chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fingers and later numb face; Mind fog; This is a spontaneous report from a contactable other HCP. This 37-year-old female other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1685), via intramuscular at left arm on 02Jan2021 08:15 AM at single dose for COVID-19 immunization. Facility type of vaccine was pharmacy or drug store. Medical history included panic disorder (last attack 2 years prior) and known allergies: latex, Iodine dye. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 02Jan2021 08:15 AM, within a few minutes while still under observation at pharmacy, her blood pressure increased and her pulse. Numb fingers and later numb face. Chest pain presented. She went to ER (emergency room) 3hours later with ongoing symptoms that never resolved until 6 or 7 that evening while still in ER waiting room. Mind fog (02Jan2021 08:15 AM) was currently ongoing. The treatment for events included lorazepam (ADIVAN), diphenhydramine (BENADRYL), ibuprofen. Outcome of event mind fog was not recovered, and the rest of events was recovered/resolved with sequel.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. 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.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72 hours. On 05-SEP-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient under 18 years of age old received vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   want to know what the follow steps are and if they should schedule a follow up. No further information provided.
WARM FLASHES; PRETTY BAD HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: warm flashes, and pretty bad headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 Total administered on 06-OCT-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: elagolix sodium (form of admin unknown, oral, batch number was not reported) dose was not reported, 2 times every 1 day, from 24-SEP-2021 for an unspecified indication. No concomitant medications were reported. On SEP-2021, the patient experienced warm flashes. On SEP-2021, the patient experienced pretty bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elagolix sodium was not reported. The patient recovered from pretty bad headache on OCT-2021, and had not recovered from warm flashes. This report was non-serious.
Beginning less than 12 hours after injection, despite taking a naproxen, had myalgias, malaise, low-grade fever (100 degrees), skin sensitivity to touch, headache. Symptoms made sleep difficult, Gradually improved over the next day, but headache and skin sensitivity persisted.
I've had all three vaccines and still got shingles/Suspected vaccination failure; shingles; I've had all three vaccines; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient had received 3 vaccines which led to Extra dose administered. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and time to onset of shingles were unknown at the time of reporting.
This spontaneous report was received from a 58 year old female consumer with hypercholesterolaemia and colon polyps, referring to herself. Concomitant therapies included simvastatin and hydrochlorothiazide. The patient had no drug reactions or allergies. On 04-DEC-2015, the patient was vaccinated with ZOSTAVAX lot number L031271, expiration date: 19-NOV-2016, subcutaneously, for prevention of shingles (dosage schedule were not reported). In April 2018 (reported as "two months ago"), the patient went to the emergency room and had an unspecified scan performed which showed kidney stones and the patient was prescribed prednisone and promethazine. The consumer reported that the kidney stones passed on their own on an unspecified date in 2018. Approximately on 30-MAY-2018 (reported as "a week ago"), the patient started to experience very itchy marks on her back and neck that she thought were bug bites. The patient reported that an unspecified amount of time later, these marks turned into full rashes that were blistering and itchy on the back, neck and shoulders; which were described by the reporter as shingles. On 05-JUN-2018, the patient went to the physician's office and was prescribed acyclovir and prednisone. The outcome of herpes zoster was reported as not recovered. The reporter did not assess the relatedness of nephrolithiasis and shingles with ZOSTAVAX. Upon internal review, nephrolithiasis was determined to be a medically significant event.
This spontaneous report was received from a pharmacist and refers to a female patients of unknown age. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On an unknown date, the patient was administered an improperly stored dose of ZOSTAVAX, lot # reported as N012492 with expiration date on 17-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Concomitant medication included diluent (manufacturer, lot # and expiration date were not reported). The administered dose of vaccine was reconstituted with sterile diluent (manufacturer unknown) which was properly stored. No adverse effects were reported. Administered dose of vaccine experienced a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which lasted for a time frame of 45 minutes. A previous temperature excursion was not reported. A digital data logger was involved in recording the excursions. Additional information has been requested.
Patient complained of pain in left thigh lower injection site, which was Varicella, on 07/08/16 AM, which resolved by 07/09/16.  However, redness and induration increased by 07/10/16, and mother took child into Urgent Care and was diagnosed with cellulitis.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. It was reported that 4 doses of MMR II (doses and units were not reported) were improperly stored and administered to patients since 11-SEP-2014. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Over 1 week later, injection site is still enflamed, and I have pain/swelling in armpit/lymph area. Vaccine was Moderna,  018B21A,  given at Gillette Stadium in Foxboro , MA
Vaccine received 10/6/22 at 2:25pm. I woke up about 12:15am 10/7/22 itching all over. No rash noted. Benadryl taken approximately 1am. Itching improved, but has returned.
It was reported that a 27 year old male patient received a Fluzone SV vaccination on 11/14/2000. Reportedly that same day the patient complained of severe pain in the area of an hiatal hernia. Further information is requested.
Abdominal pain, vomiting, purpura rash (HSP). Admitted to hospital for observation R/t severe abdominal pain, vomiting, dehydration 12/20/2018.
Patient transferred from small hospital to a larger for higher level of care; positive for COVID; hypoxic; O2 supplementation; treated with remdesivir, dexamethasone, Lovenox, inhalers; required intubation; critically ill; developed fever; given ABX; no improvement; developed A Fib with rapid ventricular response; sinus rhythm resumed; Patient continued to worsen and passed away in the hospital.
Information has been received from a nurse concerning a 52 year old caucasian female who, in the morning, on 10/25/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P).  On 10/25/2004 (also reported as 3-4 days post vaccination) the patient had severe reactions to the vaccine with the development of chills all over her body; fever; trembling; numbness, tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down her arm about two inches from the injection site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that on 10/25/2004, the patient developed severe arm pain (beginning 2-3 hours after injection) and chills.  The following day, on 10/26/2004, the patient was unable to use her arm.  It was reported that the patient recovered from severe arm pain, chills and inability to use her arm.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has bee requested.
late second doses/first dose on Feb 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked with case US2021075958, reported for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021075958:same reporter
THE BOOSTER SEEMED TO BURN A BIT MORE THAN THE INITIAL DOSE; This spontaneous report received from a patient via a company representative concerned a 44 year old adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 total administered for prophylactic vaccination. The patient experienced burns at injection site when treated with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported (dose number in series 2), 1 total, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 6-DEC-2021, the patient's booster seemed to burn a bit more than the initial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burns more at injection site on 06-DEC-2021. This report was non-serious.
metallic taste, lightheaded, flushed Tx: 2 hour observation- placed on stretcher Discharged 11:48 am - flushed feeling and dizziness subsiding, metallic taste faint. Underwent Desensitization Procedure 1/12/21
Administration error: MA was administering patient's first dose of Moderna and the needle unattached from the syringe during injection. Patient reports the vaccine splashed all over her car door, and onto the person sitting behind her in the car. Pt requested another dose because she does not believe she received any of it. Patient informed she still may have received some of the dose, and was offered an antibody test several weeks after her second dose. Patient informed there is still an unknown risk of receiving a double dose. Patient states she spoke with her physician, understands the risks, and would like to proceed with a re-dose. Patient given an additional dose of Moderna in her left arm by RN. Pt continued to monitor area for a 30 minute observation. Patient did not report any complaints to observation staff.
My father started showing symptoms of Covid such as low grade fever and muscle aches on 3/28 which was 11 days after receiving the first dose of moderna vaccine
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two- months old male patient who received 0.5 mL first dose of DTAP-IPV component only from the vaccine PENTACEL (lot number of DTAP-IPV C5324AC; Lot number on box is C5507AA that matches HIB component), expiry date- 05-Sep-2019 via intramuscular route in the thigh (not specified) on 20-Sep-2018. On an unknown date, the patient also received a dose of suspect PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE not produced by Sanofi Pasteur (batch number, expiry date, route and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether patient experienced any adverse reaction after the vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
No additional AE reported; GARDASIL 9 was administered after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-MAR-2022, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, dose: 0.5 mL, lot number: T036812, expiration date: 28-APR-2023 (strength, formulation, anatomical location and route of administration were not reported) for prophylaxis (product storage error).  There was a reported temperature excursion of the vaccine of -4.8 degrees Celsius for 1 hour. There were no previous temperature excursions reported.
One week after vaccine developed itching, pain, redness, and mild swelling at injection site. The initial pain at injection site had gone away prior to coming back on day 7 with the itching, redness, and mild swelling.
On Saturday night, April 10th, at bedtime I started to feel muscle pains in my hamstrings.  This made it extremely difficult to fall asleep. The pain subsided a little during the day on Monday, April 12th, but the pain returned again in the middle of the night.
Patient was administered both vaccines and then stood up then passed out and fell to the floor. EMS was called and all the child's vitals came out normal. The parents choose to take their child home instead of taking him to the hospital.
Morning after receiving the second Covid shot started experiencing debilitating head and face pain on the left side, it was tender to touch. After several weeks of the constant pain, I went to see my a doctor. My doctor ordered an MRI and referred me to a neurologist. My neurologist reviewed the MRI and said it was normal. She suggested it may be trigeminal neuralgia and prescribed Carbamazepine 100 Mg Chewable Tablet. I then missed a week of work.
I had a rash that started between my breasts.  I was itchy and burning along my breastbone.  It comes and goes, more in the evening. The doctor about it twice because it was not going away. She is having me go see a specialist for it.
At 9pm on 3/6 felt fatigued and went to bed. Awoke at 11 pm with nausea, severe muscle pains, inability to breathe. Crawled back to bed and had fatigue until night of 3/7. Had a temp off 100.7 in the morning of 3/7 that was gone within 2 hours. On 3/8, started waking up to neuralgia in both hands with hands burning and inability to grasp objects. Since 3/8 (continues to this day) this has continued almost nightly and now occurs during the day along with major muscle aches and pain and stiffness in neck all the way down to the back.
Patient experienced pain radiating from injection site up to neck, neck stiffness and SOA. Patient was evaluated in ED and toradol and benadryl were administered. Patient's neck pain and SOA have resolved but neck stiffness persists.
This case was reported by a consumer via another manufacturer and described the occurrence of screaming in a 2-month-old subject of unspecified gender who was vaccinated with DTaP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTaP vaccine (unknown). At an unspecified time after vaccination with DTaP vaccine, the subject experienced screaming, crying and a red area on their leg. At the time of reporting the outcome of the events was unspecified.
Clinical Summary Patient is a 82 y.o. male with a history of CVA with left sided weakness who presented to RMH 10/11/2022 with 1 day of SOB, fever and increased weakness. Found hypoxemic and COVID-19 positive. Course prolonged by placement and need for isolation. Patient stabilized and discharge to facility.    1. Acute Hypoxemic Respiratory Failure: due to COVID. Weaned off O2 10/13/22.  2. COVID-19 Pneumonia: Vaccinated. Symptoms started 10/10/22. Tested positive on 10/11/22. CXR 10/11/22 showed left hazy opacity course markings. Pt family declined remdesivir. COVID 19 pneumonia only, no sepsis. Decadron discontinued 10/17/22. 3. AKI: Cr 1.1 on admit. Baseline 0.7. Likely pre-renal due to poor po intake in addition to loss of autoregulation. Held home ACEi on admit. Resolved to normal on 10/13/22. Resumed home medications on discharge.  4. Urinary Retention: with history of BPH s/p TURPT in the past. Has had foley in the past. Foley placed on admit. Voiding trial when more ambulatory at IPR.  5. CVA: with left sided weakness.  6. HTN: Continued home meds.  7. Waldenstrom's Macroglobulinemia: per history no longer on treatment.  8. Code status: DNR CCA DNI discussed on admit
Pt called reporting severe abdominal pain 7/10. nausea, and irregular bowel movements since starting on the Typhoid oral pills.  She is on day 3 of the pills.  No reports of fever, diarrhea, vomiting, difficulty breathing, swelling of throat or mouth.  Advised pt not to take remaining dose of Typhoid oral pill d/t inability to tolerate side effects of vaccine.  Pt advised to take an OTC pain reliever for the pain and Pepto Bismol to help alleviate the stomach pain.  Also advised to rest and hydrate well for the rest of the day.
Student received the influenza (TIV) vaccine. After leaving the clinic while waiting in line at the exit table, student fell backwards on cement, hit her head and sustained a lump on the back of her head.