chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 15-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (lot # R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
got sicker, side effects; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient for himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine last Wednesday from the day of reporting and got sicker than all hell and till the time of reporting it was still gotten out of his/her pjs. The patient thought that he/she got every side effect that was listed which could experience from the shot. Now the patient had to receive the 2nd dose within 6 months.
Expired first dose; She has two doses done on the same date with different lot numbers; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers) had resolved.            The first lot number recorded is 030M20A; the second one added is 022C21A. The patient was not sure which dose she received. No concomitant medications were reported. Treatment information was not provided by the reporter.
Inability to lift arm evening of injection continuing for two days. Extreme redness and swelling locally began same evening. Redness increased and spread around arm extending down to mid-forearm. Client took Celebrex 9/15 and 9/16 and oral Benadryl on 9/16 when itching at site began. She was seen by Dr. on 9/17 and was given Cortisone injection. Reaction reported to this facility on 9/20.
SICK FROM YOUR VACCINE; This spontaneous report received from a patient via a company representative (via social media) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick from your vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick from your vaccine was not reported. This report was non-serious.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for a few hours before the administration. There were no adverse reactions reported after the administration.
On 10/02/2022, I woke up with a headache and fatigue. On 10/03/2022, the headache and fatigue continued but I also developed a low-grade fever and nausea. Those symptoms persisted until 10/12/2022 with almost no change over that period of time. The symptoms were severe enough that I was pretty much consigned to bed. I was able to drink but was not able to eat much at all. I was seen at my health clinic to rule out COVID-19, flu, and I also had a chest x-ray to rule out pneumonia. On 10/06/2022, due to my symptoms, my doctor arranged for me to be seen at the local emergency room where they performed a CT scan, urinalysis, a head MRA, a lumbar puncture and blood work, as well as an additional COVID-19 test. All of those came back negative except for the urinalysis which showed a urinary tract infection. Also, the blood work was abnormal in a number of ways, one of which being low sodium along with elevated factors for inflammation. They started me on a course of antibiotics for the urinary tract infection. I continued with the same symptoms and continued to have repeat blood work done which continued to be abnormal in some respects. On 10/11/2022, my physician started me on a course of 60 milligrams of prednisone once a day. On the morning of 10/12/2022, my symptoms were improved. That same day, I went to the vascular lab and had a Temporal Artery Ultrasound which was also negative. My symptoms began to improve but I continued to have blood work and urinalysis done and they were improving. On 11/03/2022, all of my lab results were completely normal, and I no longer have symptoms.
This was the booster shot.  i had no reason to the initial first shots. I received the booster shot in my left harm a little after 6pm on Wednesday December 22. Then my arm was hurting very bad. I went to bed. Thursday morning I woke up feeling very sick/all my body hurt, my arm hurting much more going into my left shoulder and chest. Then on Friday my arm and chest still hurt and I notice a bump or swelling under my left arm. I took a tylenol. Today Saturday, i feel much better, my arm hurts less, the bump/swelling is down a little bit.  thank you.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle cramp in a 69-year-old male patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st January 2019, less than a day after receiving SHINGRIX, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was not recovered/not resolved. It was unknown if the reporter considered the muscle cramp to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm.
30 min post vaccine, patient c/o itchiness in tongue and lips. Patient completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - itchy tongue and itchy bottom lip.   DIPHENHYDRAMINE HCL 12.5 MG/5 ML ORAL ELIX given  25mg dose of benadryl  Patient advised to discuss second dose considerations with a clinician.  patient left in stable condition
angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezing; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed hyperlipidemia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on Jan2021 via intramuscular. On 17Jan2021, the patient experienced nasal and sinus congestion, rash on chest and face, angioedema of lips and periorbital area and wheezing. The outcome of the events was not recovered. The patient received an OTC antihistamine and monitored the condition.   Information on the batch/lot number has been requested.; Sender's Comments: Based on a chronological association and known product safety profile, a causal relationship between event angioedema and BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Could not sleep last night; Fatigue; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep last night), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INSOMNIA (Could not sleep last night), FATIGUE (Fatigue) and HEADACHE (Slight headache). At the time of the report, INSOMNIA (Could not sleep last night) had resolved and FATIGUE (Fatigue) and HEADACHE (Slight headache) outcome was unknown.            Concomitant medication  include High blood pressure medication.  No Treatment medication was provided.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Approx. 5 min following vaccination, patient became nauseas, closed his eyes to help it pass and lost consciousness. Brought patient to lie on the floor, he immediately regained consciousness. Sweating, loss of color in face, nausea continued. EMS called for follow up. Normal BP and HR, no further concerns
PUNCTURED VIAL ADMINISTERED; This spontaneous report received from a pharmacist concerned two patients .  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced punctured vial administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vial administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121732.
Rash and hives on right arm, right leg, and back x3.5 weeks.
Employee mixed Shingrex powder with MMR/Varicella Diluent instead of the Shingrex diluent. No patient harm per Drug Information Hotline. She will need to repeat the injection.
No adverse effects reported; HCP called to report an AE.  An adult patient was inadvertently administered a pediatric dose of RECOMBIVAX. No adverse effects reported.  Cross reference with cases 02381997 and 02381963. No additional AE/No PQC.; This spontaneous report was received from a nurse, regarding an adult patient of unspecified age and gender.     The patient's medical history, concurrent medication, concomitant medication, and allergies were not provided.   On 01-MAY-2023, the patient was inadvertently vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) dose of 0.5 mL (pediatric dose) (Incorrect dose administered) (frequency, route of administration, Lot #, and expiration date were not reported) as prophylaxis. No adverse events were reported.
Tinnitus.  I had preexisting Tinnitus that was not bothersome but after the 1st shot is has increased in volume and has not subsided. I am waiting for my appointment with an ENT that is scheduled for Jan 10
pt states he has sore left arm after getting covid vax but when he woke up he had fever, body aches, chills and headache.  Pt as not taken any medication for these symptoms but still has them at this time.
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
Expired Bexsero Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comments: The nurse reported that the patient was administered with an expired dose of Bexsero since July 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Prior to yesterday I had gone over a month without requiring my rescue inhaler, even for excercise. For context it has been 3 years since I've had an attack bad enough to go to the ER. One day post-dose 2, I had a serious attack  of uncontrollable coughing that my inhaler could not control. I had to go to the ER and needed a prednisone burst.
- Feelings of nausea one hour after vaccine injection - Feelings of lightheadedness one hour after vaccine injection - Notice small raised red itchy bumps on inside of right forearm which was mistaken for an insect bite ( these appeared the same day I received the vaccine), the following day  I noticed a few more appear on the left hand side of my forearm, within a course of a few days I noticed several more appear in my lower extremities, and buttocks. Today is March 16,2021 and the bumps are still appearing. The bumps are not filled with fluid, feels hard to the touch and irritated. Is this normal?
Got the vaccine but still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine but still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that she received Shingles vaccine and still experienced Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Varicella vaccine given on 11/24/2004 and 2/21/08. Chicken pox disease dx on 3/25/10 >50 erythematous macules.
1/9/21 & 1/10/21 Body ache, dizziness, fatigue, nausea. No fever
Swelling and redness at site of injection (left). Fever 101 degrees F. Lack of energy/fatigue. Pt. reported that will see MD 9/20/15. Pt reported feeling better 9/20/15 than Thursday 9/17/15.
Parent noted on immunization questionaire that child threw up 1 hour after received, and proceded to throw up an hour x 18 hours, also had diarrhea.  Also has fever of 102.  3rd shot of immunizations defected as dr office notified.
hit me about 7:30pm - very tired, pain in my joints and fever during the night. Slept for 13 hrs Sat night and 10 hrs Sun night. Right arm has some swelling
hardness at the injection site; pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PATIENT REPORTS EXPERIENCING MILD FATIGUE AND FEVER (101.8) ABOUT 2 HOURS AFTER RECEIVING VACCINE.  THE FEVER WAS TEMPORARILY RELIEVED BY TYLENOL AND CONSISTENTLY SUBSIDED WITH TYLENOL USE FOR THE FOLLOWING 24 HOURS.  PATIENT REPORTS FEELING BETTER AND WILL CONTINUE TO MONITOR SYMPTOMS.
Pt stated that within 15 minutes the fingers on her left had were tingling. Pt stated that, later,  her left leg also began to tingle and felt like it was numb and was "dead weight". Pt stated that at one point her knee went out. Pt also stated that her head was cloudy and that things in the background seemed blurry. The pallor of the left hand was different than that of the right hand. Pt was able to lift and move her left arm and hand.  Pt was also able to walk without assistance. Pt was released to the custody of her father and symptom progression will be monitored by family members. Pt stated that she would seek medical attention at the ER if symptoms progressed.