chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son had a 3 seizures. The first on 11/6 and the other two on 11/7. He was admitted to ICU with Doctors thinking the seizures were febrile related. He was taking motrin and tylenol to prevent fever and keppra for seizures. We stayed two nights in ICU. On 11/9 he broke out in a rash from head to toe. We were seen on 11/10 in the peds office and advised to stop Keppra as Dr was unsure if the rash was an allergic reaction to Keppra or if it was viral. The doctor advised me to put fill out this form at that appointment. We were seen in the office again 11/13. Rash is improving but is still present on his entire body. With having an abdnormal EEG in the hospital, the specialist was unable to say if seizures were viral or if my son has an underlying seizure disorder. We are to follow up with the pediatric neurologist and have a repeat EEG.
Received Tdap vaccine on 4-15-10. Left armpit sore on 4-16-10. No redness or swelling at injection site. Hoarseness started on 041810. Weakness, no energy, upset stomach (nausea, no vomiting). Low grade fever on 041810. No Md present.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/6/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/6/2023 BPH (BENIGN PROSTATIC HYPERPLASIA)  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/6/2023 HEMORRHOID
Needle separated from hub; Partial dose; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and where in needle separated from hub and received partial dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 26-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On 26-Jan-2021, while patient was receiving vaccine, in the middle of administration the needle got separated from the hub and patient received partial dose. The exact volume was unknown. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, needle separated from hub and partial dose was considered resolved on 26-Jan-2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Underdose without any associated adverse events.
Tinnitus  starting 2 hours post-vaccination (possibly earlier but I was outside) and still ongoing. Appears to be fluctuating in intensity but has been persistent.
Patient immediately had an inflammatory reaction after immuzation was given at injection site. Patient then began to sweat and then got nauseous and vomited.
Slipped and hurt ankle, fractured mildly displace fibula; This spontaneous case was reported by a consumer and describes the occurrence of FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula). At the time of the report, FIBULA FRACTURE (Slipped and hurt ankle, fractured mildly displace fibula) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) fractured mildly displace fibula.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Within one hour of receiving HPV vaccine pt developed (L) hip cramping & stiffness that have continued since, thus far <24 hours. No injury, no new activity or exercise. Pt states discomfort due to vaccine.
The pt developed a 9cm x 9cm are of erythema, warm to touch at site of DTaP and IPV injections.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and muscle soreness. On an unknown date, the outcome of the fever and muscle soreness were unknown. It was unknown if the reporter considered the fever and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient chatted in to inquire about side effects of the 2nd dose of SHINGRIX. The patient mentioned a slight fever and soreness. Chat transcript disappeared due to technology glitch so unable to confirm details, the information provided was all that could be remembered.
Swollen arm( 3 inch circle), red, painful, diarrhea, lethargy. Took Tylenol 1000mg prn for pain, Alternated heat & cold to arm for two days, Nothing for diarrhea
This literature marketed report has been received from the authors of the published literature article, refers to a 78 year old male patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, lot # and expiry date were not provided). On an unknown date, the patient presented with a diffuse pruritic rash 1 day after receiving polyvalent (23-valent)(manufacturer unknown). The rash had initially developed over his right arm but had spread to involve other parts of his body. Physical examination was significant for a diffuse erythematous, non-dermatomal papular rash on the scalp, face, chest, back, abdomen, groin, and bilateral upper and lower extremities. Fluid filled vesicles were not noted. A left periorbital edema was also noted. Biopsy revealed a small intraepidermal blister with degenerated keratinocytes showing multinucleation and chromatin margination, which were highlighted by Varicella-zoster virus (VZV) immunostain. Tissue culture was also positive for VZV, confirming the diagnosis of Disseminated Cutaneous Herpes Zoster. The outcome of the event was unknown. The authors considered the event of Disseminated Cutaneous Herpes Zoster to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown). Upon internal review the event of Disseminated Cutaneous Herpes Zoster was considered to be medically significant.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: First BP reading was 108/49 pulse 45 at 4:08pm and second reading was 122/77 pulse 76. Patient experienced profused sweating, dizziness, and hypotension. After hydrating and laying down he gradually felt better.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 17 year old female who was vaccinated with GARDASIL. Concomitant vaccinations included DTAP and MENACTRA. Subsequently the patient fainted. The patient recovered on an unspecified date. This is one of two patients reported from the same source. Additional information has been requested.
Broke out in a rash all over face, trunk of body, arms and legs Ran a temperature from 99-101 A lot of swelling on face, especially eyes and ears Itched Dry skin
Fever - started 4 hours after receiving vaccine. Temp: 104 (tympanic) in office today. Decreased PO/, still febrile now (28 hours after receiving vaccine).
77-year-old male with past medical history of hypertension, hyperlipidemia, diabetes mellitus, nicotine dependence, and depression presented to the emergency department complaints of worsening weakness.  Patient was usual state of health until approximately few days ago when he started having weakness and flank pain.  Patient came to the emergency department at that time.  He was diagnosed with urinary tract infection and was discharged with a prescription for Keflex.  Patient also had a CT abdomen due to transaminitis which was negative.  Patient was discharged and over the last few days, has had significant worsening in his weakness.  Has had multiple falls.  Over the last 24 hours, patient's weakness has room medically worsened and he has been having a hard time doing basic activities such as getting up from the toilet seat.  Last night, patient laid down on the bathroom floor for over 40 minutes as he was unable to get up.  Eventually was able to do so with the help of his wife and grandson. His wife was worried therefore, brought him to the emergency department for further evaluation.   Upon arrival to the emergency department, patient was found to have COVID-19 pneumonia. Chest x-ray consistent with atypical multifocal pneumonia.  CT head otherwise unremarkable for any acute intracranial process.  Lab work negative for leukocytosis.  Patient did have anemia and thrombocytopenia.  Rest of the lab work consistent with hyperglycemia, hypoalbuminemia, hypomagnesemia, transaminitis, and hyperbilirubinemia.  Also noted to have significantly elevated alkaline phosphatase levels.  Patient reports that at baseline, he is able to exercise and works in his yd and mows his lawn.  Has not been able to do any of this in over the past week.  Patient reports that he has had no shortness of breath however, does have some nonproductive cough.  No nausea/vomiting/diarrhea.  Patient reports that he gets occasional fevers/chills/shakes.                 Of note, patient had CT abdomen on 09/10/2021 were common bile duct was noted to be normal caliber.  In the emergency department today, patient ambulated to the bathroom and back and maintain his O2 saturations on room air. Tested positive on 9/16/2021
Information has been received from a physician's assistant concerning a male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and "now", on 22 February 2006, has breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Swelling near the ribs; Resulting in pain; Experienced neurological symptoms; This is a spontaneous report from two contactable consumers via a Pfizer colleague. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included comorbidity of celiac disease. The patient's concomitant medications were not reported. Patient had experienced neurological symptoms and swelling near the ribs, resulting in pain since the administration of the vaccine in Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician stating that one of his colleagues has received a phone call concerning a female patient who on an unspecified date, was vaccinated with GARDASIL.  Subsequently, the patient was paralyzed after vaccination.  The patient sought for unspecified medical attention.  No additional information is available at this time.  Upon internal review, paralysis was considered to be an other important medical event.  No further information is available.
pt recv vax in OCT or NOV96;an unk # of pt were vaccinated w/flu vax;12DEC96 over 40 pt devel the flu however it is not known how many of thee pt recv flu;
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (doses, frequencies and route were not reported, lot # L016283 with expiration date: 07-AUG-2016; lot#K010630 with expiration date: 30-OCT-2015). IT was unknown which lots # of ZOSTAVAX were administered. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Pt states she had 3.5 inch by 2.5 inch bruise surrounding injection site as well as a red itchy rash above and below injection site.
Hepatitis A vaccine given when VARICELLA was needed.  Patient's mother contacted.  Patient scheduled to receive correct vaccine 4-1-10.
Early Saturday morning I felt intense pain around the injection site, slight swelling from shoulder to wrist and muscle pain. There was also a knot and heat around the injection site. Pain is only now starting to subside but still uncomfortable. No other symptoms prior.
Patient was taken to ER approximately 6:00 12/5/07.  Had swollen arm with red area.  States swelling has gone down a lot.  Right arm circumference 12/6/07, arm 9" 25 mm red area at varicella site.  Instructed use of cold compresses 10 minutes on 10 minutes off several times a day.  Take Tylenol for age, weight.
had this reaction to the DTap / at 2 months old / whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a 21-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown.   It was unknown if the reporter considered the pertussis to be related to DTaP vaccine.  Additional details were provided as follows: The patient received DTaP vaccine and had pertussis. The patient never had the vaccine again or whooping cough.
BP 122/94, P132, R28, T99.5, n/v, tingling, SOB, tachycardia secondary to dehydration began 5NOV96 pt adm for tx;t102.3 on admission;
MIGRAINE, NAUSEA, VOMITING, DIZZINESS, FEVER, CHILLS, DIARHEA, FATIGUE
Patient aged 7 months received product that was licensed for ages 4-6yrs of age and for DTaP #5, IPV#4. Patient did not have any adverse side effects due to the medication error. Error was discovered by the immunization coordinator upon doing charting audits.
Patient stated she felt fine when she got home and about 2 hours later she started to feel funny. Her abdomen became distended, her eyes felt funny and her esophagus felt like it was a little swollen. The patient waiting several hours after the symptoms began to see if they would go away but headed to the emergency that evening when the symptoms didn't resolve. She was treated with IV steroids and BENADRYL. She immediately started feeling better and when I followed up with the patient this morning (8/15) she was at home.
she was expecting her menstrual cycle, but is 4 days late.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 13:00 (Lot number: EW0198) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Pfizer Covid 19 Vaccine: First Dose: 11Jun2021, LOT: EW0181, Expiry Date: Unknown, NDC: Unknown, Route, Anatomical Location: Not provided, No. of Previous Doses: one, Date: 11Jun2021, Age at Immunization if date not available: 29 years old), administration date: 11Jun2021, when the patient was 29 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 15Jul2021, outcome "not recovered", described as "she was expecting her menstrual cycle, but is 4 days late.".  Additional information: The patient states it was supposed to be around 15Jul2021, she usually had a 28 day cycle and now it seems to be 31 or something, The patient still waiting. Prior Vaccinations (within 4 weeks) patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
101 degree fever shakes and shivers Sweats Dizziness Fatigue Vomiting Headache   The tiredness hit at 11am the day of the vaccine, the rest of the systems started occurring around 10pm that night. Symptoms continued until the next morning when primary health gate provider was contacted and ibuprofen regimen was started. Ibuprofen lightened all of the systems except the tiredness and nausea.
4/15- Had what looked to be heat rash on arms in the morning. Took benadryl before bed.  4/16- Woke up with head to toe rash and swollen. Went to emergency remove. Received steroids. Redness and swollen reduced by afternoon.  4/17- Woke up with redness head to toe and lips swollen. Fingers tingly and soreness throughout body.
Pt received Pfizer bivalent and fluad quad on 12/17/22. Pt called on 12/20/22 stating on 12/18/22 pt awoke feeling dizzy and shortness of breath. Pt went to urgent care oxygen levels were normal but cardiac enzyme were "off" and thus told he may have suffered a heart attack. the urgent care suggested doing a cat scan but did not conduct it because pt has stage 3 kidney disease. Pt proceeded to visit hospital, also cat scan not conducted due to stage 3 kidney disease and diabetic. Upon reassessing enzyme levels were normal and after 6 hours of observation pt was released from hospital. On 12/20/22 pt states he feels better today.
49 yo F with a history of right-sided Bell's Palsy following Botox injections for Migraine HA (3 years ago) presenting with (mild) right-sided facial droop x 5 days s/p first dose of vaccination with (Moderna) COVID-19 vaccination on 21 JAN 2021 at approximately 1200. Injection site was left deltoid. Symptoms started on morning of 22 JAN 2022. No other vaccine given within 1 month of COVID-19 vaccine. No treatment indicated at this time. Pt will follow up with provider in 1-2 weeks.
Caller states he was doing fine this morning until he looked at his card and started to panic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANIC REACTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "Caller states he was doing fine this morning until he looked at his card and started to panic". Additional information: Patient received first dose on 20Feb2021. He was told his second dose was scheduled for 31Mar2021. His card said second dose was due 13Mar2021. He did not receive second dose on 13Mar2021. He checked his vaccine card today, and on the back of his card it said he should have taken his second dose on 13Mar2021. The patient was also asking what should he do about this. He was doing fine this morning until he looked at his card and started to panic. He went for his first dose of the covid vaccine on 20Feb2021. After receiving the first dose of the covid vaccine, the gentlemen that the patient spoke too, who was very professional said to him, he will see him on 31Mar2021. Then patient had to go over and sit for 15-20 minutes to make sure he was okay, before excusing himself to his car. He talked to the nurse, and the nurse also told him she would see him on 31Mar2021. So now he was getting his stuff together because 31Mar2021 was right around the corner. He flipped the card over and the card said 13Mar2021. He was asking if 13Mar2021 was the date that he was supposed to get the second dose of the covid vaccine. He was not sure what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning an around age of 10-13 year old male who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported). Subsequently the patient experienced a small seizure and fainted. It was unknown if the patient sought medical attention. At the time of this report, the outcome of the events was unknown. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Onset papular rash 2 wks after vaccine discrete lesions, 1 vesicular - dx atypical varicella secondary vaccine. Tx BENADRYL.
no sign and symptoms at this time. Sister tested positive for covid few days back and this time she herself got tested  for covid.  Is positive for covid-19 in Rapid Antigen
Initial unsolicited case received from a consumer on 24 November 2014, during routine media monitoring. Five patients, whose ages and genders were not reported, received Influenza vaccine (manufacturer and lot numbers not reported) on 07 November 2014. It was reported that the patients immediately developed a fever, and all died within one week of vaccination. No additional information pertaining to the patients was reported. Documents held by sender: None.
Patient presented to emergency department on 11/21/2021 with weakness and shortness of breath for 2 weeks. She was admitted for further management. Patient was treated with dexamethasone, baricitinib and supplemental oxygen. Her oxygen requirements increased and patient was intubated on 12/7/2021. Patient's condition did not improve and was made comfort measures only on 12/20/2021. Patient expired on 12/20/2021 from complications due to COVID-19 infection.
R arm + blisters at site of HPV vaccine + red but not today.  L arm swollen, red, painful, itchy likely cellulitis.  Fever yesterday.  Treatment BENADRYL, KEFLEX.
pt rcvd vax & developed syncopal episode w/in 10mn; EMS called; pt transported to MD; pt had another syncopal episode in car on way home; EMS called again & Pt transported;
Only symptom was uncontrollable shaking for about 15 min about 4 hrs after immunization. Feeling better the next day 10-8-11.
Per mother approx 24 hrs after receiving Fluzone injection, pt developed a "strawberry type rash" that looked like "wind-burn" that was very pruritic. Involved area included injection site left deltoid, left face, neck and hairline. No respiratory involvement or compromise, no fever. Benadryl topical very helpful in alleviating itch. All S/S resolved 24 hrs after onset.