chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 7 lbs 10 oz. The patient had no siblings. Concomitant therapy included sterile diluent (manufacturer unknown), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007512: US-009507513-2206USA007513: US-009507513-2206USA001254:
Patient was administered booster vaccine of the Pfizer COVID vaccine. Patient was 15 years old and was to turn 16 in Feb 2022. The event was discussed with the patient and her mother. The patient's mother was made aware of the report to be made and was educated on warning signs for adverse effects in which to present to the emergency room. The patient was monitored for 15 minutes after administration and no adverse effects were seen. The patient was discharged with no signs of distress.
From May 30th to present I have been experiencing the following: Seizures Irregular heart beat Heart palpitations Sharp Chest pain Fevers Chills Dizziness Severe stomach pain Nausea severe headaches Tremors Rapid heart beat randomly throughout the day Diarrhea Weight loss Shortness of breath Memory issues Heaviness in chest Sweating and have been hospitalized 3 times from seizure related illness and admitted once.
Information has been received from a health professional concerning a 78 yr old retired white female with allergies to aspirin, codeine, raloxinfene hydrochloride (Evista), and cilostazol (Pletal) who on 01Sep04 at 11:40AM was vaccinated IM in the left arm with the second dose of pneumococcal 23v polysaccharide vaccine (lot 647359/0740N) (previous vaccination with pneumococcal 23v polysaccharide vaccine was in Oct92). The pt had no illness at the time of vaccination. Concomitant therapy included risedronate sodium (Actonel), diltiazem hydrochloride (Cardizem CD), famotidine, aspirin and tolterodine tartrate) (Detrol LA). On 01Sep04 at 3:00PM the pt experienced throbbing sensation/pain, swelling, redness and fever in the arm. Unspecified medical treatment was sought. The pt subsequently recovered from the throbbing sensation/pain, swelling, redness and fever in the arm (recovery date unk). Additional information is not expected.
Child was taking a shower and father noted left arm was swelling up into his shoulder. He had a rash on his chest and was complaining of pain at midnight. His temperature was 102F and he was given Motrin. He saw MD and he said it was a reaction to asthmatic meds. He put him on prednisone and Augmentin. On 1/22/02, talked to father and he said the pt was fine now and the swelling is gone. Advised could be contacted later.
an infant patient was administered an expired dose of Daptacel vaccine/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a eight months old female patient who was administered an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA, expiry date: 05-OCT-2019 via unknown route in the left thigh on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB).  It was an actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  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.
p/vax pt exp pain in lt arm; charley-horse; felt washed-out; felt like was getting a cold;
recieved vaccine at 3pm, around midnight started having the chills and took tylenol for fever and woke up in a sweat when the fever broke. This happened three times from midnight to 7am. Also, the day after noticed LEFT EYE swelling, my right eye is normal. The swelling still has not gone down after ice and advil for 2 days after vaccine.
Fatigue, chills, fever,  headache, swelling and redness at injection site, lymph swelling armpit same side as injection for 2 or more days after injection. (Same reaction to 2nd Shingrix injection a couple years ago)
A mother reported that her son received a 1st dose of Acel-Imune, Hib-Titer and Polio vaccines on 11/30/98, when he was 2 months old. Subsequent to immunization, he developed a high pitch scream and "high" fever. In the summer of 2002, he was diagnosed with autism. The child experience daily fever, headache, constipation and has completely white hair with a piece of jet black hair scattered here and there. The mother thinks thimerosol in the vaccine is to blame for her son's condition. This case was considered serious since these events were considered medically important in this case. The mother reported that after her son received a 2nd and 3rd dose of Acel-Imune vaccine he developed a high pitch scream and "high" fever. See related cases: HQ4067004SEp2002 and HQ4067104SEP2002. The mother also reported that a twin brother of the pt and a female sibling experienced a similar events following immunizations. See related cases HQ3981728AUG2002, HQ4066504SEP2002, HQ4066604SEP2002, and HQ4066704SEP. No additional info was available as of the date of this report.
Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 13-JUN-2022, the patient was vaccinated with a dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # U036586 was confirmed to be valid, expiration date reported as 21-OCT-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided). Vaccine was improperly stored for an unknown amount of time in an unknown temperature. Data logger was used to capture the temperature excursion.
Pt reported that with the 1st dose he experienced fatigue 2 days post-vaccination which lasted for two days. Pt reported with 2nd dose, morning of 4/29/2021 he felt tired (not as tired as with first dose) and approx. ~1000 - 1100 hours he got chills, feeling hot and cold, body ache and spike a fever ranging from 101 - 102 F.Pt reported he took Aleve 1400 hours today, and advised did not provide and relief. Recommend pt to go ahead and take Tylenol now to help with reducing fever; counseled to not exceed 4,000 mg of Tylenol product in a day or consume with alcohol to avoid liver injury. Recommmend to stay hydrated, rest and consume proper meal. Advised pt to keep an eye on his temperature, if temp exceeds 102.5 F or symptoms worsen to seek medical care right away.  Advised ADEs usually more common with 2nd dose and occurs within first 3 days of post-vaccination, ADEs should resolve in 1-2 of onset but if symptoms does not get better recommend to contact MD.  4/30-Feels improved; medications helped.
Patient received vaccination 9/20/11 -> had MD appt next day & found out she had a compromised immune system. Patient reported flu like symptoms on Saturday 9/24. Patient went to hospital & treated for dehydration & released.
Information has been received from an unspecified health professional and a 71 year old male consumer with no known allergies or pertinent medical history who on 14-FEB-2008 was vaccinated IM in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). There was no concomitant medication. "13 days post vaccination," on 27-FEB-2008 the patient experienced severe joint pain, cough, flu symptoms, headache, runny nose and also developed pleurisy. No medical attention was sought. The patient called the physician's office on 11-MAR-2008 to complain of flu symptoms. The patient thought it was a side effect of the zoster vaccine live (Oka/Merck). The patient was advised to schedule a follow up appointment. The patient never scheduled an appointment, and per the patient he would schedule if he was worse. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Extreme swelling at injecting site and high fever. Uncontrollable screaming and crying for 3 days straight. Unable to sleep. Constant head banging.
I think shingles. I have a small patch of red, raised bumps on my right lower back. They don't hurt but I can constantly feel them. They hurt to touch. My front right torso is also slightly tingly in certain spots to touch. Forget this.
One day after vaccine, temperature of 103-104 degrees lasting sparatically for four days. Nausea, dizziness, temporary loss of vision,  temporary loss of speech, hallucinations all occured simultaneously with the temperature. The sixth day paralysis of the left side of face has occurred and has not improved, as it is the tenth day now. Treatment is being sought in the form of massage, accupunture and advice from neurologists.  Patient had a fever of 100 degrees when she entered the emergency room and had been having problems with faintness, however the doctor still elected to reccomend and administer the vaccine.
Horrible arm pain; Depressed, sad; does not feel well; fatigue; crying; Nauseous; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's parent stated, "I have a question. My daughter (patient), she had a vaccine this last Monday and she was nauseous today. How long does it last? One person said she is OK. She is kind of have horrible arm pain which is pretty normal and today she feels pretty depressed, sad, she went on crying and crying and she does not feel well. She felt nauseous and kind of fatigue and she is not herself". The events was experienced on 14Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Muscle Aches, fatigue, fever, headache, pain radiating from the injection site to my underarm and side.
The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.).    No concomitant medication information was provided. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication were provided.
This spontaneous report was received from a physician referring to a 19 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 13-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to an unspecified multiple patients of unknown gender and unknown age. On an unknown date, the unspecified multiple patients were vaccinated with doses of VARIVAX (Merck) (lot/batch number, expiration date, dose, route and indication not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Donor became hot, room started to darken, became weak, lost consciousness for approx 5-10 sec. Assisted to floor by 2 staff members, then assisted to office, placed on bed with feet up. Gave juice and crackers after 15 min donor stated felt fine upon leaving center.
s/s nausea, vomiting, diarrhea, malaise; acute viral Gastroenteritis;
I had my 2 vaccines 7 weeks apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2 vaccines 7 weeks apart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2 vaccines 7 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my 2 vaccines 7 weeks apart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
This is a spontaneous report from a noncontactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 39, via an unspecified route of administration, in the left arm, on Apr 23, 2021, at 10:30, single dose, for COVID-19 immunisation. No medical history provided. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8734), at the age of 39, via an unspecified route of administration, in the left arm, on Apr 2, 2021, at 10:30, single dose, for COVID-19 immunisation. On Apr 23, 2021, at 23:00 (overnight after receiving the second dose of vaccine), patient had restless legs all night. The patient never experienced restless legs previously. All night they felt itchy, tingly and weak when she tried to walk. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of restless legs all night, felt itchy, tingly and weak when trying to walk resolved on an unknown date in Apr 2021. No follow-up attempts possible. No further information expected.
Within 30-45 minutes of receiving vaccine I experienced mild dizziness which lasted continually for about 4 hours.  I have had numerous flu vaccines in years past and never experienced any reaction.
Severe allergic reaction after the second done,  large rash all over the body, unstoppable itching , fatigue  Benadryl was not helping had to be put on steroids and Hydroxyzine twice. Rash came back again after a month
Pt was seated in the waiting area after receiving his first dose of covid 19. His parents who also received the vaccine were waiting with him. I was preparing another dose for patients waiting for their covid vaccination. I heard pounding on the clinic room and ran to check. The mom had knocked on the door because her son had fallen out of his chair.. when I arrived he was on the floor and his parents said he was regaining consciousness and moved him in to a seated position. At this point another customer was calling 911. I had my technician call management.  I observed the patient and asked if he was doing ok. His parents asked him if he was hurt and he responded in the negative. The patient was feeling cold and his hands were "cold and clamy" according to his mom so I held off on the cold compress. He wanted water but was also nauseous so I told the parents that I do not want to risk aspiration. We gave him a bag to throw up. I recommended that they take him to get seen when the paramedics arrived as I was concerned about him shaking before fainting. At this point the paramedics arrived and he was taken to the hospital as he was not feeling well. I followed up with the patient's mom and she said all his tests came back normal (EKG, et) and that the doctors may think it could have been due to anxiety from getting the vaccine. She was really appreciative of the call.
attacked my nervous system; attacked my muscles; attacked my bowel; it attacked my immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Lot number: EW0167) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for blood cholesterol. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 05May2021, outcome "not recovered", described as "attacked my bowel"; MUSCLE DISORDER (non-serious) with onset 05May2021, outcome "recovering", described as "attacked my muscles"; NERVOUS SYSTEM DISORDER (medically significant) with onset 05May2021, outcome "recovering", described as "attacked my nervous system"; IMMUNE SYSTEM DISORDER (non-serious) with onset 05May2021, outcome "recovering", described as "it attacked my immune system". Therapeutic measures were taken as a result of nervous system disorder, muscle disorder, abdominal discomfort, immune system disorder.  Clinical course: The patient went, and I got the Olympus, that the Monoclonal Infusion (Intent Treatment) and next morning half symptoms were gone. When probed for permission to file the safety report consumer stated patient lost 13 months of life and patients bowel is not going to be right again. Patients husband got the same Vaccine. Consumer stated, they did not write Expiration date of Pfizer Covid-19 Vaccine, all they did was, they did not write it down on my card. The Consumer stated that Start date of event (nervous system attacked) was Immediately. The patient received treatment Chiropractor all the time, Chiropractor and the doctors were not interested because they said that the Vaccine is safe. Patient was not healthcare professional like Physician, Nurse, Pharmacist but consumer know her body. The patient just had a checkup. The patient did not receive any other vaccines.  Follow-Up (10Jun2022): Follow-up attempts are completed. No further information is expected.