chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a male patient of unknown age regarding himself. The patient's pertinent medical history, concurrent conditions, concomitant medications and laboratory data were not reported. On 16-APR-2018 (reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies were not reported. On 16-APR-2018, the patient reported that after he received the vaccine, he felt tired in a weird way, drained at "2:24pm" and experienced pain at the injection site. On 17-APR-2018 (reported as today), the patient reported that he was feeling better, but he was nauseated from eating and on the same day, the patient was vaccinated (reported as booster) with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. The experience of feeling tired in a weird way, drained and pain at the injection site had resolved. The experience of feeling nauseated while eating was ongoing. The causality of the events were not reported. This is one of the 2 reports with the same reporter. Sender's Comments: US-009507513-1804USA008015.
After I got the shot I looked in my arm and I did not see much redness, but I could see something purple starting to appear. The next day it got more purple and more purple and more purple, until I got a big bruise on the top part of my arm. Higher than where my bicep is. On 04/01/2021 I woke up and my arm was very stiff and I thought it was weird. Through the day it started becoming stiff and hurting. The next day it was worse. The following day I could barely raise my arm. I could not raise it to the front or to the side. I waited a few days and started to do some research. I read about frozen shoulder, which you can get from a vaccination that is injected too high and it goes into the bursa and creates. I decided to see my PCP. I told him about the research I did and the vaccine I had. He said he was not sure about that and he blew me off. Eventually I ended up at my orthopedic surgeon's office and he diagnosed me with frozen shoulder, and he said this sometimes happens with vaccines. He sent me to physical therapy and we did a cortisone shot. My pain went away. I started going to physical therapy and I was able to regain all the use of my arm. I looked into my physical therapy appointments and insurance, and they said I could not take any more. I stopped going to physical therapy and stopped doing my exercises. Then I had and accident and I ran my car into a tree and flew off 10 ft. I injured my shoulder even more. Now I can barely use it. I have been back to seeing my orthopedist. He thinks that my accident caused more damage. They did x-rays, MRI, which showed considerable arthritis in my shoulder but the doctor did not think that could cause that and he diagnosed me with frozen shoulder. I am not having any more vaccines in my life.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medicine were reported. Age of the patient is 68 Years 4 Month. The patients received this Moderna vaccine between 08 Apr 2022 and 15 Dec 2022. Completion date provided as 16-Jun-2022.  No treatment medicine were reported.
Patient received Tdap and FLUZONE in the right deltoid on 10/24, then received PNEUMOVAX in the right deltoid on 10/25. They developed a fever on 10/16 (Tmax 39.5), and large (12 x 15 cm) area of erythema on the right deltoid on 10/27. They were treated with IV and PO diphenhydramine, and were discharged on 10/28 after resolution of fever and reduction in the erythematous area.
1 wk later, it happened all @ once, lt side of neck & shoulder got stiff & painful; This lasted aobut a month or two; Seen by doctor 2 wks later; site of inject was sore for 3-4 wks;
gave the vaccine past the 12 hour mark,26.5 hours at room temp; 26.5 hours at room temp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave the vaccine past the 12 hour mark,26.5 hours at room temp) and PRODUCT STORAGE ERROR (26.5 hours at room temp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains Reporter details included Email address and Fax number.
Patient received Pediarix, Prevnar13, Pedvax, Rotarix at 2 mo of age. Mother called the next day describing he developed papular rash on both legs. Couldn't bring baby. At 4 mo of age, baby received only Pediarix and develop inconsolable crying for 30-40 minutes and then a papular itchy rash B legs.
patient received vaccine past its 30 days expiry date/ Vaccines went in to 2-8C thawstate; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ Vaccines went in to 2-8C thawstate) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 4:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 4:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ Vaccines went in to 2-8C thawstate). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (patient received vaccine past its 30 days expiry date/ Vaccines went in to 2-8C thawstate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine administration time 16:35:43. The patient was administered booster dose that went into 7-8c thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. No treatment medications were reported.
Patient called. Received Twinrix about 15:30 pm on 04/24 and at 18:00 had severe headache. Woke up on 04/25 with cold sweats, dizzy, fatigue and weak muscles. No complaint of trouble breathing, emesis or diarrhea. ASA did help. No redness or swelling at site of injection. Feels better about 48 hours later. Has seasonal allergies and is not on any other medication. Does not remember having a reaction to any other vaccinations.
Patient claims her INR usually runs 2.5 and 2 days after her Moderna booster shot her INR was 4.3. She could not think of anything else besides her booster shot that was different that could have caused this.
This spontaneous report as received from a physician refers to a 11 year old male patient. On 20-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported), and on 04-OCT-2013, patient was inadvertently given the third dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular, early. Concomitant medications were not reported. Additional information has been requested.
patient reports feeling hot and sweaty the evening after she received Menommune. Patient states she did not have fever, did have 2 episodes diarrhea that PM. Next day, had pounding headache and neck pain. Neck pain next day _> went to PMD given muscle relaxer and pain med. Recovered 5/26/07.
Information has been received by the contract pharmacy from the prescriber concerning a 52 year old male patient with asthma and multiple myeloma, started on REVLIMID 10 mg orally daily for 21 days of a 28 day cycle in January 2008, and he received 2 cycles.  The dose was increased to 15 mg for 3 cycles, and then increased to 20 mg for cycle 6.  In approximately June 2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided).  Concomitant medications included ADVAIR, ATROVENT, azithromycin, and albuterol.  In the middle of the REVLIMID cycle 6 in June 2008, the patient had to stop the REVLIMID for 2 weeks due to a pruritic rash with diffuse maculopapular eruption and confluent erythema over the trunk and lower extremities.  Treatment included BENADRYL and prednisone.  The rash resolved after 2 weeks.  The REVLIMID 20 mg was restarted on 30-JUN-2008 with no rash or lesions noted as of the progress note of 24-JUL-2008.  On 28-JUL-2008 the patient continued cycle 8 of REVLIMID 25 mg daily for 21 days of a 28 day cycle.  The prescriber reported that the rash was likely due to PNEUMOVAX 23 since this patient was continued on a higher dose of REVLIMID 25 mg daily.  A causal relationship between therapy and pruritic rash (Diffuse maculopapular eruption, erythema) is considered unlikely due to confounding by co-suspect PNEUMOVAX 23.  There was negative rechallenge after REVLIMID was re-introduced and REVLIMID continued on a higher dose.  The reporter considered pruritic rash to be an other important medical event.  No further information was provided.
This spontaneous report as received from a consumer (patient's mother) refers to a 12 month old male patient. The patient had no pertinent medical history, drug reactions or allergies. There were no concomitant medications. On 07-MAY-2015, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K022446, expiration date: 12-MAY-2016, subcutaneously (exact dose and anatomical location were not reported). On 07-MAY-2015, immediately following the vaccine for two weeks the patent ran high fevers. He also became lethargic. The patent was given ibuprofen and acetaminophen (manufacturer unknown) as a treatment for his fevers. In July 2015, two months after the vaccine, he stopped speaking, he had a flat affect and was not smiling anymore. He was taken to a specialist, who had diagnosed him with autism (considered as disability) and recommended that he started early intervention speech therapy, which the patient was still enrolled in at time of this report. The outcome of high fevers was reported as recovered/ resolved, on approximately 21-MAY-2015 (duration of high fevers was reported as "for two weeks"). The outcome of autism and lethargy was reported as not recovered/not resolved. Causality assessment was not provided. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
numbing on right side of face/numbness in my right arm; hard time swallowing; dizziness; fogginess; disorientation; hard of hearing; right ear felt very clogged; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age (reported as 43 with unspecified units) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. The patient reported that he received the covid vaccine on Monday late afternoon on 11Jan2021. He reported side effects of numbing on right side of face, hard time swallowing and numbness in his right arm on Jan2021. On Jan2021, he had initial symptoms of dizziness, fogginess and disorientation and then went to bed and woke up with additional symptoms (what he mentioned earlier). The patient added that his right ear felt very clogged and was hard of hearing at the time, but now it has resolved (that was the last thing that went away). The patient inquired if he should get the second dose. He mentioned that all the symptoms cleared up and he inquired as to what are the recommendation. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.
Red rash on neck, chest, abdomen, and back. Hot, but not very itchy. Present between 24 - 60 hours after vaccine, treated with Benadryl. Also, very intense pain in left arm, treated with ibuprofen. This began several hours after the vaccine and lasted about 48 hours.
Pt was into clinic at the Health Department for a routine well child check and was due for DTaP, Polio, and Hib (as well as pneumonia and HepB) which qualified pt for Pentacel shot. Nurse (this person filling out report) did not mix DTap/IPV solution with Hib powder - only administered DTaP/IPV solution. Mistake was realized whenever vaccine count was off on routine check - supervisor and state consultant were notified.  Per state consultant, recommendation was to mark dose as inadequate in system and repeat Pentacel vaccine at earliest convenience. Attempted to notify parents of vaccine error - no answer, given nursing supervisor's direct extension to call back.
arm became swollen down to elbow.hard......red.....hot to touch..........DR verified more than normal reaction to vaccination;took course of Doxycycline.I do not take flu shots either, for same reason, but needed this one.
This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. Th reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has been requested.
DIZZINESS, NAUSEA, VOMITING, COLD SWEAT WITHIN 15 MINUTES OF INJECTION.
mom relates w/in 5min of vax 14MAR96 became non-responsive-slept for long period-spiked temp (not taken) but came down from1 1/2days;took day feedings only & would not play;did not call MD;pt glassy eyes x 1 1/2 days
I felt like I was getting a cold, I had nasal and chest congestion, fatigue and body aches. On 04/04/2023 I took a home COVID-19 test and was positive. I reached out to the Hospital, and they prescribed Paxlovid for 5 days. I am feeling much better but still have lingering fatigue.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In March 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Information has been received from a female consumer who on 23-FEB-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Lot# was not reported. Concomitant therapy included PREVACID. She reported that she developed itching and burning over the feet after getting the vaccine. At the time of reporting (19-MAR-2009) the patient was not recovered. Follow up information was received from a physician concerning the 68 year old female patient with osteoporosis, tubulovillous adenoma and tubular adenoma, recent stress and anxiety related to her son's alcohol abuse and history of hiatal hernia and polyp and physical therapy for shoulder and neck pain in November 2008 who on 23-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663638/1706X). On 18-MAR-2009 the patient was seen in the physician's office with a chief complaint of redness, swelling and itching of feet and hands for 3 weeks. Hands and feet had been itching which would not resolve by 4 days ago (14-MAR-2009). No rash had occurred, but "crawling and itching" were present. Discomfort had been 10/10 and improved with BENADRYL. No new foods, detergents or soaps were present. KEFLEX was started for bladder infection several months ago by doctor for prevention of UTI's on daily basis. However, she stopped this medicine 2 weeks ago. Significant pain was noted in right breast. She has had significant stress relating to son's disappearance last week (ongoing severe issues relating to alcohol abuse). Physical examination revealed no other abnormal symptoms. Laboratory tests were performed to check for complete blood count, lipids, liver panel, Urine, thyroid stimulating hormone. All of these tests were within normal limit. The assessment included: "recent onset of intermittent pruritus/burning hands and feet-unclear etiology", "anxiety-situational-recently worsening in view of son's alcohol abuse", "recent right breast pain". At the time of this report the outcome was unknown. Additional information has been requested. All available medical records are available upon request.
This spontaneous report was received from a 34 year old nurse referring to a herself. The patient's medical history includes the drugs DEMEROL which resulted in anaphylaxis and AMBIEN which resulted in hallucinations.On an unknown date in 2010 the patient was vaccinated with PNEUMOVAX 23 intramuscular. Concomitant therapies included SINGULAIR, for asthma. Lab diagnostic tests included blood tests, x-rays and bronchoscopy. On an unknown date in January 2014, the patient developed pneumonia (hospitalization and disability). On 27-JAN-2014, the patient was hospitalized. The patient received the treatment with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown) and recovered from pneumonia on 14-FEB-2014. On 14-MAR-2014, the patient developed pneumonia again (disability) which resolved on 21-MAR-2014 with LEVAQUIN, ZITHROMAX, BIAXIN, doxycycline (manufacturer unknown) and morphine (manufacturer unknown). The patient missed 3.5 months of work due to ongoing (unspecified) disability related to pneumonia. On approximately 15-MAY-2014 (3 weeks ago), the pneumococcal antibodies showed a negative titer result. The patient sought medical attention. There was no intervention required to prevent the seriousness criteria. The event was not life-threatening and there was no PQC involved. The outcome of the events, pneumonia and recurrence of pneumonia was reported as recovered/resolved. The causality of the events was unspecified. The case has been linked with the case 1406USA004888 (Same reporter link) Additional information has been requested.
red streaks that hurt on right arm next morning.  Later the next day hives for at least 4 days.
Pt. developed itching, redness/pinkish spots on arms and legs pt thought similar to chicken pox. Pt self treated with lotion and itch cream which seemed to control itching. Pt did not report to doctor as pt. thought it was just a reaction. Pt seems OK one month afterward.
Patient received second dose of Pfizer vaccine 6 days early. No adverse reactions to 2nd dose after patient monitoring on site. Education was provided on early vaccination patient verbalizes understanding of teaching and instructions.
Site of varicella vaccine swollen to the size of a half dollar, red and hot. Tender to the touch. No Shortness of Breath.
# Hep A site swollen,  Hep a given 6 days ago -- notes swelling, mild pain only, ess FROM of extremity -- no fever, systemic sxs, N/V. -- Some itching, but not very much. -- Overall it is persisting -- since yesterday maybe a little bit bigger. -- no prior reaction to vaccines
Pt recvd 3 doses of Engerix-B & was found to have a neg titer; recvd 4th dose 28JAN92 & now has pos titer result;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 07-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
muscle aches in back, arms, legs. soreness in joints.  fever 12 hours after injection, 99.7 , lasted 6 hours.