chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a non-serious spontaneous case, initially received from other non-health professional on 25-Jan-2018, concerning a 38-year-old, adult, male patient. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient was administered with non-company suspect drug COSENTYX (dose: 300 mg, single via subcutaneous route) for severe plaque psoriasis. On an unspecified date, (reported as over the last 4 or 5 months), the patient's psoriasis had flared up and had covered over 75 percent (explicitly coded as contraindicated product administered). The outcome of the event psoriasis flare-up was not reported.
Patient was under-dosed and given 0.25mL rather than the required full dose of 0.5mL
Initial and follow-up information has been received from a 71 year old female consumer and a nurse practitioner concerning the consumer herself with no known allergies and a history of breast cancer who on 11-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck) (lot no. 659409/0409X) into the left upper arm. Concomitant therapy included LEVOXYL, Delaval XY, aspirin, metformin, simvastatin (manufacturer unknown) and Lisinopril (manufacturer unknown). The patient experienced severe constipation five days after vaccination. At the time of report, the patient's constipation persisted. The patient did not seek medical attention. In follow up the nurse practitioner reported that the office was never notified of any adverse reaction to "this immunization". Additional information is not expected.
Extreme arm soreness, extreme fatigue, lightheadedness, mild nausea, mild breathing difficulties overnight
Information has been received from an office manager concerning a 25 year old female patient with no pertinent medical history and no drug reactions/allergies who on 21-JAN-2010 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 662529/1317Y) IM. Concomitant therapy included hormonal contraceptives (unspecified). 2-3 days after the first dose of vaccination, on approximately 23-JAN-2010 the patient developed left-sided cervical, axillary and inguinal lymphadenopathy, as well as redness at the injection site. The lymphadenopathy resolved without requiring treatment. The patient reported the adverse symptoms when she arrived at the office on 12-APR-2010 for her second dose of GARDASIL. The patient sought unspecified medical attention. No laboratory test was performed. At the time of the report, the patient recovered on an unspecified date. Additional information has been requested.
Patient is a 48yo female presenting for her second COVID-19 Vaccine. She reported a prior reaction with first dose of COVID-19 vaccine, with throat tightening and some chest tightness onset approximately 13 min after receiving the first vaccine dose. She took oral Benadryl and was monitored by EMS  with complete resolution of symptoms after approximately 20 minutes. She did not require transport or hospital evaluation but saw her allergist for evaluation prior to presenting today for second dose. She was advised by her allergist to proceed with second dose of vaccine given her comorbidities and risks associated with COVID-19 infection. This medical evaluator reviewed risks with her, and possibility for allergic/adverse reaction with her second dose of the vaccine, and she chose to proceed with vaccine. She was initially doing well and was positioned next to EMS for close monitoring. Approximately 20-25 minutes after receiving second dose of the vaccine, she started to have a dry persistent cough, with some upper airway wheezing, no stridor or retractions, with auscultated normal breath sounds and good air exchange however with noted slight increase in respiratory effort and pale skin color, no diaphoresis. She took oral benadryl 25mg at 11:27am, but cough persisted and she developed lightheadedness and was transferred to the ambulance from her personal vehicle.10L oxygen was placed by nasal cannula. Within a few minutes, cough improved and skin color improved. Breath sounds continued to be clear with good air exchange. No wheezing or stridor or retractions were noted during this evaluation. She was transferred to another stretcher and oxygen removed, to allow for transport to the hospital via another ambulance. Within a few minutes off oxygen, cough returned. She was then transferred to local hospital for further monitoring and evaluation.
Pt complained of headache and respiratory distress and then soon went "coma" per her husband on 12/20/01 and impaired consciousness and speech at the end of February. Final dx: "viral encephalitis".
See by PCP on 12/29/11 for rash that started on 12/24/11. Dx vaccine associated varicella infection started from legs to body.
Pt received FLUAD shot on 11/09/2017 in the afternoon. Pt woke up in the middle of the night with lightheadedness, vertigo, and palpitations. Vertigo lasted 3 days and palpitations lasted 1 week. Pt was forced to remain laying down with head elevated for relief. Pt informed her MD who told her to take meclizine. Pt took DRAMAMINE and natural ginger. After 3 days, vertigo was relieved but pt still could not lay down in supine position without head raised even though vertigo ceased while standing. As of today, patient is completely over her reaction.
3 weeks ago with 1st dose patient experienced itching all over body.  Today 2/5/21 ~0915 pt. received 2nd dose of Pfizer COVID vaccine.  Within 5 minutes patient felt intense itchiness (greater than last time).  Today she is now feeling tightening and swelling feeling in her throat.  At ~0920 given diphenhydramine 25mg po and at 0930 given famotidine 20mg po.  Symptoms are resolving while under observation and patient is being picked up by father so she does not drive.
Tremor, weakness, dizziness,. this non-serious case was received from a patient on 05 December 2008. A 68 year old male patient, with a history of thimerosal and penicillin allergies and a heart rhythm abnormality, received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2791AA) on 13 October 2008. Eight hours post-vaccination, he experienced weakness, tremors, and dizziness. The events lasted for several hours. The patient reported the events via phone call to his physician, who prescribed TYLENOL. Outcome was unknown. Follow-up information received 16 January 2009 from a health care professional who reviewed the case information, had no new relevant medically significant information to provide at this time. Follow-up information received 13 April 2009 from a health care professional who reported that the patient recovered from the events. No additional information was provided.
Swelling, pain, hives, and hard down to elbow. Reported swelling of face. Epi used in emergency room.
Underage patient was given the second dose of Pfizer. Patient was verified to have had 1st dose a month earlier.
Autoimmune encephalitis flare.  Rage, brain fog, dizzy.  GI Mast Cell reaction
5/11/21 Day 1 (within in 12 hours) - 3 cold sores appeared on left side of mouth the same side as shot. lasted for over 10 days. 5/20/21 - brown spots appear on left side hand (top of hand near thumb) 5/21/21 - browns spots increase on left side hand (top of hand near thumb and in the middle) total of 8 or more brown spots and 1 smaller sized brown patch on left hand 5/24/21 - brown spots and patches are still present but not increasing as of today
Pt. w/ "multiple medical problems including failed renal transplant x 2 with ESRD on HD, SAH, HTN, OSA 2018, afib and acute DVT in Dec 20 on eliquis, orthostatic hypotension, adrenal insuff (secondary), recent pseudomonas sepsis who presented to facility on 3/25/2021 with infection of L leg wound. Was sent from surgeon's office when noted to have increased pain, increased drainage from wound. Left lower extremity wound with exposed muscle and tendons."... "initially transferred to a different department on 4/23/21 but transferred off on 5/8/21 due to cough and fevers to 104.4 attributed to new diagnosis of COVID-19." Pt. died on 08/24/21 in hospice, after D/C from ICU due to MRSA bacteremia, ESRD, Arrest, Shock, Septic Emboli to the brain.
Joint aches; Headache; Lump swelling under right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Nov2021 16:00 (Formulation: solution for injection, Lot number: FH8027) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; ATORVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Joint aches"; HEADACHE (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Lump swelling under right armpit". Therapeutic measures were not taken as a result of arthralgia, headache, lymphadenopathy.  Additional information: The patient had not received any other vaccine within 4 weeks. Before being vaccinated he did not have COVID and had not been tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Irregular heartbeat lasting at least one week following my second dose of Pfizer. Began around May 14 & is beginning to settle as of May 23. Frequency has decreased immensely over the last few days. Was having irregular heartbeat consistently throughout the day for nearly five days straight & am now only experiencing 0-1 times per day. I am currently living out of the country & had returned to my home to receive my first dose of Pfizer in April. I had been home for one month before departing back on May 10th & began experiencing side effects four days after my return (roughly one week after my second dose). I currently do not have a doctor to report to back home, & had not yet seen my doctor here to report the irregularity. Note: I did not experience symptoms with my first shot.
Pain redness and swelling at injection site. Fever, body aches, stiffness >48 hrs.
Information has been received from a nurse practitioner referring to four female patients of unknown age. There was no medical history or concurrent condition reported. On unspecified dates these four patients received the GARDASIL (dosage, strength, route and lot # were not reported). On unspecified dates, they reported "high risk PAP smears" while on therapy with GARDASIL. There was no concomitant medication reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Symmetrical loss of hair on arms, legs, back and face. Diagnosed as Alopecia Areata by MD dermatologist
Rash on her two arms, especially on the inside; Her skin looks like an elderly woman's; Itchy, it hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away). At the time of the report, RASH (Rash on her two arms, especially on the inside), SKIN DISORDER (Her skin looks like an elderly woman's) and PRURITUS (Itchy, it hasn't gone away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Tinnitus, vertigo, nausea, shortness of breath, tremors, daily headaches, eye twitches, depression
Events: Shortness of breath, chest pain, fatigue, severe shortness of breath while laying down, severe shortness of breath of while exercising, chest pain,  foot and ankle swelling.   Time course: Symptoms appeared 6 days after first dose, continued for approximately 3 months and increased inflammation in severity after second dose. Resolved completely after approximately 6 months
Severe headaches and nausea, and lightheaded and also chills and sweating and arm pain and muscle aches and very tired.
was down for two days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling down in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on back and chest when patient was about 45 years and was out of work for two weeks). Previously administered products included shingles vaccine with an associated reaction of depressed mood (1st dose received on an unknown date refer case US2021AMR195300).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling down. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling down was recovered/resolved.   It was unknown if the reporter considered the feeling down to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The patient was given the shingles vaccine and had a bad reaction to shingles shots where the patient was down for two days. The follow up would not be possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195300:Same reporter
Deep Vein Thrombosis L leg popliteal + gastrocnemius veins
lighter red circle, it is around 4 inches in diameter; Vaccination site pain; red circle  around the injection site.; red circle rash  the injection site.; Swelling gland in the left arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (lighter red circle, it is around 4 inches in diameter), LYMPHADENOPATHY (Swelling gland in the left arm), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red circle  around the injection site.) and VACCINATION SITE RASH (red circle rash  the injection site.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling gland in the left arm). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red circle  around the injection site.) and VACCINATION SITE RASH (red circle rash  the injection site.). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (lighter red circle, it is around 4 inches in diameter). At the time of the report, VACCINATION SITE WARMTH (lighter red circle, it is around 4 inches in diameter), LYMPHADENOPATHY (Swelling gland in the left arm), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red circle  around the injection site.) and VACCINATION SITE RASH (red circle rash  the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient went to urgent case and was prescribed prednisone on 24-Jan-2021.
Extreme headache, the worst I have ever had.  Extreme body ache over my entire body, could barely walk or stand.  Headache got better around 7pm same day, one day after vaccine.  These symptoms weren't  just inconvenient, they were very extreme.  Not just a little headache and body discomfort but absolutely extreme.  All better today, two days after vaccine.
I believe that I was exposed to COVID-19 in the airport on 07/15/2022. On 07/19/2022 I was not feeling great in the morning but didn't feel ill. In the afternoon I felt tired and took a nap. When I woke up, I did not have a fever but I felt feverish. I had prickly skin, was congested, my eyes felt feverish, and I had a slight cough. I took an at home COVID-19 test that afternoon which was immediately positive. I called my primary care physician who prescribed PAXLOVID which was a 5 day course. My husband went and got that for me so I began taking it the evening of 07/19/2022. I finished on 07/23/2022 in the morning. I was feeling much better by 07/22/2022. I felt well on 07/23/2022. On 07/25/22 I started to feel ill again and had a rebound effect that lasted until 07/27/2022. I tested myself several times and was negative, but the symptoms were the same. By 07/29/2022 I felt well again and have been feeling well ever since.
Patient was due for second dose of her Pfizer vaccine but was mistakenly given Moderna instead. Talked to patient 30 minutes after immunization and she did not report any adverse effects yet. Told her to let her know if she experiences any side effects that she feels are not usual effects from immunization. She said she would call us if she feels unwell at any point. I will call again tomorrow to check in on her as well.
No adverse effects reported; improperly stored M-M-R II was administered to a patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 02-AUG-2019, the patient was vaccinated with an improperly stored dose of recombinant human albumin (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (M-M-R II) with lot # R015165, expiration date 29-MAY-2020, for prophylaxis (dose, dose number, route and anatomical location were not provided). The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to a temperature of 50 degree Fahrenheit (F) for a time frame of 4 hours. No previous temperature excursions were reported and a digital data logger was involved. No adverse effects and no product quality complaints were reported.
Child had high fever of 104.3  Could not bed fingers and toes next 2 days after vaccine
Pt. received FLULAVAL 2013-14 MDV on 10/10/13. She came in to pick up another Rx at pharmacy 10/18/13 and showed me her deltoid; looked red, blotchy and felt warm. Said it had been like that for a week. (Right deltoid only)
Covid injection instead of flu shots with no adverse event; Initial information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved adult patient who received corona virus (covid ) injection instead of INFLUENZA VACCINE (wrong product administered).  The patient medical history, medical treatment, vaccination, concomitant medication 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 unknown route at an unknown administration site for Prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported "pharmacy gave a whole family the corona virus (covid) injection instead of flu shots."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
significant hair breakage/loss; significant hair breakage/loss; her toenails becoming brittle, three toe nails break off completely; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA431468.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; dupilumab (DUPILUMAB), subcutaneous since 05May2020 (Batch/Lot number: unknown) at 300 mg for dermatitis atopic. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing), notes: Historical Condition: Thyroid disorder. The patient's concomitant medications were not reported. The following information was reported: TRICHORRHEXIS (non-serious), ALOPECIA (non-serious) all with onset 01Aug2021, outcome "unknown" and all described as "significant hair breakage/loss"; ONYCHOCLASIS (non-serious) with onset 01Aug2021, outcome "unknown", described as "her toenails becoming brittle, three toe nails break off completely". The action taken for dupilumab was unknown.  Additional information: On 01Aug2021, the patient developed a non-serious event 'significant hair breakage/loss' (Latency:1 year 2 months 27 days) following the first dose intake of Dupilumab. On 01Aug2021, the patient developed a non-serious event 'significant hair breakage/loss' (Unknown Latency) following the administration of Pfizer BioNTech Covid-19 Vaccine. It was reported 'patient received her Pfizer covid vaccine around end of Jul, beginning of August. She has noticed significant hair breakage/ loss since that time as well as her toenails becoming brittle. She has had three toe nails break off completely, only changes in her life around that time were getting her Covid shot and possibly starting menopause'.It was not reported if the patient received a corrective treatment for the events significant hair breakage/loss, her toenails becoming brittle, three toe nails break off completely.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.