chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This is a spontaneous report from a contactable pharmacist reporting for herself. This 36-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL 9263) on 24Jan2021 at 00:15, in left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypothyroidism. Allergies to medications, food, or other products: no. Prior to vaccination she was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient underwent a nasal swab on 01Feb2021 which was negative. On 09Feb2021 the patient right temple started hurting on and she had severe pain radiating down to my jaw. She was diagnosed with shingles on 13Feb2021. The event required Doctor or other healthcare professional office/clinic visit and treatment with tizanidine, amoxicillin, ibuprofen, then valaciclovir (VALTREX) and gabapentin. The event had not yet resolved. Pfizer COVID 19 vaccine: Herpes zoster (shingles): related.
Pt aquired large firm knot around insertion site, sore to the touch. Ice pack was applied.
itching; tenderness to touch; redness at the site of the injection; discomfort at the injection site; A spontaneous report was received from a Healthcare Professional concerning a 66 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, redness at the site of the injection, discomfort at the injection site, itching, tenderness to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events, redness at the site of the injection. discomfort at the injection site. On 15 Feb 2021, the patient experienced the events, itching. tenderness to touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events, redness at the site of the injection, discomfort at the injection site, itching, tenderness to touch was not reported.   In Feb 2021 the outcome of events, discomfort at the injection site was resolved.  The outcome of events include, redness at the site of the injection, itching, tenderness to touch was not reported.; Reporter's Comments: Based on the information provide which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. The reported events are consistent with the known safety profile of the mRNA-1273 vaccine .
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not expected. On an unknown date the patient was administered with an improperly stored dose of GARDASIL, 0.5 ml, intramuscular (strength, dose number, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
In May, I experienced diarrhea that lasted about a month.  I went to my doctor and they did a bunch of tests that all came back normal. There was no diagnosis. Luckily, that subsided. End of June, I noticed behind my right ear I had a bald spot. Then I noticed a bald spot on the top of my head, I went to the dermatologist and she did hormone injections in the bald spots. A month later she did more hormone injections. She prescribed additional experimental meds but I do not take them. I am now balding all over my head. I was diagnosed with Alopecia Areata.
Information has been received from a nurse concerning a male patient who was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient presented to the office with a full blown case of chicken pox ten days after receiving varicella virus vaccine live. Unspecified medical attention was sought. No product quality complaint was involved and no other information was provided. It was also reported that another patient (WAES0404USA01756) experienced skin lesions after vaccination with varicella virus vaccine live. Additional information has been requested.
pt had a syncopal episode 5 minutes after dose administered.  Pt states he has had similar episodes before d/t needles, blood, etc. Pt did not fall, pt recovered quickly.
pt recv vax 27AUG96 & MAY97 pt devel breakthrough pox consisting of greater than 300 lesions;pt also exp a fever;
Severe nausea, difficulty breathing, muscle weakness, loss of sensation in hands and feet for 5-6 hours
Jansen COVID-19 Vaccine EUA Fever, chills, headache for about 16 hours
After administration of the vaccine (about 5 min) pt experienced an episode of syncope. Pt regained consciousness after a few seconds w/out further complaints.
pt recv vax 9OCT95&devel warmth&a pink area around the inj site;no tx was necessary;pt has recovered;
When I woke up in the morning I could not keep my eyes open I was so tired and I was aching all over.
Headache/migraines 3/13 night with limited relief from imitrex. Body aches starting with injection site working down arm to hand, then all joint throughout the night. Unable to sleep with pain. By morning I had a fever. Took two Tylenol and slept. Final helped with aches and fever. 4pm Sunday still have pains in the head when I get out of bed.
Moderna Covid 19 vaccine was thawed and refrigerated on 05/13/2021. Per Moderna, vaccine is does not expire until 30 days have passed.  The vaccine was mistakenly given to the patient 1 day past expiration date on 6/13/21
Four days after first dose, experienced inflammation of Left eye with pain and redness. Sought care at urgent care setting. Treated with artificial tears and erythromycin ophthalmic ointment. Symptoms subsided after 1 week.  Three days after second dose, experienced same symptoms, but more intense. Sought care at opthalmologist's office. Diagnosed with corneal abrasion. Treated with artificial tears and erythromycin ophthalmic ointment. Symptoms resolving 10 days after vaccine. Sibling experienced same symptoms after vaccine administration. Dx with corneal abrasion by opthalmologist.
sore on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore on injection site arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore on injection site arm). At the time of the report, VACCINATION SITE PAIN (sore on injection site arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Large rash around the site of injection. Started about one week after shot was received. Started small, but was hot, red, and itchy and arm was swollen. It has become less hot and swollen but the rash has gotten bigger over the last five days. It is now about the size of an adult hand. No treatment has been done - I am not in pain or severe discomfort.
the site of injection was red and itchy; tired; the site of injection was red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (the site of injection was red and itchy), FATIGUE (tired) and VACCINATION SITE PRURITUS (the site of injection was red and itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the site of injection was red and itchy), FATIGUE (tired) and VACCINATION SITE PRURITUS (the site of injection was red and itchy). At the time of the report, VACCINATION SITE ERYTHEMA (the site of injection was red and itchy), FATIGUE (tired) and VACCINATION SITE PRURITUS (the site of injection was red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.       Reporter did not allow further contact
arm pain; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and PYREXIA (fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm pain), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 17-SEP-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 16 hours at a highest temperature recorded of 47 degrees F (8.333333333 degrees C) and other for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is an 80-year-old male with a history of coronary disease with prior CABG, hypertension and chronic back pain.  Patient presents to the emergency room by EMS complaining of severe weakness over the last 48 hours.  2 days ago patient developed some nasal congestion, sore throat and an occasional cough.  Today he has been feeling increasingly weak as the morning progressed to the point where he had a very difficult time standing up on his own.  His wife had to help him stand which is very unusual for the patient.  His main complaint is generalized fatigue and weakness.  He denies shortness of breath or chest discomfort.  He has been vaccinated for COVID but only received 1 booster.  He denies any sick contacts with similar symptoms.  Patient is noted to have a temp of 101.6 °F on arrival. Associated Symptoms: back pain, cough, dizziness, dysphagia, fatigue, fever, sore throat, URI symptoms, weakness, wheezing
With in 15 minutes my son started getting red bruise splotches all over his chest and up his neck and on his face.   I asked the nurse if this was normal and okay and was told that if it gets any worse bring him back.   It is now 2.5 months later and he still has the red splotches on his collar bones.
Lumps return on neck and were larger; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lumps return on neck and were larger) and CHILLS (Chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced NECK MASS (Lumps return on neck and were larger) and CHILLS (Chills). On 29-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, NECK MASS (Lumps return on neck and were larger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Ultrasound scan: normal normal (normal) No biopsy, Advised to wait two weeks before ultrasound.         No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable. 15 Jan 2021 lab work only. No biopsy, Advised to wait two weeks before ultrasound as per caller.   This case was linked to MOD-2021-020597 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received on 07 May 2021 which included no new information.
couldn't lift her arm; achy joints; chills; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her arm), ARTHRALGIA (achy joints), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her arm), ARTHRALGIA (achy joints), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). On 11-Apr-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her arm), ARTHRALGIA (achy joints), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) had resolved.            No concomitant medications were provided by the reporter. Reportedly the patient is very thin.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074747 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074747:Mother's case
Initial case received from a health care professional on 06 November 2009. This case contains information for one of a cluster of four patients who experienced similar events following FLUZONE administration. Information for the other patients is captured in 2009-04184 (serious), 2009-04795 (non-serious) and 2009-04509 (non-serious).
I woke up at approx. 3AM to urinate. I began to black out as I was standing and caught myself before I fell. I then attempted to walk about 40 feet to get water and food and i proceeded to completely lose consciousness about 5-7 times. I fell from fully standing and hit my face on the ground. for about two or three hours I ran a fever, though I don't know how high seeing as every time I tried to stand I'd lose consciousness. I we
245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain.  It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
Welts on her legs and arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on her legs and arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2UA) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts on her legs and arm). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts on her legs and arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information was provided.
administered the liquid DTAP-IPV without being reconstituted with the ACTHIB component with no adverse event; Initial information was received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 15 months old female patient who administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Feb-2023, the patient received a dose of 0.5 ml suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Suspension for injection) (lot UJ682AAA) (strength, expiry date unknown) via intramuscular route in the left vastus lateralis for Immunization.  On 09-Feb-2023 the patient developed a non-serious event of administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event (single component of a two-component product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event.  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 the 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.
trembling, jerking about 1min & hyporextended x 1min for 5min;obtunded aftewards 10min;grand mal sz-most likely;congential epilepsy ws not yet been r/o as a poss cause of sz;no sxs suggesting encephalitis;
Nursing home staff member was on the list along with residents to recieve 2nd dose of Moderna. RN administered 2nd Moderna to staff member. Upon entering vaccine into state registry health department nurse realized staff member had recieved 1st dose only 10 days prior.
Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to vaccines containing thimerosal beginning in or about 1998 and thereafter up through and including 3/01 and each and every time he received a multidose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including the MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, severe autism, other neurological disorders, severe and permanent personal injuries and exacerbation of neurological disorders were considered to be "Other Important Medical Events". Additional information has been requested.
Pt recvd vax during 1990 & 1991; pt devel fibromyalgia described as muscle weakness, fatigue, pain in shoulder blades & neck;
She was fine until 2-3 hours, post vax, then screamed for 6-7 hours. Temperature slight, but not checked. Tylenol given, then Motrin.
His CDC shot card only indicated he received a Covid Booster, it did not have the words Bivalent on the Card.  When charting this information into patients Chart there was no indication he had received a Bivalent booster.  When he was researched in Immunization system again there was no indication he had received a Bivalent booster.  His CDC card had a date of 10/18/2022 and was given Pfizer and unsure who had delivered that vaccine. NO adverse reaction-no symptoms, no signs , no treatment, no reaction
Pain, Red, swollen, warm to touch, itchy, lasted over 1 week.
Initial report received on 29 August 2012 from an investigator. A male subject (age not reported) developed chest pain, shortness of breath and dizziness on 21 August 2012, six days after receiving a left arm injection of ACAM2000, SP Biologics Co., (Lot number and route not reported); TYPHOID VACCINE, manufacturer unknown, and ANTHRAX, other manufacturer, (lot numbers, routes and sites not reported on 15 August 2012. The subject had an ECG, which was reported as normal on 24 August 2012 and a chemistry Troponin I test with results reported as less than <0.10, which was reported as normal on 24 August 2012, which according to the Investigator makes cardiac etiology unlikely. No treatment was reported as prescribed. The subject was referred to Medical. The subject did not have any reported past medical history relevant to the adverse event and concomitant medications were not reported. (However, progress note noted subject had surgery for broken right tibia "tibula" as well as fibula and subtalar "subtaylor" fracture left ankle in February 2006, which causes swollen painful joints. No further medical history was reported). The subject was reported lost to follow-up. The patient's outcome was not reported. According to the investigator the event of chest pain was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Erythema over site of shot administration measuring 9x10cm day after immunization. Treated with BENADRYL.
Adult dose Pfizer given to 10-year, 8-month-old patient in error at mobile clinic site: 0.3mL of COVID-19 mRNA (PFR). The patient should have received the pediatric dose of the Pfizer vaccine. This was the first vaccine in the series. The father was present with the patient and notified via phone.  Father states patient is doing well and is not experiencing any side effects.
Severe abdominal pain with three episodes of vomiting. Lasted for 5 hours and finally ameliorated by treatment with 10 mg CLARITIN and PEPCID AC. Pain finally completely subsided 11 hours after symptoms first surfaced. Diarrhea experienced 24 hour after initial symptoms.
Approx one min after immunization, donor experienced lightheadedness and warmth, and hypotensive.