chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58; Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58; 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 thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 12:12 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Feb-2022 at 12:12 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thawstate on or about 24-Dec-2021 and administered on 12-FEB-2022 at 12:12:58) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine was administered on 12-Feb-2022 at 12:12:58. It went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Immediately after receiving Hepatitis A, Flu, MMR, MCV4 and Varicella, the patient stated he didn't feel well. His color became pale and he passed out for a few seconds. When he recovered, he said the same thing happened a couple of weeks ago when he gave blood. He laid on the exam table for about 10 min. and stayed in the office for another 30 min. and was fine when he left with his mother and brother.
Pharmacy negligently administered an Adult Pfizer Covid-19 vaccine to my son who is 7 years of age and required a  pediatric Pfizer Covid-19 vaccine.
decrease sensation to the left side of my face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (decrease sensation to the left side of my face) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced HYPOAESTHESIA (decrease sensation to the left side of my face). At the time of the report, HYPOAESTHESIA (decrease sensation to the left side of my face) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment information was not provided.
Diffuse polyneuropathy, myalgia and arthralgia. MRI, Neurology appt, Lab work. Treated with prednisone.
Patient presented w/RA red, swollen, itchy,  warm to touch at injection site. Could feel a knot.
Breaking out in hives head to toe including palms of hands. Treating with Benadryl
Immunizations were given on 10/26/01 at 14:00. On 10/27/01 at 14:30, the child experienced a seizure while in the grocery store with his grandmother. The child had a temperature of 102F that Tylenol was Tylenol was being given for. The child was seen by ER and released home.
Patient states that she began experiencing tingling and numbness in her right hand approximately 10 minutes after receiving Hepatitis A vaccine in right deltoid. Patient did not complain of any other symptoms at time of report.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting & Angina Narrative:  Other Relevant History:
Flat red area around site of injection, about size in diameter of baseball, no swelling or hardness there, some warmth. Has been tender since receiving vaccine on Friday afternoon. Took ibuprofen on Sat for the pain and did help some. Nothing since then. Not bothering  much. Noticed the redness around the site last night after taking off his shirt, so sometime between morning and evening it developed. He called to notify us this morning about reaction. Instructed him to see Dr or call RN if further concerns arise. RN will follow up with him in 1 week to see how he's recovering. Reminded to go to VSAFE website/app as well. Told him RN would report to VAERS.
Pt recv vax on 6/10/98; in mid-July before 2nd dose vax pt exp macular,papular rash under her breasts covering stomach & on anterior thighs.  Rash sometimes itchy & painful. Pt tx=Hydrocortisone & Zyrtec. Pt gradual improving
6/17/2022 I developed head cold symptoms. I had a runny nose, sneezing and coughing. I took an at home COVID test on 6/18/22 which was positive. I called my doctor and was prescribed PAXLOVID and began taking it that day. I got better after that.
Onset of hives in 1/7/2021, occur everyday, worse in the evening. Taking Zyrtec to control symptoms.
I went to work that day and while I was at my desk, I was feeling anxious. I had had anxiety attacks over 10 years ago for 2 years. I haven't carried my medication for the past couple of years. When I felt an anxiety attack coming on, I tried to calm myself and I couldn't. It really escalated.  I asked a co-worker to call the ambulance. In the ambulance, They took blood pressure reading and they did EKG - 210/ 110 blood pressure reading; my EKG was fine. I was slowly getting better. I opted out of going to ER. And my blood pressure came down a little bit  to 160 over something. An hour later, I went home and took my medication. .5 mg - 1/2 pill - Generic form of Xanax. I went back to work the next day. Two days later, I saw my doctor and I renewed my medication and now I'm making sure to always carry it again. My blood pressure was 140 something at the doctor. But I did feel a little anxious when I went to the doctor because I had just had a bad anxiety attack so I was just apprehensive. Lately, I do feel a pressure in my head - generalized in my head. I feel tired. No coughing or shortness of breath but I don't feel good. I am wondering if I need to get tested. But there are times when I feel fine, though, so I don't know.
marked localized erythematous, swelling 3x3" @ inj site lt deltoid;devel ? rxn p/inj;
CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: unknown,expiry:unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMYOPATHY and MYOCARDITIS in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Thyroid disorder, and Anxiety. Concomitant products included PREDNISONE for an unknown indication.  On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING FACE. In July 2021, the patient experienced PERIPHERAL SWELLING. In August 2021, the patient experienced CARDIOMYOPATHY (seriousness criterion medically significant) and MYOCARDITIS (seriousness criterion medically significant). On an unknown date, the patient experienced LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, SKIN DISCOLOURATION, and RASH. At the time of the report, CARDIOMYOPATHY, MYOCARDITIS, SWELLING FACE, LACRIMATION INCREASED, SKIN EXFOLIATION, PARAESTHESIA, PRURITUS, PERIPHERAL SWELLING, SKIN DISCOLOURATION, and RASH outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.  Concomitant product was provided as Concomitant: BP medicines, Thyroid medicine, Anxiety medicine, Pain medicine Lab data was not provided.  Treatment product was provided as topical and oral steroids.   Caller is calling to report adverse event for her father. Her father received his 1st dose on 11Mar2021. After 3 days of receiving vaccine, he started with ride side of facial swelling. He also had dripping in eyes. His back was rashy. His body turned red in color. He had tingling in his arm and back. It was itchy. His skin turned white flaky like dandruff. Sometime in July2021, he had moderate swelling in his legs and feet. He is also diagnosed with cardiomyopathy and myocarditis in 2nd week of August. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
During my pregnancy last August 2018, I was encouraged to get the Tdap vaccine prior to her birth. I was due on 8/28 and was checking in weekly. I was primarily healthy, and had no issues during the pregnancy. I had the vaccine upon arrival of my visit with our midwives clinic. Like most vaccines, I knew there would be some pain following the visit. After days upon weeks of numb pain, trouble sleeping on it, loss of feeling in my arm (tingling), I notified my doctors and midwives of the consistent pain. They all assured me that it could take some time to disappear. After giving birth to my daughter via cesarean, she was brought to their nicu with sepsis and was resuscitated after delivery. She was born at 6lb .4 oz. Following her stay, she has been a relatively normal baby. After her birth, I was still experiencing terrible pain, which was only increased after having surgery and an infection myself. I sought out the help of our midwives one more time for a check-up but with no help I went elsewhere. I was referred to a chiropractor who specialized in Active Release Technology and dry needling. He examined me and administered the dry needling upon our first visit. I did feel a sense of relief in my upper arm after our visit, but the pain soon came back. I visited the chiropractor several other visits and he said that he had never seen anyone with that type of muscle issue prior, and was concerned he may not be able to help and that I should seek a medical doctor. Feeling hopeless,  I gave up on finding a solution and continued on using self techniques such as roller balls and muscle rollers. My husband and I moved to another state in May, and I immediately set up an appointment to see a doctor as I was still having issues with everyday tasks and sleeping. The sleeping was the worst, as at the end of the day all of the pain and aches started to settle. I went in to establish care with a new primary doc, I told her about the issues with the shot and she said she would recommend reporting the issue to the CDC. She also gave me some in home therapies that I had already been aware of (such as the roller balls).
4 weeks after the vaccine. I'm a doctor and my patients started telling me my face was red. 4 weeks and 1 day my face was swollen and red.  for a week. My sister found out through Google, swollen face and red was normal symptoms. ONly on the face no where else. Benadryl for 1 day was getting better. It took about 3 days after the benadryl to disappeared.
Symptoms-dizziness, numbness around the lips area, fainting spells, tightness in the throat, chest pressure.
19yo healthy female who had contact with primary Smallpox vaccinee (vaccination date 10/30/2012) between 14-25Nov while sleeping (the vaccinee discontinued covering the site on 11/17/12 when the site developed a scab.). The pt. noted a blister on the MCP joint of her left index finger on 11/19/12 which she "popped" releasing a small amount of liquid (of note, the pt. fell around 11/11/12 and scraped this knuckle which had not completely healed). The pt. was seen in a ER on 11/26/12 and the on 11/27/12 by her PCM and a dermatologist. The pt. was prescribed 3 oral antibiotics. The lesions tested positive for non-variola orthopox on 11/29/12.
Information has been received from a consumer regarding a case in litigation concerning her daughter (now nearing 3 years of age) who was born healthy and who was vaccinated with a dose of MMR II (date and dose not reported).  It was reported that after being vaccinated the patient developed an unspecified central nervous system disorder and digestive tract disorder and has lost the ability to walk and to talk.  The reporter felt that central nervous system disorder, digestive tract disorder, loss of ability to walk and loss of ability to talk were related to therapy with MMR II.  Upon internal review loss of ability to walk and to talk were considered to be disabling.  The outcome at the time of the report was unknown.  No further information is available.
Information has been received from a physician concerning a 2 month old female who on 24-MAR-2008 was vaccinated with a 2 milliliter dose of Rotateq (Lot number: 659773/0020X) PO.  There was no concomitant medication.  The physician reported that the patient received Rotateq and immediately regurgitated the vaccine.  The patient regurgitated 2 ounces of milk and stomach contents along with the vaccine.  The patient sought medical attention in the office.  Outcome was not reported.  There was no product quality complaint.  Additional information has been requested.
pt recvd vax in 1988 & w/in 4 hrs of inject, pt exp severe nausea & vomiting; No further doses were administered; No further details were provided;
This is a spontaneous report from a noncontactable consumer (patient). A 33-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 33, via an unspecified route of administration, right arm, on an unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant medication not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. The patient is allergic to nuts. Prior to vaccination, it was unknown whether patient was diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 2, 2021, patient felt like she had flu and had swollen arm pits (lymphadenopathy). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of felt like flu and swollen arm pits recovered on an unknown date in Apr 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Event- Hives all over body Treatment- Medrol Dose Pack, Benadryl, Singular and labs Outcomes- itching has subsided, hives still present at this time
6:15 PM Coughing 9:00 PM bumps on inside of R. Leg & on torso 11/07/2009 3:00 AM  Temp 103.2 rash on stomach 8:30 AM Rash from chin down his body 9:30 AM Saw Dr.- Prescribed Amoxicillin and 1/2 tsp of Benadryl every 6 hr. 4:00 PM Called Dr. (regular Dr.) Instructed to DC Amoxicillin and Give 1 tsp Benadryl and then continue 1/2 tsp Benadryl every 4 hours. 9:00 PM Temp 102-103 hand and feet swelling. Admitted to Hospital.  Received IV Therapy with steriods Sun. 11/08/2009 Home from Hospital late afternoon 11/09/2009 Rash nearly gone. Remains on oral steriods. 11/16/09 Hospital records received from date to 11/7/09 to 11/8/09. DX: Allergic reaction.  Pt. presented with systemic rash, fever after H1N1 vax. Pt. tx and sx resolved at dc.
Tacrolimus levels dropped a lot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at dose 2, single for COVID-19 immunisation; patient started to receive tacrolimus as anti-rejection medicines. Medical history included kidney transplant 5 years prior the report, in 2016, and all was good. Concomitant medications were not reported. The patient received the first dose of BNT162B2 for COVID-19 immunisation on an unspecified date. The patient received the 2 doses of vaccine with any issues. The first bloodwork since the vaccine were fine except for tacrolimus levels that dropped a lot. That was one of the patient anti-rejection medicines. That was a big concern to the patient. The action taken with tacrolimus was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vax w/ MMR in 1972; 2nd vax 07Aug90.  Serological testing for measles antibody was neg on 02Jan91.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 31 months old patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ045AA; expiry date: not reported) via intramuscular route in the right thigh on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was not reported whether the patent had any adverse reactions. On 14-Nov-2018, the patient had a doctor visit. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient stated that approximately 2 hours after administration, she began to feel excruciating pain in her left arm and shoulder where it was no longer functional. She went into the ER later that night and received 5 tablets of Norco 5-325 and exercises to do to maintain shoulder flexibility. She can no longer do daily activities like dressing herself. She can no longer hold her 3-month-old granddaughter because her left arm is too weak.
High Fever started Wednesday Morning at 0900. He had a Febrile Seizure at 1440. Made it to the ER around 1510 and they gave him Tylenol and 15mins later Motrin to get his fever of 104 down. Saturday at roughly 0800 he developed a rash all over his body known as Roseola.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2017, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 07-JUL-2017, she was treated at a hospital for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Arm pain in the upper part, numb hand, tingling fingers more accentuate in the thumb. It's been 9 days since I got the vaccine, it seems unusual that I still have these symptoms.
rash; itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 56-year-old male patient who received SHINGRIX (batch number 5JT9C, expiry date 28th August 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   On 11th September 2020, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. In September 2020, less than 3 weeks after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX.  Additional details were provided as follows: The patient on 11th September 2020 received first dose of SHINGRIX intramuscularly. The patient experienced rash and itching that lasted 2 to 3 days. The patient had completely recovered. The reporter did not consent to follow up.
Redness, hot spot, itching, stiffness, sore. Area about 4 inches. IBP given. 4 days later symptoms still persist.
Pt presented to our emergency room at 1:30am 2 days after his vaccine (8/1/02)with a fever above 105 (rectal)and repeated seizures. He had few other symptoms. Initially, he had a 10 minute seizure followed by several shorter ones.  Later in the morning, he had another 5 minute seizure.  Serum chemisties, CBC, and a head CT scan were normal.  An EEG is preliminarily abnormal, but may be repeated in 2 weeks due to the findings potentially being due to the patient being postictal at the time.  He was treated with Phenobarbital, and is having difficulty with the side effects (ataxia, poor coordination, somnolence.)  He was considered developmentally advanced before this.  His fever persisted through 8/3.  He is being referred to a Pediatric Neurologist for further opinion regarding ongoing treatment. Per hospital discharge summary, diagnosis is complicated febrile seizures.