chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Sore arm; After the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: ER8737) at the age of 56 years as dose 2, single and administration date 18Mar2021 (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food intolerances" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn; "The caller has food intolerances like gluten" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn; "The caller has food intolerances like dairy" (unspecified if ongoing), notes: The caller has food intolerances like gluten, dairy, and corn. Family history included: "Genetic blood clotting" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): genetic blood clotting, the caller only has one of 2 genes. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "After the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in".  Additional information: Adverse event, product problem or error: Adverse event checked. Date of events: 2021. Suspect product name: BNT162B2, Manufacturer: Pfizer. Start date: 1st dose: 18Mar2021 (Lot: ER2613, Exp: Unknown): 2nd dose: 08Apr2021 (Lot: ER8737 Exp: Unknown). The only thing that happened after the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in. This happened 3 days after getting the vaccines and that was the only thing that happened other than the sore arm. Family Medical History Relevant to AE(s): genetic blood clotting, the caller only has one of 2 genes.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101686099 Same reporter, patient/ different dose and events
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: 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 (159558). The reporter is the parent. A 11 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 11 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: RHINORRHOEA (non-serious) with onset 25Nov2021, outcome "not recovered", described as "runny nose"; COUGH (non-serious) with onset 28Nov2021, outcome "not recovered", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer said that her 11-year-old son received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 12Nov2021. Last Thursday, 25Nov2021, he started having runny nose, and yesterday, 28Nov2021, he started to have cough. She said her son is scheduled for his 2nd dose on Friday, 03Dec2021, and wants to know if he should proceed with it despite his symptoms. She said she had him tested for Covid this morning. She wants to know if he should still push through with the 2nd dose if he tests negative but still has symptoms or if he should wait instead. ORANGE CAP: Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for 5 through 11 years of age- DILUTE BEFORE USE. Version: 1; LAB-1486-1.0; Revised: 29Oct2021.Caller says her son's runny nose started on Wednesday or Thursday last week, she thinks on Thursday. She says his cough started yesterday on Sunday. AE Treatment: None. AE Outcome: Caller says as far as the runny nose and now he has cough, she would say that is getting worse. She says the cough has stayed the same. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only sore arm 1st vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported in response to consumer letter sent in the cross-referenced case.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EN5318) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hormone therapy", start date: 2020 (unspecified if ongoing), notes: Hormon inhibitor; "Cancer", start date: 2020 (ongoing); "Blood pressure high", start date: 1990 (ongoing), notes: H BP; "Nerve pain", start date: 2019 (unspecified if ongoing), notes: Hip/Leg nerve pain; "Breast cancer", start date: Feb2019 (unspecified if ongoing), notes: Mar2019 Lumpectomy, Apr2019 Lumpectomy; "Lumpectomy", start date: Mar2019 (unspecified if ongoing), notes: Apr2021. Concomitant medication(s) included: LETROZOLE taken for hormone therapy, neoplasm malignant, start date: 2020 (ongoing); PLAVIX taken for hypertension, start date: Oct2020 (ongoing); LISINOPRIL taken for hypertension, start date: 1990 (ongoing); GABAPENTIN taken for neuralgia, start date: 2019 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "only sore arm 1st vaccine".  Additional Information: Patient medical history: Illness/AE: Breast cancer Onset date: Feb2019 Pertinent details: Mar2019 Lumpectomy Apr2019 Lumpectomy. Concomitant drugs: Drug name : Letrozole Reason for use: Harmon inhibitor, Cancer Route: Oral Start date: 2020 Ongoing: Yes. Drug name : Plavix Reason for use: H BP Route: Oral Start date: Oct2020 Ongoing: Yes. Drug name : Lisinopril Reason for use: H Bp Route: Oral Start date: 1990s Ongoing: Yes. Drug name : Gabapentin Reason for use: Hip/Leg nerve pain Route: Oral Start date: 2019 Ongoing: Yes. Vaccination facility type: Other. Vaccination facility address: Available. Relevant tests: None. Dose: 01, Date: 08Feb2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# EN5318. Dose: 02 Date: 01Mar2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# EN6198. Dose: 03 Date: 05Oct2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# FF2587. Only sore arm 1st vaccine 2nd and booster same pain and discomfort (scary). Current or recent cancer (including blood cancers such as Hodgkin disease, leukemias, and myelomas. Specific relevant test for thromboembolic events with thrombocytopenia: None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Nasal discomfort
Clinical narrative: Nose rinse; excessively losing her hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 12:15 (Lot number: FH8030) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", stop date: 25Aug2021, notes: After recovering from Covid 25Aug2021, I recovered my since of taste, smell back. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: , Lot: FF2593, Dosage text: Injection in the left arm for both doses), administration date: 25Oct2021, for Covid-19 Immunization, reaction(s): "altered taste", "smell horrible", "nauseous". The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "excessively losing her hair"; NASAL DISCOMFORT (non-serious), outcome "unknown", described as "Nose rinse". Therapeutic measures were taken as a result of nasal discomfort.  Additional information: It was reported that caller said that she had noticed losing hair within the last 3 weeks. No prior vaccinations within 4 weeks. No family Medical History Relevant to AE(S). no relevant Test or specific relevant test for Thromboembolic events with Thrombocytopenia. It was reported that after receiving first dose a few days after I noticed an altered taste and smell. Coffees, chocolate, voxmery, peppermint down, dove soap, deodorant just to remove a few smell horrible that it causes me to nauseous. If I drink coffee, eat chocolate or teas the taste was so bad. I've thought long and hard on how to describe. burnt oil l geese, smoke. This was 24/7. Paste with meat sauce has zero flavour. After receiving second dose same symptoms no improve meat.  No follow-up attempts are possible. No further information is expected.  Follow-Up (06Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, X-ray
Clinical narrative: back muscle ache; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:30 (Lot number: ER8730, Expiration Date: 03Apr2021) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Date: 04Mar2021, Time: 10:30 am, Anatomical site of injection: Left arm, Batch/Lot Number: EN6205), administration date: 04Mar2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "back muscle ache"; INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "inflammation". The events "back muscle ache" and "inflammation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, inflammation.  Additional information: I have had back muscle ache ever since second Vaccination on 25Mar2021. The muscle ache began the next morning 26Mar2021. I have gone to an orthopedic specialist and they x-rayed my back and said backbone is fine with no problems. They say it must be inflammation so they prescribed Meloxicam for 30 days. I have been on them 21 days and back muscles still ache. So what I am asking is were there any reported problems on back muscle ache during the testing period? If so can someone tell me the fix before the orthopedic medical field wastes their time and my time researching what to do. Any assistance on the fix would be much appreciated.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye disorder, Fatigue, Headache, Malaise
Clinical narrative: Left shoulder pain; worse with movement; Malaise; fatigue; headache; worse on back of eyes bilaterally.; Fevers; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 10:00 (Lot number: BD32030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose brand=Pfizer , Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 14Jan2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Prev dose brand=Pfizer , Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 22Dec2020, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Left shoulder pain"; PAIN (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "worse with movement"; MALAISE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Malaise"; FATIGUE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "headache"; EYE DISORDER (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "worse on back of eyes bilaterally."; PYREXIA (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Fevers". Therapeutic measures were not taken as a result of arthralgia, pain, malaise, fatigue, headache, eye disorder, pyrexia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. Left shoulder pain, worse with movement. Malaise, fatigue, headache, worse on back of eyes bilaterally. Fevers. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Left shoulder pain; worse with movement; Malaise; fatigue; headache; worse on back of eyes bilaterally.; Fevers; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 10:00 (Lot number: BD32030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose brand=Pfizer , Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 14Jan2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Prev dose brand=Pfizer , Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 22Dec2020, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Left shoulder pain"; PAIN (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "worse with movement"; MALAISE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Malaise"; FATIGUE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "headache"; EYE DISORDER (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "worse on back of eyes bilaterally."; PYREXIA (non-serious) with onset 29Nov2021 14:00, outcome "not recovered", described as "Fevers". Therapeutic measures were not taken as a result of arthralgia, pain, malaise, fatigue, headache, eye disorder, pyrexia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Hospital. Left shoulder pain, worse with movement. Malaise, fatigue, headache, worse on back of eyes bilaterally. Fevers. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single and administered in arm left, administration date 27Mar2021 (Lot number: EK8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerance" (ongoing), notes: Verbatim: Lactose intolerance; "dry eyes" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: He started taking the Flonase within the last 3 years for seasonal allergies. Concomitant medication(s) included: HYDROEYE taken for dry eye, start date: 2021 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm".  Additional Information: The only other medical condition that he has, he doesn't know if it is medical, but he has lactose intolerance. Patient is on FLONASE started taking within the last 3 years at a dose of 1 to 2 sprays in each nostril, 50 mcg/ spray for seasonal allergy. Vitamin D has been taking for the last 2 to 3 years at a dose of 5,000 iU as regular supplement from unknown to Ongoing. Multi-vitamin has been taking for over 5 years as regular supplement from unknown to ongoing. Probiotic has been taking for the last 2 years as regular supplement from unknown to Ongoing. Hydroeye started taking two months ago from 2021 to ongoing for dry eyes. Patient received the first two doses of the Pfizer COVID vaccine and he also had the booster. He had the first two doses he thinks in Mar2021 and Apr2021. After each he had a sore arm and then he did just get the booster last month, Oct2021, and after the booster he had a sore arm as well which resolved in a few days and that's what happened after the first two doses, too. He confirms that they were all the Pfizer COVID vaccine and that his 1st dose was in Mar2021, 2nd dose was in Apr2021 and his booster dose was in Oct2021. No emergency room and physician office required for AE. Prior Vaccinations (within 4 weeks) if any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. AE(s) following prior vaccinations: After flu shots he will have a sore arm, but that's all. Family Medical History Relevant to AE(s) and Relevant Tests reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: experiencing soreness in upper arms bilaterally; difficulty sleeping last night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): EC-2021-103486.  A female patient received bnt162b2 (BNT162B2), administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "endometrial carcinoma" (unspecified if ongoing), notes: Diagnosis C54.1. Concomitant medication(s) included: LENVIMA taken for endometrial cancer, start date: 22Oct2021. Past drug history included: Keytruda infusion, notes: Infusion. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experiencing soreness in upper arms bilaterally"; INSOMNIA (non-serious), outcome "unknown", described as "difficulty sleeping last night". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient began Lenvima 20 mg once daily on 10/22/21. Since start of therapy, patient has experienced tongue sensitivity. Stated tongue is sensitive to hot temperature and mint in mouthwash. Unknown date of onset of symptoms. Patient stated also received COVID-19 booster and influenza vaccine on 11/4/21. Since that time has been experiencing soreness in upper arms bilaterally. Stated had difficulty sleeping last night secondary to pain. Spoke with oncologist's office and advised okay to take Motrin for pain. Diagnosis C54.1 Endometrial Carcinoma, Lenvima 20 mg once daily, start date 10/22/21 Relevant history includes endometrial carcinoma, Keytruda infusion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Vomiting
Clinical narrative: Developed motion sickness, with nausea, and vomiting, after first vaccine; Developed motion sickness, with nausea, and vomiting, after first vaccine; Developed motion sickness, with nausea, and vomiting, after first vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FTHRSASK5127, Expiration Date: 10Jan2022) at the age of 8 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: MOTION SICKNESS (non-serious), VOMITING (non-serious), NAUSEA (non-serious) all with onset 14Nov2021, outcome "not recovered" and all described as "Developed motion sickness, with nausea, and vomiting, after first vaccine". The event "developed motion sickness, with nausea, and vomiting, after first vaccine", "developed motion sickness, with nausea, and vomiting, after first vaccine" and "developed motion sickness, with nausea, and vomiting, after first vaccine" was evaluated at the physician office visit.  Additional information: Children go on one long car ride a week and it happened on 14Nov2021, 21Nov2021, and 28Nov2021. No additional vaccines were administered on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks), patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  The reporter considered "developed motion sickness, with nausea, and vomiting, after first vaccine" not related to bnt162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events motion sickness,  nausea,  vomiting and the administration of the vaccine cannot be excluded.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: left armpit gland swelling and pain; Fatigue; left arm soreness; left armpit gland swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 16:00 (Lot number: FH8027) at the age of 14 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Juvenile idiopathic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Sulfasalazine, reaction(s): "Known allergies: sulfasalazine". Vaccination history included: Bnt162b2 (Dose 2, single; Lot Number: Ew0173), administration date: 16Jun2021, when the patient was 13 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, single; Lot Number: Ew0179), administration date: 29May2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 27Nov2021, outcome "recovering" and all described as "left armpit gland swelling and pain"; FATIGUE (non-serious) with onset 27Nov2021, outcome "recovering", described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovering", described as "left arm soreness". Therapeutic measures were not taken as a result of axillary pain, fatigue, pain in extremity, lymphadenopathy. Additional information: Non-healthcare professional reporting for a patient. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: complaints of her left arm being sore after receiving the first dose of the purple cap Pfizer Covid-19 vaccine in her left deltoid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 09Nov2021 (Lot number: FH8020, Expiration Date: 28Nov2021) at the age of 34 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 22Mar2019 (ongoing); "Sleep apnea", start date: 29Sep2020 (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "complaints of her left arm being sore after receiving the first dose of the purple cap Pfizer Covid-19 vaccine in her left deltoid".  Additional information: She said that her arm hurt really bad and she felt like it was going to fall off and that is why she wanted the second dose in the gluteal area. She did not have prior vaccinations (within 4 weeks). She did not have any AE(s) following prior vaccinations. She did not have any family medical history relevant to AE(s). The AE(s) did not require a visit to: emergency Room or physician office.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 08:30 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2017 (unspecified if ongoing); "Spleen removed", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN6205), administration date: 20Mar2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine".  Additional Information: The patient received any other vaccines within 4 weeks prior to the covid 19 vaccine was unknown. The patient received any other medications within two weeks was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation; temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: 301458A) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome unknown and all described as temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation.  Additional information: Reporter reported a temperature excursion for the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Also stated that they had undiluted vials of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) that have been on the freezer since 03NOV2021. No patients got the effected vaccines, they did not did a vaccine clinic the week of Thanksgiving and the only ones used in the health clinic were ones that were removed from the freezer in an appropriate amount of time  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anion gap normal, Aspartate aminotransferase decreased, Aspartate aminotransferase increased
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Basophil count, Blood albumin, Blood bilirubin, Blood calcium, Blood chloride
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine, Blood glucose, Blood phosphorus, Blood potassium, Blood sodium
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Blood urea, Carbon dioxide, Dysgeusia, Electrocardiogram, Eosinophil count
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Haematocrit, Haemoglobin, Lymphocyte count, Mean cell haemoglobin
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Neutrophil count, Platelet count
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Red blood cell count, Red cell distribution width increased, White blood cell count
Clinical narrative: metal taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 (Lot number: EK5730, Expiration Date: 31Mar2021) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adenomyosis", start date: 04Nov2014, stop date: 17Sep2015, notes: total hysterectomy 17Sep2015; "Follicular neoplasam of thyroid", start date: 03Jul2019, stop date: 06Sep2019, notes: Thyroidectomy 06Sep2019; "Cough" (unspecified if ongoing); "Ex-Smoker" (unspecified if ongoing); "Chest coldness" (unspecified if ongoing); "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 30Dec2020 10:20, outcome "recovered" (30Dec2020 10:30), described as "metal taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  No follow-up attempts are possible. No further information is expected
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick with the first one; 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 (159558). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Jan2021 (Lot number: EL9261) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: RISPERDAL taken for anxiety. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with the first one".  Additional information: He became sick with the first one. Its been over a week and the symptoms come and go. He went to urgent care on Saturday they felt it was the vaccine. He hearing that some people have these last for 5 or so days, he just concerned. No any additional Vaccines administered on same date of the pfizer suspect. No emergency Room required. He had a Tetanus shot back in May2021 with no issues. No any event prior to vaccination, no family history and relevant test reported.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Had hives on his legs, that progress from his nipple to his kness; Being itchy. on his belly and legs, no visible rash at that time; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg right, administration date 24Nov2021 18:00 (Lot number: FK5618) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Non pertaining to hives" (unspecified if ongoing), notes: had hives in the past and been worked up by allergy with no known etiologies.; "Allergies" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC taken for hypersensitivity (ongoing); FLOVENT HFA taken for hypersensitivity (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Past drug history included: Benadryl, reaction(s): "Allergic to benadryl", notes: Allergic to benadryl. The following information was reported: PRURITUS (non-serious) with onset 24Nov2021 18:30, outcome "recovered" (Nov2021), described as "Being itchy. on his belly and legs, no visible rash at that time"; URTICARIA (non-serious) with onset 24Nov2021 19:00, outcome "recovered" (26Nov2021), described as "Had hives on his legs, that progress from his nipple to his kness". Therapeutic measures were taken as a result of pruritus, urticaria.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. His mother gave zyrtec (4ml instead of his normal 2.5 ml nightly dose) and gave an oatmeal bath.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: Dose 1 given 25Aug2021; Dose 2 01Nov2021; Severe hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 16:00 (Lot number: 33026BD) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing), notes: Chronic pain due to botched surgery; "botched surgery" (unspecified if ongoing), notes: Chronic pain due to botched surgery; "allergies: sulfa drugs" (unspecified if ongoing), notes: known_allergies: Pain meds, sulfur drugs. Concomitant medication(s) included: FLU, administration date Oct2021; XOLAIR; METHADONE; PAMELOR; ATIVAN. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: FC3138, Location of injection: Arm Left, Vaccine Administration Time: 16:00), administration date: 25Aug2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Nov2021, outcome "unknown", described as "Dose 1 given 25Aug2021; Dose 2 01Nov2021"; ALOPECIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Severe hair loss". Therapeutic measures were not taken as a result of alopecia.  Additional information: Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Malaise
Clinical narrative: dizziness; felt terrible; fever; chills; really tired; Felt lousy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 00:20 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EM9810, Expiry: Unknown), administration date: 09Feb2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot: EM9810, Expiry: Unknown), administration date: 02Mar2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt terrible"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "really tired"; MALAISE (non-serious) with onset 29Nov2021, outcome "recovering", described as "Felt lousy".  Additional information: No prior Vaccinations were taken (within 4 weeks). No AE(s) following prior vaccinations.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizziness; felt terrible; fever; chills; really tired; Felt lousy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 00:20 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EM9810, Expiry: Unknown), administration date: 09Feb2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot: EM9810, Expiry: Unknown), administration date: 02Mar2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt terrible"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "really tired"; MALAISE (non-serious) with onset 29Nov2021, outcome "recovering", described as "Felt lousy".  Additional information: No prior Vaccinations were taken (within 4 weeks). No AE(s) following prior vaccinations.   Follow-up attempts are completed. No further information is expected.