chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Closed fracture of neck of right femur, initial encounter  - t total hip replacement, right. Recovery in hospital. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 7 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 7 years child patient was given the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Systemic: Fainting / Unresponsive-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Patient reported redness and soreness at sight of injection. She has been using topical Benadryl. She said it did get worse from Saturday to Sunday but no other significant problems.
Burning chest pains that started within 24 hours after receiving the injection. The chest pain lasted for over a month and are still mild. That is why I took myself to the ER on 9/12/2021 that showed an elevated D Dimer, but not any blood cots. Was diagnosed by the attending physician with atypical chest pain.  I have zero history of chest pain or any heart condition or blood pressure issues. I have also been dealing with significant fatigue and have been sick with cold/flu like symptoms more in the last 3 months than I was in the previous 5 years. Have a follow up appointment on 11/30/2021 with a primary care physician
fever, fatigue, headache, sweating, they lasted about 1 day. The patient started feeling better the next day
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II, lot number L041457 with expiration date 22-OCT-2017, and lot number M004305 with expiration date 25-JAN-2018 (dose, route and anatomical location were not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours in the first cycle; Also on these dates from 04-JAN-2017 to 06-JAN-2017; from 09-JAN-2017 to 11-JAN-2017, on 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017, from 23-JAN-2017 to 27-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002864: US-009507513-1702USA007377: US-009507513-1702USA007375:
Pt come into health center 2 days after Pneumonia injection, c/o tenderness and redness right arm, evaluated by MD 7/20/06 who described erythema, swelling at distal aspect right upper arm with tenderness, erythema right axilla, MD no adenopathy. MD prescribed Medrol dose pack. Benadryl 25 mg TID x 7 days. cold compresses to right upper arm, Advil PRN, will be follow up in one week.
Fever pain for  2 days and some nausea then two weeks paralysis of right face developed Bell?s Palsy
Ache - joint muscles;pain legs, back, lower back; arthritis, blood high cholesterol, and cramps leg.
extremely itchy rash at vaccination site which  began on 8th day and lasted 2 or 3 days.   nothing serious
A report has been received from a Health Professional concerning a 33 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 17-Sep-2013. The patient was administered two full doses of FLUMIST QUADRIVALENT, one in each nostril which started on 17-Sep-2013. The outcome of the event of two full doses of FLUMIST QUADRIVALENT, one in each nostril is unknown. The report was considered to be non-serious.
Moderna COVID-19 Vaccine EUA.  I had a fast heartbeat of 130bpm, chest tightness, dizziness and weakness as well as fatigue, headache, muscle pain, joint pain, uncontrollable shaking and chills, nausea and fever of 101.4
Pt started complaining of itching at the roof of her mouth. It was noted she had oralpharynx swelling, uvula swelling at the 17 minute mark post vaccine. Report was called to the ED Charge Nurse. Pt walked over to ED check in.
Information has been received from a licensed practical nurse concerning an approximately 22 year old female patient with no drug reactions or allergies who on 20-MAR-2007 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MIRENA. The nurse reported that the patient now had vulvar dysplasia (VIN II). The nurse was unsure when the dysplasia developed, but the patient was first seen in their office in April of 2011. The patient had an area that was raised with dysplasia in April of 2011 and another discolored area noted in January of 2012. The patient had had two biopsies and both indicated moderate vulvar dysplasia (VIN II) one in April of 2011 and the other in January of 2012. No treatment was given for the event. At the time of the report, the patient had not recovered. Follow-up information has been received from a licensed practical nurse refers to a patient who on 23-JAN-2012 was performed a biopsy. The result was discolored lesions, bilateral epithelial changes. The patient had laser ablation in February 2012. The patient had consultation with the physician. On 18-JUL-2012 the patient was treated with chemical ablation with trichloroacetic acid. The reported stated the patient was doing well. Additional information has been requested.
pain in her left shoulder; dry throat; sore throat and throat pain; feel severe pain on her arm; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; a burning sensation in all of her left arm combined with a tingling sensation and cramps,; fell generalized weakness; was not able to breath properly, her breathing was similar to an asthma attack; vomited; heart was beating like never before; feel severe pain on her arm that would not aloud her to move her arm; had a nervous breakdown; This is a spontaneous report received from a contactable consumer, the patient. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at 10 am SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Approximately on an unspecified date in Apr2021 from 4 pm the patient experienced to develop a lot of adverse reactions that increased over time: she presented pain in her left shoulder that did not allowed her to move properly, dry throat, sore throat and throat pain. She returned home to rest and overnight she started to feel severe pain on her arm that would not allowed her to move her arm, she put ice on her left arm which allowed her to sleep for a couple of hours, at midnight she started to experience a burning sensation in all of her left arm combined with a tingling sensation and cramps, this sensation extended through one of her legs and then the other one, she started to fell generalized weakness and was not able to breath properly, her breathing was similar to an asthma attack and she had to choose between speaking or breathing because she was unable to do both at the same time, she had to be send to the emergency room where she vomited, had a nervous breakdown and after a couple of hours was stabilized, she felt that her heart was "beating like never before", this worries her because she believes that she could go into a heart attack or have a stroke, today she only has pain in her arm. The Patient wants to know if she can take Advil to treat the adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Within about 45 mins .  after I received the shot (and had left the facility), I was driving home and began to feel the left side of my mouth (my lips) swell up (as if I had been give  novacane at the dentist), then the area under my left cheek bone began to swell up as well; nothing hurt, I had no chest/back pains (had a double by-pass 16 yrs. ago, no further heart problems), no pain, tingling, in arms, legs; my doctor's office is closed Friday afternoons, so went to Emergency Medical office where was diagnosed with Bell's Palsy; went to my own doctor following Tuesday; swelling had decreased, on and off; by Saturday (i.e. one week after the shot) I also had a red very itchy rash on my left arm at the vaccination site; swelling still not gone by third week after shot, so went   to my ENT (allergist) who said it was not Bell's P., recommended not getting 2nd shot; then (4th week after the shot and still some swelling around the cheek) went to my Cardiologist, did EKG, all OK, but he said both the rash and swelling were allergic reactions and I should not get the second shot - so I will not get the second shot.  Now (7 weeks from shot, am still "aware" of lips and cheeks - not exactly swollen, but like an injury that is not completely healed - this occurs when I am "tensed up" about something (l trying to get to an appointment on time :)
Pt. wa sdx. with  cellulitis at injection site. Swelling of site rash occured. Lowgrade fever
Extreme fatigue, fever, aches, low oxygen, high pulse, diarrhea, loss of appetite. All started 72 hrs after vaccine, and were worse on Day 4.
dermatomal pruritic rash on left foot, leg, buttocks.  SHINGLES
Overnight, my arm started itching and when I woke up the shot site was swollen, warm, red, and itchy.  My upper arm is also a bit sore overall. At the time of the shot, it became swollen and very sore but the soreness went away after a couple of days. The swelling went down but I haven't paid much attention to it since. I'm assuming it went back to normal.
This spontaneous report as received from a registered nurse via a company representative refers to a 17 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot, dose and route not reported) for childhood vaccination. Concomitant medication was not reported. On an unspecified date in February 2014, the patient came down with mild virus. On 28-FEB-2014, the patient was seen by the nurse. Blood tests were administered on the patient and it was found that he had elevated liver function enzymes and his Hepatitis B titers were not adequate (less than 3.10). The nurse stated that they will readminister RECOMBIVAX HB series. The nurse also stated that the patient was recovering, his "levels are coming down," and he felt some fatigue. Additional information is not expected.
Hives; facial swelling; felt throat closing; late phase reaction; This case was reported by a physician via call center representative and described the occurrence of hives in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives (serious criteria other: as per reporter), facial swelling (serious criteria other: as per reporter), throat constriction (serious criteria other: As per reporter) and delayed type hypersensitivity (serious criteria other: as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives, facial swelling and throat constriction were recovering/resolving and the outcome of the delayed type hypersensitivity was recovered/resolved.   It was unknown if the reporter considered the hives, facial swelling, throat constriction and delayed type hypersensitivity to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced Immediate severe reaction as hives, facial swelling, felt throat closing. The patient was given 50 mg Benadryl and symptoms improved but the patient had a late phase reaction that clear with Benadryl. No adrenaline given. The reporter asked what are the ingredients in the Flulaval Quadrivalent season 2020-2021?  The reporter wanted to know if the vaccine contain Flulaval Q contain PEG or polysorbate? The reporter did not consent to follow-up. No additional information was provided.
Severe allergic reaction; Redness on her face; Gum started bleeding; Platelet count was down to 1000; Platelet count went up to 3000, then suddenly went back to 1000 again.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), ERYTHEMA (Redness on her face), GINGIVAL BLEEDING (Gum started bleeding), PLATELET COUNT DECREASED (Platelet count was down to 1000) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 HYPERSENSITIVITY (Severe allergic reaction) (seriousness criteria hospitalization and life threatening), ERYTHEMA (Redness on her face) (seriousness criteria hospitalization and life threatening), GINGIVAL BLEEDING (Gum started bleeding) (seriousness criteria hospitalization and life threatening), PLATELET COUNT DECREASED (Platelet count was down to 1000) (seriousness criteria hospitalization and life threatening) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) (seriousness criteria hospitalization and life threatening). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction), ERYTHEMA (Redness on her face), GINGIVAL BLEEDING (Gum started bleeding), PLATELET COUNT DECREASED (Platelet count was down to 1000) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information included IV infusion (8 bags of platelets).
On 08/25/2002 at apprx. 10 am, client stated left arm became swollen and reported a large raised red patch on area above left elbow which felt hot to touch. Took Alegra at 11pm and today arm continues to be red and swollen, but less painful. Also C/O both ankles itching on 08/25/2002.
About 4 hrs after vaccine - developed scattered hives, swelling at fingertips, lots, contact dermatitis like rash - Grosred viser; Benadryl quiet
"Fainting" eyes rolled back of head. Pale. Mom watched at home. Refused appmt.
Case number PHHY2011US65540 is a combined initial and follow up spontaneous report received from a consumer and a physician via another pharmaceutical company (ref: 7068842) on 19 Jul 2011. This case refers to a 39 year old female patient. Her medical history included miscarriage (9 weeks of gestation), type-2 diabetes mellitus (diagnosed in May 2006), and multiple sclerosis (diagnosed in Jan 2006). Concomitant medications included metformin and insulin. She was also receiving REBIF 22 microgram three times per week subcutaneously from 19 Jul 2006. She stopped treatment with REBIF in Aug 2009 when she learned that she was one month pregnant. She was vaccinated with H1N1 influenza vaccine (manufacturer and batch number unknown) on an unspecified date in Nov 2009. At 4 and half months of gestation (2 weeks after vaccination), she was diagnosed with miscarriage and was hospitalized. Heartbeat of the foetus was not detectable. A dilatation and curettage was performed. The outcome was not reported. The causality was not assessed. However, both H1N1 vaccine and REBIF were reported as suspect medications.
Patient Came into clinic 2 days after receiving immunization. Patient right upper arm was red, significantly swollen and warm to the touch. Patient advised to go to ER. Patient sent to ER due to no physician in building when Patient came in.
12 hours after my shot I woke up and started vomiting.  My legs felt like they were on fire.  I had severe chills and a pounding headache.  This lasted for about a half hour.  After that, I slept for around two days. It scared me because I hadn't heard of the vomiting or burning reactions.
Swelling spot and soreness where flu shot was given on 10/07/2006. Pt abo stated that swelling was Y2 dollar size. On exam today induration 1.5 cm x 1 cm erythema and swelling at injection site no adenopathy no numbness decreased rash and profusion. No evidence of secondary infection. Skin warm but not hot.
Chills that night until the next morning, head cold and tiredness the next day,  Treated with acetaminophen
My entire family has developed a cough and fever and congestion.  2 kids and spouse and I have similar symptoms
Information has been received from a 67 year old female pharmacy technician who is also the consumer with sulfonamide allergy and no other pertinent medical history who on 02-APR-2008, was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous.  Concomitant therapy included PREMARIN.  On 01-AUG-2008 the patient developed 101.9 F degrees fever and stinging, shooting pain over her entire body, after receiving a dose of ZOSTAVAX.  The pain is now (11-AUG-2008) "across her shoulder blades" and under her left arm, the patient also reported that she experienced lethargy.  The patient was being treated with gabapentin.  Unspecified blood tests were performed (no results provided).  The patient considered the symptoms to be disabling.  Additional information has been requested.
pain when receiving injection. Sore/stiff arm for 3 days after. A week or so later noticing pain similar to when I received the injection at the injection spot. Feels kinda like burning sensation. My arm is not swollen or red. Does not appear to be infected on the surface. No other side effects.
NOSE/HEAD CONGESTION; UNABLE TO BREATH; NIGHT SWEATS; CRAZY DREAMS; DIARRHEA; VOMITING; DEHYDRATION; DRY HEAVING; NAUSEA; SLUGGISH/TIRED; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included flu, and concurrent conditions included overweight, and pcn (penicillin) allergy, and other pre-existing medical conditions included patient took a product (vaccine) as directed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced sluggish/tired. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced dehydration. On 25-MAY-2021, the subject experienced dry heaving. On 25-MAY-2021, the subject experienced nausea. On 26-MAY-2021, the subject experienced nose/head congestion. On 26-MAY-2021, the subject experienced unable to breath. On 26-MAY-2021, the subject experienced night sweats. On 26-MAY-2021, the subject experienced crazy dreams. Treatment medications included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sluggish/tired, nausea, vomiting, diarrhea, nose/head congestion, dehydration, dry heaving, night sweats, unable to breath, and crazy dreams. This report was non-serious.
Repeated episodes of cold sore outbreaks beginning in 12/12 in my nasal passages - most recent outbreak 6/05/13 and recurrence of cold sore outbreak in nasal passage on 6/25.
Pelvic Mass - Exploratory laparotomy,tah, bso, omentectomy, appendectomy, nodes. Treated and discharged. This visit was within 6 weeks of receiving the COVID vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 at 14:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Underactive thyroid" (unspecified if ongoing), notes: Other medical history: Underactive thyroid; "High cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (Lot number: 2707499) started on 04Jan2023 and stopped on 10Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.