chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Feeling abnormal, Illness, Pyrexia
Clinical narrative: Second Covid Shot: sick; Second Covid Shot: fever of 101; Second Covid Shot: threw him off for like a half day; Second Covid Shot: uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Second Covid Shot: sick"; PYREXIA (non-serious), outcome "unknown", described as "Second Covid Shot: fever of 101"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Second Covid Shot: threw him off for like a half day"; DISCOMFORT (non-serious), outcome "unknown", described as "Second Covid Shot: uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The prior Covid Shot he had before the booster shot, the second Covid Shot, he got sick with as expected, had fever of 101, threw him off for like a half day, uncomfortable, but no big deal.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Their palms are bright red; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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: ERYTHEMA (non-serious), outcome "unknown", described as "Their palms are bright red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: All three of them that live in the household had two Pfizers and the booster. Their palms are bright red. They had the shots and they all had the minor side effect of of sore arm. Caller clarified that he, his wife, and his son all have bright palms. That is who lives in the household. Caller's got red and then he looked at theirs's and their palms were red also. Caller is not sure if this is a long term thing.  This report is for caller's wife.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: experiencing swelling under his armpit which is extremely painful; experiencing swelling under his armpit which is extremely painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "he also experienced adverse reactions on the 1st and 2nd dose"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "he also experienced adverse reactions on the 1st and 2nd dose". The following information was reported: SWELLING (non-serious), PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "experiencing swelling under his armpit which is extremely painful".  Additional information: Caller would like to report an adverse reaction for the covid-19 vaccine. He said that he took the booster shot last week and was currently experiencing swelling under his armpit which was extremely painful. He also mentioned that he also experienced adverse reactions on the 1st and 2nd dose but subsided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Butterfly rash, Dizziness, Headache, Systemic lupus erythematosus, Vascular calcification
Clinical narrative: lupus; butterfly looking rash on face; vomiting; headache; dizzy; calcium in his artery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; BUTTERFLY RASH (medically significant), outcome "unknown", described as "butterfly looking rash on face"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VASCULAR CALCIFICATION (non-serious), outcome "unknown", described as "calcium in his artery". The events "lupus", "butterfly looking rash on face", "vomiting", "headache", "dizzy" and "calcium in his artery" were evaluated at the physician office visit. The patient had never in his life shown signs or had Lupus. It did not run anywhere in his family. Around 2 months after his second shot, he woke up vomiting, headache, dizzy and a butterfly looking rash on face. For 3 weeks straight he was dizzy and had rash for even longer. After going to hospital, family doctor, dermatologist and rheumatologist they said he had Lupus, and knew he was seeing a cardiologist for calcium in artery.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lupus; butterfly looking rash on face; vomiting; headache; dizzy; calcium in his artery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; BUTTERFLY RASH (medically significant), outcome "unknown", described as "butterfly looking rash on face"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VASCULAR CALCIFICATION (non-serious), outcome "unknown", described as "calcium in his artery". The events "lupus", "butterfly looking rash on face", "vomiting", "headache", "dizzy" and "calcium in his artery" were evaluated at the physician office visit. The patient had never in his life shown signs or had Lupus. It did not run anywhere in his family. Around 2 months after his second shot, he woke up vomiting, headache, dizzy and a butterfly looking rash on face. For 3 weeks straight he was dizzy and had rash for even longer. After going to hospital, family doctor, dermatologist and rheumatologist they said he had Lupus, and knew he was seeing a cardiologist for calcium in artery.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: rash; her sister went out to dinner with her in-laws like through marriage on Saturday night and the husband has this too Skin lesion; her sister went out to dinner with her in-laws like through marriage on Saturday night and the husband has this too, terrible itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash "; SKIN LESION (non-serious), outcome "unknown", described as "her sister went out to dinner with her in-laws like through marriage on Saturday night and the husband has this too Skin lesion"; PRURITUS (non-serious), outcome "unknown", described as "her sister went out to dinner with her in-laws like through marriage on Saturday night and the husband has this too, terrible itching".  Additional Information: The patient did not taken any other vaccine prior vaccinations or within 4 weeks and no medical history. He was not in emergency room. The man at the gym said he had the vaccine and he went to the doctor and beginning of vaccination there was nothing there and everybody looks at you like you are a mental case and said yeah but are you still itchy and goes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After the first shot, 2-3 hours later, she lost sensitivity in her fingers; This case is considered invalid other- duplicate case as it was found to be a duplicate to AER 202200498883. Serious: No  Originating AE Request: withheld  Attachments: 2 Patient Age: Unknown  Reporter Subtype: Caregiver AE Present: Yes  Product: COMIRNATY  Question: Customer Verbatim: My daughter cannot feel her arms, hands and feet. We need help as you can draw a straight line to you vaccine. Not looking for dollar. Just help. Please, I am begging at this point.  Made an outbound call on 30Mar2022 at 9:22AM.   Caller clarified that he is asking for treatment recommendations for his daughter. His daughter had the first shot of the Pfizer COVID-19 vaccine in her left arm. After the first shot, 2-3 hours later, she lost sensitivity in her fingers. The next morning, it went away. Two weeks later or something like 28 days after (caller said whichever the interval was, he believes it is 28 days), immediately after the second shot, she lost feeling in her hand then her arm. After a couple days she could not feel her right arm and hands. Subsequently, she lost feeling on the left side of her hip. Eventually, couple of months later, she lost feeling in her feet.  They had MRIs which were clean. They had EMG in which needles were poked through the muscles in her daughter's arm, in which her daughter couldn't feel the needles going in. The test was normal. They have went to neurologists and to a chiropractor in which nothing worked. The psychologist thinks it is in her head. Caller believes it isn't a psychological issue. He firmly believes it is from the shot.  Caller hung up before he was offered to be transferred. E-transmitting AE.  Question: "My daughter was injected with your vaccine. Perfectly healthy kid. And now she is in a situation with her whole life ahead of her and nobody wants to help me. And you're just deflecting. I don't know what to do. I hope somebody is listening to this recording. Thanks for your time."
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: I developed a hissing and ringing in both ears and was diagnosed with tinnitus; I developed a hissing and ringing in both ears; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 13:00 (Lot number: el3249) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301ssba, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 11Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "I developed a hissing and ringing in both ears and was diagnosed with tinnitus"; TINNITUS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "I developed a hissing and ringing in both ears". The events "i developed a hissing and ringing in both ears and was diagnosed with tinnitus" and "i developed a hissing and ringing in both ears" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information: Medical qualification reporter: Other Health Professional. If other vaccine in four weeks: No. Other medications in two weeks: Yes. If COVID prior vaccination: No. Known allergies: Yes. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Premenstrual pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 14:00 (Lot number: FE3590) at the age of 38 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Sleep disorder" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ADDERALL. Past drug history included: Nuvigil, reaction(s): "Known allergy: Nuvigil". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eh9899, administration time 09:00AM, vaccine location: Left arm), administration date: 12Dec2020, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: El0140, administration time 09:00AM, vaccine location: Left arm), administration date: 07Jan2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: BREAST SWELLING (non-serious), PREMENSTRUAL PAIN (non-serious) all with onset 15Nov2021, outcome "not recovered" and all described as "left breast became swollen & painful 1 week prior to the menses to the week of, a total of 1.5 weeks each month since receiving the 3rd dose"; MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 15Nov2021, outcome "not recovered" and all described as "the period, which up till now had been regular, now was irregular, heavier and very painful". The events "left breast became swollen & painful 1 week prior to the menses to the week of, a total of 1.5 weeks each month since receiving the 3rd dose" and "the period, which up till now had been regular, now was irregular, heavier and very painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of breast swelling, premenstrual pain, menstruation irregular, heavy menstrual bleeding, dysmenorrhoea. Additional information: There was no other vaccine in four weeks. The patient had no Covid prior vaccination. The patient had no Covid tested post vaccination. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Product temperature excursion issue
Clinical narrative: Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 28Mar2022 10:00 (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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 28Mar2022 10:00, outcome "unknown" and all described as "Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.".  Additional information: BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F. Caller would want to know if there is extended stability info for the vial to know if they should do revaccination for the people who got the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hyponatraemia
Clinical narrative: Hyperhidrosis; hyponatremia due to excessive sweating?; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Hyperhidrosis"; HYPONATRAEMIA (non-serious), outcome "unknown", described as "hyponatremia due to excessive sweating?".  Additional information: It was reported that patient would like to know if there has been any reported cases of Long term, short term hyperhidrosis after receiving the booster dose or any dose of Pfizer BioNtech covid vaccine. or hyponatremia due to excessive sweating.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Product expiration date issue
Clinical narrative: If he is concerned about receiving an expired vial, suggested him to verify first the expiration of the vial in the vaccination center or place where he will receive the second booster shot.; 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 (159558). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "If he is concerned about receiving an expired vial, suggested him to verify first the expiration of the vial in the vaccination center or place where he will receive the second booster shot.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Impaired quality of life, SARS-CoV-2 test, Tinnitus
Clinical narrative: Severe Tinnitus in both ears. Low and high ringing; hearing didn't get affected too much; Just the loud ringing noise that is absolutely unacceptable to live with; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 11:30 (Lot number: FJ8762) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose lot number: ER8732, Prev dose administration time: 10:00AM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 02Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Prev dose lot number: EW0164, Prev dose administration date: 23Apr2021, Prev dose administration time: 10:30 AM, Prev dose dose number- 2, Prev dose vaccine location- Right arm), administration date: 23Apr2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Severe Tinnitus in both ears. Low and high ringing"; HYPOACUSIS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "hearing didn't get affected too much"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Just the loud ringing noise that is absolutely unacceptable to live with". The events "severe tinnitus in both ears. low and high ringing", "hearing didn't get affected too much" and "just the loud ringing noise that is absolutely unacceptable to live with" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, hypoacusis, impaired quality of life.  Additional information: Adverse event: Severe Tinnitus in both ears. Low and high ringing. Just unbearable. Went to ENT and did Ear test and hearing didn't get affected too much. Just the loud ringing noise that is absolutely unacceptable to live with. Patient did not had any other vaccine in four weeks not any other medications in two weeks. Patient did not had covid prior vaccination and was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients; Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "Caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients".  Additional information: Caller was a pharmacist who wanted to report an administration error for Pfizer-BioNTech COVID-19 Vaccine (purple cap). Vaccines were stored in the refrigerator (temperature not known) for 42 days (not confirmed with caller). Upon checking the expiration information for this vaccine, caller noticed that the vaccines could be used only for 31 when stored in a refrigerator. 2 doses were administered to patients and caller wanted to know if those were valid doses. During the call, caller confirmed that the refrigerator containing the purple top Pfizer BioNtech vaccine has a temperature of 35 to 40 degree Fahrenheit and they have stored the vaccines 11 days past the expiration days (total of 42days). Previously they administered the affected supply to 2 patients and today it was administered to another 2 for a total of 4 patients. Patients were: 61 year old female / 53 year old Male / 61 year old Male / 64 year old Male.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200501508 Same reporter/drug/event, differnet patinents.;US-PFIZER INC-202200501509 Same reporter/drug/event, differnet patinents.;US-PFIZER INC-202200501510 Same reporter/drug/event, differnet patinents.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Protein S deficiency, Thrombosis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PROTEIN S DEFICIENCY (medically significant), outcome "unknown", described as "S-protein deficiency"; ASTHENIA (non-serious), outcome "unknown", described as "experienced not being able to drive, use legs and arms, he says he couldn't put his cap when he even used to take and pick literal engines up". The event "s-protein deficiency" was evaluated at the physician office visit. Caller said they want to talk to a corporate vaccine technician, the group who put up the Pfizer Covid vaccine according to him. Reporter said he have a rare blood disorder called S-protein deficiency and that the same protein is being used in the vaccine which he doesn't have; caller said he has had 4 shots of the vaccine already and experienced blood clots where he also experienced not being able to drive, use legs and arms, he says he couldn't put his cap when he even used to take and pick literal engines up. Reporter said he went to a vascular surgeon and was checked for 2 days and was confirmed that he have S-protein deficiency. Reporter said he wants to talk to the corporate vaccine technician as he found out from his self-research that the vaccine apparently strips away the S-protein from his body which he doesn't have in the first place. Reporter displays propane language towards the vaccine calling it junk and related words. He was concerned that he got the vaccine and was not informed about the vaccine "stripping away" something in his body which he lacks in the first place, and that he also mention "BNT" compound being in his body and wanting to get it out of his system. Reporter said he didn't want to be backdoored again and would want to speak to the one who made the vaccine or threatens that he will go to the media with regards to this. Tried to reason with caller but they were hesitant on the information that was provided, saying that the information we have is wrong and that the one he has is right. Tried to give caller Pfizer's legal department's address to write his claim but caller dropped the line abruptly. "The nucleoside-modified mRNA in COMIRNATY is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Inappropriate schedule of product administration, Inflammation, SARS-CoV-2 test
Clinical narrative: anemia; inflammation; administration date=23Jan2021, dose 1, administration date=03Feb2021, dose 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2021 (Lot number: en5318) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cardiac issues" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: en3248, Location of injection: Arm Right), administration date: 23Jan2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: ANAEMIA (non-serious) with onset 18Aug2021, outcome "not recovered", described as "anemia"; INFLAMMATION (non-serious) with onset 18Aug2021, outcome "not recovered", described as "inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2021, outcome "unknown", described as "administration date=23Jan2021, dose 1, administration date=03Feb2021, dose 2". The events "anemia" and "inflammation" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anaemia, inflammation.  Additional information: Patient had mysteriously developed anaemia and significant inflammation as confirmed in multiple batteries of blood tests without any identifiable cause as of yet especially at the time of the booster being received. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. COVID test post vaccination COVID test type post vaccination: nasal Swab, COVID test name post vaccination was unknown. Other medications in two weeks: Yes. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; a rash type thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 20Jan2021 (Lot number: EL3302) 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: PRURITUS (non-serious), outcome "unknown", described as "itching"; RASH (non-serious), outcome "unknown", described as "a rash type thing". The events "itching" and "a rash type thing" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: It was reported that, this report is not related to study or program. Information about other conditions and investigations not provided. Patient is the reporter. He had a lot of itching and a rash type thing going on for quite a while. He said he had shown allergists and dermatologists and they can't seem to find any solutions. He said he had steroid shots, so he wanted to know if the people who manufactured the vaccine have come up with any solutions for this. He said he has heard of other people who have the same thing, he has been on the internet, and everything has side effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200503395 same reporter/drug/AE with different patient
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; a rash type thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; RASH (non-serious), outcome "unknown", described as "a rash type thing".  Additional Information: Consumer spoke to someone with company named (withheld) who is a nurse, and he doesn't know what option, maybe 3, that he was supposed to dial regarding having possible side effects. He says he had a lot of itching and a rash type thing going on for quite a while. He says he has seen allergists and dermatologists and they can't seem to find any solutions. He says he had steroid shots, so he wanted to know if the people who manufactured the vaccine have come up with any solutions for this. He says he has heard of other people who have the same thing, he has been on the internet, and everything has side effects. Caller declines to provide Email Address. Caller clarifies he got the Pfizer COVID-19 vaccine, and his first dose was 20Jan2021 with LOT: EL3302. Caller says NDC/LOT/EXP were not written on his vaccine card for any doses. He says his second dose was 10Feb2021 of LOT: EN6201. He says his booster dose was LOT: FG3592 which was given on 02Oct2021. He provides unknown number from vaccine card: 1-7-217.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200503314 same reporter/drug/AE with different patient
Sex: M
Vaccine: FLUX
Symptoms: Surgery
Clinical narrative: having surgery on the "24th" and he was discharged on the "25th; Initial information received on 23-Mar-2022 regarding an unsolicited valid serious case was received from a patient.  This case involves an unknown age male patient who had surgery on the "24th" and he was discharged on the "25th after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number: UI684AE or UT5570BA, expiry date: 30-Jun-2017) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  Patient stated that health care provider may not have recorded accurately the flu vaccine that he received. His health care provider stated that they did not give him an intradermal shot, but he thinks he may have been given an intradermal shot, because it was different from any shot he had received before. At one place in material, he had about what may be his case, it mentions a quadrivalent flu shot and then elsewhere it mentions a trivalent flu shot. Patient stated that the trivalent vaccine may have been expired. The healthcare provider gave him one lot number UI684AE, but he thinks a different lot number may be involved, lot UT5570BA. Patient mentioned having surgery on the 24th (month and year not specified) and he was discharged on the 25th (month and year not specified) (surgery, latency: unknown) but unable to clarify further details. At one point he mentioned going to the emergency room.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (having surgery on the "24th" and he was discharged on the "25th).  At time of reporting, the outcome was Unknown for the event having surgery on the "24th" and he was discharged on the "25th.  Seriousness criteria: hospitalization for the event of surgery.; Sender's Comments: Sanofi company comment dated 25-Mar-2022: This case concerns an unknown age male patient who had surgery on the "24th" and he was discharged on the "25th after receiving vaccine influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants, would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Diarrhoea, Haematology test, Headache, Laboratory test
Clinical narrative: Myalgia for 2 weeks Fever for 2 days Severe headache for 2 weeks Nausea for 1 week Diarrhea for 1 week Pressure behind eyes ongoing Adverse reaction
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Ocular discomfort, Pyrexia, Venipuncture
Clinical narrative: Myalgia for 2 weeks Fever for 2 days Severe headache for 2 weeks Nausea for 1 week Diarrhea for 1 week Pressure behind eyes ongoing Adverse reaction
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiparesis
Clinical narrative: STROKE, LEFT-SIDED WEAKNESS, 1030PM 4/26/2021.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal paraesthesia, Pruritus, Throat tightness, Tongue discomfort
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient complained of tingling in throat & "felt like her tongue was thick". Patient was monitored and was breathing normally with no signs of struggling. A few more minutes passed and patient said she still felt itching and thickness, but still being monitored with no issues or struggling with breathing & she asked about benadryl.dose of benadryl was given & remained to be monitored for an additional 40 min. Patient said she felt fine and it could've been anything that caused itchiness
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Psoriatic rash all over the body-Severe
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Psoriatic rash all over the body-Severe
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: patient stated she experience brain fog dizziness headaches neck pain and back of head pain as well as memory issues patient going to md next week
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Memory impairment, Nausea, Neck pain
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: patient stated she experience brain fog dizziness headaches neck pain and back of head pain as well as memory issues patient going to md next week
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Flushing, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Fainting and dizziness new onset
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Electrocardiogram normal, Interchange of vaccine products, Joint swelling, Magnetic resonance imaging abnormal
Clinical narrative: Pfizer (Comarty) booster administered into left shoulder (3rd shot for patient).  First two shots administered in MAY21 (Moderna).  Significant edema occurred following booster.  Left side of body swelled (shoulder, arm, breast, latismus dorsi), edema lasted 5-7 days.  Two months following the vaccine patient had blood markers tested and observed elevated troponin and NT PROBNP indicating heart damage.  Patient had contrast MRI to assess heart condition and was diagnosed with Pericarditis.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial injury, N-terminal prohormone brain natriuretic peptide increased, Oedema, Pericarditis, Peripheral swelling
Clinical narrative: Pfizer (Comarty) booster administered into left shoulder (3rd shot for patient).  First two shots administered in MAY21 (Moderna).  Significant edema occurred following booster.  Left side of body swelled (shoulder, arm, breast, latismus dorsi), edema lasted 5-7 days.  Two months following the vaccine patient had blood markers tested and observed elevated troponin and NT PROBNP indicating heart damage.  Patient had contrast MRI to assess heart condition and was diagnosed with Pericarditis.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast abnormal, Troponin increased, Ultrasound scan normal
Clinical narrative: Pfizer (Comarty) booster administered into left shoulder (3rd shot for patient).  First two shots administered in MAY21 (Moderna).  Significant edema occurred following booster.  Left side of body swelled (shoulder, arm, breast, latismus dorsi), edema lasted 5-7 days.  Two months following the vaccine patient had blood markers tested and observed elevated troponin and NT PROBNP indicating heart damage.  Patient had contrast MRI to assess heart condition and was diagnosed with Pericarditis.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Death, General physical health deterioration, Systemic lupus erythematosus
Clinical narrative: Pt.'s health "tanked" over a short period of time after being vaccinated.  A lifelong athlete, pt. completed a (15) mile charity swim in summer of 2021.  So, a vigorous individual's health crashed very fast.  In Feb 2022, she called off her wedding a few weeks before it was scheduled to take place.  Several weeks later, I received a call from her daughter that she died.  Pt. was a Lupus patient and 25% of persons with an autoimmune disorder that are vaccinated for Covid experience exasperation of their disease.  This is beyond a shadow of a doubt what happened to pt., but she was not warned that the vaccine may exasperate her Lupus.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: It just came on like cold, congestion, and cough. Then it went into runny nose and voice loss. The voice loss lasted over a month. The cough eventually tapered off. The congestion lasted about 10 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: It just came on like cold, congestion, and cough. Then it went into runny nose and voice loss. The voice loss lasted over a month. The cough eventually tapered off. The congestion lasted about 10 days.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Dyspnoea, Echocardiogram abnormal, Fatigue, Heart rate irregular
Clinical narrative: heart palpitations and racing heart started soon after vaccine - a few days later, irregular heart beats/palpitations consistently throughout the day and would frequently happen during sleep.  This continued quite heavily for 3 weeks-  I was extremely tired and out of breath.  After 3 weeks, the irregular heart beats would come and go during different times of the day.  This lasted over 2 months, when I consulted my general practitioner (DO).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular tachycardia
Clinical narrative: heart palpitations and racing heart started soon after vaccine - a few days later, irregular heart beats/palpitations consistently throughout the day and would frequently happen during sleep.  This continued quite heavily for 3 weeks-  I was extremely tired and out of breath.  After 3 weeks, the irregular heart beats would come and go during different times of the day.  This lasted over 2 months, when I consulted my general practitioner (DO).
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Axillary pain, Chills, Dizziness, Flank pain, Nausea
Clinical narrative: Pain in arm/arm pit that is shooting down side of body. Nausea/ vomiting. Chills, Dizziness
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Pain in arm/arm pit that is shooting down side of body. Nausea/ vomiting. Chills, Dizziness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Safety Officer called to vaccinator table. Client just recently vaccinated.  Vaccinator noticed that the date of vaccination on card and spreadsheet did not match date on database.  Spreadsheet and vaccine card said 2/25/21 for 2nd dose. Registered by staff with incorrect year.  Database date for 2nd dose Pfizer reads 2/25/22 - 1 year difference. Client confirmed that she was vaccinated earlier this year.  Vaccinator on 2/25/22 wrote incorrect year on client?s card.  Client notified of error, assured of safety of vaccine. Gave information on when/when not to return.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Each time I received a Covid shot - 03/29/21 and 04/26/2021 - I developed joint pain - on the days I received the shots, the joint pain happened at night and for a few weeks after. It got better and then only happened on occasion. When I received the booster shot, it happened again..the pain I had that night was excruciating. All my joints hurt...ankles, hips, knees , elbows, wrists fingers, shoulders. This time the pain has not really went away. I continue to have pain at night and during the day in various joints.  They are now offering another booster for people over 50. I will opt out of this shot. I can directly relate the joint pain to the Covid shot. I am not willing to risk getting another one of these vaccines due to the joint pain caused by the previous vaccines.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash/hives itchy
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Epistaxis, Eye haematoma, Headache, Ocular discomfort
Clinical narrative: I had a real bright blinding light then a spiderweb effect. I got a bad headache that came along with it. I could barely see and I had to put on sunglasses when I got home. My doctor found a hematoma behind my eye that was about to detach my retina. When the pressure got bad in the eye I would get a nose bleed and the pressure would feel better. I am still sensitive to light until this day.