chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a currently 6 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion (Product storage error). The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Covid19 breakthrough.  1st Vaccine received 01/24/2021.  Pt brought to ER from ALF with AMS, generalized weakness, fever and dry cough.  Per daughter, pt had recent Covid exposure and over the last 6 hours has been unable to get out of chair, left leg is weaker and she is not acting like herself.  Pt receiving IV ABX and steroids. On O2 at 2L NC and O2 sat 100%.
bodyache; Headaches; diarrhea; nausea; fever; chill; This is a spontaneous report from a contactable other health care professional (patient). A 64-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: 30130, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 21Sep2021 at 03:30 PM (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cancer survivors, had covid last May. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 31Sep2021 at 02:30 PM (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No other medications received in two weeks. No known allergies reported. On 22Sep2021 at 03:00 AM, the patient experienced body ache, headaches, diarrhea, nausea, fever, chill. No seriousness criteria were reported. Therapeutic measures were taken for events with Motrin, plenty of hot tea. The outcomes of events were recovering.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
I got the shot at 8:00 A.M. at 8:45 after I arrived home, I got dizzy and felt very weak. I went to the E.R. They tested my blood and urine. Nothing showed up. The dizziness gradually went away. However I felt lightheaded the rest of the day.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-MAY-2014, patient received improperly stored VARIVAX dose 1, from batch/lot # H018451 (expiry date, dose, units, route and anatomical location were not specified. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Left side headache that worsened as day progressed. Pain with, side of head eye, ear and shoulder. All left sided. 12/7 still complain of pain "nerve pain" in left cheek and teeth.
Pt's reaction occurred, that PM at approx. 18:00. She had red face, was hot and had itching. Pt very agitated. On 12/18/00, spoke to mother. Rash had spread from her face to her neck, lasting 2 days. Mother gave Benadryl. No respiratory effects.
Exanthem with crusted papules on torso -> extrom - 1-2 dozen lesions, pruritic, increased past 2d.
ACUTE RESPIRATORY FAILURE 6/8/2022 ACUTE RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 6/8/2022 PLEURAL EFFUSION
8/5/2022: Presented to ED after fall x2, unable to stand after second fall at facility where he lives.  No other contributing symptoms noted at the time. A pelvic x-ray is normal. Head CT reassuring. No signs of a stroke or definitive weakness. He has A. fib on his EKG.  He has mild renal insufficiency. BNP noted to be elevated but nothing to suspect florid congestive heart failure. At this point it is unclear why he is weak.  8/9/2022 transitioned to Hospice with a terminal diagnosis of covid 19 virus infection. Evaluation revealed hypoxia and covid 19 infection. His hospital course was complicated by worsening dementia, atrial fibrillation with RAPID VENTRICULAR RESPONSE and an episode of presyncope.  Passed away on 8/11/2022 Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact  Hospital
Patient had a febrile seizure on 3/11/2018 at 3 AM. Mom described him waking up suddenly and screaming and crying then staring off and having bilateral upper and lower extremity jerking. He then fell asleep. He was seen in an ED and was diagnosed with a LOM and started on AUGMENTIN. On 3/12 he began having episodes of vomiting and diarrhea. He has had fever since 3/11 - Mom is alternating TYLENOL and MOTRIN and says the fever comes back before he is due for the next dose of anti-pyretic.
Flu like symptoms night of the vaccination - body aches, dry heaving and chills. Arm pain for the following 3 days finally starting to progress.
Itching when I sweat. Since October 8, 2021 in the morning.
Approximately 2 weeks after 2nd vaccine I experienced paranoia and thought my son's girlfriend was out to get me. In the back of my mind I knew it wasn't true and paranoia doesn't last long and comes and goes. I've had a memory problem for years but it has greatly accelerated since the second vaccine. My short term memory is declining at an alarming rate,
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # K022995 with expiry date 22-JUL-2016), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 20APR95 & 24APR95 pt exp h/a;pt was seen by MD & treated w/an analgesic;
Within a day of the flu shot, I began experiencing and continue to experience constant pain and tingling in my left hand ring finger. Patient reported to RN on 02/02/05, states he has intermittent pain and tingling in left ring finger, started in left middle ring and pinky fingers. Now it is just in the ring finger and severity is decreased. However, is noticeable most of the time per patient. Patient was advised to contact PMD for neurological exam.
Headache, weakness, muscle aches, joint aches, chills Unable to do most activities for 24-3- hours
Patient received first dose of Moderna COVID-19 vaccine on 1/11. Received second dose on 2/8. On 2/22, pt undergoes routine COVID-19 testing. Denies any COVID-related symptoms (i.e., fever, chills, cough, SOB, etc.). Nasopharyngeal swab obtained 2/22 at 0913. Coronavirus PCR test resulted positive later that day.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. Additional information has been requested.
13 year of age female vaccinated in error.  Under age of 16. Height 5 feet 5 inches; Weight 136 pounds.
The patient received the third/booster dose of BNT162b2; The most current period a week after my 3rd booster has been a lot heavier than usual and started early as well; The most current period a week after my 3rd booster has been a lot heavier than usual and started early as well; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 16:45 (at the age of 35-years-old) as a dose 3 (booster), single for COVID-19 immunisation. Medical history included Irregular menstruation, have noticed changes in periods/They have been starting a day or 2 earlier than usual,medical device removal from an unknown date and unknown if ongoing Had a nexplanon implant removed at the end of May, mild asthma, seasonal allergies from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received etonogestrel (NEXPLANON) implant. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 35-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation, experienced hormone imbalance. The patient had received the third/booster dose of BNT162b2 on 03Nov2021 at 16:45, a week after the most current period a week after her 3rd booster has been a lot heavier than usual and started early as well on Nov2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event the most current period had been a lot heavier than usual and started early as well was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
gross hematuria and vasculitic rash  48 hours after vaccines received she got both Pfizer booster and shingrix at same time
Sore arm where vaccine was given. A bright red spot and hard to move for few days. Headache.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with improperly stored PROQUAD (therapy type: rHA) (strength, dose and route of administration were not reported) (lot # N025926, expiry date: 18-MAR-2019) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). The vaccines were exposed to a temperature of 47 degree Fahrenheit (F) to 77 F for 53 minutes. The prior temperature excursion was from 47 F to 77 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further details were provided. No product quality complaint (PQC) was involved.
This spontaneous report was received from two nurses via company representative and refers to a 4 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-SEP-2016, the patient was vaccinated with a dose of M-M-R II in her left leg (dose, route of administration, lot number and expiration date were not provided, albumin status could not be determined). It was not known if it was first or second dose of M-M-R II. On an unspecified date in September 2016, the patient experienced redness and unspecified swelling at the injection site at an unspecified time after vaccination. No Product Quality Complaint (PQC) was involved. The outcome of events was not reported. The relationship between events and M-M-R II was not reported. Additional information has been requested.
Significant pain and swelling at the site of injection. Pain commands within three hours after the injection and finally completely subsided after about three days. Shivering/chills began in the evening about nine hours after the injection and continued intermittently throughout the night. Fever developed about 24 hours after the injection and continued intermittently through about 48 hours after the injection. The patient's normal temperature is typically around 97.8°F, the fever reached a high of 100°F the day after injection and a high of 99.5°F on the second day after injection.  Acetaminophen (2x500 mg) was taken in response to the fever on the first day And I had limited affect in lowering the temperature to about 99.3°F. The patient?s temperature return completely to normal ( 97.8°F) by 50 hours after the injection. The patient had to limit his activities during the 48 hours after injection
Visible signs are total body itching. Tb swollen, res and itchy. Patient stated she was short of breath and lips swollen which were not evident to this nurse.
Breakthrough case admission after three vaccines: Moderna 2/23/21 Lot# 029L20A; Moderna 3/23/21 Lot# 010A21A;  Moderna 3/17/22 Lot# 026L21B.
Swelling and pain in right armpit started Thursday February 25 in the early afternoon.  Causing pain to radiate down arm.  acetaminophen and cold packet to help with pain
She received her 2nd dose of Pfizer Covid 19 vaccine on 7/24/2021 at 10:15 am and woke up on 7/25/2021 with a major headache around 6:30 am. Within 10 minutes of being awake, the headache became very bad and caused her to pass out. She could recall all basic information when she woke up to her mother.
Patient reported tingling sensation in hands and feet ~15 minutes after Moderna Vaccine Administration.  Patient states the tingling sensation was not present prior to receiving vaccine.
5-6 vesicular lesions-2 on back, one on head, on face, one on leg.  One lesion on back was large and surrounded by erythema.
Patient came in with daughter asking for a vaccine, when taking the order she said she wanted to get the Flu vaccine and was writen and charged from the Flu vaccine. After patient was asked again, siged the concent papers and was vaccinated, daughter claimed that the Flu vaccine was not what they asked for, that instead they wanted the pneumonia vaccine. No negative outcomes or adverse events were present.
Swelling of fingers and feet the next day after receiving the vaccine. It has been over 2 weeks and I still have swelling of my fingertips, hands, and feet. I also have excessive dryness on both hands and feet. My fingers feel like they are secreateing sticky moisture. Fingers feel sticky like they have glue on them.
ulcers in her mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 32 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MOUTH ULCERATION (non-serious), outcome "not recovered", described as "ulcers in her mouth".  Additional Information: The patient is the reporter's niece. The reporter said that her niece has the same experience but she didn't report it. She said her niece didn't connect it to vaccine until the reporter told her what side effects she had. She said her niece didn't think it was related to the vaccine. ulcers in her mouth was reported as worsened. The reporter does not have the patient's vaccination card with her. The reporter does not know any information about her niece's primary care provider. The reporter said her niece's ulcers were more in the corner of her mouth. The reporter was not sure of the start date of her niece's ulcers and said her niece got the vaccine about a month before the reporter. She said it ended recently; probably about after a month. The reporter said her niece received both doses but the reporter does not know the dates or times of her niece's vaccinations. She said she got it a month before the reporter. Adverse event does not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks), Patient's Medical History (including any illness at time of vaccination)- Allergies, Surgeries, Relevant Tests were unknown to reporter. Family Medical History relevant to AE were none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
an extra dose of IPOL was administered to a patient instead of the intended GARDASIL vaccine with no reported AE; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old male patient who was administered an extra dose of ipol instead of the intended gardasil vaccine with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 06-Jan-2023, the patient received a  dose of suspect poliomyelitis vaccine (inactivated) (Ipol) Suspension for injection at a dose of 0.5 ml with lot U1A601M and expiry date- 27-Feb-2023 via intramuscular route in the left deltoid for Immunization (strength unknown).  On 06-Jan-2023 the patient was administred an extra dose of ipol instead of the intended gardasil vaccine with no reported AE(wrong product administered) (latency same day).  Action taken: not applicable  Outcome: Unknown   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.
Moderna COVID-19 Vaccine EUA My entire left arm started to heat up at approximately 5 minutes after the shot. It started at injection point and the heat spread to my fingers. Felt some tingling in the same arm and on my head. The nurse place cold pack on top of my arm for 15 minutes. I felt better. Then, approximately 2 hours later I felt pain every time I moved my arm and it felt very heavy. That night I started to have cramps in both feet and both legs. At approximately 11pm I felt very heavy like I was going to sleep instantly. I went to sleep, during the night I had several cramps in both feet and legs. I felt numbness through all my body. When I woke up the next day I felt completely numb. I could move but in slow motion. I had a sharp pain in my left arm when I moved it. The numbness lasted til March 28. I started feeling better in March 29. The arm pain started to feel better on March 31 but I still not feel 100% well from the arm. Sometimes I feel it very heavy and feel pain again.
SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient by a Business partner (Pfizer Inc., US-JNJFOC-20210714002) on 02-JUL-2021 was received on 12-JUL-2021 and concerned multiple 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: 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 to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sars-cov-2 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V1 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a licensed practical nurse concerning a 9 year old female with no known medical history or allergies who on 08-FEB-2000 was vaccinated in the left arm with a 0.5 mL SC first dose of Varivax (lot # 631779/1354J). There was no illness at the time of vaccination. On 11-APR-2006 the patient went tot he office complaining of a fever and a rash on the neck and back that started on 10-APR-2006. It was reported that she developed a fever of 101 and about 80 vesicular lesions on her neck and trunk, also described as multiple varicella-like lesions on back and neck. Unspecified medical attention was sought. The patient recovered on 20-APR-2006. There was no product quality complaint involved. Additional information is not expected.
Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after vaccine. Never reached out for treatment.
This spontaneous report as received from a registered nurse refers to unspecified multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M042324 with expiration date of 10-JUN-2018, for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009565: US-009507513-1709USA009566.