chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 18-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
UNABLE TO EAT; LOST WEIGHT; HAIR LOSS; COLITIS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; COVID-19; This spontaneous report received from a patient concerned a 7 decade old female. 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 09-MAR-2021, and dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced unable to eat, lost weight, hair loss, colitis, off label use, and inappropriate schedule of vaccine administered. Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19, and the outcome of unable to eat, lost weight, hair loss, colitis, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220336953.
Information has been received from a licensed partner nurse concerning her 20 year old white daughter student with pertinent medical history and drug reactions/allergies reported as unspecified who on 01-NOV-2006 was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0702F) IM left arm at 1500 hours.  On approximately 17-JAN-2007, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported).  Following each dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), the patient experienced a metallic taste.  The metallic taste was more pronounced after the first dose. The patient sought medical attention.  Subsequently, the patient recovered. No other information was available at the time of reporting.   Additional information was received from the licensed practical nurse.  The patient complained of strong "metal" taste at the back of her tongue immediately after the first injection. This odd taste sensation lasted somewhere between 30 and 60 seconds and then slowly disappeared after 2 to 3 minutes.   No additional information is expected.
H1N1 immunization was given to a child under 4. Manufacturer states the immunization was meant for children 4 and above.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2016 the patient was vaccinated with an expired dose of ZOSTAVAX administered intramuscularly, lot # L036454 and expiration date on 22-DEC-2016 (strength, dose and anatomical location were not reported) for prophylaxis. No product quality complaint (PQC) was involved. Additional information has been requested.
open wound with pain, burning sensation and raw. localized to the injection site. 1/2 centimeter big diameter
mild headache the following morning; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and HEADACHE (mild headache the following morning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (primary series). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced HEADACHE (mild headache the following morning). In November 2021, the patient experienced VACCINATION SITE PAIN (sore left arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In November 2021, HEADACHE (mild headache the following morning) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient received her Moderna COVID-19 vaccine in her left arm shoulder deltoid muscle. The patient reported that she was concerned because there were two different vial presentations of the Moderna COVID-19 vaccine that wrong doses might be given to patients from the wrong vial.  No treatment information was provided by the reporter for the event vaccination site pain.
Left deltoid. Swelling mildly indurated. Induration , erythema 2.5cm x 3.75cm. Central punctate, red papules, no Fluctuance. No Abs. No drainage.
Patient mistakenly administered a full vial of Pfizer at 3:20 PM.  No adverse events observed.  Vitals WNL, patient reported that he felt fine.   Patient texting on his phone and talking intermittently with his mother at the clinic.  Per instructions, patient was given two 500mg tablets of Tylenol (total:  1,000 mg of Tylenol).  Patient instructed to take 2 tablets of Tylenol every 6 hours.   Patient's mother was instructed to call RN's personal cell phone number at any time of day or night.  Patient's mother instructed on when to seek medical care.  RN to call patient's mother the next day.  RN received no call overnight.  RN spoke with patient's mother the next morning at 9:30 AM.  Patient's mother reported that patient had not had any symptoms last night and that the patient took second dose of Tylenol at 10:30 PM.  Patient' s mother stated that patient reported that he had slept well all night.  Patient's mother stated that patient reported that his arm was sore and that he felt tired.  Patient's mother reported that patient's temperature was taken at 7:15 AM.  Result  37 degrees Celsius (=98.6 degrees F).  Patient's mother reported that patient  took third dose of Tylenol at 7:30 AM.  Patient's mother reported that patient will stay home from school today so that he can rest.  RN to follow up with patient's mother by phone.
He felt dizzy and became pale. Gave him water to drink and called 911. Paramedics checked him and he recovered in about 20 minutes.
High fever of 103 F. for two full days, chills, and would not go away with Tylenol/Motrin.
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RAMIPRIL (ALTACE), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash) had not resolved. Not Provided          concomitant medications include OTC supplements. Treatment details included Benadryl, Hydrocortisone topical. Action taken with mRNA-1273 in response to the drug was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Patient still have a rash despite dermatologist treatment , urgent care visit and visit to primary care physician.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/09/21 2nd dose02/09/21 Diagnosed covid positive:08/17/21 Symptom onset:08/14/21 Exposure:Home Symptoms:fever, HA, muscle aches, sorethroat
Information is in follow-up to report (s) previously submitted on 8/14/2007. Information has been received from a nurse concerning a female who on unspecified dates was vaccinated with a first and second dose of GARDSIL (658094/0524U) 0.5mL. On 16-JUL-2007 the patient was vaccinated with her third dose of GARDASIL (lot# unknown). On 16-JUL-2007, the patient developed a fever over 102 degrees F, nausea, headache and "flu like symptoms". Medical attention was sought. At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received. The onset of the adverse event was also reported as 17-JUL-2007 (previously reported as 16-JUL-2007. The patient also experienced chills. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.
Fever 102 and taken Tylenol 650 mg q8h for 3 dose Fever spike again twice in 24 h  Symptoms resolved on 01/06/2021
Information has been received from an approximately 25 year old female patient with "cysts in the ovaries that were not a problem", papilloma viral infection and an allergy to benzyl peroxide and a history of caesarean section (2002) who in 2008 was vaccinated with GARDASIL. The consumer already had HPV prior to vaccination with GARDASIL. Concomitant therapy included DEPO-PROVERA. The patient reported that she experienced dizziness after each dose of GARDASIL. All 3 doses were given over a 6 month period. The physician assistant recommended GARDASIL because "it would be helpful for her current HPV infection". The dizziness lasted for a couple of weeks after each vaccination. There was swelling at the site of injection after each dose and the site was pretty painful for 2 or 3 days. There was an occasional nausea within 1 week after each dose which seemed to coincide with the dizziness. The dizziness seemed to cause the nausea. The patient also had increased pain with cysts in the ovaries that had gotten worse since she received all 3 doses. ON approximately 28-JUL-2009 one of the cysts that was 2 inches in size ruptured and the patient was hospitalized. The patient still has day to day pain from the cysts. The patient did not have dizziness or nausea that stopped a few weeks after the 3rd dose of GARDASIL. At the time of the report the patient was not recovered from the other adverse events. The patient sought medical attention at office visit. On an unknown date a blood test was performed and it was normal, also a biopsy of cervix prior to vaccinations was performed (results not provided). Additional information has been requested.   9/14/09 PCP medical records received DOS 9/7/07 to 10/18/07. Patient complains of ovarian pain and cyst.
Initial case was received from a healthcare professional on 14 November 2013. A male patient whose age, concomitant and medical history was not provided has received a dose of FLUZONE HD vaccine on 16 September 2013 (anatomical site, dose and batch number were not reported). On 16 September 2013, the patient developed pain at the vaccination site. Corrective treatments were not reported and laboratory investigations were unknown. At the time of this report, the patient had not recovered from the event. Documents held by sender: none.
Pt recvd vax & devel red welts; No further details are available; This case is considered to be invalid;
By 8:00pm, R/upper arm, swollen, red, painful, warm to touch. On 10/23, saw MD & placed on antibiotic rx. On 10/25, pain going away & redness decreasing.
pt recv vax; MD stated that description of episode sounded like a sz or vascular shut down;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. I was in bed for 10 days, I could not function to work even. Fatigue, fever up to 100.6, body aches, diarrhea, stomachache, and headaches are what I experienced.
Discharge Provider: DO Primary Care Provider :  Admission Date: 9/11/2022 Discharge Date: 09/14/2022  PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: Patient is a 71 y.o. female with past medical history significant for spastic cerebral palsy, wheelchair bound, suprapubic catheter secondary to neurogenic bladder, legally blind who presented to the emergency department via EMS for concern of weakness and confusion associated with poor intake and new cough. In the emergency department, she presented febrile and tachycardic at HR of 106. Breathing on room air.  CMP and VBG unremarkable. CBC showed no leukocytosis.  Normal lactate and pro-calcitonin.  She was given 2 L of IV fluids and Tylenol with improvement in mentation to baseline. COVID testing was positive. She was started on remdesivir given high risk and was otherwise feeling well. Completed 4 days of remdesivir. Required oxygen overnight on 9/13 and sent with home oxygen. Not requiring oxygen during the day time. Discharged home per patient request on 9/14 as she was feeling better and wanted to go home.
pt recv vax 17AUG95 & 29NOV97 pt devel less than 20 little red, blister like lesions all over the body;pt was afeb;
Racing heart  maximum rate 156 Palpitations  Anxiety Symptoms lasted approximately 4 hours
No adverse event; Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.).    No concomitant medications details were reported.  Patient received Moderna bivalent 6m-5y of age dose after the beyond use date. 11-Jan-2023 was beyond use date and product was administered on 14-Jan-2023.  No treatment medications details were reported.  This case contains information for the 3rd of 3 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698191:first patient case
Pt c/o SOB, after receiving 1st dose Pfizer. No other symptoms. Provider on-site evaluated patient ordered Ventolin inhaler. Pt advised per provider to f/u with the Asthma doctor, prior to her 2nd dose.  Pt went home, states breathing with ease no longer feeling SOBP
Headache, Myalgia, Arthralgia, fatigue Narrative:  Headache (migraine), extreme fatigue, myalgia, arthralgia; took fiorcet/Sumatriptan, tylenol, tramadol; lasted through day 12, mostly resolved, lingering fatigue.
red area and knot at the site of the injection and a rash that spread down the arm and itched
This spontaneous report was received from a nurse via company representative, concerning a 12-year-old male patient. Information regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies was unknown by reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml), by intramuscular route (IM) (frequency, anatomical location, vaccination scheme, lot number and expiration date were not reported).  On an unknown date, the patient passed out (loss of consciousness). It was unknown if the patient sought medical attention, if he received a treatment for the event or had any laboratory diagnostics or studies performed.  At the time of the report, the outcome of the event was unknown.  Causality assessment was not provided by the reporter.     Upon internal review, the event of loss of consciousness was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA004378:
4:30pm on 1/13/21 my arm started to get sore, but not bad, just normal vaccine sore. Then by the next day it had gotten worse and throughout the day it just kept getting worse and spread to the left side of my chest. I can't lift my arm and most movement hurts.
developed macula-papular rash to extremities, torso, back, neck approx 48 hours after vaccination similar to prior rashes after Covid vaccines (Moderna and Pfizer vaccines).  Resolved after approx 48 hours
Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved. Not Provided          No concomitant medications were reported. No treatment information were reported.
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085032:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Entire single dose Moderna child vial administered to child; child developed fever and next day, had a febrile seizure x 1; went to emergency room and was treated there; father reports that child has had febrile seizure in the past unrelated to vaccines; no other issues since then.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 24-JUN-2015, the patient was vaccinated with a dose of VAQTA, intramuscular (lot# and expiration date were not provided). On 14-DEC-2015, the patient received a vaccine boost (inappropriate schedule of drug administration). No concomitant therapies were reported, neither was any adverse effects. Additional information has been requested.
Woke up morning after receiving flu shot with hives on face, chest, neck arms.  Denies SOB.  Hives were "itchy".