chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male 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.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  On an unknown date, patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  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 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. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
Blindness Right Eye, Diagnosis of Multiple Sclerosis, IV Steroids, and oral steroids. Use of Rebif and now Capaxon.
PATIENT HAS HAD LOSS OF TASTE STARTING 7-10 DAYS AFTER VACCINATION AND IS STILL EXPERIENCING LOSS OF TASTE AS OF 6/7/21
Rigors, chills, pain at sight of immunization, erythema greater than expected at immunization site.
Large local reaction with redness and swelling 24-48 hours after DTAP and HibTiter given in left thigh.  No fever, no systemic symptoms (6x3 inch left anterior thigh).
Bell's Palsy L sided facial droop/weakness Predniesone ValcycloviR
resident received a dose of pfizer on 10/20/21 resident had previously been vaccinated with J&J 4/6/21. On 11/4/21 received a booster dose . no adverse reactions to extra dose was seen.
Date: 3/22/2021  Problem:  Notes:   Time: 12:40P Upon arrival to nurses station. Patient noted pale, clammy & sweaty. BP 60/33 HR 48, RR18. Call placed to EMS Patient awake, alert &oriented x 3. Vaccinator stated that patient loss consciousness approx. 1-2 minutes after receiving vaccine. Patient states that she had a granola/ breakfast bar for breakfast & had not eaten lunch. Patient feet elevated to elevate patient BP. EMS Arrival pending. Will continue to monitor.  Time: 12:50p EMS Arrived. Patient assessed by HFD. Patient declined to go to hospital. Snacks & water provided to patient. Patient rested an additional 15 minutes. Will continue to monitor.  Time: 1320 Patient went home with fiancé in stable condition.
patient was given her injection where she developed itchiness of her throat, neck, chest, and abdomen.  then she began to get lightheaded.   12:31 BP 192/ 86 HR 85 12:38 BP 179/84 HR 99 she then began  to develop a raised macular rash on her chest and neck 12:45 patient given 25 mg of po benadryl. 13:00 BP 150/77 hr 87 oxygen sats of 98% room air patient feeling better rash disappeared 13:07 BP 150/82 hr 78 oxygen sat 100 % room air  13:10 patient was released with her mother and she was escorted to the exit with staff
sore injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) 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 treatment and concomitant drugs are provided   This case was linked to MOD-2021-325771 (Patient Link).
Developed bad pain to both calves and difficulty walking.  Never developed true paralysis or had loss of sensation.  Improved over course of 2 weeks.
Arm was numb immediately. Within the hour extremely painful, red, hot. 24 hours later I had red bloches around the site.
first dose of Shingrix on January 6th 2020 /  due to the pandemic situation / the second dose was delayed / administered on December 15th 2020; This case was reported by a nurse via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th January 2020).   On 15th December 2020, the patient received the 2nd dose of Shingrix. On 15th February 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not reported. No expiration date or vaccine lot number was provided. The patient received 2nd dose of Shingrix, more than the recommended interval, due to pandemic situation. Nurse was at the same time the patient that received the doses. The reporter consented to follow up.
moderna shot given to a 16 year old female. Only approved for emergency use for 18 years and above.
painful, swollen, pruritic lt deltoid inject site x 24 hrs; erythema; no abscess;
High fever of 102.4 for almost 12 hours with tylenol.  Fever gone in 2 days.
Nurse who had worked the shift and had drank an " energy drink" prior to vaccine. she felt palpitations and and elevation of blood pressure. No itching hives or angioedema. No dyspnea. Pt observed and discharged home without any therapy
Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling tired around 5:00pm the day of the vaccine and I have continued to feel tired after 4 days. Muscle/Joint pain - Started getting sore arm first a couple hours after shot then progressively getting worse on my entire body for 3 days.  On day two is was almost unbearable with my lower back being the most painful.  I could not sleep because of the pain with no position that would relief it. Chills - Started getting chills on the evening of the vaccine.  They came and went for 3 days. On the second day it was uncontrollable shakes no matter how many blankets I used. Fever - Started the night of my vaccine increasing to 102.4 and reaching the highest on the second day at 103.5.  I took ibuprofen every 6 hours for two days straight with it staying steady at above 100. Nausea - Started the evening of the vaccine and got very severe.  It has continued for 4 days. Fast Heartbeat - It has stayed consistently above 110  and sometime getting up to 130 while laying in bed shivering.
Medication error.  1st dose was Moderna.  2nd dose should have been Moderna, but was given Pfizer.
After the first dose, shortness of breath and heart racing, muscle pain at the site of the injection  Once in 3-4 days and for 2 weeks After second dose, after an hour, she had mild symptoms similar o her first dose, elevated heart rate, shortness of breath, felt lightheaded, palpitations, back pain, chest pain with the shortness of breath.
Rapid onset of headache, muscle aches, joint pain, and fever the evening after getting the shot. Injection arm soreness, general weakness. Minor cough, and possible throat swelling. Swollen lymph nodes. Treated fever with cool washcloth to the head all night . Fever reached a maximum of 103 °F at midnight. Around 5:30am took ibuprofen. All symptoms subsided by late morning around 9:30am, except for slight headache.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and allergies were not reported. In approximately 2013 (reported as "26 months apart"), the patient was vaccinated with a dose of ZOSTAVAX strength reported as 19.4 munit, (dose, route, anatomical location, lot number and expiration date were not reported). On 24-SEP-2015, the patient was vaccinated with a second dose of ZOSTVAX strength reported as 19.4 munit, (lot number reported as 1021612 with expiration date: 10-SEP-2016), (dose, route and anatomical location were not reported). Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
ADMINISTERED MONOVALENT INSTEAD OF THE BIVALENT. NO ADVERESE SYMPTOMS REPORTED BY PATIENT
No adverse event; 3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator/Lot number 014H22A, beyond use date 18Jan2023. Date of administration: 20Jan2023 for the 3 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator/Lot number 014H22A, beyond use date 18Jan2023. Date of administration: 20Jan2023 for the 3 patients.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2023, 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 20-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator/Lot number 014H22A, beyond use date 18Jan2023. Date of administration: 20Jan2023 for the 3 patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator/Lot number 014H22A, beyond use date 18Jan2023. Date of administration: 20Jan2023 for the 3 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator/Lot number 014H22A, beyond use date 18Jan2023. Date of administration: 20Jan2023 for the 3 patients.).    No concomitant medications were reported. No treatment information was provided. This case belongs to 1 of 3 patients described by the reporter.
I had numbness in my right hand consistently about two hours after the shot (noticed when putting son down for bed). Figured it would go away by morning. The next morning, the numbing had left my right hand but moved mainly to my fingers and toes and was no longer constant but sporadic. Every few minutes a toe would become numb or a finger (sometimes a side of my leg or arm but usually a digit). It has lasted for a week now. Not painful but annoying. I am not getting the second dose given this side effect for a "safe" shot and the unknown consequence of getting what often results in worse side effects for the second shot. I feel the response from CVS and my doctor has been poor and leaves me with significant doubt on our medical system and vaccination program.
This spontaneous report as received from an other health professional refers to a patient of unknown gender and age. Medical history was not provided. On an unknown date the patient was vaccinated with improperly stored PROQUAD (Merck) (lot number J004322 with expiration date 17-OCT-2014). This is a corrected report. On 30-OCT-2013, information has been received from the registered nurse, who stated that the doses of PROQUAD (Merck) Lot # J004322, expiration date on 17-OCT-2014 were exposed to unknown temperature for 5 hours during interoffice transport. All vaccines were unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Unsteady gait with left arm weakness.  Fatigue and slurred speech which I initially thought was a stroke
Received 1st dose of Moderna vaccine on 09/02/2021. Two weeks later starting on 09/15/2021 around 3 pm began experiencing blepharospasms when eyes closed and eyes flutters when eyes shut. Have volitional control to stop blepharospasms, however, if not actively focusing on preventing spasms, spasms will presist. Symptoms evolve from being quick and rapid contractions of ocularis muscle to being strong, prolonged rhythmic spasms lastig 4-12 seconds approximently 5 days later. Sleep quality and insomnia began as symptoms of blepharospasms worsen. Other inconsistent symptoms appear as right-sided buccal muscle tightness, tongue spasms (occurred 1 time), and right scalene tightness. Lingering subtle tingling sensation of right-sided buccal and right scalene present from weeks 3-current.  Schedule appointment with primary care physician on 09/28/2021 and prescribed xanax to assist with sleep deprivation and referred to a neurologist. Neurologist ruled out MS, GBS, and early-onset PD on  10/18/2021. Stated presentation was unusual for typical blepharospasms as most of the time they occur while eyes are open. Offered Botox injection to the eyelids to stop spams but patient denied as symtpoms appeared to be decreasing in severity (neurologist agreed that symptoms no longer severe enough) The neurologist referred me to ophthalmologist. Visited the Ophthamologist on 10/29/2021, no treatment provided but vision intact. Ophtamologist suspected that this was likely result of vaccine and recommended reporting it.   Currently 6 weeks out from the initial onset of symptoms and spasms still present but usually with initial eye closing and strength of spasms has weakened. Still having lingering tingling sensation throughout right buccal region and occasionally into right scalene. Have decreased use of xanax and increasing ability to sleep without need for medication. Stopped taking birth control pill as recommended by PCP.
5wk p/vax pt rt deltoid area @ center of deltoid became red & inflamed;swelling then produced a larger blister @ the site w/eruption of blister w/moderate amounts of clear fluids draining from site;dx cellulitis;abscess visible 5wk post vax
Patient states she developed a 102+ degree fever, passed out in the morning and didn't wake up for hours, and had difficulty breathing.
Patient was administered a Pfizer Booster on 04/22/2022   Pt had requested the Moderna . All previous vaccinations were Moderna.  Patient and spouse were notified.  Observed for 15 min per routine with no adverse reaction/ side effect noted.
IMMEDIATELY AFTER THE INJECTIONS WERE GIVEN THE PATIENT FAINTED. THE NURSE SUPPORTED HER IN THE CHAIR AND AN INTERN CAME OUT TO HELP LOWER HER TO THE GROUND. THE PATIENT REGAINED CONSCIOUSNESS AND THE INTERN PLACED AN ICE PACK ON THE BACK OF HER NECK. THE PATIENT STATED THAT SHE HADN'T EATEN ALL DAY AND HAD PASSED OUT DURING CLASS THE WEEK PRIOR. THE INTERN GAVE HER A PACK OF GUMMIES TO EAT. WE OBSERVED HER FOR 20 ADDITIONAL MINUTES AND SHE SAID SHE WAS FEELING FINE. SHE LEFT WITH HER FRIEND WHO WAS DRIVING.
3/3 10:00 AM ET mild fever (99.5), fatigue, mild headache, tenderness in arm at injection site; 3/3 10:00 AM ET mild fever (99.5), fatigue, mild headache, tenderness in arm at injection site; 12 hours post-injection symptoms started3/2 10:30 PM ET mild fever, chills3/3 1:00 AM ET mild fever (100.7), chills, pain/tenderness in arm at injection site; 12 hours post-injection symptoms started3/2 10:30 PM ET mild fever, chills3/3 1:00 AM ET mild fever (100.7), chills, pain/tenderness in arm at injection site; 12 hours post-injection symptoms started3/2 10:30 PM ET mild fever, chills3/3 1:00 AM ET mild fever (100.7), chills, pain/tenderness in arm at injection site; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, on 02Mar2021 at 10:15 (at the age of 50-year-old), as dose 1, single in left arm for COVID-19 immunization at Workplace Clinic. The patient's medical history was reported as none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination were reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 at 22:30, 12 hours and 15 minutes after first dose of vaccine, the patient experienced fever (100.7), chills, pain/tenderness in arm at injection site; all for a duration of 1 day 11 hours and 15 minutes. On 03Mar2021 at 22:30 fatigue, fever (99.5); and mild headache for 11 hours and 15 minutes. Patient received treatment for adverse events with Acetaminophen (Tylenol), recommended dosage. On 04Mar2021 at 9:45 AM, the patient had no fever, slight fatigue, no headache, and no arm pain. The patient underwent lab test and procedure which included SARS-CoV-2 test: positive on an unspecified date prior to vaccination; body temperature: 100.7 on 02Mar2021; 99.5 on 03Mar2021; and no fever on 04Mar2021. The clinical outcome of the event fatigue was resolving. The patient had COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all other events was resolved on 04Mar2021 at 9:45 AM.  No follow-up attempts are needed. No further information is expected.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided. Date place in refrigerator: 27-Sep-2021. The vail did not undergo any temperature excursion and patient not experienced any adverse event.
7/9/13 she was unable to move arm and noticed increase pain with swelling and redness around site. Developed fever, headaches, buzzing to Lt ear, body aches on 7/9/13 in the afternoon. Taking Tylenol 2 tablets last dose was last night. Patient was seen in our office on7/11/13 with the above complaints. On physical examination left deltoid was (approximately 5 in x 4 in area) red, slightly edematous and warm to the touch. Patient instructed to continue Tylenol 325 mg tabs 2 tabs every 6 hours. May take Benadryl 25 mg every 6 hours as needed and use aloe vera ointment on the affected for comfort.
This spontaneous report as received from a consumer refers to her child - a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, after receiving the vaccine, the patient experienced convulsions and paralysis. The outcome of convulsions and paralysis was unknown. The relatedness between adverse events and M-M-R II was not reported. Upon internal review the events of convulsions and paralysis were considered to be medically significant. Additional information is not expected as the reporter refused to provide any further details regarding the experience.
Swollen and tender lymph nodes under left armpit that appeared after the 2nd day and has continued so far in to day 4; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications include LEXA PRO 10 mg and wellbutrin 300mg (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN) from an unknown date. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Feb2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine with four weeks prior to the COVID-19 vaccine. On 17Mar2021, the patient experienced swollen and tender lymph nodes under left armpit that appeared after the 2nd day and had continued so far in day 4. Patient did not receive any treatment for the swollen lymph nodes. The clinical outcome of swollen and tender lymph nodes was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
c/o lightheaded, dizzy nausea (L) BP 110/60 (R) BR 104/60
Had the first shot of the Moderna vaccine in the late morning (~10am). Around early afternoon, perhaps 3-4 hours after getting the shot, I began experiencing stomach issues. After defecating, I noticed there was blood on the toilet paper after wiping, and there was blood in the toilet bowl. There was not a lot, and it looked as though the blood was just on the outside of the stool. This happened at least 1 other time with the same result. This would have been toward the late afternoon, perhaps around 5. By the end of the day, around 10pm or so, there was no longer any blood. My stomach was still upset the following day, but it has abated mostly.
9/1/2020 - Pt receives Shingrix Dose #1 9/17/2020 - Burning/pain in Rt Scapular begins 9/22/2020 - Papulo-besicular groupl red hyperesthetic rash left scapula/Left lateral breast
(R) thigh became red, swollen, hard & tender. Advised to apply ice compress, antibiotic was not ordered. Patient to follow-up if symptoms persist. (Pt followed-up with MD).