chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. Concomitant medication(s) included: LEXAPRO. Past drug history included: Ibuprofen, reaction(s): "Allergy: Ibuprofen", notes: Known allergies: Ibuprofen; Naproxen, reaction(s): "Allergy: naproxen", notes: Known allergies: naproxen; Aspirin, reaction(s): "Allergy: aspirin", notes: Known allergies: aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received paxlovid (Lot number- Ge3011) for COVID 19 treatment from Dec2022 till Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a Moderna booster shot (0.25ml); but she was 15 years old.  No adverse affects reported.  Contacted patient's father concerning  provision of Moderna vaccine.  We discussed possible side effects and advise father to contact her personal physician for medical concerns.
Bell?s Palsy , sudden onset, treated with high dose prednisone and valacyclovir 7 day treatment. Unresolved to date
Patient received a large welt down her arm on the side the pneumovax was given.  Patient's discharge was held until the next day. 10/1/09 D/C Summary received.  Pt in hospital for GI bleed received Pneumovax and developed redness and pain in the Left deltoid which was resolved at the time of d/c.
Patient had already received a flu vaccination on 10/3/22 during a previous hospitalization. The hospital did not report her vaccination and it was not in any of the reports that were faxed to center, so she received a second flu vaccination at center on 11/1/22.
His prescriber gave him a prescription to receive GARDASIL 9 but he was 56 years old and he was not sure if he should used it since there was no safety or efficacy data available for his age.; No additional adverse event (AE) reported; This spontaneous report was received from a consumer referring to himself as a 56 year old male patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On an unknown date, the patient was prescribed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis (product prescribing issue). The patient was unsure if he should be using HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since there was no safety or efficacy data available for his age. The patient stated there should be more information available to the public as to why people over 45 years old were not included in the clinical trials involving the suspect vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event was reported.
Pt fainted after flu shot BP 104/57. Pt regained full consciousness. Evaluated by 911 crew. Pt left with father.
unusal fatigue that evening; chills 3-330AM; took temp 104.5; surface numbness on skin; tingling; temp next AM 101; took Motrin for fever; no fever following afternoon;
>25cm injection site reaction; slightly swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Contact dermatitis (reaction to 'decyl glucoside').    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen). At the time of the report, VACCINATION SITE REACTION (>25cm injection site reaction) and VACCINATION SITE SWELLING (slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment was reported for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Symptoms began as follows: throat tightness, chest tightness, rapid heartbeat, body aches, fatigue, headache, extreme chills, vomiting, vision changes, (red & white flashes) hallucinations (things crawling on walls, a jet engine in bedroom door),
Pt recv vax and several days p/vax pt exp swelling under the site of the injection.
Pneumonia; headaches; fever; fatigue; chills; This is a spontaneous report from a contactable consumer (reporting for himself). A 75-years-old male patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced headache, fever, fatigue and chills. On 20Feb2021, the patient experienced pneumonia. The patient was recommended to get the Bamlanivimab infusion, which the patient did. The patient was told to wait 90 days after the infusion before getting his second dose of the series. The patient stated his 90 days will be up in about a week or so. The outcome of the event headache was recovered on 17Feb2021; fever and chills was recovered on 18Feb2021; fatigue was recovered on 20Feb2021; and pneumonia was recovered on 10Mar2021.  Information on the lot/batch number has been requested.
Syncope; Unresponsive to stimuli; Asthenia; Confusional state; Diarrhoea; Dizziness; Hyperventilation; Hypotension; Injection site bruising; Lethargy; Headache; Pyrexia; Fatigue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient received vaccination at 10:45am and by 10:50am patient informed others she felt light headed. Nurse rushed to the patient with the Epi pen.  They observed patient head tilted backward and unresponsive. The patient started to response and become confused. Nurse didn't administer the Epi Pen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4348488-00.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Apr2021, outcome "recovered" (05Apr2022). The action taken for adalimumab was unknown. Additional information: The patient also received second and booster dose on 21Apr2021 and 01Feb2022.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was possible. The reporter's assessment of the causal relationship of the events with the suspect product Humira (adalimumab) was not provided at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Had vaccines listed in box 13 on 6/5/06. Was brought in on morning of 6/7/06 with "swollen arm" on the left. On exam, he had slight swelling of upper arm with some redness. On applying pressure complained of some pain/itch. Dr felt this was a local reaction to the pertussis component.
A few days after having an ear infection, still didn't feel good; Took a home COVID-19 test and was positive; No medications prescribed; Also tested positive one year prior.
Diarrhea; Severe pain at the vaccination site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site). At the time of the report, DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
11/22/19 - received vaccinations about approx 12:15 pm 11/22/19 - 8-9 pm - feeling tired with down and out feeling 11/23/19 - 3:30 am - awoke shivering violently, lasted 20 minutes; 7 am - extreme flue conditions (not GI) - strep throat type nausea with sore joints and muscles throughout body. Temp fluctuated between 100.3 and 101.5 throughout day; covered with blankets to avoid goosebumps and shivering. Slept 4-5 hours intermittently. Same through evening. Went to bed at 10:30 pm - still had chills. 11/24/19 - awoke with  temperature heading back to normal range; symptoms diminishing by noon and by evening - feeling more or less back to normal.   Local reaction: Right arm.  Extremely sore and felt severely bruised, reddened and bruise like feeling spread around the side and fron of bicep area in band like appearance about 4-4.5 inches wide.   11/25, all symptoms receded 11/26/19 - bruise like feeling and redness in right bicep diminished to 50% of peak by this date.
Pt. vomited a few minutes after receiving vaccine.  Pt. was observed, vitals taken and WNL, water given.  Pt. condition improved and she left with her mother.
Patient with history of chronic kidney disease and mantle cell lymphoma currently on chemotherapy. She was brought to the ED by her family on 1/22/23 for evaluation of weakness. She had a fall a few days ago and had to be helped up by others. Family and patient reports worsening generalized weakness, generalized pain, and lack of appetite. They reported this has been going on since her COVID infection back in November 2022 - she previously tested positive on 11/27/22. Ultimately, patient admitted to the hospital 1/22/23 - 2/1/23.  Repeat COVID testing done on 1/23/23 resulted positive. Discharge diagnoses include acute hypoxic respiratory failure due to COVID pneumonitis, delirium, and malnutrition. During admission patient required supplemental O2, however was able to be weaned off. Of note, patient recently had received a COVID booster on 1/12/23.
Member had a titer lab done on 14 April 2017 that said he is a reactive to this shot. No symptoms or signs noticed on 11 Feb 2018.
Pt. was given vaccines at Kdg visit 2 days prior to reporting to clinic. Stated at that time s/s began 1 day ago. S/S inc. pain, swelling, redness to left thigh. Pain was improving as well as limp.
lost another daughter to this damn vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Meningococcal B vaccine.  Additional details were provided as follows:  The reporter was the patient's parent. After receiving Meningococcal B vaccine, the patient was died due to unknown cause. This case was linked with case US2020AMR218484, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218484:same reporter; Reported Cause(s) of Death: Unknown cause of death
partial first dose; a now 15 yr old male received a partial first dose of GARDASIL 9 when he was 10 yrs old; No additional AE; This spontaneous report was received from an other reporter via company representative, concerning a 10-year-old male patient. The patient's concurrent conditions, concomitant medication and pertinent medical history was not reported. The patient had no underlying disease and no previous history of allergy to vaccines.  On an unknown date (reported as approximately 5-6 years ago), the patient was vaccinated with the partial first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot #, expiration date, anatomical location and route were not provided) at age 10 years old for prophylaxis (underdose). Questions about revaccination are addressed in request case reference 02398424 (inappropriate schedule of product administration). The pediatrician at that time deemed the dose to be invalid. No additional adverse event (AE) (no adverse event).
Within 30 seconds after the 2nd vaccine injected to my left arm, I immediately felt my upper body numb or either blood pressure suddenly rise or drop. On the way driving to a parking lot for 15-minute recovery, I could hardly breath. During the waiting period, my heart was off beat and still hard to breath. Then, I went back to work. After 20 to 30 minutes, I suddenly lost energy and felt drowsy. I immediately went home and felt all the joints hurt so much and I still could hardly breath. One month after the 2nd shot, my left middle finger start hurting, then, left knee and then right middle finger. Until September 2021, I have symptoms like arthritis. I could not bend fingers after resting. The worst is in the morning, I can not bend fingers, my toes and ankles are still. From October through March 2022, I could hardly walk. The most serious I could not stand up from a chair. I have seen family doctor, immunologist, rheumatologist and will see nerve doctor next week. However, none of them could diagnose what happen. I am suffering. Can any one help??? Thanks!!!
The client remained in the immunizations office 15 minutes to see if symptoms were noted. The clients mother phoned at 4:15 PM and stated that her son had experienced shortness of breath and swelling to the throat and her mother had  to take him to the hospital.
This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of VAQTA (dose, frequency and route of administration were not reported, lot # L036300 with expiration date: 04-NOV-2016, lot # L039659 with expiration date: 14-MAR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt vaccinated with Recombivax HB experienced a seizure & was involved in an automobile accident. Pt experience was considered life-threatening. Reporting MD felt seizure was not related to vaccination. Additional details being requested.
Fever treated with ibuprofen and rash over entire body for at least 2 days
Soreness over upper extremity with no remarkable swelling, erythema at site; tersearerexia.
Red, hot, swelling, itching at injection site about 3 inches diameter, all started 7 days after injection and 4 days after initial side effects went away.
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported.On 05-MAY-2014, the patient was vaccinated with one dose of GARDASIL (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored GARDASIL was administered. The healthcare worker reported that the GARDASIL, was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Red, Bullseye rash surrounding area, painful area. Being treated with Cephalexin 500 mg three times a day for seven days.
This literature marketed report as received from the authors of the published literature article, refers to an 18 year old female patient with no significant past medical history presented with bilateral lower extremity pain for the past 4 years. On an unknown date the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date (5 months after receiving HPV vaccine), the patient experienced pain Symptom localized to bilateral upper calves to knees. The pain was described as aching and pressure-like, worse with physical activity and severe by the end of the day. She noted bilateral hand tingling improved by wearing braces. She was initially diagnosed with patellar tendonitis with no response to nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or physical therapy. Magnatic Resonance Imaging (MRI) of the knees, brain, and lumbar spine were unremarkable. Autoimmune disease workup was negative. Electrodiagnosis (EDX) studies were unremarkable. Skin biopsy on the left thigh and calf showed low normal sweat gland fiber density of 38.8 and 39.5, respectively. The patient diagnosed through clinical presentation and neurological examination, supported by normal laboratory workup, normal EDX studies, and low normal sweat gland fiber density on unknown dates. The outcome of the event was unknown. The reporter considered small fibre neuropathy to be related to HPV vaccine (manufacturer unknown).
a patient received 2 dose of Fluzone High-Dose Quadrivalent in 2020/ NO AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 81-years-old male patient who received two doses of 0.7 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ450AA and expiry date 30-Jun-2021) and (lot number: UJ499AA and expiry date: 30-Jun-2021) frequency: once, syringe, via an intramuscular route in the deltoid muscle on 24-Aug-2020 and 29-Sep-2020 respectively for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  No other vaccines were used by the patient.  It was an actual medication error case due to extra dose administered (latency: at the time of administration of second dose).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe dizziness, whiting out of vision, lasting more than 4 hours with recurrence the following day.
Late afternoon n 11/8, I developed pruritis with hives and weals on the back of my neck, arms, legs, and abdomen that would disappear and reappear in different locations.  I self-medicated with Benadryl through the morning of 11/11 and had an appointment with my dermatologist that afternoon.  After reviewing the affected areas of my body, her opinion was that I had an allergic reaction to the second Moderna booster received 10/29.  Cetrizine was prescribed for daytime use (10mg) and Hydroxyzine (10mg) was prescribed for night-time use - for 90 days.  Up until yesterday, 10mg of each was enough to mask the lessen prurities (although hives/weals continue) but neither dose continues to be effective.  Will start 20mg Cetirizine 11/17.