The patient received second vaccine dose around 10 days ago (unspecified date) and had chills and body aches. The patient had rash on his side and was described as hives and it was lingering at the time of reporting. The reporter stated that patient was working as normal. Outcome of events (rash on his side that described as hives) was not recovered and other events (chills and body aches) was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021508896 Same Reporter/drug/AE, diferrent patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Joint swelling, Pain in extremity
Clinical narrative: arm soreness; inflamed knees; had inflammation and swelling in the knees; This is a spontaneous report from a contactable consumer or other non hcp.  A 64 years old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) as dose 1, single via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021 the patient experienced arm soreness, inflamed knees, had inflammation and swelling in the knees that has last for 10-11 days. She went to her doctor and was told it was not a common side effect and prescribed an inflammation medication. She went to Pharmacy where she got the vaccine and the pharmacist said they were not aware of this side effect and to call Pfizer. Patient stated that still has it and it's not gone all the way, not all of it and it's getting much better from the beginning, but she still had it. She went to the doctor and showed it to them and they know and she was prescribed a medicine for the inflammation. Because this was a reaction and read it was common when reading the paperwork, she wants to know if this happens often and should she get the second dose, since she was to get it soon. The patient asked will this happen again. No further details provided.  The outcome of events arm soreness were unknown, inflamed knees and swelling in the knees that has last for 10-11 days was recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: arm soreness; inflamed knees; had inflammation and swelling in the knees; This is a spontaneous report from a contactable consumer or other non hcp.  A 64 years old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) as dose 1, single via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021 the patient experienced arm soreness, inflamed knees, had inflammation and swelling in the knees that has last for 10-11 days. She went to her doctor and was told it was not a common side effect and prescribed an inflammation medication. She went to Pharmacy where she got the vaccine and the pharmacist said they were not aware of this side effect and to call Pfizer. Patient stated that still has it and it's not gone all the way, not all of it and it's getting much better from the beginning, but she still had it. She went to the doctor and showed it to them and they know and she was prescribed a medicine for the inflammation. Because this was a reaction and read it was common when reading the paperwork, she wants to know if this happens often and should she get the second dose, since she was to get it soon. The patient asked will this happen again. No further details provided.  The outcome of events arm soreness were unknown, inflamed knees and swelling in the knees that has last for 10-11 days was recovering.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Joint swelling, Pain in extremity
Clinical narrative: Swelling and joint pain in both knees/inflammation in both knees; Swelling and joint pain in both knees; Arm was sore after vaccination; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 27Apr2021 (at 65-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced arm soreness after the vaccination. On 30Apr2021 (3 days later), patient had swelling and joint pain in both knees/inflammation in both knees and had pain in the knees. Patient was prescribed naprosyn and some inflammation medicine as a treatment for the events. After the vaccine, she got some inflammation in both  knees. It was so bad. She waited to see if the inflammation would go away, but it didn't. She went to the doctor and the doctor said its  not common after the vaccine and prescribed her some inflammation medicine. She talked to the pharmacist at the vaccination site and she showed them her knees. She was given this number and told to report it. She clarifies this was her first dose, not the second  dose of the COVID-19 vaccine. Patient wanted to know if she is ok to get the second dose of the Pfizer Covid vaccine. Patient didn't have common side effects like headache, chills, light fever instead she had inflammation of the knees which her doctor said was not common. Patient asked if it is common. Patient had a very hard time with her knees and stated that this is her first time ever having pain in the knees and patient had nothing before the vaccine. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: Swelling and joint pain in both knees/inflammation in both knees; Swelling and joint pain in both knees; Arm was sore after vaccination; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 27Apr2021 (at 65-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced arm soreness after the vaccination. On 30Apr2021 (3 days later), patient had swelling and joint pain in both knees/inflammation in both knees and had pain in the knees. Patient was prescribed naprosyn and some inflammation medicine as a treatment for the events. After the vaccine, she got some inflammation in both  knees. It was so bad. She waited to see if the inflammation would go away, but it didn't. She went to the doctor and the doctor said its  not common after the vaccine and prescribed her some inflammation medicine. She talked to the pharmacist at the vaccination site and she showed them her knees. She was given this number and told to report it. She clarifies this was her first dose, not the second  dose of the COVID-19 vaccine. Patient wanted to know if she is ok to get the second dose of the Pfizer Covid vaccine. Patient didn't have common side effects like headache, chills, light fever instead she had inflammation of the knees which her doctor said was not common. Patient asked if it is common. Patient had a very hard time with her knees and stated that this is her first time ever having pain in the knees and patient had nothing before the vaccine. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Hypersensitivity, Mastocytosis, Pruritus
Clinical narrative: mastocytosis of the stomach; Depression; allergic reaction; tired; Itching all over; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date: not reported ), via an unspecified route of administration on 19Apr2021 11:40 (at age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. In Apr2021,The patient on the line experienced depression for no reason and an allergic reaction, itchiness all over, and was tired after getting the vaccine. She called her doctors office and talked to them but she forgot to tell them that she had masacytosis of the stomach, caller says she can't spell it the call handler would have to look it up online, basically it was a chemical off balance in the body that makes to many histamines naturally. Some things set it off like too much stress, wrong foods, whatever. She reports in Apr2021 within 12 hours or less she was very depressed for no reason, she thought she was the worst person in the world. Her daughter in law looked it up and said it does show as one of the side effects that it had and told her to go back to sleep. She got up Thursday morning and then Saturday morning when she got up, the depression was gone. She reports starting itching within about 12 hours of getting the shot in Apr2021 and continued to get worse like a crazy person itches for about 5-6 days and she took Benadryl to help control the itching. She reports this makes her nervous because her therapist said the patient could get worse and she could end up in the hospital. Her therapist said that one of the side effects started with an s, not sure what it is.Her body makes histamines. Histamines keep our body well but, so whatever is in there, her body is beefing it up, so she can get rid of it, maybe it is supposed to make her sick but having an allergic reaction is a different thing or is it the same thing. Either way she just wanted to talk to some medically to make sure she is going to be safe. She had a 9:30 appointment on the day of reporting to get the second shot but, she was not sure about getting the shot. Therapeutic measures were taken as a result of itching all over and got controlled. She was to get the second dose on day of reporting (06May2021) and inquired was it safe to take the second dose after having these symptoms. The outcome of depression was recovered. The outcome of the events itching, mastocytosis of the stomach, allergic reaction, tired was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Vaccination site erythema
Clinical narrative: red mark around the injection site; Also some spots have sprouted away into the inner side of her arm; She stated that it keep getting worse and it is abnormal/it keeps getting larger and larger and it is now as big as her hand; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736, expiry date: unknown) via an unspecified route of administration on 04May2021 (at the age of 78-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: not reported) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for covid-19 immunization. Stated that she had a history of lot of allergies but, a low thyroid from an unknown date and occasionally take hydroxy, which is an antihistamine for hives. If something causes her to get hives, she doesnt take it daily, takes as needed. She had a route canal and was taking Amoxicillin; she took the last pill the day before she had the second Covid shot, and this was her primary suggestion. Patient was suggested that it was alright to get the Covid shot with the Amoxicillin, it wouldnt cause a problem. Patient's concomitant medication included small amount of levothyroxine sodium (SYNTHROID) for low thyroid from an unspecified date. Reporter stated that she had the second dose of the Pfizer Covid-19 dose a week ago tomorrow, and she started had red mark around the injection site but it keeps getting larger and larger and it was now as big as her hand. Also some spots had sprouted away into the inner side of her arm. She stated that it keep getting worse and it was abnormal. She started out with a little red around the shot, the size of a penny, size of a quarter and now it was the size of the palm of her hand on her upper arm. She stated that it was red and was getting larger and larger and she was wondering and queried for was that considered a rash that will soon cover her arm and then her chest and then her body.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Bladder disorder, Blood test, Defaecation urgency, Discomfort
Clinical narrative: A little bladder problems; urge to go to the bathroom/it's slowly goes out but I need to keep pushing and press to get the rest out mostly at night time; discomfort over the hair line; smell, face and blurry eye symptoms; smell, face and blurry eye symptoms/Blurry vision; taste foully taste, taste like chemical in something I eat; urge to go to the bathroom/it's slowly goes out but I need to keep pushing and press to get the rest out mostly at night time; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration, administered in right arm on 07Apr2021 (at the age of 60-year-old) as DOSE 2, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number : Not reported), via an unspecified route of administration, administered in right arm on 16Mar2021 (at the age of 60-year-old) as DOSE 1, SINGLE for Covid-19 immunisation. She took the shot on last month on the 07Apr 2021, and at least a week after it got stronger. On 2021, the patient experienced a little bladder problems, urge to go to the bathroom/it's slowly goes out but she need to keep pushing and press to get the rest out, mostly at night time, discomfort over the hair line, smell, face and blurry eye symptoms and taste foully taste, taste like chemical in something she eat. Treatment not received for the adverse event. The patient underwent lab tests and procedures which included blood test: normal, everything look fine. They also took urine sample but not hear for the urine sample. (Further not clarified hence, not captured). Outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.