chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm (left); Tingling down entire left side of body; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 15:00 (Lot number: ff8841) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing), notes: PCOS. Concomitant medication(s) included: ERYTHROMYCIN; VITAMIN D [ERGOCALCIFEROL]. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin; Amitriptyline, reaction(s): "Known allergies: amitriptyline", notes: Known allergies: amitriptyline. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Oct2021, outcome "recovered" (16Oct2021), described as "Sore arm (left)"; PARAESTHESIA (non-serious) with onset 15Oct2021, outcome "recovered" (16Oct2021), described as "Tingling down entire left side of body"; HEADACHE (non-serious) with onset 15Oct2021, outcome "recovered" (Oct2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia, headache. Additional information: The patient was non pregnant at time of Vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination included Erythromycin, Multi vitamin and vitamin d. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced the event sore arm (left), tingling down entire left side of body for 24 hours and headache for over a week.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: My arm hurt; sleep alittle more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ptsd" (unspecified if ongoing), notes: Ptsd; "Known allergies: Metal allergy" (unspecified if ongoing), notes: Known allergies: Metal and latex; "Known allergies: Latex allergy" (unspecified if ongoing), notes: Known allergies: Metal and latex; "tendinitis" (unspecified if ongoing), notes: I had tendinitis in it from cleaning hoard houses for over 10 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Bc), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "My arm hurt"; SOMNOLENCE (non-serious), outcome "recovered", described as "sleep alittle more". Therapeutic measures were not taken as a result of pain in extremity, somnolence.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Also no other medications received within 2 weeks of vaccination. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Taste disorder
Clinical narrative: my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Oct2021 17:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history: No. Reaction: Allergy. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious), PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "my taste and smell has changed. Foods taste and smell horrible/It has a metal smell and taste". Therapeutic measures were not taken as a result of dysgeusia, parosmia, taste disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Reported Event: A week after taking the shot, my taste and smell has changed. Foods taste and smell horrible. Such as bacon. Patient did not have relevant medical history and concurrent conditions, Relevant past drug history, Family medical history and Relevant tests. Patient had no Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received dose 2 BNT162B2 on 25Oct2021, Time: 18:00, Anatomical site of injection: (name) arm, Route of Administration: Intramuscular for covid-19 immunisation. Specific Relevant Test for Thromboembolic events with Thrombocytopenia: None. Comments/Narrative: Since Recalling my first shot. A few days later Food has smelled and tasted horrible. It has a metal smell and taste. Some foods are worse than others. This has still not gone away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Concomitant: There is no concomitant list. Patient also reported that people who go the Pfizer first shot felt flu like symptoms also. Treatment: unknown. Product Complaint: There is no product complaint associated with this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the first one got sore; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 (Lot number: EN6201) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (ongoing); "bipolar" (ongoing); "asthma" (ongoing); "high blood pressure" (ongoing); "anaphylaxis to MRI contrast" (ongoing). Concomitant medication(s) included: TOPAMAX taken for bipolar disorder (ongoing); PROZAC taken for depression (ongoing); GABAPENTIN taken for depression (ongoing); LISINOPRIL taken for hypertension (ongoing); EPIPEN taken for anaphylactic reaction; VENTOLIN ACCUHALER (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Feb2021, outcome "recovered" (13Feb2021), described as "the first one got sore".  Additional information: Pfizer Covid 19 Vaccine: Indication: She states because she believes in it and because she has asthma and she wanted to get it early, in a state nobody really wants to get it here. Concomitant Medications: EpiPen: Caller states she also carries an EpiPen because she had anaphylaxis to MRI contrast and before she even had the vaccine, she talked to Pfizer and the FDA to make sure there was no matching ingredients and none of the ingredients were the same, so she went ahead with it. First dose: right arm got sore: 12Feb2021, sore arm started within about 2 hours then it was gone within 24 hours. Confirms started 12Feb2021, ended 13Feb2021, and has recovered completely. Caller stated now she's afraid to ever get another one, and she knows they will come around again.Concomitant Products Daily vitamins: (Start: Unspecified Stop: Ongoing)  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Procedural pain
Clinical narrative: felt like a bee sting, barely could feel it; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EN6201) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "depression" (ongoing), notes: diagnosed 32 years ago; "bipolar" (ongoing), notes: diagnosed 32 years ago; "asthma" (ongoing), notes: diagnosed 32 years ago; "high blood pressure" (ongoing), notes: diagnosed 5 years ago; "anaphylaxis to MRI contrast " (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX taken for bipolar disorder (ongoing); GABAPENTIN taken for depression (ongoing); PROZAC taken for depression (ongoing); LISINOPRIL taken for hypertension (ongoing); EPIPEN taken for anaphylactic reaction; VENTOLIN ACCUHALER (ongoing). Vaccination history included: Bnt162b2 (First dose: , LOT: EN6201, Injection, right upper arm, unknown dosage, Verbatim: right arm got sore (From: 12Feb2021 To: 13Feb2021)), administration date: 12Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "right arm got sore". The following information was reported: PROCEDURAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "felt like a bee sting, barely could feel it".  Additional information: It was reported that the patient taking Pfizer Covid 19 Vaccine because she believes in it and because she has asthma and wanted to get it early. Concomitant Products was ongoing Daily vitamins and Ventolin Inhaler. Caller states she also carries an EpiPen because she had anaphylaxis to MRI contrast and before she even had the vaccine, she talked to Pfizer and the FDA to make sure there was no matching ingredients and none of the ingredients were the same so she went ahead with it. First dose on 12Feb2021 with sore arm started within about 2 hours then it was gone within 24 hours. Confirms started 12Feb2021, ended 13Feb2021, and has recovered completely. Reporter seriousness for Second dose for felt like a bee sting, barely could feel it was Unspecified.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Ear pain
Clinical narrative: 4 Days after first shot my eye started twitching of and on; Then I got an ear ache towards the end of month for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jan2021 10:00 (Lot number: EN6201) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: B12-VITAMIN; HYDROCHLOROTHIAZIDE. The following information was reported: BLEPHAROSPASM (non-serious) with onset 14Jan2021, outcome "recovering", described as "4 Days after first shot my eye started twitching of and on"; EAR PAIN (non-serious) with onset Jan2021, outcome "recovering", described as "Then I got an ear ache towards the end of month for 4 days". The event "4 days after first shot my eye started twitching of and on" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of blepharospasm, ear pain.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Women's Vitamins, B12, Hydrochlorothyazide. Reported Event: 4 Days after first shot my eye started twitching of and on, then I got an ear ache towards the end of month for 4 days. 11Feb received 2nd shot. Few days later my eye starting twitching again for a couple of weeks and toward the end of the month I got another massive ear ache. I do not get ear aches and was not sick. 15Mar I slept for a straight 36 hours. 17Mar felt better and then on 18Mar, at 10 a.m I told my sister to take me to emergency my face just fell and I got a headache. Went to clinic nearby, PA told me to go to hospital It looked like I got Bells Palsey and my heart rate was extraordinarily high. Kept me in hospital for 3 days brought blood pressure down and set me up with a neurologist, cardiologist and neurosurgeon. They found a meningioma that was about 10 years old (who knew). Neurologist was at a seminar and said they talked about vaccine waking up the Bells Palsy Virus. Booster is in question?. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19?: No, Since the vaccination, has the patient been tested for COVID-19?: Yes. Covid test type post vaccination: Nasal Swab, Covid test date: 18Mar2021, Covid test result: Negative, Known allergies: No  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Decreased appetite, Diarrhoea
Clinical narrative: aches; loss of appetite; nausea; diarrhea; extreme tiredness; chills; oral temp max of 101.7; slept almost that entire time; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:45 (Lot number: FF8839) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin, sulfa drugs; "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; OMEGA 3; LYSINE; VIT D; MG; FLU, administration date 21Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 11Jan2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 21Dec2020, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "aches"; DECREASED APPETITE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "loss of appetite"; NAUSEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "nausea"; DIARRHOEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "diarrhea"; FATIGUE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "extreme tiredness"; CHILLS (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "oral temp max of 101.7"; SOMNOLENCE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "slept almost that entire time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, decreased appetite, nausea, diarrhoea, fatigue, chills, body temperature abnormal, somnolence.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: B Complex,   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Somnolence
Clinical narrative: aches; loss of appetite; nausea; diarrhea; extreme tiredness; chills; oral temp max of 101.7; slept almost that entire time; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:45 (Lot number: FF8839) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin, sulfa drugs; "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; OMEGA 3; LYSINE; VIT D; MG; FLU, administration date 21Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 11Jan2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 21Dec2020, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "aches"; DECREASED APPETITE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "loss of appetite"; NAUSEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "nausea"; DIARRHOEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "diarrhea"; FATIGUE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "extreme tiredness"; CHILLS (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "oral temp max of 101.7"; SOMNOLENCE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "slept almost that entire time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, decreased appetite, nausea, diarrhoea, fatigue, chills, body temperature abnormal, somnolence.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: B Complex,   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness near the area of injection; 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 female patient received bnt162b2 (BNT162B2), administered in arm, administration date 09Apr2021 (Lot number: ER8735) at the age of 64 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 PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "soreness near the area of injection". The event "soreness near the area of injection" was evaluated at the physician office visit.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had the first shot and was fine, maybe some soreness near the area of injection for 1 day but nothing she had to take anything for.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 74-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), for COVID-19 immunization. The patient had a headache (outcome unknown). Additional information: The patient reported she was in excellent health. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 74-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), for COVID-19 immunization. The patient had a headache (outcome unknown). Additional information: The patient reported she was in excellent health. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: She had back pain with the second shot so she wasn't too concerned about that.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Lot number: EL9269, Expiration Date: May2021) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose (lot number EL8982, Expiration: May2021), administration date: 21Jan2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "She had back pain with the second shot so she wasn't too concerned about that.".  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: She had back pain with the second shot so she wasn't too concerned about that.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Lot number: EL9269, Expiration Date: May2021) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose (lot number EL8982, Expiration: May2021), administration date: 21Jan2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "She had back pain with the second shot so she wasn't too concerned about that.".  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell abnormality
Clinical narrative: red blood cell problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 17Sep2021 (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: RED BLOOD CELL ABNORMALITY (non-serious) with onset 2021, outcome "unknown", described as "red blood cell problems".  Additional information: Reporters sister has red blood cell problems now, and patient not getting the booster. The patient was fine after first one, this was after the second one 17Sep2021. Her sister's red blood cells are also small. The patient is now receiving iron transfusions.  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, Pruritus
Clinical narrative: arm itchy and sore; arm itchy and sore; 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: PRURITUS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm itchy and sore".  Additional information: Received call from consumer who provided her middle initial as (Withheld). While reporting for herself, she mentioned that everyone has itchiness and soreness. She did not have anyone specific to report on except two ladies that live in the same senior community.  They had an itchy arm and soreness.  Other than that, they were fine and did not have any lethargy, sore throat and did not have the feeling that they were not going to be able to make it that she had.  She did not wish to complete a report for them. This report was not related to a study or programme. Reporter seriousness for arm itchy and sore was unspecified. This report was to capture information for the first lady.  No further details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (26Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (2nd dose of covid vaccine), when the patient was 83 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelled".  Additional Information: Dates for arm swelled: (From: Unspecified To: Unspecified), Dates for Covid booster shot: (Start: Unspecified Stop: Unspecified), NDC number of Covid booster shot: Not Provided. Reason for no lot number of Covid booster shot: Complainant hung up abruptly/transfer incomplete. Caller, a husband calling for his wife reporting on the Pfizer Covid booster shot. Her arm swelled up and he wants to know how to treat this. Caller remarks he did not have any reaction, but her arm is swollen, and he wants to know what to do about it. Follow-up (28Oct2021): Phone Out 5:36 pm EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer, consumer does not want to be contacted any further.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  Additional Information: Dates for arm swelled: (From: Unspecified To: Unspecified), Dates for Covid booster shot: (Start: Unspecified Stop: Unspecified), NDC number of Covid booster shot: Not Provided. Reason for no lot number of Covid booster shot: Complainant hung up abruptly/transfer incomplete. Caller, a husband calling for his wife reporting on the Pfizer Covid booster shot. Her arm swelled up and he wants to know how to treat this. Caller remarks he did not have any reaction, but her arm is swollen, and he wants to know what to do about it. Follow-up #02 (28Oct2021): Phone Out 5:36 pm EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer, consumer does not want to be contacted any further.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up #01 (28Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up #02 (28Oct2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to non hcp letter sent via follow-up letter which included that: Upon follow up, No new AE/ was added. No other medical information was added.  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
Clinical narrative: Headache; 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: HEADACHE (non-serious), outcome "unknown", described as "Headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache post covid vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. This consumer(patient) reported for self.  A patient (no qualifiers provided) 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: HEADACHE (non-serious), outcome "recovered", described as "Headache post covid vaccine".  Additional information: Headache post covid vaccine 22Oct-23Oct, Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Vestibular migraine
Clinical narrative: Vestibular migraine; hyperacusis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Oct2021 11:30 (Lot number: EW0217) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Mango" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; FLU, administration date 15Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Right, Vaccine Administration Time: 01:15 AM, Route of Administration: Intramuscular), administration date: 25Feb2021, when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK4176, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 13Jan2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: VESTIBULAR MIGRAINE (non-serious) with onset 15Oct2021 15:00, outcome "not recovered", described as "Vestibular migraine"; HYPERACUSIS (non-serious) with onset 15Oct2021 15:00, outcome "not recovered", described as "hyperacusis". The events "vestibular migraine" and "hyperacusis" were evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination patient not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Eye movement disorder, Eye pain, Headache, Intraocular pressure increased
Clinical narrative: left eye increased intraocular pain; pressure; it felt as if I had been punched directly in my eye and was suffering from a black eye; pain in moving/touching eye; pain in moving/touching eye; it felt as if I had been punched directly in my eye and was suffering from a black eye; blurred vision changes to left eye; left eye increased intraocular pain; pressure; pain in moving/touching eye; headaches located directly behind left eye; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "discectomy for herniated disk lumbar region; i have lasting sciatic nerve problems" (unspecified if ongoing); "i have lasting sciatic nerve" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; TIZANIDINE. The following information was reported: INTRAOCULAR PRESSURE INCREASED (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "left eye increased intraocular pain; pressure"; EYE CONTUSION (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "it felt as if I had been punched directly in my eye and was suffering from a black eye"; EYE MOVEMENT DISORDER (non-serious), OCULAR DISCOMFORT (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "pain in moving/touching eye"; VISION BLURRED (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "blurred vision changes to left eye"; HEADACHE (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "headaches located directly behind left eye". Therapeutic measures were not taken as a result of intraocular pressure increased, eye contusion, eye movement disorder, ocular discomfort, ocular discomfort, vision blurred, eye pain, eye pain, headache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Vision blurred
Clinical narrative: left eye increased intraocular pain; pressure; it felt as if I had been punched directly in my eye and was suffering from a black eye; pain in moving/touching eye; pain in moving/touching eye; it felt as if I had been punched directly in my eye and was suffering from a black eye; blurred vision changes to left eye; left eye increased intraocular pain; pressure; pain in moving/touching eye; headaches located directly behind left eye; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "discectomy for herniated disk lumbar region; i have lasting sciatic nerve problems" (unspecified if ongoing); "i have lasting sciatic nerve" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; TIZANIDINE. The following information was reported: INTRAOCULAR PRESSURE INCREASED (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "left eye increased intraocular pain; pressure"; EYE CONTUSION (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "it felt as if I had been punched directly in my eye and was suffering from a black eye"; EYE MOVEMENT DISORDER (non-serious), OCULAR DISCOMFORT (non-serious), EYE PAIN (non-serious) all with onset 23Oct2021 09:00, outcome "recovering" and all described as "pain in moving/touching eye"; VISION BLURRED (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "blurred vision changes to left eye"; HEADACHE (non-serious) with onset 23Oct2021 09:00, outcome "recovering", described as "headaches located directly behind left eye". Therapeutic measures were not taken as a result of intraocular pressure increased, eye contusion, eye movement disorder, ocular discomfort, ocular discomfort, vision blurred, eye pain, eye pain, headache. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; 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 (COMIRNATY) (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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  Additional information: It was reported that the patient was supposed to receive her second dose now (at the time of report).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Paraesthesia
Clinical narrative: paresthesia which started in right hand and then left foot and has since spread to both hand, both feet and both entire legs./a vibrating sensation in some areas/ Pins and needles; burning cool sensations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Sep2021 10:15 (Lot number: FF2588) at the age of 43 years as dose 1, single for covid-19 immunizations. Relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing), notes: Other medical history: Palindromic Rheumatism; "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Sep2021, outcome "not recovered", described as "paresthesia which started in right hand and then left foot and has since spread to both hands, both feet and both entire legs. /a vibrating sensation in some areas/ Pins and needles"; FEELING COLD (non-serious) with onset Sep2021, outcome "not recovered", described as "burning cool sensations". Therapeutic measures were taken as a result of paranesthesia, feeling cold.  Additional information: 3 weeks post vaccine caused began having paresthesia which started in right hand and then left foot and has since spread to both hands, both feet and both entire legs. Pins and needles, burning cool sensations, and a vibrating sensation in some areas. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks.    No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site hypoaesthesia
Clinical narrative: My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand; My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 11:00 (Lot number: EWO183) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO183, Dose Administration Time: 11:00 AM, vaccine location=Left arm), administration date: 24Aug2021, when the patient was 63 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 29Sep2021 06:00, outcome "not recovered" and all described as "My left arm has been numb from the area around the injection site down to the tips of my fingers on my left hand". Therapeutic measures were taken as a result of vaccination site hypoaesthesia, hypoaesthesia.  Additional information: The patient was not pregnant at the time of vaccination. No known allergies. No other medical history. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included vitamins. Treatment for event included lymphatic massage. No covid prior vaccination. Patient not tested for covid post vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Headache, Myalgia, Pain in extremity
Clinical narrative: chest pain; muscle pain; aches in his arms and legs; anxiety; pain in back of his head; 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. The reporter is the patient. A 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE: 2), administration date: 13Apr2021, for COVID-19 immunization, reaction(s): "Chest pain"; Comirnaty (DOSE: 1), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Oct2021, outcome "unknown", described as "chest pain"; MYALGIA (non-serious) with onset 23Oct2021, outcome "unknown", described as "muscle pain"; PAIN IN EXTREMITY (non-serious) with onset 23Oct2021, outcome "recovered" (24Oct2021), described as "aches in his arms and legs"; ANXIETY (non-serious) with onset Oct2021, outcome "unknown", described as "anxiety"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (24Oct2021), described as "pain in back of his head". The events "chest pain", "muscle pain", "aches in his arms and legs", "anxiety" and "pain in back of his head" were evaluated at the physician office visit.  Additional information: Patient received his booster dose on 22Oct2021 and noticed the symptoms the following day. Reports having chest pain and asked if this symptom was a side effect of the vaccine and if this symptom was transient or permanent. He also having muscle pain and aches in his arms and legs. His chest pain symptom was more significant this time than the second shot, which he received on 13Apr2021. Chest pain was similar but less pronounced and said he had forgotten all about it. The pain was not related to gas and that he haven't been to the gym or lifting weights. He also said because of it, he was having some anxiety, referring to the chest pain. Caller reports having reached out to his doctor yesterday (25Oct2021) and before contacting Pfizer today. He experienced pain in his arm, leg, and back of his head and chest pain subsided on the 24th except for the chest pain. He ended up going to the hospital on the 27th overnight advised by his physician.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.