chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022; No adverse event; Patient received expired booster dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022).    No concomitant medication was reported.  The vial was thawed on 29-Jul-2022 and kept in the refrigerator.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case contains information for the 2nd of 8 patients described by the reporter.
As per patient - 2hrs after vaccines - developed numbness in arms, hands, felt lightheaded and heart rate speeding. Rescue was called and taken to ER. Few days later (4) Pt confirmed with "problems" and was hospitalized x 48 hours. 9/9/09-ICD-9 codes received 780.4. 785.1. 780.97. 9/9/09-ED report received presented om 8/11/09 with C/O feeling tired and dizzy, improving upon arrival to ED. Observed by parent to have tremors and when assessed without parent present, completely normal.  Clinical impression acute dizziness. Palpitations. Altered mental status. Histeria.
I felt fine the day of the vaccine. About 28 hours later I began having spells of dizziness/vertigo. It lasted the rest of the day but was not severe enough to keep me from doing my daily routine. I did feel very tired but I often do not sleep well and experience tiredness so I cannot say that it was vaccine-related. The dizziness was though, for sure. I felt normal the next several days and then began experiencing the dizziness again on day 9 after dose one. I also have a headache, sinus pain, ear pressure, body aches, and fatigue. I guess just a general sense of malaise. Our state just went through an extreme weather shift from highs in the 80s to highs in the 30s with snow. That might very well explain everything except the bouts of vertigo/dizziness. Today is day 9 after vaccine.
Developed vertigo, dizziness, spinning sensation and continued HA.  Symptoms started insidiously about 1 week after second dose, became daily around week 3
pt recvd MMR lt arm on 8JAN93 had small bump-no redness on 11JAN92 area became red 7 slowly cont in size & redness; area now measures 10.5cm x 8.5 cm erythema w/induration; a central area is more swollen 7 measures 3cm x 3cm induration;
"Pt w/ hx of allergy to Sulfa medications (hives).  PMH significant for Sjogren's disease, enlarged liver, hypothyroidism, DM.  Other PMH/medications unknown to this writer. 3mins post vaccination, pt had a syncopal episode.  Pt c/o feeling floppy, warm.  Of note, the pt had nothing by mouth all day. Vitals: BP 169/98, HR 97, O2Sat 98% -- > 148/90, 78. Pt symptons self resolved w/ in 5mins of monitoring."
Burning sensation in right upper arm for 1 hour after injection. Pain in right under arm began 2 days after injection. Redness/rash on right arm began 3 days after injection.
On March 3rd, I received a shingles vaccine at the local pharmacy. Early morning, March 5, I had chills, a fever of no more than 100 and urine urgency every 45 minutes. I was examined by a local DR., received an RX for an antibiotic. A hemo stick was used and ruled out a bladder infection. The urine sample was sent to the lab for a culture which was negative. The fever lasted one week. From that point I was extremely exhausted, nauseated and weak. I complained about this and blood work was done on March 27, 2009. For some reason my TSH was 0.05 and the T4 was also high. I have never had any thyroid problems, ever. The coincidence of the vaccine, the fever then the blood test showing hyperthyroidism is very suspicious. Have there been any more reports like this? If so, what has been done? I had a CT scan that determined my thyroid was normal. I was put on thyroid meds when it was determined on 6/1/09 that the high reading on 3/27 was rather permanent. In addition I developed a urine infection and am on an antibiotic. All of this is not pleasant. Let me know if there have been others.
Woke up with Ringing in my left ear and slight hearing loss, hoping it subsides in a day or 2
Body aches, chills ,fever of 101 at 8:30pm Extreme fatigue, loss of appetite, chills until around 2 am on the 30th diareah and cramping but chills and fever gone. Body aches gone. Appetite back.
Shingles-like rash and blisters on left hand behind thumb, underneath right forearm, back of calf left leg and stomach at belly button.
Flu shot on 11/4 (left arm). After that the next few days I had pretty intense discomfort/pain in my shoulder and after a few days it mostly did go away. However, it's now 11/21 and I still feel some discomfort/pain when lifting my arm up high and especially when trying to lift an object/weight. Stretching my left arm up and across my body probably causes the most pain.
Patient developed dizziness, slight tingling and muscle tension in neck 45 minutes post Covid vaccination Dose #1 on 3/25/21. States symptoms stayed a day and went away however he felt 'off' for a few days. About 4 days post-vaccination developed tingling/numbness and intermittent lightheadedness with slight difficulty breathing at night when trying to get to sleep. No swelling of face and no hives reported. Able to exercise (weightlifting & biking) without SOB. Became concerned and went to ER on 4/6/21. Per ER report stated that substernal chest pain started one week prior and worsens at night along with BL leg numbness, numbness in hands, L sided facial tingling and muscle tightness that wraps around neck. Denies SOB except when trying to go to sleep. Not sleeping well due to the feeling of not getting enough air when trying to fall asleep.  No fever, chills, N/V/D. ACS ruled out: EKG showed no signs of ischemia & troponins WNL. PE ruled unlikely d/t no DOE, sats 99%, HR 71 in ER. Chest pain not reproducible on palpation. Referred for sleep study to evaluate for sleep apnea.
Moderna Covid -19 Vaccine: Patient reports noted soreness and sensitivity to left thumb 2 days following receiving Moderna Covid-19 vaccination IM to left deltoid on 01/15/2021 at Hospice. Patient states sensitivity has lessened over time but is still mild today.  This reaction was unwitnessed and first reported 02/01/2021.
Patient was vaccinated for COVID-19 on 12/27/20 at 11am. 2 days later, upon waking up she developed pain at the injection site (left deltoid), and a rash on her right hand and right side of her stomach, not itching reported.  The patient reported to employee health the reaction, she was seen in urgent care and given prednisone, benadryl, and famotidine.
Information has been received from a physician assistant concerning "approximately 12 month old" male patient who on approximately 09-JUL-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # not reported). On 22-JUL-2009 physician assistant friend went to her office and brought along her infant son and showed her that the infant had a mosquito bite. Physician assistant saw that the bite looked like chickenpox and she recommended her friend to bring the infant back to her pediatrician. To have it checked. Follow up information received on 01-SEP-2009 from the physician's assistant indicated that she does not had any additional information regarding this case as he was not her patient. The patient was lost to follow up. Follow-up information was received from the physician's assistant indicating that she had no knowledge of the patient except that he was okay. No further information is available.
Patient got a dose of an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got a dose of an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a dose of an expired vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a dose of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator 1 or 2 days before 20-Oct-2021 and the vial did not undergone any temperature excursions. The vial was expired on 11-Oct-2021. No concomitant medications were reported No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Non Significant follow-up received reporter fax number added.
LVN administered second dose Moderna without double checking the patient's first dose. First dose was administered 3/1/2021 and second dose was 3/25/21. Full disclosure to patient done after the dose was administered.
Information has been received from a registered nurse concerning a 12 year old female patient with no pertinent medical history, egg allergy and lactose intolerance who on 08-MAY-1999, was vaccinated SQ with the first 0.5ml dose of VARIVAX (Merck) and on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot# 659360/1577U). Concomitant therapy included ZYRTEC. On 05-APR-2010, the patient developed shingles. The patient had a linear popular vesicular rash on her trunk and "a small line" on her buttocks and her upper leg. It was unspecified if the rash was one side or not. The patient had an office visit on 07-APR-2010 and she complained of itching but no pain. No medication was prescribed. The nurse had not heard back from the patient or her mother so she thought the patient was "fine" at the time of the report. No diagnostic tests were performed. Follow up information has been received from the registered nurse who indicated that the patient was a child with no adverse events following prior vaccinations (vaccinated during childhood) who on 05-MAR-2008, was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (Lot# 659360/1577U) into her right arm. No illnesses were reported at the time of vaccination. On 07-APR-2010, the patient presented with shingles, she had lesions for 3 days. The patient had 12 vesicles in total: 8 lesions on her abdomen, 3 on her buttocks and 1 on her neck, they were described as papular, vesicular, pink/red lesions. The shingles had a linear distribution. On a pain scale from 0 (least) to 10 (most), the patient reported pain of 1. No treatment was given, the patient was reported as afebrile (oral temperature 97.8) with itching. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. No diagnostic laboratory tests were performed. A specimen was not collected for PCR and no photos were taken. There was no direct fluorescent antibody done. On an unspecified date the patient  recovered. No further information is expected.
beginning 4 hours after - lethargy, aches beginning 12 hours after - fever, chills, significant headache,  took 3 ibuprofen @ 10 pm.  slept from midnight till 8:00 AM  feeling generally better, sensitivity of skin.
exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (exhaustion). At the time of the report, FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Rash on neck and both wrists; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in arm left on 18Feb2021 14:45 (at the age of 72-year-old) at dose 2, single for covid-19 immunisation. Medical history Hashimoto thyroiditis, Blepharitis. Patient had no known allergies. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient did not tested for covid post vaccination. Concomitant medications included levothyroxine (LEVOTHYROXINE); clonazepam (CLONAZEPAM); doxycycline (DOXYCYCLINE) taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, administered in arm left on 28Jan2021 14:45 (at the age of 72-year-old) at dose 1, single for covid-19 immunisation. On 04Mar2021 the patient experienced rash on neck and both wrists. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not received treatment for the adverse event. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
72 hours after receiving my 2nd dose of the Pfizer vaccine I developed a pain on the right side of my neck, which then led to a headache on the back right side of my head.  I began seeing black spots in my vision, which then developed into kaleidoscope vision affecting both eyes but in my left field of view.  I took ibuprofen and laid down with a cold compress.  The vision issues lasted for approximately 30 minutes.  The headache and neck pain persisted until the next morning which was accompanied by vertigo.  I then decided to go to the ER and was diagnosed with a migraine with aura.  I have never experienced a migraine or visual problems before.  The doctor at the ER recommended I make this report in case my symptoms are linked to the vaccine.
Symptoms noticed on 10/15/2008.  Itchy, swollen, red, warm to touch area extending 4.5 * 5.5 inches left upper arm
02-25-2021 4:30 p.m. Body Aches, Headache, Weakness 02-25-2021  8:30 p.m. Cold Chills with uncontrollable shakes 02-25-2021 11:30 p.m. 3:00 a.m. (02-26-2021) -Fever, Nausea, Hallucinations, Severe Weakness, Bed spins.  Once during this time, I was unable to stand/walk.  I also lost bladder control once during this time. Finally went to sleep around 5:00 a.m. 02-26-2021  7:30 a.m. woke with body aches and severe headache, weakness.  This lasted until I went to bed at about 8:30 p.m. 02-27-2021  7:30 a.m. Woke with all symptoms GONE
This spontaneous report as received from a registered nurse refers to a 13 year old patient of unknown gender. On an unknown date, the 13 year old patient was vaccinated with a dose of PROQUAD, dose, route and lot # not reported. IT was not known if this was the first dose of PROQUAD this patient was administered. No adverse effect reported. Additional information has been requested.
Proquad is intended for patients 12 month to 12 years of age. This vaccine was given to this patient who is 14 years old.
Pain in Right side of face and numbness. Fatigue, muscle weakness. Dizziness, fainting, shortness of breath.
OCT97 c/o dizziness & falling against walls, tired;18DEC97 saw MD while in office exp rt sided sz;lab workup done-results WNL referred to MD;neuro stated people w/these sx often devel MS later in life;
pt tested positive for covid19 on 10/18/21, symptoms started on 10/17/21: congestion, cough, sore throat
About 20 minutes after getting the shot, I had shortness of breath. I kind of blew it off thinking that I was just nervous. It lasted all that day and into the next especially when walking and talking. My chest felt tight. I took my inhaler yesterday and this morning and am fine now. I didn?t want Togo to the doctor and make a big deal of it.
A few days after the shots, I had a roaring sound in my left ear, and I noticed poor hearing had developed.  I could hear my pulse in my left ear as well.  I contacted the Dr, and hearing test was performed, showing about an 85 % loss of hearing in my left ear.    The hearing of my pulse is probably pulsitile tinnitus.  My right ear was not affected.  and subsequently hearing aids were provided.   I was also sent to Dr, at the Health Clinic for an exam to verify the condition as Tinnitus.  Their phone is private.  I mentioned to both doctors that I believed the condition was an effect of the covid shots.
Started having blurry vision, rapid eye movement, dizziness, vertigo on 1/1/2017, it has been getting worse and confusion is added.. tiredness. Feels like, I'm drunk, but without the actual being drunk part.
On 10/9 at approx. 9 pm my daughter awoke with a fever of between 100-101.  I tried all night and into the afternoon of 10/10 to break her fever with motrin, tyleonl, bathes, and nothing.  I called her Dr. in the afternoon and they said not to worry because it is due to her MMR shot on 10/3.  Right after I hung up the phone with the Dr. my daughter started having a seizure with vomiting that lasted at least 5 minutes.   By the time the paramedics got her into the ambulance she was turning blue from lack of oxygen.  She had another seizure on the way to the hospital.  She had blood work, urine test and spinal tap done at the hopsital and everything was negative so they think it was a seizure due to a fever due to the shot.  Her fever was 103 when she arrived at the hospital. She is scheduled for an EEG on Oct. 18th at Hospital to test further.
Day after patient received vaccine she broke out in an itchy, lower extremity rash that went up to her knees. Patient had no other allergic reactions, detergents, outside factors that she believes could have contributed. She did not seek medical attention. Pt did apply Calamine lotion to the rash. Spoke with her today (1/12/16) - rash is still present but clearing up and not as itchy. Patient reported event on 1-11-16 via phone.
Feeling lightheaded, color pale, c/o chest tightness at shot table. Taken via w/c directly to private observation. Removed mask, opened doors. Lips gray. Feels "cloudy" headed. BP 59/40 HR 84. Resp 18 on r/a.  1253 O2 99% HR88 Drank 4 oz water, denies nausea. Had some pretzels for breakfast this morning. Did not drink prior to vaccine. States chest tightness gone.  1258 BP 102/87; HR 82 finished graham crackers. 1304: Sitting BP 101/85 states she feels better. Color pinker. Stood at w/c and BP recheck while standing is not palpable. Upon standing states head is clouding over again. Placed on cot, supine with legs elevated. Instructed to call friend to drive her home. 13:11 BP lying down is 114/72 HR 68 O2 99%  1330 BP 108/70 HR 78 O2 99% , still supine.  1331 BP sitting up is 118/88; stood at cot and BP standing is 127/83  1345 Taken via w/c to awaiting car driven by friend
Breakthrough case admission after 3 vaccines Pfizer 2/21/21 Lot# EL9267;  Pfizer 3/14/21 Lot# En6200;  Pfizer 9/22/21 Lot# EW0179
pt recvd vax;mom called approx 4:30,states pt broken out w/ whelps;PHN instructed to take PT to MD;pt irritable & feverish; large whelps on legs, trunk, chest & back;also playful;mom will call PHN in am after MD visit;
Initial unsolicited report received from an office staff on 06-Jun-2018. This case involves a patient (age and gender were not reported) who was vaccinated with an expired dose of PENTACEL (Batch number, expiration date: 04-Jun-2018, dose, dose in series, route and site of administration were not reported) on 05-Jun-2018. It was a case of actual medication error due to expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
An initial spontaneous report was received on 11-JUL-2016 from a registered nurse who reported a 28 year old female patient with adverse event while on therapy GARDASIL 9. The nurse reported that another nurse from her facility administered GARDASIL 9 intramuscularly to the patient on 08-JUL-2016. The patient later discovered she was pregnant via a pregnancy test. She was reported to be 9 weeks pregnant. It was reported that the patient sought medical attention. The patient was advised to go directly to the emergency room if there were any incidents of cramping and /or bleeding. To date no such symptoms were reported. Additional information has been requested.
about 3 hrs p/shot pt had fever of 104.8-ran high fever all noc; had already given APAP & continued;
I came home from work feeling like a had a fever and when  I got here every muscle in my body went limp and I laid down on my bed and feel asleep very quickly and woke up about 10 pm and feel right back asleep again and woke up about 5 am and got up and went to work. I felt tired and sore muscles throughout the week and alot of fatigue.  Today I feel tired and my arm is still sore where I got the vaccine. Otherwise I am feeling pretty good.
Episodes of vomiting begain on 7/2/2020 - resolved after several days. Esotropia of left eye then moving to right eye over time starting 7/8/2020 and has continued requiring patching of both eyes.
Patient came into the office as a walk in for what he stated was his second covid vaccine of Moderna. Pt was given vaccine and waited for the hold period. No physical side effects, however when we went to enter into system we then seen patient's first dose of the vaccine was Pfizer.