chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8/22/01 the pt began to vomit and had a seizure. He was taken to the ER and admitted to the hospital. He underwent a number of test including a lumbar puncture with results pending. The reporter noted that the physicians are leaning towards a diagnosis of encephalitis. The pt's physician wanted to submit a CSF specimen for PCR analysis. It was unknown if the pt had a recent exposure to varicella or other viruses. Follow-up states the pt's symptoms are related to herpes virus and not to varicella. Therefore the remaining SCF was sent to be analyzed for herpes as well as enteroviruses. It is noted at this point the pt's symptoms do not appear to be related to the varicella vaccine. Additional information has been requested. F/U states: Information has been received from an RN and a physician concerning a 12 month old white male with no allergies and no significant medical history, including no recent illnesses, no immunosuppression and no recent travel. On 8/6/01, the pt was vaccinated with the 1st dose of varicella vaccine (lot 634492/0931K also reported as 638250/0467L) SC in the right thigh. Concomitant medication on an unspecified date included 1 dose of Haemophilus B conjugate vaccine. On 8/22/01, at 04:33, the pt began to vomit and had a fever and a prolonged seizure. He was taken to ER and admitted to the hospital for 7 days. It was noted that he was somnolent for days after the event. The pt was irritable and unsteady, gradually improving over 1 week. "By history, the pt was recently immunized and certainly A.D.E.M. is a possibly, although this is typically seen in the subcortical white matter". The RN noted that the physicians are "leaning towards a dx of encephalitis". The pt's physician wanted to submit a CSF specimen for PCR analysis; however, it was noted that a CSF specimen for PCR analysis will not be sent because only 0.5cc of the CSF was remaining and the treating physicians suspected the child's symptoms were related to herpes virus and not to varicella. Therefore, the remaining CSF was sent to be analyzed for herpes, as well as enteroviruses. The physician noted that there was insufficient CSF for VZV PCR or other viral studies. It was noted that "the doctors do not feel at this point, that the child's experiences are related to (varicella virus vaccine live, and that unknown if the pt had a recent exposure to varicella or other viruses. Subsequent follow-up information from a physician noted that the dx was acute disseminated encephalomyelitis. The physician noted that there was no evidence of a bacterial infection. No further information is available.
pt to ED with hx of COPD; presents with increasing SOB x 4-5 days; positive test for COVID; placed on supplemental O2, given remdisivir and steroids; pt's condition worsened and he was admitted to ICU; intubates; developed left intramuscular neck hematoma; condition declined; placed on comfort care and extubated; pt died in the ICU
Headache; Shoulder was achy; Feeling wiped out; Heart palpitations; arm was really sore and this soreness went down to her elbow; she had a little headache that worsened; This is a spontaneous report from a contactable consumer (patient). A female patient (age:69; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history was covid previously (Patient thought she had covid previously and wanted to know if having covid made the side effects to the vaccine worse). Patient concomitant medications were not reported. Patient stated she received the first dose of the Pfizer covid 19 vaccine on 24Feb2021. Patient did not have symptoms until 30 hours later. Patient stated she had a little headache that worsened and the second day her shoulder was achy. She reported feeling wiped out and having heart palpitations. She reported her arm was really sore and this soreness went down to her elbow. She stated she did not rest after the vaccine and wanted to know if this is what caused her to have these side effects and is it normal to have late onset of these side effects. She stated she heard the side effects to the second dose are more severe. Patient wanted to know how much she would be protected if she did not get the second dose. There was no PQC (Product quality complaint). The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Swollen/tender lymph nodes under arm.  Swollen/tender breasts.  Very heavy menstrual flow. Took Tylenol, which didn't help much. Symptoms lasted approximately 2 weeks.
Patient c/o (L) arm being very swollen, red, painful and itchy 24 hours after varicella immunization given. During exam on 7-29-10, patient's (L) arm very tender and warm to the touch. See #12 for treatment.
Moderna booster vaccine administered 11/5/2021 with an expiration date of 10/11/2021. Inquiry  submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected between 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in the database lookup tool is 12/31/2069.  Patient contacted on 12/4/2021. No adverse effects reported.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 30Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have any known allergies. Concomitant medication(s) and other medication in 2 weeks included: GUAIFENESIN; NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Oct2022 to 05Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
3 1/2 x 2 cm red area right upper arm. Watch area, MOTRIN discomfort. No fever, no vomiting/diarrhea.
On 04/18/2022 I received my 2nd booster shot. My adverse event started on 04/21/2022-04/22/2022. When I woke up in the morning, I noticed a stye form on my right eye, whole size of my left swelled up, irritation, followed by a change in my vision. I treated with Erythromycin. It resolved within 5-6 days. Then I noticed my glasses weren't working any more. I saw there was change in my vision. I am going to my Optometrist for new prescription. On May 5 I had an Ophthalmologist exam which showed no change organically, but I still need new glasses which I will get it tomorrow. Even though I got a new prescription on Jan 20,2022. This vision change happened after my 2nd booster shot. I will be going to the Optometrist for my glasses tomorrow.
RASH ALL OVER THE BODY 2 HOURS AFTER VACCINE ADMINISTRATION.
Ischemic stroke on 10/14/2022.  Clot Buster within hour. Flown to larger hospital. ICU for 3 days.  Released home with change of meds, speech theraphy and oc.  No lasting weakness.  Occasional aphasia.  Agraphia.  For several weeks prior to stroke ocular migraine and upper back spasms
Patient reported feeling dizzy to store management approx 30 min after receiving vaccine. Patient had instant glucose monitoring device and was able to determine that her blood sugar was in the mid - 50's range. Cause of low blood sugar undetermined. Patient reported that she had eaten as normal that day. Report made to VAERS in order to have documentation of low blood sugar reading following vaccine.
One week after receiving my first covid 19 vaccine I developed a rash that started out as just a few red areas but is now approximately 4x3 inches.
Within about 12 hours of getting the vaccine, I started having chills, fever and severe body aches. I took extra strength Tylonol and those symptoms subsided within about 48 hours. The symptom that worries me is the tingling in both my arms that seems to get worse when I lay down. Each night since I received the vaccine, my arms have gone completely numb in the middle of the night. Once I move them repeatedly for about 5-10 min, the numbness goes away. Before the numbness starts, my arms usually begin to tingle.
Fever ranging from 100-102, body aches, chills and increased heart rate (110 bpm)--resolved 24-36 hours after onset
MIGRAINE ALL DAY; HEART RACING; ACHY; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported.  On an unspecified date, the subject experienced migraine all day, heart racing, achy, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine all day, heart racing, fever and achy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
SEVERE Vertigo - could not move my eyes or body for 3 days (had to remain in bed and use a paint bucket for elimination) Told to take heavy doses of Benedryl (given a prescription for extra strength) - that made me nauseas.  took nausea meds -  5 days later told by my PCP to take ADVIL or ALEVE to reduce swelling Could not drive for 2 weeks (turn my head quickly from side to safe/safely)  7 weeks out... I am still experiencing mild vertigo - from lying down on my back to sitting up or looking up to a ceiling ... or bending over and standing.  I DID NOT have heart pain/ trouble breathing or a rash of any kind
Tiny non- raised red spots covering both legs from knee down. Swelling and pain in joints especially hands and knees. General redness and mild itchyness throughout the body, fatigue, feeling winded and mild nausea, loss of appetite. Numbness and tingling crawling feeling in feet and hands. I had an appointment with my doctor 3 days after my vaccination and was told symptoms are transient. Symptoms started the day after my 2nd dose of hepatitis A vaccination and got worse the next three days. Symptoms are now slowly improving one week vaccination, but still present at the time I am writing report. Ice packs are extremely helpful in extremities. Keeping cool helpful.
p/vax pt exp fever of 100 w/swollen hands & feet;sx had progressed to erythema multiforme;presented to MD & was hosp;tx w/DPH;pt recovered & was discharged;
Pt recvd vax & exp pain & stiffness; pt recvd 2nd & 3rd dose of Hep B & the sx recurred p/each dose; No further details were provided;
The primary reporter is RN. The nurse is reporting the patient, who was intended to receive ZOSTAVAX, was inadvertently administered VARIVAX on 11/26/2012. The patient was then administered a single subcutaneous dose of ZOSTAVAX on 12/03/2012. No adverse effects reported. No further information provided.
46 year old woman who hasn't had a period in a year and a half (due to having an IUD in place) developed feminine bleeding akin to a monthly cycle (period).  This occurred 2 weeks after her Janssen vaccine.  She also developed what she called "ovarian pain" that preceded the bleeding.  Since that occurrence, she has had multiple rounds of spotting.  She finds this very strange and concerning considering she still has the IUD in.  The pain has resolved, but the spotting/bleeding has not.
A non-serious spontaneous report of pale, flushed, "breaths sounds like a rattle in her nose", fever, headache, loss of appetite, rash on cheeks and cough has been received from a parent of a child concerning a 34-month-old female subsequent to FLUMIST and H1N1 MONOVALENT vaccine, Intranasal. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 27-Oct-2009 and H1N1 MONOVALENT vaccine, Intranasal on 16-Oct-2009. On 29-Oct-2009 the patient stated daughter became ill with fever, headache, loss of appetite and pale. When the parent called to report the event on 04-Nov-2009 she stated her daughter is now flushed. The parent also stated the daughter has a little rash on her cheeks, has a cough due to a tickle in her throat and when she breaths it sounds like there is a rattle in her nose. The outcome of the event of pale did not resolve but the other events are all not recovered since the mother stated her daughter was still not feeling well. Required follow-up attempts have been performed, requested information unable to be obtained. 18-Feb-2010.
Light-to-medium breakthrough menstrual bleeding for four days after shot. I usually do not have periods due to the type of birth control pill I take.
10-15 minutes post injection I had a syncopal episode. Once I had awoken, I felt better but both of my hands began to tingle and quickly went numb. I then had another syncopal episode. Once I had awoken again, I had moderate body shakes. 911 was called. Once paramedics arrived on the scene, I was feeling better. My vitals were stable.
This case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 89-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. On 22nd October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, several days after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shortness of breath, sore throat and runny nose. On an unknown date, the outcome of the shortness of breath, sore throat and runny nose were unknown. It was unknown if the reporter considered the shortness of breath, sore throat and runny nose to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that she received a flu vaccine (unknown brand) and experienced shortness of breath, sore throat and a runny nose a few days later.
This case was reported by a consumer and described the occurrence of rash in a 4-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix), plus separate injections of 23-valent pneumococcal polysaccharide vaccine (Pneumovax) and Haemophilus influenzae type b conjugate vaccine. (Hib vaccine, non, unspecified manufacturer) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 18 April 2006 the subject received 2nd dose of Pediarix plus separate injections of Pneumovax (dose number not reported) and Hib vaccine (dose number not reported).On 18 April 2006, less than one day after vaccination with Hib vaccine, Pediarix and Pneumovax, the subject experienced rash, restlessness and pain. The subject was seen at a physician's office. At the time of initial reporting, 26 April 2006, the rash and pain had improved and the restlessness was ongoing.
About 2 1/2 days later, a rash started at the injection site. It was raised, bright red, itchy and some of it was blistered. There was also swelling at my injection site down to my elbow on the front side of my arm. About a week and a half later, it had spread across my arms, neck, chest, back, shoulder, sides and started going down my legs. The first doctor put me on a low dose steroid that didn't help. The second doctor wouldn't even touch me and sent me to the dermatologist. The dermatologist put me on Prednisone and a steroid cream. I also had to take Benadryl, Claritin and another OTC steroid cream. Once I got on the medication, it started to get better. I can still see where it started on my arm, but he did tell me that it would take a while for it to clear.
I made my arm sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received shingles shot 8 years ago).   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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as per vaccine indication. The patient had the shot 8 years ago. The physician advised the patient get the new one.  The patient had the 1st dose and the patient experienced  arm sore for a few days. The patient had time till end of February to get the last part.
Got Both doses, 6 months later  shingles/ Suspected vaccination failure; Received both doses of Shingrix and developed Shingles approximately 6 months later; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior history of shingles once or twice).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and unknown after receiving Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comments: The reporter had stated that an individual patient who had received both doses of Shingrix and developed Shingles approximately 6 months later.  No other information known on the patient. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
a VAQTA vaccine which had been improperly stored was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 28-DEC-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) (lot # T013204, expiration date 03-DEC-2021, 1 injection) for prophylaxis (product storage error). The temperature excursion was supported, at below 36 Fahrenheit degree (32.1 Fahrenheit degree) for 5 hours and 40 minutes. There were no previous excursions, and a data logger was used. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient came into pharmacy and had rash on injection site area. She said it was slightly itchy and is red. She went to emergency room was told it was fine. A reaction to injection. No medications/treatment was given. Not shingles.
Fever that reached 102 degrees took tylenol once.  Covid Like massive headaches (forehead and temples) for over three days resulting in difficulty with normal function and being bed ridden one day.  An egg sized red welt at the site of injection in the left arm that is still hard discolored and sore.  Muscle aches and pains particularly in the hands and the low back.
Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 14-Dec-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was on 26-Jun-2020. Number of fetus was found to be one.  Concomitant product also included coonid.   Treatment information was not provided.
mom reported sleeping alot today but can awaken;not eating only taking 20z at feeds;recv vax 7MAY97, no fever or crying;
Warmth, erythemic wheal about 14 mm diameter. Pain radiating into shoulder and down to elbow. Conservative treatment.
From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alternated between Tylenol and Advil to treat fever symptoms.
Developed 12 hours after vaccine administration. First chest discomfort, then with fever to 103 with rigors. Admitted to Hospital, cultures drawn and IV antibiotics administers and fever came down slowly over first 36 hours. Discharged on oral antibiotics.
Four red itchy lesions that looked like red pimples developed on the top of my right ankle and the top of that foot. Two were about the size of a grain of barley, two smaller. By the next day the two larger ones had formed little blisters in the center. A fifth lesions appeared on the top of the right foot. I also became very sleepy and lethargic. By Sunday 8/15/10 all five lesions were very red. Three of the five had developed blisters. Once the blisters burst on their own, the lesions started healing but continued to itch. By 8/16 all lesions began to heal and stopped itching. I stopped feeling drowsy and lethargic.