chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 51.37 years.  No concomitant medications were reported.  The vial was initially stored in the fridge on 09-Feb-2021, moved to clinic on 13-Feb-2021 and proposed beyond use date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 12-Feb-2021, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit that has been reached by the vial.  On 13-Feb-2021, at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Mother states on 4/16/07 she went in to check on pt and he was having a seizure, she tried to awaken him but unsuccessful. Took to clinic then on to hospital by ambulance where URI was dx.
Patient received a hi-dose Flu shot at a off site flu clinic. That afternoon, the patient got itchy and developed patches of redness on: legs, arms, breasts. On Monday 9/24/18 at 3am, patient was having difficulty breathing. She went to ER, got prednisone and BENADRYL and symptoms resolved. Her primary care physician has alerted her to no longer get the flu shot.
PATIENT STOPPED BY THE PHARMACY ON 08/13/19 WITH HOME CARE NURSE TO INFORM PHARMACIST THAT SHE SEEMED TO HAVE AN ALLERGIC REACTION TO THE FLU VACCINE. UPON EXAMINING HER ARM THERE WAS A SMALL RASH NEAR THE INJECTION SITE BUT SCRATCH MARKS AT OTHER AREAS OF THE BODY AS WELL. PATIENT REPORTED TO BE ITCHING ALL OVER BODY, TOOK BENADRYL WHICH SEEMED TO HAVE HELPED BUT STILL SOME ITCHING PERSISTS. PATIENT WILL FOLLOW UP WITH MD IF SYMPTOM STILL PERSISTS AFTER BENADRYL DOSE ON 08/15/19. REVIEWED STEPS ALL PROTOCOL STEPS WERE FOLLOWED AND COMPLETED BY RPH CORRECTLY FOR SAFETY FOR PATIENT AND PHARMACIST.
Itching, dryness, eye redness and swelling of cornea in the left eye.
Just over 28 hours after booster dose of Moderna (10/30), fever began. First gradual, then escalated to around 101 Fahrenheit. Also, swelling and intense pain under left arm (lymph node) - arm shot was administered in.  On 11/1, experiencing some light sensitivity.
high BP hives/ Vitals taken q10 min till EMS arrival/BENADRYL 50mg IM given 08:45 EMS notified/Pt refused to go to ER
Approximately 30 minutes after injection, employee had an anxiety attack. States he has not had anxiety attacks for awhile and has not been on any medication for them. States he had an anxiety attack after receiving a Predisone shot. BP, pulse, respirations, and oxygen saturations were all WNL. Employee was allowed to rest and was released after approximately 30 minutes.
The patient is 17 years old and was mistakenly given Moderna vaccine. The pt and parents were notified.
HPV vaccine given at 12:30 pm, 12:44 pm pt fainted in waiting room, hit back of head appeared pale and diaphoretic. Pulse 76. EMS was called and arrived by 1pm loss of consciousness was noted by med assistant prior to falling.
I asked the patient to take a sit for 15 minutes after administering COVID vaccine. Right around after 15 minutes, he came to the counsel window to let me know that he was not feeling good and he passed out. He became conscious right away as our staff members called his name to check if he was ok and called our store manager. We asked him if he was ok and gave him a bottle of water to drink. We asked him to call his family member to get a ride for the safety of the patient. I checked his status as he was waiting for a ride.  After 30 minutes, he left our pharmacy with his family member. I called him for the follow up and left message to call us if he has any concerns.
The patient returned to the pharmacy area a few minutes after receiving her vaccine saying that she felt like she was going to pass out. Her mother caught her as she lost consciousness in a chair, saying she did not hit her head. She regained consciousness as I entered the area to care for her and said she felt warm and like "she was dreaming." She lost consciousness a second time and was having involuntary muscular contractions in her body and clenching her hands. I was holding her so she didn't fall out of her chair and it felt like she was also shaking. She regained consciousness after a minute or so and said again she felt warm and like "she was dreaming". We gave her water, orange juice, and hard candy and monitored her until paramedics arrived. They examined her and said she declined to go to the hospital. She walked out of the store about 15-20 minutes after her initial episode.
Patient reported at 0820, 10 minutes after receiving her second dose of Moderna, that she was feeling hot. She stated it felt like a "hot flash". At this time patient was asked to lay down and was given a wash cloth and water. Patient denied shortness of breath, chest pain, or rapid heart rate. At this time this nurse asked patient to stay for 30 minutes to assure that her symptoms didn't worsen. At 0835 nurse gave patient crackers, more water, and a new wash cloth but denied any new symptoms. At 0908 patient left, prior to leaving she denied any "hot flash" symptoms or tingling. Patient stated she was starting to get a head ache but she would take a tylenol when she got home.
Patient delivered a baby girl at 35+6 wks via c-section for placenta previa. She delivered at Hospital. The female child  was taken to the (hospital) NICU due to prematurity and myelomenigocele (subsequently repaired).   Pattient was vaccinated on 12/12/20 for varicella (2 days postpartum). Patient visited NICU and breastfed/ held her infant daily.  Female Child (FC) required prolonged NICU stay due to hydrocephalus requiring VP shunt placement on 12/16/20 and infection of VP shunt with staph epidermidis on 1/1/21 which was successfully treated with vancomycin.   As she was being prepared for discharge on 1/12/21, FC was noted to have multiple vesicular lesions throughout legs, trunk and arms,  concerning for varicella. On 1/13/21 PCR testing done both  on serum sample and swabs of lesions which resulted positive for varicella.  FC and other infants in surrounding area of NICU were placed on airborne precautions. FC was started on acyclovir. Other infants were given prophylaxis varicella Immunoglobulin as they were considered potentially exposed. After consultation with MERCK, swabs of the lesions were sent to a separate lab to determine if the varicella strain was wild type or Oka (vaccine) strain. The results came back positive for Oka (vaccine) strain. FC only exhibited cutaneous symptoms and recovered completely. Her hospitalization was prolonged due to varicella and she was discharged on 1/20/21
4/22/99, the pt rcvd the vaccine, on 4/29/99 the pt experienced anosmia and ageusia. The MD reports that these events resulted in permanent disability.
Skin rash with bumps and large blisters on arms, neck, back, under chin, and fingers.  Rash very red and swollen, more sever on arm where shot was given.  Itchy. The arm are where I had the shot is very sore. The Urgent Care doctor gave me Curad Bacitracin Zinc Ointment, and told me to take Benedryl 1-4 times daily as needed, Zyrtec once daily.
Did not get the second dose of Shingrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak before 1st dose of Shingrix). Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Did not get the second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter wanted to know how to proceed if the patient got the first dose of Shingrix vaccine and had an outbreak (he believed outbreak started before the first dose).  The reporter wanted to know how to proceed if the patient got the first dose of Shingrix vaccine in the past and did not get the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
heart problems; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart problems). At the time of the report, CARDIAC DISORDER (heart problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient stated that she saw people who had experienced heart problems after taking Moderna vaccine, Blood clots after taking Pfizer vaccine and Johnson & Johnson vaccine, happened with women's of age 20-20, she linked it with taking birth control medications.  No concomitant medications were reported No treatment medications were reported.
4/24/21 right leg ultrasound no DVT, 5/20/21 right leg CT no DVT. 1st Pfizer vaccine 5/16/21, 5/27/21 ultrasound right leg with multiple DVT's now
Last PNEUMOVAX 4/25/2012 (less than a year prior) - no adverse effect noted.
After receiving HPV #1 - pt felt faint, put head between legs - fainted, lasted 2-3 sec then ok
Vomiting / unable to keep any fluids down, due to the vomiting; Experience nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were not recovered/not resolved.   It was unknown if the reporter considered the vomiting and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received first dose of Shingrix. After getting the shot, he experienced nausea and vomiting and was unable to keep any fluids down, due to the vomiting.  The symptoms had not yet resolved, patient advised to speak with health care professional. No further information was available. The reporter did not consent to follow-up.
vomiting twice today; bad headache; nauseous; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. D13H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous). At the time of the report, VOMITING (vomiting twice today), HEADACHE (bad headache) and NAUSEA (nauseous) outcome was unknown.            No concomitant drug was reported. Patient did not feel well enough to report her medications. The patient received first Moderna Covid 19 vaccine primary series on 9-Feb-2021 Lot number (024M20A) expiration date was not known, Right arm of administration. The patient received second Moderna Covid 19 vaccine primary series on 12-Mar-2021 Lot number (031A21A) expiration date was not known Right arm of administration.  The patient received first Moderna Covid 19 vaccine booster dose on 10-Nov-2021 Lot number (067F21A), expiration date was not known right arm of administration. The patient received second Moderna Covid 19 vaccine booster dose on 9-Mar-2022, Lot number was not available no expiration date was not known, right arm of administration. Patient reported no adverse reactions to dose 1, dose 2, first booster and second booster dose. No treatment drug was reported.
This spontaneous prospective pregnancy report as received from a physician refers to a 20 years old female patient. The patient became pregnant with LMP (Last menstrual period) of 29-APR-2013 and EDD (estimated date of delivery) of 03-FEB-2014. On 24-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (lot number, expiry date, route and dose were not reported) while she was pregnant and hence the patient had vaccine exposure during first trimester of pregnancy. No adverse event reported. The patient sought medical attention (details unspecified). The pregnancy outcome was unknown (outcome pending). Additional information has been requested.
he developed chest pain after 2nd Moderna COVID-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.). At the time of the report, CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
10 Post vaccination of Influenza vaccine patient diagnosed with Guillain-Bare Syndrome. 1/13/2009 MR received for DOS 11/7-12/5/2008 with D/C DX:  Guillain-Barre Syndrome. Pt presented 11/6/2008 with progressive extremity weakness, malaise, migrating neuropathies and difficult ambulation. Paresthesias noted in upper and lower extremities, reflexes decreased bilaterally, sensation intact. Tx with IVIG. Pt developed hyponatremia c/w SIADH.  Developed some SOB and atelectasis was noted-tx with incentive spirometry. Transferred to rehab 11/12/08 and by d/c was able to ambulate 1000 feet and assume most ADLs.
I received the 2nd shot of the Moderna  CoVid 19 vaccine on Sunday, August 1, 2021.  The next morning Monday, August 2, 2021 I woke up as usual about 6:30 a.m. and could not barely get out of bed by myself.   By 8:00 a.m. I needed assistance from my wife to get up from bed and to walk.  Other symptoms during the day were:  Headache, fatigue, muscle and joint pain, chills, and fever.  By the afternoon this symptoms continued and my fever remained over 100 degrees and when to 102.3 degrees.  Symptoms including walking and standing issues continued until I when to bed around 11:00 p.m.  On Tuesday morning, August 2, 2021 was able to walk by other symptoms remained.  The rest of the week including today August 8, 2021 side effects have continued.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003594: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003814.
I had swelling in my legs, feet ankles and also my fingers. They gave me a water pill, like a diuretic and it went away and it took like 2 weeks. I did get COVID-19 and it happened, what I think was I had a medication change in Cartia XT and my heart rate was higher that is why I was at the doctor, I am not sure if the vaccine or the change in the medication was the cause of the swelling. My doctor blames it on the vaccine. My doctor gave me extra medication because my HR was high, it seems like people who have COVID-19 has a increase in heart rate. COVID-19 Outbreak December 2021, I had a scratchy throat and congestion I thought it was allergies. I had a little bit of wheezing almost like a scratchy chest a little wheezing. My symptoms lasted about a week, 7 days.
Vaccine #166 Please see sympton diary.   Approx days 6,7,8, *9 ..began with generalized lymphadenopathy..more at neck (esp L side), and axillary, but also groin.  Generalized fatigue, sore throat, occassioanal internal mouthsores..precede dermal, scalp breakouts.  Appears somewhat cyclic.  Vaccine given 18 December 2002...continues to present with ocassional breakouts and lymph swelling.
Specs or floaters in eyes; Hazed over eye like cateract is returning; flash of light in left eye when looks to right/ flash of light in right eye when looks to left; Vision impaired; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cataract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left) and VISUAL IMPAIRMENT (Vision impaired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract (right) (First cataract surgery on right eye) on 10-Dec-2020 and Cataract (left) (Second cataract surgery on left eye) on 05-Jan-2021.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left   ) and VISUAL IMPAIRMENT (Vision impaired). At the time of the report, VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left   ) and VISUAL IMPAIRMENT (Vision impaired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# N002202, expiration date 04-NOV-2019 and lot# N006321, expiration date 08-NOV-2019 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursions was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008140: US-009507513-1708USA008141.
Myalgia and soreness, redness, warmth, swelling left upper arm. Diphenhydramine 25 mg Qweek, prednisone 30 mg once, cephalexin 500 mg BID.