chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On February 8th, 2021 patient came home early from work around noon due to not feeling well. She was feeling tired, slightly nauseous and very low energy. At about 4:50 PM that day, patient got up to walk to the pantry after eating some peanut butter toast. She suddenly stopped and shut her eyes and froze and then she began having a seizure (and she has never had a seizure before and seizures do not run in her family). After the shaking from the seizure ceased, her body tensed up and she fell flat backwards and she hit her head on the refrigerator. She then was going in and out of consciousness, she had a big laceration on her forehead and was bleeding rapidly. I, her daughter, witnessed this and then at 4:54 PM I called emergency services and paramedics arrived and took her to the hospital. Later that evening, the family was notified that the patient had bleeding in her brain, a concussion, a forehead laceration that received 15 stitches and a broken neck (C2 fracture). She was taken to the hospital that evening on February 8, 2021. Patuent experienced a second seizure while at the hospital during a CT scan. Patient later was able to come home February 11, 2021 in the afternoon. Patient now has to wear a neck brace for up to 12 weeks, cannot drive, cannot work for up to 12 weeks, and is still recovering cognitively from the concussion.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 8 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.
Patient received the high-dose flu vaccine rather than the regular dose. The nursing supervisor stated there were no issues or adverse effects whatsoever with this patient. She will continue to monitor the patient for any signs or symptoms of an adverse effect and will report it to us.
Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with a dose of ROTATEQ oral, lot # K011663, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 40 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
acute dystonic reaction 1hr p/vax, resolved p/25mg DPH IV & observation x 3hrs in ER:
Sharp pain in deltoid when he reaches up and around. Instructed to ice deltoid and apply aspercream with lidocaine 2-3 times daily as needed.
Progressive and relatively constant tightness in chest.  Fluttering and skipped beats after eating, exertion, alcohol, caffeine and often when lying down in night and morning.  One intense episode of electricity washing over body.  Mild tingling washing over body. Various other times.  Zero health issues, zero heart risk factors.  Husband is experiencing similar episodes a week after mine. Also vaccinated a week after me.  His mother was seen for same symptoms in clinic and her doctor said many are reporting this.
redness at the injection site; redness and tenderness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5) for prophylaxis.   On 22-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site) and injection site tenderness (Verbatim: redness and tenderness at the injection site).  The outcome of the injection site erythema and injection site tenderness were resolved.   The reporter considered the injection site erythema and injection site tenderness to be related to Arexvy.     The company considered the injection site erythema and injection site tenderness to be related to Arexvy.   Additional Information: GSK receipt date 28 Sep 2023 The reporter was the wife of the patient. She reported that her husband received a shot of AREXVY  last Friday. He experienced redness and tenderness at the injection site. These issue was resolved. The reporter provided limited information.  The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023133798:Same reporter, different patient
Case number PHEH2015US020601, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 38 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration (expired vaccine used).
Felt pain and weakness in left arm around injection site around 12 hours after injection. Redness and swelling started overnight. About 26 hours after injection, started to feel fever, chills, headache, fogginess, nausea. Fever ended up peaking at 102F. Swelling and redness at injection site still prominent 4 days after injection.
Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 09-Nov-2021.No  temperature excursions for the vials was reported. Total of 168 doses were reported with the lot number 048C21A.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received and had no significant information.
Pt came in to pharmacy presenting with redness around injection site that had slowly increased in size over the past day or two. Referred her to see PCP.  Diagnosis of cellulitis. Pt prescribed cephalexin 500mg, 2 caps twice daily x 10 days with instruction to return to md office if not improving by 11/2/15.  Redness margins marked for reference. Our records show pt had similar response to shingles vaccine 9/3/13 with MD diagnosis of local allergic reaction treated with Benadryl.
17 yo s/p varicella vaccine admin #1 on 2/11/05 presented for varicella #2 today with c/o pruritic rash on face and trunk x 2 days.  No fever or constitutional symptoms.
On 02/25/05, after receiving vaccinations and a PPD, client states rash on trunk area (abdomen and back areas). The rash was itchy, pink raised areas, pinpoint in size. Patient was afebrile. History of this rash for 2 years, exacerbated by vaccines on
Hives appeared on back and arms 48 hours after vaccine was administered.  No previous history of allergies or adverse reaction to any vaccine or medication. No preexisting skin condition. The hives were very itchy. They cleared up after a few days, however continue to reoccur occasionally with persistent itch in those same areas.
MUSCLE ACHES ALL OVER; INCREASE IN URINE/PEEING A LOT; THROWING UP ACID, LIKE REFLUX/ HAD LIKE ACID COMING UP THAT SHE HAD TO SPIT OUT; URINE WAS DARK; CHILLS; FELT COLD; TINGLING IN WRIST, ANKLES AND HANDS; HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia (she had been diagnosed with anemia in the past), and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2022 for prophylactic vaccination. Age at time of vaccination 32 years old. No concomitant medications were reported. On 13-MAY-2022, the patient experienced increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out, urine was dark, chills, felt cold, tingling in wrist, ankles and hands, and headache. On 14-MAY-2022, the patient experienced muscle aches all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAY-2022, had not recovered from tingling in wrist, ankles and hands, and muscle aches all over, and the outcome of chills, felt cold, increase in urine/peeing a lot, throwing up acid, like reflux/ had like acid coming up that she had to spit out and urine was dark was not reported. This report was non-serious.
Pt reports becoming warm, clammy, with minor tinnitus in left ear. No hx of allergy. Placed in semifowler position on cot. BP 110/80 HR 60, RR 14 SPO2  98%. at 10:05 SPO2 up to 99% and he reports being asymptomatic. He stood up with no vagal response.
Missed her third dose of Vivotif; Spontaneous report received on 13DEC2019.  A pharmacist reported that a female consumer who "missed her third dose of Vivotif" (PT: Product dose omission), while being on Vivotif for typhoid prophylaxis. The consumer took first two doses of Vivotif on 07DEC2019 and 09DEC2019 respectively. Then, she did not take any further doses, so she had two doses left till now. Action taken with Vivotif with respect to reported event was not applicable. At the time of report, the outcome of the reported event was unknown.  Company Comment: A consumer missed her third dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.; Sender's Comments: A consumer missed her third dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not related to Vivotif.
pt recv vax & exp 2 sz, eye tonically deviated to one side along w/head;rt arm & lt leg were twitching, would not respond;to hosp;conscious but could not speak;balance off;MD felt benign focal epilepsy of childhood or true complex sz;
Booster received 12/31/2021. Symptoms of blood clot began 1/12/2022.
There was no adverse event noted. Patient was to receive a flushot (afluria) and the Moderna Bivalent booster. The patient received the Afluria flushot and the Fluzone HD instead of the Moderna Bivalent. Patient still requested to get the Moderna Bivalent booster. So the patient received two flu shots (one a high dose) and the Moderna Bivalent Booster. Again, no adverse event reported.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 73-year-old male patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 1st April 2019, the patient received SHINGRIX (intramuscular). On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced pain (serious criteria hospitalization), chest pain (serious criteria hospitalization), injection site erythema and injection site discomfort. The patient was treated with nitroglycerine (Nitroglycerin). On an unknown date, the outcome of the pain and chest pain were recovered/resolved and the outcome of the injection site erythema and injection site discomfort were unknown. It was unknown if the reporter considered the pain, chest pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were reported as follows: On Monday, the patient received a dose of SHINGRIX on the left arm. At the vaccination night, the patient experienced severe pain in his left side and down through his chest. The pain was improved on Tuesday, but was worsened on Wednesday. On Thursday, on 4th April 2019, the patient was hospitalized for the pain with concerns that it might be related to his heart.  n Monday, 8 April 2019, the patient had a catheterization with did not show anything. The patient was given nitroglycerin while in the hospital. The emergency room visit required.
got sick a little bit with the 1st two dose but that was minor; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick a little bit with the 1st two dose but that was minor) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Nerve damage (Due to a car accident in 1991). Concurrent medical conditions included Psoriatic arthritis, Scoliosis, Blood pressure high and High cholesterol.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick a little bit with the 1st two dose but that was minor). At the time of the report, ILLNESS (got sick a little bit with the 1st two dose but that was minor) outcome was unknown.        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 concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-404515, MOD-2021-404473 (Patient Link).
Per patient, rash appeared about 6 to 8 hours after vaccine was administered.  Patient complained of rash on left arm, area below injections site.  Area was red, about 2 to 3 inches wide and 5 or 6 inches in length, wrapped around from outer to inner part of arm (front side).  Complained that area felt warm to touch.  No rash anywhere else, no shortness of breath or difficulty breathing.  Advised that this may be an expected side effect from vaccine, and advised to see a physician for a second opinion.
MODERNA COVID-19 Vaccine 2023-2024 Formula for 6 months - 11 years use for COVID-19 under Emergency Use Authorization (EUA): "Moderna COVID-19 Vaccine 2023-2024 Formula for 6 months - 11 years" is improperly filled for volume / improperly labeled for volume. The pharmacy received a box of 10 vials labeled "0.25 ml Single Dose Vial".0.25 ml is the proper dose for this age group as indicated on the CDC website. Upon drawing up the contents of the vial into a syringe, however, it was noted that the actual volume was 0.55 ml - more than double the intended dose. This could result in high risk of overdose within the toddler and child category for this vaccine. Particularly when standard procedure for any single dose vial is to draw up and administer the full vial contents, and the provider is not expecting such a variation in volume. Moderna was informed of this discovery on 10/6/23 via telephone, and the pharmacy was instructed to quarantine the remainder of the box until further investigation and notice. As of 10/9/23 no update or additional information was available from Moderna to the original reporter. Lot number of product in question AU5555B and expiration date 2024-06-07.
This spontaneous report as received from a medical assitant, refers to a currently 12 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 21-OCT-2012 01:25, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
On day 4 after the first dose, I woke up with a whistling noise in my ears. I never had this condition before. After some research, I learned that Tinnitus is a rare but known side effect primarily for Moderna but also for Pfizer Covid vaccine. The whistling sound is not extremely loud but it's definitely there and has made sleeping at night difficult. Twelve days later, it still there and it's quite bothersome. It gives me pause to take the second dose scheduled for April 29.
No Aes; temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.   On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T013546 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47°F during a time frame of 1 hour. Previous excursions included 50°F for 45 minutes.
This case was reported by a healthcare professional and described the occurrence of abnormal movement in an 6-month old male subject who was vaccinated with KINRIX vaccine (GlaxoSmithKline). Concurrent medical conditions included eczema. Previous and/ or concurrent vaccination included poliomyelitis vaccine, unspecified; manufacturer unspecified; unknown; unknown given on 8 February 2010. Concurrent medications included MOTRIN. On 8 February 2010 at 14:30 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). On 8 February 2010, at the time of vaccination with KINRIX, the subject experienced overdose of wrong vaccine administered. At an unspecified time after vaccination with KINRIX the subject experienced abnormal movement and cranky. The mother of the subject, a registered nurse, reported that her son was supposed to received a hepatitis b vaccine, but received KINRIX. The subject planned to continue follow-up with his physician on an unknown date. At the time of reporting the abnormal movement and cranky were unresolved.
INTUSSUSCEPTION 6/20/08-records received for DOS 4/30-4/2/08-DC DX: Inussusception now resolved, status post surgical repair. Leukocytosis. Presented to ED with decreased activity, decreased oral intake, increased irritability and emesis. Bloody stool with diarrhea, lethargy. Surgical laparotomy with appendectomy. 7/7/08-ER recs received for DOS 4/29/08-C/O vomiting, lethargic, . Dehydration, irritability.
Pediatric dose of vaccine was accidentally given to patient instead of adult dose. An additional dose of pediatric dose was given in order to equal the adult dose.
patient/didn´t received Shingrix 2nd dose/1st dose was given more than 6 months ago.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 6th months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by a nurse. Age at vaccination was not applicable for this report. The patient did not received second dose of shingrix till the time of reporting, which led to incomplete course of vaccination.  the reporter consented to follow up
Initial report received from consumer on 13 DECEMBER 2013. A male patient whose age, medical history and concomitant medications were not reported, received TDAP (lot number, expiration date, route and site of administration were unknown) on an unknown date. ON an unknown date, patient developed hives after receiving vaccine when he was 12 or 13 years of age. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none
pt recv vax 14JUL & that evening exp nausea, cold & hot flashed that lasted until following morning;no local rxn or hives or SOB;
A couple days after vaccine I experience a slight sore throat which increased over next 2 weeks, bought throat lozenges and then noticed about 2 weeks in, mouth ulcers followed by throat ulcers and was sick with malaise, felt miserable for 4 days, 2 days off work, I am an RN.   Contacted my PCP,  Dr and she told me I most likely had Covid 19 virus.  Was tested and it was negative. ( the test at a center that takes a coupe days.)   Afraid to get 2nd Shingrix.   Have already had both Covid 19 injections without much reaction. I day of exhaustion after 2nd Covid 19 vaccine.
the problem was observed 20OCT96;ER pt exp sudden onset of SOB, vomiting, diarrhea;pt reports that has had itching since flu vax given 18OCT96;