chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching sensation- all over body; my face felt numb; redness - of the face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching sensation- all over body), HYPOAESTHESIA (my face felt numb) and ERYTHEMA (redness - of the face) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itching sensation- all over body), HYPOAESTHESIA (my face felt numb) and ERYTHEMA (redness - of the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching all over, Numbness facial and Redness of face, at a dose of UNK dosage form. On 27-Jan-2021, PRURITUS (itching sensation- all over body), HYPOAESTHESIA (my face felt numb) and ERYTHEMA (redness - of the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment included Benadryl to alleviate the symptoms and symptoms seemed to go away by 27-Jan-2021.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Reporter details, patient details, suspect product batch number, event verbatim updated.
Pulsatile tinnitus in right ear has persisted since early October. Started with migraines and facial twitching within a week of receiving the booster shot before shifting primarily to pulsatile tinnitus.
Patient developed what appears to be zoster on her left neck and shoulder region within 24 hours of the vaccine.
Inflammation x 1-2 days, neuralgia in upper trunk and shoulder starting approximately 72 hours after administration and worsening, no rash, tingling comes and recedes.
Localized reaction. Redness and swelling with pain. No fever. 5 day duration. Complete resolution acheived.
inadvertently received MENACTRA with no reported adverse event; inadvertently received MENACTRA on 24FEB2022 in the office which had expired on 18FEB2022 with no reported adverse event; Initial information received on 24-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who inadvertently received menactra on 24-Feb-2022 in the office which had expired on 18-Feb-2022 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine (HPV vaccine); influenza vaccine (flu); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP).  On 24-Feb-2022, the patient received a 0.5 ml  dose (First Dose) of suspect meningococcal A-C-Y-W135 (D conj) vaccine (lot U6827BA, expiry date: 18-Feb-2022) (strength and formulation not reported) via intramuscular route in the left deltoid as prophylactic vaccination   An hour after the administration, the reporter informed that 2 patients had inadvertently received Menactra on 24-Feb-2022 which had expired on 18-Feb-2022 (expired product administered) (accidental exposure to product) (latency same day). Caller asked if these patients needed to be revaccinated and if it was safe to give another full dose of MENACTRA right away since full doses were given on 24FEB2022.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  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.
The week of Feb 20th, I began to experiencing pain in the right heel that slowly began to go up my right leg. The next day the same symptoms started on my left leg/calf. Went to the doctor on March 18th where they ran some tests and prescribed 5days of anti-biotic which did not help. On March 25th 2021 both legs felt very fatigued. I began to develop red spots on my lower legs which lasted for a couple of days. By the time I saw my doctor it had cleared up.  Went to doctor again on April 20th which was more bloodwork and a lower extremity test on  4/22. I was then referred to a neurologist whom I saw on June 3rd. The doctor stated at this visit that it was most likely not due to the vaccine. I started physical therapy on July 1st and ended Oct which helped. In Dec, the leg tingling began again and in Jan, it was getting harder to get out of bed and the sensation had spread to my hips. By the end of Jan, the sensation had gone back down.
he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atopic dermatitis (atopic dermatitis on both hands). Concomitant products included hydrocortisone (Hydrocortisone Cream).   On 15-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several weeks after receiving Shingrix, the patient experienced red rash (Verbatim: he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips). The patient was treated with prednisone. The outcome of the red rash was not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.     It was unknown if the company considered the red rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-AUG-2023 The patient had a history of atopic dermatitis on both hands that he used topical and injectable steroids. The patient stated he received Shingrix dose and a few weeks later he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips (not yet resolved). The patient went to Primary care physician (PCP) who prescribed prednisone and referred to dermatologist.  The patient was referred to HCP. The reporter consented to follow up.
she states she became ill 5 days after receiving the vaccination with nausea, headache, diarrhea. The next day her arm was sore and it progressed to arm numbness, swelling, joint pain in all her joints(knees, hips, fingers). She has missed 3 days of work because of the  pain. She has never had this happen before from a vaccination.
Pt lost consciousness within 5 min of vaccine administration, then bradycardia to 42 persisted with hypotension to 66/23 for approx 30 minutes.
Vomiting, weakness, difficulty walking, lasted 24 hours. Passed after sleeping  12-14 hours
BELLS PALSY; This spontaneous report received from a patient concerned a Male of unspecified age. The patients weight, height, and medical history were not reported. On 08-APR-2021, the patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the patient experienced Bells Palsy after receiving Janssen vaccine and went to the Doctor but waiting for the diagnosis. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of Bells Palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210508205-covid-19 vaccine ad26.cov2.s -bell's palsy- This event(s) is considered unassessable . The event(s) has a 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).
RN at offsite clinic administered patients second dose of Pfizer 13 days after patient received the first dose.
Was given Pneumo and flu shot on Monday Oct 10 developed soreness (pain in upper arm) Monday evening, Tuesday AM deltoid area swollen, red, warm, tender to touch, no fever, but having body aches.
Rash. Diphenhydramine 25mg once, Prednisone 60mg once, Ranitidine 150mg once.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site and redness that spread from the injection site "all the way to their armpit" on an unspecified date in 2014. The patient also developed malaise and nausea on an unspecified date in 2014. No treatment was given. The patient sought medical attention by calling the pharmacist. The patient's husband received ZOSTAVAX on the same date and experienced the same adverse event which was captured in MARRS # 1412USA001968. The outcome of adverse events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt w/ needle-phobia and hx of vasovagal response following injections, blood draws in past.  fainted 1 min following vax (1st dose).  was still in immunizing chair, and was unresponsive x 10 sec.  pt then awoke and was able to move to observation area x 15 min w/o issue.  provided water, and pt's daughter was present w/ him the entire time.   pt was educated  and to alert future immunizers of potential for reaction.
THE PATIENT HAD A SYMPTOMS OF NASUEA, VOMITING, TACHYCARDIA, DIZZINESS, AND SWEATING
After receiving the vaccine a few months later I began getting sick for no reason and in extreme pain in my joints. The pain has gotten worse and worse since. I went to the doctor to see what's going on and now my blood work shows I have a autoimmune desease that was never there before! This seems to be happening to alot of people!
covid arm - delayed cutaneous hypersensitivity (itchy lesion) exactly as described in :  https://www.health.com/condition/infectious-diseases/coronavirus/covid-arm-rash-moderna
This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAR-2013 to 01-APR-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 11 year old male patient who on 01-APR-2013 (at 11:22 am) was vaccinated in left arm with the first dose of GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.
Within 2 weeks of the moderna booster it started with eczema on one knee and gradually spread to both lower legs and hip area.  Within several days of the eczema rash these areas also broke out in hives.  I could differentiate the hives from the eczema because the hives went away within an hour whereas the eczema rash remained.   Applying  mometasone furoate and benedryl creams to the itchy areas.
pain / right arm pain / pain is more localized to injection site; difficult to lift his arm up; Vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient was stated the injection was given above the deltoid muscle which led to vaccine administered at inappropriate site.  The patient stated a day before reporting he started to have right arm pain and the pain was more localized to the injection site but the patient was finding it difficult to lift his arm up. The reporter consented to follow up. This case had been linked to the case US2019171934, reported by same reporter.
Patient woke up at 10:30am on 1-6-21 with her (L) upper arm itchy. Area of injection was red, swollen, and hot to touch. Patient saw PCP on 1-6-21 and was prescribed a prednisone taper, Atarax, and betamethasone cream. As of 1-7-21 the area is still red and swollen.
first dose was administered on March2019 (specific date not given).; Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st January 2020, 306 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for the 2nd dose. Due to pharmacist being a floating pharmacist no more patient, vaccine or reporter information could be collected. The pharmacist asked how to proceed for a second dose of Shingrix given that the first dose was administered on March 2019 (specific date not given).  The pharmacist also mentioned that the patient had experienced a Shingles outbreak on January 2020 (date not specified) and they wanted to administer a second dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Pt developed chickenpox subsequent to receiving the varicella virus vaccine live. Unspecified medical attention was sought. Additional information has been requested.
Initial unsolicited report received from a Consumer (Patient's wife) on 18 April 2017. This case involves a 64-year-old (reported as 65 year) male patient who was vaccinated with a single dose of ADACEL (batch number: UI567AA, expiry date and route of administration not reported) in left deltoid on 07 December 2016. Patient had no ongoing illness, birth defects, medical conditions and concomitant medications were not reported. It was reported as pre-existing physician diagnosed allergies: NKA (No known allergy). On 07 December 2017, same day following the vaccination, the patient had experienced stopped talking, continues to have left arm pain with stiffness and rigidity and it hurts to use like arm has a rod down through it, it is ruining their lives as patient was so much discomfort. The patient required ER visit. No lab data was reported. The patient regularly with a yoga instructor and gets treatments 2 times a day. On an unspecified date the patient was recovered from stopped talking and not recovered from other events. List of documents held by sender: none.
Extreme fatigue and muscle soreness, my body has been very stiff continuing through today 4/13/21, yesterday 4/12/21 being the worst.  Energy levels are Zero. My arm continues to hurt at the injection site and have headaches and sore neck at times.
Muscle pain, joint pain, headache, rapid heartbeat.  Took Tylenol.  Day after vaccine.
This subject is a 66 year old male who was taken to the emergency dept after collapsing in his home while enrolled in RSV11 study. The subject received his second dose of RSV vaccine or Placebo and influenza vaccine on 10/22/03. Subject collapsed at home on 11/12, 21 days post immunization. Subject's wife and stepson attempted CPR. An ambulance was called and subject was taken to the emergency dept. There was little EKG activity on arrival and subject died in the ER on 11/12/03. Cause of death was not reported. The death was reported by the investigator as not related to the study vaccine.  Follow up on 12/16/2003: "Additonal information received 12/01/2003, CIF and ER report.  CIF: Cause of death-cardiac arrest w/secondary underlying cardiac disease.  Additional information received 12/03/2003.  Subject attempted to get out chair at home in the AM of 11/12/2003, and collapsed, hit a wall and landed on the cough.  EMS notified and responded.  Subject in asystole, CPR was started, IV fluids, intubated and sent to ER for further management, but remained asystole. Cause of death, cardiac arrest with secondary underlying cardiac disease.  The cardiac arrest with secondary underlying cardiac disease was assessed by the investigator as unrelated to the study vaccine.  Additonal information available with source documents. ER report
Legs aching terribly; Difficulty walking; Severe muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Solitary kidney.   In February 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain). At the time of the report, PAIN IN EXTREMITY (Legs aching terribly), GAIT DISTURBANCE (Difficulty walking) and MYALGIA (Severe muscle pain) outcome was unknown. patient reported adverse events after receiving first dose of Moderna Vaccine.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No concomitant medication were reported. Patient also received second dose of Moderna Vaccine on unknown date, and did not experience any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional details provided regarding second dose of Moderna Vaccine and reporter details updated
Redness, swelling, warmth, swelling, blistering, open area to skin.
Received immunization on 03/11/2002 at 4:30pm. Mom called on 03/13/2002 to report adverse event and told to bring child to clinic for evaluations. Right thigh red, warm to touch at entire thigh, edema, and temp of 100 deg. F. Told mom to use cool, moist compresses.
Left upper arm has tender mass 5 inches by 3 + 3/4 inches. Subcutaneously and erythema w/warmth 1 + 1/2 by 1 + 1/2 inches. Neg axillary nodes.
Sore arm; A little achy in back; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 08Apr2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation.  Medical history included rheumatic fever as a child, chronic allergy and sulfonamide allergy (sulfa drugs). Concomitant medications included chlorphenamine maleate, pseudoephedrine hydrochloride, ibuprofen (ADVIL ALLERGY SINUS) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 16Mar2021 at 12:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 18:00 the patient experienced sore arm and a little achy in back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm and a little achy in back were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
First shot, arm hurt, headache for a week, kind of a flu feeling for 3 days... Second shot had a very bad reaction... Very sick with ALL Flu symptoms for 2 days, along with a Migraine for 3 days then headache for 2 more days then pressure in eyes and forehead for 2 days, tightness in neck and shoulders, redness and swelling around eyes for 2 days.. very tired for a week...
I had increased arm pain from the second dose, swelling in the upper arm, a splotchy rash that was raised, and increased neurological seizure activity with loss of sleep, mania, and weakness in the upper torso. I had issues with speech, reading, and word pronunciation. I called the neurologist who referred me to psychiatry and went to the ER who determined there was " nothing they could do", to check in with my GP who had referred it to neurology and the ER.
Significant pain at injection site and shoulder has continued x 1 month and treatment through chiropractor and taking ibuprofen -> othopedic physician 11/16/15.