chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-369020 (Patient Link).
Patient arrived to clinic at 2:30pm very upset registered for the vaccines. When I called her back to get vaccinated she said she was going to be sick. Father talked to her. Administered shots. She said she was going to faint and vomit. She did lay down. After 10 min felt better sat up for 5-10 min then left. Starting "feeling better".
ARM ACHE; SLIGHT FEVER; TIREDNESS; This spontaneous report received from a consumer concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm ache, slight fever, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm ache, slight fever and tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20211260580.
No adverse event; staff gave vaccine to a patient that was out of the 12 hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2022 at 2:40 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (staff gave vaccine to a patient that was out of the 12 hour window).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 01-Nov-2022. Date and time vial was first punctured on 02-Nov-2022 around 10:00 AM. The vial did not undergo any temperature excursions. No treatment information was reported.
Had joint pain, fatigue and headache . Started about 8 hours after vaccine and continued through the following day. About 24 hours
This spontaneous report was received from a medical assistant refers to a 40 year old female patient. On 26-JUL-2017, the patient was vaccinated with a dose of pediatric VAQTA (lot#, dosing details and route unspecified) for prophylaxis, instead of an adult dose (drug administered to patient of inappropriate age). No adverse effects reported. No product quality complaint was involved. No further information provided. There was a consent to follow up.
Patient had soreness in arm since injection. He says it's difficult to raise arm, he cannot sleep well because it hurts to sleep on this arm. He indicated pain at top of shoulder down thru elbow area. He showed technician and pharmacist that he believes the shot was given a few inches down from top of shoulder
Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better.  I literally slept all of the next day only getting up occasionally and most of the day after that.  I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable.  Sore neck and joint pain and a slight headache.  I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm.  That persisted for several days. I slept and took 1 800 mg Ibuprofen (on   1/27/2021). Am feeling better but still not feeling 100 %.  That may be due to increased allergies due to time of year of etc a
her left arm was sore; started having diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-AUG-2023, the patient received the 2nd dose of Shingrix (injection, left deltoid). In AUG-2023, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: started having diarrhea). On 23-AUG-2023, the patient experienced pain in arm (Verbatim: her left arm was sore).The outcome of the pain in arm and diarrhea were not resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.   It was unknown if the company considered the pain in arm and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-AUG-2023 The patient received Shingrix vaccine. The reporter stated that one day after receiving the vaccine her left arm was sore and she started having diarrhea. The reporter consented to follow up.
WHOLE VIAL ADMINISTERED TO PATIENT; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: Unk) 2.5 ml, administered on 21-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced whole vial administered to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of whole vial administered to patient was not reported. This report was non-serious.
p/vax pt devel full blown chickenpox;pt was irritable & feverish prior t spots erupting;pt recovered;
Next day pt calls with 3" x 5" area on arm that is hot, red, swollen, painful. Treating with Tylenol and ice.
Information has been received from a medical assistant, concerning an approximately 11 month old patient of an unknown gender. The patient's medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date, one day before him/her 1st birthday, the patient was vaccinated with VARIVAX and M-M-R II, reconstituted with sterile diluent (MRK), (strength, doses, routes of administration, anatomical locations, lot numbers and expirations dates were not provided) for prophylaxis. No adverse effects were reported.
In 2006 I had Graves Eye Disease.  Have been in remission since treatment.  The morning after my second Covid vaccination I started having blurred vision in left eye.  Continues to today.
pt reported today that she had general "flu like symptoms" the day after the vaccine until yesterday. She developed tongue swelling/ tingling on Friday, 1/29/2021 and redness on her L deltoid area. As of today, she only reports the redness on her arm still remain. No hospital visit was required. The tongue tingling/ swelling subsided on their own.
This spontaneous report was received from a physician refers to an adolescent patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date (reported as "younger than 15 years of age"), the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (dosing details unspecified). On an unknown date (reported as "older than 15 years of age", two years later), the patient was vaccinated with second dose of GARDASIL 9 for prophylaxis (dosing details unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Concern for COVID pneumonia, we obtained a chest x-ray which does look like he has COVID pneumonia.  Given the patient's weakness and his progressive difficulty managing, I think he warrants admission to the hospital especially given the hypoxia.
Patient received Pfizer COVID vaccine on 2/28/21 (lot # EN6198), 3/26/21 (lot # ER8732), and 10/22/21 (lot # FH8020). On 5/15/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia due to COVID-19 pneumonia. Patient lives with multiple family members, all of whom were recently tested positive for COVID19.  Patient was admitted to our med/surg unit and discharged home on 5/17/22.
Pain at injection site, fever of 101 degrees, chills, aching body.  Lasted 2 days and needed ibuprofin for fever and pain management.
24 hours, post vax, pt suffered maculopapular rash on chest, back and buttocks. No oral lesions. No fever.
stomach ache; vomiting; body ache; headache; 102°F fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache) and HEADACHE (headache) in a 55-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.     Concomitant products included PREDNISONE for Sinus infection, ESTRADIOL and PROGESTERONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), VOMITING (vomiting), MYALGIA (body ache), HEADACHE (headache) and PYREXIA (102°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high.         Concomitant medications included Antibiotics and Cough syrup with Codeine.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 30-JUL-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of minus 40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several reports, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
A report was received from a health care professional on 10/27/03, concerning a 30 year old female vaccinee who was thought to have been pregnant at the time of receiving the Fluvirin vaccine on 10/7/03. On 10/7/03, the vaccinee received Fluvirin but is now thought to have been pregnant, this has yet to be confirmed. There was insufficient info to determine the reporter's causality. Follow up info received from a health care professional indicated that the vaccinee miscarried on 11/10/03. She had a positive pregnantcy test on 10/29/03. Follow-up pending. Upon review of this report was found to be medically significant (OMIC).
oval area of erythematous warm raised skin @ inj site w/sl tenderness;was noticed 2 days p/vax & lasted 7 days & reached peak side of 2" x 3";
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008779: US-009507513-1712USA008780: US-009507513-1712USA008781: US-009507513-1712USA008782: US-009507513-1712USA008783: US-009507513-1712USA008784: US-009507513-1712USA008785: US-009507513-1712USA008786: US-009507513-1712USA008787:
Patient is a 81 y.o. male admitted to the hospital on 12/28/2022 for weakness and falls at independent living. He tested positive for COVID and was having increased weakness of the legs thus MRI lumbar spine was performed; no acute findings were noted. He will follow-up with neurosurgery; he will be discharged.
*Headache started on day 1 following vaccine and has persisted through day 9. Comes and goes varying in intensity, usually a dull ache at the front of my forehead. Gets worse later in the day and into the evening. * Body aches--started in the shot arm, then moved to shoulders and neck and sometimes lower back. Comes and goes with varying intensity. Has persisted through day 9. Sometimes it feels like achey area is emitting heat. * Night sweats- started around day 3 * Congestion/sinus pressure--intense sinus pressure (not a runny nose or cough) starting day 4 persisting through day 9. C Currently taking a steady dose of tylenol and sudafed. Have been taking tylenol since the shot on 4/11. GP admits she has no idea if this is related to the vaccine or another virus. I would love to get some clarity.
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2009, the patient was inoculated, in a Health Clinic, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On or about 11-JAN-2010, according to the report, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure). As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered all the events to be related to ZOSTAVAX.
7 hours after injection, nausea, diaphoresis, dizziness, cool/clammy, symptoms still occurring 1.5d after vaccine. Missed work.
This case was reported by a nurse and described the occurrence of incorrect product storage in a 4-year-old female patient who received KINRIX (batch number EP2A3, expiry date 30th September 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to KINRIX. Additional information received: KINRIX stored at 0.5 degrees C and administered to the patient.
one week following the vaccine, 1/11/2021 I noticed pain and swelling and itching on my left arm surrounding the injection site. The area was reddish and raised, - about  3 inches by 5 inches and was hot to the touch, itchy and sore.  It kept me awake at night. I was seen by my primary doctor the next day 1/12/2021 and he said to apply a Benadryl cream to ease the itching and report back if I spiked a fever. I started using the Benadryl cream that evening of the  12th and the pain and itching has been gradually decreasing. The shade of pink is lighter today  1/14 and swelling is mostly gone but skin is still hot to the touch and Im still putting on the Benadryl cream 2x/day. I have not had a fever and have no other symptoms.
For almost 4 weeks after the second vaccine shot (April 6) I was extremely tired, light-headed, and my thinking was kind of fuzzy/distracted.  It lasted almost 4 weeks and then resolved.
Hematoma sort of bump on shoulder deltoid at site of injection. Pt. was feeling pain and trouble raising arm for few days thereafter.
large area (506cm) swelling @ inj site;pain radiating down arm to elbow;pain radiating across shoulder blade & down back;small amount reddened;T103 last evening;
Information has been received from a registered nurse concerning an elementary school aged child who on 27-JUL-2000 was vaccinated with a dose of varicella virus vaccine live. On 03-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
R09.02 HYPOXEMIA 2/12/2023 OBESITY, BMI 30-34.9, ADULT
This case was reported by a consumer via call center representative and described the occurrence of flare up of arthritis in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced flare up of arthritis, inflammation localized and pain. On an unknown date, the outcome of the flare up of arthritis, inflammation localized and pain were recovered/resolved. It was unknown if the reporter considered the flare up of arthritis, inflammation localized and pain to be related to SHINGRIX. Additional details were provided as follows: The patient asked what was the longest amount of time that could be elapsed before receiving the second dose of SHINGRIX. It was less than 6 months the patient had received the 1st dose of SHINGRIX. Currently at the time of reporting, the patient received a new immunosuppressant drug series and had a strong reaction with the 1st dose of SHINGRIX, so the doctor had asked the patient hold off until after the next infusion therapy, that is till March. The patient experienced inflammation flare up in the wrist and hands, aches and pains for 3 days. The patient asked if there was any problem in receiving the 2nd dose of SHINGRIX in early March without receiving the repeated series.
pt states she had a positive COVID test on 1/16/22; came to ED on 1/19/22 with SOB, weakness, cough; found to be hypoxic; O2 supplementation; admitted and given dexamethasone and started on Lovenox; on 1/23/22 a code FAST was called due to pt being less responsive and right sided weakness; transferred to CCU; head CT scan showed intraparenchymal hemorrhage, possible deep vessel aneurysm; family requested no interventions; transitioned to comfort care; pt passed away in the hospital
A few hours after vaccine patient became sleepy and went to bed. Patient then woke up approximately 1:00 am and felt pain in right side of jaw/teeth/face. Patient fell back asleep around 3:00 am and has had pain in back right side of mouth daily since. Pain somewhat alleviated by brushing teeth and orajel. Patient advised to take Nsaids when reported to pharmacist on 6/16/22. Patient did not tell pharmacist of naproxen allergy at the time. Patient tried taking 1/2 tablet of aleve on 6/18/22 and 1 tablet on 6/20/22. Patient reports some reduction inflammation temporarily. Patient reports site is sore to touch and inflamed. Patient also reported slight inflammation at injection site occurred on 6/18,  but has reduced.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with VARIVAX, (lot#, expiration date, dose and route not reported). The patient experienced rash on an unknown date. The outcome of rash was reported as recovering. The patient had contacted the physician's office on an unspecified date. This is one of several reports from the same source. Additional information has been requested.