chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 101; Chills; loose watery stool; stomach problems; threw up a couple of times; headache; Nausea; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration on 05Jan2021 at a single dose (with a syringe left shoulder once; as reported) for Covid protection. Medical history was reported as none. There were no concomitant medications. It was reported that the patient experienced side effects on first Pfizer Covid injection that he had. He got it on Tuesday, 05Jan2021, and got a headache and nausea which started Tuesday evening. His temperature is 99.6. On Thursday, 07Jan2021, he had a fever of 101, nausea, chills, loose watery stool, stomach problems and threw up a couple times. He was under a blanket for the chills all day. His lasting effects was that he still has watery loose stool and went to the bathroom an hour ago. He took Tylenol for fever. He took Immodium yesterday three tablets and woke up at 3-3:30 am and took a couple (also reported as started taking it at 11am then took some at 4am and then two this morning) then some Tylenol. He was still feverish and has loose stools. The patient underwent lab tests and procedures which included body temperature: 99.6 on an unspecified date and 101 on 07Jan2021. The outcome of the events headache, nausea and loose watery stool was not recovered; the events fever of 101 and chills was recovering; and the event threw up a couple of times was resolved on 07Jan2021; while the outcome of all other events was unknown.
This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients' were vaccinated with improperly stored M-M-R II (lot # L036851, expiry date 23-SEP-2017, lot# L039551 expiry date 07-OCT-2017, lot# M004063 expiry date 25-JAN-2018). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Unknown if Bexsero or Trumenba. Patient was seen at another clinic for sports physical and MenB vaccination on 7/10/23. Developed localized soreness and dizziness/nausea that evening lasting through 7/12/23. Called PCP and was advised to be checked at this clinic. Localized swelling and mild erythema at injection site.  No systemic swelling, no difficulty breathing, no wheezes, no fever.
Chilling and shaking for about 1 hour. Covered with 3 blankets, even though the room was 74 degrees.  This stopped on its own and I felt fine after that.
Rash & UrticariaPruritus Narrative:  Developed quarter sized circular rash over injection site 7 days after  receipt, which persisted for 3x days. Resolution a/w topical hydrocortisone. Described as pruritic, erythematous and warm to touch. Unknown if indurated. No associated hives, flushing, swelling, sloughing or other adverse effects noted.
HIVES; SHORTNESS OF BREATH; RASH; A spontaneous report has been received from a consumer. The report concerns a male patient.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number CH2023) 0.2 ml once/single administration, via nasal route, during 2014.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced mild hives (preferred term: Urticaria). On an unknown date, the patient experienced mild shortness of breath (preferred term: Dyspnoea). On an unknown date, the patient experienced mild rash (preferred term: Rash).     The patient recovered from the event(s) of shortness of breath on an unspecified date. The outcome of the event(s) of hives and rash was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Patient received the HPV/GARDASIL vaccine on August 3, 2017. He had a case of diarrhea that occurred on August 11, 2017, and continued from that day forth. The condition gradually worsen. Thinking that it may just have been a virus, we did not seek immediate attention. But when it continued for a month, we began looking into seeing his doctor to figure out what was causing it. He began bleeding from the rectum in October. October 3, 2017-saw PA at clinic. Ordered O/P stool culture. October 9, 2017- follow-up appointment with PA at clinics. Negative results for Salmonella, Shigella, Campy, S aureus, E Coli 0157, STEC, Yersinia, Aeromonas, Plesiomonas, or Vibrio. October 10, 2017-saw Dr. from gastrology clinic. Scheduled MRI to look at appendix to approve colonoscopy. October 17, 2017-ER visit to Hospital. Ran bloodwork and was dismissed later that evening with no results. October 19, 2017-admitted to Hospital by Dr. for colonoscopy the next day. October 20, 2017-patient was diagnosed with ulcerative colitis and C Diff from colonoscopy results. Began on Prednisone and FLAGYL (7 day dose). November 13, 2017-follow-up appointment with Dr. January 26, 2018-follow-up appointment with Dr. Began ulcerative colitis medication regimen. February 25, 2018-appointment with Dr. December 21, 2018-first iron infusion. January 2, 2019-second iron infusion. January 7-11, 2019-hospitalization for severe GI virus. Lost 15 pounds in several weeks. January 17, 2019-second colonoscopy to confirm that his ulcerative colitis is severely worse. January 31, 2019-follow up with Dr. February 6, 2019-follow up with Dr.
Pt called dept to say her eyelids and face were swollen, she attributed it to hepatitis B vaccine. Said she had a milder reaction when she previously received hep B: mild eyelid swelling 1 week post vaccination. Note: she also received TD at the same time, both occasions.
This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 14:58 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
patient felt like her tongue and lips were tingly, then patient developed pain in her right arm that radiated to her head
Headache, Myalgia, FATIGUE AND ABD DISCOMFORT Narrative:  developed myalgias, headache and fatigue on 1/8, those symptoms resolved with tylenol , but also developed abdominal discomfort and went to local ED, was told unclear if related to covid vaccine , was given tylenol and stomach medication, with some improvement , has follow up with her PCP and an abd US scheduled
three patients who got 6 doses injected at one time and overdose; she had administered the vaccine with the administration error; diarrhea; reported 2 nights of fever; nausea; This is a spontaneous report from a contactable Physician reported for a male patient. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number: EWO187; Expiration Date: 31Aug2021) via an unspecified route of administration on 17Aug2021 as dose 1, single (age at vaccination: 16 years) for COVID-19 immunisation. Medical history included COVID-19 from 20May2021 to an unknown date the patient previous had Covid around 20May2021 and recuperated at home and was not hospitalized. Concomitant medications were not reported. No prior vaccinations. On an unspecified date, it was reported that they have three patients (16 years old male, 23 years old female, and 37-year-old female) who got 6 doses injected at one time and overdose. She wanted to know if we have information on this situation and what advice can she give to her patients and had already contacted the CDC and made a VAERS report and followed their internal policy processing and will be notifying the patients and asked if there some adverse reaction they should look for following the event. On 17Aug2021, it was reported 2 nights of fever, nausea, diarrhea and is feeling better today 20Aug2021. No additional medical care or treatment was sought. For the overdose event, HCP reporter suspects full vial of diluted vaccine was administered. Her nurse prepared all the vaccines the same way and realized she had administered the vaccine with the administration error. They had been giving Moderna and JNJ covid vaccines prior to this day, and that was the first time administering Pfizer's. The clinical outcome of the event three patients who got 6 doses injected at one time and overdose, she had administered the vaccine with the administration error was unknown and rest of the events on 20Aug2021 was resolved.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101066605 same reporter/drug/event with different patient
inadvertently administered a dose of MenQuadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching minimum temperature of 30 degrees F with no AE; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old male patient who was inadvertently administered a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine (Menquadfi) that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching minimum temperature of 30 degrees f with no ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL) for Prophylactic vaccination.  On 10-Feb-2023, the patient inadvertently received Total 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (lot number: U7594AC, strength, formulation, expiry date: Unknown) via intramuscular route in the right deltoid for Immunisation had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching minimum temperature of 30 degrees f with no ae (poor quality product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event inadvertently administered a dose of menquadfi that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching minimum temperature of 30 degrees f with no ae.  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 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.; Sender's Comments:  01489379: 01493585: 01493618: 01493871: 01493882: 01493896: 01495050: 01495112: 01495133: 01495161: 01495184: 01495203: 01495215: 01495235: 01495279: 01495295: 01495310: US-SA-2023SA056272:01493906
This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, route of administration, anatomical location and lot# was unknown) which were stored improperly. Concomitant medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected as reporter was not willing to be contacted.
minimal erythematous & swelling on (R) upper arm - Second to tdap vacc
No additional AE information; Patient Date of Birth: 09/12/2003/ during that time the vaccines were administered to patients/ AE Onset Date: 2/23/2021; temperature excursion for PROQUAD/ Temperature: -10C; This spontaneous report was received from an office manager referring to a 17-year-old patient whose gender was not reported. The office manager did not provide information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.   On 16-FEB-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (lot number T027111, expiration date 07-FEB-2022, which were verified as valid) went through a temperature excursion of -10 degrees Celsius (C) for a timeframe of 1 hour and 15 minutes (product storage error). There was no previous temperature excursion, and a data logger did not detect the temperature excursion.   On 23-FEB-2021 (also reported as "during that time"), the vaccine was administered to the patient, 0.5 milliliters (ml), as prophylaxis (product use issue) (formulation, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not reported).   No additional adverse event (AE) information was reported (no adverse event). The office manager facility reported the excursion to The program.
4 days after began to have crohns flare (cramping, bleeding,bloating, etc) as well as joint pain
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Numerous maculopapular lesions on trunk and back in different stages.  Diagnosis-Varicella; Treatment-Acyclovir.
Pt began feeling hot and shaky 25min after vaccination.  Pt noticed blotchy skin to upper chest. No signs of hives. No further complaint.
Site: Pain at Injection Site-Medium, Systemic: pt said her arm tingled from elbow to hand then spread to shoulder-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Pt developed fever 101.7. 15 cm area of redness, tenderness, and swelling. Localized just to vaccine location. Treated with oral MOTRIN and BENADRYL, ice
Swollen Aux lymph nodes under both arms. Larger on the left side.  Swollen for more than 3 months out from vaccine.
Pt received vaccine yesterday and developed red, swelling around injection site next morning. Swelling increased as day progressed. No fever, wheeze, facial edema.
Severe lower jaw pain began one and a half weeks after injection.  Pain has improved but is still present after 12 days. At the same time I developed, and continue to have, some facial swelling. I have also developed severe neck, shoulder and arm pain.  On 2/12, I began to have a higher than normal temperature.  The high has been 100.2, which I recognize is not technically a fever, but for me it is very high and very unusual.  I also seem to have sinusitis with facial pain and headache.
Mom states infant began crying and vomiting about 2 hours, post vax. She was unable to console pt. She gave Pedialyte and called MD. Was told to give Tylenol and call back if symptoms continued. She called MD and talked with nurse who told her to go to the ER and call UCHD in the morning. She called EMT at 10:30. They did not transport pt. Pt fell asleep.
Arm became red and swollen from injection so to elbow and to the axilla area. Reaction began the day following vaccine administration. Patient stated that at doctor visit was told it was an allergic reaction.
Pustules on left shoulder and left leg. Ruptured pustules on left wrist. Developing rash on right shoulder.
redness around the injection site, she describes the redness as spread and with blisters; redness around the injection site, she describes the redness as spread and with blisters; This is a spontaneous report from a contactable Other HCP reporting for herself. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 08Jan2021 and is experiencing a lot of redness around the injection site, she describes the redness as spread and with blisters. Onset date of the events was 08Jan2021. She wanted to know if there's information about this side effects. The outcome of the events was unknown.  Information on lot/ Batch number has been requested.
MODERNA FOR AGES 18 AND OLDER ADMINISTERED TO 17 YEAR OLD FEMALE.  NO ADVERSE EVENTS EXPERIENCED DURING 30 MINUTES FOLLOWING ADMINISTRATION.
On 08/17/2023 Employee noticed that she was having pain above L eye brow/temple. she went to urgent care where Employee  states that the provider diagnosed her with Shingles. Lesion started 08/18 slightly itchy and now states that it is painful. 7 days of treatment x3 times daily.
aft dtp/ovp pt ex swelling, induration, redness and heat sensation at inject site.  area was 3" in diam. and 1/2" in thickness/induration.  later that day had 2 episodes of high fever and persistant crying for 4-5-hrs seen in er.
Patient reported feeling achy, tired, intestinal pain, vomiting , diarrhea, rectal bleeding and increased liver enzymes
Rash developed 12-24 hours after Tdap vaccine.Also complained of "achey" all over.Seen in the ER 48 hours after vaccination.ER gave oral Prednisone 80 mg per day for 5 days.
This spontaneous report as received from a physician refers to a pediatric patient of unknown age. On 22-APR-2013 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported) rather than VARIVAX (Merck). This is one of several reports received from same source. Additional information has been requested.
pt recv vax 21JUN95 & 17MAR97 pt exp rash;pt sibling also recv vax & had similar exp WAES 97031818;
Admitted to hospital on 3/25/21 with left side numbness, dizziness and ataxia (leaning to Left side)
Slight bleeding immediately from/at injection (hit a vein, apparently). Immediate bruising and small, hard knot bump at injection site. Mild soreness. All on Friday 11/12. Felt extra sleepy that night too. Didn?t realize at first but think due to vacc reaction. Like a numbing sleepy but okay.  On Saturday 11/13, still bruising but bump less hard. still tender.  Sunday 11/14, large red rash right underneath bruised injection site. Same reaction and timing I had from first initial Moderna Dose #1 back in January.  Slight itchy at rash area and still tender but tolerable.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was given on 29Sep2022 and stopped on 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 available information in the case, the causal association between the events 'Drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a licensed practical nurse refers to patients of unknown age and gender. Approximately on an unknown date in 2012 the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route not reported). Improperly stored GARDASIL had been administered to an unknown number of patients. The dates GARDASIL were improperly stored were between 30-JUN-2012 to 24-JUL-2012 (exact dates of administration were unspecified). No adverse event reported. The office did not wish follow-up for a safety report. No other information to report. This is one of several reports from the same source. Additional information is not expected.
Itching at injection site Significant swelling at injection site (small baking potato size)  Hot to touch at injection site
6 m/o with 3 episodes of trembling of R arm and head while breast feeding.  1st ~7/12/08 last ~8/7/08.  +Aunt with seizures.  Last vaccines given 6/11/2008 COMVAX, DAPTACEL, IPV, PREVNAR, rotavirus.  No reaction after vaccines.  No clear relationship between episodes & vaccines.
Outbreak of white skin patches over entire body, deterioration quickly the entire body disfiguring patient for life, with no answers. Specialist, claims sudden vitiligo, which does not occur in either family history.
Information has been received from a health professional concerning her 16 year old daughter who on 15-JUN-2007 was vaccinated with a first dose of Gardasil. on 01-JUL-2007 the patient developed joint pain in her fingers. It was reported that the patient developed joint pain one week after initial dose of vaccination. Staff member stated that her daughter plan on receiving her second injection as per schedule. Unspecified medical attention was sought by the patient. Subsequently, the patient recovered. Additional information has been requested.
Injection site had a hard lump,  had and extremely large red circle around the site, and was hot and itchy for about two weeks.  Also caused an elevation in blood pressure and fluid retention for about two weeks.  Slight headache.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 12-Jan-2016, the patient received an improperly stored dose of PROQUAD with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.