chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with expired Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with expired Moderna dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with expired Moderna dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with expired Moderna dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The pharmacist was called to verify an expiration date for Lot 026L21B, the pharmacist says that he thought that the vaccine expired in June 2022, however the vaccine expired on 01-Apr-2022, and 80 patients received the expired vaccine.   Vial was initially stored in refrigerator on 04-Apr-2022. Vial undergo no temperature excursions.  No treatment drug was reported.
bleeding in left eye; had little pain in arm; had some chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (bleeding in left eye) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (had little pain in arm) and CHILLS (had some chills). On 12-Apr-2021, the patient experienced EYE HAEMORRHAGE (bleeding in left eye) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (bleeding in left eye), PAIN IN EXTREMITY (had little pain in arm) and CHILLS (had some chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  Reportedly, the patient does not know if the event of bleeding in left eye was from vaccine or not.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
10/29/07 350 pm Shot given; 530 pm Headache severe, very sore, ill, weak feeling; 750 pm excessive coughing, wheezing, hoarse, sore throat; Hoarse and Sore Mouth, tongue lasted for 2days
Twinrix vaccine (recommended for ages 18 and up) was administered to a patient age 15 years and 11 months.  No adverse effect occurred. Contacted manufacturer of vaccine GSK.  Was provided study data from a 180 patient sample of 15-18 year olds. Study reported 100% seroconvergence at 7 months to the Hepatitis A component of the vaccine and 98% and 100% seroconvergence to hepatitis B vaccine component among 2 sample groups in the study 7 months after receiving Twinrix.  Also contacted CDC and was told that Twinrix can count as a dose for the 15-18 year old population however with subsequent vaccinations, the child should receive the pediatric Hep A vaccine in 6 months and the pediatric Hepatitis B vaccine in 1 and 6 months.
Substernal Chest Pain 8 days s/p Vaccine with assoc dyspnea, n/v, diaphoresis and radiation of pain to left axilla and jawà ER  lumbar puncture done = negative à  treated and released à10 days s/p áchest pain à ERàHospitalized
Lip tingling after 10 minutes from shot. 30 minutes later had difficulty breathing, was induced by Anxiety and Asthma. Went to the ER just to be sure.
From phone contact w/PT's daughter it was reported that an 89 y.o. female who received a TD adult vaccination on 6/9/01 for a wound at an emergency room. From the next day onward, the PT has experienced systemic internal feeling of itchiness. Benadryl does not alleviate this feeling of acute itchiness. She had been to 2 diff't dermatologists and they cannot find any reason for this nor help.
Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; brain bleed; split lip; A spontaneous report was received from a consumer concerning a 79-years-old, female patient who received Moderna's COVID-19 Vaccine, and who blacked out, fell down the stairs, brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip.   The patient's medical history included diabetes, two unspecified high blood pressure medications and naproxen sodium. Products known to have been used by the patient, within two weeks prior to the event, included Sitagliptin and blood pressure medication.  On 21 Jan 2021, approximately one and half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 21 Jan 2021, the patient "blacked out" while walking downstairs after one in and half hours of receiving vaccination. Patient was hospitalized from 21 Jan 2021 until 22 Jan 2021. Patient has a brain bleed and a concussion, damaged 6th cranial nerve to right eye, and split her lip which need stitches. Treatment for the event included Tylenol as needed.   Action taken with mRNA-1273 in response to the events was withdrawn.   The events blacked out and fell down the stairs was resolved on 21 Jan 2021. The outcome of the events brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip was unknown.; Reporter's Comments: This case concerns a 79 year old female patient with medical history of diabetes, two unspecified high blood pressure medications and naproxen sodium, who experienced serious unexpected events of fall, cerebral hemorrhage, loss of consciousness, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The event occurred approximately one and half hours after first dose of the study medication administration. Treatment included Tylenol as needed.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the subject's underlying medical condition could remain a confounder.
Pt received the seasonal flu on 10-20-09. On 10-22-09 2:38 pm- mother was called child had temp of 102. Pt had an occasional moist non-productive cough this am. No other c/o. Not yet recovered.
Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2.  My normal is 97.6
Someone had an adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Someone had an adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Someone had an adverse event) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (Someone had an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the clinical trial researcher wanted to know if someone had an adverse event and had financial problem would Moderna reimburse them. It was tried to gather the information about the adverse event, and they refused to give the information, until they got a guarantee that Moderna would reimburse them for the ambulance ride, and hospitalization of the pediatric under 16 years of agefamily member. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, event of Adverse Event NOS which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, event of Adverse Event NOS which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
After receiving her first dose of Pfizer Peds shot, the patient vomited approximately 2 minutes after vaccination. She was offered water and observed for an additional 10 minutes following the episode. No other issues were reported.
DTaP and Hib given same arm right- swollen and red down to elbow (12 x 14 cm)
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine has undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 16-Sep-2022 at 1:57 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Sep-2022 at 1:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine has undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine has undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine has undergone several temperature excursions and may have been administered to patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medications were reported. The patient received previous three doses of vaccine intramuscular in deltoid. For Dose 4 anatomical location was reported as deltoid with concentration 0.5 It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No treatment products reported.
The pt experienced facial swelling hours post vax, the worsening of eczema 24 hours post vax, the swelling of hands, feet 24 hours post vax. Diagnosed with an egg allergy.
Patient felt aching/fever and was sent via 911 call to local hospital. MD there felt it was a result of flu vaccine given earlier in the am.
-Seen 10/22/2004. Visit for sinus congestion. From the flu vaccine. Right upper arm 3 mm eschar. Seen 10/28/04 visit for fever and sinus congestion. 3mm eschar right upper arm unchanged.
Patient began to have diffuse urticaria 7-10 days after Moderna Vaccination. Went to ER x2. then referred to allergy.
Left arm - (entire) postop vaccines is (+) for pain traveling up to neck, fingers swollen.
about 5mins after (covid) vaccination, felt ill and asked for help. 5-10mins of nausea and stopped tingling in left arm and then went numb, hot, sweaty. pt reports she nauseous and sweaty 5-10mins post vax. brought to medical tent and assessed. arm was completely numb for about 15mins and PMS intact after assessment. she states it was still tingly after 20 mins, but not numb, BGL 104, all symptoms subsided except tingling left arm and release. pt felt comfortable walking and leaving alone. stated she felt better. PMH:pre-eclamsia, allergies: morphine, med-related hypothermia, MS or MD 10:30 170/114 p92 r20 10:40 120/75 p74 r16 98%
Received PENTACEL, Rotavirus 1/10/18. Fever 104 degrees F 1/11/18. Febrile seizure 1/11/18. Hospital diagnosed roseola?
Approximately 6 hours after injection, I began feeling very tired.  I was up walking around office working on some computer updates and  then cam back to my office.  About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
Siblings in clinic to receive their COVID booster on 1/13/2023. The Clinic RN had ordered the appropriate dose (5-11 bivalent) however obtained the incorrect dose (12+) bivalent from the vaccine refrigerator. Clinic RN then prepared the COVID vaccines for both siblings, who were both to receive the 5-11 bivalent, with the incorrect dose (12+). Clinic RN had everything prepared and because of the business of the clinic during that time, this RN asked if the Clinic RN needed help with any tasks, and she handed this RN the COVID vaccines (drawn up and ready to be administered). This RN took the vaccine syringes into the patient room, reviewed consent with guardian, and administered the vaccines. It was not noticed until after the vaccines were being discarded, and the med room where they were prepared, that the vial that remained in the baggie it came in, had a hot pink label. It caught the attention of this RN, that the hot pink sticker indicates the 12+ bivalent. When this RN confirmed the lot and expiration date that was on the sticker that had been placed on the actual syringe holding the vaccine matched the hot pink label on the outside of the baggie holding the vial, it occurred to this RN the error had been made. Because there are now multiple versions of the COVID vaccine, and they are not pre-filled as the rest of our vaccines are, the syringes do not have specific medication labels to indicate product information unless the RN or tech who prepares the syringes place on the syringe. With the addition of multiple versions of COVID vaccine that require RN to prep further complicates and adds opportunity for error.
Ever since I received I have skin rashes. Mainly contained to my left upper arm. Small itchy raised bumps. My dr did give me a cream but doesn't really work.  He just attributed to unknown rash-eczema.  But seems odd to me that I had no issues until the vaccine.  It hasn't really gone away in over a year. Sometimes gets a little better but never fully clears up.
Approximately 10 hours after vaccine, started feeling exhausted. 15 hours after vaccine, woke up with fever/immense sweats. 16/17 hours after vaccine, still feeling horrible, ran temp of 101.5degrees. (Called in work & stayed in bed entire day.) 24 hours after vaccine, could  barely move from exhaustion. 27 hours after vaccine in completely drenched sweat after walking 25 steps to bathroom. 39 hours after vaccine, felt I had finally turned corner, was improving and temp back to normal. 48 hours after vaccine, feel fairly normal and myself again.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, administered expired product (doses administered past the published expiry date) resolved.  The reporter did not provide any causality assessments, concomitant medication or treatment information. Vaccine taken from freezer on Oct 26, 2021 at 8:00 am.
Severe low back pain stretching length entire low back.  Most severe day after but has continued to present.
Shingles. Started is tingling sensation in torso. Then became red and painful, then erupted into fluid filled boils with extreme pain. Video visit with doctor gave me the diagnosis. I though it could be poison ivy. They wanted to prescribe an antiviral medication but we were in rural at the time and I couldn't get to a Pharmacy or any other pharmacy in time. Once I returned home I got gabapentin which offered little help. Increased dosing did a little more. Scarring is still present to this day.
Onset time is approximate as I don't think patient complained as the fever began to creep up.  At 11PM he woke up to use the bathroom and complained of a severe headache and then immediately began to vomit.  His temperature, taken by temporal thermometer, read as high as 104.2F.  Fever brought down to low grade with Tylenol, dosed at 12AM and 5AM.  Patient felt better by morning, but wasn't fever free until at least 11AM on 10/16/2010.
This spontaneous report has been received from a medical assistant, concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not provided. The reporter stated that the unspecified number of patients were vaccinated with an improperly stored doses between 15-AUG-2017 and 12-SEP-2017 of VARIVAX lot # N014366 and expiration date 09-MAY-2018 (dose, frequency and route of administration were not provided) for prophylaxis, which were reconstituted with an improperly stored sterile diluent (manufacturer unknown) exposed at a temperature of 59.4 Fahrenheit for 12 hours. The vaccines were stored at a temperature of 32.2 Fahrenheit, time frame 11.5 hours and previous temperature excursion of 46 Fahrenheit for 108 hours. Digital data logger was involved. No adverse effects reported.
Approximately 5 hrs after receiving shots, patient reports having pain in her entire left arm. The next morning she had swelling described as 1/2 inch raised area 5 in. up her arm and 7.5 in. around her arm just above the elbow. She then iced her arm. She also reports pain and swelling of lymph nodes in armpit groin areas. She did not to to the doctor. She took BENDADRYL and continued to apply ice and the swelling was no longer present after 3 days from the shot date.
December 3, 2022 I had the 24 stomach bug with diarrhea and nausea December 10-17, 2022 I had scratchy, sore throat, slight nasal congestion.
Feeling warm/heat, unable to sleep, nervousness. Felt cold/shaky. Kept waking up from sleep. (Right after getting immunizations). 2-3 days later reports difficulty having bowel movements/constipation lasting weeks (still experiencing). Reports increased abdominal pain. Went to MD, taking 2 meds for past 2 days (unable to recall).
This spontaneous report as received from a nurse refers to multiple sclerosis patients. On unknown dates the patient were vaccinated with (Oka/Merck) VARIVAX which had been stored improperly. No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Site redness and pruritis, 8 days after administration. Treatement Benadryl re-exam in 2 days, re-exam if worse/problems.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      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.
My left cheek started tingling and then it moved across my whole face and was numb for 3 hours; My left cheek started tingling and then it moved across my whole face and was numb for 3 hours; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 11Mar2021 16:45 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Medical history included Known allergies: PCN (drug hypersensitivity) from an unknown date and unknown if ongoing. Patient did not test for COVID prior vaccination nor tested post vaccination. She did not receive other vaccine in four weeks. She had other unspecified medications in two weeks. On 11Mar2021 17:00 the patient experienced my left cheek started tingling and then it moved across my whole face and was numb for 3 hours. No treatment received for events. The outcome of the events was reported as recovered on 11Mar2021 20:00. No follow-up attempts are possible. No further information is expected.
p/vax pt exp shaking chills; trembling & pt hands turned white; resolved spontaneously (w/o treatment) before arrival @ ER where EKG, chest x-ray & vital signs found to be nl
5 mins post HPV vaccine, child stood up and felt dizzy. Had one minute LOC with brief generalized seizure activity. Stopped spontaneously. Patient awake & alert. Skin pale, extremities cool. C/O dizziness. Transported to hospital via EMS.
This spontaneous report as received from a healthcare student refers to a 60 year old female patient with no known allergies. On 11-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K000326, expiration date 27-FEB-2015, dose not reported, subcutaneously). On 11-OCT-2014 the patient experienced upper respiratory infection after receiving ZOSTAVAX. The patient sought medical attention via seeing physician. The patient was prescribed prednisone (tapering doses) and Z-PAK (also reported Z-PACK) on 28-OCT-2014 to treat the event. The outcome of the event was unknown. Additional information has been requested.