chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports feeling flushed and lips/tongue tingling. Physical examination in the emergency department noted as normal. Patient given diphenhydramine 25 mg orally with resolution of symptoms.
pain in his arm and hands; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in his arm and hands) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in his arm and hands). At the time of the report, MYALGIA (pain in his arm and hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medication were reported.  Didn't clarify if the vaccine was from Moderna.
Low grade fever, headache, body ache and severe pain and swelling in right arm (at site of injection) for 1 day, today - 2/5/21 only slight headache and discomfort and swelling in right arm (at site of injection)
Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 013F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Lot number; 1805018 and 0.5 mL in left deltoid) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Diabetic (No recent change in condition status).   On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-May-2022 at 9:13 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 9:13 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine expired on 13-May-2022, stored in refrigerator on 17-May-2022 and administer on 19-May-2022).    No concomitant medication was provided by the reporter.  The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realize this on the 08-Jun-2022.  On 17-May-2022, vials were initially stored in refrigerator.   Vials did not undergo any temperature excursion.  The patient did not seek medical care for events.  There were no other potential causes for the event.  No treatment medication was provided by the reporter.
pt recvd vax & devel wheal & flare @ the inject site which was described as white welts in a flat red area;
Tested positive for COVID-19 on 09-06-21.  Presented with a 102* fever (lasted for two days), loss of sense of taste and smell (ongoing), severe sinus congestion and related headache (congestion for a week however the headaches persist) continuing loss of energy and lethargic
welts; itchiness in her head; big spots on her head, big spots and rash on her stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: ER8736) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "penicillin allergies" (unspecified if ongoing). Concomitant medication(s) included: REQUIP taken for neuropathy peripheral. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN5318), administration date: 14Apr2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "itchiness in her head"; RASH MACULAR (non-serious) with onset Oct2021, outcome "not recovered", described as "big spots on her head, big spots and rash on her stomach"; URTICARIA (non-serious), outcome "not recovered", described as "welts". The events "itchiness in her head", "big spots on her head, big spots and rash on her stomach" and "welts" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient states that she has got an itchy head, to the point where it has opened up in her scalp. She has got spots on her stomach, in big circles, about the size of her palm, in the evening they become welts. In the morning, it is much better than in the evening. There are little teeny tiny spots on her head, all about the same size probably about a quarter of an inch, and smaller, around the side of her neck and underneath the hairline. These spots are smaller than the ones on the stomach. She states she has had this now for several months. Caller states they she just got through a biopsy they did on her scalp. They took one of the spots and it came through that she has an allergic reaction to something. No vaccinations were taken within 4 weeks prior to COVID vaccine. No adverse reactions occurred following prior vaccinations. Clobetasol Propionate foam .05% was advised by doctor to her but still it did not clear.
This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored private stock PEDVAXHIB (reported as PEDVAX HIB) (lot# M032148, expiration date 18-APR-2019) (dose, frequency and route were unknown) for prophylaxis. The vaccines were exposure to 31.6 Fahrenheit for 16 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537.
Day after immunization, the school nurse where the pt is an employee caller to report had rash from breast to anale with raised quarter size red spots to joint pain by lateral more intense on right than left. Took Benadryl and ibuprofen.
Telephone call from mother (11/30/17) reporting pain from shoulder area with tingling down to the finger tips. Improved each day until resolved on 11/30/17.
t101, broken out all over body; itching all over; swelling above rt patella - c/o pain rt knee & rt wrist;
48 hours after vaccination developed large local reaction with edema, redness >150cm. Unable to fully flex arm from swelling.
Received ADACEL injection 4/4/12 and awoke next day with fever, arm soreness and unable to move x 2 days. Today reporting pain to touch, redness. 4-9-12 office visit, dx cellulitis, treated KEFLEX.
Fever, fatigue for 2 days followed by a head cold and wheezing. Then, symptoms appeared to lift for a few days, then high fever and ear pain.
This case was reported by a healthcare professional and described the occurrence of seizure in a 57-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included asthma, chronic obstructive pulmonary disease, gastroesophageal reflux disease and hyperlipidemia. Concurrent medications included PREVACID, LIPITOR and SPIRIVA. On 16 July 2012 at 16:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, right arm). On 19 July 2012 at 10:00, 3 days after vaccination with BOOSTRIX, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject, who was a truck driver, went to the emergency room on 19 July 2012 due to having a seizure. He had never had a seizure before and medically, the only difference was the vaccination. At the time of reporting, he had not had another seizure. He was seen by a neurologist on 30 July 2012 and was awaiting results. The outcome date was reported as 19 July 2012, however, the outcome was reported as unknown. Follow-up information was received on 28 August 2012 via healthcare professional who reported the subject had a seizure on 19 July 2012. The subject was reported to be "unable to drive subject is a truck driver due to reporting to DMV (department of motor vehicles)". The reporting healthcare professional considered the seizure to jeopardize the subject or required intervention. The healthcare professional attributed the seizure to "per neurology report, subject slept four hours before drive for work". The subject was advised not to received BOOSTRIX in the future. Neurology reports still pending. At the time of the report the outcome was unknown.
Sparse fine papulopustular rash upper chest and upper back upper arms. Nothing at the site of injections.
Swelling of the face, stomach and hip; Swelling of the face, stomach and hip; Swelling of the face, stomach and hip; Itching; This spontaneous case was received on 02-Oct-2020, from pharmacist via Health Authority (reference number: SEQW20-02810) and concerned a 45-year-old, male patient.     The patient's medical history and concomitant medications were not reported.  On 28-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 276535 and expiry date was 07-Jun-2021.  On the same date, after receiving Flucelvax QIV, the patient experienced itching, swelling of the face, stomach and hip and was treated with Benadryl (diphenhydramine hydrochloride) orally.  On 01-Oct-2020, the patient recovered from the events.  The reporter assessed events as non-serious.  The reporter did not provide causality assessment.  The case is linked to case 202004781 due to same reporter.  Company comment: A 45-year-old patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed pruritus, face swelling, joint swelling and abdominal distension. The patient was treated with Benadryl (diphenhydramine hydrochloride) orally. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.; Sender's Comments: A 45-year-old patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed pruritus, face swelling, joint swelling and abdominal distension. The patient was treated with Benadryl (diphenhydramine hydrochloride) orally. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.
The grey top Pfizer vial was inadvertently diluted with 1.8 ml of saline before the dose was given.  It did not need any diluent added to it.     The nursed discovered the error immediately after administration.   We called Pfizer and were told that they had no information about the stability of the vaccine when diluted.  A proper dose from a different vial was then given to the patient as directed in the CDC guidelines.
Activation of DISSEMINATED HERPES ZOSTER. As such, severe nerve pain has occurred along with eye and ear impairment. Started treatment of Valacyclovir with no resolve of symptoms. Gabapentin for treatment of postherpetic nerve pain. Prescription eye glasses for correction of visual impairment.
go to er 4 time-after2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows:  The case was reported by the wife of the patient. The age at vaccination was not reported.  The patient received Shingles vaccine and felt ill pass. The patient went to emergency room 4 time.
CANNOT PERFORM DAILY ACTIVITIES AND AFFECTS QUALITY OF LIFE; CANNOT STAY IN BED; FEELS WEAK; CANNOT MOVE KNEE; GOUT; SWELLING IN RIGHT ARM ,LEFT LEG SWOLLEN FROM GROIN DOWN, HAS BEEN GOING ON FOR 5 MONTHS; This spontaneous report received from a patient concerned a 75 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hip replacement, and concurrent conditions included: high blood pressure, latex allergy (latex rash), social alcohol drinker (glass of wine with meals occasionally), and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 at about 10:54 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, a week later after vaccination, the patient had a swelling on right arm and 2 weeks later on MAR-2021, the patient had a swelling in right toe, and went to doctor twice. On MAR-2021, patient was diagnosed with gout and was provided with cortisone shots. On MAR-2021, the patient also experienced swelling in left leg, from groin down which had been going on for 5 months. The patient had been visiting the doctor since 12-MAR-2021. The patient had been visiting the doctor's office almost every week. The patient believed that his primary care physician was not providing him the proper care. On 24-AUG-2021, the patient's left leg was swollen and was unable to move his knee. The patient was unable to stay in bed. 3-4 days ago, the doctors provided antibiotics to the patient. On unspecified date, the patient felt weak and was unable to perform daily activities which had affected his quality of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felts weak, swelling in right arm ,left leg swollen from groin down, has been going on for 5 months, gout (swelling in right toe), cannot perform daily activities and affects quality of life, and cannot move knee, and the outcome of cannot stay in bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210848967-Covid-19 vaccine ad26.cov2.s- Gout- This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Dull pain; Pressure in head (especially behind eyeballs); Pressure formed and released in several places such as legs and arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 14:00 (Lot number: EW0180) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Allergy: Onions" (unspecified if ongoing), notes: Allergy: Onions; "possible PMDD" (unspecified if ongoing), notes: possible PMDD; "Neck injury" (unspecified if ongoing), notes: Neck injury; "Allergy: Cinnamon" (unspecified if ongoing), notes: Allergy: Cinnamon; "Allergy: Sulfa drugs (IV)" (unspecified if ongoing), notes: Allergy: Sulfa drugs (IV). Concomitant medication(s) included: ASPIRIN; VITAMIN C; CALCIUM. The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Dull pain"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "Pressure in head (especially behind eyeballs)"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "recovering", described as "Pressure formed and released in several places such as legs and arm". The events "dull pain", "pressure in head (especially behind eyeballs)" and "pressure formed and released in several places such as legs and arm" were evaluated at the physician office visit and emergency room visit. No follow-up attempts are possible. No further information is expected.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
near fainting spell/like intermittent fainting spells; feels like vertigo; This spontaneous case was reported by a non-health professional and describes the occurrence of SYNCOPE (near fainting spell/like intermittent fainting spells) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced SYNCOPE (near fainting spell/like intermittent fainting spells) (seriousness criterion medically significant) and VERTIGO (feels like vertigo). At the time of the report, SYNCOPE (near fainting spell/like intermittent fainting spells) and VERTIGO (feels like vertigo) outcome was unknown.            Onset date of events was 4 hours after second shot, which is again 03-apr-2021 and outcome as unknown.  Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  No further information is expected at this time.
redness; induration; chills; fatigue; This case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced erythema, induration, chills and fatigue. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the induration, chills and fatigue were unknown.   It was unknown if the reporter considered the erythema, induration, chills and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received shringrix 24 hours ago and the redness, induration has increased to 7cm and also experienced 2 episodes of chills and fatigue. The reporter was concerned when should be concerned. The reporter wanted to know when should he/she expect the redness to resolve.
Varicella vaccine given 09/07/07. Noticed lump Sat (09/08/07) morning. By 9/10/07 had erythema of 4 3/4" x 4 3/4", induration of 2" x 1 3/4 inch tender to touch and itching. Possible cellulitis - tx Levaquin x 5 days.
Patient came into the clinic c/o painful swollen left arm from the Pneu23 shot that she got on Tuesday.  Patient stated that she could not get out of bed and felt like she was going to died.  Patient stated that she does not want that she shot ever again.  She wanted to let employee know so that it does not happened to anyone else.
I had my vaccination on 09/12/2022. I started to experience a sore throat, low grade fever, body aches, stiff neck on 11/04/2022. I tested COVID-19 positive on 11/04/2023. They did 2 rounds of prednisone for the cough in 11/18/2022 and 12/09/2022. I was referred to specialist Pulmonologist 01/13/2023 in which I had a deep hacking cough with shortness of breath. I was referred to the Long COVID program and also a cardiologist for the heart arrhythmia that started with COVID-19 12/27/2023. I am also seeing an allergist for the asthma 12/04/2023 who is also treating the shortness of breath and prescribed SPIRIVA. I did see an Ear Nose and Throat for a CT scan of my sinuses. I am still having sore throat with shortness of breath and coughing.
12 days after the vaccination I woke To see my arm was puffy, red and warm at the injection site.  No pain at all. Later in the day it was itchy.
SPOTTY RASH ON RIGHT HAND THAT  SPREAD TO LEFT HAND/RASH ON WRIST/SPOTTY RASH ON BACK; SORENESS AT THE INJECTION SITE; PAIN IN ARM/SORE ARM; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced pain in arm/sore arm. On 08-APR-2021, the subject experienced spotty rash on right hand that spread to left hand/rash on wrist/spotty rash on back. On 08-APR-2021, the subject experienced soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spotty rash on right hand that spread to left hand/rash on wrist/spotty rash on back on 09-APR-2021, and had not recovered from pain in arm/sore arm, and soreness at the injection site. This report was non-serious.