chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anemic; tested positive for Covid after receiving both doses Covid vaccine; tested positive for Covid after receiving both doses Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; rituximab (RUXIENCE [RITUXIMAB]) (Batch/Lot number: unknown) at every 6 months for rheumatoid arthritis. Relevant medical history included: "legally blind" (unspecified if ongoing), notes: Verbatim: legally blind. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "tested positive for Covid after receiving both doses Covid vaccine"; ANAEMIA (non-serious), outcome "unknown", described as "anemic". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) she states she is anemic, notes: She states she is anemic and that it is only one point down; sars-cov-2 test: (31Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
exaggerated inflammatory response to moderna vaccine - muscle  & body aches; tactile static allodynia; chills; headache with sinus pain and photosensitivity; extreme fatigue and malaise with sob and activity intolerance; progressed to bilateral pneumonia requiring IV antibiotics, oral antibiotics; prednisone, nebuilzed steroids and other meds  for supportive care.....loss of work 1-15-21 through  current date.  Still working through dx of moderate persistent asthma, unexplained prolonged sinus  congestion and fatigue with activity intolerance.
Vial was not diluted prior to vaccine administration.  0.2ml was injected of a concentrated, pediatric covid-19 pfizer vial.  We do not know at this time what the reactions are because we are unable to reach the parent at this time.  The realization of the error was not found until several hours after the administration and the family was gone by that time.
I never had eye issues before and I used to spend a lot of time on screens.  Rather quickly after the first 2 shoots I had eye sensitivity, burning sensation in the eye, sensitivity to light, feeling of pressure in the eye, pain but I thought it might just be a sign of aging.  My eyes would be burning to the point I couldnt open them after I would spend time on screen, outside when sunny or after crying. When they would start hurting, it would slowly get worst. If I stopped everything and closed my eyes for few hours, it would help. Otherwise it would be bad all day and even the following day. I want to insist that I had few episode where it was so bad I could not keep my eyes open while driving.  After my first 2 shoots the symptoms lasted for about a year, slowly getting better overtime. After about a year I could cry and not have the burning sensation that would last all day.  After my booster the symptoms came back, this is how I associated with the vaccine, they came back 4 days after my booster shoot. My doctor gave me steroid drops, which helped a lot so he concluded it was an inflammation.
extreme, unusual fever of 41.5 C despite taking acetaminophen and ibuprofen; 48 hours;  extreme fatigue; bad, persistent headache for 6-7 days.
Expired vaccine. The expiration in system (states vaccine tracking system) was 5/31/22. We were unaware that the use by date was 3/17/22.
Much redness and swelling around the site of injections About the size of a baseball.  Hot and sore to touch
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
two-inch wide, puffy red rash, still painful to slightest touch over 96 hours after injection.
I had the most extreme head ache with nausea I have ever experienced in my whole life and I am used to having migraines, but this was much worse than my worst migraine, weakness in my body to the extent I couldn't get up from the bed, chills, all started 12h after the vaccine and lasted 24h. The following 7 days I felt several times a day a very localized severe pain on my left side of the brain, it felt like an aneurysm about to burst. Even now 7 months after the vaccine my menstrual cycles are still extremely irregular. Having my periods every 2 weeks sometimes, some other times every 6 weeks or 3 weeks or 4 weeks apart, I literally don?t know anymore when to expect my periods, also I had extremely high flow on several occasions, severe pain, and concerning big blood clots during my periods. Before taking the Covid vaccines I always had very normal periods, never had irregular times or flows.
severe burning, on face from eye to jawbone, over chest to groin; severe rash, on face from eye to jawbone, over chest to groin/painful, over chest to groin; had what looked like chicken pox, on side that was injected; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Family History) (patient's kids had it).   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced burning sensation, painful rash and vesicular rash. On an unknown date, the outcome of the burning sensation, painful rash and vesicular rash were unknown.   It was unknown if the reporter considered the burning sensation, painful rash and vesicular rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and immediately after the shot he/she got a severe burning rash on his/her face from his/her eye to his/her jawbone.  The patient had other burning painful rashes over his/her chest to his/her groin area. The patient also had what looked like chicken pox spots interspersed. These were only on the side that he/she was injected on. The nurse that injected he/she told him/her the same thing. Since his/her kids had it he/she had been exposed & needed the shot. The patient thought most people who take the shot had no problems. However, this was what happened to him/her. Additional supportive information: The follow-up would not possible, as no contact, details were available.
12/8/09 T.C. from mom. Per mom, within minutes after receiving H1N1 nasal spray pt experienced runny nose, nasal drainage into throat, dizziness and felt warm. When pt got home, mom gave her 1/2 BENADRYL tablet and ranitidine as pt was c/o acid reflux sx. That evening pt experienced fever, N/V, belching, coughing and wheezing. Per mom, pt did vomit 1 x this am and is still running a low grade temp of 100.3. Mom is using fever reducing meds and will take pt to MD tomorrow if not better. PHN will f/u in 1-2 days to assess health status.
Info has been received from a physician concerning a pt who was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the pt developed encephalitis. Unspecified medical attention was sought. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional info has been requested.
Mild temperature elevation within couple hours up to 100.3F (tympanic). Patient was seen by her PCP in the other office for this practice and was well and healthy.  Had a WCV this morning.  Received COVID-19 and influenza vaccines today.  Was fine before appointment and at appointment and then after appt, went for smoothies and then was cleaning her room before all this started.  She has had both of the covid and flu vaccines before.  Had pfizer vaccine this time but has had covid vaccines in past. Afterward, she started acting very strange--felt weird. Was really sleepy.  Seemed like she was going to take a nap.  Was hanging out on the couch--started crying and repeating 'I wanna go home,' but was on the couch in h
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284730,  2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 13 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. 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.
developed a Bartholin cyst; the cyst got infected; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration on 17May2021 (at the age of 25 years old) (Lot number was not reported) as unknown, single for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and experienced hypersensitivity. On 20May2021 (3 days after receiving the vaccine), the patient developed a Bartholin cyst. It was the first time this has happened to the patient and the cyst got infected. Patient had to go to the ER to drain the cyst. Patient said It seemed too much of a coincidence. Patient is a healthy young lady that almost never has health issues. As soon as she took the vaccine, she needed to go to the ER for a Bartholin cyst. Treatment received was Surgical drainage and antibiotics. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received influenza vaccination while at the hospital for a gynecological surgical procedure. Had no complaints of pain at injection site or other related pain at time of injection. One week post op patient required no pain medications either narcotics or ibuprofen. 2 weeks post operatively patient begins complaining of shoulder pain. This pain has not been relieved by traditional methods and physician referred patient to a specialist as it may have nerve involvement. Patient is convinced it is related to the influenza vaccine she received and wishes for a form to be completed.
in the first couple of hours, felt lethargic, and run down, low energy and body aches and disoriented that lasted about 3 days.  Continued to feel lethargic was able to return to work on the following Monday.  Five days later, started with diarrhea, nausea, vomiting, fever, headaches.  Vomiting stopped about 2-3 days later.  On 04/13/20201 or 04/14/2021 started noticing a big patch of hair falling out on the left side, believes same arm as vaccine was given.  Was Dx with bacteria called "Campy" on Monday.   Client verbalized feeling better as of Monday  04/19/2021.
Received flu shot 10/31/08 at 13:18 hrs. Developed symptoms of throat swelling and difficulty breathing. Treated with ALBUTEROL Nebulizer 2.5 mg in 3 mlns, BENADRYL, 25 mg IVP.
Admin error - on 2/7/2013 pt. was administered ENGERIX B - Adult dose instead of Pediatric/Adolescent dose.
Left upper arm inflammation, edema, erythema for two days. Pt treated with Benadryl and antibiotic for cellulitis. Follow up 04/20/2000: "Patient recovered from adverse event. "
Information has been received from a female consumer who on 10-APR-2007 was vaccinated with one dose of Zostavax. Subsequently on 13-APR-2007 the patient developed a red swelling about 2 to 3 inches at the injection site on her arm. Medical attention was not sought. At the time of the report, the patient had not recovered. No additional information is expected.
No adverse events. Dose given: Maroon cap mixed with 1.3mL instead of 2.2mL.
Narrative: Patient is a 34-year-old female who received her first Pfizer vaccine in 3/2021; around 45 minutes later, patient developed acute rash over her whole vaccinated arm (right) associated with tingling sensation over her toes, constant nausea, and dizziness. She took diphenhydramine with partial relief. The symptoms subsided after 4 days.
Product Lot number issue; No adverse event; Extra GARDASIL 9 DOSE #4 administered on 03-AUG-2022; DOSE #1 administered on 15-NOV-2012 DOSE #3 administered on 22-MAY-2017; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 15-NOV-2012, the patient administered first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# H013831), 0.5 milliliter, valid lot #H013831, expiration date: 06-MAR-2015, administered for prophylaxis (strength, and route of administration were not provided). On 22-JUL-2013, the patient administered second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# J002641), 0.5 milliliter, valid lot # J002641, expiration date: 10-DEC-2015, administered for prophylaxis (strength, and route of administration were not provided) (product lot number issue). On 22-MAY-2017, the patient administered third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) formulation vial, 0.5 milliliter, lot #N000326, expiration date: 14-OCT-2019, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). 03-AUG-2022, the patient accidentally administered additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, lot # 178076, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (extra dose administered). It was because the patient's records had not reflected the previous completed series. No additional adverse event information was provided (no adverse event).
19MAY91 SOB, tremors, inc P, dizziness; 24MAY91 lt shoulder red, swollen painful inject site; 27MAY91 hives, SOB, blurred vision, difficult to swallow x 2wks; 13JUN91 blurred vision spot in field of vision;
pt recvd vax; devel fever of 103; n,v; adm to hosp for rehydration; as of 28-oct-93 was afebrile;
Patient felt nauseous after vaccine and her mother tried to take her to the restroom.  When she stood up she got lightheaded.  Her mother caught her. She did not hit anything.  The paramedics were called.  She remained reclined on the floor until they arrived.  She said she felt fine. They monitored her for a short while. She required no further treatment.  On follow-up several hours later she states she feels fine.
I began experiencing sharp pain near my naval that got worse. The pain got worse and I felt sick. I went to a freestanding ER and they gave me pain meds and sent me home. 5 hours later the pain was unbearable so went to the hospital where they dx me with appendicitis. I had an emergency appendectomy on 2-7-21.
mild biting in my arm the day of then a week later; Then a week later I feel like I have the flu; I have a bad cold; 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 LIMB DISCOMFORT (mild biting in my arm the day of then a week later), INFLUENZA LIKE ILLNESS (Then a week later I feel like I have the flu) and NASOPHARYNGITIS (I have a bad cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (mild biting in my arm the day of then a week later), INFLUENZA LIKE ILLNESS (Then a week later I feel like I have the flu) and NASOPHARYNGITIS (I have a bad cold). At the time of the report, LIMB DISCOMFORT (mild biting in my arm the day of then a week later), INFLUENZA LIKE ILLNESS (Then a week later I feel like I have the flu) and NASOPHARYNGITIS (I have a bad cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
No adverse event; Patient received bivalent dose >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >12 hours post puncture).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 02-Nov-2022. Date and time vial was first punctured on 02-Nov-2022 at 4pm. The time of administration of vaccine was around 10 o'clock.  The vial did not undergo any temperature excursions. No treatment information was reported.
Pt reported to feel subjective fever, chills, diarrhea, nausea and vomit, fatigue since receiving COVID vaccine yesterday. She vomiting clear x5 since yesterday and is unable to hold food down. She had x6 episodes of mild diarrhea.
Received Pfizer vaccines on  1/27, 2/17/21 COVID-19 positive by PCR on  2/2/22 admit to hospital on 2/2/22 d/t weakness, COVID infection Underlying DM2 w/ neuropathy, CKD 3, PAD s/p bilateral BKA, HTN, seizure d/o Per CXR: Imaging features can be seen with COVID-19 pneumonia
Reaction Report on Covid vaccine:  I am a 69 year old male. On 3/11/2021 I received my first Covid-19 vaccine. It was the Pfizer vaccine. For a little more than 3 weeks I was fine, sore arm for a few days but that's all. Then all little more than 3 weeks later, on 4/4/2021, I started to feel chills, very tired and achy all over. I thought I was coming down with a cold but I never developed a cough, teary eyes nor a runny nose. I did have a headache but no sore throat and no cough, just the other symptoms of a cold. Those symptoms started on 4/4/2021 and lasted for about 3/4 days waning every day until 4/11/2021. That was the first day I felt back to normal. I was supposed to get my second shot on 4/8/2021 but canceled and rescheduled it for 4/21/2021. I am very concerned about getting the second shot and have actually considered canceling that shot too. I am very unsure what to do.
Received 2nd dose of Pfizer vaccine; sore arm after first dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MARIJUANA for Muscle spasms, GLATIRAMER ACETATE (COPAXONE), TROSPIUM CHLORIDE, SERTRALINE, CLONAZEPAM, VITAMIN D NOS and LATANOPROST for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine). On 08-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She was on a drug for multiple sclerosis.
pt recv vax& 2min p/vax had a syncope rxn & fell;pt was observed in office for five hr w/recurrent n/v, vertigo, h/a & vague cold sensation in chest;pt was transferred to hosp for over noc observation;
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2020, the patient received Shingrix (intramuscular). In September 2020, couple of days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his upper arm intramuscularly around and experienced a sore arm which lasted for a couple days then resolved. The event was got better.  The reporter did not consent to follow up. This case has been linked with case US2020187908, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187908:Wife's case