chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Eye irritation
Clinical narrative: Eye irritation; Very large puffing eye that I could not open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious), outcome "unknown", described as "Eye irritation"; EYE DISORDER (non-serious), outcome "unknown", described as "Very large puffing eye that I could not open". The events "eye irritation" and "very large puffing eye that i could not open" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye irritation, eye disorder.  Additional information: The patient received 1st shot and within 7 days started experiencing eye irritation. The patient's physician was very curious he had 2 patients in 2 hours with the same thing. Later that week I received an article about this same issue being studied in withheld.  Follow-up (18Feb2022): 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073209 same reporter/drug/event, different patient;US-PFIZER INC-202200073160 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Periorbital swelling
Clinical narrative: eye irritation; very large puffing eye that I could not open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  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: EYE IRRITATION (non-serious), outcome "unknown", described as "eye irritation"; PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "very large puffing eye that I could not open".  Customer Verbatim: I received my 1st shot and within 7 days started experiencing eye irritation which later turned into a very large puffing eye that I could not open I received meds but my physician was very curious he had 2 patients in 2 hours with the same thing. Later that week I received an article about this same issue being studied in withheld.  Follow-up (18Feb2022): 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200073208 same reporter/drug/event, different patient;US-PFIZER INC-202200073160 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Growth disorder, Weight decreased
Clinical narrative: They feed him breastmilk; He originally was not growing as quickly; Had around a pound of water weight that he lost after initial birth.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An infant male patient was exposed to bnt162b2 (BNT162B2), transmammary (Batch/Lot number: unknown) as dose 1, single and transmammary (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother's relevant medical history included: "has had TBI in 20s" (unspecified if ongoing), notes: has had TBI in 20s and is on blood thinners. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "They feed him breastmilk"; GROWTH DISORDER (non-serious), outcome "unknown", described as "He originally was not growing as quickly"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Had around a pound of water weight that he lost after initial birth.".  Additional working: Baby came two days before set induction date. He originally was not growing as quickly, but (withheld) started feeding more, and now he is wearing 2-3 month old clothes. Had around a pound of water weight that he lost after initial birth. They feed him breastmilk. "Patient's mother contractions started the day before or estimated 12 hours before labor. Knees locked when her water broke (was leaning over bed)and legs cramped (such as thigh) to where doctors had to roll her onto the bed. She is estimated 36 years old. She definitely has received first shot of vaccine, but cannot remember whether got second. Her husband, early to mid 40s, was also vaccinated and may have been vaccinated 2 dose during pregnancy or conception, unsure timeline (separate AE submitted for this previously). Cannot confirm, but spouses may have gotten Moderna".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725165 mother/baby case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing), notes: she usually gets migraines once a year so she knows how it feels and has medication for it. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of her arm".  Additional information: The patient had no reaction to the first dose of Pfizer BioNtech covid vaccine aside from the usual soreness of her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2), administration date 16Jan2022 11:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of chills, headache.  Additional Information: Additional Context: Reporter stated, "he is calling for his wife who had a shot this morning about 11 o'clock. And she is having chills and a headache. He stated, "Is there anything we can do other than, he gave her two Tylenol extra strength a half hour ago (treatment)." Reporter was suggested to visit the nearest Physician or ER in case of emergency. Further probing could not be done as the reporter was unwilling to share any further information. Hence limited information available over the call.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: arm was a little sore; lymph nodes in my neck and armpit were swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillian" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VIT B12; CITALOPRAM; LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), for COVID-19 Immunization, reaction(s): "tired". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was a little sore"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph nodes in my neck and armpit were swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: The most recent COVID-19 vaccine was administered at Vaccination Site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: her face got numb on both sides; her nerve pain in the body got worse and lasted for 8 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to latex" (unspecified if ongoing), notes: she is allergic to latex. The patient's concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovered" (Jan2022), described as "her face got numb on both sides"; NEURALGIA (non-serious) with onset 2021, outcome "recovered" (Jan2022), described as "her nerve pain in the body got worse and lasted for 8 months".  Additional information: Caller also mentioned that prior to her vaccination, she was asked what allergies she has and she mentioned she is allergic to latex. She said that may have contributed to her bad reaction to the vaccine. It was reported that that Patient received her first dose of the vaccine last May2021 but she had a bad reaction to it and did not get her second dose as she concerned that the adverse reaction she had would get worse. She mentioned that her face got numb on both sides and her nerve pain in the body got worse and lasted for 8 months. She is unsure if she is allergic to the vaccine but she mentioned that she is allergic to latex  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: his PSA level increased. Caller said he checked his PSA level 8 weeks after the 2nd shot and it's now at 18; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, he received 2 shots of the Comirnaty vaccine last year), administration date: 2021, for COVID-19 immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset 2021, outcome "unknown", described as "his PSA level increased. Caller said he checked his PSA level 8 weeks after the 2nd shot and it's now at 18". The event "his psa level increased. caller said he checked his psa level 8 weeks after the 2nd shot and it's now at 18" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated he has a Safety Question. Reporter states last year when he had his yearly physical and blood draw, his PSA or Prostate Specific Antigen, test was at a level of 6, which was very good for his age. Reporter states, then a year later when they drew his blood after the 2 shots of the vaccine, his PSA level was 3 times that at a level of 18. He couldn't believe it, so he had them retest and it came back the same. Reporter stated that he went to (PRIVACY) to a Urologist who rechecked his level and gave him advice, but the urologist thinks it is possibly connected to the vaccine and the doctor is going to watch it for a while. The urologist said he could order a biopsy, but that is particularly painful and invasive for him. Reporter stated that he found out from the CDC there are 44 ongoing studies on PSA levels from the Pfizer and Moderna Vaccines if patients experiencing higher levels after the vaccines. Reporter stated  it was very irritating to have his levels suddenly jump up to 3 times the level they were., and he was calling to find out what is going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pain
Clinical narrative: Pains; Headache; Discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "Pains"; HEADACHE (non-serious) with onset Jan2022, outcome "not recovered", described as "Headache"; DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "Discomfort".  Additional information: Reporter wanted recommendations because yesterday she received her first dose of the Pfizer COVID-19 Vaccine and she's experiencing some pains and a headache. So, she wanted to know if she could take Ibuprofen for her discomfort, Disclaimer provided, responded per attached document: Talk to a doctor about taking over-the-counter medicine, such as ibuprofen, acetaminophen, aspirin (only for people aged 18 or older), or antihistamines for any pain and discomfort experienced after getting vaccinated. Referred caller to HCP for further guidance, this report is not related to study or programmed, Reporter declined to complete a report, additional details and clarifications unable to be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: dizziness; headaches; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The patient received two doses of the Pfizer COVID-19 vaccine and developed some side effects such as dizziness, headaches and chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: recurrent and consistent canker sores in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 15:30 (Lot number: EW0153) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Graves disease" (unspecified if ongoing), notes: Recovered from Graves disease at 40 yrs old.; "canker sores", start date: 2013 (unspecified if ongoing), notes: had a shorter bout with recurrent canker sores (4 months in duration) after multiple vaccinations. Concomitant medication(s) included: CALCIUM; COLLAGEN; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: APHTHOUS ULCER (non-serious) with onset May2021, outcome "not recovered", described as "recurrent and consistent canker sores in my mouth". Therapeutic measures were taken as a result of aphthous ulcer.  Additional information: Other medications received in two weeks were : Calcium, multi-vitamin, tumeric, collagen. Beginning about 4 weeks after patients first dose, patient had recurrent and consistent canker sores in mouth. Patient had not had a single day in nearly 8 months when have not had one or have not had one forming. Treatment was received with steroid dental paste. Facility type vaccine: Pharmacy or Drug Store. No covid reported prior vaccination and post vaccination. No known allergies reported.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysmenorrhoea, Menstruation irregular, Pain, Pityriasis rosea
Clinical narrative: My periods are messed up; had the worst cramps; excruciating crippling pain; this was worse than anything I've ever felt; flare up of pityriasis rosea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: 14364) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Intermittent Cushing's syndrome reoccurrence" (unspecified if ongoing); "Addison's disease due to bilateral adrenalectomy" (unspecified if ongoing); "Addison's disease due to bilateral adrenalectomy" (unspecified if ongoing); "vulvodynia" (unspecified if ongoing); "chronic pelvic pain" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Pityriasis rosea" (unspecified if ongoing), notes: I also had a flare up of pityriasis rosea when I had my second injection in Feb. The last time I had that virus was 10 years ago; "birth control" (unspecified if ongoing), notes: I don't remember ever missing a period except for on birth control and I, am not currently on any. Concomitant medication(s) included: HYDROCORTISONE; FLUDROCORTISONE; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (Dose:1, lot number=14165, location=Left arm), administration date: 25Jan2021, when the patient was 31 years old, for covid 19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 18Feb2021, outcome "not recovered", described as "My periods are messed up"; DYSMENORRHOEA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "had the worst cramps"; PAIN (non-serious) with onset 18Feb2021, outcome "not recovered", described as "excruciating crippling pain"; CONDITION AGGRAVATED (non-serious) with onset 18Feb2021, outcome "not recovered", described as "this was worse than anything I've ever felt"; PITYRIASIS ROSEA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "flare up of pityriasis rosea". Therapeutic measures were not taken as a result of menstruation irregular, dysmenorrhoea, pain, condition aggravated, pityriasis rosea.  Additional information:Patient was not tested Covid post vaccination. The patient was not taken other vaccine in fourweeks.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Penile swelling, Testis discomfort
Clinical narrative: Flu like symptoms; side effects as testicular discomfort/problem with the testicle area, not a pain but a discomfort like puberty that kind of situation, discomfort in that area; penis swelling in the "circumcision area" that lasted for only one day; 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 41 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Jan2022 (Lot number: FJ7611) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "circumcision" (unspecified if ongoing), notes: many years ago. There were no concomitant medications. The following information was reported: TESTIS DISCOMFORT (non-serious) with onset 07Jan2022, outcome "not recovered", described as "side effects as testicular discomfort/problem with the testicle area, not a pain but a discomfort like puberty that kind of situation, discomfort in that area"; PENILE SWELLING (non-serious) with onset 07Jan2022, outcome "recovered" (08Jan2022), described as "penis swelling in the "circumcision area" that lasted for only one day"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms".  Follow-up (26Jan2021): This is a spontaneous follow-up report received from the same contactable Consumer. Updated information included: Patient details (DOB, Age, height, weight, age at vaccination), dosage regimen (Lot number), Event information (onset date, stop date, outcome of event)  Follow-Up (02Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Enlarged lymph nodes; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 (Lot number: EW0185) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number=EW0182, dose number=1, vaccine location=Left arm), administration date: 07May2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31May2021, outcome "recovered with sequelae", described as "Enlarged lymph nodes"; INJECTION SITE PAIN (non-serious) with onset 31May2021, outcome "recovered with sequelae", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of lymphadenopathy, injection site pain.  Additional information: No other vaccine in four weeks, No Other medications in two weeks  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Neck pain
Clinical narrative: it is really bad, like someone hit him in the back of the head; Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck/like throbbing headaches; Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck; 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 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2022 (Lot number: FK97Z9) at the age of 40 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: FEELING ABNORMAL (non-serious) with onset 23Jan2022, outcome "not recovered", described as "it is really bad, like someone hit him in the back of the head"; HEADACHE (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck/like throbbing headaches"; NECK PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "Maybe 2 hours after that he started getting bad headaches/still getting them today in the back of his head and down to his neck". Therapeutic measures were taken as a result of headache, neck pain.  Additional information: Reporter stated that he went to the dentist 2 weeks prior to the shot, but he didn't have any headaches then so he does not feel its relevant.  Reporter stated that 2 hours after receiving his dose, and persisting today he's been having really bad headaches. Feels like someone hit him in the back of the head. Reporter says at times it is really bad, like someone hit him in the back of the head. So intense that he wants to go down onto his knees. States its so intense he sticks his fingers in his ears, like you do on an airplane. States he is leaving work right now because of one. Response given from attached doc, also provided data.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: First COVID vaccine dose on 19Jan2021/ Second vaccine was 02Feb2021; After the 2nd vaccine, he had toe nail fungus that started to disappear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EN9581) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Toe fungus" (unspecified if ongoing), notes: had toe fungus for 20 years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot number EC9231, UNKNOWN MANUFACTURER), administration date: 19Jan2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "After the 2nd vaccine, he had toe nail fungus that started to disappear"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, outcome "unknown", described as "First COVID vaccine dose on 19Jan2021/ Second vaccine was 02Feb2021".  Additional Information: He has had toe fungus for 20 years while he was active duty military service, and for 20 years after that. After the 2nd vaccine, he had toe nail fungus that started to disappear. It started on all of his small digits , and he even started to grow new toenails. His big toes started to get better as well, and the toe nail fungus is 1/4 gone. He is getting a new nail on his big toes too. He has done nothing different with his medical care or anything. The only thing that changed was the vaccine. He got his first COVID vaccine dose on 19Jan2021 with lot number EC9231, and his follow up for the second vaccine was 02Feb2021, with lot number EN9581. He got the COVID booster 18Oct2021 with lot number EP7533. He noticed an improvement in his toenail fungus probably 1.5-2 months after the second COVID vaccine. The toenail fungus was beginning to improve, and has continued to improve. He has not received any other vaccines. He had an appointment at the VA this morning. His rheumatoid arthritis doctor, said her 15 year old young son had the Pfizer vaccines as well, that his toe nail fungus is starting to improve too. He doesn't have further information to do a report on him, but he is going to message his doctor the Pfizer safety department number because she said she would report it. He has pictures of his toes as well if he gets contacted by Pfizer.No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: Pfizer BioNTech Covid 19 vaccine that was placed in the freezer on 27Oct2021 and were administered on 31Dec2021; Pfizer BioNTech Covid 19 vaccine that was placed in the freezer on 27Oct2021 and were administered on 31Dec2021; Pfizer BioNTech Covid 19 vaccine that was placed in the freezer on 27Oct2021 and were administered on 31Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202200175752 (PFIZER).  A 16 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 31Dec2021 10:15 (Lot number: FF2590, Expiration Date: 31Mar2022) at the age of 16 years as dose 1, 0.3ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT STORAGE ERROR (non-serious), EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "Pfizer BioNTech Covid 19 vaccine that was placed in the freezer on 27Oct2021 and were administered on 31Dec2021".  Additional information: LPN calling about two patients who received the Pfizer BioNTech Covid 19 vaccine that was placed in the freezer on 27Oct2021 and were administered on 31Dec2021.  Vaccine was never moved to the refrigerator.  The vaccines were first doses for 2 female patients ages 14 and 16.  Vaccine was not expired but used beyond use date because it was in the fridge beyond 14 days. This is for 1st of 2 reports. This was the patient's first dose of the covid vaccine that was administered 31Dec2021 around 10:15am. Reporter mentioned that they received email from Pfizer which says that there is no stability data to support the excursion. She mentioned the interaction number from the previous interaction. She also mentioned that it was sent back after they submitted the facility form to report their temperature excursion. She verbally read the email and mentioned that their vials were stored in a freezer from 27Oct2021 to 31Dec2021 and were administered. She wants to know if there is any revaccination guidelines for patients who received doses from the vials who experienced an excursion, given that there is no data to support their excursion.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: calling because they gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "calling because they gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date".  Additional information: Gave Pfizer covid-19 vaccines for the age group of 5 to after the expiration date, six days at the expiration date to be exact (withheld), Reporter wants to know if they have some guidance to see.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Nephropathy, Renal function test
Clinical narrative: kidney disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Lot number: EW0186) at the age of 34 years as dose 2, single and administration date 23Jun2021 (Lot number: EW0186) 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: NEPHROPATHY (non-serious), outcome "unknown", described as "kidney disease". The event "kidney disease" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the first dose, his kidney valued changed from being totally normally to decreased and doctor said he had stage one kidney disease. After the second dose, his kidney value also dipped down and doctor stated he had stage two kidney disease.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: and has some heart conditions that may be exasperated by maybe taking the vaccine; 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 parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "and has some heart conditions that may be exasperated by maybe taking the vaccine".  Additional information: Caller was asking about the safety of the Pfizer-Biontech Covid19 vaccine for her daughter who was already perfectly healthy, already had covid, and has some heart conditions that may be exasperated by maybe taking the vaccine"? She stated that her daughter was "otherwise healthy" and has "already had covid" and "her cardiologist doesn't really recommend it [the vaccine] since she's already had covid". She also noted that  personally shehave known children her age, from friends, who have had some heart issues after receiving the vaccine. Quite frankly it's kind of very disturbing how any little child could be having these issues and how this is being forced on everyone and anyone to take it". She wants to know "if the scientists at Pfizer feel it was safe for children with heart conditions?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Hand dermatitis
Clinical narrative: developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:30 (Lot number: EW0167) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ST. JOHN'S WORT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 19Aug2021, when the patient was 29 years old, for COVID-19 Immunization.  The following information was reported: ECZEMA (non-serious), ECZEMA (non-serious), HAND DERMATITIS (non-serious) all with onset 15Sep2021 09:00, outcome "not recovered" and all described as "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists". The event "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists", "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists" and "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eczema, eczema, hand dermatitis.  Additional information: I developed eczema on my left ring finger within a week of the second vaccination. The eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists ever since the vaccination. I had to get topical corticosteroids to treat the eczema which temporarily helps, but has still not fully resolved the condition. I have never had eczema or any type of skin condition before in my life until I received the Pfizer COVID-19 vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge
Clinical narrative: My breast started leaking; looking like when you touch, like milk comes out like I am breastfeeding and I am not like I don''t have any baby; 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. Other Case identifier(s): US-PFIZER INC-202200174707 (Pfizer).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FH8027) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "pregnant 9 years ago" (not ongoing), notes: pregnant 9 years ago. Concomitant medication(s) included: LABETALOL taken for blood pressure measurement. The following information was reported: BREAST DISCHARGE (non-serious) with onset 29Jan2022, outcome "not recovered", described as "My breast started leaking; looking like when you touch, like milk comes out like I am breastfeeding and I am not like I don''t have any baby". Therapeutic measures were not taken as a result of breast discharge. Additional information: Patient was taking a shower and noticed it, and thought it was soap but then she realized it was milk, and that she was still lactating at the time of report. She was last pregnant 9 years ago and she has no "tubes", so she can't get pregnant anymore. Patient reported that everything was fine with her until she received the vaccine.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain across my right foot, my instep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2022 (Lot number: FD7218) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2022, for Covid-19 Immunization, reaction(s): "soreness in the arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Pain across my right foot, my instep". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FD7218) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in the arm".  Additional Information: Consumer stated that, about two weeks ago, I received COVID-19 vaccine. Well, the first dose, I had no problems, I just had soreness in the arm. When clarified the concern, consumer stated that first I would like to get some medical information. I do not know if it was an allergic reaction, or I do not know what to do.  QR Comment: Reporter type was not clarified over the call. Hence captured as consumer or other non-health professional by default.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Muscle spasms
Clinical narrative: muscle spasms; shivering; migraine headache; Head ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 28Jan2022 20:15 (Lot number: FJ1614) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pain relief" (unspecified if ongoing). Concomitant medication(s) included: NAPROXEN SODIUM taken for pain; IBUPROFEN taken for pain. Vaccination history included: Bnt162b2 (Dose 1, Time: 13:00, Anatomical Location: Upper left arm, Patient route of administration: Intramuscular, Lot No: EP6955), administration date: 26May2021, when the patient was 19 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Time: 13:00, Anatomical Location: Upper left arm, Patient route of administration: Intramuscular, Lot No: EP6955), administration date: 17Jun2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 30Jan2022, outcome "recovered", described as "shivering"; MIGRAINE (non-serious) with onset 29Jan2022 14:30, outcome "not recovered", described as "migraine headache"; MUSCLE SPASMS (non-serious) with onset 30Jan2022 01:00, outcome "recovered", described as "muscle spasms"; HEADACHE (non-serious) with onset 28Jan2022, outcome "recovered", described as "Head ache"; CHILLS (non-serious) with onset 28Jan2022, outcome "recovered", described as "chills".  Additional information: The facility where the COVID-19 vaccine was administered is Pharmacy or drug store. Prior Vaccinations (Within 4 weeks): None. Typical AE post vaccination with third Comirnaty dose, Headache, chills/ shivering. Though she also experienced uncontrolled muscle spasms in the legs the night following the vaccination, which self resolved and have not returned.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in my fingers of the feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FJ1614, Expiration Date: 28Feb2022) at the age of 61 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: PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "Tingling in my fingers of the feet". Therapeutic measures were not taken as a result of paraesthesia.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: The experience is "like having nickels in your mouth,"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "The experience is "like having nickels in your mouth,"". Therapeutic measures were taken as a result of dysgeusia.  Additional information: The sensation came on within minutes of receiving his first dose of the Pfizer Covid-19 vaccination this past week. He tried to get rid of it with coffee, then mouthwash. Twenty-four hours later, the metal taste remained. "It's certainly not debilitating or anything like that," (Name), a contributor for (Organization Name), said. "But I do hope it goes away. I would like my coffee to taste normal."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200169519 Same reporter, different drugs/patients/events;US-PFIZER INC-202200169566 Same reporter, different drugs/patients/events
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: he tasted something that reminded him of nickels after both of his Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 52 year-old male patient received bnt162b2 (BNT162B2) (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: DYSGEUSIA (non-serious), outcome "unknown", described as "he tasted something that reminded him of nickels after both of his Pfizer shots".  Additional information: The sensation came on within minutes of receiving his first dose of the Pfizer Covid-19 vaccination this past week. He tried to get rid of it with coffee, then mouthwash. Twenty-four hours later, the metal taste remained. He tasted something that reminded him of nickels after both of his Pfizer shots. The metallic taste went away after a few days . The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200169518 Same reporter, different drugs/patients/events;US-PFIZER INC-202200169566 Same reporter, different drugs/patients/events