chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left side of her face is red since waking up; itching around the injection site; pain in left arm; swelling in the left arm; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number J79G7, expiry date 27th August 2022) for prophylaxis.   Concurrent medical conditions included penicillin allergy (allergic to Amoxicillin) and allergic reaction to drug (allergic to isoamylalcohol).   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, swelling arm and injection site erythema. On 28th November 2020, the patient experienced injection site itching. On 2nd December 2020, the patient experienced red face. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the injection site itching, swelling arm and injection site erythema were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the red face was unknown.   It was unknown if the reporter considered the injection site itching, pain in arm, swelling arm, injection site erythema and red face to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the 1st dose of the Shingrix vaccine in the left arm.  The patient reported that same day after receiving the vaccine she had pain in the left arm, redness around the injection site that was a 4 to 5 inch area going down from the injection site, and swelling in the left arm.  The Patient reported the pain has resolved.  The patient reported the redness around the injection site and the swollen arm is still ongoing.  The patient reported itching around the injection site began and was not resolved.
On December 22nd I became tachycardic with heart rate ranging from 105 to 130.  I then went to the Ed thinking I may develop a pulmonary embolism.  Fortunately, cta of chest was negative.  On 12/23/20 at around 10:30 I develop diffuse erythema rash essentially from face to groin, arm.  I went to the hospital?s employee health to report my adverse effects.  I took prednisone 80 mg and benAdryl 50 mg and symptoms subside.  However, I woke up this morning and the rash is more pronounced with slightly tachycardic.
This spontaneous report as received from a medical assistant refers to 113 patients of demographics. Since an unknown date in August 2012, the patients were vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). It was unknown as to how many patient received just GARDASIL and how many received just PEDVAXHIB or how many patients had received both. Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated 19 children received PEDVAXHIB. This is one of the several reports from the same source.
Patient received first  dose on 05/22/2021 (12 days ago)  and was given the second dose 12 days after. Patient did not have CDC COVID-19 ID card. As per the vaccinate administrator,  computer system could not locate the first dose information on the patient and the second dose was given. patient did not stay for 15 minutes observation and later after the patient had left, it was discovered that the patient had gotten the first dose earlier than the normal waiting interval.  The matter was discussed the Pfizer medical information agent over the phone and it was suggested that the no additional dose is needed and there is currently no study done thus far looking at the safety profile of the vaccine given out of the normal interval.
Soreness around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced injection site soreness which was resolved in 3 days. For tolerance of 2nd dose of Shingrix, refer case US2020221389, reported by same reporter. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221389:for 2nd dose
Got COVID-19; Did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet). The patient was treated with PLASMA at a dose of 1 dosage form. At the time of the report, COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs are provided.  No treatment information was given.
This spontaneous report as received from the patient's mother referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event is unknown. The reporter considered product use issue and no adverse event to be not related to VARIVAX.
Patient developed morbilliform rash starting on torso on 27Jun2020, with spread to extremities and face and associated decreased appetite and fussiness but tolerating liquids and breastfeeding well with normal hydration status. Has been gradually but slowly improving since onset of the rash
3/21 Discovered a Development of a painful rash under right arm on upper chest and under right Breast. Due to pain, went to Urgent Care on 3/23 , diagnosed with Shingles.  Prescribed Valtrex to slow Shingles progress. 7 day on Valtrex.  Now Shingles are internal and external.  Very painful.  Follow doctors appointment on 3/30,  Prescribed Prednisone, but I was concerned with side effects and my upcoming 2nd covid vaccine shot on 4/15/21.   Doctor then prescribed Gabapentin 1-3 100mg per day...due to my intense internal nerve pain.
Fainting, collapsing, vomiting, tachycardia 911 call. Taken to emergency room.
The pt's arm swelled up and turned red. It was swollen from the shoulder to the middle of lower left arm (pneumonia shot). Took antibiotics.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 5:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 19 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that improperly stored doses of M-M-R II (lot # L012482, expiry date 10-APR-2017, dose and route were not reported) were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
After vaccination patient felt dizzy and shaky. Stomach upset. Syncope with no injuries. Afterwards slightly shaky but resolved after sitting for 10 minutes and drinking water. No seizure symptoms.
stiff neck & back; h/a & sinus h/a; fever;sore throat;sore lower back & hips
Given vaccine left deltoid, c/o itchiness, then became red, approximately 3" area of edema and warm to touch on 10/17/01. Reaction increased in size, approximately 6" red area, swollen and warm. Put cool - warm compresses and took Benadryl. On 10/18/01 decreased redness and warmth.
a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045A21A and 031M20A) for COVID-19 vaccination.     Patient has no allergies. Patient has never been diagnosed or tested positive for COVID-19. Patient has no acute or chronic illness at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu shot (patient  doesn´t remember the exact date.) in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.            Patient did not seek medical care for the event.   This case was linked to MOD-2022-556239, MOD-2022-555509, MOD-2022-556237 (Patient Link).
Menomune vaccine ordered from website (stated on website vaccine was for all ages).  Administered and later discovered this vaccine was for ages above 55 only, unless the appropriate vaccines were not available.
faint, pale color, cold sweat, vomiting, nausea, tingling in fingers. EMS was called to the pharmacy lobby. After patient drank some water and juice, he felt better.  EMS treated on the scene for suspected panic attack. (Patient saw blood running down arm post injection). Patient and parent left the pharmacy after about 45 minutes from time of injection feeling and looking much better.
head to toe rash; a red solid band of 4 inches wide on the injection site and on the back which is also very itchy; a red solid band of 4 inches wide, then it appeared on the injection site and on the back; a red solid band of 4 inches wide,then it appeared on injection site and on the back; felt tired; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE REACTION (a red solid band of 4 inches wide, then it appeared on the injection site and on the back), RASH (head to toe rash), VACCINATION SITE PRURITUS (a red solid band of 4 inches wide on the injection site and on the back which is also very itchy) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-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) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (body aches) and PYREXIA (fever). On 20-Mar-2021, the patient experienced FATIGUE (felt tired). On 21-Mar-2021, the patient experienced VACCINATION SITE REACTION (a red solid band of 4 inches wide, then it appeared on the injection site and on the back). 21-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (a red solid band of 4 inches wide on the injection site and on the back which is also very itchy) and VACCINATION SITE ERYTHEMA (a red solid band of 4 inches wide,then it appeared on injection site and on the back). On 22-Mar-2021, the patient experienced RASH (head to toe rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (body aches), VACCINATION SITE REACTION (a red solid band of 4 inches wide, then it appeared on the injection site and on the back), RASH (head to toe rash), VACCINATION SITE PRURITUS (a red solid band of 4 inches wide on the injection site and on the back which is also very itchy), PYREXIA (fever), FATIGUE (felt tired) and VACCINATION SITE ERYTHEMA (a red solid band of 4 inches wide,then it appeared on injection site and on the back) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-059084 (Patient Link).
Night of vaccine - right arm sore, achy.  Then back of neck got very hot - looked red.  Today better.  Skin - negative.  Neck - normal.  Lungs - clear.  Heart - normal.
Woke up this morning with nausea and vomiting yellow liquid. Also has intense pain in low back, headache, pain in legs and arms, injection site soreness that seems to have spread to L shoulder and neck. Has been experiencing chills but no fever.
Patient presented to the ED and was subsequently hospitalized within 3 days of receiving booster dose for CVA.
Patient died on the same day she got the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of sudden death in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number MH5BH, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included chronic kidney disease (had chronic kidney disease). Concurrent medical conditions included type ii diabetes mellitus.   On 9th October 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 9th October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. The patient died on 9th October 2020. The reported cause of death was sudden death.   It was unknown if the reporter considered the sudden death 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: The pharmacy technician reported that a patient received a dose of the 2020-2021 FluLaval, and the patient's husband reportedly sent an email stating that the patient (his wife) died on the same day. Thecertificate of death lists 15th April 2021 as the date of death. The cause of death was listed as natural. Other possible causes were listed as uncontrolled type II diabetes and chronic kidney disease.  The patient's husband reportedly asked for a copy of the prescribing information for the vaccine his wife received. The reporter consented to follow up. There was discrepancy in death date, on certificate of death it was 15th October 2021, but as death was occurred on 9th October 2020, hence death date captured as 9th October 2020 instead of 15th April 2021.; Reported Cause(s) of Death: Sudden death
Right toes turned solid purple/blue 2 hours after shot.; No clot but blood flow restricted.; Feet always feel cold and ache; Feet always feel cold and ache/Toes hurt to walk on.; This is a spontaneous report from a contactable consumer.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Aug2021 17:00 (Batch/Lot Number: FA7485) (at the age of 39-years-old ) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 22Jul2021 12:00 AM in Left arm (Lot number  EN0180). Medical history was none.  The patient was not pregnant.  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. Concomitant drugs included vitamins. Two hours after shot on 12Aug2021 at 19:00 the patient experienced right toes turned solid purple/blue. Went to ER. No clot but blood flow restricted. Symptoms continued to come back 10 days after. Feet always felt cold and ache. Toes hurt to walk on. It was reported that the events resulted in Emergency room/department or urgent care, disability or permanent damage. . Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
administered IPOL instead of Prevnar to the patient, with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 15-month-old female patient who was administered IPV (VERO) [IPOL] instead of prevnar to the patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 16-Jun-2023, the patient received a Primary 0.5 mg dose of suspect IPV (VERO) Suspension for injection (strength, expiry date: unknown) (lot: U10571M) via intramuscular route in the left thigh for Prophylactic vaccination (immunization).  On 16-Jun-2023 the patient had an event of administered ipol instead of prevnar to the patient, with no reported adverse event (wrong product administered) (latency: same day) following the administration of IPV (VERO).  It was unknown if nay lab data/tests results available.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: unknown.  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 the 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.
August 1989: Tick bites while hiking, rash 2-week course of tetracycline. Some persistent symptoms & problems from 1990 to present, but not suspected of being Lyme-related.  May - August 2000: Received 3-injection course of LYMErix vaccine from family doctor. I requested vaccine because of possible exposure to ticks through sports & hobbies. January 2000: changed primary care physician because of move.  Late 2002 (September?): joint pains, eye inflammation, facial muscles twitching,stabbing pains in costovertebral area, odd rash base of spine. Tested for Sjogren's Syndrome, Lupus (both negative) Because of foreign travel history, tested for hepatitis (negative). Late 2004: Joint inflammations and immobility (R. shoulder, R. knee), severe sacroiliac pain, irritable bowel & urethretis, increased facial pain, eye inflammation and "bleeders", acute GI symptoms. Had complete physical,doctor still didn't suspect Lyme. January 2005: Right shoulder immobile, Orthopedist ordered Xray that showed unexplainable calcifications in tendons. February-March 2005: Fever & chills, severe bronchitis, bleeding sinuses, joint pains.  Prescribed Augmentin 2 weeks did not work. Prescribed 20 days of Ciprobay, bronchodilator & inhaler. Symptoms subsided but never entirely stopped. Late November 2005: Acute flare-up of joint pains, extreme fatigue & headaches, vertigo. December 10, 2005: Blood tests again for Brucella & Lupus (both negative), also tested for LYME - the IgG assay was VERY HIGH. Waited entire month for test results and return doctor visit because of Brucella cultures. January 12, 2006: Doctor reviewed test results, I was referred to an infectious disease specialist because of high Lyme result. January 18, 2006: Infectious disease specialist diagnosed Lyme disease, took blood sample for Western Blot test, I have started a long course of doxycycline hyclate 100mg 2x daily. I.D. physician will review after first month. Do not know if current disability (joint problems, IBS, neurological problems) will be resolved.