chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child found dead in crib 7 days after receiving vaccines.  Parents report no symptom prior to death.  3/22/07 Received Autopsy Report which reveals COD as SIDS.  Manner of death as natural.  Findings at autopsy: moderate hydrocephalus & aqueductal stenosis.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017), (dose and route of administration were not reported). Concomitant medications were not provided. No adverse symptoms were reported. Additional information has been requested.
This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502D, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced didn't feel good. On 25-MAR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced pinched nerve. On 13-APR-2021, the subject experienced felt like hot fluid was running down the inside of his right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, pinched nerve, felt like hot fluid was running down the inside of his right arm, and didn't feel good on APR-2021, and tired on 28-MAR-2021. This report was non-serious.
Hypertensive urgency with severe epistaxis, requiring hospital admission for six days and three to five antihypertensive agents to control blood pressure.
At present time there is NO adverse reaction. Third Moderna vaccine was given in error.-----Patient had received both Moderna vaccines on 2/10/2021 (lot 031120A) and  3/12/2021 (Lot 027l20A). On August 3, 2021 patient was here for Pneumovax 23 and Shingrix. Pneumovax 23  had been given in right arm then Shingrix in left arm but Moderna was given in error in the left arm( Lot 042B21A).  Went ahead and gave the first Shingrix in the left arm after error was discovered. patient has now received 3 Moderna vaccines.
Vision changes; blurriness, unable to visually focalize; Tingling & numbness traveling down shoulder into lower back; pain and soreness; Nausea; vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Vision changes; blurriness, unable to visually focalize"; HYPOAESTHESIA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Tingling & numbness traveling down shoulder into lower back"; PAIN (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "pain and soreness"; NAUSEA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vision blurred, hypoaesthesia, pain, nausea, vomiting, headache. Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. known allergies: No. other medical history: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated she noticed a red mark on the arm of vaccination about one week after vaccine - "covid arm"
No adverse event. Reporting patient received vaccine at 15 yes 26 days old... under 16 year old guideline
Achy, feverish, myalgias and shivering over the course of approximately 5 hours, at which point pt. slept for the night. Upon awakening today, continues with fatigue and weakness, no fever.
Approximately 12 hours post vax pt reported distinct reddening of skin resembling sunburn over neck, chest, abdomen antecubital, as well as spots of same lower back and at injection site. No pain or pruritus, a febrile, and otherwise well. Erythema resolved over course of proceeding 48 hours no treatment given. Assessment: local inflammatory reaction.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of M-M-R II (lot # N023150 exp date 24-AUG-2019) (dose not reported) intramuscularly. Concomitant therapies included sterile diluent. There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009098: US-009507513-1809USA009099.
fever; illness; the doctor even divided the dose into 2 parts to help manage the reaction; Adverse reaction to MMR; there was also some problem with the lot number; This spontaneous report was received from a other health professional regarding to herself;  a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's  concomitant therapies and historical drugs was not provided.   On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced adverse reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II)  (vaccination complication), fever (pyrexia) and  illness. There was also some problem with the lot number and she had to be vaccinated again on an unknown date. At that time, the doctor divided the dose in two parts to help manage the reaction.  The outcome of pyrexia, vaccination complication and illness was unknown.     The reporter considered vaccination complication to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) while the causality between fever and illness with the suspect vaccine was not provided.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2101USA010753:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild
Information has been received from a nurse concerning a 6 month old male with no pertinent medical history or known drug allergies who on 19-SEP-2008, 30-OCT-2008 and 27-JAN-2009 was vaccinated PO with the first, second and third dose of ROTATEQ respectively, (lot #: 1st dose 661032/0469X; 2nd dose 661429/0594X; 3rd dose 662801/1102X). On 15-FEB-2011 the patient was admitted to the hospital (intensive care unit) with severe rotavirus confirmed by stool culture. He was vomiting and had diarrhea and also dehydrated. The patient was treated with intravenous (IV) fluids. On 17-FEB-2011 the patient recovered from severe rotavirus and dehydration. He was released from hospital on the same day. The patient continued to do well. Severe rotavirus and dehydrated were considered to be immediately life-threatening and not disabling by the reporter. No further information is available. Lot checks have been initiated.
Fever between 101/102. Little red bumps all over body. Body aches- child screaming, would not eat, play or sleep longer than one hour for 2 days.
Sudden redness over chest, neck, and face. Heart rate at rest jumping from 73 to 165 bpm, sweating, dizziness, feeling on verge of passing our. Heart rate and symptoms subsided at 15 min. Dizziness continued for next hour with fluctuations in heart rate and Blood pressure taken at 110/88.
14-year old female was administered a Pediatric Pfizer dose instead of an Adult Pfizer dose for the second dose of the series.  The patient received the Pfizer (>12 yrs) correctly for the first dose on 12/6/2021.  The patient presented with mother and 9-yr old brother without their previous COVID vaccination cards.  I used a translater via language line to communicate with the mother.  I administered the Pediatric Pfizer dose to both children and recognized the error in the dose for the 14-year old and when making a new COVID vaccination card.  Normally, I complete the paperwork first, including the documentation on the card, where I likely would have caught this error in advance of the administration.  I recognized that the previous Pfizer lot number was for dose ages = or > 12 yrs of age.  I immediately explained the error to the mother and patient and consulted additional nursing staff to see if we could administer an incremental dose.  Per the guidance, it is recommended that we not administer an incremental dose but explain the situation to the patient (and parent) and give them the option of returning to the clinic for an adult dose of Pfizer in 21 days.  With the use of RN, we explained the protocol to the mother and patient and they agreed to return in 21 days for a Pfizer dose >12 yrs of age.
on  9/29 received 0.5mcg IM left arm of Hep B engerix-B.  the second half 0.5 mcg was given 10/1 right arm.  Both were of the same lot number and exp date. on 10/1 within 10 minutes of the dose, shaking, flushed face/cheeks and vomiting occurred. 911 called. Epinephrine given and transport to ED for follow up care.
C/O right shoulder and arm pain, and limited ROM after PNEUMOVAX 23 2/27/18. Pt was seen by PCPC day after, 2/28/18. Ibuprofen as needed every 6 hrs, ice to area, follow-up as needed.
PATIENT RECEIVED VACCINE AROUND 3:43PM. HE  LEFT FOR HIS DOCTOR  APPOINTMENT NEXT DOOR. HE CAME BACK TO PICK UP HIS MEDICATION AROUND 4:55PM. PATIENT COLLAPSED ON THE FLOOR. HE HAD DIFFICULT STANDING BUT HE WAS FULLY CONCIOUS AND ABLE TO COMMUNICATE. WE CALLED 911 AND HAD DR. FROM VILLAGE MEDICAL TO CHECK ON HIM WHILE WAITING FOR EMS. PATIENT TRIED TO LEAVE AND COLLAPSED ON THE FLOOR AGAIN. EMS ARRIVED A FEW MINUTES LATER. VITAL ARE NORMAL. PATIENT MENTIONED HE HAD A FEAR FOR VACCINATION AND HE HAD NOT HAD ANY MEAL. PATIENT REFUSED TO GO TO HOSPITAL. EMS CONTACTED A DOCTOR, AND CONFIRMED PATIENT IS STABLE, HE JUST NEEDS TO REST FOR 20-30 MINUTES. PHARMACY STAFF CHECKED ON PATIENT EVERY 5 MINUTES FOR ABOUT 20 MINUTES. PATINET WAS ABLE TO WALK TO THE PARKING LOT. PATIENT 'S MOTHER CAME TO PICK UP HIM.
This is a 5 year old girl who had received no vaccinations in the past except for 1 DTaP vaccine at 11 months without significant adverse effects who agreed to vaccination as discussed with the doctor on 3/15/05. In her right thigh she was given IPV and MMR.  In her left thigh she was given DTaP. 2 days after vaccination her mother phoned me reporting that patient had a 105 degree temp which was not responding to Motrin 1 and a half teaspoons and that she had a large painful lump on her thigh and headache and lethargy.  I asked her to bring the patient in ASAP, where she was immediately given 1 and a half teaspoons of Tylenol and 25 mg of Benadryl.  On exam she was lethargic, flushed, and had a >5 cm tender, firm lump on her left thigh.  She walked with a limp.  Her exam was otherwise normal.  AFter 20 minutes of observation after the tylenol and benadryl she became more awake and alert, less flushed, and her temperature reduced to 100.8.  I sent her home with instructions for the mom to give her tylenol and benadryl as above every 6 hours until her symptoms resolved.  I told her to give a lukewarm bath for fever >104 and call me.
It was itching; It was swollen; It was hurting; Started to turn red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE PAIN (It was hurting) and VACCINATION SITE ERYTHEMA (Started to turn red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included CITALOPRAM, SIMVASTATIN, TIZANIDINE HYDROCHLORIDE (TIZADINE), MULTIVITAMIN [VITAMINS NOS], CALCIUM, VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Started to turn red). On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itching), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE PAIN (It was hurting). At the time of the report, VACCINATION SITE PRURITUS (It was itching) had resolved and VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE PAIN (It was hurting) and VACCINATION SITE ERYTHEMA (Started to turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was histacort cream.  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.   Reporter did not allow further contact; 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.
positive for covid; chills; Fever; headache; loose stool; swelling in mouth; tenderness in her mouth; slight cough; shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (loose stool), MOUTH SWELLING (swelling in mouth), TENDERNESS (tenderness in her mouth), COUGH (slight cough) and DYSPNOEA (shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (loose stool), MOUTH SWELLING (swelling in mouth), TENDERNESS (tenderness in her mouth), COUGH (slight cough), DYSPNOEA (shortness of breath), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache). On 23-Jan-2021, the patient experienced COVID-19 (positive for covid). At the time of the report, DIARRHOEA (loose stool), MOUTH SWELLING (swelling in mouth), TENDERNESS (tenderness in her mouth), COUGH (slight cough), DYSPNOEA (shortness of breath), COVID-19 (positive for covid), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Additional concomitant medications included blood pressure pills.  The patient went to the emergency room  on 23-Jan-2021 because of the side effects. While in the ER she was tested for COVID because of her symptoms and tested positive. The patient was experiencing a fever at that time which has gone down, had slight cough, her breathing was  better but she was having shortness of breath. She was not admitted.   On 25-Jan-2021, the patient was treated with an antibody infusion. She was told by her doctor she cannot get the second shot for 90 days because of the antibody treatment.
that was "bothering him."; he had a red, pink injection site; pink injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site discomfort, injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site discomfort, injection site erythema and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site discomfort, injection site erythema and injection site discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine sometime around the holidays, it was cold outside and had a red, pink injection site, that was bothering him. The reporter did not consent to follow up. No other information available about this AE.  The reporter declined all demographics and declined further details.
DYSMENORRHEA  AND MENORRHAGIA -  UNRESOLVED. RECENTLY PRESCRIBED MEDICATIONS MYALGIA - UNRESOLVED NEUROPATHY L ARM - RESOLVED WITHIN 2 MONTHS LYMPHADENOPATHY - UNRESOLVED
constant buzzing on both ears that started about 4 to ,5 months ago; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Past drug history included: Known allergies: doxicicline, reaction(s): "Known allergies: doxicicline"; Known allergies: nickel, reaction(s): "Known allergies: nickel". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. na), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. na), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 26Mar2021, outcome "unknown", described as "booster"; TINNITUS (non-serious) with onset 20Dec2021, outcome "not recovered", described as "constant buzzing on both ears that started about 4 to ,5 months ago". The event "constant buzzing on both ears that started about 4 to ,5 months ago" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: It was reported that patient have a constant buzzing on both ears that started about 4 to 5 months ago right after taking a normal shower. Saw a clinician but the sound hasn't change. The patient was treated with decongestants though she wasn't congest. The patient did not received any other vaccine in four weeks. No COVID prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 08-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Patient received 2 doses of the flu shot (one of 8/15 and one on 8/22). Patient did not report any adverse events.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (in the eye, experienced in 1998) and ischemic optic neuropathy. On 5th October 2018 12:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, nausea, feeling unwell, general body pain and fatigue. On an unknown date, the outcome of the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue were unknown. It was unknown if the reporter considered the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The night after receiving of SHINGRIX, the patient experienced headache, body aches, fatigue and felt somewhat nauseated. His arm was sore in the weekend of reporting date, but it was not as bad as at the time of reporting. The patient at the time of reporting was still not feeling right overall.
Pt recvd vax & 12 hrs following vax pt devel cellulitis @ inject site, fever, chills & myalgia; @ the time of the report, pt had recovered;
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
Pt recv vax 18OCT95 230PM & by 430PM pt would not move leg & it appeared that leg was sore (pt cont to say ow);pt also had a sl fever;the reporter felt the vax may have been given incorrectly;
1 of 3 pts (out of 200 pts vaxed) who exp a red swollen arm; the edema extended below the elbow; treatment included APAP Q 4 hrs & warm soaks @ the site; pt recovered;
Pt vaccinated with HIB/MMR rash developed 13 days following immunization.
A report has been received from a Health Professional concerning a, female subject, who had been receiving FLUMIST, 0.2 millilitres. FLUMIST started on 04-Jan-2016. It was reported that patient had received expired dose of FLUMIST on 04-Jan-2016 who dose was expired on 30-Dec-2015. The outcome of the event of patient received expired dose is unknown. The report was considered to be non-serious.