chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache; nausea; muscle pain; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  Additional Information: Patient has been experiencing tiredness, headache, nausea, muscle pain questioning that how long will the symptoms last, Husband died and she is just living alone, she wants an assurance that she is ok and nothing to worry about her symptoms. Physician's Assistant told patient to rest and drink fluids. Patient reclarified states she takes Lexapro, and her husband died suddenly and she moved to (Name withheld) and her grandkids are there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Nausea; chills; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.    A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "diarrhea" (unspecified if ongoing), notes: she had diarrhea when she first started meds but has not had any in a while. Concomitant medication(s) included: IBRANCE, start date: 30Sep2019. Vaccination history included: Covid-19 vaccine (Dose 1 MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: she has heart complications; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Pfizer Sponsored Program. The reporter is the patient.  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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "she has heart complications".  Additional Information: Caller [withheld], mentioned that she and her son were due to get the second dose today which was 08Apr2021 at 3:30 PM and she would also have a Doctor's appointment because she has heart complications. Caller wants to know if she can reschedule her appointment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Toothache, X-ray
Clinical narrative: toothache; Tooth pain was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 02:45 (Lot number: EN6208) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot number: EN6198, Anatomical Location: Right arm), administration date: 06Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: TOOTHACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "toothache"; CONDITION AGGRAVATED (non-serious) with onset Apr2021, outcome "not recovered", described as "Tooth pain was reported as worsened". The events "toothache" and "tooth pain was reported as worsened" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the Pfizer vaccine and experiencing a toothache as a side effect. She had a toothache after the 2nd dose. She read with the Moderna vaccine several people complained of toothaches. It was just one tooth. The patient had x-rays and CT scans been to 2 dentists but they couldn't find anything wrong so she thought may be it had to with the vaccine. Tooth pain was reported as worsened. The tooth pain started about 7 to 10 days.The patient taking COVID Vaccine to hopefully not contract COVID. She got the first COVID vaccine on 06Mar2021 and the second one on 27Mar2021.The outcome of tooth pain was reported that it had probably worsened. It was ongoing, but it comes and goes. She received both doses in her right arm. She was wondering if any one else has had any tooth pain with Pfizer COVID vaccine. She has had both doses of the vaccine and is having tooth pain. She his guessing 195 pounds  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years; Feel sick; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 32196 (BioNtech).  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 02Apr2021, outcome "recovered" (08Apr2021), described as "Feel sick"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got his shot on Friday 02Apr2021, around noon and his lungs do feel "sick" which was fine in the sense he didn't enjoy or wanted to smoke marijuana. He was smoking marijuana through what felt like COVID symptoms. He would have contracted COVID before any tests were around and tested negative when the tests were produced, given he thinks he got COVID in 2019. It was unknown if the Health Authority was notified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung disorder, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years; Feel sick; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 32196 (BioNtech).  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 02Apr2021, outcome "recovered" (08Apr2021), described as "Feel sick"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I got my first Covid-19 Booster, which was the Pfizer one, and my brain cleared up... better than it's been for years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got his shot on Friday 02Apr2021, around noon and his lungs do feel "sick" which was fine in the sense he didn't enjoy or wanted to smoke marijuana. He was smoking marijuana through what felt like COVID symptoms. He would have contracted COVID before any tests were around and tested negative when the tests were produced, given he thinks he got COVID in 2019. It was unknown if the Health Authority was notified.  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, Limb discomfort
Clinical narrative: her arm feels like someone punch it; mild headaches; 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 63 year-old female patient 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 (DOSE 1, SINGLE), administration date: 14Mar2021, for Covid 19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "her arm feels like someone punch it"; HEADACHE (non-serious), outcome "unknown", described as "mild headaches". Therapeutic measures were taken as a result of limb discomfort, headache.  Additional information: She explained despite her appointment, she waited over 5 hours to get the shot. She specified there was a waiting line; and the pharmacist encouraged her to go home after vaccination instead of being monitored as recommended stating it would be more dangerous to stay in the store with over 30 people. The patient got her first dose a week ago 14Mar2021. However, the facility where she visited scheduled her four weeks later instead of three. She was asked to return on 11Apr2021. According to her, perhaps the reason why she was scheduled four weeks later is because the facility administers the vaccines. Pfizer-BioNTech and Moderna. She wants to know the efficacy of the vaccine when received four weeks instead of three after the first dose. She explained she received the second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday. She added she spoke with somebody from the CDC who confirmed that the vaccine would maintain its efficacy, when the second dose is given 28 days after the first. She mentioned she's happy she's experiencing side effects post vaccination as it indicates that she is building a response to it. She specified her arm feels like someone punch it and she have mild headaches. She added she took Tylenol and has been drinking a lot of water.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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: MALAISE (non-serious) with onset 06Apr2021, outcome "unknown", described as "felt sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: her back is still aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back Pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "her back is still aching".  Additional information: Husband called in behalf of his wife who took the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE today 12Apr21 - She had back pain prior to getting the 1st dose - After getting vaccinated her back was still aching and wanted to know if she could take pain medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: dizzy spells; chills; pain at the left side of her neck to her head; headache; elevated blood pressure; she felt as if her body was rumbling inside; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: B6, reaction(s): "toxicity", notes: Verbatim: "She said this reaction is similar to the toxicity she previously had with B6.". The following information was reported: DIZZINESS (non-serious) with onset 09Apr2021, outcome "unknown", described as "dizzy spells"; CHILLS (non-serious) with onset 09Apr2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 09Apr2021, outcome "unknown", described as "pain at the left side of her neck to her head"; HEADACHE (non-serious) with onset 09Apr2021, outcome "unknown", described as "headache"; BLOOD PRESSURE INCREASED (non-serious) with onset 09Apr2021, outcome "unknown", described as "elevated blood pressure"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "unknown", described as "she felt as if her body was rumbling inside".  Additional information: Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 9Apr2021. She said she was scheduled to receive the 2nd dose on 19Apr2021, but plans not to get it anymore. This was because of the reaction she had 12 and a half hours after receiving the 1st dose. She said she had chills, pain at the left side of her neck to her head, headache, elevated blood pressure, and dizzy spells. Consumer said she felt as if her body was rumbling inside. She said this reaction was similar to the toxicity she previously had with B6. She wants to know how much protection she would have with just 1 dose, and how long the vaccine works.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: dizzy spells; chills; pain at the left side of her neck to her head; headache; elevated blood pressure; she felt as if her body was rumbling inside; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: B6, reaction(s): "toxicity", notes: Verbatim: "She said this reaction is similar to the toxicity she previously had with B6.". The following information was reported: DIZZINESS (non-serious) with onset 09Apr2021, outcome "unknown", described as "dizzy spells"; CHILLS (non-serious) with onset 09Apr2021, outcome "unknown", described as "chills"; NECK PAIN (non-serious) with onset 09Apr2021, outcome "unknown", described as "pain at the left side of her neck to her head"; HEADACHE (non-serious) with onset 09Apr2021, outcome "unknown", described as "headache"; BLOOD PRESSURE INCREASED (non-serious) with onset 09Apr2021, outcome "unknown", described as "elevated blood pressure"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "unknown", described as "she felt as if her body was rumbling inside".  Additional information: Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 9Apr2021. She said she was scheduled to receive the 2nd dose on 19Apr2021, but plans not to get it anymore. This was because of the reaction she had 12 and a half hours after receiving the 1st dose. She said she had chills, pain at the left side of her neck to her head, headache, elevated blood pressure, and dizzy spells. Consumer said she felt as if her body was rumbling inside. She said this reaction was similar to the toxicity she previously had with B6. She wants to know how much protection she would have with just 1 dose, and how long the vaccine works.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Coagulation factor V level abnormal
Clinical narrative: factor 5 liden; 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 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: COAGULATION FACTOR V LEVEL ABNORMAL (non-serious), outcome "unknown", described as "factor 5 liden". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of coagulation factor v level abnormal.  Additional Information: The female patient received first dose at, she did not mention that she had factor 5 Liden and was on blood thinners.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The caller also states that she had soreness in her arm after her first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The caller also states that she had soreness in her arm after her first dose".  Additional information: The reporter also states that she had soreness in her arm after her first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: First shot got a raised red bump for a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 17:15 (Lot number: En6199) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Paroxmal afib" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Graves' disease" (unspecified if ongoing); "Hashimoto" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT; ATENOLOL; HCTZ; VITAMIN D NOS; POTASSIUM. The following information was reported: RASH PAPULAR (non-serious), outcome "recovering", described as "First shot got a raised red bump for a day".  Additional information: The first shot got a raised red bump for a day. No symptoms at all.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: my mother got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: ILLNESS (non-serious), outcome "unknown", described as "my mother got sick". A dditional information: She had the first Pfizer shot. We never notified, how to go on for second but I had my second so when I talk to the person who did my second, they told, she just have to came here so that time my Mother got sick so she had not been able to get second Pfizer shot. Instead she had six week to get it but they cannot scheduled her until the 12th, that would be 4 days past 6 weeks. I am trying to find out is she have to retake the first shot again or how would that work. Is would be do work for her to do the second shot." Reporter stated, "My concern is, my mother first took the first Pfizer shot on February the 26th (Not clarify hence not captured in tab). She was not, never got a notification for her second Pfizer shot but I suggest that I have got mine and someone I talk with the Physician there, they told me that she can just come in there and take it her second shot but my mother got sick in between that time but now they are telling her, they cannot do her second shot until April the 12th but Is it that okay to her second shot or she would still be ask to able to take it because it's 6th week. I want to know, Is still be effective? Is it okay 6th week on her first shot?"    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: After 1st dose got sick and ended up in E.R; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  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: ILLNESS (non-serious), outcome "unknown", described as "After 1st dose got sick and ended up in E.R". The event "after 1st dose got sick and ended up in ER" was evaluated at the emergency room visit.  Additional information: Reporter reported that patient not had 2nd dose of vaccine and has been over 3 weeks. Reporter wondered if his mom can get 2nd dose or does she needed to start all over.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: I received my second shot in my right arm, and my right jaw was painful, but not nearly as much. And no locked up jaw.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 15:30 (Lot number: ER8734) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP controlled with medicine" (unspecified if ongoing); "slightly low thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19 , Brand= Pfizer, Lot number= EP6955, Lot unknown=False, Administration date=12Mar2021, Administration time=10:30 AM, Vaccine location=Left arm , Dose number=1), administration date: 12Mar2021, when the patient was 53 years old, for Covid-19 Immunisation. The following information was reported: PAIN IN JAW (non-serious) with onset 2021, outcome "recovered" (2021), described as "I received my second shot in my right arm, and my right jaw was painful, but not nearly as much. And no locked up jaw.". The event "i received my second shot in my right arm, and my right jaw was painful, but not nearly as much. and no locked up jaw." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in jaw.  Additional information: Patient received his second shot in his right arm and right jaw was painful, but not nearly as much. And no locked up jaw. Patient talked to dentist and he did not know if it was related or not. Just wanted to make sure he passed this along. No covid prior vaccination and covid tested post vaccination. No other vaccine in four weeks and patient took unknown other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache; 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) (Lot number: Not Provided) 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: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache".  Additional information: Reporter confirmed that he had the Pfizer Covid 19 shot on Wednesday.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Experienced fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A contactable consumer reported for her husband.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Experienced fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: aches; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 16:30 (Lot number: Er2613) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ibs-d" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB]; SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]. Past drug history included: Tramadol, reaction(s): "Known allergies: tramadol.", notes: Known allergies: Darvocet, Vicodin, tramadol.; Darvocet, reaction(s): "Known allergies: Darvocet", notes: Known allergies: Darvocet, Vicodin, tramadol.; Vicodin, reaction(s): "Known allergies: vicodin", notes: Known allergies: Darvocet, Vicodin, tramadol. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Gastrointestinal disorder
Clinical narrative: digestive issues; loss of appetite; Loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:30 (Lot number: EW0151) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, lot number: EN6208), administration date: 15Mar2021, for COVID-19 immunization, reaction(s): "she was pretty much fine". The following information was reported: DECREASED APPETITE (non-serious) with onset Apr2021, outcome "not recovered", described as "loss of appetite"; DIARRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Loose stools"; GASTROINTESTINAL DISORDER (non-serious) with onset 06Apr2021, outcome "unknown", described as "digestive issues". Therapeutic measures were taken as a result of decreased appetite, diarrhoea, gastrointestinal disorder.  Additional information: AE treatment: Caller says she was taking a probiotic and eating pretty light. She says the probiotic was pharmacy generic version of probiotic, LOT: 61278 EXP: July 2022. Caller says she has not had any other recent vaccinations within the last four weeks or day of COVID-19 vaccination. Patient underwent intestinal surgery in Mar2019.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: little soreness where they put the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Lot number: EL3302) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "Diabetes" (ongoing). Concomitant medication(s) included: IRBESARTAN; METFORMIN; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little soreness where they put the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, the first shot (Captured as Unspecified medication) she didn't had any reaction other than little soreness where they put the injection for few days. Consumer stated, she took an antacid pill twice a day it was an just over the counter. Consumer stated, She had blood work at doctor's office but that was in general for what he was treating her not in reference to the shot, She did not had the results back (not clarified further). Consumer was informed about Pfizer Medical Information Consumer further stated, she already went through, she did not go through this much detail but she talked to someone and they gave her medical information number she thought got the medical department. Consumer was provided with the number of Pfizer Medical Information. She thought she was talking to medical department. Consumer was babysitting a little 2 yr old so they can talk as long as he was watching his show. Patient was taking medication for both high blood pressure and sugar diabetic  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: excruciating pain from my shoulder to my wrist down the entire arm; It's just feel like a nerve pain not just soreness; I cannot use my hand; I cannot move the left arm with this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 80 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: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "excruciating pain from my shoulder to my wrist down the entire arm"; NEURALGIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "It's just feel like a nerve pain not just soreness; I cannot use my hand"; PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I cannot move the left arm with this pain". Therapeutic measures were taken as a result of pain in extremity, neuralgia, pain.  Additional Information: The reporter stated, "I had my first vaccine, approximately one hour after the vaccination I have had excruciating pain from my shoulder to my wrist down the entire arm and this is over three weeks now almost I cannot move the left arm with this pain. Well it's just everyone is little away it's just feel like a nerve pain not just soreness I am in a shaft I cannot use my hand without using a pain pill I have taken Tylenol does help once".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: excruciating pain from my shoulder to my wrist down the entire arm; It's just feel like a nerve pain not just soreness; I cannot use my hand; I cannot move the left arm with this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 80 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: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "not recovered", described as "excruciating pain from my shoulder to my wrist down the entire arm"; NEURALGIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "It's just feel like a nerve pain not just soreness; I cannot use my hand"; PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I cannot move the left arm with this pain". Therapeutic measures were taken as a result of pain in extremity, neuralgia, pain.  Additional Information: The reporter stated, "I had my first vaccine, approximately one hour after the vaccination I have had excruciating pain from my shoulder to my wrist down the entire arm and this is over three weeks now almost I cannot move the left arm with this pain. Well it's just everyone is little away it's just feel like a nerve pain not just soreness I am in a shaft I cannot use my hand without using a pain pill I have taken Tylenol does help once".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: I have had excruciating pain from my shoulder to my wrist down the entire arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 80 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: PAIN (non-serious), outcome "unknown", described as "I have had excruciating pain from my shoulder to my wrist down the entire arm". Therapeutic measures were taken as a result of pain.  Additional information: The patient stated, "had my first vaccine (Unspecified Vaccine, Pfizer was not checked as the manufacturer was not probed over the call) on 02Apr2021, approximately one hour after the vaccination patient had excruciating pain from my shoulder to my wrist down the entire arm and this is over three weeks now almost I cannot move the left arm with this pain." The patient stated "Well it's just everyone was little away it's just feel like a nerve pain not just soreness patient in a shaft patient cannot use my hand without using a pain pill patient had taken Tylenol did help once, patient had the second shot last Friday patient got extremely sick two hours later but very bad flu like very bad flu like patient was sick at patient had been on bed for days patient better today however patient did not seem to care any taste in mouth." When paraphrased the above concern, patient stated, "Yeah was there anything patient can, my primary care said sometime that happens, so what was patient supposed to do for this now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: I have had excruciating pain from my shoulder to my wrist down the entire arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 80 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: PAIN (non-serious), outcome "unknown", described as "I have had excruciating pain from my shoulder to my wrist down the entire arm". Therapeutic measures were taken as a result of pain.  Additional information: The patient stated, "had my first vaccine (Unspecified Vaccine, Pfizer was not checked as the manufacturer was not probed over the call) on 02Apr2021, approximately one hour after the vaccination patient had excruciating pain from my shoulder to my wrist down the entire arm and this is over three weeks now almost I cannot move the left arm with this pain." The patient stated "Well it's just everyone was little away it's just feel like a nerve pain not just soreness patient in a shaft patient cannot use my hand without using a pain pill patient had taken Tylenol did help once, patient had the second shot last Friday patient got extremely sick two hours later but very bad flu like very bad flu like patient was sick at patient had been on bed for days patient better today however patient did not seem to care any taste in mouth." When paraphrased the above concern, patient stated, "Yeah was there anything patient can, my primary care said sometime that happens, so what was patient supposed to do for this now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site reaction
Clinical narrative: minor allergic reaction; hands started swelling a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Unknown) at the age of 27 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: VACCINATION SITE REACTION (non-serious) with onset 26Mar2021, outcome "unknown", described as "minor allergic reaction"; PERIPHERAL SWELLING (non-serious) with onset 26Mar2021, outcome "recovered" (27Mar2021), described as "hands started swelling a lot". Therapeutic measures were taken as a result of vaccination site reaction, peripheral swelling.  Additional information: The patient took pfizer Covid vaccine because of general wellness. Had a minor allergic reaction five hours after. Caller report a history of getting hives as a reaction randomly throughout caller's life. Most recently caller had a reaction after receiving the typhoid vaccine, like 5 years ago. Hands started swelling a lot: Began 5 hours after receiving first dose Pfizer Covid Vaccine. By the next day the swelling was completely gone. Caller confirms it was gone entirely, without lasting effects. Zyrtec was received as treatment and caller's hand swelling had gone away. Reports Zyrtec alleviates that, no covid prior to vaccination, no investigation assessment. Event Caller reports the Typhoid Vaccine reaction was 5 years ago. Reports it was the oral Typhoid vaccine you take for five days in a row. Caller's body didn't like getting Typhoid every day for three days.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: didn't feel well; my arm was hurting; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: XELJANZ XR. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "didn't feel well"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "my arm was hurting".  Additional Information: The patient received COVID-19 vaccine a few weeks ago (2021) and then didn't feel well and her arm was hurting. She was supposed to get her second dose soon but would like to postpone it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very tired; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 49 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 17:00 (Lot number: ER2613) at the age of 49 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma (moderate); "Post-traumatic stress disorder" (unspecified if ongoing), notes: PTSD; "Fibromyalgia" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medications included: ZOLOFT; DULERA; FLONASE [FLUTICASONE PROPIONATE]; ALLEGRA; SINGULAIR. Past drug history included: Vicodin, reactions: "Drug allergy", notes: known allergies: Vicodin; Dilaudid, reactions: "Drug allergy", notes: known allergies: Dilaudid. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Very tired".  Additional information: On an unknown date in 2021, after the first vaccination on 18Mar2021, the patient was very tired. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I did have some headaches probably within that first week; This is a spontaneous report received from a 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 right, administration date 19Mar2021 10:30 (Lot number: ER6199) at the age of 45 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: HEADACHE (non-serious) with onset 09Apr2021 11:45, outcome "recovering", described as "I did have some headaches probably within that first week". Therapeutic measures were not taken as a result of headache.  Additional information: With the first dose I didn't receive the nausea side effect although I did have some headaches probably within that first week  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392242 same reporter/patient, different vaccine dose with partial same AE
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Pain, Vomiting
Clinical narrative: vomiting; achy; sick; felt bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 12:15 (Batch/Lot number: unknown) at the age of 68 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: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN (non-serious), outcome "unknown", described as "achy"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt bad".  Additional information: Reporter reports her son was sick and he had to take off work. She reports he got sick vomiting at work and the next day he didn't go because he felt bad. He got sick at work, she's not sure of the exact date, maybe over the past weekend. He was also achy. She reports he feels ok now. Onset of AE was one week after receiving the Covid 19 vaccine. No prior vaccinations within 4 weeks and no AE(s) following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: pain in her feet; a sensation of heat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her feet"; FEELING HOT (non-serious), outcome "unknown", described as "a sensation of heat.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.