chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 16-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 16-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 16-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 16-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported
has chills and she is cold all of the time and she has never had that before.; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (has chills and she is cold all of the time and she has never had that before.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 011J20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced FEELING COLD (has chills and she is cold all of the time and she has never had that before.). At the time of the report, FEELING COLD (has chills and she is cold all of the time and she has never had that before.) had not resolved.      The patient stated that she had been getting chills for about a year at the time of report and was thinking it was just because of she was getting old but wondered if it could be connected. Also reported she doesn't know whether to take more boosters or not because she suffers with that chill. She just (at the time of report) had knee surgery she was moving slowly.  No treatment information was provided.
Fever, chills, headache, body aches came on on suddenly at 11pm.  Took ibuprofen at 5 a.m. Fever and chills gone by 7a.m.  Then felt low energy, tired on 3/6 fine by 6 p.m.
Information has been received from a pharmacist concerning a 53 year old female with penicillin allergy who on 21-OCT-2010 was vaccinated (IM) with 0.5 ml PNEUMOVAX 23 (lot# 667912/0933Z, expiration date 25-FEB-2012) on right deltoid. There was no concomitant medication. On 21-OCT-2010 the patient experienced swelling and pain in her right upper arm to her elbow. The pain interfered with her sleep and her arm is sensitive to touch. The patient treated her arm with an alcohol wrap. No lab/diagnostics studies were performed. The patient sought unspecified medical attention. The patient was recovering from the events. This is one of several reports received from the same source. Additional information has been requested.
p/vax pt devel burning (intense) for 2min;15min p/vax tingling numbness in lt hand & finger tips for 2hr then resolved;24-36hr later achiness in joints, fatigue lasted 3-3 1/2 days;swelling @ site of inj w/redness & itchness;
hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Treatment of these events were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described   This case was linked to MOD-2021-104070 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described
Patient experienced no adverse events. Dose was drawn up and administered on 6/10/2022 at approximately 3:20pm from a vial first punctured at 8am on 6/9/2022.
Breakthrough case:  On 07/31/2021, I started feeling these symptoms: Muscle ache Loss of taste and smell Severely cold and hot Terrible headache Fatigue
Ever since I got my shot my left shoulder has been hurting me. The sports medicine doctor said I have adhesive capsulitis. I?ve been seeing the doctor and doing PT  for almost 3 months with no sign of improvement.
This spontaneous case reported by a patient, describes the occurrence of nausea (after the first dose she was queasy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. The patient's past medical history included anxiety disorder (had an anxiety attack while getting the booster). On Feb 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nausea (after the first dose she was queasy). At the time of the report, nausea (after the first dose she was queasy) outcome unknown. No concomitant medication or treatment information provided. This case linked to MOD-2022-593718, MOD-2022-593732, MOD-2022-593068 (patient link).
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. on 14-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 88, 192, 320, and 40 hours, with the lowest recorded temperature of 30, 33, 29, and 34 degrees Fahrenheit (-1.11, 0.55, -1.66, and 1.11 degrees Celsius) respectively; and lasting for 64 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a Medical Assistant (M.A.) concerning a female patient who was vaccinated with a first dose of Gardasil. The patient developed her arm being sore, red and hot one day after the injection was given (a Friday). The patient was seen on Monday and the arm was not as red, swollen and hot. She was told to take Tylenol for discomfort. The MA believed that the patient had the second dose of Gardasil and she was okay. The outcome was unknown. Additional information has been requested.
PATIENT STARTED HAVING SHOULDER BLADE PAIN ON LEFT SIDE ABOUT A DAY AFTER SHOT.  SHE HURT ALL WEEK BUT WAS THE MOST PAINFUL ON THE AFTERNOON OF 06/11/21. STATED THAT SHE FELT PAIN DOWN HER BACK AROUND KIDNEY AT ONE POINT DURING THE WEEK,BUT PAIN WAS GONE.  SHE ALSO HAD GENERALIZED LEG PAIN, BUT NOT ANYMORE.   PATIENT TOOK IBUPROFEN ON AFTERNOON OF 06/11/21 WHEN PAIN WAS HIGHER AND SHE ALSO APPLIED A COLD PACK.  PHARMACIST PROVIDED FOLLOW UP CALL 2 HOURS LATER AFTER PATIENT USED IBU /COLD PACK.  PATIENT STATED THAT SHE FELT BETTER AND WOULD CALL US IF ANYTHING CHANGED.
CLIENT HAD WELTS/HIVES THE EVENING FOLLOWING HIS VACCINES ON BOTH ARMS, HIS BACK LASTING LESS THAN 24 HOURS. CLIENT DENIED SHORTNESS OF BREATH.
Within 30 minutes of getting the 2nd dose of Moderna, I started to feel tingling in my hands and feet. This tingling has continued since then, although it has seemed to dull a bit. I visited with my primary case doctor on 5/19/21. She took some labs and referred me to a Neurologist at the Clinic. I saw Dr. at the Clinic on 6/17/21. She did an exam and didn't notice anything concerning. She told me that her recommendation would be to get an EMG, but I decided to wait a couple weeks to see if anything improved. I then scheduled the EMG for 7/30/21. I had a follow up with Dr on 8/16/21 where she told me the EMG was normal. She then recommended an MRI of my cervical spine. I had the MRI on 8/31/21. I had another follow up with Dr. on 9/3/21 where she told me that the MRI was normal. I now have an appointment for second opinion on 9/29/21 with the Neurology Clinic .
NUMBNESS IN LEFT ARM; WEAKNESS IN LEFT ARM; NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced numbness in left arm. On JUL-2021, the subject experienced weakness in left arm. On JUL-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness in left arm, and numbness in left arm, and the outcome of not feeling well was not reported. This report was non-serious.
Pt states she felt shakey immediately after receiving vaccines. Later the same dat her Left arm became red, swollen and warm at injection site.  08/12/2022 UPDATED *Pt went to Emergency dept for continued swelling yesterday 08/11. Today improving
Pt with cellulitis (L) upper arm (inj site was (L) deltoid) and diarrhea with general malaise. Started on KEFLEX 11/3/11. Pt did have chills.
pt recv vax 14JAN94 & 15JAN94 pt exp itching & devel rash around the inj site; pt tx w/ATB ointment; 17JAN94 pt exp burning @ inj site; rash lasted for several days; lab testing on 14FEB94 revealed neg anti-HBs of 0.9; No further info;
Presented to ED 4/5.  Fever 102 on 4/3.  Headache, myalgias, chills, cough, shortness of breath.
Fatigue, body aches and nausea started at 12 hours and lasted up till the 48 hour mark. Fever of 100..6f started at 24 hours and lasted about 6 hours. Diarrhea at 24 hours for about an hour. Chills intermittently but significantly less that after the 1st dose.
Fever, nausea, body aches, headache, fatigue, knot in arm, redness (size of lemon), hot to touch
Patient had facial numbnes and tingling from nose down 5 minutes post vaccine administration involving right and left side of head.
This spontaneous consumer report (initial receipt 27-Oct-2014) concerns a 62 year-old female patient. Last year, the patient developed same reactions (as this year) after receiving flu vaccination, that lasted approximately 2 weeks. The reporter did not report the product she received last year (Refer to case: 2014046048). On 27-Oct-2014, at 2 pm, the patient received AFLURIA (batch number not reported) at 0.5 ml via intramuscular route for influenza vaccination. On 27-Oct-2014, in the evening, the patient started experiencing headaches and felt achy. She felt like she has a head cold. The symptoms began about 4 hours after receiving vaccine which included neck ache, tossing and turning and she could not sleep. Outcome was not reported.
This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K008824, 19-JUN-2016, lot # L026410 with expiry 15-FEB-2017). No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient vomited one time approximately 48-72 hours after vaccination. Pt presented to the Immunzations clinic on 30 June 2010 complaining of itching, hot & clammy skin, vomiting X2 days. Patient had redness on neck, chest, and back. Patient took Benadryl X3 days starting 27 June 10. Patient was examined. Patient is to proceed with vaccinations as normal.
FAINTING; SHE FELL AND HIT HER HEAD ON WALL; LAID DOWN FOR A FEW  HOURS AND WAS SCARED TO MOVE; HEADACHE; FELT TIRED; This spontaneous report received from a consumer concerned a 34 year old female of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: unknown) dose was not reported, 1 total, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021 (reported as following morning), patient experienced a fainting. She woke up to go to the restroom and when she came out of the bathroom, she fell. She hit her head on the side of the wall as she fell, and immediately went to the emergency room. Patient received X-ray (result not reported), heartbeat, and lungs were evaluated as well as blood tests (result not reported). They determined that she would not faint again and discharged her. After she returned home, she experienced headache and felt tired. She laid down for a few hours and was scared to move. On the day of reporting, she was no longer having any side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, she fell and hit her head on wall, headache, laid down for a few hours and was scared to move and felt tired. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837758- Covid-19 vaccine ad26.cov2.s- Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Throat became itchy, irritated, and a little restricted about 4 hrs after shot. Eyes irritated, red, itchy  watery. About 7 hrs after shot, swollen face, especially lips & around eyes. Lasted 24 hours. Also had low grade fever, body aches, chills.
Patient had vasovagal type reaction at 1:59 PM .    Appeared pale, felt faint and complained of facial tingling .  BP was 164/81   P 102 .  Rechecked after 10 minutes.  BP 134/84 and P 81.    Symptoms resolved after 20 minutes and  patient left .  Writer attempted contact with client later that day and left messages on 1/29/21 and 1/30/21 .  Spoke with patient on 2/2/21 and he reported no further symptoms.
body aches; tested positive for the mononucleosis virus; fever of 102.5; couldn't get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Sep2021 16:00 (Lot number: FE3592) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: factor V" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII; HPV VACCINE. The following information was reported: PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (2021), described as "fever of 102.5"; BEDRIDDEN (non-serious) with onset 26Sep2021, outcome "unknown", described as "couldn't get out of bed"; MONONUCLEOSIS SYNDROME (non-serious) with onset 01Oct2021, outcome "recovering", described as "tested positive for the mononucleosis virus"; PAIN (non-serious), outcome "unknown", described as "body aches". The events "fever of 102.5", "couldn't get out of bed" and "tested positive for the mononucleosis virus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She said her daughter By Sunday night, 26Sep2021 was feverish, and couldn't get out of bed. She went to the doctor a couple times. They couldn't figure out what the fevers were connected to. Her daughter tested positive for mono. She hadn't been around anyone they know of. She was not sure if it was related to the vaccine or not. Her daughter still have active mono. Her daughter's fever reached 102.5. Her daughter also had body aches. She couldn't come out of her room for a week. She couldn't lift her head off the pillow. She was back at school, but could not play any sports or activities. The doctor did blood work that next Thursday, and a Strep test that Tuesday after the vaccine. The doctor was looking at every single scenario. Her daughter does have factor V , but she has had no blood clotting issues with it. Prior Vaccinations (within 4 weeks): flu vaccine and HPV.  Follow-up attempts are completed. No further information is expected.
COVID Breakthrough Case. This was not due to the vaccine. Very fatigue, slept 3 out of the 4 days, scratchy throat lower area which is why I had the cough which didn't clear up for months, body aches and a slight fever maybe at 100 but nothing higher. I normally 96.8 or 97.0. I did not lose taste or smell didn't have lung issues other than some congestion and sinus but not server to the point of sob thanks to the vaccines. My symptoms were about the same as the common flu thanks to the vaccine. Still to this current day I am still having issues with "Long haul COVID"
complete redness on chest & back, raised;as of 21OCT95AM was extremely itchy;began topical DPH;saw MD on 1NOV95;itching/rash beginning to improve as 1NOV95
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. No medical history was reported. Approximately on an unknown date in June 2011 (reported as 2 years ago), the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. The patient was resistant to receiving the second dose of GARDASIL because on an unknown date, the patient experienced severe migraine, fainting and weakness after receiving dose 1 of GARDASIL. The outcome of severe migraine, fainting and weakness was unknown. Additional information has been requested.
This spontaneous report was received from a physician via company representative concerning 200 patients of unknown age and gender. The physician reported that an unspecified article provided information regarding patients who on dates were vaccinated with GARDASIL and died an unspecified time after vaccination. There was no product quality complaint reported. The reporter did not provide the causality assessment for the events. the cause of death was not specified. Upon internal review death was considered to be medically significant. Additional information has been requested.
Patients arm was swollen, red, warm to the touch. Swollen from left shoulder to her wrist. Twice the size of her right arm. Provider gave BENEDRYL for swelling.
Patient received his 1st dose of the COVID-19 vaccine on January 8, 2022. About 5 minutes after his dose, he experienced an odd visual that he described as "the carpet having moved up off of the floor" that was understandably unsettling to him. I reassured him, had him take some deep, slow breaths, and we waited out the rest of the 15 minute time at his pediatrician's office.    When we arrived home and were walking in, he stopped walking and said, "everything is the wrong color." When I asked him to describe what was happening he said that "everything changed color to green, pink and some other colors" and "nothing looked right." He experienced this change in vision for about 5 minutes. I had him sit down and relax, and eventually it passed but it was very frightening for me as his Mom that he had experienced two changes in vision shortly after the vaccine.    This was particularly scary for me because we had not discussed any side effects of any kind with him, and he had never experienced anything like this with any other vaccine.