chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 17 January 2007 from the patient. A female patient (date of birth not reported), who has no concurrent illnesses or pre existing medical conditions, but who had tested positive for egg allergy (date of testing not reported), had received a right arm dose of Fluzone on 08 November 2006. The lot number, route and site of administration was not reported. Three days post-immunization, the patient had chills, numbness, tingling, and shooting pain in her arms that spread to all four extremities over the next month. At an unspecified amount of time later, the patient was evaluated by two neurologists at a hospital (contact information for the hospital was provided) and all tests were normal. Diagnostic testing included a Brain scan, and "ANA" test that were normal. The patient had not received any other vaccinations within four weeks of the vaccination on 08 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 20 February 2007. There was no additional information . Follow up information received on 15 March 2007 from the patient. The patient reported that she still had "sharp pains in my bones" and the numbness has continued now for four months. treatments received and diagnostic testings performed were not reported. Due to this new information, the seriousness of this case has been upgraded to serious.
pt recv vax 23AUG96 & approx 24hr p/vax pt devel whelps of lower extremities, big round whelps;pt totally recovered from sx by 26AUG96;
Diffuse macular papular rash over axilla (left). Persisted for 5 days. No vesicles. (+) pruritus. No respiratory distress or stridor.
Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
-Severe abdominal pain, projectile vomiting, severe diarrhea that lasted for 3 days.  - spasms and pain in legs
Patient stated she had swelling in the top lip and bottom after about 4 hours. Patient took benadryl and swelling decreased in lips
Patient developed a red rash over his trunk and extremities the evening after receiving the SHINGRIX vaccine. Rash was not painful or pruritic, just present. Patient reported the issue 19 days after it occurred and the rash was still present.
Pt states fatigue started 7/17/10, and vomiting, loss of appetite, nuasua started on 7/18/10.
No adverse event; given 0.25ml of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-655875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655875:Crosslink case with same reporter
Information has been received from a physisican concerning 2 patients (ages and gender unknown), who, on unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, the patients experienced urinary tract problems, then later experienced chills and nausea. At the time of the report, the outcomes of the patients were unknown. This is one of two reports from the same source. Additional information has been requested.
Pt recvd vax on 29JUN92 & 4OCT92 exp malaise, nausea, emesis, diarrhea, fever, h/a, achiness; Lab eval showed elevated levels of serum alkaline phosphatase, SGOT, SGPT & ESR, nl throat culture & neg anti-HBS;
This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccine of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccines was exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015 01:49, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. NO adverse effects were reported. The high temperature and low temperature were 11.8 (2hours 18mins) and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.). At the time of the report, PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees 102 degrees Farenheight..         No concomitant and treatment medications were reported. The patient had received her second dose of the Moderna Covid-19 vaccine and had a temperature of 102 degrees Farenheight.
5/2/03 Patients guardian called stating RAT has large round knot, red, baseball sized.  LAT knot silver dollar size.  Guardianstated temp 98.8 little whinny, but active and ambulatory.Monitor swelling, apply warm compresses.
04/03/23 presents to ED for "fatigue, SOB". PMHx of "asthma and bronchitis"
There was severe swelling in the left upper/lower arm where the shot was administered. That area was painful to the touch, hot, and the arm was restricted movement on the arm as well.
On Friday night evening getting really sob thought it would go away. When I got up that Saturday morning getting worse couldn't take couple of steps without struggling. I called the on-call doctor went to urgent care then went to ER. I was hospitalized, did tests to look at my lungs was told I had a very bad reaction to the vaccine. When I woke up on Sunday feeling better. As of today, still have effects while exercising.
2/21 On a trip, started to feel bad so I took an at home COVID-19 test positive.  Televisit on 2/23 started taking Paxlovid.  Symptom improvement happened quickly.  Cough lingered for about 3 weeks, but by the weekend recovery was assured.
On 4/12/01, stiff neck, trouble swallowing and trouble moving neck. No medication. Referred to PMD.
A report was received from a healthcare professional on 10/29/2003 concerning a male vaccinee of unspecified age who experienced dizziness, fatigue and pain at the injection site on the night after receiving Fluvirin at 9AM on 10/28/2003. On the night of 10/28/2003 the vaccinee experienced dizziness, fatigue and pain at the injection site after receiving Fluvirin.  The symptoms had not resolved at the time of report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 02May2021, outcome "unknown", described as "after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating".  Additional information: Reporter stated that son, age 20 (unit: unknown), informed me yesterday 09May2021 that 2 days after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating. He received his 1st dose on 30Apr2021. Please let me know if you need any further information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient did report feeling ill 1-2 days following the vaccine. He reported conscious whole body shaking (?rigors), for 7 minutes. On 9/26, 13 days following the vaccination, he reported feeling hot but did not have any fever. He reported a funny smell immediately preceding the seizure. He then had a witnessed tonic clonic seizure. No prior history of seizures. Inpatient workup was notable for urine drug screen only positive for cannabinoids and opioids, lumbar puncture (with normal microbiologic studies). MRI and CT/CTA all did not show a lesion. EEG was normal without epileptiform activity. He was discharged with plan for neurology follow up.
Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 36- year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) solution for injection, administrated at arm left on 16Mar2021 12:30 PM as a single dose for COVID9 immunisation (age at vaccination is 36 year). Medical history included guttate psoriasis. Concomitant medication included Fluocinolone ointmentmanufacturer unknown). The patient is not allergies to medications, food, or other products. At an other Pfizer facility the most recent COVID-19 vaccine was administered to the patient. The patient did not receive 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 had not been tested for COVID-19. On 16Mar2021 the patient developed Sore arm at injection site. The patient does not received any treatment for the adverse event. The clinical outcome for the event Sore arm at injection site was not resolved. Pfizer have permission to contact the reporter about this report. Pfizer does not have permission to contact the patient's healthcare provider about this report. No follow-up attempts are possible. No further information is expected.
Information has been received for the pregnancy registry of GARDASIL, from a 24 year old female patient who on 15-JUN-2009 was vaccinated with a first 0.5 mL dose of GARDASIL (LOT #660620/0571X). There was no concomitant medication. It was reported that as of 30-JUN-2009 the patient was 8 weeks pregnant. On an unknown date a urine test was performed; results were not reported. The patient's last menstrual period was 25-MAY-2009 and the estimated delivery date is 01-MAR-2010. The patient sought unspecified medical attention. No adverse events were involved. Follow up information received from a registered nurse indicated that the patient was a female with migraine, anxiety, depression, hypersensitivity, nausea and tooth pain, and a previous live birth. Concomitant therapy included CLARITIN, PROZAC, COMPAZINE, XANAX and TYLENOL WITH CODEINE. On an unspecified date during her pregnancy, the patient developed bacterial vaginosis. The patient was treated with CLEOCIN VAGINAL, cream and with METROGEL VAGINAL cream. The outcome of the patient's bacterial vaginosis was not reported. On 28-AUG-2009, 14-OCT-2009 and 13-JAN-2010 the patient had normal ultrasounds tests done. On 22-FEB-2010 at 39 weeks and 4 days from her last menstrual period, the patient gave birth to a normal female who weighed "07.3" ounces, the baby's length was 20 inches and her apgar score was 8/9. Follow up information received via medical records indicated that the patient had a term baby through a repeat c-section. On 01-MAR-2010, the baby had a newborn weight check and the assessment was a normal newborn. Additional information has been requested.
Pain, redness and swelling around injection began evening of the vaccine; continuing to increase in size.  At office visit of 10-22-20 at 4:20 pm area of redness, swelling, warmth was 10 inches by 5 inches.  Started on Keflex for possible cellulitis.
High fever (103) for 3 hours, even after Tylenol and Ibuprofen were given. Child was very upset and uncomfortable.
Pt tested positive for COVID on 6/8 and completed course of paxlovid. Pt presented to ER on 6/16 with lethargy, myalgia, dry cough, diarrhea, decreased urine output and hypoxic with O@ of 91% on RA and 87% on 2L. Chest xray showed no infiltrates. Pt started on dexamethasone and delsym. Pt improved and was discharged after 6 days.
Dizziness - everything got dark. Vitals wnl. Nausea. Given apple juice and crackers.
dizziness; queasiness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date ere not reported), via an unspecified route of administration, on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced dizziness and queasiness on an unspecified date. He wanted to know how long these side effects would last. Outcome of the events as unknown.   Information on lot/batch number has been requested.
Headache; fatigue; diarrhea; mental foggy; sore in the area where shot was given; lightheaded; joints achy; This is a spontaneous report received from a contactable Other HCP. The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 12:45 (Lot number: 30145BA) at the age of 61 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "intermittent peritoneal dialysis" (unspecified if ongoing), notes: IPD; "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "fybromyalgia" (unspecified if ongoing). Concomitant medication(s) included: INSULIN RAPID; INSULIN N; PREDNISONE; IMURAN [AZATHIOPRINE]; THYROXINE. Past drug history included: Iodine; Zantac. The following information was reported: HEADACHE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "fatigue"; DIARRHOEA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "diarrhea"; FEELING ABNORMAL (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "mental foggy"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "sore in the area where shot was given"; DIZZINESS (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "lightheaded"; ARTHRALGIA (non-serious) with onset 24Sep2021 13:30, outcome "recovering", described as "joints achy". Therapeutic measures were not taken as a result of headache, fatigue, diarrhoea, feeling abnormal, vaccination site pain, dizziness, arthralgia.  Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination as Insulin R and N, prednisone, Imuran, thyroxine, etc.. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pt fainted, presented nystagmus of eyes, and muscular rigidity of arms and hands for less than 30 seconds following administration of vaccine.
TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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, intramuscular, batch number was not reported) dose was not reported, administered on 15-JUN-2021 14:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced temperature excursion. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210632861.
Information has been received from a registered nurse concerning a 12 month old black male patient with no relevant medical history and no known drug allergies who on 12MAY2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live or measles virus vaccine live that was diluted with a HIB diluent of 0.04 sodium chloride, instead of sterile water. Concomitant therapy on 12MAY2003 included a subcuataneous first dose in the left arm +mumps virus vaccine live+rubella virus vaccine live+second generation MSD, a third dose of pneumococcal 4 6B 14 18c 19f 23f conj vaccine (CRM197)(PCV 7) intramuscularly in the left leg, a subcutaneous third dose in the right arm of poliovirus vaccine IPOL and an intramuscular fourth dose in the right leg of Haemophilus B conjugate vaccine ACTHIB. It was noted that the mother of the patient reported no adverse events immediately following vaccination however, the mother did not state that on approximately 22MAY2003, 'approximately 10 days following vaccination the child ran a fever of 101F and developed a flat rash over his entire body that lasted about 1 week". Unspecified medical attention was sought. There was no product quality compliant reported. No additional information was provided. Follow up info on 18AUG2003 revealed that the patient who received the vaccine reconstituted with an improper diluent, never had an adversereaction. It was reported that the child was revaccinated and was fine.
Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Patient went to sit 15 minutes for recovery post-vaccine with her mom.  All of a sudden she said "My arm feels funny," then laid her head on her mom.  Her mom said her eyes rolled back and she passed out and slid down the chair onto the floor.  911 was called, pharmacist ran to scene.  Patient remained on floor, started puking.  Told her to breath deep, offered water.  She slowly started feeling better.  Paramedics arrived and examined her.  After about 30  minutes, patient left with mom.  No ER needed.
Information has been received from a registered nurse (RN) concerning a 24 year old female with no drug reactions or allergies who on 26-JUN-2008 was vaccinated intramuscularly in the right deltoid with her first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #654272/0073X). On 26-JUN-2008, after vaccination with GARDASIL vaccine (yeast), the patient was nauseous for the entire day. Subsequently, the patient recovered from the event. The patient sought medical attention by speaking to the nurse. Additional information has been requested.
10/1/09 pt states got flu shot for 1st time, 10/08/09 seen in Dr's office, 10/09/09 admitted to hosp. 10/26/09 Hospital records received for dates 10/9/09 to 10/13/09. DC DX: postvaccinial transverse myelitis. Presenting SX: pt. seen in ER on 10/8 c/o 4 days after flu vax began sx. of tingling and paresthesias starting in feet and eventually all of lower extremities. Pt. c/o urinary retention, HA. Assessment: WNL, bladder scan WNL. Pt d/c and returned following day,  sx. progressively getting worse. Pt. admitted, diagnostics performed pt. tx. And d/c improved stable condition.
This spontaneous report was received from a pharmacist referring to a 77 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N003997 with expiration date of 20-OCT-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was reported that the patient returned to the pharmacy on 20-JUL-2017 (reported as today) to report that on an unspecified day in July 2017, he experienced "blisters" or a bump (vaccination site vesicles) and itching at injection site (vaccination site pruritus). There had been no treatment for the events. At the time of reporting, the patient had not been recovered from the vaccination site vesicles and the vaccination site pruritus. The causal relationship between the events and the PNEUMOVAX 23 was not reported.
Patient received Pfizer Covid vaccination, then his wife came back and told us he has already gotten the 2 dose series of Moderna Covid vaccine.  This would be considered a booster, but with a different manufacturer.