chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypersensitivity, Investigation, Laboratory test, Scan
Clinical narrative: very bad allergic reaction starting around 19:30-20:00 on 14Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left Arm on 14Apr2021 17:20 (at age of 53 years old) as single dose for COVID-19 immunization. Medical history included arthritis, asthma when she was a kid. Concomitant medications included meloxicam taken for arthritis from Apr2021 to 15Apr2021; omeprazole (OMEPRAZOL) from Apr2021 to 15Apr2021. For Concomitant Products Meloxicam and Omeprazole: Started unknown date last week, in Apr2021. She has not taken this today due to the very bad allergic reaction event. This consumer is the patient who was administered her first dose of Pfizer-BioNTech Covid-19 Vaccine on 14Apr2021 at 17:20. She reported onset of very bad allergic reaction starting around 19:30-20:00 on 14Apr2021. She was seen in the emergency room where she was kept for observation and treatment where they gave her some medicine and then released her; but was not admitted to the hospital for this event. She had to go to the emergency room, she broke out in hives and the right side of her face was swollen. The right side of her face is still swollen a little bit, especially over the top of her eye is swollen; but when she got to the emergency room her whole face was swollen and she had hives all over her body. In the emergency room they gave her medication and she stayed in the emergency room for like maybe 3 hours. She drove herself to the emergency room, but someone had to drive her home from the emergency room because she could not drive herself home. AE required a visit to Emergency Room. No Physician Office visit. The patient was not hospitalized, seen in emergency room only. Regarding testing/investigations such as blood work, lab work, cultures, scans, x-rays caller reported they did all that last night (14Apr2021), but she has no further information or results to provide for this report. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: very bad allergic reaction starting around 19:30-20:00 on 14Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Left Arm on 14Apr2021 17:20 (at age of 53 years old) as single dose for COVID-19 immunization. Medical history included arthritis, asthma when she was a kid. Concomitant medications included meloxicam taken for arthritis from Apr2021 to 15Apr2021; omeprazole (OMEPRAZOL) from Apr2021 to 15Apr2021. For Concomitant Products Meloxicam and Omeprazole: Started unknown date last week, in Apr2021. She has not taken this today due to the very bad allergic reaction event. This consumer is the patient who was administered her first dose of Pfizer-BioNTech Covid-19 Vaccine on 14Apr2021 at 17:20. She reported onset of very bad allergic reaction starting around 19:30-20:00 on 14Apr2021. She was seen in the emergency room where she was kept for observation and treatment where they gave her some medicine and then released her; but was not admitted to the hospital for this event. She had to go to the emergency room, she broke out in hives and the right side of her face was swollen. The right side of her face is still swollen a little bit, especially over the top of her eye is swollen; but when she got to the emergency room her whole face was swollen and she had hives all over her body. In the emergency room they gave her medication and she stayed in the emergency room for like maybe 3 hours. She drove herself to the emergency room, but someone had to drive her home from the emergency room because she could not drive herself home. AE required a visit to Emergency Room. No Physician Office visit. The patient was not hospitalized, seen in emergency room only. Regarding testing/investigations such as blood work, lab work, cultures, scans, x-rays caller reported they did all that last night (14Apr2021), but she has no further information or results to provide for this report. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Consumer also mentioned someone who also received the vaccine who cannot lift her arm afterwards.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer also mentioned someone (patient) who also received the vaccine who cannot lift her arm afterwards on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Pain in extremity, Parotitis, Renal pain, Salivary gland pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral herpes
Clinical narrative: she had a fever sore on the righthand corner of her lower lip; she had a little bit of a headache; This is a spontaneous report from a contactable consumer (patient). A 64 years old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 10:45 (Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were none. The patient experienced she had a fever sore on the righthand corner of her lower lip, she had a little bit of a headache on 12Apr2021. Reported as: She said on 12Apr2021, she started having a lip reaction. She said she had a fever sore on the righthand corner of her lower lip. Reported her fever sore didn't come right after getting her first COVID 19 Vaccine. She said she took Tylenol right after she had the COVID 19 Vaccine because she had a little bit of a headache. Stated she was putting Vaseline on her fever sore. She said she was using the Vicks product to oil her lips. She said when her lips were dry, she used the Vicks product to moisten her lips.  The events did not lead to emergency room or physician office visit. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pruritus, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Have a lump there now, over from the injection site, it's really itching; Have a lump there now, over from the injection site, it's really itching; it was a little sore/ sort of sore; left side was really itchy; had a small lump; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 at the age of 67-years-old (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included ongoing inactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for thyroid disorder from an unspecified start date in 2001 (20 years before 15Apr2021) and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she was just having a lump there now, its not at the injection site, its over from it and its really itching. She stated the lump started on 13Apr2021. The patient received her shot on 08Apr2021 and it was a little sore from 13Apr2021. Her left side was really itchy, had a small lump, and was sort of sore, but is unsure if it's from her laying on that side. She did not know if it's one of the side effects. No treatment was received for the adverse events. The outcome of events sore, left side was really itchy, had a small lump was not recovered, of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dizziness, Feeling cold
Clinical narrative: Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury
Clinical narrative: stated that he hurt his back; This is a spontaneous report from a contactable consumer(patient). A 56-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 19-MAR-2021 at the 56 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient stated that hurt his back last week in Apr2021 and his appointment was Friday of last week for the second shot. Wanted to know what to do about second shot. Stated that he worked and wanted to know if there was somewhere that he could go. Wanted to how long to wait to get the second one. Stated that he had the first one on 19Mar2021 and the second one was scheduled for 09Apr2021. Wanted to know if it was too late. Stated that he was just getting ready to go back to work. Stated that he thought that he was a He-man. The outcome of the event was unknown. Clarified hurting his back was not from the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the event Back injury is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable other nurse. A 16-year-old female patient received first dose of BNT162B2 via intramuscular administered in deltoid left on an unspecified date (Batch/Lot Number and expiration date were unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient just had a sore arm on an unspecified date with outcome of unknown. Reporter think the causality between event and suspect vaccine was related.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 16:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included sulfa allergy and was diagnosed with COVID-19. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with anti-viral and steroid. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: reports having the usual sore arm after day or two/had a sore arm, but states that was normal soreness; This is a spontaneous report from a contactable consumer (patient). The patient reported events for two doses. This case is regarding dose 1. A 73-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Feb2021, patient received her 1st dose of the Pfizer COVID vaccine and reported having the usual sore arm after day or two (Feb2021), but stated that was normal soreness. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Tremor
Clinical narrative: back pain; Left leg it keeps shaking alone; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 09:30 at 17-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter (caller) calling about her daughter. Asked if these were normal symptoms and should be worried. Caller reported that her daughter took her first vaccine dose at 0930 this morning. She reports that her daughter has never had a flu shot or vaccine of this kind. She reports that they waited the recommended 15 minutes after getting the vaccine. They got home and about 30 minutes after the vaccine (15Apr2021 10:00) her daughter started having back pain, slight back pain and her left leg it keeps shaking alone. She reports that when she stands up it shakes, and it comes and goes. She asks if this is normal or should she be concerned. Caller reports that she already spoke with safety, no reference number for that encounter. Caller reported that she wanted to end the call so she could call her doctor, she did not provide any additional information at this time. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Haemoglobin, Herpes zoster, Investigation, Mean cell volume
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old patient of an unspecified gender received BNT162B2 (COVID-19 VACCINE, lot number: ER8733, expiration date: 31Jul2021), via an unspecified route of administration on 01Apr2021 at 2nd dose, single for COVID-19 immunisation. Medical history included follicular lymphoma in which the patient had undergone chemotherapy, they finished the last round of chemo in August; and white blood cell count which has been lower from the very beginning. Concomitant medication included rituximab (RITUXAN) from 2019 as immunotherapy. Knowing that the patient was going to be getting the vaccine, his/her physician held off the last treatment. The patient hasn't had treatment in almost probably 9 weeks before receiving the first vaccine. The patient previously received BNT162B2 (COVID-19 VACCINE, lot number: EN6204, expiration date: Jun2021), via an unspecified route of administration on 12Mar2021 at 1st dose, single for COVID-19 immunisation. The patient received the second vaccine dose on 01Apr2021 and on 02Apr2021 or 03Apr2021, the patient thought he/she was coming down with a kidney infection, his/her whole body around the kidney area (all over the body, back, and lower back on right hand side) was in excruciating pain. They did full range of tests, blood work and stuff on Apr2021 and the emergency room send the patient home saying that he/she pulled a muscle. The patient then clarified that he/she went to the emergency room because the symptoms were similar. The patient thought that he/she was coming down with kidney infection, but nothing came through. They sent the patient home, saying that he/she pulled a muscle, but it's was incorrect (as reported). By Tuesday evening (06Apr2021), the pain had not subsided, it had increased actually, and a rash started down his spine, and on Thursday of last week (08Apr2021), the patient was diagnosed with shingles. So, the patient believed that this has to do with the vaccination. With regards to treatment, the patient mentioned that the only thing that they did in the emergency room was they sent him/her home with the pain pills and that was it because they assumed that the patient pulled a muscle. When he/she went to see the doctor the following Thursday, the doctor was treating the shingles once the patient was diagnosed with shingles. When asked for lab tests, the patient stated that the only thing was the white blood cell count which has been lower from the very beginning. Her white blood cell count was low at 3.29, hemoglobin was 15.3, and MCV was 91.5, all on an unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old patient of an unspecified gender received BNT162B2 (COVID-19 VACCINE, lot number: ER8733, expiration date: 31Jul2021), via an unspecified route of administration on 01Apr2021 at 2nd dose, single for COVID-19 immunisation. Medical history included follicular lymphoma in which the patient had undergone chemotherapy, they finished the last round of chemo in August; and white blood cell count which has been lower from the very beginning. Concomitant medication included rituximab (RITUXAN) from 2019 as immunotherapy. Knowing that the patient was going to be getting the vaccine, his/her physician held off the last treatment. The patient hasn't had treatment in almost probably 9 weeks before receiving the first vaccine. The patient previously received BNT162B2 (COVID-19 VACCINE, lot number: EN6204, expiration date: Jun2021), via an unspecified route of administration on 12Mar2021 at 1st dose, single for COVID-19 immunisation. The patient received the second vaccine dose on 01Apr2021 and on 02Apr2021 or 03Apr2021, the patient thought he/she was coming down with a kidney infection, his/her whole body around the kidney area (all over the body, back, and lower back on right hand side) was in excruciating pain. They did full range of tests, blood work and stuff on Apr2021 and the emergency room send the patient home saying that he/she pulled a muscle. The patient then clarified that he/she went to the emergency room because the symptoms were similar. The patient thought that he/she was coming down with kidney infection, but nothing came through. They sent the patient home, saying that he/she pulled a muscle, but it's was incorrect (as reported). By Tuesday evening (06Apr2021), the pain had not subsided, it had increased actually, and a rash started down his spine, and on Thursday of last week (08Apr2021), the patient was diagnosed with shingles. So, the patient believed that this has to do with the vaccination. With regards to treatment, the patient mentioned that the only thing that they did in the emergency room was they sent him/her home with the pain pills and that was it because they assumed that the patient pulled a muscle. When he/she went to see the doctor the following Thursday, the doctor was treating the shingles once the patient was diagnosed with shingles. When asked for lab tests, the patient stated that the only thing was the white blood cell count which has been lower from the very beginning. Her white blood cell count was low at 3.29, hemoglobin was 15.3, and MCV was 91.5, all on an unspecified date. The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus rt. side dominant. beginning < 7 days after last dose; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, at age 60 years, administered in right arm on 18Feb2021 15:30 (Batch/Lot number was not reported) as 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. No other vaccine in four weeks and no other medications in two weeks. Patient historically took first dose of BNT162B2 on 28Jan2021 03:30 AM, on the right arm at age 60 years for COVID-19 immunisation. On 23Feb2021, the patient experienced tinnitus rt. side dominant. beginning < 7 days after last dose and ongoing to date. Therapeutic measures were taken as a result of tinnitus includes offer of biotherapy. AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 13Apr2021 (post-vaccination). Facility type vaccine was other. The outcome was not recovered.   Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: had blotches on her arm; This is a spontaneous report from a contactable consumer reported for herself. A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 Immunization. The patient experienced had blotches on her arm on Apr2021. She went to the dermatologist Friday and she didn't think it was that. She stated now that she knows some people might have this, she might mention it to her. The dermatologist prescribed her with a cream. She stated the internet was saying take Allegra or Benadryl. How long does this last. She stated this was with her second dose of the vaccine on 01Apr2021, but this didn't show up until Thursday, 2 weeks later. Therapeutic measures were taken as a result of had blotches on her arm. Outcome of the event was unknown.    No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Pain
Clinical narrative: tiredness and weakness; tiredness and weakness; back aches; side aches; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included very bad neck pain from an unknown date and doctor wanted him to take methylprednisolone for this. The patient's concomitant medications were not reported. The patient experienced tiredness and weakness on an unspecified date in Apr2021. Patient asked was tiredness and weakness a side effect of the vaccine? He was getting back aches and side aches in Apr2021, but that could be from laying down. He stated he just has so many things going on with him. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: his tinnitus has been "bothering me more than usual" and "seems like it's getting louder".; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (reported as "last Saturday") at single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were unknown. The patient's tinnitus had been "bothering me more than usual" and "seems like it's getting louder". The patient asked if this was a reported side effect after receiving the vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nerve injury, Paraesthesia
Clinical narrative: Experiencing a "burning, tingling" sensation in her upper body, chest, back, face,  head, and arms/she felt this sensation in her feet and leg as well; experiencing a "burning, tingling" sensation in her upper body, chest, back, face,  head, and arms/she felt this sensation in her feet and leg as well; She is worried that she may have some type of nerve damage; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The following Wednesday night on 14Apr2021, the patient started experiencing a "burning, tingling" sensation in her upper body, chest, back, face, head, and arms. She reported that yesterday she felt this sensation in her feet and leg as well, and reported that today she still had the "tingling" going on in her body. She reported that when she drink water, it seemed to help. Caller would like to know if this was a normal side effect following the vaccine. She was worried that she may have some type of nerve damage. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Immune system disorder, Influenza like illness
Clinical narrative: the arthritis in my hands which had been dormant for several years flared up quite painfully; overactive immune system; flu-like symptoms; This is a spontaneous report received from a contactable consumer reported for herself. This 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EP6955) in left arm on 15Mar2021 02:30 PM at single dose for COVID-19 immunization. Medical history included high blood pressure, allergies: sulfa, mold. Arthritis in hands. Concomitant medications included medications (unspecified) for blood pressure. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  About five days after on unspecified date, the arthritis in hands which had been dormant for several years flared up quite painfully, lasting almost two weeks now.  She had been diagnosed with an overactive immune system and suspect reaction to the second shot. Patient did get flu-like symptoms the second day, but no big deal. No treatment received for the adverse events. Patient did not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: spasms in the lower back; headache; little dizziness; tiredness; weakness; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN); colecalciferol (VITAMIN D3); paracetamol (TYLENOL); zinc chloride; lactobacillus acidophilus (FLORAJEN) and Multivitamin. The patient took the first dose of bnt162b2 lot number EN6204 on 15Mar2021 in left arm for Covid-19 immunization. The patient experienced the side effect of muscle spasm in her lower back, a headache, a little bit of dizziness, weakness and tiredness. She had a pain in the neck and shoulder that was kind of more like tightness rather than pain, that she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back she said her neurologist gave her an injection of some kind and she is taking goody powder to help with that pain, she said it goes away for little while and comes right back and she said she also know another female who has the same pain on neck and shoulder after she received the Pfizer vaccine as well. Treatment for events was Tylenol, rapid Tylenol, goody's powder. The outcome was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Muscle spasms, Muscle tightness, Neck pain
Clinical narrative: spasms in the lower back; headache; little dizziness; tiredness; weakness; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; having pain and tightness in her neck and shoulders; she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN); colecalciferol (VITAMIN D3); paracetamol (TYLENOL); zinc chloride; lactobacillus acidophilus (FLORAJEN) and Multivitamin. The patient took the first dose of bnt162b2 lot number EN6204 on 15Mar2021 in left arm for Covid-19 immunization. The patient experienced the side effect of muscle spasm in her lower back, a headache, a little bit of dizziness, weakness and tiredness. She had a pain in the neck and shoulder that was kind of more like tightness rather than pain, that she describe as pain and tightness in her neck and shoulder and the end it is now moved down to her lower back she said her neurologist gave her an injection of some kind and she is taking goody powder to help with that pain, she said it goes away for little while and comes right back and she said she also know another female who has the same pain on neck and shoulder after she received the Pfizer vaccine as well. Treatment for events was Tylenol, rapid Tylenol, goody's powder. The outcome was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus, Vision blurred
Clinical narrative: tinnitus had gone up; hard to sleep.; blurry vision; This is a spontaneous report from a contactable consumer reported for himself. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (on Friday 8:30 am) as single dose for covid-19 immunisation. The patient medical history included tinnitus for several years. The patient's concomitant medications were not reported. The patient experienced after his first shot, tinnitus had gone up, hard to sleep, Friday night started getting a blurry vision. The patient asked what the efficacy after the first dose was and he was not planning on getting his second dose. He read online after the vaccine tinnitus can get worst. So many people have reported tinnitus post vaccination. Also Friday night he started getting a blurry vision. He closed eyes for 20-30 minutes and it got better. It felt like he was staring at a screen for 10 hours. It was odd. Outcome of the event blurry vision was recovering, of the other events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: body pain; Headache; Nausea; Fever; This is a spontaneous report received from a contactable consumer (patient). A 21-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Patient stated that after getting the second dose of the Pfizer COVID 19 vaccine she experienced body pain, headache, nausea and fever. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Bone pain, Chills, Diarrhoea
Clinical narrative: Had a mild fever since then; He has also had back pain; Pain in his bones; Chills; Sweats; Diarrhea; Stomach ache; This is a spontaneous report from a contactable female consumer. This female consumer reported for a 39-year-old male patient. A patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient had a mild fever which was continued, he also had back pain, pain in his bones, chills, sweats, diarrhea and stomach ache. The patient was referred to HCP. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Had a mild fever since then; He has also had back pain; Pain in his bones; Chills; Sweats; Diarrhea; Stomach ache; This is a spontaneous report from a contactable female consumer. This female consumer reported for a 39-year-old male patient. A patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient had a mild fever which was continued, he also had back pain, pain in his bones, chills, sweats, diarrhea and stomach ache. The patient was referred to HCP. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache
Clinical narrative: headache during the day; a big bruise on her leg; This is a spontaneous report from a contactable consumer(patient).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Apr2021 16:50 (Lot Number: ER8735) as single dose for covid-19 immunization.  Medical history included ongoing high blood pressure(she had this condition for the last year), ongoing acid reflux (this had been a while that she's had this, she was not sure how long), ongoing anxiety(she had this condition for a few years). Ongoing concomitant medications included citalopram taken for anxiety; omeprazole taken for acid reflux; acetylsalicylic acid (ASPIRIN (E.C.), baby aspirin) taken as blood thinner which she had been taking this off and on whenever she felt and blood pressure medication taken for hypertension. Historical vaccine included first dose of BNT162B2 at left arm, upper arm, lot: EP7533, on 24Mar2021 at 7:15pm at 59-year-old for COVID-19 immunization. There was no prior Vaccinations or events following prior vaccinations.  She declined being sick at the time of vaccination. After the second shot on 15Apr2021, she began taking aspirin because she heard about blood clots and stuff. And then she got a pedicure where they did a massage. She woke up Saturday morning(17AprR2021) and had a big bruise on her leg(not at the injection site), but she had gone the day before and got a massage so maybe the bruise was from that pedicure massage. She was not sure what caused it, she didn't hit anything, that they sometimes hit you up there, it was a deep tissue massage, under her right knee, the calf, the under side. Since 17Apr2021, she had been waking up with a headache in the morning for a few days, headache didn't start until the 17Apr2021, she was taking ibuprofen(treatment), headache has not worsened, it was a dull headache. There was no emergency room, no physician office needed. Outcome of a big bruise on her leg was recovering, of headache was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (100.1); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 6955), via an unspecified route of administration, in right arm on 10Apr2021 11:00 (at the age of 47-years-old) at single dose for COVID-19 immunization. Medical history included asthma and amoxicillin allergy. The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced fever (100.1) on 18Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was resolved on an unspecified date.  No follow-up attempts are needed. No further information is expected.