chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his son who at 4 weeks old was vaccinated with a booster dose of RECOMBIVAX HB (manufacturer unknown). The consumer reported that his son went into infantile spasms due to a hot batch of the vaccine. The consumer reported that the patient was originally diagnosed to be retarded. Subsequently the patient grew to be a developmentally delayed 16 year old who still cannot spell but talks and interacts. At the time of the report the patient's outcome was unknown for infantile spasms and not recovered for developmental delay and retarded. It was unspecified if the patient sought medical attention. Upon internal review "retarded" was considered to be an other important medical event. No further information is available.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
her son was given Ipol vaccines,his second and third doses were 2 weeks apart; her son was given Ipol vaccines,his second and third doses were 2 weeks apart; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional by phone.  This case was cross-referenced with case 2019SA113641 (same reporter).  This case involves a 10 years old male patient who was vaccinated with a second and third doses of IPV (VERO) [IPOL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Oct-2018 and 25-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to extra dose administered and inappropriate schedule of vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
Husband called 2/3/19 at 10:37 AM to report wife felt very lethargic/weak all night last night after receiving 2nd dose of SHINGRIX. Denied rash, fever, swelling, localized redness. Took TYLENOL. Stated "could not get out of bed last night but better this morning".
High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
body aches; fever of 100F; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills). At the time of the report, MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 100 (High) fever of 100F.         no concomitant and treatment medications are provided by the reporter
states she developed sx and tested positive on home antigen test 12/8/2022 has completed primary series of Moderna- no boosters rec'd
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels under the weather), PAIN (achy), HEADACHE (headache), PAIN IN EXTREMITY (her arm hurts) and DISCOMFORT (her body feels heavy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced MALAISE (feels under the weather), PAIN (achy), HEADACHE (headache), PAIN IN EXTREMITY (her arm hurts), DISCOMFORT (her body feels heavy) and FATIGUE (feels tired.). At the time of the report, MALAISE (feels under the weather), PAIN (achy), HEADACHE (headache), PAIN IN EXTREMITY (her arm hurts), DISCOMFORT (her body feels heavy) and FATIGUE (feels tired.) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient had left arm numbness and tingling, lips numbs, and headache at 15 minutes. Symptoms continued to increased headache, SOB, nasal congestion, nausea and vomiting, all extremities numb. face pale.
Syncopal episode within 5 minutes of immunizations. Patient's father was with her and eased her to chair, then to floor.  Patient did not fall.  BP 120/70.  Applied cool compress to head.  Rested for 10 minutes, then left (ambulatory) with father.
Admitted for sepsis due to covid pneumonia. Fully vaccinated. Treated with cefepime, steroids, singulari, zinc, remdesivir (stopped mid-treatment due to elevated LFTs). Initially looked to be stabilizing but was found unresponsive 9/11 with oxygen removed. Pt had expired.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2014, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot #: L042817, expiration date on 26-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. No previous temperature excursion was reported. It was unspecified if PROQUAD (Merck) lot #: L051101, expiration date on: 17-JUN-2017 was administered to the patient. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
collapsed lung; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMOTHORAX (collapsed lung) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMOTHORAX (collapsed lung) (seriousness criterion medically significant). At the time of the report, PNEUMOTHORAX (collapsed lung) 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.   No Concomitant medication was reported. Patient was 24 or 25. Three days after the vaccine patient had a collapsed lung. Patient mother mother, thought it was from the vaccine. No treatment was reported.  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.  Further information is not expected.; 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.  Further information is not expected.
Vaccine eligibility form did not list any reasons not to give H1N1. H1N1 given @ 0904, 0907 client fell to floor, unresponsive, hit head (nose) when fell, placed client on back, lips swelling, client then responsive able to speak to staff w/confusion, client went unresponsive 2nd time, epinephrine give @ 0912 in LD blood pressure taken x 2 pulse monitored on-going, EMS arrived; client went by ambulance pt became responsive during emt treatment. vitals stable. Left @ 0922 w/emts.
I started feeling sick on 11/13/2022 for like 10 days; it was pretty mild in the beginning, and then got progressively worse. I had a lot of coughing, stuffy and runny nose, low-grade fever, and body chills. I also had super body fatigue. My symptoms started getting better, but I started losing my sense of taste and smell. So I took a COVID-19 home test on 11/15/2022, which came back positive. I didn't call my doctor or anything. I started taking MUCINEX and then alternated ibuprofen and TYLENOL when the body aches started getting bad. I heavily hydrated and started taking vitamin C as well to try to rebuild my immunity. By 10 days or so, I got better. Ironically, I got the the flu two weeks after recovering which was kind of upsetting.
On 10/2/21 received my Pfizer Booster shot. Had a slight fever & arm was sore.  On 10/11/21 was taking my son back to school feel asleep in the car... neck was down, got out the car & my neck was hurting & my hold arm was numb.  A few days past & my neck was still hurting & my arm was still numb.  Spoke to Primary, she told me to go to the ER wanted to rule out CVA.  10/13/21 ER Dr. said its probably a pinched nerve, I did tell her that the only new thing I did was get the Booster shot & sleeping wrong in the car ride.  She told me its not the Booster.  Made a follow up appointment with my Primary on 10/22/21 took an x-ray, X-ray revealed discs between vertebrae & spine have degenerated as well as some arthritis C4-C5 & C5-C6. Was giving naproxen & muscle relaxer (gabapentin 100mg).  Naproxen didn't help & Gabapentin made me dizzy.  1 year has passed neck is better & now my hand is still numb.  F/U appointment on 10/20/22 was referred to a hand doctor to  schedule a nerve test.
pt recv 1 dose of vax 1/98 following day pt exp pain, swelling, redness at inject site, not use arm  3-4 days. recv 2nd dose 3/98, 3 days p/vax pt devel vesicular rash over arms, legs, trunk lasting for about 1 wk. pt says was varicella not
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning an Adult patient of unknown age and gender who on 14-MAY-2015 was vaccinated with a dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 103 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Within 3 hours of receiving the influnza vaccine he developed a warm red slightly swollen upper arm. It did not progress any further. Mom used topical BENADRYL cream and progressively improved. Resolved after approximately 48 hours.
Potential AE due to doses administered from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The Beyond Use Date of vaccine  was reported as 01-DEC-21 to 15-DEC-21 The Moderna ordered date was reported as 01-Nov-2021 and 15 Nov. No treatment medication information was given.
The patient reported having severe nerve pain, acute nerve pain in the right arm on June, 10 2019 which lasted for 3 days.  The patient had acute nerve pain again on 6/17/2019 which lasted for 5 days.  The patient also reported having enlarged lymph nodes in the right arm also.  The patient saw a shoulder doctor due to the pain.
Broke out in rash on legs and arms over weekend. Spent weekend at grandparents house who have several dogs. Also went fishing and swimming in a pond over weekend. Rash very itchy. No fever. Active and eating well. had kindergarten vaccines 2 weeks ago. Mom states other than swimming in the pond (dad and bother also swam in same pond and are unaffected), the only other exposure is to scabies a couple of weeks ago, and to flea. He stayed with grandparents over the weekend and they have 4 dogs in their home who all have fleas. The animals do not sleep with him while he is there. The rash is extremely itchy and seems to be spreading.
Patient is a 68 y.o. male referred to Infectious Diseases Clinic for possible reaction to yellow fever vaccine. He is an orthopedic surgeon who is planning to travel in September 2018. In preparation for his trip, he had injectable typhoid vaccine, yellow fever vaccine and hepatitis A vaccine on June 1, 2018. On June 6, he developed mild headache, dizziness and chills, no documented fever. Soon after that, he then developed thoracic and low back pain. He was very fatigued with diffuse aches for several days, with skin sensitivity. These symptoms persisted for several days. On Saturday, June 9, he developed decreased appetite and bloating, associated with five mucousy loose bowel movements daily. He noted that certain food and wine did not taste good, and he discontinued. His appetite continued to worsen, still with GI symptoms, but muscle aches resolved. On 6/13, he weighed himself, and he was 6-8 pounds lower than baseline. On that day, he had labs performed at his work place on 6/13 and found WBC 2.5, plt 100,000; LFTs, coag studies and CK were normal. Yesterday, he called, when he felt much worse, and was unable to pack for a trip that he planned for this weekend. He notes that if he lies down and dozes, he feels much better, with less GI symptoms. His current symptoms are poor appetite, and fatigue with ongoing loose bowel movements. He is making himself eat and drinks plenty of liquids. He feels that the most problematic symptom is a feeling of panic, that resolves if he lies down. His wife had the same vaccinations is having no side effects. He has not been around anyone ill. He is a semi-retired orthopedic surgeon, but still runs his residency program. He has limited patient contact. He traveled in May (he did see a tick there, but had none on his body), in March, and in Feb.
Client states he received his 1st dose of Hep-B vaccine on 1/23/02 around 18:00. He did not have any symptoms of illness prior to receiving the vaccine. He woke at midnight on 1/29/02 and had a fever of 101F and diarrhea. The diarrhea has continued. Referred to physician. (2/12/02 TC with MFR, who states this could occur again with dose #3 but it is not reason to discontinue series). Felt better on Saturday, 1/26/02. Went to work in the evening.
Patient was seen by me on 8/23/2013 due to rash x 3 day duration and low grade fever. Rash was classic chickenpox rash (diffuse). Had received Varicella vaccine 2 weeks prior at clinic on 8/9/2013.
Swelling & redness to entire upper left arm. Benadryl given. Swelling and redness still evident 10/28/02.
Information has been received from a nurse practitioner concerning a 23 year old female who was vaccinated with complete GARDASIL series. On 13-FEB-2009, the patient had a PAP test, the result showed positive for HPV and had atypical cells during a recent PAP test. The reporter nurse did not know what types of GARDASIL were positive. The patient was not recovered from the adverse events. It was reported that the patient sought medical attentions: seen in office. Additional information has been requested.
Deep joint pain in bilateral hips; pain while walking or externally rotating beginning 17h post-vaccine and largely resolving 42h post-vaccine. Did not take any meds.
That same night, she woke up and noticed that her left clavicle was swollen; That same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot Number: EM9809), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6207), administration date: 18Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 3, Lot Number: FC3183), administration date: 20Sep2021, when the patient was 71-year-old, for Covid-19 immunization. The following information was reported: BONE SWELLING (non-serious) with onset 26Apr2022 at 02:00, outcome "not recovered", described as "That same night, she woke up and noticed that her left clavicle was swollen"; VACCINATION SITE SWELLING (non-serious) with onset 26Apr2022 at 02:00, outcome "not recovered", described as "That same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine)". The events "that same night, she woke up and noticed that her left clavicle was swollen" and "that same night, she woke up and noticed that her left clavicle was swollen (the same side that she took the vaccine)" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She went to bed that night and woke up at 2 am and her left clavicle was swollen. She had received the shot in the same arm as the swelling. She explained that she has consulted doctors and made x-rays. Her case has not improved since that date. Caller wanted to know if there was some compensation program that could help her to cover the large medical bills that she has. It was reported that the doctor was scratching his head. They have done x rays which did not show anything wrong. They could not find anything wrong except that her clavicle was swollen. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not have any prior vaccinations (within 4 weeks). It was reported that there were no diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not go to emergency room as a result of the event.