chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US003925 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 13-years old female patient. Her medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in NOV 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Two days after immunization with ZOSTAVAX, patient noted one lesion on left upper forehead that she thought was an insect bite.  There was swelling down to temple area and by next two day swelling worsened around eye.  She took Benadryl.  It resolved over a weeks time.  Mild headache persists.  Unknown if lesion was Zoster.
This spontaneous report as received from a healthcare worker refers to patients of unknown ages. Since February 2012, RECOMBIVAX HB was exposed to repeated temperature excursions as low as -9 C. The RECOMBIVAX HB was also exposed to temperatures above 8 C multiple times. On unknown dates, doses of vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the tine of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Pt. rec. Gardasil 1/9/08.  Fainted 2 mins post vaccine.  Awoke immediately.  Ice applied.  No laceration/no sx. head injury.
Between 6-8 hours post vaccination, patient presented with left arm and axillary swelling and redness. Temperature 102.4 degrees, nausea. 48 hours post shot, symptoms continued. Patient went to ER for fluid administration. All blood tests came back negative. No antibiotics given. ER doctor said vaccine reaction.
Irritable, redness and warm diffuse on right thigh. No hives. No difficulty breathing.
got the vaccination and got shingles/Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 Information: GSK Receipt Date: 21-MAY-2022 Reporters comment: The case was reported by the patient's son/daughter via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
person reported heart racing, SOB, chest tightness. Tachycardia 140-160's. Did remember that she had rxn to unknown medication around age 7. transported by EMS for on site observation
I did not have a reaction to the vaccine. I was exposed to COVID-19 on 06/23/2022. On 06/24/2022 I had a weird electrical charge feeling down my neck. On 06/25/2022, I had rapid sneezing and my left nostril dripped like a faucet. I tested positive for COVID-19 on 06/27/2022. At 11:00AM on 08/17/2022, I had my first nosebleed from my left nostril. For the next two weeks, I had a nosebleed more often than not. Some days I would have a nosebleed only once but sometimes I had a nosebleed twice in a day. I went to the emergency room for observation because my blood pressure was high. The emergency room doctor thinks the nosebleeds is what caused the spike in my blood pressure. Also, I was told that the nosebleeds were a possible rare side effect from long COVID-19.
lightheadedness within 5 minutes of vaccination vomiting within 7 minutes of vaccination
Pain at injection site and entire muscle within 1 day of injection. Minor swelling and continued pain for 4+ days...to the point I avoided using arm to reach above my head....gradually subsided. Yesterday, 7 days post injection, I noticed itching. Today, 8 days post,  I noticed an oval redden area which is the size of a jumbo hen?s egg, inflamed,  and itching.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions included asthma. She had contact dermatitis at the time of vaccination. She did not have any pre-existing physician-diagnosed allergy or birth defects. Concomitant therapies included VENTOLIN and ZYRTEC. Historical vaccine included VAQTA. On 14-SEP-2018,  the patient was vaccinated with (rHA) M-M-R II, lot # R008196, expiration date: 16-SEP-2019, (dose not provided) subcutaneously (SC) in the left tight (LT); and with QUADRACEL, lot # C5325BA (dose and expiration date not provided), intramuscularly (IM) in LT. Both vaccines were administered for prophylaxis. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002764: US-009507513-1809USA010598: US-009507513-1901USA002763: US-009507513-1901USA002753: US-009507513-1901USA002765: US-009507513-1901USA002754.
Itchy, red, rash.  Under right eye, above right eye brow, back of neck on right side, along  waist, front, on right side
This spontaneous report was received from a physician referring to a 15 year old female patient. There was no description of medical history or concurrent conditions. On 24-Nov-2014 the patient was vaccinated with the second dose of GARDASIL (dose and route of administration were not provided). On 08-DEC-2014, the patient developed a severe case of hives and went into anaphylaxis. Then, the patient was admitted to the Intensive Care Unit of an unspecified hospital. Additionally, on an unknown date, the patient experienced blood pressure decreased during hospitalization and was treated with unspecified vasopressor medication. The patient was discharged from the hospital, on an unspecified date and she was recovered of the anaphylactic vaccine reaction and blood pressure decreased. On an unspecified date, the patient was seen by an unknown allergist who determined that GARDASIL may have caused the hives and anaphylaxis. The causality between the blood pressure decreased and therapy with GARDASIL was not reported. The physician considered anaphylaxis reaction and blood pressure decreased Life Threatening. Additional information has been requested.
Administered flu vaccine during flu clinic for employees on 10/06/2023. On 10/23/2023 reported to Employee Health Services that arm was still painful. Submitted WC claim and sent to  Health clinic for eval.
Patient was given 2nd dose however the needle was not correctly tightened onto the syringe so once the plunger was pushed the needle came off and the dose was not properly administered (patient did not recieve at least half of the dose)
Narrative:  Patient received second dose of Moderna COVID vaccine on 3/11. per caregiver, was diagnosed with a stroke at hospital ~ 3/17/21. He was transitioned to hospice and expired last week.
Recently, starting about May 7, I developed problems with my right jaw - the jaw joint is painful making it difficult to open mouth wide. Sometimes the joint gets caught but quickly disconnects. No symptoms of this problem in my past so I am wondering if this is vaccine related so I'm reporting it.
This spontaneous report as received from a Registered Nurse regarding a 12 year old Adolescent patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 07-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
pt recvd vax 18AUG95 & 19AUG95 exp redness, pain, itching @ the inj site & swelling for several days p/2nd dose;pt recvd 2nd dose of vax 12 wks p/1st dose;No further details were provided;
4th Year pharmacy student was preparing a Pfizer vaccine but failed to dilute it prior to administration.  The patient received the entire undiluted dose.  Upon discovery the patient was contacted but the parent reported no issues at 7 hours post vaccine administration.  She was then educated based on available literature on these types of overdoses in the past few months.
Patient was given 1st dose of Moderna vaccine on 8/5/21, but received 2nd dose of Pfizer on 8/31/21. After talking with mother, no adverse effects seen at this time.
Fine bumps and rash on hip and truck, and under arms. Skin now appears dry and improved. Information provided per caregiver.
red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction; This is a spontaneous report from a contactable consumer (patient).    A 20-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 12:00 (Lot Number: EW0182) as single dose (at the age of 20 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. Medical history none. Concomitant medication included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), Vital protein collagen and protein powder, all taken for an unspecified indication, start and stop date were not reported. On 26May2021, the patient experienced: red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction. The outcome of the events was not recovered. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The clinical course was reported as follows: Within 4-5 days after I got the PfizerBioNTech vaccine, I started seeing red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs. It does not itch or anything, the most it does is get more red than usual and that happens whenever I am exercising or working out. As of now this is starting to spread more and more and I'm assuming it's an allergic reaction.   Follow-up attempts are completed. No further information is expected.
Child turned 12 on 11-9-21, this was not noticed by staff, child was given  the pediatric dose instead of the adult dose.
later died.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (later died.) in a 7-decade-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) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Caller reported that she heard from her friends about their two aunts in their 70's that received the second Moderna COVID-19 dose and they each later died. No additional information known or provided.  No concomitant medication provided.  No treatment information mentioned   This case was linked to MOD-2022-445279, MOD-2022-445768, MOD-2022-445950.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 7decade-old female patient with no reported medical history, who experienced the serious  unexpected event Death, on an unknown date after receiving  the second dose of mRNA-1273.  The cause of death was not reported. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Immediately following IM injection of vaccine, patient reported feeling flushed and slight shortness of breath as needle was being removed. Patient denied progression of SOB, wheezing and sx resolved immediately. On auscultation, patient lungs were CTAB without w/r/r/c. No angioedema.  Vitals: temp 98.8, HR 72, RR 22, BP 128./76  Patient reported all symptoms of feeling flushed and SOB resolved by 10:50 AM.
The patient developed high fever >102 the night of vaccination 9/11/09. The patient, over the course of 72hrs, developed cellulitis at site of injection - left deltoid - went to er and was treated accordingly
Patient was dizzy, flushed; fell down stairs, sustained mild concussion. At 8 p.m. had a fever of 103.
pt recv vax 18APR96 & started vomiting 20APR96 & persisted 1wk;pt adm to hosp 26APR96 by MD;liver enzymes reported to be high WBC was high;spinal tap neg; d/c 29APR96;fever, pale, nasal congestion;dx r/o meningitis
3/23/2022 at 1658 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date - 3/18/2022 Booster Dose - Yes Location - Right Deltoid Date of Symptom Onset - 3/19/2022 Symptoms - Right arm pain at injection site that radiated to Left shoulder blades and down Left side of back; Menses started yesterday and is heavy (Which is 3 weeks early) Last Day of Work and Shift - 3/23/2022 (No missed days of work) Home Remedies - N/A Any Improvement - Left side of back pain continues as of 3/23/22
Very large, painful lump (not a lymph node) under the injection arm, in axillary area that almost reached my breast. Not warm to touch, but painful.  Not an abscess or cyst.
Patient came to the pharmacy ten days after the vaccine had been administered to show a fresh bruise at the site of injection. She said it was not painful or tender.
At the facility where the vaccine was administered, Moderna COVID-19 vaccines are prepared in a sterile compounding space and given a BUD of 12 hours under refrigeration.   The vaccine was prepared at 07:43 am on 7/23 and set to expire at 07:43 pm on 7/23. The vaccine was given to the patient on 7/24 at 03:00 pm (~ 19 hours beyond BUD). The attending physician was notified and the patient is being closely monitored.   As of the day of this report, the patient has not reported any adverse reactions.
He arrived encephalopathic due to hypercapnia and elevated ammonia. A Dobhoff was placed for tube feeding and reliable medication administration. His ammonia level began to drop. His mental status fluctuated and he remained mostly BiPAP dependent and when on Vapotherm for short periods he had significant O2 needs. He was made DNR/DNI by his wife when we met at the time of admission. On 8/14 his wife notified the covering NP that she wanted to transition him to comfort care. He died later that day.
This is a spontaneous report obtained from a contactable pharmacist.  A 71-year-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot. R45377, Expiration date: Dec2017, NDC number: 00005197101) at 0.5 ml, single dose, on an unknown date, in 2016, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced neck pain. Clinical outcome of the adverse event was unknown. The reporter believed that the neck pain was related to the pneumococcal 13-val conj vac (dipht crm197 protein).
Within an hour of receiving the shot on my left arm, my deltoid (or where I got the shot) hardened like a brick, became painful like a punch in the arm, and started to get very hot at the site of the shot. These symptoms worsened within an hour with the problems above widening to extend to the entirely of that part of my arm. Swelling and redness increased even with the use of ice and Ibuprofen (which I delayed starting until that night to allow the vaccine to ?do its work?). As of the morning of Tuesday, 5/3/21, the circumference around my arm of this area is now at 12 ½? but the other arm is only 11?. Even worse, as of yesterday I got a ?bubble? of swelling and blotchiness on my bicep that has a defined line around the muscle and then became itchy. The circumference around my arm in this area swelled to 11? whereas the opposite arm is only 10?. The topical heat has now extended into my armpit and the left side of my breast. Note: my other symptom was flu-like soreness all over my body, so I had to take a sick day from work yesterday, Mon. 5/3/21. This all-body flu-like symptom passed. But my arm situation continued to worsen for 3 days. After 7 days the swelling went away but itchyness at the site continued to 10 days.
Despite having mood disorders, I had achieved stability before the COVID-19 vaccine. About 8 hours after receiving it, my mood crashed. I felt angry, agitated, irritable, and dysphoric. This continued for over 3 days. I felt much worse during nighttime, with symptoms ranging from rage and violent ideation to desire for self-harm and suicidal ideation. I left a message with my psychiatrist. He responded that he hoped my symptoms would lessen the further away from the vaccine I got. The past 2 nights I have started to notice the symptoms subside.
LEFT DELTOID AREA REDNESS, TENDERNESS, SWELLING, ITCHING, FATIGUE. 6/21/15-URGENT CARE VISIT- ICE PACKS, ARM ELEVATION, CORTISONE CREAM. 6/22/15 CELLUTIS OF LEFT ARM, CEFADROXIL 500MG TWICE A DAY.
This spontaneous report has been received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 27-OCT-2015, the patients received doses of improperly stored ROTATEQ, (Lot # K009745, exp. date on 17-FEB-2016), (strength and dose were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fully vaccinated and booster 10/26/21.  COVID infection breakthrough with inpatient ICU stay.
Patient donated plasma and then received a tetanus shot. Approximately 20 minutes later lost consciousness for approximately 10 seconds, was pale and sweating. Vaccination site appeared normal. 500 ml normal saline given and feet elevated. Patient was monitored. Ate lunch and then reported he felt normal.
Information has been received from a physician concerning an 85 year old male who on 08-APR-2008 was vaccinated with a "regular dose" of VARIVAX vaccine (Merck) instead of ZOSTAVAX vaccine (Merck) for prevention of shingles. This was a medical error by the medical assistant. The physician reported that the medical assistant though they (varicella virus vaccine and zoster vaccine) were the same thing. The patient was not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Pt stated that she awoke with her eye black.  Sought treatment at the opthamologist but was unrelated to her eye itself.
Vial of vaccine had been short dated by manufacturer, but office was not informed of shortened date and gave vaccine with expiration information that was given to them at delivery.
Noticed a strange smell to my urine the day after the shot and a week later had pain upon urination and blood in my urine. I was diagnosed with a UTI.
The patient received a pediatric dose of 0.2mL instead of the recommended 0.3mL adult dose.  patient was observed post injection with no adverse outcomes. A follow up phone call was done on 01/04/2022 and 01/05/2022. The patient's mother reports no adverse events at home and patient has no pertinent past medical history.  Patient mother was informed about per CDC guidelines that there is no repeat dose based on clinical judgement. She was informed to follow up with the patient's Pediatrician with any concerns.
horrible itching on the arm where the vaccine was given/itches like wildfire; large red area; Hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot). At the time of the report, VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Feeling of 'pounding heart' to the degree that it interrupts my sleep.  Elevated heart rate compared to my normal.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. Information regarding the patient's medical history and historical drugs was not provided.   On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of virus varicella virus vaccine live (oka/merck) (VARIVAX) lot # S025609, expiration date 18-AUG-2021, subcutaneous for immunisation (reported as "booster shot") (dose, vaccination scheme frequency and anatomical site of vaccination were not reported). Concomitant therapies included properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was stored in temperatures of  6 degree Fahrenheit (°F) to 14°F (7.9F) for 25 hours (multiple excursions) as recorded by a data logger. There was no previous temperature excursion reported.
This spontaneous report was received from a registered nurse, concerning a 19 year-old female patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. The patient received altered dosing administration schedule as she was intramuscularly vaccinated on 18-AUG-2008 and 17-DEC-2014, with the first and second dose of GARDASIL injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. No side effects were reported. Additional information has been requested.