chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.  No concomitant medications were provided.; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 003B21A)  with no associated AEs.
It was reported that a 68-year-old female patietn received a dose of TD Adult .5mL administered in her left deltoid on 2/11/02, wound prophylaxis. Three to four days after administration she went to ER with symptoms of swollen tongue, difficulty breathing and rash over entire body. The patient has received tetanus vaccination in the past without symptoms of this nature. Date of ER visit not confirmed at this time.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine 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.   The age of patient was provided as 58.68   Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt states having pain/swelling/itching at injection site approximately 24hrs post injection. Pt presented at pharmacy 3 days post injection. Pt's left arm was red, swollen and warm to touch. Pt states using TYLENOL for pain and applying an ice pack to the injection site which decreased swelling and pain.
Stiff neck/could not turn the neck around; Shingles; left part of body is sore; Rash on chest and back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR and GABAPENTIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck/could not turn the neck around), HERPES ZOSTER (Shingles), PAIN (left part of body is sore) and RASH (Rash on chest and back) had not resolved.        Patient visited HCP and started taking prescribed medications. Patient was reported events are still ongoing. Patient said he was generally not allergic and has no other pre-existing conditions or side effects.
The day of the vaccine everything was fine sore arm. On the following morning notice rash on the right side of the mouth was flare of shingles on day 7 rash had crusted over. Around 2 more weeks still exp nerve pain right side of the mouth.
Temp 103.4 2 days after administration of vaccine. Vomited x 1.
episode of paleness & unresponsiveness preceded by episode of vomiting;episode duration 15min;
tested positive; lost all smell and taste; lost all smell and taste; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (lost all smell and taste), AGEUSIA (lost all smell and taste) and SARS-COV-2 TEST POSITIVE (tested positive) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced ANOSMIA (lost all smell and taste) and AGEUSIA (lost all smell and taste). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive). At the time of the report, ANOSMIA (lost all smell and taste), AGEUSIA (lost all smell and taste) and SARS-COV-2 TEST POSITIVE (tested positive) had not resolved.        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.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.      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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Patient reports having chest pain and involuntary tremors. Evaluation is carried out S/V. Patient is well oriented at this time of place and herself/person. A consultation with Doctor is made, which indicates that she remains under observation then contacted the ambulance to transport the patient to the nearest hospital. After evaluation of the ambulance staff. Vital signs are reassessed and an EKG is performed.
3/17/03 - DTaP injection at right deltoid. 3/18 a.m. - pain, swelling, redness, 5 x 8 cm area of right shoulder. Fever of 101.1 deg F.
This was the third of Gardasil vaccine.  Feeling Faint and light-headed, headache - worse with movement and activity. Fever over 102, not brought down with Motrin, Tylenol given, temp down to 99.7. Severe muscle aches primarily in calves, chest and injection site.  Shortness of breath, somewhat resolved with bronchodilators.  Malaise, treated with hydration and rest.  Almost all symptoms resolved by the following day about 5pm.  However, activity and movement seem to provoke SOB and headache.  Missed a day of work.
Pt came to the pharmacy explaining the Janssen imz he received on 5-29-2021 gave him adverse reactions. As soon as the imz was administered he felt faint and dizzy. He had hot/cold sweats and an increased heart rate. He stated right after the imz he felt fatigue for months (6-8 months). He did not have any reactions to other vaccines. He did not do a COVID test until July of 2021. He stated that for the most part he is recovered now .His employer is requiring booster COVID imzs and he would like us to provide in writing his reaction so he is not required to receive the booster imz. I apologized that I would not be able to provide anything in writing about his adverse reactions.
FEVER; This spontaneous report was received from a consumer, and concerned a female patient of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and vaccination site not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced a fever. Laboratory data included: body temperature: 9 degrees Fahrenheit (F).  The caller mentioned that her mother received the Janssen COVID-19 vaccine today, and started developing a low-grade fever.  Action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Right Leg was swollen and red with a large lump under her skin at the injection site.
it was rpt fr RN pt was vax & exp stinging at time of inject & 1 day later rpt large area around inject that was swollen, hot, hardened & red
Started having diarrhea, 12+ stools per day. 2 weeks later started having bloody diarrhea. Persisted for 2 months through maternal elimination diet of dairy, soy, gluten, corn, nuts, and eggs, finally started to subside after maternal total elimination diet of eating same few foods. Slowly was able to add more foods back, still reacts to meat at 14 months old.
I received the flu shot 10/31/19 at about 2:30pm to my left shoulder. Initially I felt ok, but after about 4 hours I started feeling itchy and tingly to my whole body. My heart rate felt very fast and my chest felt a little tight so I took 2 puffs of my albuterol inhaler which I had previously been prescribed for exercise induced asthma. The rest of the night I still felt itchy and tingly but was able to go to sleep. The next morning I went to work still feeling a little itchy and tingly. Around 10:30am I started feeling an intense itching and burning to my left shoulder and when I looked down I noticed some hives to that shoulder. At this point I went to Employee Health to be evaluated. The nurse saw me and noticed the hives and asked if I had any shortness of breath. At that point I did not but I did tell her it felt as though my heart rate was fast. She told me the NP would not be in for a little while and that I could wait or go back to work and come back if my symptoms got worse. I decided to go back to work and to have her call me when the FNP was back in. I was called that the FNP would be back at 1:00pm so I went there around 1:30pm. At this time the hives had gone away, my heart rate felt to have decreased a little from before, the itching and tingling had decreased. At this point my heart rate was checked and it was about 109bpm calm and  sitting down which is still elevated from my normal of about 50-60bpm. The FNP was concerned that my heart rate was elevated from my normal and that I had had hives to that shoulder earlier so she gave me Zyrtec and Benadryl to have on hold in case the symptoms came back or got worse. The rest of the day I had some itching and tingling but by the morning of 11/2/19  my heart rate has normalized and the itching and tingling has just about completely subsided. I did not take the Zyrtec or Bendadryl.
This case was reported by a consumer via interactive digital media and described the occurrence of injection site injury in a patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced injection site injury. On an unknown date, the outcome of the injection site injury was unknown. The reporter considered the injection site injury to be possibly related to DTPa vaccine. Additional details were reported as follows: This case was reported by a consumer via Interactive Digital Media. The age at vaccination was not reported. The reporter stated that, the vaccine was mutated and didn't give lifetime protection. The reporter had two family members that were injured from the DTaP vaccine. This case has been linked with US2017GSK139600 as reported by same reporter.
This spontaneous report was received from a pharmacy technician referring a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant mediations were not reported. On 14-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 Plaque Forming Unit, lot #L017165 and expiration date 13-AUG-2016. (The route of administration was not reported). No adverse effect reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
- One day after received FLUMIST, developed fever to 103, nausea, dry cough, body aches, throbbing headache (has been ill x 6 days).
10/14/03 4p-parent brought child back to office (24 hrs post injection) large swelling L deltoid area warm to touch. Appt scheduled to be seen by MD in evening-given oral antibiotics by MD. Parent called 10/15 re: "itching and spreading of swelling. PHN contacted MD, who saw pt approximately 11:30 a. Admitted to hospital on 10/15/03 re: increased swelling L arm/ elevated WBC count. Anticipated discharge 10/17 or 10/18/03.
I have itching all over my body, but especially behind knees and around my waistline where my pants fasten.  Sometimes it is between my thighs.
about 12 hours after her vaccine, her diaphragm started "twitching." Full body random spasms/tremors then came and persisted all night. Persisted into next day as well and she just can't control it or stop it. This is not painful for her but becoming tiring.
Pt. fainted 1 minute after getting vaccinated.  Pt. stated, "I'm afraid of needles."  Vital Signs done: B/P 130/84, O2Sat 100%, HR 60, R 16, Glucose 92.  At 9:56am pt. stated, "I feel better but I'm still dizzy."  Pt. refused to go to the hospital.  At 10:11am pt. went home with family member.
Shortly after receiving injection arm was very sore. By evening arm was extremely painful to move or touch. Difficult to sleep due to pain. Day after injection arm was very sore,  also felt body aches, headache  and fatigue.
Development of autoimmune pemphigus reaction 3-5 weeks after Hep B vaccine.
1/14/2023, morning around 7AM: Woke up with headaches; weakness; swelling at lower left of back of my head; rash and blisters developed over the following two days; painful upon touching, blisters reached my neck. On 1/16 I called Doctors office, describing symptoms, and provided picture of the blisters on my head. Received medication against Shingles:  Valtrex 1 gm three times a day for 7 days, starting on 1/16. Symptoms started to fade by 1/19, rashes started to disappear, however, it took another two weeks until the blisters vanished.
Woozy, light headed, low blood pressure (80/50), called primary MD, told to take it easy and stay in bed, Fell 12-1pm on 11-8-2014 and broke hip, requiring hospitalization.
During the time of 1st dose  dated:04/04/2021 didn't knew I was pregnant. After second dose dated: 05/4/2021 we went for first scan on May 13th ,2021 and doctor suggested that the baby growth is not as per the weeks being calculated .They suggested that this might lead to miscarriage and asked us to come after 1 week date: 05/21/2021 .But soon after the visit I started noticing bleeding and spotting , we went back on Friday next week and there was no heart beat ,so they diagnosed it to be a miscarriage and gave  medications following that. My blood reports and urine reports are normal. Wanted to report the event .
During the waiting period after vaccine administration, employee developed dizziness, mild chest pain  and headache. 911 was called and employee was taken to the hospital
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: She also had sweating. We called 911 and the EMS was here. Her heart rate was 100. BP 130/90.
expired dose of a TENIVAC administered with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 57 years old male patient for whom expired dose of a diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jul-2023, the patient received a standard expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5ML (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in the left deltoid for  Immunization with no reported adverse event (expired product administered) (latency- same day). Caller would like to know if the dose should be readministered?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
none-inadvertently given 2022-2023 formulation expiring 6/30/23
Chills, sweats, headache, intense back ache, nausea, fatigue, body aches, two weeks later I got shingles
Pt had Varicella vaccine 11-16-2011. Mom took pt to ER 1st week of January & was diagnosed with chickenpox - pox drying but continues - returned to ER Saturday & DR again diagnosed chickenpox.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # N008829, expiration date 16-MAR-2019 and N014632, expiration date 11-MAY-2019 (dose, concentration and route of administration were not reported). Concomitant therapies included sterile diluent. There were no adverse symptoms or effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 36 hours (not as previously reported 9 degrees Fahrenheit for 9 hours). Previous temperature excursion was of 6 to 14 degrees Fahrenheit for 512 hours. Digital data logger was not involved. Outcome of the event was not reported.
TOOK UNREFRIGERATED COURSE OF VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-596) on 07-Mar-2019. It described a 35-year-old adult male consumer who "took unrefrigerated course of Vivotif". The consumer was receiving oral Vivotif (one capsule every other day; lot number: 3003241) for typhoid prophylaxis.  It was reported that the consumer did not refrigerate Vivotif after it was picked up on 16-Feb-2019 and complete course between 18-Feb-2019 to 24-Feb-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated course of Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated course of Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.
Inadvertent Vaccine Misadministration. MMRV vaccine was administered to 16 months old child by a nurse. The child received MMRV despite Doctor's order and CDC recommendations to give two separate vaccines in order to avoid the increased risk of the side effects.
Anaphylactic reaction; I felt as if my throat was closing off; I have cramping feelings in my throat; felt as if my throat was closing off; I was very sick for 3 days; This is a spontaneous report from a contactable nurse.  A nurse of unknown age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The nurse reported that she had her COVID 19 shot the past week and she reported her symptoms and wondered should not take the second dose because she was very sick for 3 days but that did not bother her. The thing that bother her was that she felt as if her throat was closing off, she had cramping feelings in throat. She was afraid that it was beginning to be 'anaphylaxis' but it was not. She reported that it did not go any further than that but she was fearful that her throat was going to close completely off. At the time of reporting the outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The suspected anaphylaxis with throat tightness and throat spasm were probably causally related to the use of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.