chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parents stated patient had fever x2 days starting on 05/07/2014 reaching 40 C. They returned to the clinic on 05/07/2014 for another test and informed the RN. RN took the patient's temperature and it was 98.4. Recommended for parents to seek medical attention for evaluation. The parents stated they then administered anti-pyretics but it did not relieve the fever. On the 3rd day after the shot, they noticed blood in his urine and took him to the emergency room. There, the patient was given IV fluids and anti-pyretics. They then transferred him to another hopsital and was admitted on 05/08/2014 for 2 days. They also complained that the patient's left arm where Tdap was administered was "red and swollen."
Hep A was given at 6 mos of age INSTEAD of using Hep B. Dr called and spoke to mom. No signs of adverse reactions.
I have had pneumonia for three months, since I received the pneumonia vaccine.  I have take two courses of Cipro and 3 courses of Levaquin and I'm still stick.  I was in the ER yesterday all day!
Debilitating fever as high as 102, chills, sweating, weakness (unable to pick up 3 month old baby), significant joint pain, headache for days
Left thigh red, raised and warm to touch (fever). 8cm x 7cm circular, right eye swollen. Only DTaP given left thigh 9/8/03. Rash - cheeks, arms and pelvic area. Cont. rash and left thigh. Instructed to take to PMD for evaluation-suggest Benadryl.
Collapsed had slurred speech, then passed out x 2; approx 30 & 35min p/vax; MD gave DPH;
Patient was administered expired flu vaccine consulted with district, state, authority, and manufacturer-revaccinated 10/05/06 no problem from expired flu vaccine.
During a vaccine clinic, a 17 year old patient was inadvertently given the Janssen Covid-19 vaccine which is approved for 18 years and older.  The patient was observed for the required 15 minutes post vaccination; no adverse events observed.
Around the middle of the day he had a sore throat, headache and fatigue. We completed a rapid test at home which was positive. The next morning he had a fever of 102.5. He  had nausea, dizziness, sore throat, and cough. He started having burning while urinating and the doctor indicated he was dehydrated. He continued to feel bad about 11 days and on the last day he had a severe headache and nausea so we took him to urgent care. He continued having fatigue for about 2-3 more days but was feeling better in other the other areas. He completely recovered within about a 2 weeks.
Diffuse urticarial rash beginning approx. 18 hours post first injection. Presented to urgent care 72 hours post injection. No airway or anaphylaxis symptoms.
Narrative: Fully vaccinated, COVID positive on admission incidentally for hypoglycemia. Patient was asymptomatic.
patient contacted pharmacy 4/19/21 to report localized rash surrounding injection site.   Not receiving medical treatment for rash at this time
Patient lost consciousness shortly after vaccination and did not recover until 30-60 seconds passed. Once aware again, he was very tired. He then vomited numerous times, therefore monitored for 1 hour. Patient left facility on his own accord.
Patient was admitted for profound weakness.  She has had several day history of nausea and vomiting.  Also shortness of breath and upper airway congestion.  On arrival to the emergency department she was fatigued appearing but nontoxic.  She did have a workup which included a COVID-19 test which was positive.
Developed headache soon after receiving second Shingrix dose.  Headache persisted for 2 days, and pt then developed an itchy urticarial rash over neck, chest, and abdomen
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown dates, the patient were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017; dose and route were unknown). The excursion temperature was 34.9 Fahrenheit degree for 22 hours. No data logger was involved. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Additional information has been requested.
Pretty strong itching from my waist down; Body aches; Tingling where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pretty strong itching from my waist down), INJECTION SITE PARAESTHESIA (Tingling where I got the shot) and PAIN (Body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dry skin.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tingling where I got the shot). On 03-Feb-2021, the patient experienced PAIN (Body aches). On 05-Feb-2021, the patient experienced PRURITUS (Pretty strong itching from my waist down). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for General body pain, at a dose of UNK dosage form. On 04-Feb-2021, PAIN (Body aches) had resolved. On 08-Feb-2021, PRURITUS (Pretty strong itching from my waist down) had resolved. At the time of the report, INJECTION SITE PARAESTHESIA (Tingling where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient used an unspecified lotion to treat itching.
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No information was reported on date of the storage of vaccine in refrigerator. Vaccine was expired on 09-Nov-2021.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow-up received.
swollen lips and cheeks/Lips got very swollen; swollen lips and cheeks/bottom of cheeks on his face swollen; body aches/Did not feel good all over and was achy; Did not feel good all over and was achy; Neck ache going up to head; Neck ache going up to head; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (reporter's husband) who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EN6205) on 06Mar2021 (at the age of 72-year-old) intramuscularly in arm left at single dose for COVID-19 immunisation. Relevant medical history included arthritis in his neck. Concomitant medications were not reported. The patient experienced not feeling good all over and was achy on 12Mar2021, neck ache going up to head on 12Mar2021, lips got very swollen on 12Mar2021, bottom of cheeks on his face swollen on 12Mar2021. Clinical course was provided as follows. The reporting consumer and her husband both received first dose of vaccine on 06Mar2021. Her husband did not feel good all over and was achy. His neck up to his head was also achy. His lips got very swollen and bottom cheeks of his face were also swollen. They were supposed to go for second shot on Saturday 27Mar2021. Swelling improved within 2 days. They did go through COVID test through this and both tested negative. At first they thought it was the virus. The patient has arthritis in his neck and thought it was a reaction from the vaccine because he was not having any issues before. She thought he was having a stroke. No ER or physician's office was required. On Saturday 13Mar2021, the patient went to his Primary Care physician. No other medical treatment other than taking Pepcid 20mg and Benadryl 25mg 2 tablets orally, both taken from 13Mar2021 to help with symptoms. The events were resolving at the time of report.
45 minutes following the injection, diziness and near fainting.Within a few hours, severe arm pain, limiting range of motion to about 30%. The day after the injection experienced diarrhea all day, as well as ongoing severe arm pain, limited range of motion to aprox 30%.
Pentacel and Quadracel were both administered to a 4 month old patient on the same day, no AE; Pentacel and Quadracel were both administered to a 4 month old patient on the same day, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old patient (gender unknown) received a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on the same day (lot number and expiry date not reported) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was a case of actual medication error due to inappropriate age at vaccine administration and extra dose administered.  At the time of reporting, 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.  Information on the batch number was requested.
it was warm; It went and then came back from a very small red lump to about 6 CM in diameter; Large red lump; Large red lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Large red lump), INJECTION SITE INDURATION (Large red lump), INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunisation.     No Medical History Information was reported.     On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump). On an unknown date, the patient experienced INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter). On 05-Jan-2021, ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump) outcome was unknown. At the time of the report, INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Large red lump), INJECTION SITE INDURATION (Large red lump), INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunisation.     No Medical History Information was reported.     On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump). On an unknown date, the patient experienced INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter). On 05-Jan-2021, ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump) outcome was unknown. At the time of the report, INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
patient die from flu vaccine; Initial information was received on 20-Nov-2020 regarding an unsolicited valid serious case from the consumer or non-health care professional (patient's friend) via social media.   This case involves an unknown demographic patient who died (death), after vaccination with INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. Also, this (death) event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, it was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient of unknown age who died (death) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination, concomitant therapy, allergic history, previous vaccination and tolerance, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: patient die from flu vaccine
Systemic: Dizziness / Lightheadedness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Rph Iman gave vaccine, approx 5 min later pt stated feeling nauseous, tired and warm. Pt was instructed to elevate feet. 1st BP was taken (67/34) HR 62. 10 min later 2nd BP was taken (97/50) HR 80 and pt stated feeling better and left with no side effects.
The patient is a 59-year-old male with history of Parkinson's disease, anxiety, bipolar disorder, hypertension, and type 2 diabetes who presents to the emergency department with 6 days of feeling unwell.  The patient reports generalized malaise, body aches, nausea, decreased oral intake.  He has a cough that is slightly productive and actually was started on antibiotics at the urgent care center a few days ago.  His symptoms worsened and he went to a different urgent care center and had a Covid test yesterday which was positive.  Patient did not get treatment and left on the same day.
Cellulite at the injection site; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cellulite at the injection site on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of cellulite at the injection site/vaccination site cellulitis cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
two-month-old patient was mistakenly administered a quadracel vaccine with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient and it was reported that mistakenly administered a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar); rotavirus vaccine; and hepatitis B vaccine all for Prophylactic vaccination.  On 23-Jan-2023, two-month-old patient was mistakenly administered 0.5 mL of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] suspension for injection (batch/lot number: UJ737AA, expiry date: 18-Sep-2023, strength: standard; 1X) via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Fever the lasted for three days. Temperature fluctuating between 100.4 and 103.3. Headache, eye sensitivity. When fever subsided small rash over body. Swollen glands.
Patient says she has headache and pain and numbness on left side -same side vaccine was administered on. Patient's mom called for ambulance & went to hospital. 8/16 - patient came into store and she was fine.
Patient was very anxious and has a history of rash with nerves. Patient got a rash 10 minutes after vaccine and then a headache. Patient did not need treatment at pharmacy. He took Benadryl and Tylenol at home. Rash remains by end of night but has not gotten worse. The rash is not itchy.
dizziness, shaking, tremor, elevated BP, anxiety, cold to touch from 09:59 AM to 10:15 AM, shakiness was still going on but patient left the pharmacy area
patient had immediate allergic reaction within an hour to dose 1, facial and lip swelling, went to outside clinic but closed, symptoms went away in 4 hours so did not go to clinic
Beginning 5/6/21, I began to experience tinnitus which became worse each day until 5/9/21 and has remained constant since.  It is high-pitched (akin to the sound from a CRT monitor) and seems to come from the right ear.  It becomes louder if I open my jaw all the way, shift my jaw to the left, or look straight up by turning my head.  It will occasionally flare up loudly for a minute or so (possibly from head movements, but I haven't been able to reliably replicate the exact conditions for this).
Received An Expired Dose of Heplisav-B; Initial Report Received on 14-Oct-2022  This is a spontaneous report, received from a nurse regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported.  Concomitant medications were not reported.  On 11-Oct-2022, dose 1 of HEPLISAV B (Lot #935843, expiration date 08-Oct-2022, NDC # unknown), intramuscular in the right deltoid for hepatitis B immunisation.   The dose was 3 days past the expiration date. No adverse reactions were reported by the patient.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
In March and April of 2021, we noticed a significant regression in patient's speech. He began to echo and script almost all of the time, and he struggled to answer yes/no questions or articulate simple choices (which he had previously been able to do). This problem persisted until September of 2021 after we removed baker's yeast from his diet. He also has been in speech therapy since May 2021, but his speech therapist has noticed the significant change since removing the yeast. We realized that saccharomyces cerevisiae (baker's yeast) is used in the Hep B vaccine, so we decided to report this adverse event.
Fever, Chills, Body Aches, Swelling from injection site in left arm through shoulder down to rib cage
This spontaneous report was received from a medical assistant and refers to a 2 months old female patient with pertinent medical history which was not reported at the time of the report and none drug reactions or allergies. The patient concomitant therapies were not reported. On 16-FEB-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, (dose was not reported) for routine vaccination. On the same date after vaccination, the patient proceeded to projectile vomit. The patient was then administered a second dose of ROTATEQ and within 5 seconds the patient projectile vomited again. No treatment was given for the event and none laboratories diagnostics were performed. At the time of the report, the patient recovered from the projectile vomit on 16-FEB-2017. The relatedness between the event and therapy with ROTATEQ was not reported. Additional information has been requested.
Starting at day 5 post vaccine develped:  Itching at injection site, progressed to itching, redness, hive like area, hot to the touch that involved upper left arm from shoulder to above the elbow. Went to  urgent care, was prescribed a steroid cream, Triamcinolone Acetonide Applied this to the area 2 times per day.  Reaction resolved in 2-3 days after using the cream.