chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of Shingrix some time in 2020, has not yet had the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received of 0.5 ml in 2020 via intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 18-NOV-2012 at a Medical Group Center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-AUG-2016, the patient was treated by her physician for a painful rash that was diagnosed as a severe case of shingles. The patient has been prescribed valacyclovir (VALTREX) for the management of her persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Pain in upper arm/shoulder area, pain is not constant and it did not develop after the immunization rather approximately a month later.
Temperature rise to 104.6F. Start alternating between Tylenol 7 Ibuprofen. Doctor visit on 03/30/2012 continue same treatment. Temperature peaked at 107.2F on 03/31/2012, rushed to ER. Temperature went down on 04/01/2012. Showing excessive irritability & fussiness. Change of behavior. Rash come out on 04/03/2012.
4yr old female pt was seen by provider for physical and MA given order for Dtap and other vaccines to be administered to pt what was given Tdap instead. Wrong vaccine. Similar vaccine abbreviations. Products stored near one another.
6 days after vaccine administration, patient woke up in middle of night with palpitations. We saw him in clinic and did ECG, which was normal. Physical exam normal at that time. He also developed hives that day after his clinic visit, which self resolved and again the next day. 7 days after the vaccine, he ended up in the ED for respiratory distress- stridor and wheezing treated with steroids. He was seen by allergist 2 weeks later, who confirmed he had a delayed allergic reaction to the vaccine and prescribed him an epi-pen.
I had pain in the injection site within hours. Had dizziness around 7pm.  I took acetaminophen at 9pm for pain and woke around 3am on 4/28 with body aches, headache, and chills. Took more acetaminophen at 3:30am. Had a low grade fever (99.6 F) between 9-10am with the Tylenol on board.  Still experiencing these symptoms as of 11:30am on 4/28.
Information has been received from a pharmacist concerning a male patient who on an unspecified date, was vaccinated wit a dose of 0.5 ml PNEUMOVAX 23 (Lot #, route not reported). The pharmacist reported that the patient developed pneumonia after receiving a shot of PNEUMOVAX 23. At the time of the report, the patient's outcome was recovered. No further information is available.
DT 0.5 mg 9/9/04. 10/21/04 pain right shoulder : radiates to neck and lower 1/3 RUE: for 2-3 weeks. Diagnosed: Cellulitis, Keflex, Motrin, Sling
COVID-19 Vaccine.    Hives on palms and feet one week later, hives lasted about 4 days and went away after taking benadryl.
Local pain at injection site. Headache, nausea, full body aches (muscles and joints). Low grade fever. Lethargy. Infrequent chills. Diarrhea.
after the 2nd dose I experienced arm pain, headache and the inability to sleep the first night; headache; inability to sleep the first night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 12:00 (Lot number: EP7534) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, administration date 28Sep2021. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 12:00 PM, Lot number: EN6202, Anatomical location: Left arm), administration date: 27Feb2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "after the 2nd dose I experienced arm pain, headache and the inability to sleep the first night"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "inability to sleep the first night". The events "after the 2nd dose i experienced arm pain, headache and the inability to sleep the first night", "headache" and "inability to sleep the first night" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, headache, insomnia.  Additional information: After the 2nd dose patient experienced arm pain, headache and the inability to sleep the first night. All symptoms were gone after 36 hours. No hospitalization prolonged. No relevant medical history and concurrent conditions. No past drug history. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
shingles; I have shingles for the second time, even though I was vaccinated; This spontaneous report was received from a consumer referring to themselves, a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient got shingles for the second time, even though they were vaccinated (herpes zoster and vaccination failure). The outcome of herpes zoster and vaccination failure was unknown.     The causal relationship of the events with zoster vaccine live (ZOSTAVAX) was not reported.  Upon internal review, vaccination failure was considered to be related to Zoster Vaccine Live (ZOSTAVAX).
Developed severe headache on 7/12/09 that resolved with Motrin 200mg + sleep. Mild headache off and on Monday - Wed. Uneven pupils size 7/13 and not resolved yet, afebrile, no distress or acute s/s. Seen in ER for pupillary difference, examined, seen by Opthamologist and released to home.
pt recv vax 9JUN95 & 12JUN95 pt devel about 10 skin lesions; No further details were provided;
Lips are puffy. little bumps along the outline of my lip. tingling sensation, extremely painful. They feel very raw and itchy, mostly around the outer edge. Hard to move them to be able to drink or eat.  I have yet to get treatment other than using blistex to reduce the pain.
Patient presented two hours later with new red, itchy rashes and hives. Reaction present on face, neck, chest, and arms. Patient was recommended to take 1 to 2 tablets every 4 to 6 hours until her rash resolves. She was to also get hydrocortisone cream. She refused both. She was told to go to urgent care to see the nurse practitioner or go immediately to the emergency room if it worsens. Her husband drove her. Also asked her if she'd like to stay for extra observation but she refused and said she'd talk to her doctor.
This case was reported by a healthcare professional via Merck and described the occurrence of hepatitis b surface antigen positive in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified time after vaccination with ENGERIX B, the subject experienced hepatitis b surface antigen positive. The nurse reported the subject was given one dose of ENGERIX B, two weeks later went to donate plasma and found to be positive for hepatitis b surface antigen. At the time of the report no other information was available. At the time of reporting the outcome of the hepatitis b surface antigen positive was unspecified.
day of shot arm had large red mark around injection site and arm itched shortly after shot.  red rash has not gone away but 8 days later red mark is itchy again and seems raised and a bit sore. Red rash has not gotten bigger but it also never went away.
I received 2010-2011 seasonal flu shot here at the medical center last Tuesday (9-7-10 around 1:30 PM). I did not take the H1N1 vaccine last year so this was my first time taking the vaccine.  That night, Tuesday night,(09/07/2010 around 7:30 PM) I started feeling tightness in my chest and was short of breath.  I told both my children that if the tightness got worse or if I felt any type of pain, that I was going to the ER.  It did not get worse, but the tightness continued throughout the next day up into the afternoon.  I called my PCP and was told that I should go to the ER.  I did, I went to the ER here at the medical center and was kept overnight so they could do a stress test the next morning. All labs and EKG were normal. The next morning the cardiologist thought we should do an angiogram in lieu of a stress test to make sure my stents were still open and functioning.  I had the angiogram and everything looked good, only 20% blockage.  Then I was sent home.   I continued to have a little shortness of breath and occasional tight feeling in my chest for about a week. For six years I have had no problems with my heart, but shortly after taking the vaccine, I felt like I was headed for another heart attack.  I took the shot around 1:30 PM on Tuesday 9/7/10 and the chest tightness and shortness of breath started around 7:30 PM 9/7/10 (about six hours later).
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 3-year-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 01-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
blotchy rash on face, tingling tongue occurred 30 minutes after vaccine administration. administered 50mg diphenhydramine IM. VSS, 15 minutes after diphenhydramine rash and tingling were fading.  with provider @4:30, released to home. patient had driver with her.
3 days after vaccination had paresthesia and decreased sensation of the left medial upper and forearm. Improved slightly each day. I examined her on day 8 post vaccine. She has signs of cubital tunnel syndrome/acute ulnar neuropathy with mildly decreased sensation in the left forearm, and sensitivity over the cubital tunnel. Otherwise normal.
pt felt funny, hot, while sitting @ work site 5min p/vax lt arm started itching w/red spots on lt arm, no SOB or throat swelling;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 2:08 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month. No concomitant medication were provided. No Treatment  medication were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Pt broke out in rash-red raised erythema- Hx of PDA on LASIX- HR increased to >200-sent to ERD-same evening-vaccine
I have a 9 month old daughter. I breastfeed her on a regular basis, every 4-5 hours. Twelve hours after receiving the vaccine along with the usual expected side effects -- fever and chills - I experienced a decrease in milk supply. My daughter was latched on the right breast and then on the left for a total of 15 minutes, there was no let down and no milk was flowing (I was intently listening and she was not swallowing which means no milk was coming out of either breast), let down usually happens after 2 minutes for me. The milk returned the following feeding, about 2 hours later although the let down took longer- about 10 minutes after she was latched on, and there was definitely less milk because my breasts were not full and at this point after 9 hours of no breastfeeding my breasts would have been very full and I would be experiencing some pain because of the fullness. My breastmilk supply is back to normal now.
Redness measured 1.5in x 1.25in diameter around injection site. Felt warm for couple days. Had pain about 4 days per mom. Hard to touch. States arm still itching as of today.
Fever, chills, arm got red, swollen and warm in a radius that exteded to 6 inches below the injections site.  Started to resolve on 9/1/15.
anxious; nausea came and went; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxious) and NAUSEA (nausea came and went) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Heart rate abnormal (has history of taking flax seed daily to lower heart rate, which often ran high.). Concurrent medical conditions included Prostate examination (Prostate issues). Concomitant products included FLAXSEED for Heart rate abnormal.    On 11-Feb-2021 at 5:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 5:21 PM, the patient experienced ANXIETY (anxious) and NAUSEA (nausea came and went). The patient was treated with WATER (oral) on 11-Feb-2021 for Nausea, at an unspecified dose and frequency. At the time of the report, ANXIETY (anxious) and NAUSEA (nausea came and went) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement: 135/92 (Inconclusive) at 5:25 pm, 126/90 (Inconclusive) at 5:30 pm, 128/83 (Inconclusive) at 5:35 pm, 129/89 (Inconclusive) at 5:40pm and 134/89 (Inconclusive) at 5:45 pm. On 11-Feb-2021, Heart rate: 103 (abnormal) at 5:25 pm, 112 (abnormal) at 5:30 pm, 100 (abnormal) at 5:35 pm, 101 (abnormal) at 5:40 pm and 98 (abnormal) at 5:45 pm. On 11-Feb-2021, Oxygen saturation: 97% (normal) at 5:25 pm, 96% (normal) at 5:30 pm, 96% (normal) at 5:35 pm, 97% (normal) at 5:40 pm and 97% (normal) at 5:45 pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   By 5:45 pm patient reported feeling better and was released with instructions to call MD or go to ER if symptoms recur.
typical fever and body ache, triggered sinus problem, 3 rounds of antibiotics, very weak heart palpitations
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # L045713, expiration date 14-JAN-2017; lot # L023936, expiration date 15-MAR-2017; dose was unknown) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received FLUZONE vaccine 10/19 & experienced throat swelling, cold chills, & sweating the night she received her vaccine. Did not seek a physician. Patient took a BENADRYL and had relief.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted after the shot was given and woke up right after. He was responsive with no pain and no injury presented. Paramedic came and took the patient vitals. His vitals were reported to be normal and no need of urgent care. His family insisted for patient to be admited to the hospital.
extra dose of MENACTRA was administered with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who experienced extra dose of menactra was administered with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO).  On 18-Feb-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7140AA (expiry date 04-Nov-2022) via intramuscular route in the right deltoid for Immunization.  On 18-MAR-2022 the patient developed a non-serious event "extra dose of menactra was administered with no reported adverse event  "(extra dose administered) 1 month following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (extra dose of MENACTRA was administered with no reported adverse event).  At time of reporting, the outcome was Unknown for the event extra dose of menactra was administered with no reported adverse 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 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.
I am aware that it is expected to have soreness at insertion site/ redness. However for 6 days I have had muscle tightness/ knots and soreness on my entire left side (my back up into my neck). I have been taking ibuprofen 800mg every 6 hrs with minimal relief.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 6 doses of improperly stored RECOMBIVAX HB lot # J013394, exp. 25-AUG-2016 (dose was not reported). No adverse effects were reported. Additional information has been requested.
COVID infection; COVID infection; COVID infection; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 28Jan2021 (Lot Number: EL0140) as single dose for COVID-19 immunization. Medical history included Alzheimer's dementia from an unknown date. Concomitant medication(s) included memantine hydrochloride (NAMENDA); donepezil hydrochloride (ARICEPT); buspirone; sertraline hydrochloride (ZOLOFT); and metoprolol taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (lot number: EL1284), first dose on 07Jan2021 at left arm, for COVID-19 immunization. The patient experienced COVID infection on 07Mar2021 16:00, along with several other residents in the facility. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient underwent lab tests and procedures which included COVID infection test: positive on 01Mar2021 (pending clarification). The outcome of the event was not recovered.