chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15:30 Client got Pfizer #2  1535 Client  had full lost of consciousness ( Syncope) in route to Observation due Vasovagal Client observed by Safety Officers and symptoms resolved Client able to leave with mom
On 8/29, patient received FLUZONE HD and PNEUMOVAX IM injections into the left arm. Patient reports to pharmacy on 8/31 stating that he was experiencing itching and swelling at the injection site as well as a "warm" sensation. Patient followed up with urgent care, where he was treated empirically for a possible (SSTI) infection. Patient was prescribed KEFLEX 500mg three times daily for 7 days. Upon consultation, patient informed notifying pharmacist of event. Patient presented with minor erythematous rash along arm, however the swelling was delocalized and located near anterior portion of elbow. Patient did not complain of pain at this time, nor was site warm. Patient stated that he did not present to urgent care with elevated temperature or elevated blood pressure (documented at urgent care).
This spontaneous case, initially received from other health professional (nurse) on 22-Oct-2018, concerns a 30-year-old, adult female patient. The patient had no relevant medical history and had not received any concomitant medications. It was reported that, on an unspecified date, the vaccine underwent temperature excursion. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, anatomical location: deltoid, batch number: 252657 (reported as 2526577), expiry date: 30-Jun-2019 and route of administration: not reported] that underwent temperature excursion. The reporter assessed this case as non-serious.
Information has been received from a certified medical assistant concerning a 26 month female with drug hypersensitivity to CEFTIN and no illness at the time of vaccination who on 22-SEP-2007 was vaccinated subcutaneously in the left arm with VARIVAX (Merck) (lot # 658409/1178U). Concomitant therapy included MMR II (MSD) (lot # 657244/0527U) subcutaneously in the right arm and PREVNAR (lot # 85407K) intramuscularly in the right arm which were vaccinated on the same day. On 25-OCT-2008 the patient developed varicella. The patient visited the office. She had 10-15 chicken pox all over with a maximum temperature of 99F. The patient was treated with CALAMINE LOTION and TYLENOL. On unknown date the patient recovered. No further information is available.
Systemic: erythema multiforme-Medium, Additional Details: She was diagnosed with erythema multiforme by a dermatologist on tops on both her hands.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 7:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 7:09 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 30 Mar 2022 19:09) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
She received her pneumacocal 13 vaccine. She has not received the next shot yet/the vaccine shots are a year apart; This spontaneous report was received from a female patient of unknown age referring to herself. In August 2019 (one year apart), the patient received pneumococcal 13v conj vaccine. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.       The patient's next shot was the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (scheduled on 03-AUG-2020) (route was reported as injection; dose detail, strength, lot# and expiration date were not provided), but she had not received it yet. The patient stated that she got the vaccines a year apart from each other. When the year was up, she had not received the next shot yet (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.  This is one of the linked reports from the same reporter.
passed out, respiratory distress, trouble breathing, chills, temp, nausea, headache, tingly of fingers epi pen was used
ADULT DOES HEP A VACCINE GIVEN TO A 15 YEAR OLD PATIENT.
PATIENT COMPLAIN OF HEADACHE, NO RASH/ITCHING/DIFFICULT BREATHING. BP ELEVATED AVERAGE 188/88
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and hospitalized on 2/5/21 after a fall and heart attack and admitted to hospice on 2/09/21. He also had prostate cancer and was living in an rehab facility on 1/2021
"pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched; Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; soreness to touch or movement of the entire upper arm inclusive of the shoulder; The soreness aside from the injection site did not abate; This is a spontaneous report received from a contactable consumer (the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the upper left arm on 21Jan2021 14:10 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history included allergies to corn (zein). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen on 16Jan2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine around 14:10 (scheduled for 14:00 but there was a line). Upon standing (21Jan2021 14:15), there was a "pins-and-needles" sensation down to the elbow, and by the time seated for the 15 minute wait, the sensation was present in the whole arm. The sensation was identical to a limb that was "asleep", including the painful jolts whenever touched all the way to the tips of the fingers. This lasted until mid-morning 23Jan2021 (about 44 hours). Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm (21Jan2021 14:15). These have shrunk but some are still present at the time of reporting. There was additional soreness to touch or movement of the entire upper arm inclusive of the shoulder (21Jan2021 14:15). The soreness aside from the injection site (21Jan2021 14:15) did not abate until late evening on 24Jan2021. The only noted adverse effects were related to physical sensation in the left arm. The patient did not receive any treatment for the events. The clinical outcome of "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched was recovered on 23Jan2021. The clinical outcome of random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; and soreness aside from the injection site, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Felt immediate pain - like the needle hit the bone. Within half an hour she had severe pain and unable to move or lift her right arm.  She took Advil the first day and then switched to Aleve. She has also used the heating pad - which has helped a bit. The pain isn?t as severe now, but she still cannot move or lift her right arm as usual. I emailed her primary doctor, Monday evening, but have yet to receive a response.
In the afternoon, after shot, started to feel sick to his stomach, shivering and feeling nauseated. Had temp of 102 and took aspirin. Temp went to 103 and next a.m. went to ER and was given IV for dehydration.
No additional AE's and no PQC's were reported.; A nurse reported that an expired dose of MMR II was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, quantity 1, lot #T034388, expiration date: 08-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered ). No additional adverse event's and no product quality complaint's were reported.
itching, red, lasted 2 days then disappeared-very mild; area 2 1/2" diameter over inject site;
A little red spot and sore arm at the injection site for a day. I tested positive for COVID-19 with a home test on 08/02/2022. I had a low fever, runny nose, congestion and fatigue. I contacted my doctor the evening of 08/02/2022 and was given the prescription PAXLOVID. After 7 or 8 days I felt much better.
Increased heart rate; Increased heart rate and blood pressure; Feeling hot; Cold fingers; This is a spontaneous report from a contactable nurse (patient).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left arm on 22Dec2020 08:00 at SINGLE DOSE as COVID-19 immunization at the workplace clinic.  The patient had no medical history and no allergies to medications, food, or other products.  The patient previously had COVID-19 test on 24Aug2020 and showed negative. Concomitant medication included levothyroxine (LEVOTHYROXINE). On 22Dec2020 08:00, the patient experienced increased heart rate and blood pressure, feeling hot and cold.  Since the vaccination, the patient had been tested for COVID-19 in Dec2020 with unknown results. The patient did not receive any treatments for the events. The patient was recovering from the events.
anxiety; fever; chills; nausea; fatigue; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; blood pressure for one hour- reaching 193/112; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient ask was the vaccine kept at -90 degrees. When its injected was it still really cold. Why do you think Covid rates are going up if more and more people are getting vaccinated. Patient received first dose of the BNT162B2 vaccine on 30Mar2021. After receiving the vaccine, the paramedics monitored her blood pressure for one hour- reaching 193/112 on 30Mar2021. She states this could have been from anxiety though. The next morning on 31Mar2021, her arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site. For six days she had fever, chills, nausea, and fatigue. After two and a half weeks the injection site was still raised and brownish, it looks more like a birthmark than a rash on her arm. Patient asking these side effects normal. She recently had an uncle die of Covid. Does the vaccine work against new strains patient was asking. Patient ask second dose side effects worse than the first dose and what are the 6 months top line analysis results of the BNT162B2. She ask should I get the second shot and say if I don't get the second dose will I be protected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient positive for COVID-19 on 04/12/21 after completing vaccination. Asymptomatic and PCR test collected the same day came back negative.
I received my first dose of the Pfizer vaccine at about 4:05 or 4:10 PM today (Wed, Mar 3, 2021). Right away I had the following symptoms briefly: chills and blurred vision. Around 4:20 or so I left in my vehicle. Shortly after, I had a few chills. I needed to use the restroom and pulled into a gas station. After starting to go the bathroom, I quickly began to feel warm and my vision began to blur. The next thing I knew, I opened my eyes laying on the bathroom floor. I then left the restroom and headed to my vehicle where I noticed I had perspiration on my forehead and was really warm.  Over the next hour or so I experienced chills frequently. They have since subsided.
(Pt's eyes rolled back in her head and appeared to have a seizure (according to mom)). Tonic/clonic movement arms & legs x 3.5 mins, eyes rolled back about 40 mins after vaccine given.
Area of injection site became red, inflammed, hard/firm, warm to touch and slightly sore. The area of induration and erythema measured approx. 3" across. Seen in a walk-in clinic by ER physician. Treatment: Benadryl.
Shaky, unstable, muscles sore, no control of balance, sweating profusely, very tired and no energy. Unable to pull himself out of chair or bed. Little strength.
Same day post vax, the pt developed soreness at the injection site almost immediately. The site was massaged. That night, the soreness increased.
15  minutes after shot, My chest felt warm. The 2 medics took me in a wheelchair to have my vitals taken.  My blood pressure was 218. I was given fluids and monitored for 30 minutes. They took my BP again and it was 198.  I was sent home and told to monitor my vitals and report to my family care doctor.
SHARP HOT PAIN THROUGHOUT BODY; DIFFICULTY CONCENTRATING; INJECTION SITE PAIN/BURNING; FATIGUE; SHARP PAIN IN FOREHEAD; This spontaneous report received from a patient concerned a 36 year old male. 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced sharp hot pain throughout body. On 26-MAY-2021, the subject experienced difficulty concentrating. On 26-MAY-2021, the subject experienced injection site pain/burning. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced sharp pain in forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain/burning on 26-MAY-2021, and had not recovered from sharp hot pain throughout body, difficulty concentrating, fatigue, and sharp pain in forehead. This report was non-serious.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route of administration were not reported) (lot number M004895, expiration date 26-JUL-2017; lot number L051095, expiration date 17-JUN-2017). No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Immediately after shot ...probably within 10 minutes or so I had vasodilation of my sinuses & headache. It came together & was quick like feeling inside of my nose swell & slight headache. I WAS VACCINATED WITH MY DAUGHTER 18 YRS OLD WITH TYPE 1 DIABETES AND SON 20 WITH PRIOR HISTORY OF DENGUE IN PHILIPPINES. At night as it was getting dark,severe symptoms hit us at home all around the same time. Severe excruciating pain in the back of our head and it ran down into our necks & jaw. I have had migraines & it was worse pain in the back of the head. My son said it felt like dengue when he spent a week in the hospital,which comes with low platelets count. To me it felt like when I had infection in my left mound after double mastectomy and spent five days in hospital hooked to Ivs with 2 antibiotics & they thought I had staff & going septic. I had horrible headache with that. My daughter reacted the worse,she was crying with head pain & shivering non-stop & her body aches hit all over first. She slept with a hot pad on her head & had ringing in the ears & if she tried to get up she heard rushing water sound in ears & felt like going to pass out. My body aches hit as I was trying to get strength to drive to ER if needs be,but if felt like crippling arthritis in arms wrists jaw legs knees & ankles. I slept with hit pad on my head & would move it to joints. Really none of us slept. Son had body aches all night too. Bad headache in back of head for all of us. Took 2 arthritis tylenil. All had stomach aches. Yesterday I was spinning & severely dizzy. We are fatigued & barely moving.
woke up with fever,  leg cramps, severe headache, body aches , arm very warm to touch 4 days after still, arm soreness at injection site  felt like I covid all over again
Awoke 02/04/2021 with sudden hearing loss of left ear.  He had "static" type noise and pressure in left ear. Static noise resolved after a few hours but left with hearing loss.
Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision resolved, no improvement in generalized body aches.
approximately 48 hrs after vaccine, experienced profound joint pain and fatigue. Saw PCP fro E&M, w/o thus far reportedly negative. PCP started pt on Medrol dose pack ~ 1/22/21 & he remains OOW.  Still with mild fatigue, arthralgia better. Has few da,ys toFatigue Ordered Prescription medication
Information has been received from a Registered Nurse concerning a 20 year old female with an aspirin allergy who on 05-JUL-2007 was vaccinated with Gardasil (Lot#657736/0389U). There was no concomitant medication. On 05-JUL-2007 the patient experienced dizziness and low grade fever. Subsequently, the patient recovered from dizzy and low grade fever the next day. Medical attention was sought. Additional information has been requested.
Information has been received from a physician concerning a 35 year old patient who on 03-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The patient was then administered a dose of varicella virus vaccine live (Oka/Merck) (MSD) on the same day. No symptoms were reported. It was unspecified if medical attention was sought. This was noted to be a case of human error and not product confusion. There was no product quality complaint involved. Additional information has been requested.
In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever. Probably 6-8 times per day lasting  greater than 30 min. This "warmth" or "flush" feeling continues to this day. I am peri-menopausal, but have not had "hot flashes" prior to the administration of the COVID immunization.
This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 17-year-old female patient who received MENVEO. Co-suspect products included MENVEO (batch number M16172, expiry date unknown). Previously administered products included MENVEO (received in 2012). In November 2016, the patient received the 2nd dose of MENVEO. On 23rd August 2017, the patient received the 3rd dose of MENVEO. In November 2016, unknown after receiving MENVEO and not applicable after receiving MENVEO, the patient experienced extra dose administered. On 23rd August 2017, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered, extra dose administered and wrong vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. In November 2016, the patient received 2nd dose of MENVEO, which led to extra dose administered. On 23rd August 2017, the patient received 3rd dose of MENVEO instead of giving BEXSERO, which led to extra dose administered and wrong vaccine administered.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (no demographics provided). ON an unspecified dates an unspecified number of patients were administered (Oka/Merck) PROQUAD that was improperly stored at temperatures outside the product insert. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, as there was no consent for contact.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that RECOMBIVAX HB the lot # was 0021AE with expiration date: 30-AUG-2014 and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of RECOMBIVAX HB vaccine. The office was in the process of contacting the patient for revaccination. The correspondence process was reviewed and reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.