chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US000708, is an initial spontaneous report received from a physician on 07 Jan 2016. This report refers to an elderly female patient. Historical condition was not reported. Current condition included formaldehyde and lidocaine. Past vaccination history included Flu vaccine (Please see case PHEH2016US001420). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly last year (year and date unspecified). The patient whole arm was red and purple with bruising after injection. The outcome of the events was complete recovery. Seriousness of the event was unknown. Causality was not reported.
arm started being acy and painful; she couldn't move it; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (arm started being acy and painful) and ADMINISTRATION SITE MOVEMENT IMPAIRMENT (she couldn't move it) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction NOS, INSULIN for Diabetes.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced AXILLARY PAIN (arm started being acy and painful) and ADMINISTRATION SITE MOVEMENT IMPAIRMENT (she couldn't move it). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (arm started being acy and painful) outcome was unknown and ADMINISTRATION SITE MOVEMENT IMPAIRMENT (she couldn't move it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It is reported that patient had hot and cold compress for treatment. Patient is taking water pill, medicine for blood pressure and medication acid reflux.
ON 7/29 OR SO HE REPORTED "NERVE SENSITIVITY" WHERE RASH EVENTUALLY APPEARED.  08/01 NOTICED ZOSTER LIKE RASH ON RT. SIDE CHEST/BACK. 08/02 SAW DOCTOR (UNKNOWN).
Child is 12 years old and was accidentally given the dose for 5-11 years old. Child did well with vaccine, no issue, but wrong type given. Consulting the CDC guidelines it shows to report incident and then to have the 2nd dose be the appropriate dose 3 weeks from now.
p/vax pt began gastroenteritis sx including vomiting, diarrhea & lethargy, irritability,abd distention & tenderness,bloody stool, dec po intake &felt warm;hosp for rehydration;Dx w/ intussusception reduced by Barium enema;
PAIN ON THE HAND ON WHICH PATIENT HAD THE VACCINE; TINGLING FEELING ON THE HAND ON WHICH PATIENT HAD THE VACCINE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. 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, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2022, the patient experienced pain on the hand on which patient had the vaccine, and tingling feeling on the hand on which patient had the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain on the hand on which patient had the vaccine and tingling feeling on the hand on which patient had the vaccine was not reported. This report was non-serious.
Got Covid after getting 3 Moderna Covid-19 vaccine shots; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006M20A and 007M20A) for COVID-19 vaccination.     Patient does not have any allergies and concomitant medical conditions.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got Covid after getting 3 Moderna Covid-19 vaccine shots) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had her flu vaccination sometime in Jan2022 or Feb2022. It was unknown that the patient was on any treatment.  This is a spontaneous case concerning  a  77-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Covid-19, Drug ineffective. The events occurred approximately 6 months day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.    This case was linked to MOD-2022-544485 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  77-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Covid-19, Drug ineffective. The events occurred approximately 6 months day after the third dose of mRNA-1273 COVID 19 Vaccine. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Given TDaP booster 11-9-07 per lot #.  Seen 11-12-07 L deltoid red, hot, tender, 5" x 3" area of firm swelling.
HCP called to report a T/E, improperly stored VARIVAX administered to patients. See related AE case #02450961. Date of administration today, 14AUG2023. Confirmed no symptoms or sided effects reported. No additional AE/PQC.          ?    Names of va; No additional AE/PQC.; This spontaneous report has been received from an other Health Professional referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliters (lot #X002101 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 19-JAN-2025) for prophylaxis (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of -7.1 degrees Celsius (C), for a time frame of 2 hours and 43 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
TOOK THIRD DOSE ON DAY 7; This spontaneous case report was received from a pharmacist (PVX2019-487) on 22-Feb-2019. The report described a female consumer who "took third dose on day 7". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the third dose of Vivotif on day 7. The doses were taken on day 1, day 3, and day 7 respectively.  The action taken with Vivotif with respect to the event "took third dose on day 7" was not applicable.  The clinical outcome of the event "took third dose on day 7" was unknown.  Company's Comment: The causality of the event "took third dose on day 7" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 7" was considered as not applicable.
245PM crying-painful type cry-cont-crying w/o being able to be consoled for over 3hrs;5PM t101;6PM to ER-quiet then,t98.7,no sx given APAP-lt leg 1 1/2in erythema
Fell down while making second appointment, he tried  to get up ,  said he is okay. he was given water, when felt comfortable went with nurse to the waiting area, his spouse got something to eat, nurse kept under observation for 30 minutes. when felt fine they left for home.
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Patient said on 9/3 she lost her hearing and believes it is from the immunization.
Child developed redness and swelling of right thigh which persisted for 3 days. Did see MD who advised it probably was due to vaccine and to watch. On 7/23/03 mother contacted health department and reported redness, swelling gone but child still has swollen area in groin 1" long and tender to touch. To see MD again for recommendations on 7/24/03.
Local injection site reaction, first noticed by parent on morning of 9/30/19. Patient complained of pain. No fevers or other signs of infection or illness. Recommended treating with cool compresses and ibuprofen.
Pfizer-BioNTech COVID-19 Vaccine EUA Soreness at injection site, body fatigue, and rash over body (mostly on abdomen--only slightly itchy red dots that showed up 24 hours after the injection); giving Benedryl.
Shortness of breath, lost of taste-smell-appetite, sore throat cough, diarrhea, weakness, fatigue, fever, heart disease and Contracted Covid 19.
Doses given to 3 patients from a vial that has undergone a temperature excursion; Doses given to 3 patients from a vial that has undergone a temperature excursion; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided.
Symptoms started about 1.5 days after injection. Presented as pressure in left ear that became more painful over the next 24 hours. Pain became constant and after four days the pain extended along the lower left jaw. Swollen nodes and the jaw was painful to the touch. Was initially diagnosed with an outer ear infection. Was given antibiotic ear drops. No relief was found using the drops. Sunday evening a pain rash appeared on my left temple. Pain was extreme. During follow up visit on 12/20/2021 and consultation with the Advising Physician, diagnosis was updated to shingles outbreak.
Patient woke up with a head cold, sneezing, nasal drip and fatigue which has not responded to homeopathic or herbal treatment over the course of past 30 days!
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). On 20-Mar-2022 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 83.78.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 37 respectively. Total doses given for the day was 184 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM vaccine was moved to fridge on 09-mar-2021 and. Vial was moved to clinic on 20-mar-2021. 20 vials from 9 AM and 4 vials from 10 AM were sent to clinic. Vaccine BUD date was 08-Apr-2021 for 9AM,10 AM and 1PM respectively.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively,  9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient states that she had a headache and axillary swelling and pain for 4 days post vaccination.
Information has been received from a nurse concerning a female patient who on 24-DEC-1999 was vaccinated with a dose of MMR II (lot #625634/0028H). Secondary suspected therapy included a dose of RECOMBIVAX HB (lot # 625096/1367E) on 06-APR-1998, a dose of RECOMBIVAX HB (lot # 625096/1367E) on 21-MAY-1998, and a dose of VARIVAX (lot # 628036/1251H) on 25-JAN-1999. The patient was suffering from a number of symptoms which may be related to "over-vaccination" after administration of the above vaccines. The nurse didn't know the specific symptoms. The child was adopted from another country so the child's vaccination history prior to starting at the physician's office was not known. The patient was brought to visit office. At the time of reporting, the patient had not recovered. Follow-up information was received from a physician, who stated that he had not seen the patient since 1999, and he was not aware of any adverse reaction to MMR II. Additional information has been requested.
Woke up next morning with my eyes, legs and ankle swollen. Severe headache.
Very itchy spot on upper arm where shot was administered 8 days after receiving the first Moderna vaccine Itchy area red, but redness disappears after itch subsides.  Hard swelling can be felt under itchy area.  After 3 days the itch seems to have lessened, but swelling is still there.
Pt was vaxed w/pneumococcal vax & 2 days p/vax devel a red, raised, hard area on the arm & @ inject site; No further details were provided;
Had bad side effects; Couldn't move my next; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had bad side effects) and MOBILITY DECREASED (Couldn't move my next) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had bad side effects) and MOBILITY DECREASED (Couldn't move my next). At the time of the report, VACCINATION COMPLICATION (Had bad side effects) and MOBILITY DECREASED (Couldn't move my next) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Pain and weakness all over body its been happening for 4 months Dr. administered prednisone.
Tongue numbness.  Given Benadryl 25mg IM.  Observed patient for 30 minutes.   Tongue numbness resolved within 30 minutes.
Moderna Covid-19 Vaccine EUA.  Diarrhea, Metal taste, Dizzy/light headed, Cold chills, Hot flashes, body feels numb.
vial was placed in refrigerator 11/1/2021. used past 31 days.
Peripheral neuropathy extended to whole body; A spontaneous report was received from a consumer concerning a 67-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event peripheral neuropathy extended to whole body/neuropathy peripheral.   The patient's medical history included peripheral neuropathy. Concomitant medications included acetylsalicylic acid, losartan and metoprolol.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.    The patient is having peripheral neuropathy from last 15 years and it was limited to hands and feet. On an unknown date, after receiving the vaccine it extended to whole body. The patient reported that the condition has been worsened from level 1 to level 3.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event peripheral neuropathy extended to whole body was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Spiked a fever of 101+  still feeling a but drained.  Fever is gone
About 14 hours post getting the second dose I started having chills and rigor and ended up having a fever of 100.5 degrees fareinheight, took 1 gram Tylenol, fever broke, 4 hours later I had rigor and chills again and was febrile again, and took ibuprofen. I also felt nauseous and have a headache.
Fever 10/5, fever no appetite, fever 10/6, no appetite, T98.6 10/7/04 Vesicular eruption >50 lesions, face, neck, trunk, upper extremities.
This report was received from a physician which described a rash in a thirty five year old male who received hep A vaccine inactivated for prophylaxis. No pertinent medical history or concurrent conditions were reported. Concomitant medications were not specified. The subject did not use alcohol or tobacco. The reporting physician was unsure of adverse event history following receipt of prior immunizations. On 6/14/02, the vaccine received his first injection of Havrix. On 6/23/02, the vaccinee experienced a rash. The rash started in the axilla area and spread to the trunk, arms and legs. The physician reported that the vaccinee developed no other problems. Treatment included Benadryl. The rash resolved on 6/24/02. The reporting physician considered the event to be possibly related to Havrix administration.
low grade temp, sweats, fatigue lasting 1 wk; local reaction w/redness, swelling, pain;
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 10-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Tens days after vaccination I started feeling drowsy. Could not hear i tried to eat and lay down. Next day I woke up and was not able to stand or walk.
A report was received from a pharmacy student on 10/24/2002, concerning a 25 year old male vaccinee who received 0.5ml Fluvirin intramuscularly.  However half the dose spilled while being administered. On 10/24/2002, the vaccinee experienced a medication error when half of the Fluvirin vaccine he was receiving spilled onto his arm.  It was reported that the vaccinee did not experience any adverse effects. The reporter has assess the relationship of the event to the medication as unclassifiable.