chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Product storage error; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
No adverse effects; mistakenly thought that temperature storage had increased from 12 hours to 24 hours; one vial had been more than 12 hours refrigerated and 2 doses were given; the patient, manufacturer, and corporate offices were contacted upon discovery of error; patient reported no adverse events; proper and correct storage guidelines have been updated, clarified and communicated with all pharmacy employees; incident report at pharmacy level.
severe back pain 24hr p/vax;treated w/Toradol & APAP #3
memory loss; 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 AMNESIA (memory loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 AMNESIA (memory loss). At the time of the report, AMNESIA (memory loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Developed blister-like eruptions on the trunk / which have not resolved; Developed blister-like eruptions on the trunk / which have not resolved; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 13th January 2021, refer case US2021111511).   On 29th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th May 2021, 7 days after receiving Shingrix, the patient experienced blister and eruption. On an unknown date, the outcome of the blister and eruption were not recovered/not resolved.   It was unknown if the reporter considered the blister and eruption to be related to Shingrix.  Additional details were reported as follows: The patient experienced blister-like eruptions on the trunk of her body. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111511:Same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning), VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F218) for COVID-19 vaccination. No medical history was reported. Previously administered products included for Product used for unknown indication: PFIZER BIOTECH COVID-19 Vaccine (lot EN6190 (8) hard to read (right arm)) on 24-Feb-2021 and PFIZER BIOTECH COVID-19 Vaccine (lot EN6206 (right arm)) on 16-Mar-2021.Past adverse reactions to the above products included No adverse event with PFIZER BIOTECH COVID-19 Vaccine and PFIZER BIOTECH COVID-19 Vaccine.Concurrent medical conditions included Hypertension.Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning). On 24-Nov-2021, the patient experienced VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore at the site, seems to be getting worse and burning), VACCINATION SITE PRURITUS (This arm is itching me so bad), VACCINATION SITE ERYTHEMA (Area were injected is red/I have a red knot) and VACCINATION SITE SWELLING (Area were injected is slowen/I have a red knot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Patient took blood pressure medication as concomitant drug. It was reported that, itching was not normal. It wasn't this bad last night but it seems to be getting Worse and having a hard time with the injection site. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contain additional information added for the events.
Pt received the ADACEL vaccine in his right arm. He was pleasant, and alert after vaccination. I sat with him in vaccination room with his mother as well and we talked about his trip and and went over how we would take his VIVOTIF. So we were probably sitting for 3 to 4 minutes. There were no signs that he was not feeling well. He even stated "that was way easier than I expected". Then we got up to go get his VIVOTIF and the receipts. After about a minute after standing the patient fainted. The security guard was nearby and she immediately 911. I turned pt on his side, and he regained consciousness about 15 seconds after fainting. He was able to walk to a chair and he said he was feeling ok but a little nauseous and he appeared a little pale. I asked if he felt he had his his head and if it hurt, he said no. I provided him with a bottle of water and some mini snickers as snacks. EMS came and examined him. After about 10 minutes they deemed he did not need emergent care and left him in the care of his mother.
This spontaneous report was received from a physician, via company representative and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 16-NOV-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt noted fine red rash on shoulder then entire body;seen by PMD 8/9/99;started DPH 8/9/99;first noted itching 8/8/99 in evening;8/9/99 seen @ clinic;
Patient visit MD office after vaccine administration (COVID 19 Pfizer) on March 18, 2021. MD explain that patient result on edema in left shoulder, left elbow and left hand  Therefore, MD send a script to alleviate those symptoms.
Noted Nov 6, 2005 to have Papulo vesicular eruption dorsal hands spread up arms to body; few noted on legs; associated with pruritis. Treated with Benadryl.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Presented to ED with SOB; + covid 9/29 at home; reports low SpO2 at home (88%); CXR: bilat patchy infiltrates compatible with atypical pulmonary pneumonia; D-dimer: 5.24 CRP 1.84; Ferritin 509.27; TX: Zithromax, Rocephin, Lovenox, Vit D3, Decadron, Singulair, Zinc; remained on Room air throughout stay
herpes zoster keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 29-JUN-2010, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified)  for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). Shortly after receiving vaccine live (ZOSTAVAX) vaccine, the patient suffered sudden and intermittent pain in her eyes and was diagnosed with herpes zoster keratitis. As a direct and proximate result of vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present to prior to using vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and sale if vaccine live (ZOSTAVAX) vaccine the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, incurable injuries, as well a significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was nor recovered Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event ophthalmic herpes zoster was considered to be medically significant, and was considered to be a disabling event.
Rash at injection site started showing 4 hours after the shot, and grew to about 6inches in diameter. Still persistent 56 hours after injection. Hot to touch, skin raised slightly, feels hard, and is read.   Severe headache, unable to complete daily functions. Began 24 hours after injection and persisted for 12 hours before I used Tylenol to relieve it. OTC Pain killers required every 6 hours to keep headache at bay to current time ( 56 hours post-injection)  Fatigue began about 18 hours after injection. Persists 56 hours after injection.
Patient provided rx for Prevnar 13 vaccine after the publication. Patient's physician wanted pt to get Prevnar 13 followed by Pneumovax 23 the following year.
I, recipient of shot, was in perfect health prior to shot on March 25, 2022. Eleven days later, on April 5, 2021, I started experiencing short 3-5 minute pockets of odd imbalance, confusion, delirium, no sense of gravity, loss of feeling in legs, and excessive high blood pressure spikes whenever I stood up. Health insurance with new kicked in late. I was finally able to go to my doctor after 90 days of experiencing adverse reactions.   Doctor ran many inconclusuve tests. On July 13, at about 11:00am I was proving child care to 4 children. I suddenly lost cognitive ability to read, to see, to understand,  and then loss consciousness.  I awoke while in ambulance transfer to hospital. I could not speak. I dud not know my name. I didn't know what year it was. After about 12 hours in ER, some speech & cognition came back.   Neurologist ran numerous tests. Some limited white matter and lesion evidence was seen. I set up follow up appointments and returned to work. I had another unexpected episode about a month later. Had been feeling fine but out of nowhere lost the ability to read, speak correctly, move correctly,  then lost the ability to know who I was and my brain underwent severe crippling pain. All symptoms subsided after about 12 hours.  Three other crippling,  terrifying, worsening episodes happened by mid September.  Multiple Neurologists have run many MRIs, and the spread of white matter and lesions gets rapidly worse.  I have lost more and more ability to focus and to hold memories.  I was given a brain biopsy on Sept 27, 2021 and am awaiting results. None of these cognitive symptoms existed before the civid shot.
fever 103, irritability in 1st 24 hrs; URI sx-watery eyes, rhinitis 48 hrs later;
tired; mild rash under chin and right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and RASH (mild rash under chin and right side of neck) in an 81-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 (no historical condition was reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (tired) and RASH (mild rash under chin and right side of neck). At the time of the report, FATIGUE (tired) and RASH (mild rash under chin and right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately a couple of months after my 2nd dose vaccination I noticed a massive hair loss and I have never experienced this so I went to the doctor and had a biopsy and was prescribed with Rogaine and steroids and up to this day 02/25/2022 I still experience some hair loss but not as much as it was before.
No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 30-NOV-2018, the patient was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) lot number R004185, expiration ate was not provided, but upon an internal verification was established on 06-NOV-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA002508: US-009507513-1909USA000371:
Sudden appearance of tinnitus in right ear. Audiology exam found hearing loss since 2019 exam which had been normal.
shingles/ suspected vaccination failure; shingles; rash with blister; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blistery rash. On an unknown date, the outcome of the vaccination failure, shingles and blistery rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blistery rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The doctor reported that patient experienced a rash with blisters consistent with Shingles. The the patient did not experienced pain after receiving a dose of Shingrix. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Patient states she missed her menses the month after administration of her first Gardasil injection. Another nurse says she heard another patient say the same thing happened to her, but she couldn't remember the second patient's name in order to fill another report.
On 10/06/06 or 10/07/06 mom noted several vesicular lesions on left thigh surrounded by erythema at injection site, increased swelling x 3-4 D, then decreased, slight tender, No fever no rash elsewhere. MD saw 10/11/06 left lower thigh with about 2cm area erythema, slight induration with overlying crusting vesicle. Non tender, Excoriated, no rash elsewhere, no evid. cellulitis/abscess. Sx TX.
pt recv vax 130-2PM & reported that pt transported via amb w/sz prior to transport;pt had fever of 105 & was being sponged & given fever med;dx febrile seizure
extreme body soreness all over , especially legs .  Bad headache that doesnt go away & the worst effect is really bad heart pain that?s constant - almost feels like a knife in my heart .
25 YR OLD MALE PRESENTS TO ED WITH CHEST PAIN, TIGHTNESS AND SHORTNESS OF BREATH SINCE HE RECIEVED SECOND COVID SHOT 2 DAYS AGO.  PT NOTES HAS TO TAKE SHALLOW BREATHS DUE TO PAIN IN CHEST WHEN A NORMAL BREATH IS TAKEN. PT HAD BLOODWORK, RESPIRATORY PANEL, EKG, XRAY  COMPLETED HERE IN THE ED. BLOODWORK RESULTS SHOWED AN ELEVATED TROPONIN AT 159(OVER 22 IS POSITIVE.)  WITH A SECOND 2 HOUR TROPONIN ADDITIONALLY ELEVATED AT 176.  IMPRESSION FROM XRAY SHOWS NORMAL CHEST XRAY BUT FINDINGS REPORTED IMAGE WAS OBSCURED BY OVERLYING WIRES FROM HEART MONITOR.  WBC BLOODWORK SHOWED ELEVATED AT 16.1 (RANGE 1.1-6.1) MONOCYTES ELEVATED AT 2.6 (RANGE .2-1.0) IMMATURE NEUTROPHILS ELEVATED .06 (RANGE .00-.04) MD SUSPECTS MIOCARDITIS HEART ECHO SCHEDULED FOR TOMORROW. PT CURRENTLY ADMITTED WITH NO COMMUNICATED DISCHARGE DATE UNTIL ECHO RESULTS.
Information has been received from a consumer concerning "three of her friend's sons" who were vaccinated with MMR II (lot number, route and site not reported). Subsequently the patients developed autism. It was unspecified if the patients sought medical attention. The outcome were unknown. This is one of several reports received from the same source. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Client reports that approximately 75 minutes after his vaccine was administered he began to have a difficult time swallowing.  He was driving at the time and drove to Hospital of where he was seen in the Emergency department.  Patient continued to have a difficult time swallowing and was given a "spitoon" to spit in.  He describes the saliva as "white and foamy. " He also reported that that over the course of the 4-5 hours he spent in the emergency department  the saliva began to be stringy, and that he believed it was mucus.  The client was treated for an "esophageal blockage - food".   The client reports he was treated with valium but does not know what other medications he was given.  He did report that none of the medications he was given made his heart race.
Pt reacted immediately to VAR + MMR with redness + swelling @ sites, generalized urticaria on legs, arms, + back + abdomen.  Given 0.2cc of Benadryl IM + monitored for 30 min. Significant reduction in urticaria.  Breathing normal throughout.  Given prescription for Benadryl 2.5-3 ml  & 4 hrs PRN.  Parent told to call 911 if breathing diff. + increase in symptoms.
I accomplish this form with a vaccine report. Sleep problems, vision problems, stomach problems, walking trouble, tachycardia, thinking abnormality, thirst increased, otitis media, pain legs, respiratory problems, pain muscle and joint, skin itching, memory difficulty, blood pressure high, diabetes mellitus, headaches continuous,