chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Balance disorder, Blood test, Fatigue, Headache
Clinical narrative: 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 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing), notes: That is with the joints and they haven't acted up in a long time. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot Number / Expiry Date: EW0198 /unknown, Route, Anatomical Location: right arm), administration date: 03Aug2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "hair falling out"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "can't seem to wake up and has been sleeping a lot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "still get tired during the day"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "had a little bit of vertigo"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "She was losing balance". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of balance disorder. Additional information: Patient received her 2nd dose of the Comirnaty vaccine last 23Aug2021 and for the last 2 weeks she has been experiencing hair loss. she had experienced headache and nausea. She added that she "still get tired during the day" but her main issue is the hair loss and she doesn't want to lose any more hair. It was worse yesterday, 12Sep2021. She also mentioned that she "had a little bit of vertigo," that she was losing balance and that her daughter-in-law also has vertigo. She said that both of them got it from the Comirnaty vaccine. stated that her side effects are definitely after the 2nd dose. stated she just want to get some treatment. Concomitant Dug: Synthroid, Dosage text: 0.150, unknown if mcg or mg, states that it is a little blue pill, once a day, Has been taking for 35 years. Test results: she just had blood work and had a physical a couple of months ago and passed with flying colors. She does have low vitamin D, which is probably normal. Prior Vaccinations (within 4 weeks) is No. Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Physical examination, Somnolence, Vertigo, Vitamin D
Clinical narrative: 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 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing), notes: That is with the joints and they haven't acted up in a long time. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (First dose, Lot Number / Expiry Date: EW0198 /unknown, Route, Anatomical Location: right arm), administration date: 03Aug2021, when the patient was 76 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "hair falling out"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "can't seem to wake up and has been sleeping a lot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "still get tired during the day"; VERTIGO (non-serious) with onset 2021, outcome "unknown", described as "had a little bit of vertigo"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "She was losing balance". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of balance disorder. Additional information: Patient received her 2nd dose of the Comirnaty vaccine last 23Aug2021 and for the last 2 weeks she has been experiencing hair loss. she had experienced headache and nausea. She added that she "still get tired during the day" but her main issue is the hair loss and she doesn't want to lose any more hair. It was worse yesterday, 12Sep2021. She also mentioned that she "had a little bit of vertigo," that she was losing balance and that her daughter-in-law also has vertigo. She said that both of them got it from the Comirnaty vaccine. stated that her side effects are definitely after the 2nd dose. stated she just want to get some treatment. Concomitant Dug: Synthroid, Dosage text: 0.150, unknown if mcg or mg, states that it is a little blue pill, once a day, Has been taking for 35 years. Test results: she just had blood work and had a physical a couple of months ago and passed with flying colors. She does have low vitamin D, which is probably normal. Prior Vaccinations (within 4 weeks) is No. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Fatigue, Headache, Investigation, Malaise
Clinical narrative: sore arm; fatigue; Headache; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 28Dec2020 11:40 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Relevant medical history included: "benign thyroid cyst", start date: 03Dec2020 (ongoing), notes: thyroid biopsy 13Jan2021; "rosacea", start date: 12Jun2017 (ongoing), notes: vey few flair up.; "latex" (ongoing), notes: Allergies to sucralose and Latex. Family history included: "Breast cancer" (unspecified if ongoing), notes: Mother deceased from Breast cancer. Concomitant medication(s) included: COQ 10 taken for supplementation therapy (ongoing); VITAMIN D 2000 taken for supplementation therapy (ongoing); BIOTIN taken for supplementation therapy (ongoing); VITAMIN A NOS (ongoing). Past drug history included: Sucralose, reaction(s): "allergy to Sucralose".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; MALAISE (non-serious), outcome "recovered", described as "general malaise". The event "sore arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient did not received any prior vaccinations (Within 4 weeks). It was noticed that there was a appointment with doctor in Nov2020 and primary care 30Nov2020 or 03Dec2020.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Thyroid function test normal, Ultrasound scan
Clinical narrative: sore arm; fatigue; Headache; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 28Dec2020 11:40 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Relevant medical history included: "benign thyroid cyst", start date: 03Dec2020 (ongoing), notes: thyroid biopsy 13Jan2021; "rosacea", start date: 12Jun2017 (ongoing), notes: vey few flair up.; "latex" (ongoing), notes: Allergies to sucralose and Latex. Family history included: "Breast cancer" (unspecified if ongoing), notes: Mother deceased from Breast cancer. Concomitant medication(s) included: COQ 10 taken for supplementation therapy (ongoing); VITAMIN D 2000 taken for supplementation therapy (ongoing); BIOTIN taken for supplementation therapy (ongoing); VITAMIN A NOS (ongoing). Past drug history included: Sucralose, reaction(s): "allergy to Sucralose".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; MALAISE (non-serious), outcome "recovered", described as "general malaise". The event "sore arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient did not received any prior vaccinations (Within 4 weeks). It was noticed that there was a appointment with doctor in Nov2020 and primary care 30Nov2020 or 03Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site swelling
Clinical narrative: having pain where the bump or where the swollen lymph node is; had a "swollen lymph node under the arm" on the vaccination site; had a "swollen lymph node under the arm" on the vaccination site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Kawasaki's disease" (ongoing), notes: Verbatim: Kawasaki's disease, Information for Other Conditions: diagnosed about 7 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number / Expiry Date: , Lot: FC3182, Exp: 21Oct2021, Route, Anatomical Location: Unknown by injection , No. of Previous Doses: 1), administration date: 20Aug2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 12Sep2021, outcome "not recovered" and all described as "had a "swollen lymph node under the arm" on the vaccination site"; PAIN (non-serious), outcome "unknown", described as "having pain where the bump or where the swollen lymph node is".  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: his serum Creatinine has risen from 1.23 to 1.48; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Transitional Cell Renal Cancer" (unspecified if ongoing); "Nephrectoimy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD CREATININE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "his serum Creatinine has risen from 1.23 to 1.48". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Depersonalisation/derealisation disorder, Dissociation, Feeling abnormal
Clinical narrative: brain fog; it triggered my brain to dissociate.DP/DR disorder; DP/DR disorder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Jun2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "allergy". The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; DISSOCIATION (non-serious), outcome "not recovered", described as "it triggered my brain to dissociate.DP/DR disorder"; DEPERSONALISATION/DEREALISATION DISORDER (non-serious), outcome "not recovered", described as "DP/DR disorder". Therapeutic measures were not taken as a result of feeling abnormal, dissociation, depersonalisation/derealisation disorder.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. The patient had really bad 'Vax-fog' or 'brain fog' as people are calling it (which was fine it's a normal side effect), but it triggered her brain to dissociate. DP/DR disorder (Depersonalization/derealization disorder). The patient got the first dose on 02Jun2021, never got the second dose because it was so bad. It's been over 3 months and it hasn't gone away. The patient had never had DP/DR in her life so it was 100% from the brain fog. The patient don't know where the vax-fog ended and where the dissociation started.  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) : 202101198459 Same drug/reporter/patient, different dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 10:15 (Lot number: FC3182) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "known Allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=FD8448, Lot unknown=False, Administration date=16Aug2021, Administration time=06:30 PM, Dose number=1, Vaccine location=Left arm), administration date: 16Aug2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Sep2021 14:00, outcome "not recovered", described as "Arm pit pain in L arm on the day following injection"; LYMPHADENOPATHY (non-serious) with onset 15Sep2021, outcome "not recovered", described as "swollen lymph node under L arm". It was unknown if therapeutic measures were taken as a result of pain in extremity, lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Depersonalisation/derealisation disorder, Feeling abnormal
Clinical narrative: but it triggered my brain to dissociate. DP/DR (Depersonalization/derealization disorder); had really bad "Vax-fog" or "brain fog"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Jun2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergy: Hydrocodone". The following information was reported: DEPERSONALISATION/DEREALISATION DISORDER (non-serious), outcome "not recovered", described as "but it triggered my brain to dissociate. DP/DR (Depersonalization/derealization disorder)"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "had really bad "Vax-fog" or "brain fog"". Therapeutic measures were not taken as a result of depersonalisation/derealisation disorder, feeling abnormal.  Additional information: lot unknown reason =Misplaced/discarded; No other vaccine in four weeks. Patient stated to have had really bad "Vax-fog" or "brain fog" as people are calling it (which was fine it's a normal side affect), but it triggered her brain to dissociate. DP/DR disorder (Depersonalization/derealization disorder). Patient got the first dose on 02Jun, never got the second dose because it was so bad. It's been over 3 months and it hasn't gone away. Patient stated she never had DP/DR in her life so it was 100% from the brain fog. Patient don't know where the vax-fog ended and where the dissociation started. No covid prior vaccination, no covid test post vaccination.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : 202101198312 Same drug/reporter/patient, different dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: After injection went home felt tired and slept for 5 hours; Woke up with middle of back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 13Sep2021 10:00 (Lot number: Fc3182) at the age of 49 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: FATIGUE (non-serious) with onset 13Sep2021 17:00, outcome "recovering", described as "After injection went home felt tired and slept for 5 hours"; BACK PAIN (non-serious) with onset 13Sep2021 17:00, outcome "recovering", described as "Woke up with middle of back pain". It was unknown if therapeutic measures were taken as a result of fatigue, back pain.  Additional information: No known allergies. 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. Adverse event resulted in None of the above. Unknown if treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal
Clinical narrative: Have injured my brain with brain fog its not going away its been almost 3weeks now; I'm also having heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). 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: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Have injured my brain with brain fog its not going away its been almost 3weeks now"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I'm also having heart issues".  Additional information: Is the reporters contact information available to you or a sub-contracted party? Yes. Is the reporter the prescribing HCP? No. Caller stated "I had an adverse reaction to the covid vaccine and I'm actually you guys have injured my brain with brain fog its not going away its been almost 3weeks now. I'm going to need also some brain scans I'm also having heart issues. How is that going to be paid for? The following information was not confirmed during the call, but retrieved from the system: Reporter phone No. The following information was not provided during the call: Patient gender.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she didn't feel good the last time she had the 1st; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she didn't feel good the last time she had the 1st".  Additional Information: Caller wants to know if she can take the 2nd dose on Monday (20Sep2021) wherein she was scheduled on Friday (17Sep2021). Got the first dose last 27Aug2021. She said she was attending a wedding event. She also said she didn't feel good the last time she had the 1st dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: It is explained that with the first 2 shots she noticed she was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "It is explained that with the first 2 shots she noticed she was tired".  Additional information: Caller reporting on the Pfizer Booster shot for Covid 19 and who explains she had it at the 6 month mark, around there. It is explained that with the first 2 shots she noticed she was tired but with the booster shot, after 4 days, her blood pressure went down to 109/69, 116/63, and 109/66. She is wondering if this is a side effect as it was not listed in the literature she was given.  Follow-up (05Oct2021): 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 (Lot number: EW0187) at the age of 51 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: Has had for years; "Asthma" (ongoing), notes: Diagnosed within the last 5 years; "Sjogren's syndrome" (ongoing), notes: Diagnosed around the same as Rheumatoid arthritis, may have been about 7 years ago.; "COPD" (ongoing), notes: Diagnosed within the last 5 years. Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "muscle weakness". No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Headache; Ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8727) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Tuberculosis (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all"; Influenza (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all"; Shingrix (standard booster shot), administration date: Dec2020, for Immunization, reaction(s): "no reactions at all". The following information was reported: TINNITUS (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The events "ringing in ears" and "headache" were evaluated at the physician office visit.  Additional information: The patient was taking a multivitamin. The patient later received bnt162b2 (BNT162B2), administered 19Apr2021, in upper muscle at 10:15 to 11:00. No additional vaccines were administered on same date of the pfizer suspect. At one point doctor prescribed Prednisone, a 7 day step down course, but it didn't really help. Doctor looked in his ear and advised caller to go to an ear, nose, and throat doctor. Prior vaccinations (within 4 weeks) were none.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac stress test, Echocardiogram, Fatigue
Clinical narrative: drowsiness; general lack of stamina; extreme fatigue with minimal exertion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; GLUCOSAMINE; MUL-TAB; CHONDROITIN. Vaccination history included: Bnt162b2 (Lot number= en6204,, Dose number =1, Vaccine location =Left arm), administration date: 12Mar2021, when the patient was 79 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "drowsiness"; ASTHENIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "general lack of stamina"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "extreme fatigue with minimal exertion". The events "drowsiness", "general lack of stamina" and "extreme fatigue with minimal exertion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, asthenia, fatigue.  Additional information: The patient did not take any other vaccine in four weeks. The patient has led an active outdoor lifestyle and felt that he was in very good shape for his age. It was like he aged 15 years after that second shot.The patient was not tested for Covid prior vaccination and was not Covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: drowsiness; general lack of stamina; extreme fatigue with minimal exertion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EW0150) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; GLUCOSAMINE; MUL-TAB; CHONDROITIN. Vaccination history included: Bnt162b2 (Lot number= en6204,, Dose number =1, Vaccine location =Left arm), administration date: 12Mar2021, when the patient was 79 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "drowsiness"; ASTHENIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "general lack of stamina"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "extreme fatigue with minimal exertion". The events "drowsiness", "general lack of stamina" and "extreme fatigue with minimal exertion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence, asthenia, fatigue.  Additional information: The patient did not take any other vaccine in four weeks. The patient has led an active outdoor lifestyle and felt that he was in very good shape for his age. It was like he aged 15 years after that second shot.The patient was not tested for Covid prior vaccination and was not Covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 38-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8734), at the age of 38, in left arm, on Apr 1, 2021, at 12:30, single dose, for COVID-19 immunisation. Medical history included allergies: Omnipaque (contrast dye) (unspecified if ongoing). Concomitant medications included vitamin C. The patient felt hot (hot, warm shot running from right pelvis down to right leg), onset Apr 1, 2021, at 20:00, with outcome of not recovered. The event evaluated at a physician office visit. Therapeutic measures were taken. Additional information: The patient did not take any other vaccine in four weeks. The patient took multivitamin and vitamin C in two weeks. The patient neither had COVID-19 prior vaccination, nor  tested for COVID-19 post vaccination. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 27, 2021, single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient developed malaise (didn't feel good the last time she had the 1st dose), with outcome of unknown. Additional information: Patient wanted to know if she can take the 2nd dose on Monday, Sep 20, 2021; she is scheduled Friday, Sep 17, 2021. She received the first dose Aug 27, 2021. She said she is attending a wedding event. She didn't feel good the last time she had the 1st dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Sperm concentration, Sperm concentration increased
Clinical narrative: increase was observed in the sperm count; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: SPERM CONCENTRATION INCREASED (non-serious), outcome "unknown", described as "increase was observed in the sperm count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that the Embryologist, who gave information about the results of the study published open in Jul2021 and conducted in the Department of Urology at the University said, According to this study, sperm analyzes of volunteers were performed before and after vaccination with Pfizer-BioNTech, one of the mRNA vaccines approved for use by the Food and Drug Institute and applied in country, and with Moderna vaccines administered in various countries and the local , both vaccine groups were tested. An increase was observed in the sperm count, quantity and movement of the volunteers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Electrocardiogram, Fatigue, Haematology test
Clinical narrative: Extreme fatigue; feeling very weak; heart palpitations; heart would skip a beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose , date-04Feb2021, Lot number-EL9265), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "Weakness", "Palpitations", "Skipped beats". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "feeling very weak"; PALPITATIONS (non-serious) with onset 2021, outcome "recovered", described as "heart palpitations"; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "heart would skip a beat"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "Extreme fatigue". The events "feeling very weak", "heart palpitations", "heart would skip a beat" and "extreme fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, palpitations, heart rate abnormal, fatigue. Additional information: On 11Mar2021 the patient experienced extreme fatigue and had a trip to ER chest x-ray, lab chemistry / hematology - EKG/ECG general resulted in no heart attack, no discernable issues. Out filled with 5 lead, 30 day heart monitor (Preventice). On 30Mar2021 the patient left for trip to and in month of April the doctor advised the patient to heart monitor report would be received mid-april. On returning the patient had heart monitor on 04Apr2021 the leeds "drained energy" while attached. The patient sew him on 23Mar2021 f/u to ER visit). Up on Follow up the patient saw doctor in mid May to see results of monitor-said interpretation was needed by Cardiologist. On 25May2021 sound nothing to be concerned about and the patient sated his heart just didn't like the vaccine shot. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate abnormal, Palpitations
Clinical narrative: Extreme fatigue; feeling very weak; heart palpitations; heart would skip a beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose , date-04Feb2021, Lot number-EL9265), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "Weakness", "Palpitations", "Skipped beats". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "feeling very weak"; PALPITATIONS (non-serious) with onset 2021, outcome "recovered", described as "heart palpitations"; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "heart would skip a beat"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "Extreme fatigue". The events "feeling very weak", "heart palpitations", "heart would skip a beat" and "extreme fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, palpitations, heart rate abnormal, fatigue. Additional information: On 11Mar2021 the patient experienced extreme fatigue and had a trip to ER chest x-ray, lab chemistry / hematology - EKG/ECG general resulted in no heart attack, no discernable issues. Out filled with 5 lead, 30 day heart monitor (Preventice). On 30Mar2021 the patient left for trip to and in month of April the doctor advised the patient to heart monitor report would be received mid-april. On returning the patient had heart monitor on 04Apr2021 the leeds "drained energy" while attached. The patient sew him on 23Mar2021 f/u to ER visit). Up on Follow up the patient saw doctor in mid May to see results of monitor-said interpretation was needed by Cardiologist. On 25May2021 sound nothing to be concerned about and the patient sated his heart just didn't like the vaccine shot. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 66 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "vitamin D deficiency" (unspecified if ongoing), notes: Patient had started oral vitamin D; "vitamin B12 deficiency" (unspecified if ongoing); "unknown cardiac condition and patient reported heart was weak" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: DYSPNOEA (non-serious), outcome "recovering", described as "prior to the start of therapy shortness of breath after receiving second dose of Covid-19 vaccination". Additional information: Cycle: Ibrance 125mg capsule by mouth daily for 21 days on and 7 days off in conjunction with anastrozole by mouth daily as prescribed by MD. Patient reported prior to the start of therapy shortness of breath after receiving second dose of COVID 19 vaccination, unchanged after the start of therapy. Reported unknown heart condition, previously reported, and remains unchanged, unknown cardiac condition and patient reported heart was weak and was pending to follow up with cardiologist. Also reported vitamin D and vitamin B12 deficiency. Primary care MD has prescribed patient with oral vitamin D to take once week and cyanocobalamin injection to be given at MD office. Patient had started oral vitamin D, shortness of breath has improved and patient was able to walk a lit bit. MD was aware. Other Relevant History, Including Pre-existing Medical Conditions, reported to CVS/Caremark by: Patient/Caregiver. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 55-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 55, in left arm, on Sep 14, 2021, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#, expiry date: unknown), at the age of 55, in left arm, on Aug 20, 2021, for COVID-19 immunization. The patient's heart rate increased (fast heartbeat), onset Sep 14, 2021, at 11:00, with outcome of recovering. Additional information: It was reported 2 hours after, she said her heart began beating fast. She wanted to know if this is something she should be concerned about. It felt like it's slowing down now/getting better. But when lying down and trying to go to sleep, she could feel it. Events did not require emergency room/physician office. Prior vaccinations (within 4 weeks)/if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: none. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Dizziness, Product preparation error, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. Other Case identifier(s): US-PFIZER INC-202101206131. A 21-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Sep2021 (Lot number: FE3592, Expiration Date: Nov2021) at the age of 21 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: ACCIDENTAL OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 13Sep2021, outcome "unknown" and all described as "Received entire vial of undiluted Covid-19 vaccine"; VACCINATION SITE PAIN (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "arm soreness at injection site"; DIZZINESS (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "slight dizziness". The events "arm soreness at injection site" and "slight dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, dizziness. Additional information: A patient yesterday was given the vaccine. Caller initially stated, today they realized that the health assistant did not dilute it and drew from the vial the 0.5ml from the vial and administered to the patient. Patient Details: Age of onset: 21 years 11 month. Event Details: Caller later clarified the patient did not receive 0.5ml from the vial that was undiluted. She clarified it was the entire vial, so whatever that would be. The health assistant decided to give it to the patient. She is a new employee and still needed to go through the training. Nurse seeking guidance for a dose of the Pfizer Covid-19 Vaccine that was administered to a 21-year-old female patient yesterday. The dose was undiluted, and the entire volume of the vial was administered. Patient was given full vial of undiluted Pfizer Covid-19 Vaccine. Patient came in next day for office visit. Symptoms noted were arm soreness at injection site and slight dizziness. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip pruritus
Clinical narrative: itchy bumps on her lip; itchy bumps on her lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Egg white allergy" (ongoing), notes: Caller states his wife has an egg white allergy and asks if it is a known component in the vaccine. The patient's concomitant medications were not reported. The following information was reported: LIP DISORDER (non-serious), LIP PRURITUS (non-serious), outcome "unknown" and all described as "itchy bumps on her lip".  Additional information: Caller stated his wife received her first dose and had itchy bumps on her lip. Caller wanted to know the chance of a more severe reaction with a second dose or would she have the same thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: Ear ringing; My right ear is so painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: TINNITUS (non-serious) with onset 10May2021, outcome "unknown", described as "Ear ringing"; EAR PAIN (non-serious) with onset 2021, outcome "unknown", described as "My right ear is so painful".  Additional Information: Reporter stated that had 1 shot Pfizer, 2 weeks later horrible T(10May) since 1 week, it was acceptable, I just hear my T when I go to bed. But now, my right ear is so painful. What does it mean. It is the last step before issuance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.