chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blackout; fell to the floor from a seated position; headache; abdominal pain; dizzy; sweat; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 19Mar2021 at 17:30 (Batch/Lot Number: EN6206) at 64-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's medical history included osteopenia, food sensitivities, seasonal allergy, allergy to molds; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of the suspect vaccine. On 21Mar2021, the patient experienced: blackout (medically significant), fell to the floor from a seated position (non-serious), headache (non-serious), abdominal pain (non-serious), dizzy (non-serious), sweat (non-serious). Therapeutic measures were taken as a result of headache and abdominal pain. The clinical outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Pt given Pneumovax and Fluzone Quad vaccines in separate arms. Within 5 min pt began to c/o SOB, flushing, face tingling. Pt given epinephrine, IV fluid, IV solumedrol, and oxygen. Sx completely resolved and pt was discharged home with wife by PA-C.
Pfizer-BioNTech COVID-19 Vaccine EUA Adverse event: nausea, chills, injection site pain, tiredness, headache, muscle pain, feeling unwell Treatment: APAP 1000mg Q6Hrs Time course: injection site pain started ~3hrs after receiving vaccine; chills, headache started ~11-12hrs after vaccine; muscle pain, feeling unwell, nausea, tiredness started ~17-18hrs after receiving vaccine; majority of symptoms improved 48hrs after vaccine administration; some tiredness and feeling unwell remain
I was very tired and and my arm was so soar for a couple of days and on the third day I noticed it was worse. It felt hot and was swollen and apparently it was the Modera arm rash. I have a concern because I had my first two shots with Pfizer with minimal reactions. I signed up to get Pfizer and they gave me Moderna even though I have an email to receive Pfizer. They said they get what they get. My arm is so soar and weak. I?m concerned.
I started having headaches a few days later and threw up as well.  Then the headaches started going on and off for long times.  I couldn't rest at night and sleeping was horrible.  My neck started hurting as well.
Varicella Information has been received from a physician concerning a female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed breakthrough varicella with 12 lesions. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) submitted on 5/12/2005. Information has been received from a physician concerning an 8 year old female, with no medical history and no allergies, who on 11-NOV-1998 was vaccinated with a first subcutaneous dose of VARIVAX (Merck) (Lo#628027/1257H). There was no illness at the time of vacciantion. Subsequently the patient developed breakthrough varicella with 12 lesions. It was reported that the patient recovered. There were no laboratory or diagnostic test performed. Unspecified medical attentionwas sought. No produt quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that on 04-MAR-2006 the patient experienced varicella lesions. It was reported that the patient recovered on 12-MAR-2006. Additional information is not expected.
My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized and is recovering.; My elderly mother and I were superinfected by an unvaccinated nurse at the workplace; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar events for 2 patients. This report is 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported stated she was a Geriatric Psychiatric Nurse Practitioner and 322 of her patients die from COVID-19. Since her patients have been vaccinated with Pfizer vaccine none of them who have been superinfected with Delta have died. Also reported said My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of covid19 and drug ineffective cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202101224473 same reporter, drug, event, different patient
Patient came in for a Pfizer Bivalent booster. Received a regular Pfizer in error.
sore arm; can not lift up; hurts so bad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can not lift up) and PAIN (hurts so bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated event outcome.
Mo states child spiked temp of 101.4 tues. 6/16/09 after vaccinations received Mon. 6/15/09. Fever broke tues afternoon. Symptoms include runny nose and "wet" cough.
Heart rate went to 170 went to ER was admitted over night.  Heart rate was converted back to normal.
After first shot, I noticed a tender lump underneath the skin at my left clavicle on 2/19/21. On 2/21/21, the lump was no longer tender. On 2/28/21, the lump began to shrink, but never totally went away. After second shot, the lump underneath the skin at my left clavicle became swollen and very tender. As of today 3/10/21, the lump is still tender and swollen.
uncontrollable shivering; high fever; Initial information received on 03-Oct-2019 and additional information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves three patients (demographics unknown) who experienced uncontrollable shivering (chills) and high fever (pyrexia), when received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   From 01-Oct-2019 to 03-Oct-2019, the patients received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious uncontrollable shivering (chills) and high fever (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was high fever and uncontrollable shivering.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for uncontrollable shivering and high fever.  Information on the batch number was requested.  List of documents held by sender: none.
Large 3" X 6" tender, erythematous swelling on left deltoid muscle following TD shot. Referred pain to left shoulder and forearm.
This case was reported by a sale representative and described the occurrence of eyes splashed with vaccine in a 26-year-old female subject who was administered ROTARIX (GlaxoSmithKline) to her child. A physician or other health care professional has not verified this report. On 21 September 2009 the subject was attempting to administer a dose of ROTARIX to her child and the vial did not puncture properly resulting in the vaccine getting in her eye. The subject experienced itching of the eye. The outcome of the event was not reported. It was the reporter's opinion that this event was probably related to ROTARIX.
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred.  Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
pityriasis rosea; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media (under reference number : US-SA-SAC20211022000959).  This case is linked to case 2021SA352054(CLUSTER).  This case involves a 37-years old female patient who experienced pityriasis rosea, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious pityriasis rosea (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I'm sorry for your losses.  All the people who have suffered after being vaccinated or death. I understand it's not one size fits all this so called vaccination! No one knows on any specific vaccine or drug how it will affect them.  I had a flu vaccination once.  Was in the hospital a month, in a coma for a week with meningitis.  We believe she had COVID-19 in the very beginning 2020 but they weren't testing people then.  My doctor said the vaccination it would probably kill me.  I can't take antibiotics without reactions.  So I do what is best with my body.  Plus I know vaccinated people sick with COVID-19 too.  Some died being vaccinated too.  How in God's name do the big pharma know how in any situation a person's body will react to either getting COVID.  Or a vaccination who can do more harm for them? It's a shot in the dark with or without.  Prayers for us all."  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.; Sender's Comments:  SanofiPVPortal20211021000555:
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an 18-year-old patient (gender not reported) who was inadvertently vaccinated with an expired dose of MENACTRA (batch number: U5523AA, expiration date: 05-Apr-2018 dose, route and site of administration was not reported) on 25-Jun-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event or not. 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. List of documents held by sender: none.
Patient had vaccine and waited the 15 minute waiting period.  He felt well after 15 minutes and left the observation waiting area. He went up front to purchase something 5 minutes later and collapsed face first on the floor as observed by a nearby customer. The customer said he started having convulsing seizures and the customer went to aid in keeping the patient safe. the pharmacy manager (myself) was alerted and I immediately ran upfront to the patient with the emergency bag. 911 was already on the cashiers phone. They dispatched an ambulance. The only treatment was keeping the patient on his side and safe. He was having some labored breathing initially which quickly calmed down. The EMT arrived and they called his Dr office off the VAR. They said he had some hx of seizure. He had selected no to question #6 on VAR (Have you had  History of seizure for which you are on medication for). He became conscious before transport to the hospital. The EMT stated that he seemed to be covering  as expected from seizure.   He was then transported to Hospital Center.
Allergic reaction.  Hives and swelling.  Goes away with steroid treatment, but returns at completion of steroid.
Pt was a poor historian. It was understood he had received only one vaccine. At first it was understood to have been given early in 2021 with no second vaccine. Then he said he had gotten it 2 months earlier. Documentation was found later that it had been a Pfizer vaccine only 3 weeks earlier. We thought this was his second vaccine. Discussing again with him today, it was his 3rd vaccine. It was very much early for a booster and he does not qualify for a 3rd primary vaccine. He is feeling fine today, just a little sleepy and had a little diarrhea. Specifically states he does not feel sick or achey.
Started 3/9/2021Itching at the injection spot, Itchy lips, Itchy tongue , itchy gums  Started  03/10/2021 Coughing and chest tightness
Severe tenderness/pain, swelling, redness, heat and inflammation around and below injection site. Area of inflammation 6+ inches in length, 3-4" in width.
3/20/03 - approx. 9PM pt. had itching under L. arm and noted several (approx. 7) papules. client covered area with OpSite dressing. 3/21/03 Patient noted several papules under L & R breast and in roof of mouth and back of scalp.  3/22/03 - continued itching.  3/24/03 - Vesicles noted S arm.  4/3/03-vesicles noted on top of breast
1/4/03- Awoke 5AM with itching of left shoulder above injection site, no rash. Later that AM noted petechaie-like rash on left shoulder and both leg calves with increased itching. Also, noticed "ringworm-looking," nickel-sized spot on right calf.  1/4 - 1/26- Itching and rash continued in those areas. Applied vitamin/body lotions, oils, OTC cortisone cream and took Benadryl--short-term, temporary relief with those. Had occas. chills and ran low grade fever entire three weeks.  1/27- Awoke to lower half of face swelling that resolved by afternoon. Large, thick, pink whelps appeared on calves, stomach, chest, on back and under both arms. Intense itching, chills and low-grade fever persisted. Took Benadryl that night and whelps, chills and fever resolved. 1/28- Went to free-standing clinic. Saw M.D. Diagnosed with ringworm on right calf and histamine reaction to third Hepatitis B vaccine. Tx: Lamisil AT 3-4 weeks on fungal lesion     Clarinex 5mg daily x 20 days for rash 1/31- Rash almost all gone, few petechaie remain on calves, some occas. itching of legs, fungal lesion resolving. No fever or chills.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Non-pruritic rash on chest.  Mild headache and intermittent nausea.
Itching and redness of the site. Benadryl given 25 mg. Help relieved symptom.
Swollen and itchy at ZOSTAVAX injection site. Patient said it felt like a "softball" was in her arm.
CROHNS DISEASE FLARE UP OF TWO ULCER SORES; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free,Solution for injection in pre-filled pen. In July 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHNS DISEASE FLARE UP OF TWO ULCER SORES) had not resolved and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 56-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease (reported as Crohn´s disease flare up of two ulcer sores), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 56-year-old female patient, with relevant medical condition of Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease (reported as Crohn´s disease flare up of two ulcer sores), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Crohn´s disease can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.