chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Some taste lingering in the mouth.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: TASTE DISORDER (non-serious) with onset 30Apr2021, outcome "unknown", described as "Some taste lingering in the mouth".  Additional Information: Reporter is calling about the covid 19 shot. Her and husband got the vaccine about 40 minutes ago. When they drank water they both noticed they have like a fruity taste in the mouth, not fruity but just some taste lingering in the mouth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Flu" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: Consumer calling to report side effects of the vaccine he had yesterday and says he didn't think it would be anything like this, the first dose he had almost no symptoms other than tiredness which was manageable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 13:00 (Lot number: BPT534) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibrous tissue in her bone marrow" (unspecified if ongoing); "red count gets low" (unspecified if ongoing); "she has to get blood transfusions" (unspecified if ongoing), notes: about once a month. Concomitant medication(s) included: RETACRIT [EPOETIN ALFA EPBX] taken for anaemia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "recovered" (23Apr2021), described as "Had a sore arm". Additional information: Patient thought lot was BPT534, she was unsure.Patient got the first dose of the vaccine at 1:00pm on 22Mar2021 and by that night her arm was a little sore and it was gone by the next day.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486025 same patient, different dose/AE
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Joint swelling, Magnetic resonance imaging
Clinical narrative: it is a cyst on his right knee; Right knee swelling got worse; 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) (Batch/Lot number: unknown) for 1 day 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: CYST (non-serious), outcome "unknown", described as "it is a cyst on his right knee"; JOINT SWELLING (non-serious), outcome "unknown", described as "Right knee swelling got worse". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: He got the second one 26 Apr 2021. He is about to have MRI done with Contrast. It kind of dawned on him that it may be an issue getting contrast after getting the second dose and he wanted to make sure before he did it. He stated he has one done without contrast in between first and second dose and it was something that he had previously. He said it is a cyst on his right knee. He did notice that after second dose, the swelling did seem to get worse for a short period of time. This MRI was prescheduled in between the first and second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Night sweats
Clinical narrative: chills; nausea; vomiting; body aches; headache; fatigue; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:15 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tuberculosis" (unspecified if ongoing), notes: history of having tuberculosis as a toddler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot unknown=True, administration date=26Mar2021, administration time=09:15 AM,, dose number=1,, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 47 years old, for Covid-19 immunisation, reaction(s): "body aches", "nausea", "fatigue", "chills", "arm soreness at the injection site". The following information was reported: CHILLS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "chills"; NAUSEA (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "vomiting"; PAIN (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "fatigue"; NIGHT SWEATS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "night sweats". Therapeutic measures were not taken as a result of chills, nausea, vomiting, pain, headache, fatigue, night sweats. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355657 Same patient and product; different events and dose
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: chills; nausea; vomiting; body aches; headache; fatigue; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:15 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tuberculosis" (unspecified if ongoing), notes: history of having tuberculosis as a toddler. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot unknown=True, administration date=26Mar2021, administration time=09:15 AM,, dose number=1,, vaccine location=Left arm), administration date: 26Mar2021, when the patient was 47 years old, for Covid-19 immunisation, reaction(s): "body aches", "nausea", "fatigue", "chills", "arm soreness at the injection site". The following information was reported: CHILLS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "chills"; NAUSEA (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "vomiting"; PAIN (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "body aches"; HEADACHE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "fatigue"; NIGHT SWEATS (non-serious) with onset 16Apr2021 21:00, outcome "recovered", described as "night sweats". Therapeutic measures were not taken as a result of chills, nausea, vomiting, pain, headache, fatigue, night sweats. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355657 Same patient and product; different events and dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: nausea; headache; pain at injection site; fatigue; body aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0158) at the age of 34 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medications (in two weeks) included: PROZAC; METFORMIN; NUVARING; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1, single, administered in left arm; Lot number EN6204), administration date: 12Mar2021, when the patient was 34 years old, for COVID-19 immunisation, reactions: "Fatigue extreme", "Feeling hot", "Pruritus facial", "Vaccination site pain", "Headache". The following information was reported: NAUSEA (non-serious) with onset 09Apr2021, outcome "not recovered" (also reported as resolved on 10Apr2021), described as "nausea"; HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered" (also reported as resolved on 10Apr2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (10Apr2021), described as "pain at injection site"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "body aches". Therapeutic measures were taken as a result of nausea, headache, vaccination site pain, fatigue, pain.  Additional information: nausea, headache, pain at injection site (starting a few hours after injection and lasted about 24 hours) fatigue, body aches (starting a few hours after injection and lasting a few days). Patient had no COVID prior vaccination, and she was not tested for COVID post vaccination. The patient had no known allergies. Patient did not receive any other vaccine in four weeks. Facility type vaccine was reported as other.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021505850 same patient, different vaccine dose/event
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Taste disorder, Toothache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Lot number: EN6206, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN CITRATE taken for neoplasm malignant. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "mouth taste really strange"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "lips kind of like salty all the time"; TOOTHACHE (non-serious), outcome "unknown", described as "teeth are aching"; DYSGEUSIA (non-serious), outcome "unknown", described as "odd taste in my mouth". Therapeutic measures were taken as a result of taste disorder, paraesthesia oral, toothache, and dysgeusia. Additional information: The retired nurse stated she had both of her doses of Pfizer, first one was on 10Mar2021 and second dose was 31Mar2021, on the news, it was said that people were experiencing like a mouth full of metal or mouth full of Nickle have you heard anything about that. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I got shot in the arm and got swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Apr2021 (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, No events reported), for Covid-19 Immunization.The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "I got shot in the arm and got swelling".  Additional information: consumer stated, "Yes, you know my arm react to the (second) shot and it begun like have little small swelling, so I put ice on it." if patient got a shot in the arm is like got a little swelling and put ice on it. Is that the correct thing to do (treatment)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cyst, Joint swelling, Magnetic resonance imaging
Clinical narrative: the swelling did seem to get worse; Right knee swelling; cyst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "the swelling did seem to get worse"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Right knee swelling"; CYST (non-serious) with onset 2021, outcome "unknown", described as "cyst". Relevant laboratory tests and procedures are available in the appropriate section.  additional information: patient stated he has one done without contrast in between first and second dose and it was something that he had previously.it was reported by the patient that cyst was on his right knee.  He did notice that after second dose, the swelling did seem to get worse for a short period of time. This MRI was prescheduled in between the first and second dose.Dates for Right knee swelling got worse after second dose was unspecified .Reporter seriousness for Right knee swelling got worse after second dose was Unspecified  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Vertigo
Clinical narrative: 10 days after vaccine, had vertigo for 10 days; Sore arm, pain on arm lead to unable to sleep; Sore arm, pain on arm lead to unable to sleep; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 15:15 (Lot number: EP7533) 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: PAIN IN EXTREMITY (non-serious), INSOMNIA (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Sore arm, pain on arm lead to unable to sleep"; VERTIGO (non-serious) with onset 14Apr2021 12:00, outcome "recovered" (Apr2021), described as "10 days after vaccine, had vertigo for 10 days". The events "sore arm, pain on arm lead to unable to sleep" and "10 days after vaccine, had vertigo for 10 days" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, insomnia, vertigo. Additional information: event treatment included nausea medication (as reported). No covid prior vaccination; no covid tested post vaccination and no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: He is not feeling well; Feels like he has been run down; Body aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW0150) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart patient" (unspecified if ongoing), notes: he is a heart patient. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Feels like he has been run down"; PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Body aches and pains"; MALAISE (non-serious), outcome "unknown", described as "He is not feeling well".  Additional Information: Consumer states that he had his first shot on 15Apr2021 of this month, it says it was Pfizer VCHD-delta EW0150. He does not know what VCHD- delta is they just gave him that card. He received the first dose of the Pfizer COVID vaccine. He has had effects from it. He has body aches and pains. He has not had fever; he has not had cough or shortness of breath, but he feels like he has been run down all the time. He is leery of having another shot so he might cancel the next shot and see if this straightens out. He says it depends on how long the report is. He guesses he is going to have to call the health department and tell them he is not going to come. He did not make an appointment, the made the appointment for him. He is not going, he already talked to his doctor and told him he is not feeling well but he had none of the other symptoms like shortness of breath or fever or coughing.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Feet swelling; 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) (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), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet swelling".  Additional information: Consumer called regarding Pfizer product: COVID-19 Shot. He reported his feet swelling, have been swollen up since he got the second shot of the COVID-19 Shot. When he rests them down his feet swell up and he has never had that problem before. He was trying to find out if that a normal side effect of the COVID-19 Shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have a little of pain in my system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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 a little of pain in my system".  Additional Information: Consumer stated, I just want to know is that alright to take medicine when you have the time of Covid shot, I have a little of pain in my system from this shot is it okay to take medicine (Unspecified Medication), is it okay to have pain formula.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: body was aching; couldn't go to work for 3 days; 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 1st dose, 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 "recovered", described as "body was aching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "couldn't go to work for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021504805 same reporter/drug/AE, different patient;US-PFIZER INC-2021487558 same reporter/drug/AE, different patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: significant metallic taste in her mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 16:00 (Lot number: EW0151) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Insulin Dependent Type 1 Diabetic" (ongoing), notes: when she was 9 years old she was diagnosed. Concomitant medication(s) included: NOVOLOG taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1, LOT: EP6955, Dosage text: intramuscular injection, left upper arm at 16:00), administration date: 21Mar2021, for Covid-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset Apr2021, outcome "not recovered", described as "significant metallic taste in her mouth".  Additional Information: Caller stated she just had a pretty significant metallic taste in her mouth, its consistent, it does not go away. Caller stated it's been about 8 to 9 days, maybe even longer. Caller states it started around maybe 18APR2021 or 19APR2021. Caller asked was this going to continue, or would it eventually go away are you able to give any sort of insight to this metallic taste, she has it even with drinking and eating. Caller stated no expiry date or NDC was on vaccine card. Caller stated unsure of dosage given.  Concomitant Products: Novolog: She was placed on a pump probably 15 years ago that basically was a drip that was constantly running. Caller stated she took Novolog, the dosage varies, it's based off of a running basal, constant drip. Caller stated she uses about 26 unites on a 24-hour basis.  Caller stated before then it was just daily injections, but all her life she' been an insulin dependent diabetic (she was 9 years old; she was diagnosed). No Vaccine administered at Military Facility. There was history of all previous immunizations with the Pfizer vaccine considered as suspect. There was no additional Vaccines administered on same date of the Pfizer suspect. Patient did not visit to emergency Room or Physician Office with respect to adverse event. No prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)). No adverse events following prior vaccinations. No patient Medical History (Including any illness at time of vaccination). No Family Medical History relevant to adverse event. No Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Tinnitus
Clinical narrative: unable to confirm if either were injected in the muscle, because she did not feel either one; Having bug sounds in ears/Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: ER8734, Expiration Date: Jul2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Peanut allergy", start date: 2005 (unspecified if ongoing), notes: verbatim: Allergic to Peanuts diagnosed 2005. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot: EL9263, Expiration: May2021, Anatomical location: left arm, unable to confirm if given in the muscle), administration date: 02Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 03Apr2021, outcome "unknown", described as "unable to confirm if either were injected in the muscle, because she did not feel either one"; TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "Having bug sounds in ears/Tinnitus". The event "having bug sounds in ears/tinnitus" was evaluated at the physician office visit.  Additional information: Two weeks ago, patient had a problem with bug sounds in her ears. Patient cannot remember the exact date and it is a constant sound. Patient went to see her doctor on Monday. Patient was examined and diagnosed with Tinnitus and said it could be not for sure and doctor gave her an antibiotic (Amoxicillin 875mg tablet, one tablet twice daily for 7 days) and said it could be a reaction. She advised her to contact Pfizer and report it. At the time of report, it was reported that, patient never had any soreness in either arm. Patient did not want to end up getting COVID. No relevant test reported at the time of report. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Additional vaccines administered on same date of the Pfizer suspect, Family medical history and AE following prior vaccinations reported as none.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in deltoid left, administration date 31Mar2021 (Lot number: EN6207) at the age of 62 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (Adverse Event:  Local Reaction; Redness at injection site., Vaccine/Brand Name:  Flu Vaccine/No Brand Name, RA, Lot Number, or Expiration date known by caller.), administration date: 16Oct2020, when the patient was 61 years old, reaction(s): "Local Reaction; Redness at injection site.".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "Sore Arm after first vaccine".  Additional information: The events did not require a visit to emergency room and physician office. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: who is feeling dizzy and nauseous after receiving the second dose.; who is feeling dizzy and nauseous after receiving the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 04May2021 (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: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 04May2021, outcome "unknown" and all described as "who is feeling dizzy and nauseous after receiving the second dose.".  Additional Information: Caller was calling on behalf of her husband, who was feeling dizzy and nauseous after receiving the second dose. She wanted to know if this was normal. She just received the 2nd dose of vaccine today and warm transferred to PMI. Created Manual AE. Medical questions was referred or forwarded to Medical Information.  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, Neck pain
Clinical narrative: back and neck pain; back and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (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: BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "back and neck pain".  Additional information: Reporter stated he was calling on behalf of his wife. Reporter confirms he was calling about the Pfizer Covid 19 vaccine. Reporter stated his wife had her first vaccine dose on 12Apr2021. Reporter stated she was scheduled today for her second dose of vaccine on 03May2021. Reporter stated that last week, his wife developed back and neck pain. Reporter stated her doctor prescribed her a muscle relaxer, unspecified, and the medication Prednisone. The reporter stated his wife took Prednisone for 3 days, on Sunday, Monday and Tuesday and then she stopped. Reporter stated the Prednisone made her feel sick and she gained 5 pounds. Reporter stated she had not taken the Prednisone for 6 days. Reporter said he read the side effects of Prednisone, and she stopped the medication. Reporter stated that his wife had pain in her back and neck before she had the Covid vaccine and declines a safety report. Reporter stated that she continues to take the muscle relaxer and feels better. Reporter stated the Prednisone was in a pharmacy bottle and does not have an NDC, Lot number or expiration date to provide. Reporter stated that when she was reading the screening form for the vaccine, the form asks if Cortisone, Prednisone, steroids or any anti-inflammatory medications have been taken. Reporter stated his wife took Prednisone for 3 days last week. Reporter states he wants to know if there was a problem with taking Prednisone, with the Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Administration site extravasation, Illness, Underdose
Clinical narrative: Some of the vaccine leaked out of the arm; Some of the vaccine leaked out of the arm; Patient is due for his second dose of the Pfizer vaccine but patient was sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADMINISTRATION SITE EXTRAVASATION (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "Some of the vaccine leaked out of the arm"; ILLNESS (non-serious), outcome "unknown", described as "Patient is due for his second dose of the Pfizer vaccine but patient was sick".  Additional information: Patient was injected into the muscle with the Pfizer Covid vaccine, and it was noticed that some of the vaccine leaked out of the arm. Patient is due for his second dose of the Pfizer vaccine but patient was 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: Nausea, Tinnitus, Vertigo
Clinical narrative: She said her head was spinning; Ringing in her right ear; She felt nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 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 and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "She said her head was spinning"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "Ringing in her right ear"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "She felt nauseous".  Additional information: The patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last week. Afterwards, she said she felt nauseous, she said her head was spinning, and there was ringing in her right ear. She wanted to know if this was a common reaction with the vaccine. The patient also said her daughter did a research on the internet and saw that tinnitus was one of the side effects of the vaccine. The patient did not wanted to provide her physician's information. The patient was offered a warm transfer, but patient declined. The patient was responded from the attached SRD, CONS-what are the risks of the vaccine (v6.0). The patient was told that there was no information about tinnitus or ringing in the ears associated with the Pfizer-BioNTech Covid-19 Vaccine. The patient was also referred to her HCP for further guidance, and told her that Pfizer cannot give any advice or treatment recommendations for individual patients.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she did not have the sound in her ears/Having bug sounds in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EL9263, Expiration Date: May2021) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic /chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing), notes: including diabetes; "Obesity" (unspecified if ongoing); "Allergic to Peanuts diagnosed 2005", start date: 2005 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she did not have the sound in her ears/Having bug sounds in ears". The event "she did not have the sound in her ears/having bug sounds in ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Reporter reported that she having bug sounds in ear approximately 2 weeks ago, unknown time of day. She saw her doctor last week, Examined and diagnosed with Tinnitus and said it could be not for sure. She prescribed Amoxicillin 875 mg tablet. One tablet twice daily for 7 days. It is in a pharmacy vial with no lot or expiration. Dr said that this was an allergic reaction and people are reporting hearing sounds in their ears. She does not have any specific information on those people to report. Her Height was provided as 5'4" or 5'5. She never had any soreness in either arm. No prior vaccinations (within 4 weeks) and no AE following prior vaccinations. Family medical history was none. Patient never had any soreness in either arm. She was unable to confirm if either were injected in the muscle, because she did not feel either one.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: dizziness; heavy headedness; Weakness; 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 male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (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), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2021, outcome "not recovered", described as "dizziness"; HEADACHE (non-serious) with onset 01May2021, outcome "not recovered", described as "heavy headedness"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness". The events "dizziness" and "heavy headedness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness.  Additional information: Patient is calling about the Pfizer BioNTech Covid-19 Vaccine. Patient states that he got his second dose on 21Apr2021 after that day everything was back to normal after 3 or 4 days. No further information provided. He states that on Saturday 01May2021 he started to dizziness on and off, on and off and it is still continuing onto today. He states that he has went to doctor, and they gave him tablets for dizziness, he has been using them since yesterday. Patient wants to know how long the dizziness and heavy headedness takes to go away. He states that his head was spinning, and he had weakness. He clarifies his head is heavy and it is dizziness, spinning, all things related to his head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after receiving CoVax/ arm is really sore he said to the point where it's annoying him/ pain in my arm after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (004756; 159558). The reporter is the patient.  A male 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), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm after receiving CoVax/ arm is really sore he said to the point where it is annoying him/ pain in my arm after the second vaccine".  Additional information: He said its been over a month; the pain hasnt gone away. He is calling not only to document his experience but to see what information we have on it. He said I will go ahead and call Medical Information what they suggest.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Loss of personal independence in daily activities, Movement disorder, Pain
Clinical narrative: Couldn't get out of bed; Bedbound and can't stand up or move; Bedbound and can't stand up or move; In a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 74 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: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Couldn't get out of bed"; DYSSTASIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "Bedbound and can't stand up or move"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "In a lot of pain".  Additional Information: Reason for no lot number: of Pfizer Covid Vaccine: Caller unwilling to complete the report.  Follow- up#1(06-MAY-2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (caregiver) reported for a 74-year-old female patient which included that New events Activities of daily living impaired, Difficulty in standing, Movement disorder, Pain was added, other medical information was added. Narrative was updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache or constant feeling; 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), administered in arm, administration date 15Apr2021 (Lot number: ER8735) 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: MYALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "muscle ache or constant feeling".  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: after the first vaccine I has extreme pain in opposite armpit of vaccine site.; This is a spontaneous report received from 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 02Apr2021 13:15 (Lot number: ER8737) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "after the first vaccine I has extreme pain in opposite armpit of vaccine site.".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Magnetic resonance imaging, Vaccination site swelling
Clinical narrative: After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.; After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (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: VACCINATION SITE SWELLING (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: EW0161) 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 the arm". Clinical course: Calle scheduled to get the second dose on 04 May2021. Caller called because he had to take antibiotics. Caller started taking the medication on 03May2021. Caller wants to know if he can proceed in taking the vaccine.  No follow-up attempts are possible. No further information is expected.