chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: Sounds Cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: Sounds Cold). The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-APR-2024 The case was received from the patient via interactive digital media. It was reported that after receiving Arexvy, the patient sounds cold. This case has been linked with US2024AMR052797, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR052797:Same reporter / same product
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain, Back pain, Breast pain, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: swollen lymph nodes in her left armpit; One or two days later she developed severe, knife-like pain in her right armpit/ she still has a milder aching pain in her right armpit; pain radiated into her right breast; pain radiated across her back; This non-serious case was reported by a consumer via call center representative and described the occurrence of axillary pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included breast cancer (patient had a history of cancer in her left breast.).   On 11-NOV-2023, the patient received the 1st dose of Arexvy (intramuscular, right deltoid) .5 ml. In 2023, an unknown time after receiving Arexvy, the patient experienced axillary lymph nodes enlarged (Verbatim: swollen lymph nodes in her left armpit). In NOV-2023, the patient experienced axillary pain (Verbatim: One or two days later she developed severe, knife-like pain in her right armpit/ she still has a milder aching pain in her right armpit), breast pain (Verbatim: pain radiated into her right breast) and back pain (Verbatim: pain radiated across her back). The outcome of the axillary pain was not resolved and the outcome of the breast pain and back pain were resolved (duration 2 weeks) and the outcome of the axillary lymph nodes enlarged was unknown.   The reporter considered the axillary pain, breast pain, back pain and axillary lymph nodes enlarged to be related to Arexvy.     The company considered the axillary pain, breast pain, back pain and axillary lymph nodes enlarged to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self reported this case. The reporter reported that one or two days later she developed severe, knife-like pain in her right armpit (adverse event). The pain radiated into her right breast and across her back.  The severe pain continued for about two weeks.  Now, about five months later at the time of reporting she still had a milder aching pain in her right armpit. The aching pain was intermittent.   The reporter saw her doctor in December 2023 due to the pain.  Tests determined that she had swollen lymph nodes in her left armpit but no return of cancer.  The doctor told her the reactions (pain, swollen lymph nodes) were due to Arexvy.  Nothing else was reported. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: swollen lymph nodes in her left armpit; One or two days later she developed severe, knife-like pain in her right armpit/ she still has a milder aching pain in her right armpit; pain radiated into her right breast; pain radiated across her back; This non-serious case was reported by a consumer via call center representative and described the occurrence of axillary pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included breast cancer (patient had a history of cancer in her left breast.).   On 11-NOV-2023, the patient received the 1st dose of Arexvy (intramuscular, right deltoid) .5 ml. In 2023, an unknown time after receiving Arexvy, the patient experienced axillary lymph nodes enlarged (Verbatim: swollen lymph nodes in her left armpit). In NOV-2023, the patient experienced axillary pain (Verbatim: One or two days later she developed severe, knife-like pain in her right armpit/ she still has a milder aching pain in her right armpit), breast pain (Verbatim: pain radiated into her right breast) and back pain (Verbatim: pain radiated across her back). The outcome of the axillary pain was not resolved and the outcome of the breast pain and back pain were resolved (duration 2 weeks) and the outcome of the axillary lymph nodes enlarged was unknown.   The reporter considered the axillary pain, breast pain, back pain and axillary lymph nodes enlarged to be related to Arexvy.     The company considered the axillary pain, breast pain, back pain and axillary lymph nodes enlarged to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self reported this case. The reporter reported that one or two days later she developed severe, knife-like pain in her right armpit (adverse event). The pain radiated into her right breast and across her back.  The severe pain continued for about two weeks.  Now, about five months later at the time of reporting she still had a milder aching pain in her right armpit. The aching pain was intermittent.   The reporter saw her doctor in December 2023 due to the pain.  Tests determined that she had swollen lymph nodes in her left armpit but no return of cancer.  The doctor told her the reactions (pain, swollen lymph nodes) were due to Arexvy.  Nothing else was reported. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: her aunt received 2 shots of Arexvy vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of overdose in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: her aunt received 2 shots of Arexvy vaccine). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 19-APR-2024 The reporter reported that her aunt (patient) received 2 shots of Arexvy vaccine, which led to overdose. The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered bexsero after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug administered in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 22-APR-2024, the patient received Bexsero. On 22-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired drug administered (Verbatim: Administered bexsero after the expiration date). The outcome of the expired drug administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter was Clinical manager. The reporter reported the patient administered Bexsero after the expiration date. The reporter enquired any side effects needed revaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The injected arm is sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included poliomyelitis (Polio disease as a child).   On 22-APR-2024, the patient received the 1st dose of Shingrix (unknown arm). On 22-APR-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: The injected arm is sore). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2024 The patient self-reported the case.   The patient received the dose of Shingrix, and the injected arm was sore. The case was linked with the case US2024051395, reported by same reporter.; Sender's Comments:  US-GSK-US2024051395:Same reporter/ different patient
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration under 4 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 20-APR-2024, the patient received the 1st dose of Kinrix. On 20-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration under 4 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-APR-2024 The medical assistant request data about how to proceed when a patient under 4 months of age received a dose of Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: a male patient received an expired dose of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 23-APR-2024, the patient received Infanrix. On 23-APR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: a male patient received an expired dose of Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-APR-2024 The reporter stated that patient received an expired dose of Infanrix which led to expired vaccine used
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received the Engerix b vaccine the first dose/she did not complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B (received first dose of Engerix B adult on 29-AUG-2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult 20 µg. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: received the Engerix b vaccine the first dose/she did not complete the series). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-APR-2024 The patient received first dose Engerix B adult and did not complete the series and wants to complete the series. The reporter did not had batch number of the first dose since the record was too old. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B adult, which led to incomplete course of vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching from head to ankles; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching from head to ankles) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching from head to ankles). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itching from head to ankles) had not resolved.            The patient never had an allergic reaction. No concomitant medication was reported. The suspect product dosage text was reported as unknown.  The patient had itching from head to ankles. Itching without much relief at all. While sleeping the patient doesn't feel it but undoubtedly scratching everywhere. It started 2 months after her booster shot. Itching had been a good year since it started. The patient may had a Pfizer vaccine after the Moderna. The patient had overdosing on Benadryl with no relief, plus had prednisone and something else. Doctor said they've exhausted everything they could try. Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-766473 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-766473:Same Reporter (for 500-600 people)
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varicella 08/20/2012, 08072013; on 21-JUN-1994, 02-AUG-1994 and on 22-MAR-1995, the patient was vaccinated with hepatitis B, vaccine; on 21-JUN-1994, 02-AUG-1994 and on 22-MAR-1995, the patient was vaccinated with hepatitis B, vaccine; This spontaneous report has been received from physician, via medical records from a case in litigation for GARDASIL and GARDASIL 9 (MARRS #2403USA003843), concerning to a currently 29-year-old non-smoker female patient.  Office visits (OV) were performed on 09-MAY-2016, 21-JAN-2017, 22-FEB-2017, 21-SEP-2017, 01-OCT-2018, 24-SEP-2018 by patient (captured in MARRS#2403USA003843). Per 03-OCT-2019 OV. Immunization records stated that on 21-JUN-1994, 02-AUG-1994 (Inappropriate schedule of product administration) and 22-MAR-1995 (Inappropriate schedule of product administration), patient was vaccinated with the first, second, and third dose of hepatitis B, vaccine (manufacturer unknown), respectively, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided. On 20-AUG-2012 and 07-AUG-2013 (Inappropriate schedule of product administration), the patient was vaccinated with the first and second dose of varicella vaccine (manufacturer unknown) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Other vaccines administered included: MMR vaccine (manufacturer unknown) (on 29-AUG-1995, 23-JUL-1998), Meningococcal ACWY (on 10-AUG-2007 and 03-AUG-2012), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (on 17-AUG-2007, 15-OCT-2007 and on 22-FEB-2008, the patient was vaccinated with) (captured in MARRS#2403USA003843), hepatitis A vaccine (manufacturer unknown) (on 31-AUG-2009, 27-AUG-2010), influenza Nasal, unspecified formulation (On 01-JAN-2013), and Tdap vaccine (On 24-JUL-2013). Additional office visit was performed on 16-FEB-2021 (captured in MARRS#2403USA003843).  This is one of two cases from the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2403USA003843:
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: the vial adaptor that comes with Abrysvo is defective. When went to snap it, it broke off and all the liquid inside the Abrysvo went everywhere; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 23Apr2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group.  No patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HP1193, Expiration Date: 30Apr2025) for immunisation. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "the vial adaptor that comes with Abrysvo is defective. When went to snap it, it broke off and all the liquid inside the Abrysvo went everywhere".  Additional Information: Reporter said the vial adaptor that comes with Abrysvo is defective. They went to mix everything and it is supposed to snaps on there. When went to snap it, it broke off and all the liquid inside the Abrysvo went everywhere. Caller needs credit or replacement. There has been no patient involvement. Caller doesn't have the carton only has a picture that the customer sent. Abrysvo Carton: NDC: 0069034401; Abrysvo Antigen Vial: NDC: 0069020701. The customer has the product available to send back if necessary.   The reporter considered "the vial adaptor that comes with abrysvo is defective. when went to snap it, it broke off and all the liquid inside the abrysvo went everywhere" not related to rsv vaccine prot.subunit pref 2v. Causality for "the vial adaptor that comes with abrysvo is defective. when went to snap it, it broke off and all the liquid inside the abrysvo went everywhere" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: pain at the injection site; fatigue; headache; muscle pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team. This case is for the 2nd twin brother, the one that received Dose 1.  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Therapeutic measures (ibuprofen was given) were taken as a result of vaccination site pain, fatigue, headache, myalgia  Additional information: the 18-year-old patient was vaccinated twice with meningococcal group b rlp2086 Dose 1. Then, he and his twin brother went to the doctor's office to get the second dose. The patient's twin was in the room. The reporter thought the patient's twin accidentally received a meningococcal group b rlp2086 dose in each arm; however, the person who administered the vaccine was not sure. The reporter stated that her son experienced: pain at the injection sites, fatigue, headache, and muscle pain. The patient was given ibuprofen.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Incorrect dose administered, Injection site pain, Myalgia
Clinical narrative: accidentally double vaccinated with the MENINGOCOCCAL GROUP B RLP2086; may have injected him twice with two injections; Pain at the injection sites; Fatigue; Headache; Muscle pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown), in arm and as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bexsero (DOSE 1), administration date: 2022, for Immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "accidentally double vaccinated with the MENINGOCOCCAL GROUP B RLP2086; may have injected him twice with two injections"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at the injection sites"; FATIGUE (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "Muscle pain". Therapeutic measures were taken as a result of myalgia. Additional information: the 18-year-old patient was vaccinated twice with meningococcal group b rlp2086. The patient received the first dose of BEXSERO in 2022, ("about 1 and 1/2 years ago"). Then, he and his twin brother went to the doctor's office to get the second dose. The patient's twin was in the room. The reporter thought the patient accidentally received a meningococcal group b rlp2086 dose in each arm; however, the person who administered the vaccine was not sure. The patient had a "tough time for 2-3 days." At the time of the initial report, it had been a week since the vaccination, and he seemed totally fine now. The reporter stated that her son experienced: pain at the injection sites, fatigue, headache, and muscle pain. The patient was given ibuprofen. The patient that may have received a double dose had a stronger reaction (more side effects) than the twin that didn't.   Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional distress, Expired product administered
Clinical narrative: The patient was administered an expired dose of Comirnaty; the patient is upset; This is a spontaneous report received from an Other HCP from a sales representative and medical information team, Program ID.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Apr2024 as dose 1, 0.3ml single (Lot number: HM7006, Expiration Date: 16Apr2024) at the age of 62 years intramuscular, in left arm 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 completed; manufacturer unknown(More than 3)), for covid-19 immunisation. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 26Apr2024, outcome "unknown", described as "The patient was administered an expired dose of Comirnaty"; EMOTIONAL DISTRESS (non-serious) with onset 26Apr2024, outcome "unknown", described as "the patient is upset". It was unknown if therapeutic measures were taken as a result of expired product administered, emotional distress.  Additional information: Patient had unkown drug allergy. Caller on the phone from a doctor's office and has a covid vaccine and it expired 16Apr2024 and they gave the patient accidentally a shot and needed some information on that and wanted to report it and stated she needed information on what to do. The patient received expired covid vaccine. The listed provider is the person that gave the shot to the patient. The vaccine was administered today 26Apr2024.  For concomitant medications states she is not sure of any and when asked for other medical conditions, states she does not think she can answer that question. Caller was asked if the patient required any treatment for the reported event or if there was any testing the patient had that she feels relevant to include and caller states that is actually what she would like to ask for what can they do. NDC number of Pfizer Covid vaccine: 00692377010.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: shocked and electrocuted; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "shocked and electrocuted".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Pemphigoid
Clinical narrative: Bullous pemphigoid; This is a literature report.   One death was noted: a 79-year-old man with whole-body BP lesions. Patients' other comorbidity included: Insulin-dependent type II diabetes, end-stage renal disease on hemodialysis, hypertension, and coronary artery disease. Drug history at the time of vaccination included Insulin. He denied any new medication. Description of mucocutaneous reactions was diffuse firm and flaccid bullae after first Pfizer dose. Started on right arm and then quickly became generalized. trunk, upper and lower extremities, head, face, feet but sparing the palms, soles, and mucous membranes. Reactions onset was 1 day. Skin or mucosal biopsy was subepidermal blisters with eosinophils. C3, IgG. Diagnosis: Bullous pemphigoid. Management of reactions included doxycycline, prednisone, niacinamide, hydroxyzine and topical triamcinolone. IV dexamethasone. Rituximab infusion. Despite numerous attempts to treat his lesions with different therapies, the patient died of refractory septic shock secondary to pneumonia 6 months after exhibiting his first symptoms (4 months after receiving his first dose of rituximab). The patient date of death was unknown. It was not reported if an autopsy was performed.; Sender's Comments: Based from patients pre-existing medical conditions and plausible temporal relationship, the causal association of reported bullous pemphigoid in relation to BNT162b2 cannot be totally excluded. Case will be reassess pending new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: refractory septic shock; pneumonia
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt a bit; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1), administration date: 02Apr2021, for covid-19 immunization, reaction(s): "felt very very tired". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt a bit".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400056748 Same patient and vaccine, different dose number and event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: The symptoms the patient had from the covid vaccine was that she was really tired. Her husband and herself felt "very very tired" because they had it the same day. They slept it off and thought they slept for like 12 hours straight.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Limb injury
Clinical narrative: arm hurt; dizzy; tired; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1), administration date: 02Apr2021, when the patient was 49-year-old, for COVID-19 immunization, reaction(s): "tired". The following information was reported: LIMB INJURY (non-serious), outcome "recovered", described as "arm hurt"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FATIGUE (non-serious), outcome "recovered", described as "tired". Additional information: The patient stated, "The second one, the arm hurt a bit but that was about it. I was like a bit dizzy, but I didn't get congestion, it was something weird. Is probably because the vaccine was battling it. I just felt tired, very tired."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Laboratory test, Suspected COVID-19
Clinical narrative: got COVID on Sep2023 after having the COVID Vaccine back in 2021; got COVID on Sep2023 after having the COVID Vaccine back in 2021; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" and all described as "got COVID on Sep2023 after having the COVID Vaccine back in 2021". The patient underwent the following laboratory tests and procedures: Lab test: (Sep2023) Unknown results. Clinical course: Patient stated: The symptoms she had from the COVID vaccine was that she was really tired. Her husband and herself felt very very tired because they had it the same day. They slept it off. She think they slept for like 12 hours straight. The second one, the arm hurt a bit but that was about it. She didn't get COVID until September of last year. She didn't even get, she was like a bit dizzy but she didn't get congestion, It was something weird. Was probably because the vaccine was battling it. She just felt tired, very tired. And the only reason that she knew was because she tested herself because she was feeling weird. She knew there was something wrong. She just felt dizzy and tired. She could not even pick up a cup of coffee. And that was how she figured out she had COVID. it was not bad.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400056748 Same product, different patient/dose;US-PFIZER INC-202400097943 Same product/patient, different event/dose;US-PFIZER INC-202400097944 Same product/patient, different event/dose;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: Some high-frequency loss of hearing in both ears; Tinnitus/Tinnitus affects both ears; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, stop date: 09Feb2024; ATORVASTATIN, stop date: 09Feb2024; BETA SITOSTEROL, stop date: 09Feb2024; LIPO FLAVONOID PLUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EM9809, At Time: 11:00, Route of administration: Intramuscular , Anatomical Site of injection: arm), administration date: 13Feb2021, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6203, At Time: 11:00, Route of administration: Intramuscular , Anatomical Site of injection: arm), administration date: 06Mar2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Tinnitus/Tinnitus affects both ears"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6203, At Time: 11:00, Route of administration: Intramuscular , Anatomical Site of injection: arm), administration date: 03Jun2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "some high-frequency loss of hearing in both ears". The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Some high-frequency loss of hearing in both ears"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus/Tinnitus affects both ears". The patient underwent the following laboratory tests and procedures: Audiogram: Some high frequency loss of hearing in both ears. Clinical course: Patient did not had family medical history relevant to adverse event. No previous symptoms of Tinnitus or any other ear problems.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400056794 Same patient/same product, different dose/event;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: some high-frequency loss of hearing in both ears; Tinnitus/Tinnitus affects both ears; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 70 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, stop date: 09Feb2024; ATORVASTATIN, stop date: 09Feb2024; BETA SITOSTEROL, stop date: 09Feb2024; LIPO FLAVONOID PLUS, stop date: 09Feb2024. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 11:00, Anatomical Site of injection: arm, Route of administration: Intramuscular , Batch/Lot number: EM9809), administration date: 13Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Time: 11:00, Anatomical Site of injection: arm, Route of administration: Intramuscular , Batch/Lot number: EN6203), administration date: 06Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "some high-frequency loss of hearing in both ears", "Tinnitus/Tinnitus affects both ears"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Time: 15:00, Anatomical Site of injection: arm, Route of administration: Intramuscular , Batch/Lot number: FF2587), administration date: 16Nov2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "some high-frequency loss of hearing in both ears", "Tinnitus/Tinnitus affects both ears". The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "some high-frequency loss of hearing in both ears"; TINNITUS (non-serious), outcome "not recovered", described as "Tinnitus/Tinnitus affects both ears". The patient underwent the following laboratory tests and procedures: Audiogram: loss of hearing, notes: After tinnitus appeared, an audiometry test showed some high-frequency loss of hearing in both ears. Clinical course: Patient did not had family medical history relevant to adverse event. No previous symptoms of Tinnitus or any other ear problems.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400056794 Same patient/same product, different dose/event;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Infection; COVID 19 Infection; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old female patient (pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy" (unspecified if ongoing). Date of last menstrual period: Jan2024. The patient was 9 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 20Nov2024. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 23Apr2024 to 27Apr2024
Sex: F
Vaccine: RSV
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Abrysvo given via subcutaneous; Slight arm pain for one day following Abrysvo vaccine.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 61-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Apr2024 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Apr2024, outcome "unknown", described as "Abrysvo given via subcutaneous"; PAIN IN EXTREMITY (non-serious) with onset Apr2024, outcome "recovered", described as "Slight arm pain for one day following Abrysvo vaccine.".  Causality for "slight arm pain for one day following abrysvo vaccine." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: shocked and electrocuted; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "shocked and electrocuted".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Long Covid; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown" and all described as "Long Covid". The patient is the reporter's brother. The reporter stated, "I understand Long Covid may not be related to the vaccine, but I wanted to check and see if I should report this to anyone".  The information on the batch/lot number for [BNT162B2 NOS] will be requested and submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event post-acute COVID-19 syndrome is assessed as not related to BNT162B2, and more likely a complication or sequelae of CoVID-19 infection.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Croup infectious, Hypoxia, Influenza virus test negative, Respiratory syncytial virus test negative
Clinical narrative: Admitted for croup and hypoxia on 2/20/2011, filing report per mother's request
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired, no adverse effects noted
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal hernia repair, Antiphospholipid antibodies positive, Computerised tomogram thorax, Echocardiogram, Electrocardiogram
Clinical narrative: MODERNA #1 8/11/2021 MODERNA #2 9/8/2021 WAS ACUTELY ILL AFTER INJECTIONS WITH FEVER INJECTION SITE PAIN MYALGIA MALAISE AFTER ABDOMINAL HERNA REPAIR 3/30/2023 SUFFERED MULTIPLE ACUTE PULMONARY EMBOLI.  WAS FOUND TO BE ANTI-PHOSPOLIPID ANTIBODY POSITIVE.  ANTI-SPIKE ANTIBODIES=7692 U/L ON 4/29/2024.  TREATED WITH WARFARIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Laboratory test, Malaise, Myalgia, Pulmonary embolism
Clinical narrative: MODERNA #1 8/11/2021 MODERNA #2 9/8/2021 WAS ACUTELY ILL AFTER INJECTIONS WITH FEVER INJECTION SITE PAIN MYALGIA MALAISE AFTER ABDOMINAL HERNA REPAIR 3/30/2023 SUFFERED MULTIPLE ACUTE PULMONARY EMBOLI.  WAS FOUND TO BE ANTI-PHOSPOLIPID ANTIBODY POSITIVE.  ANTI-SPIKE ANTIBODIES=7692 U/L ON 4/29/2024.  TREATED WITH WARFARIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: MODERNA #1 8/11/2021 MODERNA #2 9/8/2021 WAS ACUTELY ILL AFTER INJECTIONS WITH FEVER INJECTION SITE PAIN MYALGIA MALAISE AFTER ABDOMINAL HERNA REPAIR 3/30/2023 SUFFERED MULTIPLE ACUTE PULMONARY EMBOLI.  WAS FOUND TO BE ANTI-PHOSPOLIPID ANTIBODY POSITIVE.  ANTI-SPIKE ANTIBODIES=7692 U/L ON 4/29/2024.  TREATED WITH WARFARIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 5/23/11 Urgent Care with dx of fever and febrile seizure, 5/24/11 ER visit for fever and febrile seizure. Discharged home. Filing report per mother's request.
Age: 69.0
Sex: F
Vaccine: PNC20, TD
Symptoms: Contusion, Mass, Pain, Swelling
Clinical narrative: Pain, swelling to golf ball size lump. Bruising and the bruising went from should to below the elbow. 360 degree around bicep and elbow.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Chills, Immediate post-injection reaction, Malaise, Pyrexia
Clinical narrative: Pt had fever, chills, malaise within 12 hours of vaccination x 24°.  Developed brain fog after immediate reaction, which has been persistent.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Supraventricular tachycardia
Clinical narrative: INCREASED HEART RATE(PSVT): PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA.  PT WAS PRESCRIBED A BETA BLOCKER.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac ablation, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: INCREASED HEART RATE(PSVT): PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA.  PT WAS PRESCRIBED A BETA BLOCKER.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Hyperhidrosis, Laboratory test, Malaise
Clinical narrative: INCREASED HEART RATE(PSVT): PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA.  PT WAS PRESCRIBED A BETA BLOCKER.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vision blurred
Clinical narrative: INCREASED HEART RATE(PSVT): PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA.  PT WAS PRESCRIBED A BETA BLOCKER.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pharyngeal erythema, Pyrexia, Rash
Clinical narrative: Diarrhea: 04/20/24 - Present (05/02/24); Fever (Tmax 102F): 04/23/24 - 04/26/24; Rash: 05/01/24 - Present (05/02/24)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt fainted about 5 min after getting the shot.
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash on back, buttocks, upper arms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: Stiffness/tightness/pain/swelling feeling across upper back and shoulders. Intense flu like symptoms for 24-36 hours following
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Vomiting
Clinical narrative: chills, feeling cold, throwing up
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Sacral pain
Clinical narrative: Joint pain and swelling in hands and knees.  Joint pain in right sacroiliac joint.    Pain is improved but persists one month later.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Bronchitis, Chest X-ray, Chest pain, Cough
Clinical narrative: On the morning following receiving the Anthrax Vaccine (April 13th at 6:00 am) I woke and went to the clinic. The symptoms that I had were a red sore and swollen throat, severe pain in the entire right arm (the arm I received the shot in), lack of appetite,pale complexion,  a heart rate of 112, a blood pressure of 130/82, and a temperature of 99.2 F. I was given 50 mg Benadryl, 800 mg of Ibuprofen, and placed on bed rest for 12 hours. The next morning (April 14th) I returned to the clinic and my symptoms were congestion, hot flashes, sore throat, lightheadedness, headaches, swollen lymph nodes and tonsils, fatigue, general weakness, a heart rate of 132, blood pressure of 120/79, and a temperature of 98.8 F. I was given  800 mg of Ibuprofen, and placed on light duty for 48 hours. Over the next few days my symptoms worsened and I began feeling severe chest pain, a pounding heart, and a dry cough. I returned to the clinic the evening of April 18th with worsened congestion, red sore swollen throat, loss of appetite, chest pain, pounding heart, dry cough, extreme pain when eating, crackling in my lower lungs, a heart rate of 110, and blood pressure of 138/92. I was sent to the hospital immediately where I received chest X-rays, and an EKG. I was diagnosed with Bronchitis with potential relations to the Anthrax Vaccine. I was prescribed Prednisone, Tessalon, and placed on light duty for 48 hours. . I was not tested for Covid, the Flu, or Strep due to no one around me experiencing symptoms, thus the Doctor concluded I was not contagious. These symptoms persisted but gradually got better up until May 1st.