chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Off label use
Clinical narrative: fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Facial pain
Clinical narrative: Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nightmare, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered.  No follow-up activities are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Rash all over his body; rash which is red patchy tiny blistery things; rash which is red patchy tiny blistery things; pain of the rash and blisters; Itching; Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced shoulder pain on 22Jan2021; itching started on 23Jan2021; rash all over his body which has worsened, rash which was red patchy tiny blistery things on 24Jan2021. Patient further reported that he had a rash over his entire body. It started as an itch on his legs which developed into more itching which turned into a rash which was red patchy tiny blistery things. Now it was on his arms, back, belly, neck, and legs. He had shoulder pain and it was hurting the day after he got the vaccine on Friday 22Jan2021. Rash started on Sunday 24Jan2021, it was like a chicken pox type rash. It was like red dots that become sensitive and look slightly blistered. Shoulder pain: this was nothing compared to the pain of the rash and blisters (24Jan2021). He had taken off the bandage and was sore. He was not even sure if he was still sore or not because he was only paying attention to everything else. It was overwhelming. Treatment: He called his doctors and they said that he should use Calamine lotion as a temporary soother for itch and rashes. They also told him to take Benadryl and his doctor prescribed Prednisone. Outcome of the event shoulder pain was unknown while the other events was not recovered.  No follow-up activities are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Thinking abnormal
Clinical narrative: Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turning over, but it was all in his head; Was hot and everything; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: PK12ER/EL9261; Expiration date was not reported) on 26Jan2021 (11:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization/to not get COVID at the public health department. The patient had no relevant medical history and concomitant medications. The patient had no history of problems with vaccines in the past. On 27Jan2021, the patient had felt as though a truck kept turning over, but it was all in his head; and was "hot and everything". The outcome of the events, 'felt as though a truck kept turning over, but it was all in his head' and '"hot and everything"', was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Pyrexia
Clinical narrative: sick; temperature of 101 degrees; headache/frontal type of headache; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249 and expiration date unknown), intramuscular on 26Jan2021 at 10:20 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), batch/lot number: EK9231, intramuscular injection in left upper arm on 05Jan2021 as COVID-19 immunization and only had arm pain/soreness. As a nurse, the patient has given tons of vaccines. On 26Jan2021, she was given her second dose of COVID-19 vaccine around 10:20 a.m. She didn't hurt right away, it started later on. By 6pm, she got home, so sick and had a temperature of 101 degrees. She didn't go to work as she has been running a temperature and she has taken Tylenol. She knows the vaccine works the same, but everybody acts different. The patient also asked if a high temperature of 101 degrees a common side effect and if it is a normal reaction and how long it typically last. The patient states she has never been so sick like this in her life. The patient never gets sick and wanted to know if this is a common thing. She hasn't called her primary doctor. She took Tylenol Extra Strength, 6 or 7pm, also in the middle of the night and then again at 9am the following morning. Her fever has gone down a little bit, but the headache was so bad. It's like a frontal type of headache and it hurts so bad. The headache also began around 6pm yesterday and has converted into fever. The patient wanted to know if it is common to have this type of reaction. The patient is getting so tired and declined to continue with the report, stating she just wants to lay down. The event temperature of 101 degrees was resolving while the outcome of the rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling and soreness at the injection site; soreness at injection site; red, and a little swollen at the injection site; felt itchy at the injection site; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular on the right arm near shoulder on 19Jan2021 09:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. There were no other vaccine received within 4 weeks prior to COVID vaccination. After she got a tetanus shot (probably needs another since it had been ten years) her arm/ muscle was sore. Patient had typical swelling and soreness at the injection site on Jan2021that went away within a couple of days and then did not have any symptoms. Then today all of a sudden it felt sore, red, and a little swollen at the injection site again. It has been more than a week since the symptoms initially resolved and now they have reemerged. It felt itchy at the injection site, it had a raised red area that was itchy on Jan2021. She did go running this morning and has been running several times, she went running the day after she got the vaccine. Events did not require emergency room nor a visit to the physician's office, and no treatment was given. Outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye discharge, Eye pruritus
Clinical narrative: runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; This is a spontaneous report from a non-contactable consumer (patient herself). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL9261), via an unspecified route of administration in the left arm on 25Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination, did not receive any other vaccine in four weeks, and was not pregnant. The patient experienced runny eyes, very itchy, discharge, and was like pink eye on 25Jan2021. It was reported that the events started about six hours after vaccine shot and lasted 48 hours. The patient had not tested positive for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate, Muscle spasms, Pain in extremity, Palpitations
Clinical narrative: legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia, Tachycardia
Clinical narrative: intense body aches; fever; joint pain; several episodes of tachycardia; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 19Dec2020 at 08:45 AM on right arm (lot number: EH9899) for COVID-19 immunization and experienced sore arm, mild headache/nausea. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jan2021 20:00, the patient experienced intense body aches, fever, joint pain; and approximately 1 week after through more than 2 weeks after (Jan2021) had several episodes of tachycardia. No treatment was received for the adverse events. The patient has not recovered from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm started to get sore; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 12:00, at single dose, for covid-19 immunization, at the workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 17:00, the patient's arm started to get sore and continued to get more sore throughout the evening. It was much better when she woke up in the morning of 27Jan2021, and the pain was fully resolved by 17:00 on 27Jan2021. No treatment was given for the event. The patient recovered from the event on 27Jan2021 at 17:00.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness around the injection site for approximately 30 hours.; This is a spontaneous report from a non-contactable consumer. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), via an unspecified route of administration in right arm on 26Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness around the injection site for approximately 30 hours on 26Jan2021 10:15 with outcome of recovered. There was no treatment for the event.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Muscular weakness
Clinical narrative: Severe joint pain; chills; muscle weakness, causing minimal ability to walk (bed bound); muscle weakness, causing minimal ability to walk (bed bound); This is a spontaneous report from a contactable nurse (patient).  A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration  on the left arm on 26Jan2021 at a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus and attention deficit hyperactivity disorder (ADHD). Concomitant medication included dextroamphetamine (dexamfetamine) and ethinylestradiol, norgestimate (TRI ESTARYLLA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 07Jan2021 on the right arm On 27Jan2021 10:00, the patient experienced severe joint pain and muscle weakness, causing minimal ability to walk (bed bound) and chills. No treatment was given for the events. The patient was recovering from the events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling of body temperature change, Pollakiuria, Urinary incontinence
Clinical narrative: lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Rash
Clinical narrative: Patient says that he has dermatitis; Rash; This is a spontaneous report from a contactable pharmacist and physician (patient himself). An 81-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261, exp date: May2021), via an unspecified route of administration on the left arm on 22Jan2021 15:30 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications reported as none.  The pharmacist was calling to report that her father who had the Pfizer COVID-19 vaccine has a rash, a lot of a rash, after his first dose on 22Jan2021. No treatment was done for the rash. The pharmacist stated that her father though that the rash was a virus reaction.  Patient (father) abruptly takes over the phone call and confirmed that he was the patient. Patient stated that he has dermatitis (this was a virus reaction) on upper and lower limbs for two days after the injection of vaccine (at night for 3 hours every night). The patient stated it was a virus reaction and he was dermatologist, a dermatology specialist, he has been for 50 yearrs experience. Patient stated it was a slight reaction, 2-3 hours of rash and physical reaction. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that her arm was sore for 24 hours on Jan2021 with outcome of recovered on Jan2021.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Leg pain and bruising; Leg pain and bruising/bruising above both kneecaps and down his legs; Muscle aches; Feet are a little colder than normal; he still aches; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 13Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included taking blood pressure medicine, medicine for uric acid, stated he takes three medications but did not provide product names. The patient had the first COVID shot on 23Dec2020 at 20:30 at the right arm at the age of 63-year-old and clarified he had no problems after first vaccination. The patient experienced leg pain and bruising which started immediately day after second COVID shot on 14Jan2021. Noticed bruising above both kneecaps and down his legs, which felt like pretty severe flu pain. After a period of time, it didn't' feel right. He didn't see anything like that listed as side effects. Has gotten a little better but was still there. Takes Ibuprofen and it helps a little with the leg pain and bruising. Feet are a little colder than normal and he still aches, also had muscle aches on 14Jan2021 which he never had before. The outcome of the event leg pain and bruising was recovering and unknown for the rest of the events.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pyrexia
Clinical narrative: had a 103 degree fever; nausea; myalgia; This is a spontaneous report from a contactable other hcp (patient). This report was received via a Pfizer sales representative.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient had 1st dose of covid-19 vaccine on unspecified date. Caller stated that she got a call from a Nurse Practitioner (patient) who gets samples from her, and the patient informed the caller that she got the second dose of the COVID vaccine, and she informed about side effect she experienced. Caller stated that the patient seemed fine with consent for follow up from Pfizer, however, the caller wishes to only provide the reporter's (patient's) email address at this time. Caller confirms that the reporter is also the patient and does not know the reporter's date of birth, age, height, weight, or ethnicity. Caller confirmed the patient had the experience.  Caller does not have prescriber information for the person who prescribed the product to the patient.  It was reported that patient got the second dose of the COVID vaccine on Thursday 21Jan2021, and after that, she had a 103 degree fever, nausea, and myalgia. She reported that symptoms started 12 hours after receiving the second shot, and they lasted for about 24 hours. Caller does not know if the patient received any other vaccines on the same day as the COVID vaccine. Outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Insomnia, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; not sleeping; it still hurts, it is very sore by his bicep; sheer exhaustion; is very uncomfortable sitting; This is a spontaneous report from a contactable consumer reporting for himself. A 67-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686, Expiry date: 31Mar2021), via an unspecified route of administration (arm left) on 18Jan2021, 12:00 (noon) at SINGLE DOSE for COVID-19 immunization, at 67 years old. Medical history included torn rotator cuffs from an unspecified date. The patient previously took Flu shot for immunization. Patient stated his last vaccination he had was the flu shot 6 months before on an unspecified date, that was a while back. Patient had pain in his left arm at the injection site. He is not sleeping because the pain is waking him up. It has been more than a week at 10 days, and it still hurts. It is very sore by his bicep. Events occurred on 19Jan2021, reported as started hurting the next day maybe, it was not immediately after. He says since then he has had pain, and in the past, he has had torn rotator cuffs, and those hurt, but he was not sleeping due to this pain now, he fell asleep at 06:00AM this morning from sheer exhaustion (Jan2021). He says he is very uncomfortable sitting, he can't lay on that side, and he can't get comfortable. He was taking MOTRIN 800 mg as needed, and he put ASPERCREME on it. He says that his MOTRIN was prescribed by a doctor, it was the only thing working for the pain for this. He says he also tried Naproxen, then says it's Aleve actually, he has only taken this once. It was 220 mg, he took one by mouth, one time. He applied the ASPERCREME to the injection site about three times last week, he says he was experimenting here, he does not know. He says he tried ice which helped a little bit, ice always helps, but when it wears out it comes back. He stated he feels the pain walking, when he is putting his shirt on, sitting in his recliner, it is constant. His vaccine card is handwritten, there is no NDC written on there. It has no information about the syringe that was used, NDC/LOT/EXP information were unknown, they didn't put it down or the information on the card for his wallet. Patient stated he saw a doctor but not for the injection site pain. He stated if it was just initial pain, he wouldn't be asking but it has been 10 days now, he thought it would be gone by now, he tried to see how long it could last on the paper they gave and called the number from the paper. He says he had no swelling, it was just really sore, he would like to know if this is normal, if so, he can hang on and tough it out. Treatment was given in response to the events. Outcome of the events Injection site pain, not sleeping, it still hurts, it is very sore by his bicep was not recovered. Outcome of the events sheer exhaustion and is very uncomfortable sitting was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fall, Fear
Clinical narrative: I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization.  Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now).   Information on the Lot/Batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain, Tinnitus
Clinical narrative: I got a big side effect dizzy and I was almost falling; dizziness; Headache; Nauseous; Feel pinch in my stomach; Lot of pain in my whole body; Chills especially at night; Tinnitus; I can't hear you very well because it's so bad. I have a lot of noise in my ear and I can't listen you very well. I couldn't hear; Little side effect of the vaccine, but it continued till now and I feel so sick now; scared because she was falling; scared because she was falling; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: unknown), via an unspecified route of administration on 21Jan2021 (also reported as on Wednesday) at SINGLE DOSE for COVID-19 immunization.  Medical history included blood pressure high and diabetes. Concomitant medication included glimepiride (GLIMEPIRIDE) for diabetes and olmesartan (OLMESARTAN) for blood pressure high. It was reported that the patient was experiencing for over a week a lot of side effect of the vaccines. She was scared because she got dizzy which she was almost falling (also reported as scared because she was falling) in Jan2021. The patient also had headaches (a lot of headaches) and every day she had to take pills. She also felt like nauseous and pinch in her stomach. She had a lot of pain in her whole body and have chills especially at night after she had the COVID-19 Vaccine. The patient also had got a lot of tinnitus (lot of noise in her ear and can't listen very well) she can't hear very well because it's so bad. She also felt so sick now that she doesn't feel like doing nothing just to be in bed. The patient events were not recovered (continued till now).   Information on the Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Headache, Somnolence, Vaccination site pain
Clinical narrative: Headache; pain in her arm at the injection site; Quivering in chest; Sleepy; Lightheadedness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports.  A female patient of an unspecified age received BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, pain in her arm at the injection site, quivering in chest and sleepy on an unspecified date. On 23Jan2021, the patient experienced lightheadedness. Lightheadedness was reported as worsened. The outcome of the event "lightheadedness" was not recovered. The outcome of the other events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117202 same reporter/drug, similar events, different patient