chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012O42A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and ALLOPURINOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Patient has developed shingles 3 weeks ago even after receiving receiving shingles shot) outcome was unknown.            Concomitant medications included BP medication. Treatment medications included steroid. Action taken with mRNA-1273 in response to the events was not applicable.
Fever of 103 C, chills, body ache, severe headache, nausea, metallic taste in the mouth 2nd dose of vaccination given at 11 am 1/14/2021. Pain at the injection site . Then body ache started. Midnight 1/14/2021 - chills started, fever 103, severe headache- Fever, body ache and headache continued till Monday(1/18/2021) Strong Metallic taste in the mouth, nausea, dizziness- still continuing.
Rash/hives on upper and lower arms (both), 2 inch diameter of swelling around the injection point, Small hard lump where needle was injected into the arm, Area around arm is warm to the touch.
This shot first caused an inflated heart rate, flushed cheeks, and then started my period. My second shot on 4/15/21 at the same place at 8:45 AM also caused inflated heart rate, flushed cheeks... but now my second period is over two weeks late which has never happened.
Patient presented to the ED and was subsequently hospitalized for COPD with a cute exacerbation, Acute bronchitis due to respiratory syncytial virus, within 6 weeks of receiving COVID vaccination. She is currently hospitalized.
Pt visited ED 6 days after vaccination w/ urticarial rash that started 1 day after receiving the influenza vaccination.
6 days, post vax, pt developed multiple erythematous, slightly hard and raised, macular rash on the right upper extremity. Rashes have pin-point, dry papules in the meddle. This was noted also at 4 months old, 6 days, post vaccinations.
First vaccine was administered 1/29/2021 and second dose was administered on 2/9/2021. No adverse event per patient when contacted.
The patient experienced extreme fatigue, severe flu-like symptoms, achiness, painful joints and a fever.
Pain, limited mobility on March 21st, Orthopedic Urgent visit 4/3/2021-prescribed anti-inflammatory, steroids, Xray 4/13/2021 Orthopaedic visit prescribed anti-inflammatory and physical therapy 4/20/2021 Began Physical therapy 2 times weekly 4/27/2021 Follow up Orthopedic visit-continue anti-inflammatory and physical therapy, 2 times weekly.
Rash around injection site.  Itchy.  Developed many days after shot.  Cortizone cream alleviates  it. Doesn't seem serious but strange that it took so long to appear.
Erythema and swelling with wheal and flare at injection site. Applied ice to the injection site for 20 minutes. Injection site improving.
I experienced swelling and tenderness to my lymph nodes and left axilla after receiving my first dose injection. I experienced large swelling up my neck , left side radiating to my shoulder blade.  I experience a large lymph node which was swollen and very painful touch.
hives; redness; itching; rise in the area size of a dime; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ERYTHEMA (redness), PRURITUS (itching), GROWTH ACCELERATED (rise in the area size of a dime) and PAIN (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (body ache) and CHILLS (chills). On 15-Mar-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), PRURITUS (itching) and GROWTH ACCELERATED (rise in the area size of a dime). On 10-Mar-2021, PAIN (body ache) and CHILLS (chills) had resolved. At the time of the report, URTICARIA (hives), ERYTHEMA (redness), PRURITUS (itching) and GROWTH ACCELERATED (rise in the area size of a dime) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included cortisone cream   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow Up received: Non Significant Information Received.
This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored ROTATEQ (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. On 16-Dec-2021, the vial was initially stored in the refrigerator.  Patient received booster half dose. The vial did not undergo any temperature excursion. No treatment drug details was reported.
pt recv vax 9AUG97 & 11AUG97 pt exp local rxn, which was swollen, sore, warm to touch, red & a fever up to 100.5;13AUG97 pt recovered;
No adverse effect; Stored improperly; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On an unknown date the patient was vaccinated with one improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) (lot # R028531, expiry date: 02-APR-2020) (dose and frequency were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK INJ).  The vaccine was stored in temperature of -9 degree Celsius (C) to 8 C (-1.7 C) for 51 hours and 9 minutes and -14 degree Celsius (C) to -10 C (-9.8 C) for 3 hours and 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.
This spontaneous report was received from a consumer refers to her 20 year old daughter. On 02-MAR-2009, the patient was vaccinated with first dose of GARDASIL (lot#, expiry not reported) intramuscularly. The patient had not received any subsequent doses in the series. Since an unknown date, the patient experienced body aches, headaches, fast or irregular heartbeat, shortness of breath and stomach aches. The patient was experiencing bouts of these adverse reactions about 4-5 times each week. The patient also developed bumps all over her body that were diagnosed as rosacea which began on an unspecified date after receiving GARDASIL and lasted for about a month. The patient had been seeing the certified nurse practitioner. The outcome of body aches, headaches, stomachaches, fast or irregular heartbeat and shortness of breath was reported as not recovered. Additionally, the reporter stated that she would be more than happy to talk with anyone at Merck to answer additional questions or provide further information about her daughter's unique adverse experiences. This is 1 of 3 reports received from the same reporter. Additional information has been requested.
Got real sick for about four days; This spontaneouscase from was retrieved on 30-Nov-2021 from other non-healthcare professional via Agency (reference number: SEQW21-05740) and concerned patient of an unknown age and gender.  The patient's medical history and concomitant medication were unknown.  On unspecified date in 2020, the patient was vaccinated with Fluad Quadrivalent  (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration, anatomical location, dose and indication: not reported). The batch number was not reported.  On unspecified date in 2020, unknown amount of time after receiving Fluad Quadrivalent, the patient got real sick for about four days. The patient stated might as well had the flu.  On an unspecified date in 2020, the patient recovered from the event.   The reporter did not provide a causality assessment.  Company comment: The event of 'sickness' was assessed as unassessable to Fluad Quadrivalent.; Sender's Comments: The event of 'sickness' was assessed as unassessable to Fluad Quadrivalent.
Systemic: see comments vaccine wasnt administered-Mild, Additional Details: this vaccine was NOT administered, child moved once needle was stuck in arm and scrached his arm.  Showed parents full vaccine in syringe before disposing. Parents went to pediatrician after to get vaccine.  opened a report for the sole purpose of documenting the incident
pt recv vax 3FEB98 & c/o sx of swollen wrist, one hand on 20FEB97 w/other wrist & both knees swelling on 22FEB98;c/o soreness @ swollen site & hard to bend down;applied ice to swollen areas & kept legs elevated;
Had an issue with mobility of injected arm for quite a while/issue with injected arm; She had a "zing" down to her fingertips; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injected limb mobility decreased and electric shock sensation. On an unknown date, the outcome of the injected limb mobility decreased was resolved with sequelae and the outcome of the electric shock sensation was unknown.   The reporter considered the injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the electric shock sensation to be related to Shingrix.  Additional details were provided as follows: The reporter was the neighbor of the patient. The age at vaccination was not reported. The patient received Shingrix and had an issue with mobility of the injected arm for quite a while and also had a zing down to her fingertips. The reporter did not consent to follow-up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 22-JUN-2015, the patients were vaccinated with PNEUMOVAX 23 1 dose, lot# L003227 (route of administration and dose were not reported). On an unknown date in June 2015, reported as within 24 hours of receiving the vaccination, the patient experienced unspecified muscle and bone soreness in an unspecified date. The patient sought an unspecified medical attention. The outcome of the events was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. There is one of two reports received from the same reporter. Additional information has been requested.
Pimple like rash started (1) spot on 7/2/12 & spread to neck, wrist, thigh, chin & chest. Looked as if it were a bug bite at 1st. When mom saw it was spreading, she sought medical treatment approx. 7 spots total. Treatment with calamine lotion per dr.
Muscle aches, chills, dizziness, sneezing, runny nose,  elevated heart rate of 107, crazy thoughts, very intense and painful.
On 5/16/00, Mom reported that the pt had a fever since 5/14/00 and swollen tonsils. Reported on 5/17/00 PM has a "blotchy red area from ear to ear under neck and diarrhea for 1 day. Denies sore throat or medical treatment. Fevers reported to 102 and 103 after Motrin. On 5/18/00, the pt experienced a temp of 99 after Motrin. Red blotches still remain. Requested phone call if treatment is sought.
It is now 6 days after the shot and I feel like my brain is working slow. Almost like being drunk. The night of the vaccine I had a 102 fever, chills. I was tired for 3 days after. Now the only remaining symptom is living in a fog. I have no health conditions. I am praying this goes away. I am not one to get sick or have any health issues. I don't use drugs or drink, smoke etc. Very scary. It is impacting my ability to do my job.
Possible bacterial infection at vaccination site. Augmentin 875mg every 12 hours for 10 days.
Had mmr, chicken pox,pcv13 and Hib vaccines on same day. He was very lethargic later that same day. Not making eye contact. Next day he broke out in a measles like rash that lasted two weeks. I feel li3me it lasted longer but its been 8 years.
Patient experienced syncope after 0.3ML(30 MCG) OF COVID vaccine was injected intramuscularly in Left arm. Patient recovered after brief syncope incident
Fever, body aches, headache, dizziness, nausea, lightheadedness.
DUE TO THE DIFFENERENCE IN THE INTERVALS OF MODERNA AND PFIZER COVID VACCINES, WE HAD A FEW DAYS INWHICH SECOND DOSES OF BOTH VACCINES WERE BEING ADMINISTERED. THIS PATIENT WAS GIVEN THE WRONG FORM AND INSTEAD OF RECEIVING HER SECOND DOSE OF MODERNA, SHE RECEIVED A DOSE OF PFIZER VACCINE. PT DID NOT SUFFER FROM ANY ADVERESE EVENT.  WE HAVE TAKEN STEPS TO AVOID THIS SITUATION IN THE FUTURE.
A spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (exact date unspecified, reported as between 26-NOV-2014 through 01-DEC-2014) those patients received an improperly stored oral, ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse symptoms reported. The temperature excursion for all vaccines was found to be supported with in-house stability data. This is one of several reports from the same reporter. Additional information has been requested.
Patient received her flu vaccine on 11/5/18 in her left arm. Per mom, within a few hours the area of her injection became red, swollen, itchy, hot to the touch and a hard lump/mass was felt by mom. Mom states that she took the patient to the iwalk in clinic on 11/7/2018 and they gave the patient penicillin thinking it might have been an infection. After taking the penicillin for a few days she started noticing a rash that formed on her arms and legs and a few spots on her lower abdomen, no rash present on her chest, back, face , neck, hands or feet. Patient then came in to be evaluated by us on 11/15/18. Mom states the patient has had her flu vaccine every year and has never had a reaction before. Asked mom what size needle was used. Mom confirmed a 1 inch needle was used, due to patient's arm size she requires a 1 1/2 to 2 inch needle. Her brother has a true egg allergy but gets his vaccine on a regular basis with no problems.
Day after shot I woke up with fairly loud tinnitus in my left ear.  This continues to this day.
positive Covid-19 diagnosis after first dose of the vaccine; A Spontaneous report received from a Healthcare Professional concerning, a 33-year-old age male patient who received first dose of the Moderna COVID-19 vaccine and experienced positive COVID-19 diagnosis after first dose of the vaccine. /MedDRA PT: [Positive COVID-19]    The patient's medical history was not included. Patient's concomitant was not included.  On 13JAN2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the first dose of the Moderna COVID-19 vaccine on 13JAN2021 and on 23JAN2021, patient received a positive diagnosis of COVID-19. No other information was report.   Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 13-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 26-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009095.
severe muscle aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe muscle aches) and ARTHRALGIA (joint aches) 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 (severe muscle aches) and ARTHRALGIA (joint aches). At the time of the report, MYALGIA (severe muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-084207 ; Sender's Comments:  MOD21-084207:
About 15 minutes after receiving the vaccine the patient returned to the pharmacy with his wife saying he was feeling dizzy. We had him sit in the consultation room for observation. After a few more minutes upon asking if he felt any swelling of his lips, tongue or throat pt reported that his mouth felt like it may be swelling but he wasn't sure if he was just having anxiety. Upon further questioning he felt like it definitly could be swelling. I administered 0.3mg of epinephrine via epipen in the right outter thigh. I called 911 and had paramedics come to the pharmacy. They took him to the hospital. Pt's wife came in a couple hours later and said that he did break out in hives and they were treating him but she didn't know with what and that they were already going away.
never received another dose to complete the schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (patient received only one dose of Engerix-b on July 2022 ).   On an unknown date, the patient did not receive Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: never received another dose to complete the schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2023. The pharmacist reported that a patient received only one dose of Engerix-B. The patient never received another dose to complete the schedule of Engerix B.  The reporter consented to follow up.
Pt devel weight loss, & exp muscle pain & weakness; It was felt that pt had poss devel multiple sclerosis; nurse reported 2 pts;
Following the first dose, I had experienced facial coldness/numbness in my cheeks and nose on 3 occasions including on 3/12/2021. The sensation went away. On 11/18/2021 I got my booster shot and 12/1 I started to feel the sensation of a cold face again. The sensations moved to primarily the left side. My tip of my tongue is numb, and sometimes the two front teeth area. The sensation will sometimes not begin to later in the day and will continue for the remainder of the day until I go to sleep. Sometimes the sensations are helped by: warm bath and pressure. There are some days the sensations go away, but then return. On 12/19/2021 I started feeling numbness/tingling in the palm of my hands.
A few hrs p/receiving DTP/OPV/HIB on 15OCT91 pt was found pale & limp lasting a few seconds; pt was responsive w/stimulation; no tx given; mom told MD about rxn 16DEC91;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies noted. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Dec2021, stop date: 06May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported that patient received antiviral drug Paxlovid, from 24Apr2022 to 29Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache rash on the legs - insect bites look like to MD though pt denies bug bites