chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diastolic dysfunction, Echocardiogram abnormal, Exercise tolerance decreased, Fatigue, Full blood count
Clinical narrative: Started experiencing fatigue, muscle weakness.  After light cardio exercise, energy depleted and would have to lie down and then would fall asleep.  I didn't feel sleepy, just extremely weak.  Most pronounced in the arms and legs, but sometimes felt like whole body.  Saw doctor on 5/12.  Later on 6/5 had a complete CBC, physical workup.  Some values were slightly out of range, but nothing significant.  Went to urgent care about a week or so later because symptoms seemed to be getting worse.  They repeated the complete CBC and also ran a lactic acid test.  Again results were insignificant.  Echo completed on 7/1 showing only mild diastolic disfunction.  I'm afraid to exercise.  I wake up in the morning with a mild tingling in hands and legs.  As the morning progresses, the tingling, weakness, fatigue get worse.   I can have some fairly good days, but most are not good.  I have experienced some fatigue in the past, but this time has absolutely been the worse.   Even as I am writing this, I feel the tingling, weakness in my hands.  Earlier my legs felt achy,  Legs feel ok at this time.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Lipids, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Started experiencing fatigue, muscle weakness.  After light cardio exercise, energy depleted and would have to lie down and then would fall asleep.  I didn't feel sleepy, just extremely weak.  Most pronounced in the arms and legs, but sometimes felt like whole body.  Saw doctor on 5/12.  Later on 6/5 had a complete CBC, physical workup.  Some values were slightly out of range, but nothing significant.  Went to urgent care about a week or so later because symptoms seemed to be getting worse.  They repeated the complete CBC and also ran a lactic acid test.  Again results were insignificant.  Echo completed on 7/1 showing only mild diastolic disfunction.  I'm afraid to exercise.  I wake up in the morning with a mild tingling in hands and legs.  As the morning progresses, the tingling, weakness, fatigue get worse.   I can have some fairly good days, but most are not good.  I have experienced some fatigue in the past, but this time has absolutely been the worse.   Even as I am writing this, I feel the tingling, weakness in my hands.  Earlier my legs felt achy,  Legs feel ok at this time.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroxine free, Urine analysis
Clinical narrative: Started experiencing fatigue, muscle weakness.  After light cardio exercise, energy depleted and would have to lie down and then would fall asleep.  I didn't feel sleepy, just extremely weak.  Most pronounced in the arms and legs, but sometimes felt like whole body.  Saw doctor on 5/12.  Later on 6/5 had a complete CBC, physical workup.  Some values were slightly out of range, but nothing significant.  Went to urgent care about a week or so later because symptoms seemed to be getting worse.  They repeated the complete CBC and also ran a lactic acid test.  Again results were insignificant.  Echo completed on 7/1 showing only mild diastolic disfunction.  I'm afraid to exercise.  I wake up in the morning with a mild tingling in hands and legs.  As the morning progresses, the tingling, weakness, fatigue get worse.   I can have some fairly good days, but most are not good.  I have experienced some fatigue in the past, but this time has absolutely been the worse.   Even as I am writing this, I feel the tingling, weakness in my hands.  Earlier my legs felt achy,  Legs feel ok at this time.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Period was supposed to come that next day and it has been postponed and still has not come; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0169 and expiration date: 31Oct2021), dose 1 via an unspecified route of administration on 27Apr2021 (age at vaccination: 44-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of vaccine about 3 weeks and was supposed to get the second dose of the Pfizer COVID 19 vaccine tomorrow. The patient stated the problem was when she got the first dose her period was supposed to come that next day and it had been postponed and still had not come. The patient thought it was related to the vaccine and wonders, for this situation if she should still get the second vaccine. The patient wants to know if this was normal for women after getting the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: He has been getting increasing joint pain in fingers, knees, hips/The joint pain is in his fingers, knees, and hips.; This is painful to move his fingers; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 31Jan2021 as single dose for covid-19 immunization. Medical history included diabetes. Concomitant medications included empagliflozin (JARDIANCE) 25mg taken for diabetes mellitus, insulin glargine (LANTUS) (quick pen dosage changes based on readings) taken for diabetes mellitus, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EL3248) on 13Jan2021 for as DOSE 1, SINGLE for covid-19 immunization. Caller had the Pfizer COVID shot back in Jan2021. Since then, he is getting increasingly worse joint pain. The joint pain is in his fingers, knees, and hips. He has never had it in the past. It is to the point he can barely close his hand. He can't pick up a coffee mug. He went to the doctor. The doctor did x-rays and blood test but couldn't identify a cause. He has had a slight arthritis in the past. This was painful to move his fingers. He heard some stories that this could possibly be related to the COVID shot. He had questions that Is there any information about that. He did not have a prescribing doctor. He never connected it to the shot at first. But it all started after the shot and continued getting worse and worse. The first shot was 13Jan2021 with lot number EL3248. The second shot was 31Jan2021 with the same lot number EL3248. He doesn't know which arms he got them in. The second one was in the morning, and the first one was in the afternoon. He went to Hospital . The first one was at 1 o'clock. He is on medicine for diabetes. Jardiance 25mg, Injectionquick pen dosage changes based on readings. The outcome of the event joint pain in fingers, knees, hips was not recovered, and outcome was unknown for the event painful to move his fingers.  Information about Lot and batch was available. Further information was expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity, Somnolence
Clinical narrative: awful problem with arthritis in hands; sleepy; hands were hurting a lot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route administration on 02May2021 (at the age of 66years) as single dose for covid-19 immunization. The patient medical history included Diabetes mellitus from ongoing to unknown, Arthritis from unknown to unknown, and A1C from unknown to unknown. The patient's concomitant medications were not reported. She has had an awful problem with arthritis in her hands since. Her husband is a veterinarian. She did not have a prescribing doctor. She has had arthritis, but it has never been this bad. Her arthritis is usually only bad in cold rainy weather. She has never had an issue before. The pain got worse the next day or maybe two days after the vaccine. she took a nap, and she never takes a nap. She took a nap the first and second day after, and then after the second day her hands were hurting a lot. She does have Diabetes, but she has never had to take anything for it. She has kept her A1C down to 6.3 through diet and exercise. She was diagnosed 11 years ago. On an unspecified date, the patient experienced awful problem with arthritis in hands, hands were hurting a lot, and sleepy. The outcome of the event awful problem with arthritis in hands was not recovered. The outcome of other events was unknown.  Information on Lot/Batch number is available; Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my shoulder was little sore from the shot; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6200), via an unspecified route of administration on 12Mar2021  as dose 2, single for COVID-19 immunization.  Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: Blood pressure high. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; valsartan (DIOVAN) taken for hypertension, start and stop date were not reported.  Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 19Feb2021 as 1st dose, single for Covid-19 immunization. The reason patient am calling was his wife and he both took the Pfizer vaccine on 19Feb2021. He had no problem what so ever once we took the first shot we waited fifteen minutes before we left area we took the shot and everything was fine. patinet took the first shot on 19Feb2021. He took the second shot on 12Mar2021. He never had any problem what so ever his shoulder was little sore from the shot. Reporter stated the reason he was calling when he and his wife  got the shot they handed down a fact sheet for recipient and care givers and they handed down a fact sheet it's Help County. They handed down a sheet and inside the sheet there was some phone numbers. There were some phone numbers inside the sheet and it says you can report side effects to Pfizer and corporate contact number below that's why he called (withheld) and that's how he got to you. The outcome of the events was unknown.  Batch/Lot number has been obtained. further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Ear disorder, Gastrointestinal disorder, Headache
Clinical narrative: weird headaches; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; Flu; Bad Shoulder; Bad Back; Arm Pain; minor leg ache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a female patient (sister) that: 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 28Apr2021 (Batch/Lot Number: EW 176) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history is none. The patient historical vaccine included BNT162B2 for Covid-19 Immunization; Lot no: ER8729, 1st dose. There were no concomitant medications. It was reported that said she started having weird headaches and something else. The caller thought to herself wait, we had identical vaccines at same time, same place. Her sister started having weird headaches and something else, too, but the caller cannot think of it. she declined to complete a report on behalf of her sister stating she does not know enough about her sister situation. She does not feel confident going through a report. Her sister told the that her headaches are starting to back off today, too, her sister had some ear, neck, and intestinal stuff going on. It was weird stuff, and the caller wants to leave it at that. It was Flu like, Bad headache, Bad shoulder, Black, arm pain, aches for about 8 days (2 weeks after shot). I did get covid test and it was negative. (I had been totally and completely isolated since onset Mar2020) As of today, I still get some minor leg/back/head aches ocassionally that I would deem unusual for me. (do not regret vaccine at all). The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date. The outcome of events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021569201 Same reporter/diff patient
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Musculoskeletal discomfort, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: weird headaches; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; ear, neck, and intestinal stuff going on; Flu; Bad Shoulder; Bad Back; Arm Pain; minor leg ache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a female patient (sister) that: 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 28Apr2021 (Batch/Lot Number: EW 176) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history is none. The patient historical vaccine included BNT162B2 for Covid-19 Immunization; Lot no: ER8729, 1st dose. There were no concomitant medications. It was reported that said she started having weird headaches and something else. The caller thought to herself wait, we had identical vaccines at same time, same place. Her sister started having weird headaches and something else, too, but the caller cannot think of it. she declined to complete a report on behalf of her sister stating she does not know enough about her sister situation. She does not feel confident going through a report. Her sister told the that her headaches are starting to back off today, too, her sister had some ear, neck, and intestinal stuff going on. It was weird stuff, and the caller wants to leave it at that. It was Flu like, Bad headache, Bad shoulder, Black, arm pain, aches for about 8 days (2 weeks after shot). I did get covid test and it was negative. (I had been totally and completely isolated since onset Mar2020) As of today, I still get some minor leg/back/head aches ocassionally that I would deem unusual for me. (do not regret vaccine at all). The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date. The outcome of events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021569201 Same reporter/diff patient
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body height, Oropharyngeal pain, Throat tightness, Weight
Clinical narrative: abdominal cramping; throat started hurting and started tightening; throat started hurting and started tightening; This is a spontaneous report from a contactable consumer(patient). A 13-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 20May2021(at the age of 13-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.it was reported that Complainant hung up abruptly/transfer incomplete. Reporter stated that I am just reporting a reaction my daughter had to the shot. It was the Pfizer Covid vaccine. On 20May2021, she had abdominal cramping and then her throat started hurting and started tightening. Her weight is approximately 135 pounds and she's probably 5'5. Product details and pharmacy details could not be probed as the caller hung up abruptly. Call back was done to gather further information however it was unsuccessful. Hence limited information available over the call. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: continuous tingling in her hands; This is a spontaneous report from a contactable consumer. and from a Pfizer sponsored program  This consumer (patient's mother) reported for a 17-year-old female patient (reporter's daughter).  A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: unknown), via unspecified route, administered in left arm on 20May2021 (at the age of 17-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21May2021, 1 day after the vaccination, the patient experienced continuous tingling in her hands. When the patient woke up both of her hands were tingling, almost like when they fell asleep, it was non-stop,; felt like needles in her hand. The tingling was worse when the patient first woke up. The tingling was always there but it changed with pressure. Second dose scheduled on 10Jun2021 from her school. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Gait disturbance, Nausea
Clinical narrative: difficulty walking; Shooting nerve pain from hip to foot on right side.; Intense pain; fever; chills; shortness of breath; nausea; chest pain; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female consumer(patient) reported that:  A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 21May2021 at 10:00 (at the age of  54-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included known allergy to epinephrine, MRI dye (MRIBUTIN) and Penicillin from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on 30Apr2021 at 10:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Ambien within 2 weeks of vaccination. On 21May2021 at 21:00 the patient experienced difficulty walking, shooting nerve pain from hip to foot on right side, intense pain, fever, chills, shortness of breath, nausea and chest pain. Since vaccination patient not tested for covid-19. This case assessed as non-serious as per reporter. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovering.  Additional information is requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pyrexia
Clinical narrative: difficulty walking; Shooting nerve pain from hip to foot on right side.; Intense pain; fever; chills; shortness of breath; nausea; chest pain; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female consumer(patient) reported that:  A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 21May2021 at 10:00 (at the age of  54-year-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included known allergy to epinephrine, MRI dye (MRIBUTIN) and Penicillin from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on 30Apr2021 at 10:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Ambien within 2 weeks of vaccination. On 21May2021 at 21:00 the patient experienced difficulty walking, shooting nerve pain from hip to foot on right side, intense pain, fever, chills, shortness of breath, nausea and chest pain. Since vaccination patient not tested for covid-19. This case assessed as non-serious as per reporter. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovering.  Additional information is requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Heavy bleeding and passed a large clot during period; Heavy bleeding and passed a large clot during period; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER; Formulation: Solution for injection; lot number: ER8733), dose 2 via an unspecified route of administration, administered in left arm on 10May2021 at 09:45 (at the age of 33-years-old) as dose 2, single for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior vaccination. Medical history included PCOS (polycystic ovary syndrome) from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d nos, probiotics, fexofenadine hydrochloride (ALLEGRA), Multi vitamin, and flonase from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER, Lot number: ER8737), in the left arm on 20Apr2021 at 14:30 (at the age of 33-years-old), as dose 1 single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heavy bleeding and passed a large clot during period on 12May2021 17:00. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered on an unknown date in May2021.  Information on Lot/Batch number was available. Additional information has been requested
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Overdose, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pain in left shoulder/arm EVERY time I reach, stretch or twist my arm in certain motions, especially stretching. It does not hinder me from daily activities, but each time it causes wincing pain for 3; On 10Mar2021, patient received BNT162b2  dose 1 and dose 2; On 10Mar2021, patient received BNT162b2  dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-year-old female patient  (Non pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6205 Expiry date UNKNOWN) dose 1 via an unspecified route of administration in arm Left on 10Mar2021 17:45 (age at vaccination was 65-year-old) and dose 2 (Lot number ER8732; Expiry date UNKNOWN) via unspecified route of administration in left arm on 10Mar2021 as single dose for covid-19 immunisation. The patient had no known allergies. Medical history included blood cholesterol from 2015 and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination was atorvastatin taken for blood cholesterol from 2015 and ongoing. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, patient received BNT162b2  dose 1 and dose 2 via an unspecified route of administration in arm Left and at on the same day at 22:00 had continuous pain in left arm when stretching or twisting-for 10-30 seconds, then it's gone. Occurs every time she twists or stretch-mostly in upper arm but sometimes radiates down entire arm. No treatment received for the event. Pain in arm is not disabling.The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) negative on 20Mar2021. The outcome of the event pain in left shoulder/arm EVERY time I reach, stretch or twist my arm in certain motions, especially stretching. It does not hinder me from daily activities, but each time it causes wincing pain for 3 was not recovered and rest of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: two days out from when her menstrual cycle should have began; This is a spontaneous report from a contactable consumer (patient's Mother). A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration, in left arm, on 21May2021, at 08:45 (at the age of 14-years-old) as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother reported that her daughter received the first dose of Pfizer Covid Vaccine this morning, 21May2021, at 08:45 and daughter was at least two days out from when her menstrual cycle should have begun, no serious heavy bleeding (in May2021). Outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness still; it was much more painful than first shot /excruciating pain in his arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via left arm on 19May2020 as single dose for COVID-19 immunization. The patient medical history included arm pain, fever, achiness, and exhaustion. The patient concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0191, and expiration date was Sep2021), via left arm on 28Apr2021as single dose for COVID-19 immunization. After his 1st dose of the Pfizer COVID 19 vaccination, he called and reported his side effects and now he had received his second dose and he had some questions regarding his side effects. On 19May2021 patient experienced Severe arm pain. It felt as if someone was stabbing him with a large dagger that night and on 20May2021 he had an ugly bruise on his arm, and it was not going away. It been a week and it was still there and on same day had Fever as Persisting. On an unspecified date 2021 patient experienced pain, fatigue, little stiffness, body aches, and He was feeling the excruciating pain in his arm, so he did not want to look, and did not look until the next day, and took a look, removed the band-aid and was surprised, he had some arm pain with the first, but there was no sign of it on his arm with anything. The outcome of event (fever and body aches) was recovered, event of stiffness was not resolved and event of arm pain was recovering rest of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness still; it was much more painful than first shot /excruciating pain in his arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via left arm on 19May2020 as single dose for COVID-19 immunization. The patient medical history included arm pain, fever, achiness, and exhaustion. The patient concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0191, and expiration date was Sep2021), via left arm on 28Apr2021as single dose for COVID-19 immunization. After his 1st dose of the Pfizer COVID 19 vaccination, he called and reported his side effects and now he had received his second dose and he had some questions regarding his side effects. On 19May2021 patient experienced Severe arm pain. It felt as if someone was stabbing him with a large dagger that night and on 20May2021 he had an ugly bruise on his arm, and it was not going away. It been a week and it was still there and on same day had Fever as Persisting. On an unspecified date 2021 patient experienced pain, fatigue, little stiffness, body aches, and He was feeling the excruciating pain in his arm, so he did not want to look, and did not look until the next day, and took a look, removed the band-aid and was surprised, he had some arm pain with the first, but there was no sign of it on his arm with anything. The outcome of event (fever and body aches) was recovered, event of stiffness was not resolved and event of arm pain was recovering rest of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Depressed mood, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding
Clinical narrative: I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was feeling extremely depressed again, teary and sad and not sure why; Very very tired; Unmotivated; I was feeling extremely depressed again, teary and sad and not sure why; excruciatingly painful; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EWC158) via an unspecified route of administration, administered in arm right on 15Apr2021 at 07:45 (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP6955) in left arm on 25Mar2021 at 12 pm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. There were no known allergies. There was no prior COVID vaccination. I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021, but it was incredibly heavy and excruciatingly painful, I was also much more sad, depressed, exhausted than normal. The feelings of depression were extremely overwhelming. This week (24May2021) I was feeling extremely depressed again, teary and sad and not sure why, very very tired and unmotivated, started my period again only 12 days later 27May2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information was expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Menstrual disorder
Clinical narrative: I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021 but it was incredibly heavy and excruciatingly painful; I was feeling extremely depressed again, teary and sad and not sure why; Very very tired; Unmotivated; I was feeling extremely depressed again, teary and sad and not sure why; excruciatingly painful; This is a spontaneous report from a contactable consumer. A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EWC158) via an unspecified route of administration, administered in arm right on 15Apr2021 at 07:45 (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP6955) in left arm on 25Mar2021 at 12 pm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. There were no known allergies. There was no prior COVID vaccination. I was on my period when I received shot #2 15Apr2021 I only had a few days left in that cycle I started my next cycle regularly 08May2021, but it was incredibly heavy and excruciatingly painful, I was also much more sad, depressed, exhausted than normal. The feelings of depression were extremely overwhelming. This week (24May2021) I was feeling extremely depressed again, teary and sad and not sure why, very very tired and unmotivated, started my period again only 12 days later 27May2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: problems with my menstrual cycle; heavy periods; lasting for almost 2 weeks; early periods; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 02Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unknown date as single dose for COVID-19 immunisation. The patient experienced problems with her menstrual cycle, which include heavy periods as well as early periods while on the pill lasting for almost 2 weeks. Patient would like to know if this was a potential side effect of receiving the vaccine. The patient had received treatment for the events. The outcome of the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, Rash macular, SARS-CoV-2 test
Clinical narrative: Wide raised rash on outer part of elbows and outer part of knees. Blotches and spots down legs to ankles and down arms to wrists; Wide raised rash on outer part of elbows and outer part of knees. Blotches and spots down legs to ankles and down arms to wrists; SARS-COV-2 infection; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0170), via an unspecified route of administration, administered in left arm on 01May2021 15:00 as dose 1, single  (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR); paracetamol (TYLENOL); zinc chloride; ergocalciferol (VIT D); ascorbic acid (VIT C). The patient did not have any other vaccine if four weeks. There were no known allergies. On 09May2021 19:00, the patient experienced wide raised rash on outer part of elbows and outer part of knees, blotches and spots down legs to ankles and down arms to wrists. On 03May2021, the patient had sars-cov-2 infection. The patient received Benadryl and inch cream as treatment for the adverse events.On 03May2021, the patient underwent sars-cov-2 nasal swab test (Rapid) which was positive. The patient did not have covid prior vaccination but was tested positive for covid post vaccination. The case was assessed by reporter as non-serious. The outcome of covid-19 was unknown and the outcome of all the other events was recovered.   Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: 3 days after second vaccine experienced severe burning sensation in calf muscles making it difficult to walk; 3 days after second vaccine experienced severe burning sensation in calf muscles making it difficult to walk; the pain has moved throughout my legs; knee has swollen making it painful to walk; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 25Jan2021 (at the age of 75-year-old) as DOSE 2 SINGLE for COVID-19 immunization. Patient medical history included asthma, hypertension, blood cholesterol and thyroid disorder. Concomitant medications included atorvastatin calcium, losartan, levothyroxine sodium (SYNTHROID), fluticasone propionate, salmeterol xinafoate (ADVAIR). Patient did not have other vaccine in four weeks. Patient was not diagnosed with covid prior or post vaccination. Historical vaccine included first dose of COMIRNATY vaccine on an unspecified date (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown) as DOSE 1 SINGLE.  On 28Jan2021, 3 days after the vaccination, the patient experienced severe burning sensation in calf muscles making it difficult to walk. It would ease up and stop after resting awhile. Did visited doctor. During next week months the pain has moved throughout her legs but is not constant. It has been 4 months and the muscle problems are still here. It was recommended to see a pain management doctor; she wants to know what is wrong not cover it up. she used Aleve and Tylenol to cope with the pain as treatment option. And her knee has swollen making it painful to walk. lab data included covid test (nasal swab) on 04may2021 which showed negative results. The outcome of the events are not recovered.  No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: 8 days after receiving the vaccine, I started menstrating . but I have been in menopause over a year; I'm also experiencing urinary pain; Not only was it painful but the rush was more than I've had in over 13 years; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (age at Vaccination 50-year-old) (Batch/Lot Number: EW0-182) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of Vaccination. Medical history included hashimotos thyroid disease, latex allergy, ginger allergy, egg whites allergy, garlic allergy and patient had been in menopause over a year. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine, liothyronine, ergocalciferol (VIT D), magnesium taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, 8 days after receiving the vaccine, patient started menstrating but she had been in menopause over a year. Not only was it painful but the rush was more than she has had in over 13 years. She was also experiencing urinary pain. Patient was not hospitalized. She did not received treatment for adverse events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Heavy menstrual bleeding, Thrombosis, Urinary tract infection
Clinical narrative: lots of clots; Heavy menstrual-like bleeding; recurring urinary tract infection symptoms; intense lower back pain.; This is a spontaneous report from a contactable consumer (patient).   A 46-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534, age at vaccination 46-years-old) via an unspecified route of administration and administered in left arm on 18Mar2021 08:00 as first dose, single for COVID-19 immunization. The patient's medical history included thyroid cancer survivor and allergies to Ciprofloxacin. The patient concomitant medication included levothyroxine sodium (UNITHROID) prior 2 weeks 112mg. The patient had no covid prior to vaccination. The patient did not take no other vaccine in four weeks. The patient experienced heavy menstrual-like bleeding, lots of clots, recurring urinary tract infection symptoms and intense lower back pain on 28Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for events. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration and administered in left arm on 08May2021 10:00 am. The outcome of events was not resolved at the time of this report.  Follow-up(30Jun2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Abnormal/heavy menstrual bleeding; Abnormal/heavy menstrual bleeding; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 50-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EW0161, Expiry date not reported) via an unspecified route of administration in arm left on 23Apr2021 11:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation at pharmacy or drug store. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: ER8737, Expiry date not reported), via an unspecified route of administration in arm left on 02Apr2021 11:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021 10:00, the patient experienced abnormal/heavy menstrual bleeding. The patient was in perimenopausal and have not had a cycle in over 6 months. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Outcome of the events was not resolved. Device Date was reported as 01Jun2021.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.