chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient's medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen's duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter's Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).
Patient complained of onset of Temp of 102 and nausea 24/hrs post injection.  Noted localized redness and swelling at the injection site. (immunzation given 4/30/08 pm) Patient was seen by physician on 5/2/08 and was given course of antibiotics. 5/3/08 report per pt much improved. Redness and swelling down and temp @ 99'.
Patient was administered vaccines and about 10 minutes later on her way our of the pharmacy she became light headed and fainted. She showed no signs of allergic reaction and was not injured. Monitored her on site for an additional 30 minutes then counseled on signs and symptoms of anaphylaxis and syncope and told her what to do it either happened then sent her home. Followed up with patient at 7:50 pm 8/12/19 and she was doing fine.
patient missed second dose of VAQTA on unspecified date; No adverse effects reported; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) lot # N020951, expiration date 15-OCT-2018 for prophylaxis (strength, dose, route and frequency were unknown).  On an unknown date, the patient missed the second dose of hepatitis a vaccine, inactivated (VAQTA). No adverse effects were reported.
Pt received flu shot and developed MS flare,visual disturbance, & dysarthria.
facial swelling/cheek swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling face (1st dose received on 7th May 2019, refer linked case US2019159156).   On 28th August 2019, the patient received the 2nd dose of Shingrix .5 ml. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced facial swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The day after receiving Shingrix, the patient experienced facial swelling on her left cheek. This exact same event and onset time happened after the 1st and 2nd dose. Both injections were administered in the left arm. The reporter consented to follow up.
Fever, headache, nausea, vomiting. dizzy, sleepiness, sluggishness, pain at the injection site (could not raise R arm without pain).
The Tdap vaccine was injected into my left arm. The initial symptoms were local reactions in the site of injection including painful and swelling arm as well as swelling hand. Then in the morning of June 17, I started having cogwheel-like jerks in my left fingers when I try to make a fist. After taking 20mg Prednisone a day for 6 days and Benadryl for 2 days as prescribed by the doctor, the swelling arm and hand went away. However, 11 days after receiving the vaccine, the cogwheel-like movements still persist. I also couldn't do heavy weight-lifting with my left arm - the muscles would become sore. My elbow, wrist and finger joints also hurt at times when I move. Starting this morning (June 29), my right finger joints felt a little stiff and slightly displayed cogwheel-like movements as well when I try to make a fist.
pt recvd vax; devel fever 24 hrs p/ vax then 36 hrs later devel szs; was hosp for 24 hrs w/ control of sz & fever;
Metal taste in mouth; Slight numbness on upper lip; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 10:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Apr2021, the patient experienced metal taste in mouth and slight numbness on upper lip. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome for the events metal taste in mouth and slight numbness on upper lip were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Red, swollen, painful, injection site beginning the evening after the second dose. Fatigue a few hours after the second dose. The fatigue continued through the second day after the dose. Headache the day after the second dose. All symptoms were treated with ibuprofen.
Information has been received from a physician concerning an approx. 4 year old pt who, before 4 years of age, was vaccinated with varicella virus vaccine live. On 8/6/01, the pt was hospitalized for dermatome zoster C6, 7 and 8 and meningitis. It was noted that the culture from 1 of the herpes zoster lesions grew VZV at the hospital laboratory. A CSF specimen was also collected. The child has been discharged from the hospital. Additional information has been requested. F/U states a CSF specimen was also collected and was VZV (+). The vaccine strain was identified by the PCR analysis. The child is fully recovered and has been discharged from the hospital. His herpes zoster lesions resolved 7-8 days after the acyclovir treatment began. The meningeal signs were mild and have also resolved. It was noted that the child is back on his maintenance dose of chemotherapy and being followed from home. Additional information has been requested. no additional info was reported.
Right deltoid erythema and induration of 11x12 centimeters.  No lymphangitis, lymphadenapathy, fever or swelling of arm.
Localized left arm swelling with a maculopapular pruritic rash over the left arm and torso with fever.
Not able to work/function past 03 PM; Ruptured Achilles tendon; Severe nausea; Extreme Fatigue/ exhaustion; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 03Aug2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer, the patient. This 42-year-old female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 15Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history included likely had COVID in Feb2020. The patient had no known allergies, no relevant family history, and no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 17Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. On 16Apr2021, the patient experienced extreme nausea and extreme fatigue, both reported as serious for disability. Patient had severe nausea and exhaustion for 13 days. Patient further described extreme nausea & fatigue resulting in inability to work functionally or care for children for 2 weeks; she was rendered useless by 3 pm each day, earlier on others. On 19Apr2021, patient had a ruptured Achilles tendon and experienced exhaustion. There was no treatment received for the events. The clinical outcome of extreme nausea and extreme fatigue/exhaustion was recovered on 30Apr2021, of ruptured Achilles tendon was not recovered, of not able to work/function past 3 PM was unknown. The patient was not COVID tested post vaccination.   The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
cluster of blistering rash in  dermatomal distribution, (back), one week post vaccination with 1st dose of Shingrix
Patient accidentally received a pediatric Pfizer Covid vaccine instead of adult dose. Patient was notified later that day and returned to pharmacy   next day and received adult dose.  Patient reported no adverse reactions.
itch real bad; had shingles, Got first shot and second/Suspected vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In November 2021, between 1 and 2 years after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got first Shingles shot on 15th December 2021 and 2nd Shingles shot in February 2020 and had shingles back in first part in November 2021. The patient was not in pain at all and just itch really bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Note: Discrepancy in 1st dose date (Year), hence not updated in product tab only mentioned in narrative.
cough; Headache; loss of taste; fatigue; This is a spontaneous report from a contactable consumer (Pfizer employee).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation.  Previously the patient received first dose of bnt162b2 in Mar2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: unknown results. Covid test type post vaccination: unknown. The patient underwent lab tests and procedures which included covid test: unknown results on unknown date. On Jul2021 the patient experienced cough, headache, loss of taste, fatigue. It was unknown if treatment was given. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
unk # of pts recvd dose of vax & immediately exp stinging @ inject site; No further details are available; This case is considered to be invalid;
Initial and follow-up information has been received from a consumer concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAR-2008, 23-MAY-2008 and 26-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # 659182/1757U, 660391/0063X and 659184/0843X), injection. Concomitant therapy included ibuprofen and AMITRIPTYLIN. In September 2008, the mother stated her daughter experienced chest pain, fever, nausea, muscle stiffness, headaches, stomach problem, and when she was not really feeling well in her pupils became "dilated", while on GARDASIL. She did not go to school and was not active because she could not even get out of bed. The patient had had chest X-rays, EEG'S, CAT Scans, sleep studies, and blood work done which all came back negative. The consumer also reported that the patient was an avid dancer before getting GARDASIL and she could not even get out of bed, "I had taken her to specialist and other physicians and no one can figure out what is wrong". The patient's outcome was not recovered. On unspecified date, the patient sought unspecified medical attention. The nurse stated that the patient's mother consented to come to the office to sign the Consent for the Release of Medical Information concerning the patient, and she would call back when the patient's mother signed the Consent Form about if the patient was able to attend school. Upon internal review she doesn't go to school and isn't active because she can't even get out of bed was considered to be disabling. This is one of several reports concerning the same source. A lot check has been initiated. Additional information has been requested.  5/18/09 Received vaccine & PCP office records of 2/20-3/23/2009. FINAL DX: fatigue syndrome Records reveal patient w/intermittent low grade fever, fatigue, HA, abd pain, chest pain since approx 9/08.  No longer able to participate in dance & missed some days of school.  Referred to Neuro, Cardio & ID.  Seen in ER for passing out.    6/1/09 Neurology consultation records received DOS 4/14/09. FINAL DIAGNOSIS: None provided. Post vaccination: Fevers, injuries, fatigue, headache, migratory aches and pains. Stomach pains, chest pain. Episodes of syncope, fell and hit head on the floor. Dizziness, short of breath, disturbed sleep, snores.  Polysomnogram, 24 hour EEG to be performed. Immunology or infectious disease consult recommended.  7/17/09 Pediatric infectious disease consultant records received DOS 6/25/09. Assessment: Symptoms most likely related to Rheumatological condition. Patient presents with intermittent fever, fatigue, chest pain, abdominal pain, headache and myalgia since Sept. '08 and fainting since March '09. Myalgia of arms and legs. Knee pain. Postural hypotension. Unresponsive during fainting spells. Weight gain.
Large red patch on arm that is tender to the touch and itchy. Appeared last night and is still here 26 hours later. No symptoms for the 7 days previous to last night.
18 hrs after injection, headache, T 100.8, dizziness, fatigue, clammy sweats. No N & V.
reported a child dose of Engerix-B was given to an adult (55 years); reported a child dose of Engerix-B was given to an adult (55 years); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 55-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On 02-OCT-2023, the patient received Engerix B pediatric. On 02-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: reported a child dose of Engerix-B was given to an adult (55 years)) and underdose (Verbatim: reported a child dose of Engerix-B was given to an adult (55 years)).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date 2 Oct 2023 The pharmacist reported a child dose of Engerix-B was given to an adult on 2nd October 2023, which led to adult use of a child product and underdose. The reporter consented to follow up.
THIS VACCINE ADMINISTERED ALONG WITH 0.50 ML IPV (POLIO) VACCINE  IN ERROR
itching over face & trunk & lt arm;mild urticaria below inj site;no wheezing;11AM BP 140/70;DPH given;1120AM BP 128/74 itching less no rash no wheezing;1140sx cleared;
Nurse (myself) grabbed combination vaccine PENTACEL instead of PEDIARIX.  Also administered PEDVAX (Hib vaccine), so child received a double dose of Hib.
Pt is a 21 yo male s/p full Pfizer COVID vaccination: dose 1 on 3/24 and dose 2 on 4/14. Pt presented to the hospital on 8/8 with night sweats, chills, fatigue, myalgias, arthralgias, headache, decrease UOP and dark urine. He recently spent 5 weeks on international trip. Confirms mosquito bites and other animal exposure including monkeys, birds, cats, and dogs. Denies any animal bites. He spent time living in a jungle where he consumed local water, alcohol, and foods. During travels patient experienced brief episode of diarrhea with no additional symptoms. Current symptoms began acutely on 7/31 and persisted since ED eval on 8/8.
Developed body aches, sore throat, cough, conjestion and weakness of lower extremities approximately 6 days after vaccination.  No photophobia or nuchal rigidity.  Patient requires assistance with ambulation due to lower extremity weakness.
Information has been received from an 18 year old, for GARDASIL, a Pregnancy Registry product, with no pertinent medical history and no known drug reactions/allergies, who in August 2010, was vaccinated with the first dose of GARDASIL (lot number not provided), on approximately 2010 was vaccinated with the second dose of GARDASIL (lot number not provided) and on 01-MAR-2011 was vaccinated SQ with the third dose of GARDASIL (lot number not provided). There was no concomitant medication reported. The patient reported that she was pregnant at the time of the third dose administration, on 03-JAN-2011. On an unspecified date a blood work test was performed. Patient's last menstrual period was not reported. Expected date of delivery was unspecified. Follow up information has been received via complete questionnaire from the medical assistant, concerning the 18 year old female patient with no concurrent medical conditions and no previous pregnancies, who in August 2010, on 01-NOV-2010 and on 01-MAR-2011, was vaccinated with the first, second and third doses, respectively of GARDASIL (lot# 0450Z, 0644Z and 1560Z, respectively). The medical assistant reported that concomitant medication using during this pregnancy included CITRANATAL. The medical assistant also reported that patient's last menstrual period was on 18-NOV-2010 and estimated delivery date was 26-AUG-2011. It was reported that on 29-MAR-2011 an official ultrasound was performed (result: normal). On approximately 26-JAN-2011, during pregnancy the patient experienced chlamydia infection and was treated with azithromycin 2g once. On the same date the patient also experienced urinary tract infection, nausea and vomiting and was treated with KEFLEX 500mg, once an PHENERGAN 25mg, prn, respectively. At the time of the report the patient's outcome was unknown. On 19-AUG-2011, at 39 weeks from LMP, the patient delivered a normal female baby with no congenital anomalies and no other complications or abnormalities. The baby's weight was 7 pounds 4 ounces, length was 20 inches, APGAR score was 8/9. It was reported that there were no complications during pregnancy, labor or delivery. Follow up information had been received from the registered medical assistant refers to the currently 21 year old female patient. The patient was given 3 series GARDASIL intramuscularly on 20-AUG-2010, 01-NOV-2010 and 01-MAR-2011 respectively. There was no adverse reaction reported. Additional information is not expected.
Vial was kept in fridge for 5 days longer then manufacture recommended time.  Per phone call to Pfizer,  we had patient return to pharmacy for re-vaccination.  No side effects were reported.
Patient had gotten vaccination for covid and Arexvy and they waited 15 mintues after and she was fine. But after they had left and got into their car in the parking lot,she developed slurred speach and confusion. That is when husband decided to take her to the hospital, where she was told that she suffered form a TIA and kept in the hospital for 2 days.
Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
WITHIN 45 MINUTES OF RECEIVING VACCINES, DEVELOPED MOUTH ITCHING, PROGRESSING TO HIVES, FACIAL EDEMA AND BREATHING DIFFICULTY. NO HX WHEEZING BY PARAMEDICS AND ED STAFF. PARAMEDICS GAVE BENADRYL AND PREDNISONE AND TRANSPORTED TO HOSPITAL ED. SYMPTOMS MOSTLY RESOLVED UPON ARRIVAL. ASYMPOTOMATIC BY 8/13/05