chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and boosters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and 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: Flu vaccine (got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost central vision", "AMPPE", a decade ago he got a flu vaccine, the flu vaccine threw his immune system into overdrive, 3 months later he developed AMPPE (Acute Multifocal Placoid Pigment Epitheliopathy) where he lost his central vision. It was gradual, plague builds up in layers of retina and gradually expands. Where central vision was focused goes into shadow, if you move vision to left side and couldn't see the left side. Move to right side and could't see right side. His was more prominent in central vision. As a result of that, he was on massive doses of steroids for probably 6-7 months. As a result of the AMPPE he now has adorated macular degeneration which he gets injections into his eyes every 12 weeks. When he was first in the hospital his dose was 100mg a day and he was in hospital for about 3-4 days. When released from hospital was on 80mg a day. That lasted at least 6 months. It took another month to lower the dosage of steroids it was either 10 or 20mg decrease per week so another month to wean off the steroids. After treatment with high dose steroids, he was able to regain his vision, although his stomach still reels from side effects. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID twice after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient received total 2 original doses of Pfizer Covid vaccines and 3 boosters, he got Covid after the 1st booster. Therapeutic measures included paxlovid were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166730 same patient, different dose/event;US-PFIZER INC-202500166729 same patient/event, different dose;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting
Clinical narrative: contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and boosters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and 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: Flu vaccine (got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost central vision", "AMPPE", a decade ago he got a flu vaccine, the flu vaccine threw his immune system into overdrive, 3 months later he developed AMPPE (Acute Multifocal Placoid Pigment Epitheliopathy) where he lost his central vision. It was gradual, plague builds up in layers of retina and gradually expands. Where central vision was focused goes into shadow, if you move vision to left side and couldn't see the left side. Move to right side and could't see right side. His was more prominent in central vision. As a result of that, he was on massive doses of steroids for probably 6-7 months. As a result of the AMPPE he now has adorated macular degeneration which he gets injections into his eyes every 12 weeks. When he was first in the hospital his dose was 100mg a day and he was in hospital for about 3-4 days. When released from hospital was on 80mg a day. That lasted at least 6 months. It took another month to lower the dosage of steroids it was either 10 or 20mg decrease per week so another month to wean off the steroids. After treatment with high dose steroids, he was able to regain his vision, although his stomach still reels from side effects. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID twice after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient received total 2 original doses of Pfizer Covid vaccines and 3 boosters, he got Covid after the 1st booster. Therapeutic measures included paxlovid were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166730 same patient, different dose/event;US-PFIZER INC-202500166729 same patient/event, different dose;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Mar2021, outcome "unknown", described as "heart palpitations".  Additional information: first couple of shots caller was sick the next day with heart palpitations.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Symbicort. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "unknown" and all described as "took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid". The clinical course was reported as follows: The patient had not received any recent immunizations since last year (2024). The patient took her last injection of the Pfizer Covid 19 vaccine on Sep2024 and wanted to know if there was a new immunization available, with a different variant. Most of her injections were Pfizer, except for the first one that was Moderna. The patient was recently, last week, diagnosed with covid and, where she got her medication, they told her they run out of medication because it seemed everybody was getting covid. The patient never had covid since 2020 until last week. She didn't have it before, and she was not exposed to it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: has no sense of smell post Covid vaccine in 2021; This is a spontaneous report received from an Other HCP.  A 55-year-old male patient received BNT162b2 (BNT162B2), in 2021 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: ANOSMIA (non-serious) with onset Jun2025, outcome "unknown", described as "has no sense of smell post Covid vaccine in 2021". It was unknown if therapeutic measures were taken as a result of anosmia.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a consumer, Program ID.  A 42-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 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 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19". The event "positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. A day before the reporting, the patient's husband got a prescription to get nirmatrelvir/ritonavir (PAXLOVID) tablet for the patient. She got positive for COVID-19, and they had an appointment with the health provider, and he prescribed PAXLOVID tablet. The patient was really sick, she actually needs this medicine and that's why the provider prescribed it last night; the medicine is prescribed for 15 days. Now that the patient is already detected with COVID-19, the patient's husband asked after how many days they can take the COVID-19 vaccine again, because they missed it for the last two years, and in 2023 they had all the Pfizer vaccines, you know taken correctly with the booster, but for 2024 and 2025 they didn't take any vaccines, and looks like she just got diagnosed with COVID-19. So now, after this medicine course has been completed, the patient's husband asked if they could take the vaccine immediately, or they have to wait for maybe 16 or 30 days. The patient's husband thinks he will get the medicine now, because the patient was already having trouble, and then he'll talk to his healthcare provider.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
Clinical narrative: Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0196) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The reporter stated that every time the patient takes the vaccine, she gets a fever of around 103 and has always pain in arm. The patient is 21 (at the time of report). Every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the reporter massaged it as gently as she could, not really pushing, just trying to make her feel better. When they came home from getting the vaccine, the patient was generally okay at first and then a couple of hours will go by and then she started getting really hot and flushed and her arm would hurt a lot; she was having a more of extreme pain in her arm and it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105 but was able to get it down pretty quickly with Tylenol. So, within half an hour she got down, but the fever has held on for a while.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167459 same patient, drug, and event, different dose;US-PFIZER INC-202500167457 same patient, drug, and event, different dose;US-PFIZER INC-202500167458 same reporter, patient, product, event; different dose;
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0196) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The reporter stated that every time the patient takes the vaccine, she gets a fever of around 103 and has always pain in arm. The patient is 21 (at the time of report). Every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the reporter massaged it as gently as she could, not really pushing, just trying to make her feel better. When they came home from getting the vaccine, the patient was generally okay at first and then a couple of hours will go by and then she started getting really hot and flushed and her arm would hurt a lot; she was having a more of extreme pain in her arm and it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105 but was able to get it down pretty quickly with Tylenol. So, within half an hour she got down, but the fever has held on for a while.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167459 same patient, drug, and event, different dose;US-PFIZER INC-202500167457 same patient, drug, and event, different dose;US-PFIZER INC-202500167458 same reporter, patient, product, event; different dose;
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
Clinical narrative: Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Lot number: EW0181) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in arm", "Pain in her arm; Very hard for her to move it", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Lot number: EW0181) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in arm", "Pain in her arm; Very hard for her to move it", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
Clinical narrative: Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush"; BNT162b2 (Dose: 2; Lot: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush"; BNT162b2 (Dose: 2; Lot: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased.  Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm would hurt a lot more than 'mine'; This is a spontaneous report received from a Consumer or other non HCP.  A 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 included: "autoimmune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm would hurt a lot more than 'mine'".
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Shoulder injury related to vaccine administration
Clinical narrative: Patient started having shoulder pain within 24 hours after receiving the shot. She took Ibuprofen by mouth as needed expecting it to get better. Pain continued so she sought medical attention on 12/31/2024 was diagnosed with bursitis (and was given a steroid shot in the left shoulder that helped for about 2 months then stared to ware off. Now her pain is  back to being 10 /10 with no pain meds usually first thing in the morning after immobility for few hours. On  good days with shoulder movement is 4/10. Patient has history of shoulder surgery but the pain experienced after the shot was sudden, severe and of a different nature suggesting it is SIRVA.
Age: 79.0
Sex: M
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom
Clinical narrative: ANCA-associated vasculitis, paralyzed left foot, stroke like symptoms (stroke was ruled out), hospitalized for multiple months
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Auto immune disease lupus doctor has prescribed me, methotrexate, hydroxychloroquine, and clobetasol
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 14-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: ALOPECIA (non-serious), outcome "recovering". Batch/lot number is not provided, and it cannot be obtained.  Additional information: Additional information: Caregiver stated that her daughter has alopecia and she was thinking maybe it was caused by Pfizer Covid19 vaccine but she can't prove it. She would like to know if there was any evidence that it can be caused by Pfizer Covid shot. Caregiver wanted to know the duration of treatment for Litfulo. She stated her daughter was taking Litfulo going on 2 years, should she continue taking it for for life. At Week 48: 43% of people taking LITFULO saw 80% or more scalp hair coverage."  Caller is the mother of the patient her daughter was taking Litfulo going on for 2 years because she has alopecia. Caller mentioned that may be the alopecia was caused by the Pfizer Covid-19 vaccine. The caller verified the information provided by the transferring agent. Caller said that a doctor mentioned and said that alopecia can be caused by vaccines. She got the vaccine less than a year before developing alopecia. Alopecia started in October or Nov2022, and her went on Litfulo in 2024. She received the Covid-19 Vaccine in 2021 and never had alopecia before that or any health issues prior to that. Caller said that  Litfulo is working great. Her daughter only has one place in the back of her head that is not growing back. If it was the covid shot that could cause alopecia, can it be reversed. She spoke to authority about this and there was nothing that they have found and nothing has been reported. Her daughter never had covid and never had anything health related. The report was filed with the information provided by the transferring agent and the caller.
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Blood test, Chest X-ray normal, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Reflex test, Vibration test, Walking aid user
Clinical narrative: Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
Age: 77.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Pain in extremity
Clinical narrative: Patient received a second dose of Arexvy outside of current CDC recommendations. They did not have any side effects other than a sore arm.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation
Clinical narrative: 5/3/2021 - Saw patient for diagnosed dyspenea on exertion.  Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 -  Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital.  Acute systolic CHF and 1 year fatigue.  Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open.  ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed.  Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024.  Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced.  Hospital inpatient stay. 4/25/2024 - 4/27/2024 -  Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities.  Given Lasix as blood thinner.  Low energy and fatigue. 7/1/2025 - 7/3/2025 -  Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma.  7/11/2025 - 7/12/2025 -  During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer.  August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough
Clinical narrative: 5/3/2021 - Saw patient for diagnosed dyspenea on exertion.  Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 -  Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital.  Acute systolic CHF and 1 year fatigue.  Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open.  ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed.  Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024.  Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced.  Hospital inpatient stay. 4/25/2024 - 4/27/2024 -  Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities.  Given Lasix as blood thinner.  Low energy and fatigue. 7/1/2025 - 7/3/2025 -  Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma.  7/11/2025 - 7/12/2025 -  During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer.  August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue
Clinical narrative: 5/3/2021 - Saw patient for diagnosed dyspenea on exertion.  Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 -  Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital.  Acute systolic CHF and 1 year fatigue.  Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open.  ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed.  Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024.  Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced.  Hospital inpatient stay. 4/25/2024 - 4/27/2024 -  Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities.  Given Lasix as blood thinner.  Low energy and fatigue. 7/1/2025 - 7/3/2025 -  Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma.  7/11/2025 - 7/12/2025 -  During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer.  August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: 5/3/2021 - Saw patient for diagnosed dyspenea on exertion.  Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 -  Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital.  Acute systolic CHF and 1 year fatigue.  Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open.  ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed.  Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024.  Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced.  Hospital inpatient stay. 4/25/2024 - 4/27/2024 -  Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities.  Given Lasix as blood thinner.  Low energy and fatigue. 7/1/2025 - 7/3/2025 -  Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma.  7/11/2025 - 7/12/2025 -  During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer.  August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin laceration, Triple negative breast cancer
Clinical narrative: 5/3/2021 - Saw patient for diagnosed dyspenea on exertion.  Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 -  Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital.  Acute systolic CHF and 1 year fatigue.  Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open.  ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed.  Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024.  Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced.  Hospital inpatient stay. 4/25/2024 - 4/27/2024 -  Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities.  Given Lasix as blood thinner.  Low energy and fatigue. 7/1/2025 - 7/3/2025 -  Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma.  7/11/2025 - 7/12/2025 -  During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer.  August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Bladder dysfunction, Computerised tomogram, Dysstasia
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Functional gastrointestinal disorder, Gait disturbance, Hypoaesthesia, Hypotonia
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lumbar puncture, Magnetic resonance imaging, Monoplegia, Muscular weakness
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myelitis transverse, Necrosis, Nerve injury, Neuralgia, Neuritis
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuromyelitis optica spectrum disorder, Pain, Pain of skin, Paraesthesia, Sjogren's syndrome
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user, X-ray
Clinical narrative: I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3, PNC21
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Neck pain
Clinical narrative: I'm not sure about my selections above - I received the seasonal flu and COVID vaccines in my left arm and the pneumonia vaccine in my right arm.  In the first few hours, I experienced the expected tenderness-to-the-touch in the COVID/flu left arm and in the pneumonia/right arm. Around 1:30AM on Saturday morning, I woke up with pain on the right side of my neck and right shoulder that made it difficult to move or get out of bed.  I stayed in bed most of Saturday with pain, getting up only to use the restroom.  I took Tylenol for the pain and got up around 4P on Saturday, feeling a little bit better. The neck pain on the right side continued through Saturday night and remains as I write this on Sunday morning.  I expect to feel back to normal by Monday.  This has been strange because I have never experienced an adverse reaction to a vaccine.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported soreness after injection. Area started to get red around the size of an egg on the arm on Friday morning, the next day. On Saturday it spread to a bigger area. It was redness, warmth, tenderness, and swollen. Recommendation patient seen by urgent care and/call primary provider.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Starting about 36 hours later, severe body aches and severe headache, 102 fever, runny nose, exhaustion. At 48 hours fever 101.5
Age: 80.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED.  THE PATIENT HAS ON RECORD 2 RSV Vaccinations.  The patient received ABRYSVO on 12/3/23 and AREXVY on 10/28/2024.
Vaccine: RVX, RVX
Symptoms: Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom
Clinical narrative: Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction;  This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported.   It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine.     The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.