chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature; Patient was administered booster doses from a vial that had been open for 24 hour; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered booster doses from a vial that had been open for 24 hour) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture/vial was kept in the refrigerator at normal room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reported stated that patient were administered booster dose from a vial that had been open for 24 hr. The vial was kept in the refrigerator at normal room temperature. The vial was initially stored in the refrigerator on 12-Apr-2022. The vial was first punctured on 13-Apr-2022 at 8:00 am. Post puncture the vials were refrigerated at 4-5 degree Celsius.The vials did not undergo any temperature excursion. Total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was 30 min or less. The patient did not have any symptoms.  No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN9269), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2020, stop date: 07Aug2022; AMLODIPINE BESYLATE, start date: 01Jan2019, stop date: 07Aug2022; HYDROCHLOROTHIAZIDE, start date: 01Jan2019, stop date: 08Aug2022; TELMISARTAN, start date: 01Jan2019, stop date: 07Aug2022; EZETIMIBE, start date: 01Jan2021, stop date: 07Aug2022; B COMPLEX (B50), start date: 01Jan2020, stop date: 07Aug2022; VITAMIN D [VITAMIN D NOS], start date: 01Jan2019, stop date: 08Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
DIFFICULTY MOVING LEGS, DIFFICULTY WALKING.  STEROID TREATMENTS FOR SEVERAL MONTHS SINCE VACCINATION. SHE HAS SEEN SEVERAL DOCTORS AND HAVE BEEN LOOKING AT DIAGNOSIS OF RHEUMATOID ARTHRITIS.   SHE HAS BEEN WEANING OFF AND ENDED THERAPY 2 WEEKS AGO.  SHE IS NOW EXPERIENCING SAME SYMPTOMS AND IS NOW SEEKING OTHER TREATMENT FOR RHEUMATOID ARTHRITIS.
EXPIRED VACCINE WAS GIVEN/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 27-DEC-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 27-DEC-2022, the patient experienced expired vaccine was given/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine was given/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150600, 20230150423, 20230150157, 20230150777, 20230149982 and 20230150588.
body ache; sore left injection site arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever). At the time of the report, PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-404697, MOD-2021-404586 (Patient Link).
On 3/14/21, I started to experience some mild pain in my left knee and thigh.  By the end of the day, I had some fairly extreme pain in my left thigh and knee.  I have a orthopedic implant screwed into my left femur.  The pain level was about a 8 out of 10.  It was barely tolerable and seemed to mitigate over the next 7 days.  I still today have a pain level of about 2 out of 10 that I treat with an NSAID.  My knee is still sore.  No orthopedic implant in this knee however.
Rash on face & legs, fussy. Temp of 100.5 on 4/2/17.
Woke up to a very sore left hot to touch and swollen about 4 inches under the injection site.  Later that day intense itching at the swollen site until Monday.  Swelling is going down and itching is starting to go away.
Started with loss of taste on Tuesday p.m.. Just after 4am, I awoke my husband because I was about to vomit. From there I was going in and out of consciousness. My husband took my temp and it was just over 104 degrees. He wanted to call an ambulance to take me to the ER, but I refused not realizing how bad off I was. This went on for about 4 hours. My husband applied ice cold wash cloths to my forehead and back of my neck for hours. He finally was able to bring my temp down some. I used the cold cloths for just over two days. I was so fatigued I was unable to walk without help. Had a bad headache too. My husband gave me Tylenol off and on for days. My fever finally broke on the 5th day. I am still left with bad fatigue and some headache.  Have also had diarrhea. My husband kept fluids in me which also included Ensure. I had terrible fever blisters on my lower lip and the inside of my mouth was sore. I am due to have my 2nd shot in about a week, but because I still have some lingering symptoms, was advised to not have 2nd shot.
Pt with a history of hypertension, CKD stage IV, and history of previous stroke. Came to ED due to difficulty of family waking the pt up. Pt had a slight cough yesterday, but no fevers. Pt was found to be COVID positive, but is on room air. Pt admitted for NSTEMI.
Patient developed rash underneath the injection site that spread down her arm within two hours of vaccine administration.  She also reported that the rash had been there prior to the vaccine but was very small and not visible.  She experienced slight itching for two weeks prior to receiving the vaccine but the rash spread "about two hours" after administration.  The rash was observed in the pharmacy to be approximately 2-3 inches below the injection site, spanning most of her upper arm.  The patient says the rash has not worsened but only minimally improved since it flared up.  She felt "just fine" otherwise.  Her blood pressure at the pharmacy was 126/85 mmHg.
Chest hurt; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest hurt) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest hurt). At the time of the report, CHEST PAIN (Chest hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2023: Live Follow up received that contains no new information.
Mammogram on 8/16/22 showed an area in R Breast that needed further scans.  2nd mammogram & ultrasound on 8/23/22 showed an enlarged lymph node in R Breast.  Radiologist stated this could be due to having a recent Covid-19 Vaccine, and that it was a common occurrence.  They will do another ultrasound in 3 months to check lymph node status.  NOTE that I also received the Shingrix Vaccine on the same day (not positive which vaccine was in which arm, but each shot was in a different arm).
Brain Fog, poor memory, dizziness, heart issues, pulmonary issues, blood clotting issues, sleep disorders, food sensitivity.....
Fever up to 102F early this AM (1/24/07). Small bump felt in legs, patient not wanting to walk. Advised alternate Tylenol and Motrin every 3 hours, cool compress to legs. If not better within 24 hours call back to come in.
Pick eye/Pink eye; her eyes itched; The green goo was in her eye; eye infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Nov2021 15:00 (Lot number: EH8027) at the age of 55 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Diagnosed 2-3 years ago; "Covid" (unspecified if ongoing), notes: She has had covid twice.; "Fuchs eye disease" (unspecified if ongoing), notes: her mother and grandmother. Family history included: "bad eyes" (unspecified if ongoing), notes: mother; "corneal transplants" (unspecified if ongoing), notes: mother. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: CONJUNCTIVITIS (non-serious) with onset 30Nov2021, outcome "recovering", described as "Pick eye/Pink eye"; EYE PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "her eyes itched"; EYE DISCHARGE (non-serious) with onset 30Nov2021, outcome "recovering", described as "The green goo was in her eye"; EYE INFECTION (non-serious) with onset 30Nov2021, outcome "recovering", described as "eye infection". The events "pick eye/pink eye", "her eyes itched", "the green goo was in her eye" and "eye infection" were evaluated at the physician office visit. Therapeutic measures were taken as a result of conjunctivitis, eye pruritus, eye discharge, eye infection.  Additional information: The patient did not receive any other vaccines on same date with the Pfizer vaccine. No Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient had first dose on 28Nov2021, and she developed the pick eye/Pink eye 2 days later on 30Nov2021. The green goo was in her eye and her eyes itched. She was prescribed with drops for her pink eye. She took them for a week and her eyes got worse. The patient called the eye doctor, and her eyes were really bad. She was given 2 different eye drops by the eye doctor and her symptoms got better within a week. The eye doctor said that she had an eye infection and said that it was worse than pick eye. She does not know if it is bacterial or viral. The patient stated that it was definitely from the vaccine. The patient was treated with Ofloxacin 1 drop every 2 hours and Prednisolone acetate 1 drops in each eye every 4 hours. The patient did not undergo any lab tests.  Follow-up attempts completed. No further information expected.
A non serious, spontaneous report of administration of expired product was received from a nurse concerning a two year-old female subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. There are no events reported after follow-up. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 08-Jan-2009 and incorporated into the narrative follow-up outcome. Follow-up information was received on 07-Apr-2009: Product Complaint Investigation results.
Pt received her 2nd Moderna COVID 19 vaccine on 4/16/2021. She has a history of crohn's disease with ileostomy managed with over the counter vit D and immodium and chronic kidney disease. She was admitted to the hospital on 6/29/21 with a witnessed, new onset seizure. Her MRI brain and CT brain were negative. EKG normal, glucose was normal. magnesium was normal, cbc and cmp were normal. She does not use alcohol or smoke or use drugs. She had no recent illness or infection. she had no fever and normal vital signs. She was on no new medication or over the counter medication or supplements. She arrived with a lip laceration and significant bilateral tongue bruising. She was discharged home on 6/20/21 to follow up with neurology for an EEG as EEG was not available while hospitalized. She has never had a seizure in her life. Neurology was consulted and did not recommend anti seizure medication at this time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-APR-2016, the patient was vaccinated with expired PNEUMOVAX 23, expiry date 23-MAR-2016 (dose, route and site of administration and lot # were not reported). No adverse symptoms were reported. Additional information is not expected, as no contact details were provided.
Information has been received from a pharmacist referring to a 74 years old male patient. The patient's concurrent condition and concomitant therapy were not reported. The patient was vaccinated with PREVNAR 13 on an unspecified date in September 2015. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date not reported) intramuscularly for trying to stay up to date with immunizations. On 09-NOV-2016, the patient experienced severe pain and tenderness at the injection site. The patient said this was the worst pain he had ever had. The patient could not move his arm. The patient sought medical attention via contacting pharmacist. Unspecified treatment was given for the events. The outcome of the events was not resolved. The causality between PNEUMOVAX 23 and the events was not provided. Additional information has been requested.
Sweats; Chills; Body aches; Nausea; Vomiting; Diarrhea; Headache; Sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 05Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced sweats, chills, body aches, nausea, vomiting, diarrhea, headache, sore throat. Patient reported as got everything except for the taste and the fever from it. The outcome of the events was unknown.
Developed Cevicalraickulatitis which is muscle spasms in her left arm.
pt exp nausea, diarrhea & achiness 4 hrs p/receiving 1st dose of Engerix-B;
Vaccine was expired at time of administration.  It was past bud of 10 weeks in the fridge.  It expired on 3/30/22.  Called patient to discuss cdc recommendation for re-vaccination.  Patient wanted us to call her pcp and get their recommendation.  That Dr. did not recommend re-vax so patient does not want it.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Engerix B for prophylaxis.  On 02 February 1999, 05 March 1999 and 10 September 1999 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (10 mcg).  In November 2006, 7 years after vaccination with Engerix B, the subject did not have antibodies to Hepatitis B.  At the time of reporting the event was unresolved.  Follow-up information was received from the reporting healthcare professional on 07 June 2007.  The reporter indicated that she had not reported the event to a regulatory agency.  There was no other additional information reported.
No additional adverse events reported. No product quality complaints reported. No further details provided.; Medical Assistant reporting that Patient received an extra dose of GARDASIL 9. Medical Assistant reports that Patient was on 2 dose series of GARDASIL 9 and Patient received a 3rd dose.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 18-AUG-2022, the patient who was on 2 dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) received an extra dose of the vaccine 0.5 mL (strength and route were not provided; lot#: 1780878, expiration date: 02-DEC-2023) for prophylaxis (extra dose administered). No additional adverse events were reported, and no further details were provided.
Upon administration of the second dose of the SHINGRIX vaccine in the left deltoid the patient said his arm hurt and he had pain down his arm into his left hand. Pharmacist immediately checked the site of administration and it was correct in the left deltoid region (not too high or low). One week later the patient comes back to the pharmacy and said he still has a burning pain in his left hand/thumb. About 2 weeks after vaccination the patient still has a burning sensation in his left hand/thumb and is seeking treatment.
MOM REPORTED NOTICED REDNESS/SWELLING OF RIGHT UPPER ARM, CONTINUED SYMPTOMATIC WITH INCREASE OVER PAST 24 HOURS. TOOK IBUPROFEN, NO OTHER COMPLAINTS. 6CMX6CM ERYTHEMA AND SLIGHT DURATION, WARM TO TOUCH, DENIES MUCH DISCOMFORT TO AREA.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 47 year old female. 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: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949219, 20210949881, 20210949901 and 20210949251.
Dtap and IPV given in left lateral thigh on 11.14.07. On 11.16.07 pt presented in the office with a 10cm x 10cm area of redness, swelling and warmth at the site of injections. No tenderness. Pt instructed to apply ice and PO Benadryl.
Information has been received from a consumer concerning her daughter, a 23 year old female with no known drug allergies and no pertinent medical history reported, who on unspecified dates was vaccinated with the first and second doses of GARDASIL. In the summer of 2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included PROZAC. On an unspecified date, the patient experienced fainted after receive the first dose of GARDASIL, for the second and third doses she was lying down while receiving it and she was fine. After receiving the third dose, the patient started experiencing nausea, vomiting, low grade fever and chills that come an go ever since. The patient sought unspecified medical attention. Blood work came back normal. At the time of reporting, the patient had not recovered. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to a 8 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 20-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional infotmation has been requested.
I had a full on body rash, started slowly the night I received the first dose. Spread from my back, to the rest of my body and lasted for two months. Two or three hours after the injection, I had issues walking on my left leg for about 6 or 8 hours.
Generalized body aches, chest pain, shortness of breath, leg cramping.  Reports onset of symptoms as same day as vaccine received.  D-Dimer negative.  Educated on reasons for urgent recheck.
2 days after vaccination, developed sudden hearing loss - responsive to oral steroids - which were administered 5 days after the vaccination (2nd dose of Moderna). Sudden hearing loss did not occur prior to or after this event.
1256 Patient c/o "slight tightness" in his throat 15 minutes after Moderna Vaccina given, No sob. No chest pain. No facial edema. No swelling noted on tongue. No redness or hives noted.  1259 VS: BP=130/93; P=100  Diphenhydramine 50mg/1ml 1ml given IM.  1316 Patient stated "tightness" in throat slightly decreased.  Patient stated he had to go to the BR so Staff escorted Patient to BR. 1318 Patient is back from BR; No further changes noted.
3hr p/vax devel low grade fever 99.2-99.5, productive cough, post nasal drip;all sx resolved 24hr later;