chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included WHEEZING PROBLEMS. FLUMIST started on an unknown date. The patient experienced ADMINISTRATION TO AN 18 MONTH OLD which started on 29-Oct-2012 and NASAL CONGESTION. The outcome of the event of NASAL CONGESTION and ADMINISTRATION TO AN 18 MONTH OLD is unknown. The report was considered to be non-serious.
I was having a hard time judging depth when I was walking.  It looked like the floor or ground was wet. I went to the doctor and had an MRI to determine if I had a stroke, but I did not. They sent me to physical therapy twice a week for almost 14 weeks. It isn't as bad as it used to be, but I still have flare ups.
pt recvd vax; 14aug95 devel rash from nipple line to collar bone;
This child had a 5 by 5 cm area of erythema and induration plus 2 areas proximal of erythema.
she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees; she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees; Urticaria (itchy bumps / rash); skin rash on her two arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2023, the patient received the 1st dose of Shingrix (left deltoid). On 13-SEP-2023, 1 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees), papular rash (Verbatim: she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees), urticaria (Verbatim: Urticaria (itchy bumps / rash)) and rash (Verbatim: skin rash on her two arms). The outcome of the itchy rash, papular rash and urticaria were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the itchy rash, papular rash, urticaria and rash to be related to Shingrix.     It was unknown if the company considered the itchy rash, papular rash, urticaria and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter called on behalf of her family member stated that his cousin (patient) received the Shingrix and this morning (reporting day) she developed itching rash with bumps on bilateral arms close to her elbows, left hand, and bilateral inner thighs behind the knees.  The patient also developed skin rash on her two arms on reporting day morning. The reporter did not consent to follow up.
weakness; swelling of the lymph nodes; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), LYMPHADENOPATHY (swelling of the lymph nodes), HEADACHE (Headache) and CHILLS (chills) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), LYMPHADENOPATHY (swelling of the lymph nodes), HEADACHE (Headache) and CHILLS (chills). At the time of the report, ASTHENIA (weakness), LYMPHADENOPATHY (swelling of the lymph nodes), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   This case was linked to MOD-2021-014394, MOD-2021-014393 (E2B Linked Report).; Sender's Comments:  MOD-2021-014394:same reporter, different patient MOD-2021-014393:
Severe bruising (patient on PLAVIX); hot to the touch; very painful to the touch; appeared to have scab like area in the center; she has never had a problem before.
This spontaneous report as received from a physician refers to an 11 year old male patient. The patient's pertinent medical history included chronic constipation, Pervasive developmental disorder (PDD) (autistic spectrum disorder), developmental delays and cochlear implants usage due to difficulty in hearing. The patient had no drug reaction/allergies. The physician reported that the patient was vaccinated with the first dose of M-M-R II and VARIVAX (Merck), when he was an infant (dose, strength, vaccination site, route unspecified). On 08-SEP-2015, the patient was vaccinated with second dose of VARIVAX (Merck) and M-M-R II in the left deltoid (strength, route, dose unspecified). Concomitant therapies included MIRALAX. After 2-3 minutes of administration of the vaccines, the patient began to feel itchy and was flushed in the cheeks and ear. Then the patient was administered with 25mg diphenhydramine. Then 7-8 minutes later, the patients lips began to swell and hives appeared scattered on his back. The patient was under observation and after 5 additional minutes, the patient developed edema of his torso and the hives continued to the torso, the patient was then administered epinephrine. The patient was observed for another half an hour, with vital signs being stable, was sent home with a prescription of prednisone. The physician reported that the patient was seen again on 09-SEP-2015 in the office for a recheck up. Although the patient complained about pain near the injection site with epinephrine, all the symptoms were resolved. Product quality complaint (PQC) was not reported. The relatedness between the events and VARIVAX (Merck) was not reported. The reporting physician considered the events to be related to M-M-R II. Upon internal review, the events were considered serious due to other medically significant events. Additional information has been requested.
pain through my entire body. The pain was going through my skull, bones on my face, chin, thighs, neck, shoulder and lower back; Thought maybe vaccine kicked up her fibromyalgia; I feel so sick now; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. She had a severe allergic reaction after a previous dose of this vaccine and to any ingredient of this vaccine. The patient experienced pain, thought maybe vaccine kicked up her fibromyalgia on an unspecified date. She stated "I got my first vaccine shot on 10Feb2021. 3-4 days after I developed pain through my entire body. The pain was going through my skull, bones on my face, chin, thighs, neck, shoulder and lower back. It's hurting so much that I feel nauseas. I was okay until I had the vaccine. I feel so sick now. The pain has not gone away. At first she thought maybe the Pfizer COVID-19 Vaccine kicked up her fibromyalgia but this happened maybe 4 days after the Pfizer COVID-19 Vaccine injection. She was nauseous from pain. Her second dose of Pfizer COVID-19 Vaccine is this Wednesday, 03Mar2021 and she does not know if she should get it relative to these events; asked for dosing recommendations relative to events." Caller wants to know if she was eligible to receive the second dose. After I told her two doses are required for full protection she mentioned her friend died from COVID after receiving the two doses of the vaccine. She already had done bloodwork, urine test and was prescribed with prednisone. She wanted to know if she could take prednisone. The outcome of the events was unknown.   Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information is expected.
PT received Pfizer Covid vaccine upon retraction of needle all vaccine squirted out down the length of Pt arm and covered nurses glove completely. Pt confirmed to staff that vaccine squirted down his arm, Pt stated "all the vaccine ran out, I didn't get any in me."  Nurse immediately  informed lead pharmacist all the vaccine squirted out of Pt.  Pharmacist directed that if 50% or more vaccine was lost Pt is able to continue with vaccination.  Pt confirmed to nurse and scribe that he was willing have vaccine readministered .
Swelling, warmth, redness at injection site itching rash, possible cellulitis.
PAINFUL SORE ARM; BAD HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 025A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive.  On 12-JUL-2021, the subject experienced painful sore arm. On 12-JUL-2021, the subject experienced fatigue. On 12-JUL-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad headache, fatigue, and painful sore arm. This report was non-serious.
Within 12 hours patient had chills, lymp node swelling, body aches, headache, ear pain, nausea, shortness of breath. slowly improved over the next few days. Needed to stay home and rest. Seen by provider on day 4 of symptoms which was the best he had felt since vaccine. Still with fatigue, lymph node tenderness, and headache.
Information has been received from a Physician Assistant (PA) via a company representative concerning to a female patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, (dosage schedule, concentration, route, anatomical location, lot number, and expiration date were not provided). Other suspect therapies included two unspecified vaccines (manufacturer unknown). Concomitant therapies were not provided.  The PA reported that on an unknown date, the patient developed Guillain-Barre Syndrome after receiving an unspecified dose of GARDASIL and the two unspecified vaccines (manufacturer unknown). The reporter stated that the patient went to an unspecified hospital on an unspecified date in regards to this event, however, it was unspecified if the patient was admitted to the hospital. No product quality complaint was involved. The outcome of Guillain-Barre Syndrome was unknown. The relatedness between the Guillain-Barre Syndrome and therapy with GARDASIL and the two unspecified vaccines (manufacturer unknown) was not reported. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
My body temperature reduced below 95.5f  7 hr after receiving the Vaccine.  My normal body temp has been 97.6f. Following are the records of body temp after receiving vaccine:  4/18/2021 12:25PM took the vaccine 4/18/2021 08:00PM  Body Temp:  95.5f 4/19/2021 6:00AM   Body Temp:  95.4f                     11:30AM Body temp:  95:36f 4/19/2021  4:20PM Body temp:   95.3f 4/20/2021  7:30AM  Body temp:  95.1 f                       9:00AM Body Temp:  94.9 f                      11:00AM Body temp: 95.1 f                      4:00PM  Body Temp: 95.2 f
pt recv vax 28SEP94 & 1 hr later devel a warm sensation, chills, nausea, vomiting & dizziness; also devel a h/a which persisted for 12 hr despite tx w/Ibuprofen; No further details were provided;
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines given at the time. On 05-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1820 and expiry date: 30-Jun-2019) (dose in series was not reported) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
First Vaccine on 3/29/2021 to right arm. Injection site was swollen, red, hot to touch, and itchy for one week post vaccine.  On 4/5/2021 the tips of my fingers and toes were painful, reddened, and swollen.  Meds: Tylenol and Bendaryl were taken with resolution on 4/9/2021.  On 4/11/2021 tips of fingers and toes became painful, reddened, swollen again.  Remains that way now with Tylenol and Benadryl, including intermittent pain in my calfs and thighs, along with a slight headache.
More than 35 days since the first shot was given; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since the first shot was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information is not applicable.
Pt reported fever for 4 days, flu like symptoms for 7 days, lethargic sleeping day and night for 2 days, patch of redness 4 inches in diameter (soft to touch but very hot) for 3 weeks - still some redness but about 1/4 the size.
Pt was given a DTAP-HIB-IPV and a HIB at the same time. No reaction documented.
sz w/fever 102.5 about 15 hr p/vax; shaking w/eyes rolled back x 1 1/2 mins;
Swollen, red, hard, itchy at the injection site.  Affected area is 5 1/4" by 2 3/4" of redness and swelling of the right arm. Reported to medical and received Benadryl capsules.
Moderate flu symptoms persisted for 21/2 weeks, after first vaccination shot. Symptoms included fever, congestion, runny nose, headaches. PCR (after 2weeks of symptoms) was negative for COViD, and also negative for Influenza A & B. Please update vaccination info handouts to reflect that vaccination side effects may last longer than the current « 3 days » stated on the  info sheets. It is irresponsible to tie up healthcare facilities for simple vaccination side effects. My test and trip would not jave been necessary if the information provided to me was accurate.
daily headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 via an unspecified route of administration in the left arm on 13Jan2021 19:45 (07:45 PM) at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included levothyroxine (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced daily headache on 14Jan2021. Treatment for the event was not received. The event was non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
VARIVAX vaccine given in right arm- Redness, warm to touch, swelling where shot was given 8.0 cm X 8.5 cm in size.
Employee experienced body aches, head ache, sore throat, and fever starting two days after vaccine was administered. Symptoms lasted for 6 days.
This was not an adverse event. Vaccine was not stored at manufacturer's recommended storage conditions making it a non-viable dose. Manufacturer and CDC recommend revaccinating immediately. Patient did not experience any adverse effects from this but will be re-vaccinated.
Heart racing/pounding, fatigue, muscle soreness, slight shortness of breath,  chills lasting for six hours
Severe headache, body ache, nausea, dizziness,  inability to focus, joint pain,. Some numbness on left arm where vaccine was administered. Today 1/29 is day 5 and sx are still persistent only control by a liquid anti nausea medication combined with meclizine (rec by cvs pharmacy) plus Tylenol alt with Motrin 2x/day.  Sx return once OTC are wearing off. The summarized description of how I felt was: Like i was dropped from a 3 story building and being constant hit on the head accompanied by terrible nausea/dizziness/dry heaves
patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.
Developed cellulitis around injection site started on antibiotc and cleared in 24-48 hours.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 2.3, indicating a low pos response;
Information has been received from a pt's mother concerning a 4 year old male who in 1997 at 16 months of age was vaccinated with MMR II. After the shot, the pt was hospitalized for fever and dx'd with autism. The pt was dx'd as autistic at 22 months. Upon internal review, autism was determined to be an "Other Medical Event" (OMIC). Additional information has been requested.
I had vaccine and am now suffering through them/ Suspected Vaccination failure; I had vaccine and am now suffering through them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had shingles vaccine and was now suffering through shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This case was reported by a pharmacist and described the occurrence of injection site nerve damage in a 51-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 December 2013 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown, left arm). On an unspecified date within months of vaccination with BOOSTRIX, the subject experienced damaged nerve endings in his arm and cannot lift his hand [unable to move hand]. On 17 January 2014, the pharmacist reported the subject experienced nerve damage in his arm following BOOSTRIX vaccination on 18 December 2013. Per pharmacist the subject saw his healthcare provider who said "the nerve damage was related to the vaccine"; "stated this is a one in a million case". The subject cannot lift his hand due to the nerve damage. It was unknown if the subject only had a doctor's office visit or a hospital visit. This case was assessed as medically serious by GSK. At the time of reporting the injection site nerve damage and unable to move hand were unresolved.
Pt recv vax on 10/13/98; 1 hr later pt exp sore arm
09/22/22 presents to EC ED for "right-sided abdominal pain with associated, urinary frequency, urgency, nausea and vomiting". PMHx of "hypertension, migraines, CAD with stents, asthma, frequent UTIs, osteoporosis, osteoarthritis and chronic pain"
Stomach pain, nausea, diarrhea, when she burped it smelled like rotting eggs and feels terrible. Had fever earlier in the day but not as of 2:49 AM on 11/04/2009 and no vomiting so far but still has nausea.  Been giving Tylenol and Motrin as needed.