chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021 at 10:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 10:36 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 73.63 during 27-Mar-2021 administration and 74.21 during 27-Oct-2021 administration.  No concomitant medication was reported by reporter.  Vials were in cooler storage and were not in frozen storage during high-pace COVID-19 vaccination at around 2021.  It was reported that each time vials were 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. Temperature recordings were taken using a traceable temperature monitor at every hour.   Vials were moved to fridge on 23-Mar-2021 (Lot: 019B21A), 29-Sep-2021 or 05-Oct-2021 (Lot: 035C21A) and moved to clinic on 27-Mar-2021 (Lot: 019B21A), 27-Oct-2021 (Lot: 035C21A). Vials were punctured right before administration. Vials best before use date were 22-Apr-2021 (Lot: 019B21A) and 29-Oct-2021 or 04-Nov-2021(Lot: 035C21A). Vials were undergone temperature excursion at 09:00 AM and 10:00 AM with 35 degree Fahrenheit both times (Lot: 019B21A) and 09:00 AM and 10:00AM with 29 and 32 degree Fahrenheit (Lot: 035C21A) respectively. After administration, the vials were returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician's assistant concerning a 17 year old female who "within the last month and a half", on approximately 22-DEC-2008, was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not provided). It was reported that after receiving GARDASIL, the patient fainted and broke her nose on the floor. Unspecified medical attention was sought. It was reported that the vaccine was discontinued "within the last month and a half". The outcome of the patient was not reported. The reporter considered the patient's events to be disabling. Additional information has been requested.
Patient received DTaP vaccine 12/18/07 IM left thigh (L2606AA).  Exp. 3/15/09.  Within 1-2 weeks, patient had painful lesion at injection site.  Lesion became fluctuant and was I & D'd 1/22/08 - culture grew Enteropacter agglomerams.  03/11/2008 MR received from PCP for 12/18/07-1/31/2008. Pt seen for WCC on 12/18/07 with cough and congestion x 5 days noted. Vax given. Seen again 1/22/08 with c/o cough, congestion and injection site redness and tenderness at DTaP site. (+) Abscess L thigh-fluctuant.  Improving by 1/31/08 after tx with Zithromax and Bactroban
Wrong vaccine given to patient.  Patient received Moderna 6mo-5yr for first dose on 6/21/22 and was given Pfizer 6mo-4yr when they came for their second dose on 7/20/2022.    No adverse reactions observed after vaccination and parents deny any adverse reactions at home
BLOOD CLOTS IN BOTH ARMS  AND BRUISERS BACKS ON BOTH LEGS SOME WHEEZING
Vaccine received, patient felt dizzy and faint after vaccine received. Laid patient down on exam table. Patient stated started to feel better when laying down.  She stated she was scared to get vaccine and had anxiety. After 5 minutes  BP 130/79. Sitting up BP 108/48. She began to feel dizzy again and laid back down for another 5 minutes. Standing up BP 93/77 and  patient stated felt better and could walk to car. Walked patient to car.
This spontaneous report was received from a consumer referring to a friend's son, a 18 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 10-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, Lot # M035486 expired on 05-JUN-2019 for prophylaxis (strength and route of administration were not reported). On an unknown day in April 2017, reported as "toward the end of April", the patient started to have incidents resembling fainting. His mother took him to a couple of doctors and they did not get an initial diagnosis. On an unknown day in June 2017, reported as "early June", the patient was driving his car and apparently lost consciousness at the wheel in a parking lot and drove the car up an embankment. The patient had not recollection of the incident. Subsequently, the patient saw a neurologist and an electroencephalogram (EEG) was performed on an unknown date in 2017, showing seizure activity. He was unable to operate a vehicle until seizure free for 6 months. At the reporting time, the patient was taking unspecified anti-seizure medication. At the time of reporting, the outcome of seizure, memory impairment, syncope and loss of consciousness was unknown. The causality assessment between the vaccination with GARDASIL 9 and the aforementioned events was not provided, however it was mentioned that the full situation was reported to the pediatrician but they dismissed a connection to GARDASIL 9. Upon internal review, loss of consciousness and seizure were considered to be medically significant events.
Pt awakened screaming fr nap, approx 4hrs post immun; Large emesis very listless; Several emesis MD ordered tylenol supp & pedialyte; 22MAR child recovered;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 08-MAY-2014, an unspecified patient was vaccinated with expired dose of ZOSTAVAX lot # J001010, expiry date 24-APR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved. Outcome of events was unknown. No further information available. Additional information has been requested.
Patient received shots -> sent to the laboratory for urinalysis & hemoglobin & hematocrit. Feels dizzy while in the bathroom. When she sat down to have her finger prick for Hemoglobin, she slid to the (L) side and passed out her (R) arm from shoulder down were jerking, face pale as per witness; lasted for less than one minute, no incontinence; child said she seem to feel that she was shaking but not sure was brought to the exam room & laid on her back she was coherent, not to seem to be post-ictal. VS were stable, did not eat breakfast - was given granola & Pedialyte popsicle = feeling better after few minutes -> discharged home. FF up call 12/16/10 -> doing well no other passing out episodes.
Was administered the Pfizer COVID-19 vaccine in our drive-thru clinic on 3/4/21 at approximately 2:15pm. Was in the driver's seat of his SUV with his father in the passenger seat. Nothing in the PQCF gave us any reason to be concerned over this particular administration. After administration, was asked to pull forward and park in a spot on the right in order to sit for his required 15 minutes post-administration. became unresponsive as he was attempting to park and continue to turn the wheel causing him to drive in a U shape into a rock covered median. The SUV was able to clear the median and the car stopped at the APEX. When I saw the car heading towards the median, I started to head toward the site safely. I approached the car slowly asking him to stop. When I did not receive a response, I knew something was wrong. Once I felt the car was safe to approach, I ran to assist the patient. The patient was barely able to communicate but did say he was dizzy.  15 seconds later he was unable to communicate, I called a second pharmacist  to run over with an epi pen just in case (this was NOT administered). I immediately called 911 at 2:21 pm. reached into the vehicle and got the vehicle into park, while I assessed his airway, breathing, and pulse from a seated position. The patient began to seize. I continued to hold the patient from outside of the vehicle to maintain the patient's airway and keep him from hurting himself on the steering wheel. The patient regained consciousness approximately 3 minutes later with no memory of what happened. EMS arrived on scene about 2 minutes after he regained the ability to communicate. While EMS assessed the patient, and I reached out to  and division one store management per SOP. EMS determined that the patient had a seizure and was able to go home if they wanted. The father moved into the driver seat. We monitored the patient for 30 minutes and allowed them to leave. We followed up with the patient via phone 2 hours later with no concerns noted. No property damage or bodily harm occurred during this incident. If we are given approval to vaccinate this patient with a second dose, we will arrange for this patient to be taken care of in the pharmacy.
This spontaneous report was received from a physician via company representative refers to a 9 year old male patient. Patient's concurrent condition included right temporal lobe discharge with MRI results as normal. On 24-APR-2015, the patient was vaccinated with GARDASIL 9 one shot (dose, route and lot # were unspecified). Concomitant medication included FOCALIN. On 27-APR-2015, 4 days after onset of therapy the patient experienced twitching and drooling, and which was diagnosed as a seizure. It was reported that the patient received GARDASIL 9 as the third dose of the scheduled 3 doses. The patient received first two doses of GARDASIL. The patient also received VAQTA at the same time as the GARDASIL 9. On 07-JUN-2015, the patient experienced second seizure. On an unknown date, the patient sought medical attention and was hospitalized. On an unknown date, the patient received treatment. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Upon internal review, seizure was determined to be medically significant. Additional information is not expected as the physician does not want to be contacted.
Inconsolable crying, extremely lethargic, fever. Pt received his vaccinations Fr. 1/10/03. In the afternoon. He slept all day Sat. We could not hardly wake him up to feed him. He slept all day Sunday also. Sun evening he was running a low grade fever about 101. During church he started crying and we prayed for him because we thought he just felt bad because of his shot. Fever is a well know side affect. When we left church his fever had subsided. Monday he seemed fussy but not bad. My daughter had a doctors appt which is is about 24 miles from where we live. So she took pt with her. She had been in the doctors office for about 30 minutes when she called me to please come get him she said he had been screaming since she left and she couldn't get him to quiet down. I drove to pick him up and when I got there one of the girls in the office was holding him and he was screaming. I took him and I couldn't console him. I had never seen anything like it. I could always get him to quit crying. I left and when we started driving he stopped crying. We went to store and bought a few things and when we started checking out he started screaming again. We left and he screamed most of the way home. He was real fussy that night. I don't remember about Tuesday but my mom who kept him during the day said that Wed. he was real fussy, and just needed to be held. He was also waking up a lot during the night. Thursday night he seemed fine, I bathed him and took him to see a friend of mine. He was laughing and talking to me. I rocked him to sleep when we got home. The next morning my daughter woke up and found him dead.
After receiving vaccine patient became light-headed and dizzy.  Pt. admits that this has happened before. She said she's not surpised that this happened.  Pt. felt better after lowering head, eating a granola bar,cheese crackers, and a diet drink.  Pt. observed in the clinic for another 30 minutes. Pt. said that she felt much better when she left with her husband.  When she arrived home she again felt lightheaded and dizzy along with some shortness of breath, chills, headache and weakness.  She then took Tylenol and called her PCP.  He asked her if her "tongue was swollen or if she had any othe swelling" and since she answered no, she was told to continue on Tylenol and see how she felt in the a.m.  By the next morning she did feel better but continued to have occasional bouts of dizziness, weakness and shortness of breath. She stayed on the Tylenol for a few days.  By Wednesday, March 25th (6 days after the vaccine given) she says she feels much better and back to normal.  Advised patient to follow up with her doctor for any further shortness of breath.
none Patient given expired covid vaccine: expired 11-22-2022 given 12-12-2022
17AUG pt called clinic told to come in-arm @ inj site red, swollen & feverish;no streaking;pt told to take DPH PRN if needed, ice to area;19AUG;pt saw MD 21AUG & no redness but 2" induration;
Joint pain through my body - especially left hip, right shoulder, left knee, muscle pain in left leg, left foot, right thumb - increased in following days to severe pain and loss of movement.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FE3540) at the age of 68 years, in left arm and on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "Allergy: Pseudoephedrine", notes: known allergies: Pseudoephedrine. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Anti viral details: [{product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=26Apr2022, Treatment stop date=01May2022, Indication=Treatment of COVID-19}]. Other medications in two weeks: Methotrexate 2.5 mg x 10, Start date: 11Feb2022, Stop date: 06May2022. Tamsulosin HCL, Start date: 08Apr2022, Stop date: 25Apr2022. Trospium chloride, Start date: 08Apr2022, Stop date: 07May2022. Atorvastin calcium, Start date: 08Apr2022, Stop date: 26Apr2022. The patient previously receive a COVID-19 Vaccine. Reported Event: A runny nose, slightly elevated temperature, congestion, aches and pains, and a lot of coughing. Adverse event start date: 05May2022, Adverse event start time: 04:00 PM. The patient was recovering. Device Date was 07May2022.
Sore arm and fatigue. Soreness started afternoon of injection. Fatigue and increased soreness all day the following day. Arm sore to the touch on Saturday.
BREAKTHOUGH COVID: Patient with PMH of HLD, Skin CA, Chronic Back Pain, and currently a smoker presents today due to SOB, cough, and fever x2 days. Pt denies any history of being diagnosed with COPD. Pt states symptoms started 2 days ago and then she began having dry mouth and palpitations which prompted the ED visit. Pt denies any CP, or N/V/D associated. Pt is vaccinated for COVID-19. CXR completed and revealed COPD, mild prominence of interstitial markings. Abnormal labs included; na 128, cl 89, glucose 116, alk phos 112, and +COVID-19. Pt was given IVF, steroids, and pain medications in ED.
Pain and swelling in arm, lymph glands in armpit swollen and sore, raised, burning red rash down arm, nausea, fever up to 102, chills, weakness, sore throat, difficult to stay awake. Lasted 5 days. Took Phenergan for nausea, Advil for fever and pain, and started taking Benadryl for rash on Day 4. Rash still visible on Day 7. Slight burning sensation continues Day 7.
Injection site arm soreness, bad headache, fatigue that began about 6 hours after the vaccine and then lasted for 24 hours, but improved over time
Case number PHEH2015US022703, is an initial incomplete spontaneous report received from medical assistant on 30 Oct 2015. This report refers to a 38-years-old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with first multidose FLUVIRIN (batch number: 1516201) at a dose of 0.5 ml intramuscularly on an unknown date, which was exposed to temperature of 55.6 F for under 8 hours (reported as between 7:50 AM to 3:50 PM). No adverse event was reported. Follow up report received from a healthcare professional (medical assistant) on 24 Dec 2015: Updated patient details (age and gender_ and vaccine information (dose, lot number and route of administration).
Tongue, gums, and lips started to tingle and then went numb.  Increased in intensity for 15-20 minutes before it started to stop intensifying.  Took 3 hours to completely go away.  Hot itchy rash on neck within that time frame also.
Presented with Acute hypoxemic respiratory failure secondary to COVID-19 /possible viral sepsis Tx with remdesivir, decadron, antibiotics, lovenox, singulairzinc; Chest x-ray no  evidence of pneumonia.  On room air at D/C
My left hand is swollen, it hurts, I can't bend it and I have small bruises.
I little bit of soreness in the arm for about a day. I tested positive for COVID-19 in July 2022 and the lingering symptom I have since COVID-19 was feeling hoarse. On 12/18/2022, I had constant runny nose and a bad cough. I went to a clinic, and they gave me a prescription for an antibiotic and a steroid. I wasn't feeling any better, so I went to my doctor, and they gave me a prescription for azithromycin and prednisone. As of today, I continue to have a cough.
first 72 hours I ran a temperature of 102. Had severe abdominal cramps and loose stool. Headaches, body aches, severe cough, stuffy and runny nose. Then on Saturday August 21st, those symptoms went away and I noticed that I lost my ability to smell. Even now , almost a week later, I still cannot smell. My nostrils feel ike their boring. I also developed a sty over my right eye on Thursday, August 19th. As of today it is finally starting to drain.
Covid vaxed and boosted x2 with Moderna given at different sites. last dose 4/25/2022. Since last summer I gradually became aware of the start of tinnitis L ear. At first intermittantly becoming constant and now disruptive to concentration, sleep, mood, increasing gradually from barely noticable to 7/10 distressing. Referred to audiology in 09/0221. Found to have new mild hearing loss in L ear only, not bad enough to be helped by hearing aids. Also having some problems with headache L>R, adjustment to new RX and Glasses and bilateral partial retinal tear as evidenced by flasher and on optometrist exam.Didn't connected to vaccincation and didn't report it to V-Safe until this past week and told to file VAERS.
Case was vaccinated for Covid in August 2021, then hospitalized for Covid in December 2021. Case hospitalized for Shortness of breath, started on Oxygen, remdesivir, dexamethosone, self proning. Weaned off oxygen by discharge.
Mom reported 17MAR92 @ 430PM that pt had been crying & screaming uncontrollably since arriving home from clinic AM; stated unable to comfort pt in any way; pt given APAP; rough noc-irritable crying;
VACCINE WAS GIVEN 10/4/22 EXPIRATION OF LOT # WAS 9/30/22
PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time.
had Covid-19 twice after receiving the vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had Covid-19 twice after receiving the vaccines) in a female patient of an unknown age 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (had Covid-19 twice after receiving the vaccines). At the time of the report, COVID-19 (had Covid-19 twice after receiving the vaccines) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient received primary series doses and a Booster dose of the Moderna COVID-19 Vaccine and had COVID-19 twice.  No Treatment details were provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of CCOVID-19 an unknown time after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the adverse event of special interest of CCOVID-19 an unknown time after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
After first dose looked like bug bites all along left side to groin ; after second dose more ?bites? got a lot worse and exploded into larger hive like eruptions that were itchy and swollen.  Took six weeks from initial dose to almost be gone but there are several still raw and sore. All were only on left side. Worse symptoms however have been very bad GI upset- diarrhea, terrible air, and nausea since about the third or fourth day after second shot.  It was present after first shot but much less intense.  Still unable to eat two weeks after second dose.. Dr thinks vaccine caused  Ileus. Also got bad chills day after second dose and was in bed for two days. My 22 year old daughter has identical symptoms and is a week behind me and is quite ill.  We are both very much fearful whether this will ever go away? Wish there was some reassurance.