chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Within minutes of receiving the vaccine I experienced a metallic taste in the back of my throat (while I had mint gum in my mouth), dizziness, increased heart rate, labored breathing, and a floating feeling. These symptoms lasted no more than 10 minutes except the floating feeling lasted about an hour.
Information has been received from a physician concerning an approximately 12 month old (reported as "1 year") male who within the last few weeks was vaccinated subcutaneously with a first dose of VARIVAX (Merck) 0.5 mL (lot# 662464/1738X). 7 days after the vaccination the patient developed diffuse red rash which looked like chicken pox, a fever, swelling of the hands and feet and a ruby red tongue and was hospitalized. On unspecified date, the patient recovered. Additional information has been requested.
Onset in evening following injection. Swelling, erythema on left arm from scapula to 2" below elbow. Maximum swelling at 48 hours. Resolved by 5/19/03. Low grade fever of 99.7 for 24 hours. Parent gave ibuprofen and Benadryl. Used cool compresses.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA012930: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
muddled feeling; chills that come and go; nausea; injection site painful; injection site itchy; injection site is red; weird headache; arm pain; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful) and INJECTION SITE PRURITUS (injection site itchy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. patient will call back to add) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain). At the time of the report, CONFUSIONAL STATE (muddled feeling), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain) outcome was unknown and CHILLS (chills that come and go) had resolved.            no concomitant medication provided patient has taken treatment ibuprofen
Information has been received from a medical assistant concerning a 7 month old (also reported as 32 weeks and 2 days) patient who was vaccinated with the first and second dose of ROTATEQ (Lot numbers not reported, on 07-DEC-2010 and 15-FEB-2010 respectively and today, on 24-MAY-2011 was in the office to receive the third dose. No adverse effects were reported. Follow-up information has been received from a certified medical assistant who reported that 7 month male patient with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions and no adverse events following prior vaccination was vaccinated orally with third dose of ROTATEQ (Lot number 669829/0076AA) on 24-MAY-2011 at 01:14 pm. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. No further information is available.
Pt had received dose 1 of COVID vaccine on 12/22/20.  On 01/01/21 pt presented to the emergency department for intractable nausea, vomiting, cough, and non bloody diarrhea. Pt had tested positive for COVID 19 on 12/30/2020. Pt was spiking high fevers and was hypotensive. Pt was admitted to the hospital from 1/01-1/06 and treated with dexamethasone, remdesivir, and convalescent plasma.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 25-AUG-2016, the patient was vaccinated with an expired dose of properly stored VAQTA injection, lot # reported as J016016 (verified to be an invalid lot #), expiry date 18-AUG-2016 (dose, route of administration and anatomical location were not specified). No adverse reactions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to multiple patients of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 03-MAR-2023, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024; lot # W007040, expiration date: 29-FEB-2024) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024; lot # W017552, expiration date: 01-JUN-2024) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.    This case is non-valid due to no patients' identifier or number of the patients.  Follow-up information has been received from the nurse referring to a 4-year-old patient of unknown gender on 19-MAY-2023. On 07-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis. No additional adverse event (AE) was reported.  This case was received from the same reporter with another 17 cases: 2305USA009079, 2305USA009080,2305USA009081,2305USA009082,2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
This spontaneous report as received from a healthcare worker refers to an 18 year old female patient (reported as currently 19 year old). The patient had drug allergies to BACTRIM and possible prednisone (manufacturer unknown). No medical history was reported. On 17-FEB-2014, 06-MAY-2014 and 17-OCT-2014, the patient was vaccinated with 3 dose series of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included SUDAFED and BENADRYL for allergies. On an unknown date in January 2015, the patient experienced leg pain and was hospitalized and bilateral fasciotomy was performed on her calves due to compartment syndrome. It was unspecified when the patient was discharged. On 28-SEP-2015, the patient was again hospitalized for bilateral thigh and calf pain of unknown etiology and diagnostics ruled out a second case of compartment syndrome. On 08-OCT-2015, the patient was discharged from the hospital. On an unknown date the patient experienced bilateral numbness, weakness and significant pain of the thighs and depression and this caused the patient to delay her college career. On an unknown dates, the patient underwent computerized tomogram (CT), magnetic resonance imaging (MRI), bone scan and muscle biopsies and the results were not reported. The patient sought medical attention. The outcome of the events was reported as not recovered. The patient's pediatric orthopaedic surgeon suggested this condition (compartment syndrome which was life threatening) could be related to GARDASIL. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. The reporter considered leg pain, bilateral thigh and calf pain were serious due to hospitalization. The reporter considered compartment syndrome was serious due to hospitalization and life-threatening. The reporter considered bilateral numbness, weakness and significant pain of the thighs, depression and this caused the patient to delay her college career were serious due to disability. This case is linked to case # 1603USA011428 via same patient link. Additional information has been requested.
Arm is very red at injection sight, the arm is very itchy and there is a lump at injection site
At an unspecified time, the pt received the first injection with Lymerix at an unspecified dose. Sometime thereafter, the pt experienced a headache and arthralgias.   The information received on 3/3/00 does not provide an outcome.
About 72 hours after receiving my first dose I experienced all expected symptoms of second dose, it was like a bad head cold and really painful ear pressure. Ear congestion continued throughout second dose. I also had a really severe episode of vertigo. It is still happening now. Continuing fatigue. Went to allergy clinic. OTC sudafed seems to alleviate some of the vertigo and fatigue.
I am a breast cancer patient that has recently experienced kidney damage from my 2nd Moderna booster vaccine.  I finished chemo mid January this year and continued keytruda immunotherapy every 3 weeks until August 15, 2022.  I had surgery 2/15/2022 and 21 days of radiation therapy in the month of April.  On July 11th I had my normal keytruda infusion and my blood panel was normal as usual.  On July 15th I had my Moderna booster vaccine.  I suffered for 3 weeks with cold chills most every day, extreme fatigue, some diarrhea and urgency to urinate.  On August 15th, I had my blood panel done by my oncologist and my Creatinine went from a normal .51 mg/dl (from July 11, 2022) to 5.27 mg/dl on August 8, 2022.  This alarmed my oncologist and he put me on prednisone 20 mg 3 times a day.  I went back on August 16, 2022 for a recheck and it is now 1.87 mg/dl. He has reduced my dose to 20 mg twice a day and I will go back in 2 weeks for another recheck. Thankfully I feel I am out of danger, but my concern is if I wasn't being seen by an oncologist, I could have ended up in the hospital or worse.  I just wanted to make sure this was reported.
Weakness within 2 days, post vax, and pains in multiple joints. Evidence of nerve injury in lower extremities.
She said at the site of injection to the elbow area it started to get hot, rash, burns, and swollen. We talked about adding an antihistamine and tylenol/Ibuprofen to help her be more comfortable. She said she was fine but her work told her to report it so she was following protocol.
Rash, swelling in the arm, symptoms severe enough patient went to ER for care.
Patient had a rash prior to COVID vaccine. Prednisone 10mg started on 1/5/21 (only one dose administered) 1/6/21, 1am - Rash worsened with increase redness, warmth and extending of body surface, Temp 100.4, 1/6/21, 1:20am Benadryl 25mg administered, (Keflex was ordered at this time, however never administered). 1/6/21, 3am rash improved, temp 99.1 1/6/21, 6:50am Right facial droop and right sided weakness, sent to ER 1/6/21 transferred to hospital, continues to be hospitalized 1/11/2021
15OCT96 viral gastroenteritis;tx w/meds & clear liquid diet;resolved 17OCT96;reoccurred 29OCT96;23OCT96 gait distrubance (problems w/ambulating affecting rt side primarily;tx w/Ibuprofen;
pt recv vax & mom noticed red whelps on trunk, under arms & on buttocks;states rash sl itchy;denies fever;denies diff breathing;advised of s/s of anaphylaxis;advised to call MD ASAP;
Hundreds of thousands of raised red bumps over every square centimeter of her body which resembles the measles. Also, she has chicken pox blisters on her back and her fron right shin. She has BOTH diseases.
Woke up at 2:45pm with fever. Eating and drinking okay, but more unhappy. 11:30pm. Crying noticed seizure activity lasting 1 minute. Was taken to ER T-102 degrees
Redness and swelling around area of injection (of Varicella vaccine #2) followed by pinch-like tenderness at the site of vaccine. Pain is still ongoing to this day and recurs with touching skin over that arm and sometimes rash like redness is still visible. Similar reaction occurred in other arm following MMR vaccine approximately 3 years ago and sensitivity is still present with light touch on that arm. Sensitivity overall improved but not completely recovered.
Fever of 103F; Flushing; loose stools; vomiting; This spontaneous report had been received from a medical assistant reporting a female patient of unknown age. There was no information about the patient's medical history, drug reactions, concomitant medications or concurrent conditions to be reported. It was stated that the patient did not have allergies.  On an unspecified date, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strengths, doses, anatomical locations, lot numbers and expiration dates not reported), both administered subcutaneously as prophylaxis.   On an unknown date after the vaccination, the patient experienced fever of 103 Fahrenheit (F) (pyrexia), flushing, loose stools (diarrhea) and vomiting. It was reported that the patient sought for medical attention as she went to see a physician. No treatment was administered for the event and it was unknown if laboratory tests or other studies were performed. At the reporting time, the patient had not recovered from the events.   The causal relationship between the suspect vaccines and the events occurred was not reported.
The patient received their 1st dose of Moderna on 6/7/21. The dose was potentially expired. The author of this report discovered through discussions with pharmacy staff that all doses of Moderna drawn on 6/7/21 were returned to pharmacy to waste at the end of the clinic day. However, 1 patient received a Moderna vaccine on 6/7/21. When looking through the clinic, it was discovered that vaccines that were drawn on 6/3/21 and expired at 0117 on 6/4/21 were still in the same clinic where the Moderna doses drawn on 6/7/21. Based on this discovery, it has been determined that the patient on 6/7/21 potentially received one of the expired doses drawn on 6/3/21. The patient has not been contacted yet as the care team is determining recommendations from the vaccine manufacturer.
Extreme dry mouth the day following the injection and small blisters on my tongue the following two days. I?ve never had that before.
Respiratory issues, slight fever; dazed feeling, head pressure, runny nose, type of rash developed on front of right leg below knee involving swelling, extreme pain, redness, shaped like an inverted triangle.  One week later same type of rash appeared on left ankle same symptoms ongoing.
Information has been received from a nurse practitioner concerning a 6 year old female pt with no relevant medical history and no known allergies who on 02/09/98 was vaccinated in the left arm with a SC (previously reported as IM) first dose of varicella virus vaccine live (Lot # 624447/1419E). Concomitant therapy on 02/09/98 included a SC first dose in the left arm of MMRII (Lot # 321490/1230E). There was no illness at the time of vaccination. On 06/17/03, the pt complained of a sore throat and developed a varicella rash described as maculo papular with vesicles. On 06/18/03, the pt was diagnosed with chickenpox and had approximately 150 lesions (previously reported as "about 40 lesions"). No throat culture was done. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No further information is expected.
she had a stroke after the vaccine; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   The consumer reported that his wife got the vaccine and about three weeks later she had a stroke after the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
headache/chills/incontinence/exhaustion/; trouble walking/ confusion/ excessive thirst/ fever/ shallow breathing/ sweaty/clammy
Patient c/o ringing in her ears, + flushing, chest pressure a coughing treated with Epi @ clinic site taken via ambulance to hospital with Decadron & Pred. Sent home with Medical PAC, Pepsid & Benadryl.
keratitis; This case was reported by a pharmacist via call center representative and described the occurrence of keratitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced keratitis. On an unknown date, the outcome of the keratitis was unknown.   It was unknown if the reporter considered the keratitis to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. It was reported that the patient experienced keratitis, after receiving Shingrix. The patient details, expiration date, batch number, first dose of Shingrix and onset of the adverse event were not provided. The reporter consented to follow up.
Fatigue, fever, body cold, shortness of breath, hair loss, sleep distrubance
shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a currently 82-year-old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-OCT-2015, the pt was administered with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions by a health care provider. Subsequently, the pt was treated by a physician for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) used: shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of herpes zoster and ill-defined disorder was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).
Engerix Was Administered for the Second Dose; Initial Report Received on 13-Nov-2020  A pharmacist reported that a 32 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization, and then Engerix for the second dose.   No medical history was reported.   No concomitant medications were reported.  On 15-Oct-2020, the patient received the first dose of HEPLISAV-B to the right deltoid (Lot # 933622, expiration date 01-Aug-2021 and NDC # not reported).  On 13-Nov-2020, 30 days after the first injection, the patient received Engerix (Lot # 239TF, expiration date 04-Jun-2022) for the second dose to the left deltoid. No adverse reactions were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
PATIENT RECEIVED PFIZER MONOVALENT VACCINE INSTEAD OF PFIZER BIVALENT VACCINE AS BOOSTER
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 on an airplane going out of town. I tested positive on 11/17/2022. I contacted my doctor over the phone and got the prescription for PAXLOVID. I tolerated the medication without any complications. I did not have any lingering symptoms of COVID-19.