chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: did fine, my arm was a little sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "did fine, my arm was a little sore".  Additional information: The patient received first dose on 18Apr2021, second dose was scheduled on 09May2021. She was asking if she could change her appointment to 03May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Weakness; Tired; cant sleep; Nausea; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 14:30 (Lot number: EW0164) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; ASTHENIA (non-serious), outcome "recovering", described as "Weakness"; FATIGUE (non-serious), outcome "recovering", described as "Tired"; INSOMNIA (non-serious), outcome "recovering", described as "cant sleep"; NAUSEA (non-serious), outcome "recovering", described as "Nausea"; CHILLS (non-serious), outcome "recovering", described as "chills"; HEADACHE (non-serious), outcome "recovering", described as "headache". It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, fatigue, insomnia, nausea, chills, headache.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea
Clinical narrative: Dizziness; Weakness; Tired; cant sleep; Nausea; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 14:30 (Lot number: EW0164) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; ASTHENIA (non-serious), outcome "recovering", described as "Weakness"; FATIGUE (non-serious), outcome "recovering", described as "Tired"; INSOMNIA (non-serious), outcome "recovering", described as "cant sleep"; NAUSEA (non-serious), outcome "recovering", described as "Nausea"; CHILLS (non-serious), outcome "recovering", described as "chills"; HEADACHE (non-serious), outcome "recovering", described as "headache". It was unknown if therapeutic measures were taken as a result of dizziness, asthenia, fatigue, insomnia, nausea, chills, headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Prior to getting the shot I would have migraines for about 4 years but since then I have not had any headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: migraines for about 4 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot, lot: EL9264), administration date: 18Feb2021, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Prior to getting the shot I would have migraines for about 4 years but since then I have not had any headaches".  Additional information included as he received Covid vaccine both shots and he had a benefit from it. Prior to getting the shot he would have migraines for about 4 years but since then he has not had any headaches, not as frequent not as nothing. He didn't expect this.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Culture stool, Diarrhoea, Pain in extremity, SARS-CoV-1 test negative, Urine analysis
Clinical narrative: Diarrhea, after both vaccines; Right arm sore, after both vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Apr2021 (Lot number: EP1533) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; Lot no. EL1283; Site: right arm), administration date: 19Mar2021, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Diarrhea, after both vaccines"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (17Apr2021), described as "Right arm sore, after both vaccines". The events "diarrhea, after both vaccines" and "right arm sore, after both vaccines" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, pain in extremity.  Additional information: The patient was treated with Pepto Bismol and it got better and then later came back. Caller states he took a COVID virus test and it came back negative. Caller states he had a doctor's appointment last Thursday, and they did a urine test, and a culture for his stool. Caller states he has a Cat Scan scheduled, but was waiting for insurance approval. No prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Premature menarche
Clinical narrative: long 24 hour after my first dose I got my period few days earlier than normal like 4 days earlier; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8733) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE MENARCHE (non-serious) with onset 2021, outcome "not recovered", described as "long 24 hour after my first dose I got my period few days earlier than normal like 4 days earlier"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea". Therapeutic measures were taken as a result of premature menarche.  Additional information:  The patient stated that she did Cystofert medicine for event of premature menarche. Patient received the second dose of the Pfizer BioNTech COVID-19 Vaccine last Friday have experienced side effects. She did not specify all the side effects she has experienced but she did mentioned nausea and she mentioned that she wanted to know menstrual cycle could be affected by this vaccine. but she didn't go to explaining what is happen exactly." Patient was calling to that what she was experiencing abnormal side effects. So, she got her second dose this past Friday and long 24 hour after her first dose she got her period few days earlier than normal like 4 days earlier and she just letting us she is not on the pills but she is very, very regular so, she wanted to letting know use to her period being, and she unusually track it and patient usually receive it 1 or 2 days before or after so, and then for the time she received her second dose she need to not for like 6 to 7 days and starting feeling like she know, to feel it, how she done, oh this is, it's coming early. The patient stated that she took OTC when she need it.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Pain in armpit of vaccinated arm; This is a spontaneous report received from a non-contactable reporter (Pharmacist). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 24Apr2021 at 11:15 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: intravenous (IV) morphine, reaction(s): "Itching", notes: IV Morphine. The following information was reported: AXILLARY PAIN (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Pain in armpit of vaccinated arm". Therapeutic measures were not taken as a result of axillary pain.  Additional information: The patient received the vaccine in the right upper arm (shoulder). The patient had not been diagnosed with COVID-19 prior to vaccination and had not testes for COVID-19 post vaccination. The patient had no other relevant medical history a part from the itching with IV morphine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: His psoriasis was cured after he got his vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1), for Covid-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "His psoriasis was cured after he got his vaccine".  Additional information: His psoriasis was cured after he got his vaccine. Patient stated, "The reason was that he called Pfizer was that he wanted to report that since he had his full vaccination which was, he got his second shot on 04Mar. He suffered from psoriasis, fairly bad and it had cleared up on his body. So, he wanted to let Pfizer know the side effect for me of having your vaccine was that it cleared my psoriasis." When paraphrased the concern, Patient stated, "Not completely but 90% cleared. He just wanted to report something positive."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Sleepy; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Feb2021 15:15 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (Flu shot in november), reaction(s): "pain in left shoulder for about a month". The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sleepy"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache". Additional information: Patient did not receive any vaccinations within four weeks. Patient did not receive any Concomitant drugs. Patients did not have any medical history. Patients did not have any relevant tests. After vaccine patient slept longer than usual (11-12 hrs for 3 days), and experienced headache for 2 days (mild, annoying).  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Dull Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 09:10 (Lot number: EW0175) at the age of 82 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for thyroid disorder (ongoing); LOVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Single; 13:15 PM; Batch/Lot No.: ER8732; Anatomical Location: Left Arm, Vaccination site, administration date: 31Mar2021, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Dizzy"; HEADACHE (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Dull Headache".  Additional information: She reported that she got 2 shots and called for the last one shot. She got her shot Friday morning and on Saturday morning when she got out of bed she was dizzy and had to hold onto the bed so she wouldn't fall down. She got up in the night and she was still dizzy. She said that it has been going on since Saturday. She also had a dull headache during the daytime and asked if this was normal. She said that the dizziness only happens when she gets out of bed after she has been laying down. Dull headache was not continuous, it kind of comes and goes during the daytime and the dizziness began in the morning. She got up in the night to go to bathroom, also in the morning when she got up, she been dizzy ever since. She experienced dull headache on Saturday night. Headache was not getting worse, it was still just kind of ongoing. The reporter stated that only medications she took was for her thyroid and cholesterol and that she did not think it had anything to do with this and has been taking levothyroxine and lovastatin for years. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. The patient never had a vaccine that she knows of in her whole life and if she did have a vaccine, it was when she was little. Additional vaccines administered on same date of the Pfizer Suspect was reported as no. Prior Vaccinations (within 4 weeks) was reported as no. The reporter denied being sick at the time of vaccination. NDC number and expiry date of COVID 19 vaccination was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: intense pain in left arm; arm was useless; slight discomfort pain; Couldn't sleep; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Apr2021 08:30 (Lot number: ER8737) at the age of 60 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Arrhythmia" (ongoing); "Diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medications included: ELIQUIS taken for arrhythmia; INSULIN taken for diabetes mellitus. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 16Apr2021, outcome "recovered" (17Apr2021), described as "slight discomfort pain"; PAIN IN EXTREMITY (non-serious) with onset 18Apr2021, outcome "recovered" (22Apr2021), described as "intense pain in left arm"; MOBILITY DECREASED (non-serious) with onset 18Apr2021, outcome "recovered" (22Apr2021), described as "arm was useless"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "Couldn't sleep".  Additional information: Caller stated he was calling regarding the Covid Pfizer vaccine. Had really bad Covid arm in the left arm. Had very intense pain. It didn't start until 10 days after the vaccination. It was good for 10 days. Had 2 days of slight discomfort. Had a week of intense pain and the left arm is useless. Couldn't sleep for two and a half days. Took the vaccine 6 Apr 2021. On 16 Apr 2021 and 17 Apr 2021 had slight discomfort pain. From 18 Apr 2021 to 22 Apr 2021, had very intense pain. Couldn't sleep 2 and a half days because of the pain, until currently, today 23 Apr 2021 am back to slight discomfort. Had an ice pack on it right now. It was much better now. Treatment received was just ice packs. Yesterday, he went to take blood work. Was just routine checkup and it was not due to the left arm.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Odd taste when eating food sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP7534) at the age of 65 years as dose 1, single and administered in arm left, administration date 05Apr2021 14:30 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: Aug2012 (ongoing). The patient's concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "Odd taste when eating food sometimes".  Additional info: Caller stated that he had his second dose of the Covid 19 Vaccine about 3 weeks ago the day of report. He was wondering if a side effect of the vaccine can be that it effects the taste of food. Stated he had an odd taste when eating food sometimes. Patient was uncertain of when his symptoms began. Stated he believes it began after the first dose and has continued. Patient didn't have bad symptoms when he had the virus. Said he would not have known he was sick, but he knew he had been exposed so he got tested. This was prior to either dose of the Vaccine. Patient denies any other medications, medical conditions, labs, testing, or treatments relevant to event. No prior vaccinations within 4 weeks. AE  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feels tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Feels tired".  Additional information: Caller stated he was calling regarding the Pfizer Covid 19 vaccine. While reporting his own symptoms, caller mentioned that his wife took the first shot and the only thing she experienced was that she feels tired. That was it. The reporter was husband. NDC number of Covid 19 vaccine was not provided. Reason for no lot number: of Covid 19 vaccine was not probed over call. Investigation Assessment was not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Severe nerve pain in left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPAR. The following information was reported: NEURALGIA (non-serious) with onset 02Apr2021, outcome "not recovered", described as "Severe nerve pain in left leg". Therapeutic measures were taken as a result of neuralgia.  Additional information: It was reported that severe nerve pain in left leg happening since the vaccine and have seen multiple doctors, she have to go scans, she need to be in contact about this with someone, she just need to talk to some body that was to report and talk to some body. The patient was treated with Gabapentin 100 mg three times a day for the event.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: noises in the head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st DOSE), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "noises in the head".  Additional information included: The patient received Pfizer vaccine two times and had tinnitus at the time of reporting. The patient enquired what could be done about tinnitus. The patient read on internet many people complaint about it. The patient was not alone. When paraphrased the concern, consumer stated, it was tinnitus, it is noises in the head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: After my 1st vaccination I was nauseous for the 2 days immediately after my vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 14:30 (Lot number: ER8733) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reynaud's syndrome" (unspecified if ongoing); "hx of DVT" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "recovered", described as "After my 1st vaccination I was nauseous for the 2 days immediately after my vaccination". Therapeutic measures were not taken as a result of nausea. Additional information: the patient did not take other vaccine in four weeks nor other medications in two weeks. The patient was nauseous for the 2 days immediately after her first vaccination. The patient had no COVID prior vaccination and was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488765 same patient/drug, diff dose/event
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: raging headache; brain fog; terribly fatigued; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 14:30 (Lot number: EN6208) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Reynaud's syndrome" (unspecified if ongoing); "hx of DVT" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; lot number ER8733;vaccine location: Left arm; administration time=02:30 PM), administration date: 11Mar2021, when the patient was 44 years old, for Covid-19 immunisation, reaction(s): "nauseous". The following information was reported: HEADACHE (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "raging headache"; FEELING ABNORMAL (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "brain fog"; FATIGUE (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "terribly fatigued". Therapeutic measures were not taken as a result of headache, feeling abnormal, fatigue. Additional information: After 2nd vaccination developed a raging headache, brain fog and was terribly fatigued on the 3rd day after shot, with increasing fatigue, brain fog and headache on the 4th day after shot. It took another 2 days for patient to feel 100% better again.No covid prior vaccination. No covid tested post vaccination. No known allergies.No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488734 same patient/drug, diff dose/event
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea, Pain, Vomiting
Clinical narrative: I was try to lay down certain way you moved that pain was hit horrible; I was so nauseous; I had vomit; A sharp pain in my right side of the lower back and like part of my body; I couldn't even move; I felt that whole night mostly on my feet because I couldn't sit, couldn't lay down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 10:00 (Lot number: EW0153, Expiration Date: 21Apr2022) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 22Apr2021 15:00, outcome "unknown", described as "A sharp pain in my right side of the lower back and like part of my body; I couldn't even move; I felt that whole night mostly on my feet because I couldn't sit, couldn't lay down"; NAUSEA (non-serious) with onset 23Apr2021, outcome "recovered" (2021), described as "I was so nauseous"; VOMITING (non-serious) with onset 23Apr2021, outcome "unknown", described as "I had vomit"; PAIN (non-serious), outcome "unknown", described as "I was try to lay down certain way you moved that pain was hit horrible".  Additional Context: The patient had a second shot Pfizer vaccine at Pharmacy, 22Apr2021 and appointment was at 9:45 the shot was given at sharp exactly 10am and came home at 3 O' Clock at the afternoon a sharp pain in right side of the lower back and like part of my body, couldn't even move, felt that whole night mostly on feet because couldn't sit, couldn't lay down. By Friday was so nauseous, fall as long as could by afternoon had vomit , was try to lay down certain way you moved that pain was hit horrible, daughter wanted to go emergency room, no, you go to emergency room you sit for 12 hrs. then couldn't sit so yesterday Saturday when got up off the couch, it wasn't quite bad, that was the third day. She wasn't nauseous anymore, so drunk some warm soda today the nauseous all gone, the pain is just certain way move, it is gladly, but it's nothing like when its 1st hit that was horrible. The patient just saw should report this in case it affect somebody else, they all know this, and that part of the after affect the shot may be. The patient came home right after the shot and at 3 pm in the afternoon same day that's when the pain grabbed, that mean grabbed couldn't move and so for that whole night you couldn't sit, you couldn't lay down, it was horrible really just horrible. Right now it's only just a certain way you move every now and then what I can live that comparative and the nauseous that's all gone. It was Thursday, Friday, Saturday today is the 4th day and guess mean today, the nauseous is definitely gone I was able to eat breakfast this morning.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Migraine, Tinnitus
Clinical narrative: Tinnitus in my right ear; pressure in right ear; migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 15:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 09Apr2021 23:00, outcome "recovering", described as "Tinnitus in my right ear"; EAR DISCOMFORT (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "pressure in right ear"; MIGRAINE (non-serious) with onset 09Apr2021 23:00, outcome "not recovered", described as "migraine headache". The events "tinnitus in my right ear", "pressure in right ear" and "migraine headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, ear discomfort, migraine.  Additional information: Patient reported that, Immediately in the next day the tinnitus spread to his left ear and it was a continuous high-pitched ringing. The patient never had tinnitus before. The tinnitus began to subside after two weeks. Therapeutic measures were taken as a result of the reported events included antibiotics (unspecified). The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have a history of any past drug therapy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Ophthalmological examination
Clinical narrative: ocular migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 12:30 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OPHTHALMIC MIGRAINE (non-serious) with onset 12Apr2021, outcome "recovered", described as "ocular migraine". The event "ocular migraine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ophthalmic migraine.  Additional information: facility type vaccine: pharmacy or drug store. Patient did not receive any other vaccines in four weeks. Patient took other medications in two weeks. The patient had no known allergies. The patient was not tested for COVID post vaccination. Patient had not COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488844 same reporter/patient, different dose/AE
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: I had to go for shot in my eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "I had to go for shot in my eye".  Additional information: I had my second shot on the 21st of April scheduled; I completely forgot to go; consumer might have been missed the second dose. can I make another appointment." When paraphrased the above concern, Consumer stated, "I had to go for shot in my eye that day and I just completely forgot the other shot. I need to get an appointment for my second shot and I went to old colony drive."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Dizziness; Ringing in ears, both the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 (Lot number: EWU151) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL; TELMISARTAN; GLIPIZIDE; JARDIANCE; RABEPRAZOLE. Vaccination history included: Bnt162b2, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Apr2021, outcome "unknown", described as "Dizziness"; TINNITUS (non-serious) with onset 13Apr2021, outcome "unknown", described as "Ringing in ears, both the ears".  Additional information: The reporter wanted to report the side effect of her second vaccine. The reporter stated, Ringing in ears, both the ears and it started 2 days after vaccination which was 13Apr2021. It was also reported that the patient was been getting light headaches. On 07Apr2021, the patient took an ultrasound on the thyroid because after 1st vaccine it swelled up and a biopsy was scheduled for unspecified year of May 4th. The ultrasound results revealed nodules 4 mm on right side and a 2 mm and a 3 mm on the left side. Biopsy was scheduled for the right side. The patient said at the time of the report that she was experiencing the event for 3 days. Patient was also experiencing dizziness and was received some unspecified medicine along with Allegra and Meclizine 25 mg . It was also reported there is no expiration date on the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: Tinnitus; usual aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 09:00 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: TINNITUS (non-serious) with onset 16Mar2021 16:00, outcome "not recovered", described as "Tinnitus"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "usual aches and pains". The event "tinnitus" was evaluated at the physician office visit.  Additional Information: patient has worked in the health care industry for many years. Patient visited to Physician Office.No Emergency Room visit. he has not received the second dose. History of all previous immunization with the Pfizer vaccine considered as suspect: None   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: First dose: felt achy; First dose: little bit of chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: asthma; "covid-19", start date: Mar2020 (unspecified if ongoing); "Pneumonia" (unspecified if ongoing). Concomitant medication(s) included: INHALERIN. The following information was reported: PAIN (non-serious), outcome "unknown", described as "First dose: felt achy"; CHILLS (non-serious), outcome "unknown", described as "First dose: little bit of chills".  Additional information: The caller reports her son received both of his Covid 19 vaccines and he was sick with both doses. The second dose was really bad for him. She does not know if her son filed a safety report. The caller reports her son had the Covid 19 virus in Mar2020 before masks were mandatory and he was one of the first groups who contracted the Covid 19 virus before anyone knew anything about the virus. He works and he traveled. He contracted the Covid 19 virus there along with two coworkers. She reports her son is a Covid 19 "long hauler". She clarified that after he had the Covid 19 virus he's had continual relapses and problems after having the virus. He decided to get the Covid 19 vaccine because he had read that people who are Covid 19 "long haulers" are having success in eliminating their long term Covid 19 virus symptoms. She reports that her son was fine the day he received the Covid 19 vaccine. She reports he was excited to have received the vaccine. Her son's first Covid 19 vaccine she reports was mild. Her son felt achy and had a little bit of chills. She does not know the dates her son received his Covid 19 vaccines, or the NDC/Lot/Expiry for either dose. She reports he was not hospitalized when he had the Covid 19 virus. Her son was advised to stay out of the emergency room. She reports her son hasn't been for a thorough check up at the doctor's office at that time in Mar2020, her son did do video doctor's appointments and he was prescribed an antibiotic for pneumonia. When probing adverse events for other vaccinations, she reports he works and travels extensively and probably was getting all kinds of vaccines for his traveling. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not experience any adverse events prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Experienced a swollen lymph gland in her armpit on the side of where she received the vaccine which is her left side; tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 12:00 (Lot number: ER8729, Expiration Date: 14Apr2021) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial hysterectomy" (not ongoing). Concomitant medication(s) included: ESTRADIOL taken for hysterectomy. Vaccination history included: Bnt162b2 (Dose 1 single, at 09:30am, lot- EN6207, Expiry date- 31Jul2021,), administration date: 20Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "recovering", described as "Experienced a swollen lymph gland in her armpit on the side of where she received the vaccine which is her left side"; TENDERNESS (non-serious) with onset Apr2021, outcome "unknown", described as "tenderness". Therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: Patient had no Prior vaccinations within 4 weeks. The patient did take an anti-inflammatory medication she had on hand and it seemed to help and was Meloxicam and was a small dose but she does not know the dosage and states it may be 0.15 but she is not sure. she took Estridol and did not know the dose but it was a low dosage and she began taking it probably about 8 years ago for a partial hysterectomy and takes it once per day by mouth.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: I had developed two small red bumps all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes type 1; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. The following information was reported: RASH PAPULAR (non-serious) with onset 2021, outcome "unknown", described as "I had developed two small red bumps all over my body".  Additional information: The patient stated About 2 weeks ago I got the first dose of the Pfizer vaccine and probably about 2 weeks later I had developed two small red bumps all over my body. Vaccine name: Pfizer Covid 19 vaccine. LOT# and expiration Date: Patient stated I am not sure what the 5th letter is its going to either be an E or S, let me get my glassed hold on. I think its an E, I am not sure what the first letter is and the second one looks like R873F its not a 7, so then last one will be number 7. NDC UPC & expiration date of Vaccine: Patient stated If that be on my card, I don't know. Treatment: Patient stated I recently got a cream tube it is Triamcinolone. Concomitant Products: Patient stated Sorry do not remember the name for blood pressure medicine. I am on Inhaler for Asthma. Other product: yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: wasn't able to roll over on top of his arm; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Lot number: EN4204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing), notes: he exercises a lot but doesn't eat right. Cholesterol was pretty good until about 2-3 years ago. Concomitant medication(s) included: TETANUS VACCINE taken for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "Sore arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "wasn't able to roll over on top of his arm".  Additional Information: The patient was on cholesterol medication as his cholesterol got bad 2-3 years ago. Patient reported that, he felt his sore arm before he left the store and he wasn't able to roll over on top of his arm. He also reported that the sore arm lasted for a day or two, matter of fact about a day. Patient works out a lot. Patient reported that, his doctor said that he works out too much. He exercises 1 to 2 hours daily except for Saturday and Sunday. It was reported that, additional administered vaccines were none. Adverse event did not result in emergency room visit or physicians office visit. It was reported that, the patient received Tetanus shot a month or two before the first dose of the Covid-19 vaccine. There was no family medical history relevant to adverse event. No adverse events following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got a little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 22Apr2021, outcome "unknown", described as "I got a little sick".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: back pain; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: Reporter stated my daughter had, she had the back pain but she had the different one. She had the chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488779 same reporter/drug, different patients/AE;US-PFIZER INC-2021490065 same reporter/drug, different patients/AE
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: She had the chills you know the whole gamut and so did her fiance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She had the chills you know the whole gamut and so did her fiance".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490064 same reporter/drug, different patients/AE;US-PFIZER INC-2021488779 same reporter/drug, different patients/AE