chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous unconfirmed report as received from a pharmacist referring to an unspecified number of patient of unknown age and gender. Pharmacist reported that a consumer saw a report on television which stated that the patients who were on therapy with unspecified cholesterol medications, including unspecified statins (all manufacturers unspecified) each received a dose of ZOSTAVAX (dose, frequency and route of administration were not reported). The ZOSTAVAX was "ineffective" against preventing shingles in these unspecified patients specifically due to their concomitant therapy with unspecified cholesterol medications. It could not be determined whether the unspecified cholesterol medications were Merck products. The outcome of lack of effect was unknown. Causality assessment was not provided. Additional information has been requested.
After vaccine about noon I started feeling sick to my stomach, after my first dose I was sick to my stomach but didn't worry with it.  This one I was really sick to my stomach and I laid down, when I got up I was severely nauseated and had diarrhea and my arm was huge swollen red and blisters going up my arm. I'm still nauseated.   I had covid in September and hospitalized 4 times up to December.
Pt vaccinated with DTP/OPV/HIB; SIDS death 1 day post injection.
Left upper arm with redness and ruber along entire length and half of circumference. Mild/mod swelling. Slightly tender to touch. Normal strength and movement.
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 1 patient of 3-4 years old with unknown gender was vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Information has been received from a medical assistant concerning a 20 year old female employee who on 03/29/2001 was vaccinated with hep b vaccine recombinant. Concomitant therapy included hormonal contraceptives. On 03/29/2001 the pt experienced nausea, vomiting, lightheadedness, temperature of 99 F and pulse 100-120, 1.5 2 hours after receiving the injection. The reporter added that a virus was going around the office. Additional info has been requested.
Pt. noticed at 1030pm 10/17/11 4-5 red, raised areas on the left deltoid area where PPV vaccine was given. Describes as painful to the touch. Reaction localized and voices no other c/o.
Rash Developed within 24-48 hours of vaccination and persisted for over 1 week. Patient seen in office 10/19/2007, and treated with Prednisone.
Patient developed papular rash on face 10/08 and spread to trunk, no rash on hands and feet. By 10/10. tactile fever on 10/11. NO further spread.
This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (lot # M036296, M041182 and N012493) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several cases from the same reporter. Sender's Comments: US-009507513-1708USA008361: US-009507513-1708USA008564.
After vaccine pt reported injection site pain that radiated to neck, pt felt hot, thirsty, chest pain, tingling of lips. Pt's blood pressure was 140/82, then 160/100 pt exhibited slowed speech. Paramedics contacted, they evaluated her and took her to hospital.
Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours. Tylenol resolved side effects for about 3 hours after taking it. Had to wait additional time to take more.
pt recv vax; exp n, fatigue & numbness in her fingers & legs; MD believed sx were caused by Hep B vax (given in 1988);
ill; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was ill (illness), when received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), past vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was ill (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient felt ill after getting flu shot every time for at least one day usually 2.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Symptoms started after almost 24 hours. Severe chills, throbbing headache, joint pains, sweating, extremely tender boobs ( nursing mom ) symptoms still going on after 72 hours of vaccine administered. Taking tylenol
At approximately 14:45 (10 minutes post Moderna vaccine booster), patient complaint of "chest tightness."  This RN immediately assessed patient who denied difficulty breathing, shortness of breath, and no evidence of hives/rash noted.  Vital signs taken - pulse 86, 21 respirations, 150/94, 100% spo2 on room air.  Patient was brought to gurney and had complaint of worsening "chest tightness." RN STAT was called, STAT team arrived at 14:49.  RN team encouraged deep breathing, vital signs were immediately taken at 14:50 - pulse rate of 76, 22 respirations, 166/107 blood pressure, 100% spo2 on room air.  At approximately 14:55, patient verbalized improvement in chest tightness.  Vital signs reassessed at 15:00 - pulse rate 82, 19 respirations, 158/81 blood pressure, 100% spo2 on room air, continues to deny shortness of breath or difficulty breathing, no hives or rash noted, respirations even and unlabored.  Patient was scheduled with Dr. in family medicine for further evaluation.  Patient escorted by RN STAT team via wheelchair to Dr. for further assessment.
Product administration error; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported The patient phone number was 2093219692   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow Up received on 22-nov-2021 and patients initial and phone number updated
Caregiver given Hepatitis B vaccine (engerix) this afternoon. Caregiver called and stated she was fine right after the vaccine administration, but started to have adverse symptoms soon after while going home. Reported increased heartrate, dizziness, dry mouth and throat, felt like she was going to "throw-up" and a "squeeze" feeling in her throat as if she may throw-up. Stated she is not short of breathe nor does she have chest pain. Caregiver is currently with her significant other. Encouraged to stay with someone during at this time and advised to seek care as needed.
nausea, fever, headache, body aches intense all day on1/13 thru mid-day 1/14/21. 1/15/21 still had slight headache.
Wrong DOSE. Used FLUCELVAX for age > 4yr old dose. Contacted RN @ HHS and stated that it would count as a valid vaccine, but to complete a VAERS report.
Pt came in mom and dad for 4 month well visit. Was doing well at that time with no illness or temp noted. Pt is former 32 weeks premie who had good weight gain was up to 8#9lb. Shots below were administered. Pt tolerated them well. When parents got home they gave dose of Tylenol at 8pm but stated no temp was noted. They then gave another dose at 12am. Pt acted very lethargic with decreased po intake. Parents awake at 6am and found pt to have passed. No fussiness was ever noted, just increased sleepiness with a decrease in po intake.
(1) Triggered migraine headaches.  I have had migraines starting around age 4, through age 53 (with a brief respite during pregnancy in 1998/90).  I have had none since menopause.  Starting 2 weeks after my first dose (3/06/21 - Pfizer EN6206) I have had migraines most days, including two severe ones.  They have been continuous since my second dose, requiring medication with aspirin and ibuprofen, but seem to be near the end of active migraines 3 weeks after my second dose.  (2)  Three days ago I noticed that my tinnitus was dramatically worse.  I have had tinnitis for more than 20 years (single frequency, corresponding to frequency at which I have a hearing loss).  This may be a response to the aspirin needed to address the migraines, but the worsening began several days after my last aspirin (or ibuprofen) dose.
Sore arm; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.    This case was linked to MOD-2021-091809.
CHEST PAIN; BLURRED VISION; LEG SWELLING (STARTED IN LEFT LEG NOW IN BOTH LEGS); ARM HURTS AT THE INJECTION SITE LIKE AN OLD BRUISE IF RUBS IT; HEADACHE; DIARRHEA; ALTERNATE CHILLS AND FEVER; THROAT HURTING; SWOLLEN TONSILS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, copd, and back problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) she had covid antibodies. On SEP-2021, the patient experienced throat hurting. On SEP-2021, the patient experienced swollen tonsils. On an unspecified date, the patient experienced chest pain, blurred vision, leg swelling (started in left leg now in both legs), arm hurts at the injection site like an old bruise if rubs it, headache, diarrhea, and alternate chills and fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, blurred vision, leg swelling, started in left leg now in both legs, arm hurts at the injection site like an old bruise if rubs it, swollen tonsils, diarrhea, alternate chills and fever and throat hurting was not reported. This report was non-serious.
Initial report was received on 08 February 2012 from an electronic lay press article. It represents a cluster of two confirmed cases of pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2012-01546. A child in elementary school (age and gender not reported) received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported to be immunized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Headache, Myalgia, fatigue, chills  Narrative:  Other Relevant History:
Epstein-Barr Virus, Antibody To Viral Capsid Antigen, IgG Test >8.0 AI swollen lymph nodes, swollen arm,  fatigue
pt recv vax 12NOV97 & a little later arm slowly started to swell & upper arm remained twice it nl size for several days;
NO ADVERSE EVENT WAS NOTED.  ADMINISTERED EXPIRED VACCINE.  EXPIRED ON 04/01/2022 AND ADMINISTERED ON 04/19/2022
Redness at inj. site cellulitis use ice on site, BENADRYL 25-50mg every 4-6 hrs, use hydrocortisone 1% cream on inj site.
my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.; my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "unknown" and all described as "my son was tested positive recently after having received Pfizer vaccine  2 doses in April of this year.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
no adverse event; adult patient received a dose of PROQUAD; This spontaneous report was received from an adult female consumer of unknown age reporting on herself. On an unspecified date in October 2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live( PROQUAD) (dose, route and lot # not reported) since her health care professional drew MMR titer levels and told her that she was not immune.
Initial and follow-up information has been received from a health professional concerning a 30 year old white female with no known drug allergies and no past medical history who on 06/17/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) subcutaneously (Lot # 639986/1213L).  On 07/18/2002 the patient was vaccinated with another dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) subcutaneously (Lot # 642181/0153M).  There was no concomitant medication.  On 09/26/2002 the patient had a serum measles immunoglobulin G antibody test that was negative.  It was reported that no adverse symptoms were noted.  The patient sought unspecified medical attention.  No additional information is expected.
no adverse event; Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of 0.25mL dosage of the dark blue cap and label with gray border presentation.).    No concomitant medications were reported.  Doses were administered from 24-28-Apr-2023. Patients were between 6m-5y of age. No reported symptoms.  No treatment medications were reported.  This case contains information for the 7th of 12th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:patient no. 01 (Master case)
Employee came in and stated she had a rash on the upper left part of her back and in both her left and right armpits. It had started on 3/22/14 which is when she noticed her rash. 2nd vaccine was given 3/10/14.
Child developed fever 101 on day 2 and 3 after vaccinations, papulomacular rash on day 3 on the face, day 4 on the trunk, teary eyes with minimal discharge on day 3. Pt was seen first time after immunizations on day 5 - no fever, rash on the face, trunk and extremities, cranky.
After receiving Pneumonia vaccine on 11/30/06 in left arm became very painful at injection site and has been painful since then. Has been taking Tylenol and it relieves for couple of hours. No redness or temp. Advised to take Benadryl and continue taking Tylenol. Cool cloths as necessary.
mom reported events 19MAY94; states 11PM 23MAR93 pt exp high pitched cry, cried for hrs, eyes rolled back in head & began to tremble; went to ER next AM; t101; given med for fever;
During observation period, became hot and not feeling well. Came to the desk c/o feeling like she was "going into VTach".  BP 160/100, P 80 and sl. Irreg, R without apparent distress, lung are clear,  Chest and neck flushed, without apparent rash,  Skin is mildly diaphoretic.  States she was having difficulty seeing and did not feel well.  Placed in supine position.  Dr. texted using tigerconnect, following up via phone.  Patient stated she was allergic to Benadryl.   Further evaluation and possible treatment indicated so rapid response called and transferred to the ED.   Discussed with her that she needed to talk with her PCP about this episode prior to the next dose scheduled in 4 weeks.
Pt started having nausea, vomiting, diarrhea, cough and congestion on 1/22/2021.  Pt went to ER on 1/24/2021 where she had a negative Rapid COVID test.  Pt was seen on 2/1/2021 still complaining of above symptoms along with dehydration.  Pt was sent back to ER via EMS.
Pt was vaxed w/1st dose of measles & 10 days p/vax pt exp febrile convulsion; No further details were provided;
excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information contain included patient  and suspect details
This case was reported by a nurse and described the occurrence of headache in a female pt in her twenties who received hepatitis B vaccine recombinant (Engerix-B) injection for prophylaxis.  On 09/22/03 the pt received the 1st dose of Engerix-B.  On that date, she also received a tuberculin skin test.  Approximately four hours post-immunization, on 09/22/03, the pt experienced headache, fatigue, fever and flu-like symptoms.  The events resolved by 09/24/03.