chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; the vaccines have been administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (route of administration: oral; lot # 1684166, expiration date  27-JUN-2021) for prophylaxis.   Administered dose of vaccine experienced the temperature excursion of 8.88 degrees Celsius (C) for 15 minutes, 9.17 C for 15 minutes and 8.24 C for 15 minutes. There were no previous temperature excursions. The event was reported due to digital data logger. There was no additional adverse event (AE) reported.  Follow-up information has been received from the medical assistant on 22-APR-2021 referring to a 2 months female patient. The reporter had not reported the adverse event previously. On 30-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (number of previous doses was reported as 9) for prophylaxis at public health clinic/hospital. The patient received the vaccine after temperature excursion occurred. She did not experience an adverse reaction due to this administrated vaccine. Excursion was noticed after administration upon review of quarterly temperature logs.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005002:
Information has been received from a consumer concerning her 16 year old daughter who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced nausea and fever. As of 31-JUL-2008 the patient had not gotten her period yet. The patient's nausea and fever persisted. The patient didn't seek medical attention. Additional information has been requested.
On day five following administration patient returned to pharmacy with red area on arm where vaccine administered. Arm was red, warm. Pt did not report itching. Referred to doctor.
cont crying from 10:30-3PM;Rt LE red & tender;no fever; sleeping now; MD gave Advil & told parents to apply ice pack to rt thigh; 27SEP 810AM pt doing fine no fever, swelling down, no crying
Pt recvd 2nd dose of Hep B & exp flat red pruritic rash lasted sl less than 3 wks; pt recovered;
This child developed hives within 48 hours of her first HPV. She had no other obvious cause for her hives.
Extreme soreness, tenderness at the site and "puffiness", Had to use R arm to lift move L arm around, Iced on the day after the vaccine. Mother called today to report Sx, child was at work. Instructed mother to call or follow up at urgent care or ER if not better. Verbalizes understanding. Will continue with ice and tyenol or motrin as needed for comfort.
About August 1999, following the 2nd injection of Lymerix vaccine, this patient developed ache and stiffness in his right knee. He saw a doctor about it and was sent to a specialist who gave him a Cortisone shot and had x-rays taken. The Cortisone shot did not help.
pt recv vax 18SEP98 & pt was not certain that one of the series was actually hep b vax;pt had a negative hepatitis b antibody titer before receiving the booster dose;1hr post vax pt devel rash, wheezing & swelling of lips & face;DPH taken; This is in follow-up to reports previouslu submitted on 03/01/1999: Information has been received from a registered nurse concerning a 52-year-old Caucasian male patient with a history of allergic reactions such as anaphylaxis and an allergy to sulfa who on 18-SEP-1998 was vaccined with a seventh dose of hepatitis b vaccine recombinant IM. Concomitant therapy included CLARITIN. It was reported that the patient received a booster dose of hepatitis b vaccine recombinant because he " supposedly had entire three dose series towice; however, the patient was not certain that one of the series was acutally the hepatitis b vaccine." The patient had a negative hepatitis v antibody titier before receiving the booster dose of hepatitis b vaccine recombinant. Approxmatley one hour post-vaccination, the patient developed a rash, wheezing, and swelling of the lips and face. The patient took BENADRYL and TAGAMET and went to an emergency room. subsequently, the patient recovered and went home. The patient was not admitted to the hospital. Follow-up information from a registered nurse reported on 11-JAN-1999 she spoke with the patient who reported he "had a red, puffy face and then wheezing followed by a rash every 7 to 10 days. These reactions were releived with BENADRYL." Additional information has been requested.
Information has been received from a physisican concerning a female in her "early twenties" who was vaccinated with her third dose of GARDASIL (lot# unspecified). There was no concomitant medication. Sometime during the last week of November 2007, the patient experienced pain down her arm that later morphed into numbness down her hand. The patient's outcome was not reported. No further information is available. 02/10/2010 On 26-Nov-2007, the patient reported shooting pain down left arm from left shoulder with numbness in her left hand lasting 3 hours. Since then has reported intermittent left hand numbness and left arm pain. Left arm pain and left arm has significant redness, swelling and bruising. A C-spine x-ray was performed on 01-Dec-2007, and the report listed no acute fracture or dislocation. The neural formained and spinal canal were of normal size. The alignment of the cervical vertbrae was within normal limits.  No further information is available.
Diarrhea, fever, chill, severe exhaustion, vomiting sweating and passed out. Risidual sweating and difficulty sleeping
patient received 2 MMR II vaccines but is showing no immunity to Mumps; This spontaneous report was received from a nurse referring to a 38-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concomitant drugs, and concurrent conditions were not reported.   On unknown dates, the patient received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for immunization.   The patient had received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), however, on an unknown date, the patient had no immunity to mumps (vaccination failure). The outcome of the event was unknown. The causal relationship between vaccination failure and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was related.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing). The patient took concomitant medications (other medication in 2weeks: Yes). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 05Dec2022 to 10Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Onset of pain in upper arm and shoulder that evening, and the next day had "frozen shoulder" where I had very limited range of motion in the shoulder. I also had some tingling in the right fingers the next day. The frozen shoulder resolved by day 3 and the pain in the upper arm resolved within 1 week. However, it has been almost 3 weeks and I still have quite a lot of pain in the shoulder. I was diagnosed with rotator cuff tendinopathy and they are not sure if this is due to improper injection technique (it was given a bit high on the deltoid muscle) or the vaccine itself.
On-set of severe chills started at 10:00pm with a 103 degree fever. I had tightness in my chest and my heart was beating irregular. After 4 hours the fever subsided as quickly as it came on and my heart returned to normal functioning. When the fever subsided I was left with a severe headache for approximately 6 hours. Once the headache subsided I felt lethargic and foggy headed. On the second night (3/14/2021) the fever returned but was only 100.4 degrees. I took an Aleve before going to bed and when I woke up this morning I felt back to normal.
localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle; localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; expiration date: unknown), intramuscularly left arm on 22Dec2020 11:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15-minute (22Dec2020 11:30) waiting period after the injection, the patient began to experience localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This reporter was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension and chest pain. The patient was observed for approximately 30 minutes post injection with no evolution of symptom. Injection site tingling that extended along the ulnar nerve distribution was improving at the time of discharge. The outcome of the events was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Facial swelling, nausea, vomiting, diarrhea, body aches, headache, dizziness, fever 101.
Per Mom, noticed Rt shoulder rash in AM of 8/17, after receiving PCV13 vaccine in this location the previous afternoon (pt received 3 doses of PCV7 in 2008 with no reaction). No fever, no vomiting, but some possible loose stools (but not watery). Tolerating well PO, no chest pain, No SOB. Mom gave diphenhydramine. On exam, Rt deltoid skin slight warm to touch, well demarcated erythematous slight indurated rash; aprox 5x5cm. Some central tiny vesicles clusters noticed) non-pitting and very tender to palpation.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        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.  Patient age was 64.34 Years.  The reported condition of the vial was not frozen.  Vaccine underwent temperature excursion on 03 Nov 2021 till 35 degrees Fahrenheit at 10 AM. Vaccine was moved to fridge on 05 Oct 2021 and Beyond Use Date for the vaccine was 05 Nov 2021.  Product moved to clinic on 03 Nov 2021.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Informationn about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K011325 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
encephalitis; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 05-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the medical office. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, on or about 05-AUG-2015, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for encephalitis and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of encephalitis was determined to be medically significant.
This study case was received from the investigator (MILVAX) in the trial on 21 July 2011. A 21 year-old male subject with no significant medical history was found to have an unspecified cause of encephalitis 21 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) and an injection of Hepatitis A (Adult) 2 (lot number, route and site of administration not reported) on 07 February 2011. Relevant laboratory data included: an abnormal MRI of the brain on 18 February 2011. Troponin I, ECG, Echocardiogram, MRI of the spinal cord and lumbar puncture (spinal tap) were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
pt fainted 5 minutes after dose, had high temperature. had to have 1 shot of 0.3mg epipen, used ice packs to cool down temperature. pt regained consciousness after 10 seconds, was able to answer questions, was pale looking. called 911, was taken to hospital by paramedics for further testing
Pt developed hives, vomiting and diarrhea. The hives lasted for 2-3 hours. Rx: Benadryl Suspension.
Hard lump to right deltoid @ injection site, red and hot to the touch with no improvement at site in over a week pain/tender to touch
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000819: US-009507513-2112USA000821: US-009507513-2112USA000820: US-009507513-2112USA000822: US-009507513-2112USA000824: US-009507513-2112USA000825.
This spontaneous report as received from a pharmacist via a representative refers to a 65 to 70 years old male patient. On unknown date, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that the male patient reported injection site redness and swelling within a 24 hour period. The patient sought medical attention since he returned to pharmacy for consultation. The relatedness for all the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008861: US-009507513-1709USA008666.
Developed Shingles. There have been numerous patients in our area that have developed shingles awhile after their 2nd vaccine. they are mainly people with compromised innume systems.
20 minutes post injection. 5-6 cm redness around injection site where VARIVAX was administered. Advised mom to monitor. Spoke with mom this AM. Pt last PM developed a nodule. Mom did warm compresses. Gave Benadryl. Afebrile per mom. Pt has no other symptoms today.
Client's mom called stating that client's right arm and shoulder were swollen eventing of vaccine.  Twenty six hours after vaccine client had temperature of 101.4, complaints of feeling dizzy, and spasms and edema around spine.  Mother had call into doctor's office - client had taken ibuprofen and used heat packs on arm/shoulder/back.
Right leg swollen, went to ER on July 17, 2021and was diagnosed with  Deep Vein Thrombosis (right leg - blood clot). Currently taking Xarelto 15 mg 2x a day for 3 weeks, then Xarelto 20 mg for 6 months.
Patient fainted a few minutes after vaccination, fell and hit back of head on counter. Patient left vaccine site for urgent care to see if stiches required for laceration at back of head.
Severe Diarrhea; vomiting, could not keep anything down; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA ( Severe Diarrhea), VOMITING (vomiting, could not keep anything down) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DIARRHOEA ( Severe Diarrhea), VOMITING (vomiting, could not keep anything down) and NAUSEA (nausea). At the time of the report, DIARRHOEA ( Severe Diarrhea), VOMITING (vomiting, could not keep anything down) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
The pts were administered the flu vaccine and the pneumococcal vaccine after obtaining informed consent, between 08:30-09:00. Later that day, the ER physician called stating that 2 pts were being admitted into the hospital with hypoglycemia. It was reported that both pts blood sugars were in the 40's with signs and symptoms of hypoglycemia. The ER/hospital progress notes were unavailable at the time of this report. There was no history of diabetes in either pt.
PATIENT RECEIVED FLU SHOT IN RIGHT ARM,  HEP A AND HPV IN LEFT ARM. COMPLAINED OF PAIN IN LEFT ARM AFTER HPV GIVEN.  MONITORED X 15 MIN , ESCORTED TO WAITING ROOM SO HIS MOTHER COULD SCHEDULE AN APPOINTMENT.  WHILE WALKING OUT OF WAITING ROOM, A PASSING NURSE NOTED HE DIDN'T LOOK WELL AND MOM WAS SUPPORTING HIM. HE WAS ASSISTED TO A CHAIR. NURSE OBTAINED VITAL SIGNS, NOTED ELEVATED HEART RATE AND BLOOD PRESSURE. I WAS NOTIFIED. PATIENT WAS ABLE TO WALK WITHOUT ASSISTANCE TO EXAM ROOM, WHERE HE LAY IN SUPINE POSITION FOR 10 MORE MINUTES. VITAL SIGNS WERE WITHIN NORMAL LIMITS X 2. HE SAT UP FOR A FEW MINUTES, SAID HE FELT WELL, AND LEFT WITH HIS MOTHER.  SECRETARY CALLED MOM 30 MIN LATER AND SHE SAID HE WAS FINE.