chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they mistakenly administered expired vaccine today which was removed from freezer on 14-Oct-2021 into refrigerator and never opened before administration and temperature was never compromised. It was also reported that it was patient's third dose, and it was a 0.25-ml dose and no information regarding first or second dose were provided.  No concomitant medications were reported.  No treatment information was provided.
DEATH; UNSPECIFIED COMPLICATIONS; This spontaneous report received from a consumer 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: Unknown) dose, start therapy date were not reported, once total, 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.  The six patients died on unspecified date due to unknown cause. It was also stated that these patients had some unspecified complications. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of complications was not reported. This report was serious (Death).; Sender's Comments: V0: 20210452419-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
THE LEFT SIDE OF HER BODY WAS PARALYZED FROM THE ARM, TORSO AND LEG ON THE LEFT SIDE.; BLOOD CLOT IN THE LEG; PNEUMONIA; CHEST PAIN; PAIN IN BOTH LEGS; BLOOD CLOT IN THE LUNG; This spontaneous report received from a patient concerned a 53 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182811, and expiry: UNKNOWN) dose was not reported, 1 total (dose number in series: 1) administered on 19-OCT-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-NOV-2021, the patient experienced blood clot in the leg, pneumonia, blood clot in the lung, chest pain and pain in both legs, and was hospitalized. The patient went to the emergency room for the chest pain and was diagnosed with pneumonia  and 2 blood clots, one in her lung and one in her leg but. She was unsure that which side of the lung and leg in which had the blood clot. Laboratory data included: CAT (computerized tomography) (NR: not provided) Blood clot in the lung, blood clot in one of the legs. The patient was admitted in the hospital 23-Nov-2021 and was discharged on 27-Nov-2021. On 05-DEC-2021, the patient admitted in hospital due to the left side of her body was paralyzed from the arm, torso and leg on the left side and chest pain, which she described as the same chest pain as before that never went away and was currently admitted in hospital. They gave antibiotics for the pneumonia and something else for the blood clots. The patient recieved physical therapy in order to treat the paralysis and to regain strength in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and had not recovered from blood clot in the leg, blood clot in the lung, chest pain, pain in both legs, and the left side of her body was paralyzed from the arm, torso and leg on the left side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20211225184-COVID-19 VACCINE AD26.COV2.S-Blood clot in the leg,Pneumonia,The left side of her body was paralyzed from the arm,torso and leg on the left side,Blood clot in the lung,Chest pain. 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).  20211225184-COVID-19 VACCINE AD26.COV2.S-Pain in both legs. This event(s) is labeled per RA and is therefore considered potentially related.
Information has been received from a pharmacist refers to a 59 year old female patient with no drug reactions/allergies. Pharmacist reporting that the patient believed that she received a dose of ZOSTAVAX (lot # K020185, EXP date 27-JAN-2016) intramuscularly in her left arm on 23-MAR-2015. The pharmacist confirmed that the patient believed that the injection needle was inserted into her muscle. On 25-MAR-2015, the patient contacted the pharmacist because she was concerned that she has redness and swelling of approximately 4 inches in diameter around her injection site on her left upper arm. The pharmacist did not clarify with the patient when the redness and swelling began, and the pharmacist recommended that the patient take ibuprofen for the discomfort and the swelling. She did not know if the patient has taken any ibuprofen, and if the patient has contacted her healthcare provider. She also did not think the patient was experiencing a rash. Follow-up AE Information was received on 26-MAR-2015 from the primary pharmacist. The pharmacist reported that the ZOSTAVAX was administered via the subcutaneous route not via the intramuscular route, as previously reported. The pharmacist stated, "the patient gave me wrong information, the ZOSTAVAX was given subcutaneous as it should have been". The patient sought medical attention by notifying pharmacist. There was none lab diagnostics studies performed. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
7pm - Muscle aches/Headache onset; took 800 mg ibuprofen 8pm - Went to bed 1am - Nausea, lightheaded, sweating 1:05am - Loss of consciousness, involuntary muscle contractions 1:40am - EMT started IV saline solution 2:00am - To ER 6:00am - Given potassium tablets, released
Raised circular rash with excessive pain and itching approximately 1.5 weeks after vaccine. Arm pain and inflammation have not receded since shot
An 11 year old white female with parents complaining of back and neck pain "spasm" while sitting on her knees giving mother a "manicure". Gave children's Motrin 3 tsp at 15:45 but continued to have left neck pain. Pt and parents deny injury, fall, chest pain, abdominal pain or SOB. No history of similar symptoms. Pt had Hep-B vaccine 2 days earlier. No fever or headache. She is crying in pain but cooperative and pleasant. Neck is tender to palpation at left anterior neck, decreased ROM of neck secondary to pain. DX: neck stiffness/possible side effect of Hep-B vaccine. Gave 2.5mg of Valium X 1 and 20 minutes later gave 2.5mg Valium X 1. Treated with Motrin 400mg q 6 hr and return if worse. Referred to PCP in the morning.
Received Booster Pfizer vaccine on 10/15/2021. I had side effects of swollen inflamed and itching at the site of vaccine injection of the left arm. Chills, fever, nausea, headache, aches and pains, lethargy  that lasted for a few days. Still had a fever and headache on 10/18/2021 and red swollen, itchy arm for about 2 weeks that has since resolved.
Moderna COVID?19 Vaccine EUA TWELVE DAYS AFTER THE  VACCINE, on March 13, I awoke with severe dizziness and weakness, and moderate nausea. I could not stand or walk.  I am reporting this because it is outside your normal prediction on the timinh of side effects.  You need to add this vaeiation to your public information. I panicked and called the Nurse Hot Line -they told me to call 911 and go to the ER.. So I called another Nurst HotLine and they ld me to call 911 and go to the ER.  Instead I simply slept for 35 hours and I am fine.  Please mention in your information that in some cases,  a reaction can occur up to 12 days later,  Btw there is nothing in my medical history to otherwise explain the incident.
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Nose bleed with black spots all over his body-Mild.
Patient came to Urgent Care  around 1800 4/12/2021 and reported that she got the first Moderna Vaccine that day at 3:22 pm,  tried to go back to work, felt dizzy, short of breath, and her vision was hazy. Checked her blood pressure and it was elevated around 150/100. Reported still having chest tightness, sob, and hazy vision at the time of visit. VS 97.7 temp, pulse 87, BP 143/98, resp 16, O2 98%. Physical exam unremarkable. EKG showed small negative T in aVF, negative T in III, slight inferior repolarization disturbance, consider ischemia, LV overload or aspecific change. Due to symptoms and abnormal EKG pt was sent to the ER for further evaluation.
Pt called and stated he had a fever for 2 days that lasted 102 degrees. The injection site became very swollen, hard to the touch, and hot. He stated he had no reaction for the first shot of the series.
This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported). On an unknown date the patient experienced erythema and swelling after receiving PNEUMOVAX 23. The outcome of erythema and swelling after receiving PNEUMOVAX 23 was not reported. The relatedness between PNEUMOVAX 23 and the events of erythema and swelling after receiving PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 22-SEP-2015 the patient was vaccinated with an imiproperly stored dose of oral, ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Big red welps all over upper arm where vaccine was given. Has been there for 2 weeks now.
Patient experienced malaise, LAD and sore throat for 2 days post-vax.
8/02/04 parents reported through an interpreter the following information; one week after child received MMR and Varicella vaccines child developed a rash which was generalized over the body. No fever was noted but child was very uncomfortable. This writer requested parents to bring child back to health dept for assessment. He was noted to have generalized reddened circular hives with majority to trunk. Child referred to pediatrician for Tx.
Over an hour after the vaccination the patient left arm became swollen, patient developed a high fever. Patient was treated by a physician.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live  Non significant Follow up received: no new medically significant information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Unusual dizziness; I could not maintain my balance; generalized flushed feeling; fuzzy feeling from head to toe from the inside. It was very weird; sore arm and tenderness over the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling), FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird) and VACCINATION SITE PAIN (sore arm and tenderness over the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL and AMLODIPINE.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm and tenderness over the injection site). On 09-Jan-2021, the patient experienced DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling) and FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird). On 09-Jan-2021, VACCINATION SITE PAIN (sore arm and tenderness over the injection site) had resolved. At the time of the report, DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling) and FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided. Patient has doubts if this is related to her blood pressure. 11-Jan-21, patient feels quite well but not fully recovered.; 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.
Patient became sweating, warm feeling, dizziness, lightheadedness, blurry vision and this lasted up until today at the time of this report. She had to sit down and regain herself but pushed through the day of work. No treatment was provided during the event on 09/10/2014.
Pt. was seen by an urgent care and given Keflex. Pt. failed to improve on Keflex and was sent to the  Emergency Department. ED started IV cefazolin, then switched to IV vancomycin . Pt. was discharged on sulfamethoxazole-trimethoprim 800-160 BID
Pt recvd 1 dose of Engerix-B & devel abdominal pain 48 hrs later; resolved w/o tx, 12 hrs later;
This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557, expiration date: 07-APR-2019 and lot # M037770, expiration date: 01-JUN-2019, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010795: US-009507513-1704USA003974.
Uncontrollable shivering and shaking. 99 Fever raised to 101.6.  Took 2 naproxin and lots of bed covers.  Shivering stopped in about 1 hour, temp has continued for 2 more days.  Treating with ibuprofen.
THE PATIENT CAME TO THE PHARMACY TO BE VACCINATED FOR COVID-19, WITH JOHNSON & JOHNSON, ON FRIDAY, MAY 21, 2021 AT ROUGHLY 2PM.  I GAVE HER THE VACCINATION IN HER DELTOID MUSCLE ON HER LEFT ARM.  SHE ALMOST IMMEDIATELY COMPLAINED OF DISCOMFORT AND ASKED IF I HAD A COLD PACK.  I PROVIDED HER WITH ONE, WHICH SHE USED WHILE WAITING THE 15 MINUTE POST-VACCINATION OBSERVATION TIME.  SHE LEFT THE PHARMACY WITHOUT INCIDENT.  ONLY A COUPLE HOURS LATER, SHE CALLED THE PHARMACY TO REPORT ERYTHEMA AT AND AROUND THE INJECTION SITE.  I DID NOT KNOW AT THAT TIME WHETHER THE ERYTHEMA WAS DUE TO THE COLD PACK OR IF IT WAS A VACCINE-INDUCED RASH, SO I INSTRUCTED HER TO TAKE A DOSE OF ANTIHISTAMINE.  AS SHE HAD CETIRIZINE IN THE HOUSE, SHE TOOK THAT.  SHE WAS HOME WITH HER HUSBAND.  I RECOMMENDED HE KEEP AN EYE ON HER AND IF SHE DEVELOPED ANY ADDITIONAL SYMPTOMS OR WORSENING RASH, SHE SHOULD GO TO THE HOSPITAL FOR EVALUATION.  ADDITIONAL SYMPTOMS INCLUDED SWELLING, TROUBLE BREATHING, WHEEZING, CHEST OR THROAT TIGHTNESS, OR HIVES.  THOUGH SHE DID NOT EXPERIENCE ADDITIONAL SYMPTOMS, SHE DECIDED TO GO TO UCONN HEALTH CENTER ER IN FARMINGTON.  THEY DID BELIEVE THE RASH WAS VACCINE-INDUCED BUT DID NOT FEEL SHE REQUIRED ANY ADDITIONAL TREATMENT AND DISCHARGED HER (I.E., NO EPINEPHRINE).  THE PATIENT NOTED THAT HER BLOOD PRESSURE AT THE ER WAS HIGHER THAN "HER NORMAL" AT 152/95.  THE FOLLOWING TWO DAYS, THE RASH STAYED THE SAME AND WAS DESCRIBED BY THE PATIENT AS THE "WORST SUNBURN SHE'S EVER HAD".  SHE ALSO HAD NORMAL SIDE EFFECTS OF BODY ACHES AND CHILLS/SWEATS.  ON MONDAY, 5/24/21, SHE FOLLOWED UP WITH HER PCP.  HE AGREED WITH THE HOSPITAL THAT THE RASH WAS VACCINE-INDUCED AND TOLD HER THAT HE DIDN'T WANT HER GETTING ANY COVID-19 VACCINES IN THE FUTURE.  HE DID BLOODWORK TO RULE OUT PLATELET ISSUES, WHICH, PER PATIENT, WERE NORMAL; SHE NOTED THAT HER RBC'S AND HEMATOCRIT WERE SLIGHTLY ELEVATED.  HER PCP GAVE HER A MEDROL DOSEPAK FOR THE RASH. THE PATIENT IS RECOVERING.  I BELIEVE IT IS WORTH NOTING, HOWEVER, THAT THE PATIENT APPLIED THE COLD PACK DIRECTLY TO HER ARM FOR AN EXTENDED PERIOD OF TIME AND DID NOT PROVIDE THIS INFORMATION TO EITHER THE ER OR HER PCP.  SHE SENT ME A PHOTO OF HER ARM WHICH SHOWS GENERALIZED ERYTHEMA (THE SIZE OF THE COLD PACK) - THE ONLY PART THAT IS COMPLETELY NORMAL IS THE SKIN BELOW THE BAND-AID.  I BELIEVE THE PATIENT CREATED AN ICE BURN BY USING A COLD PACK TOO DIRECTLY, FOR TOO LONG, AND THAT THE UNDER BAND-AID AREA WAS NOT RED BECAUSE IT PROTECTED THE SKIN FROM COLD BURN.  I SUGGESTED TO THE PATIENT THAT SHE RUN THIS THEORY BY HER PCP, AS I BELIEVE IT IS IMPORTANT "MISSING INFORMATION", THAT COULD POTENTIALLY CHANGE THE DIAGNOSIS AND ALTER HIS RECOMMENDATION TO AVOID FUTURE COVID VACCINATION.  WHETHER OR NOT THE PATIENT CONTACTED HIM AGAIN IS UNKNOWN.
LISTLESS; NO APPETITE; ABDOMINAL CRAMPING; This spontaneous case (PVX2019-786) was received from nurse on 01-Apr-2019. It describes a 12-year-old female consumer who felt listless and experienced abdominal cramping and had no appetite, while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif so far. The doses were taken on 28-Mar-2019, 30-Mar-2019, and 01-Apr-2019 respectively. After the second dose, she experienced terrible abdominal cramping, felt listless, and had no appetite. On 01-Apr-2019, after taking the third dose the events got worse.  She was not taking any concomitant medication and did not take any treatment medications for the events. She did not have any other medical history. She did not eat any unhygienic food or water.  Action taken with Vivotif with respect to the events listless, abdominal cramping, and no appetite was unknown.  The consumer had not recovered from the events listless, abdominal cramping, and no appetite.  Company's Comment: In this case, it was reported that the consumer experienced abdominal cramping, felt listless, and had no appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced abdominal cramping, felt listless, and had no appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Began vomiting around 9:30pm on 9 Jan. Became lethargic. Vomited  5 times in a  one hour period.  Was taken to a local Hospital ER. Abdominal Ultrasound preformed which showed intussusception. Fluid enema performed under XRay which reversed the intussusception. Patient was monitored in hospital for next 48 hours.
This spontaneous report as received from a physician refers to a 5 year old patient. On 08-MAR-2013 the patient was vaccinated with a dose of M-M-R II (lot# not reported) and PROQUAD (merck) (lot# not reported), subcutaneously. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Onset of abdominal pain starting in LLQ radiating to left side of  chest at 4:05pm
Person experienced vertigo, vomiting, double vision, low body temp of 95*.   Took him to the ED Hospital.  It was determined that he had suffered a small Ischemic Stroke.  He was given Asprin and Lipitor (Atorvastatin) and an anti nausea medication. Several tests were done as outlined in Item 19 below.