chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain, Vitamin A
Clinical narrative: shortness of breath; night sweats; feverish feelings; pain in injection site; extreme fatigues; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues) in a 46-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   On 10-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 11-Oct-2024, the patient experienced DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), NIGHT SWEATS (night sweats), PYREXIA (feverish feelings), VACCINATION SITE PAIN (pain in injection site) and FATIGUE (extreme fatigues) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lipids: Normal. On an unknown date, Vitamin A: Normal.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. Patient had no concomitant disease or risk factor. Patient had annual checkup just before receiving the flu and COVID shots in the same arm. All lab results were normal.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: without major side effects, except of course for the upper arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (without major side effects, except of course for the upper arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (without major side effects, except of course for the upper arm). At the time of the report, LIMB DISCOMFORT (without major side effects, except of course for the upper arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had all vaccinations from Moderna without any serious side effects, except for the upper arm. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2024: Live Follow-up received, and no new information was added.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Fatigue, Loss of personal independence in daily activities
Clinical narrative: disoriented; difficulty to do things; Sore shoulder; very tired; This spontaneous case was reported by a patient and describes the occurrence of DISORIENTATION (disoriented), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to do things), ARTHRALGIA (Sore shoulder) and FATIGUE (very tired) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042573) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 15-Oct-2024, the patient experienced DISORIENTATION (disoriented), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to do things), ARTHRALGIA (Sore shoulder) and FATIGUE (very tired). At the time of the report, DISORIENTATION (disoriented), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to do things), ARTHRALGIA (Sore shoulder) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient was on blood thinner. No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vertigo
Clinical narrative: Vestibular symptoms - vertigo with a bit of nausea; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vestibular symptoms - vertigo with a bit of nausea) in a 58-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 13-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 16-Oct-2024, the patient experienced VERTIGO (Vestibular symptoms - vertigo with a bit of nausea). At the time of the report, VERTIGO (Vestibular symptoms - vertigo with a bit of nausea) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient had no medical history, concomitant disease or risk factor.   Patient had new COVID booster shot in arm and also had flu shot at the same time.  The patient did not experience any additional symptoms/events. There were no lab data/results available.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Eye discharge, Eye swelling, Headache, Vitreous floaters
Clinical narrative: Patient also experienced vision loss; Left eye became swollen with congenital injection and significant drainage; Left eye became swollen with congenital injection and significant drainage; Left eye became swollen; Patient experienced a severe left temporal headache; This serious initial Spontaneous safety report was received by Novavax on 15-Oct-2024 from a Physician via Publicis (ref. no. US-1000000406-NVAX).   A 67-year-old Male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (Lot number was requested but was unknown to the reporter) on 05-Oct-2024.  The following medical history was reported: HYPERTENSION and RETINAL DETACHMENT.   The following concomitant medication was reported: INFLUENZA VACCINE (influenza vaccine).  On 06-Oct-2024, 1 day after vaccination the patient experienced a severe left temporal headache (Headache). On 07-Oct-2024, 2 days after vaccination the patient's Left eye became swollen (Eye swelling), and the patient's Left eye became swollen with congenital injection and significant drainage (Vitreous floaters) (Eye discharge). On an unspecified date after vaccination the patient experienced vision loss (Blindness) (Serious: Other Medically Important Condition).   Treatment given included from unknown date Augmentin (co-amoxiclav); Fuoxetine topical; Tobramycin topical; Neosporin ointment topical and from 15-Oct-2024 Prednisone drops.   At the time of reporting, the event outcome of Blindness, Headache, Eye swelling, Vitreous floaters, and Eye discharge was Unknown.; Sender's Comments: This 67-year-old Male experienced Blindness, Headache, Eye swelling, Vitreous floaters and Eye discharge after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Blindness was reported as serious.  The event Headache was reported as non-serious.  The event Eye swelling was reported as non-serious.  The event Vitreous floaters was reported as non-serious.  The event Eye discharge was reported as non-serious.    Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Blindness, Headache, Eye swelling, Vitreous floaters and Eye discharge is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Neuropathy peripheral, Pain
Clinical narrative: peripheral neuropathy was aggravated; flu-like symptoms; Body aches; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "peripheral neuropathy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "peripheral neuropathy was aggravated"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; PAIN (non-serious), outcome "unknown", described as "Body aches". Clinical course: The patient dialed in to report side effects that she experienced with the Comirnaty vaccine. She mentioned that her peripheral neuropathy was aggravated after getting the shot. She experienced flu-like symptoms but four times more intense. She wants to know if this side effect is normal. She also mentioned that she has received six COVID vaccines from Pfizer, and this is the only time she has experienced this side effect. The patient wanted to know the difference between the most recent formulation of Covid-19 vaccine from the previous ones she received before. She is looking at the paper with reactions listed down there. She wanted to know what happens if have some reactions sometimes and other times not. She clarified she just got a shot. She had a reaction and has been up for two days. She wants to know why she keep getting body aches. She has peripheral neuropathy and these shots aggravate it badly and it's to the point where she is thinking about not getting anymore. She wants to know if this is normal or abnormal.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dysphagia, Dysphonia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: crick in her neck; arm started hurting at the injection place; tongue is so swollen; Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles; Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles; voice vibrates when talking; hard to swallow; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jul2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2024, outcome "not recovered" and all described as "Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles"; VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "not recovered", described as "arm started hurting at the injection place"; NECK PAIN (medically significant) with onset 2024, outcome "recovering", described as "crick in her neck"; DYSPHAGIA (non-serious) with onset 2024, outcome "not recovered", described as "hard to swallow"; SWOLLEN TONGUE (non-serious) with onset 2024, outcome "not recovered", described as "tongue is so swollen"; DYSPHONIA (non-serious) with onset 2024, outcome "not recovered", described as "voice vibrates when talking". Therapeutic measures were taken as a result of neck pain.  Clinical course: The patient explained that she had Pfizer's RSV vaccine and had a reaction and couldn't get anywhere with her doctor because they were out of town. The primary care provider was booked up today. She was in assisted living and did not have the name of the vaccine. The paper that she received from them when she got the vaccine did not give the name it just said Pfizer, some numbers, RSV sterile H20. She got the vaccine on 03Jul2024 and had been dealing with this since. She had never had a reaction with a vaccine before.  Her arm started hurting at the injection place and 3 weeks later she was in the bed and all she could do was eat a little and go to the bathroom. She couldn't turn her head, she had a crick she got a cortisone shot and that helped so she could turn her head but the pain was still there and she kept massaging it at the base of her skull. Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt. Her knees hurt, the joints and muscles. Her tongue was so swollen that her voice vibrates when talking. It was hard to swallow. Nothing had gotten better except the crick in her neck.  She just had the flu shot by the same nurses on 04Oct2024. She wanted to know what she could do for herself for her symptoms.
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Swollen tongue
Clinical narrative: crick in her neck; arm started hurting at the injection place; tongue is so swollen; Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles; Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles; voice vibrates when talking; hard to swallow; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Jul2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2024, outcome "not recovered" and all described as "Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt/Her knees hurt, the joints and muscles"; VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "not recovered", described as "arm started hurting at the injection place"; NECK PAIN (medically significant) with onset 2024, outcome "recovering", described as "crick in her neck"; DYSPHAGIA (non-serious) with onset 2024, outcome "not recovered", described as "hard to swallow"; SWOLLEN TONGUE (non-serious) with onset 2024, outcome "not recovered", described as "tongue is so swollen"; DYSPHONIA (non-serious) with onset 2024, outcome "not recovered", described as "voice vibrates when talking". Therapeutic measures were taken as a result of neck pain.  Clinical course: The patient explained that she had Pfizer's RSV vaccine and had a reaction and couldn't get anywhere with her doctor because they were out of town. The primary care provider was booked up today. She was in assisted living and did not have the name of the vaccine. The paper that she received from them when she got the vaccine did not give the name it just said Pfizer, some numbers, RSV sterile H20. She got the vaccine on 03Jul2024 and had been dealing with this since. She had never had a reaction with a vaccine before.  Her arm started hurting at the injection place and 3 weeks later she was in the bed and all she could do was eat a little and go to the bathroom. She couldn't turn her head, she had a crick she got a cortisone shot and that helped so she could turn her head but the pain was still there and she kept massaging it at the base of her skull. Her shoulders, the joints, her elbow, hands, legs, feet, they just hurt. Her knees hurt, the joints and muscles. Her tongue was so swollen that her voice vibrates when talking. It was hard to swallow. Nothing had gotten better except the crick in her neck.  She just had the flu shot by the same nurses on 04Oct2024. She wanted to know what she could do for herself for her symptoms.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Physician from medical information team.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Benign prostatic hypertrophy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed.), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 3(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 4(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 5(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 6(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 7(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 8(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 9(BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER 10(BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID". The patient had 10 different Pfizer COVID vaccines and he just had the 24-25 formulation (Comirnaty 12 plus) 2 weeks ago on 07Sep2024. Weeks later, he acquired COVID, the patient was prescribed with Paxlovid (as treatment). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2024) Positive, notes: I tested positive for COVID. Therapeutic measures were taken as a result of covid-19, drug ineffective.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the events lack of effect (COVID19) with COMIRNATY (2024-2025 FORMULA) can not be fully excluded.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Pain
Clinical narrative: severe pain, achiness; tiredness; This is a spontaneous report and received from Pharmacists from medical information team. A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "severe pain, achiness"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness". The events "severe pain, achiness" and "tiredness" required physician office visit. Therapeutic measures were taken as a result of pain. Additional information: Pharmacist reported that a patient had side effects with the use of Abrysvo. Patient wanted to call to see if there was anything she could do for her symptoms. The patient, went to the doctor and she was experiencing severe pain, achiness, and tiredness for 14 days (past the date of the vaccine). She went to an urgent care a couple days after the vaccine and still having symptoms and she went to the doctor and they prescribed another anti-inflammatory. Pharmacist stated it sounded like they gave her an anti-inflammatory in the urgent care. The pharmacist believed the patient said this week, yesterday or day before, the patient saw PCP, primary care doctor, and PCP wanted to make sure reported everything. Patient did follow-up with PCP. The physician's office asked for the pharmacy to report it because it was not reported by the doctor's office.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: after the patient received this booster dose in May2022, three weeks later she got covid; after the patient received this booster dose in May2022, three weeks later she got covid; This is a spontaneous report received from a Physician.  A 6-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 3 weeks after the suspect product(s) administration, outcome "unknown" and all described as "after the patient received this booster dose in May2022, three weeks later she got covid".  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400278709 same patient, different dose/event;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Flank pain, Inflammation, Meniere's disease
Clinical narrative: Meniere's Disease diagnosis; imbalance; right flank pain; inflammation; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: EW0164) at the age of 33 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Pfizer COVID-19 vaccine (dose 1, batch/lot number EN0734, vaccine location left arm, facility type vaccine other), administration date: 26Mar2021, when the patient was 33-year-old, for Covid-19 immunization. The reporter informed that the facility type vaccine was other, no other vaccine same date, no other vaccine in four weeks, no other medications in two weeks. The patient experienced Meniere's Disease diagnosis, vertigo, dizziness, imbalance, right flank pain, inflammation on 30Apr2021. The adverse events resulted in hospitalization, disability or permanent damage. The number of days of hospitalization was 1. Therapeutic measures were taken as a result of the events which included IV, meclizine. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis
Clinical narrative: encephalitis; This is a spontaneous report received from a Physician.  A 6-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) 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: ENCEPHALITIS (hospitalization, medically significant) with onset Aug2022, outcome "recovered" (2022). Therapeutic measures were taken as a result of encephalitis. It was reported that patient developed encephalitis. This was not bacterial and it was not viral. It was antibodies. This occurred in 2022, later clarified as in Aug2022. For treatment and intervention: There were lots. She was in the hospital. Physician confirmed she does not specifically know what the treatment involved. For treatment and intervention: There were lots. She was in the hospital. Physician confirmed she does not specifically know what the treatment involved. For treatment and intervention: There were lots. She was in the hospital. Physician confirmed she does not specifically know what the treatment involved.  While attempting to capture if any historical conditions caller added after the patient received this booster dose in May2022, three weeks later she got COVID. However, she does not know the exact date she got COVID. The physician explained the patient got COVID before she was diagnosed with the encephalitis. Physician does not know if the previous doses of the COVID vaccine were manufactured by Pfizer, but she assumes they were.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based from plausible temporal relationship, the causal association of reported event Encephalitis in relation to suspected drug BNT162b2 cannot be totally excluded.  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,Linked Report(s) : US-PFIZER INC-202400278599 same patient, different dose number and event;
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), in Apr2022 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. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset Apr2022, outcome "unknown". Therapeutic measures were taken as a result of myocarditis. Clinical course: It was reported that had myocarditis requiring ablation. Was in a class and he was talking about COVID vaccine. Patient had myocarditis post his 4th dose of Comirnaty. The cardiac ablation has been scheduled in next two months. It was unknown if other vaccine had been received on the same date, if other vaccine had been received in four weeks and if any other medications had been received in two weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity
Clinical narrative: Lump from Shoulder To Collar Bone on Right Side; Pain down arm to fingers; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Oct2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: BACTRAM, start date: Oct2024, stop date: Oct2024; INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: LIMB MASS (non-serious) with onset 17Oct2024 at 14:00, outcome "recovering", described as "Lump from Shoulder To Collar Bone on Right Side"; PAIN IN EXTREMITY (non-serious) with onset 17Oct2024 at 14:00, outcome "recovering", described as "Pain down arm to fingers". Therapeutic measures were not taken as a result of limb mass, pain in extremity. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: NEURALGIA (non-serious) with onset 2024, outcome "not recovered", described as "nerve pain".  Additional information: Patient had been having nerve pain since taking the COVID 19 vaccine. Patient was wondering if others have had the same problems, and what, if any, treatment had helped.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: mothers 90 years old passed; This is a spontaneous report and received from Consumer or other non HCPs.  A 90-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "mothers 90 years old passed". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400095544 same reporter, different patient/events;; Reported Cause(s) of Death: Unknown cause of death
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Kind of tired; Was going to throw up; Felt like was going to faint; Got the shot in the right arm, I had some pain; Got a bit lightheaded; Got the pain down my back, down to my lower back; Got the chills; Started to shake; Arms and hands were moving around; This spontaneous case, initially received on 08-Oct-2024, was reported by a non health professional (Patient) and concerns an elderly female patient.  Past medical history included ulcer, three joint replacements. At the time of the event the patient had Blood pressure. Concomitant medication: Ramipril 10mg, supplements. Patient was on Pantoprazole for a bleeding ulcer back in May/June, they rechecked her after and they said everything was fine so she didn't take any more of that medication.  Administration of company suspect drug(s): On 27-Sep-2024, the patient received Fluad (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical location: Right Arm, Lot number: 388464, Expiry Date: 24-Apr-2025.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Sep-2024, the patient experienced Felt like was going to faint (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the shot in the right arm, I had some pain (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got a bit lightheaded (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the pain down my back, down to my lower back (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Was going to throw up (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the chills (outcome: Recovered / Resolved, stop date: 28-Sep-2024), Started to shake (outcome: Recovered / Resolved, stop date: 28-Sep-2024), Arms and hands were moving around (outcome: Recovered / Resolved, stop date: 28-Sep-2024). On 28-Sep-2024, the patient experienced Kind of tired (outcome: Recovered / Resolved, stop date: 28-Sep-2024).  The patient got the shot in the right arm, she had some pain and then she got up and started to walk out of the room and she got a bit lightheaded, like she was going to throw up. So she turned to the nurse and then she brought her water. She felt like she was going to faint, she got this pain down her back, down to her lower back, it didn't last long, though, maybe a minute, it started to gradually subside. All symptoms went away in half hour, then they called the EMT, they took all her vitals, everything was good. My arm did not hurt. She never had a reaction like that. That same night, she started to shake, got the chills and her arms and hands were moving around. It didn't last long either, she took her temperature and it was normal, she was kind of tired the next day (28-Sep-2024)  Fluad (TIV) action taken: Not Applicable  Reporter assessment:  The reporter considered all the events as non-serious and did not provide the causality for all the events.; Reporter's Comments: Causality: Related for all events due to plausible temporal relationship (on same day and 1 day after vaccination).
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Tremor
Clinical narrative: Kind of tired; Was going to throw up; Felt like was going to faint; Got the shot in the right arm, I had some pain; Got a bit lightheaded; Got the pain down my back, down to my lower back; Got the chills; Started to shake; Arms and hands were moving around; This spontaneous case, initially received on 08-Oct-2024, was reported by a non health professional (Patient) and concerns an elderly female patient.  Past medical history included ulcer, three joint replacements. At the time of the event the patient had Blood pressure. Concomitant medication: Ramipril 10mg, supplements. Patient was on Pantoprazole for a bleeding ulcer back in May/June, they rechecked her after and they said everything was fine so she didn't take any more of that medication.  Administration of company suspect drug(s): On 27-Sep-2024, the patient received Fluad (TIV) for Influenza immunization, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical location: Right Arm, Lot number: 388464, Expiry Date: 24-Apr-2025.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Sep-2024, the patient experienced Felt like was going to faint (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the shot in the right arm, I had some pain (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got a bit lightheaded (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the pain down my back, down to my lower back (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Was going to throw up (outcome: Recovered / Resolved, stop date: 27-Sep-2024), Got the chills (outcome: Recovered / Resolved, stop date: 28-Sep-2024), Started to shake (outcome: Recovered / Resolved, stop date: 28-Sep-2024), Arms and hands were moving around (outcome: Recovered / Resolved, stop date: 28-Sep-2024). On 28-Sep-2024, the patient experienced Kind of tired (outcome: Recovered / Resolved, stop date: 28-Sep-2024).  The patient got the shot in the right arm, she had some pain and then she got up and started to walk out of the room and she got a bit lightheaded, like she was going to throw up. So she turned to the nurse and then she brought her water. She felt like she was going to faint, she got this pain down her back, down to her lower back, it didn't last long, though, maybe a minute, it started to gradually subside. All symptoms went away in half hour, then they called the EMT, they took all her vitals, everything was good. My arm did not hurt. She never had a reaction like that. That same night, she started to shake, got the chills and her arms and hands were moving around. It didn't last long either, she took her temperature and it was normal, she was kind of tired the next day (28-Sep-2024)  Fluad (TIV) action taken: Not Applicable  Reporter assessment:  The reporter considered all the events as non-serious and did not provide the causality for all the events.; Reporter's Comments: Causality: Related for all events due to plausible temporal relationship (on same day and 1 day after vaccination).
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: She had mild dizziness with the same vaccine; This spontaneous case, initially received on 24-Sep-2024, was reported by a health professional and concerns an adolescent female patient.  Administration of company suspect drug(s): On an unknown date in 2022, the patient received Flucelvax Quadrivalent for indication not reported, Dose: Not reported, Route of administration: Not reported, Lot number: 942389.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Sep-2022, the patient experienced she had mild dizziness with the same vaccine (outcome: Not Reported).  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment:  The reporter considered the event as non serious and causality assessment.; Reporter's Comments: Causality : Related
Sex: U
Vaccine: RVX
Symptoms: Asthenia, Pain
Clinical narrative: severe pain; Weakness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: severe pain) and weakness (Verbatim: Weakness). The outcome of the pain and weakness were not reported.   It was unknown if the reporter considered the pain and weakness to be related to RSV vaccine.     It was unknown if the company considered the pain and weakness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-OCT-2024 This case was reported by a patient via interactive digital media. The patient received RSV vaccine and then got severe pain and weakness.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Aphthous ulcer, Diarrhoea, Fatigue, Headache, Night sweats
Clinical narrative: headache; sore throat; sneezing; canker sore; fatigue; diarrhea; night sweats; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HT75Z, expiry date 10-DEC-2024) for prophylaxis.   Concurrent medical conditions included insulin-dependent diabetes mellitus.   On 27-SEP-2024, the patient received Arexvy (intramuscular, left deltoid). On 28-SEP-2024, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: fatigue), diarrhea (Verbatim: diarrhea) and night sweat (Verbatim: night sweats). In OCT-2024, the patient experienced sneezing (Verbatim: sneezing) and canker sore (Verbatim: canker sore). On an unknown date, the patient experienced headache (Verbatim: headache) and sore throat (Verbatim: sore throat). The outcome of the fatigue and headache were resolving and the outcome of the diarrhea, sneezing and canker sore were not resolved and the outcome of the night sweat was resolved and the outcome of the sore throat was unknown.   It was unknown if the reporter considered the fatigue, diarrhea, night sweat, headache, sneezing, canker sore and sore throat to be related to Arexvy.     It was unknown if the company considered the fatigue, diarrhea, night sweat, headache, sneezing, canker sore and sore throat to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-OCT-2024 The patient's concomitant product included insulin pump. The patient received Arexvy shot and next day she felt fatigued, which increased over the next several days and it had now decreased some but was still with her. The diarrhea started the morning after the shot and was still with her. The patient experienced night sweats for a few days (did not specify how many), and a headache that continues today (on the day of reporting), although less severe than when it first began. The patient had been sneezing for the last couple of days and complains of a canker sore in her mouth which just began.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Oropharyngeal pain, Sneezing
Clinical narrative: headache; sore throat; sneezing; canker sore; fatigue; diarrhea; night sweats; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HT75Z, expiry date 10-DEC-2024) for prophylaxis.   Concurrent medical conditions included insulin-dependent diabetes mellitus.   On 27-SEP-2024, the patient received Arexvy (intramuscular, left deltoid). On 28-SEP-2024, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: fatigue), diarrhea (Verbatim: diarrhea) and night sweat (Verbatim: night sweats). In OCT-2024, the patient experienced sneezing (Verbatim: sneezing) and canker sore (Verbatim: canker sore). On an unknown date, the patient experienced headache (Verbatim: headache) and sore throat (Verbatim: sore throat). The outcome of the fatigue and headache were resolving and the outcome of the diarrhea, sneezing and canker sore were not resolved and the outcome of the night sweat was resolved and the outcome of the sore throat was unknown.   It was unknown if the reporter considered the fatigue, diarrhea, night sweat, headache, sneezing, canker sore and sore throat to be related to Arexvy.     It was unknown if the company considered the fatigue, diarrhea, night sweat, headache, sneezing, canker sore and sore throat to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-OCT-2024 The patient's concomitant product included insulin pump. The patient received Arexvy shot and next day she felt fatigued, which increased over the next several days and it had now decreased some but was still with her. The diarrhea started the morning after the shot and was still with her. The patient experienced night sweats for a few days (did not specify how many), and a headache that continues today (on the day of reporting), although less severe than when it first began. The patient had been sneezing for the last couple of days and complains of a canker sore in her mouth which just began.
Age: 14.0
Sex: M
Vaccine: HPV9, MMR, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient did not have a adverse reaction, Patient received a menquadfi to early.  Patient is doing well and parents were notified.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Erythema, Periorbital swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash started on legs 10/17 PM - not itcht but also present on arms, ears were red + itchy, rash on leg red + itchy and legs were warm to touch on 10/18 PM. Mild puffy eyes on arm of visit. No other known case but pt with hx of rash, illness + sensitive skin
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Skin warm
Clinical narrative: Rash started on legs 10/17 PM - not itcht but also present on arms, ears were red + itchy, rash on leg red + itchy and legs were warm to touch on 10/18 PM. Mild puffy eyes on arm of visit. No other known case but pt with hx of rash, illness + sensitive skin
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Loss of consciousness, Palpitations
Clinical narrative: Racing heartbeat. Palpitations. Passed out. (sought care from physician ) Similar adverse event 10/16/2024 just I didn't  pass out (this is the time I went to the ER) Still doing ongoing care
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site rash, Injection site urticaria, Rash erythematous, Rash pruritic
Clinical narrative: Reported Symptoms: 10022069:INJECTION SITE HIVES; 1002094:INJECTION SITE RASH: 10023089:ITCHY;  10037844:RASH; 1005530:INJECTION SITE DISCOLORATION; Narrative: Pt experienced a rash day after injection of HepA/HepB vaccine at injection site. Pt reported to Primary Care Provider who ordered prescriptions for a Medrol Dose Pak and hydroxyzine tablets prn itchy. Provider flagged pt's chart with allergy to it. Other Relevant HX: Other: itchy pink  rash/hives at injection site started day after injection
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haematocrit decreased, Haemoglobin decreased, Heavy menstrual bleeding, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; 10046735:URTICARIA; Narrative: The patient received her 3rd COVID-19 vaccine on June 30, 2022. On 11/18/2022she stated that for approximately 5 months, and after receiving her COVID-19 vaccine, she has been undergoing a persistent skin rash to her upper extremities, neck, shoulders, and back. She began self treating with cetirizine and diphenhydramine without relief. She stated that she does have sensitive skin that is prone to uriticaria, however she denies any new medications, new soaps, new laundry detergents, dryer sheets, etc. The patient does also have chronic iron deficiency anemia which can cause a skin rash. Labs on 11/8/22: Hgb-10.0 g/dL, Hct 33.5%. Patient was referred to gynecology to evaluate heavy menstruation, allergist to evaluate urticaria, and prescribed montelukast 10 mg. Patient  saw the allergies on 3/15/23 and suspected the COVID-19 vaccine due to timing. The allergist discontinued montelukast and started the patient on famotidine and cetirizine. On 11/8/23 she stated that she was stil experiencing allergy symptoms despite taking fexofenadine, cetirizine, and famotidine. Patient is getting another referral to an allergist. It does not appear that the patient has gone to the allergist as of 10/3/24 and she continues to take fexofenidine, cetirizine, and famotidine today. Other Relevant HX: The COVID -19 vaccine is her only listed allergy. However on 11/18/22 she stated that she has very sensitive skin and breaks out in hives with minor skin irritations. Other: URITICARIA
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes
Clinical narrative: Reported Symptoms: 10048294:MENTAL STATUS CHANGES; Narrative: Other Relevant HX: Other: ALTERED MENTAL STATUS
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: Reported Symptoms: 10042458:SUICIDAL IDEATION; Narrative: No information on ADR. Other Relevant HX: Other: SUICIDAL THOUGHTS
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Erythema nodosum, Morphoea, Rash
Clinical narrative: Reported Symptoms: 10015226:ERYTHEMA NODSUM; Narrative: 75 year old male with biopsy features most consistent  with erythema nodosum. The rash on his right posterior calf was initially treated with cephalexin and doxycycline without improvement. Biopsy was then done and indicated drug induced morphea. Etanercept was thought unlikely to be a culprit since he had been on it for over 15 years without issue. However, it was stopped and switched to an alternative treatment (ixekizumab). Dermatology thought the COVID vaccine to be the most likely culprit. The patient was able to receive subsequent COVID vaccines without recurrence. The patient was screened for other possible causes of erythema nodosum, such as TB. The rash improved with clobetasol. Other Relevant HX: Psoriasis, psoriatric arthritis Other: erythema nodosum
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; Narrative: Other Relevant HX: Other: CHEST PAIN
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Reported Symptoms: 10002424:ANGIOEDEMA; 10014257:EDEMA TONGUE; 10043934: TONGUE ABNORMAL FEELING OF; Narrative: From notes scanned into facility from provider's office: Encounter for immunization Patient did report feelings of "her tongue feeling fuzzy/swollen" 25 minutes after the injection, she was evaluated by Dr. who ordered 1 Benadryl and she states her symptoms went away. No other symptoms reported. Other Relevant HX: Other: "her tongue felt fuzzy/swollen"