chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had smallpox vaccination on 03/10/03.  It was a take. She had been vaccinated as a child.  That also was a take.  The week of 03/31/03 began with symptoms of myalgia in the large muscles of both legs, in the shin area, the calf area and the gluteus.  Week of 04/06/03 discomfort reached a peak where it kept her awake at night.  She began using Darvocet.  This was keeping her comfortable. She was due for her yearly checkup with internist.  She had her routine lab work on 04/14/03.  All labs were normal except the CPK 693, LDH 308.  This caused her some concern.  Labs were repeated on 04/16/03.  The CPK was 418 and the LDH 209.  Her symptoms continue along with some tingling of both hands. She saw her MD on 04/21/03.  he repeated her lab work. CPK 270.  he was not sure if smallpox related, advised to report to consultants.  He would continue follow up.  Her symptoms have not subsided, but have not gotten worse. She has had arthritic studies and they were normal.  In Dec. 2002 had episode of chest pain.  Heart catherization done and was normal.  Was diagnosed having GERD.
Patient called to inform us that she had an allergic reaction to Pfizer booster vaccine. She has blotches on her hairline. It does not itch. she is not having any breathing difficulty. She overall feels fine. Advised patient to take Benadryl over the counter and if symptom worsens or any other problems call primary care or go to ER
Tested Covid-19 positive; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested Covid-19 positive) in a 43-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested Covid-19 positive). At the time of the report, COVID-19 (Tested Covid-19 positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: (Positive) Covid-19 tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
middle of the night started vomiting, headache, diarrhea, fatigue, legs collapsed, feet feel like she is wearing wool socks, lost of taste, joint pains everywhere and high fever and no appetite
Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022; Received its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 2:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication was reported. Patient received booster dose of Moderna. Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Dose was given at 11-Mar-2022 14:02:27. No treatment medication was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Wart like rashes all over body, Itchy, More like water filled pimples.
Information has been received from an 85 year old female patient with asthma, blood pressure abnormal, heart problems and allergy to VISIPAQUE who on 05-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included BYSTOLIC, PLAVIX, ADVAIR, ACTONEL, CRESTOR and KEPPRA and "Renidine". On 07-OCT-2010 the patient had joint pain and weakened legs, difficulty breathing, felt very weak, a little pain, and noticed her resting heart rate went up 40 points. No laboratory diagnostics studies were performed. The patient mentioned that she was feeling better at the time of reporting. She mentioned she would contact her doctor. No further information is available.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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 and shingles were unknown.   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 had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got a horrible case of shingles. The patient's doctor said, worse case that the patient had ever seen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.; Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: covid 3 times -, once in 2020, once in 2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Young lady in video with recent covid test results has gotten covid 3 times - once in 2020, once in 2021, and now in 2022. Do not know whether or not vaccinated but video has hashtag #getvaccinated.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Noticed few small welts/Getting progressively worse throughout the day; Itchiness; condition worsened; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Noticed few small welts/Getting progressively worse throughout the day), PRURITUS (Itchiness) and CONDITION AGGRAVATED (condition worsened) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 09-Nov-2021 contains non significant information, based on previous report additional event of condition worsened were added. Narrative updated.
Information has been received from an 84 year old female consumer who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included atenolol (manufacturer unspecified), lisinopril (manufacturer unspecified), "chlorchalid" and meloxicam. The patient reported that in 2008 she had a break out of shingles after having vaccine administered. Patient sought unspecified medical attention. Additional information has been requested.
Patient presented to the hospital with severe abdominal pain and acute pancreatitis. Had an ERCP with stone removal. Also tested positive for COVID-19. Received IV steroids and oxygen. Patient discharged.
No additional AE reported; a patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a physician and refers to a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.  On 24-MAR-2022 (also reported as today), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) (dose and route not reported; valid lot #1741376, expiration date: 06-MAR-2022) for prophylaxis. It was confirmed that the vaccine never experienced any temperature excursion. The reporter was provided the supported disclaimer based on the post expiry memo, and was provided the case number for reference. No additional adverse event was reported (no adverse event).
have had a persistent low to medium grade headache since the evening of the vaccine.  concentrated in the back left part of my head.  some relief with advil but as of today (4/29/2021) is still present.  Had a low-grade fever, fatigue, joint and body aches for the first 48 hours following the shot.
pt recvd vax;adm to hosp w/ pneumonia/septicemia; Blood culture positive for H.influenza; fully recovered;
High fever; Chills; Joint pain; Incredible headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP-7534), via an unspecified route of administration in the left arm on 18Mar2021 at 13:15 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included seizure, hay fever. The patient was allergic to melons, avocado and sometimes bananas. Concomitant medications included phenobarbital (MANUFACTURER UNKNOWN) for unspecified indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 25Feb2021 at 12:45, (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 05:00, the patient experienced high fever, chills, joint pain and incredible headache which continued through 21Mar2021 (Sunday). The patient was able to eat and drink, but fever and joint pain and headache went on and on. The patient had been struggling to get back into the routine. The patient did not receive any treatment for events. The clinical outcome of the events high fever, chills, headache and joint pain was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Patient was given a vaccine that was diluted with sodium chloride. The new vials are already diluted which means the patient did not receive a full dose.
Information has been received from a registered nurse concerning a female who was vaccinated with the second dose of GARDASIL (lot no. not reported). The nurse reported that the patient experienced lingering muscle pain and was unable to move her arm for two weeks after receiving her second dose of GARDASIL. On an unknown date, the patient recovered. Follow up information was received from a registered nurse which reported that the patient received her first two doses of GARDASIL (lot no.  not reported) at a different facility. It was reported that the patient experienced arm muscle soreness which lasted two weeks with each dose. The nurse reported that the initial facility refused to administer the third dose to the patient. The patient's mother insisted the daughter get the third shot, so the patient came to the reporter's facility requesting the third dose. At the time of reporting it was unknown if the patient received the third dose of GARDASIL. It was determined that the patient's adverse event was not serious. Additional information is not expected.
Reports she developed a headache approx 30mins after receiving Flu Mist. Continues to have headache without relief. Afebrile, denies any other symptoms other than persistent HA.
Sore arm, pain discomfort, pain around heart, pain and tightness behind left ear, nausea,
witnessed Syncopal Episode, patient walked from bedroom to bathroom, eyes rolled up, fell to the ground, had brief LOC for 3 seconds, no seizure like activity before or after
Vaccine Hepatitis B given on 06/15/2005, that PM developed hives, treated and improved 06/16/2005 PM - severe hives, ER visit, treated with steroid injection and Medrol dose pack.  06/21/2005 - Saw doctor - history included hives, paleness, increased heart rate, weakness.
The day after my second dose injection on the left arm, I found that my left armpit was visibly swollen and uncomfortable.   That was yesterday.    I have not taken anything for it and have massaged the area as well as put warm compress on it last night.  It?s still swollen today.
Erythematous reaction at injection site. Suspect allergy to preservative. Will monitor x 24 hrs. Improving erythema after 48 hrs. Still itchy, probable allergy to thimerosal.
Presented to ED on 8/23/17 for chest pain, neck pain and sore throat. Sent home with prednisone script.
Fever up to 100.7  Pins and needles feeling on skin - mostly on back
Reddened area 3"X5" (band around arm) "hot", swollen hardened welts 1/2" X3" around injection site. very painful
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 21-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 25-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 10th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case, Patient 10
3 days after the shot patient developed uncontrollable facial tics, blinking, grimacing and shrugging that he?s never had prior.
This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a elderly female patient who received SHINGRIX (batch number JE45P, expiry date 29th May 2021) for prophylaxis. Concomitant products included SHINGRIX. On 22nd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister. On an unknown date, the outcome of the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister were recovered/resolved. It was unknown if the reporter considered the vesicular rash, burning sensation skin, touch sensitivity increased, papular rash and blister to be related to SHINGRIX. Additional details were provided as follows: On 11th December 2018, the patient received 1st dose of SHINGRIX. The patient received 2nd dose of SHINGRIX in her left arm. One to two days after receiving the 2nd dose of vaccine, the patient broke out in a vesicular rash in her right antecubital. The rash had persistent burning and hypersensitivity to touch. The blisters became papules then resolved 4 to 5 days later.
Having an adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Having an adverse reaction) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Having an adverse reaction). At the time of the report, ADVERSE REACTION (Having an adverse reaction) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  No further follow up.
pt recv vax & 2 1/2wk post vax pt devel less than 50 lesions;
head felt heavy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (head felt heavy) and NAUSEA (Nausea) outcome was unknown.            No medical history and concomitant medications were provided.  Treatment information include Valium   This case was linked to MOD-2021-049548 (Patient Link).
Presented from facility with Afib with RVR; SOB/fever x 1 week; dx Covid PNA; treated with steroids, zinc, supplemental O2; discharged home on room air
tingling in her fingers immediately after receiving the vaccine; feeling of coldness on the shoulder of the site where the shot was   given; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given). At the time of the report, PARAESTHESIA (tingling in her fingers immediately after receiving the vaccine) and VACCINATION SITE COLDNESS (feeling of coldness on the shoulder of the site where the shot was   given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient had this symptoms with a flu vaccine 4 years ago but no other time, was pretty quick and went away quickly too.  No concomitant medications reported by investigator No treatment medications provided by the reporter.    This case was linked to MOD-2021-058974, MOD-2021-009606, MOD-2021-005584, MOD-2021-063094 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.