chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a patient (26 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F). It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of and was released. Additional information has been requested.
Shoulders was all sore both of them; He was sore all over; Chills; Running 101 fever; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included COVID-19 (reported as "has had that virus before"). There were no concomitant medications. On 30Jan2021, in the morning after the vaccination, the patient's shoulders were both sore. By the afternoon of the same day, the patient was sore all over, ran in a 101 fever (unit was not reported), and was having chills. The patient did not receive any treatment for the reported events. The outcome of the events, 'shoulders were both sore', 'sore all over', 'ran in a 101 fever' and 'chills', was recovering; patient was feeling better at the time of reporting.  Information on lot/ batch has been requested.
36 hours after the flu vaccine, felt intense muscular aches and pain, had fever and chills for 2 days.  Lesser aches and pain lasted for 2 more days.  It was exactly like having a caose of the flu with the exception of the absence of a sore throat and cough.  I was very ill the 1st few days.  Finally felt ok after 5 days.  Follow up: Don't have that info.
2/15 vaccinated:  rash (flat) appeared on neck behind ears, abdomen, buttocks, chest; none on arms/legs - within 24 hrs.  fever <101R on evening of day of vaccine; given tepid bath; not given analgesic; seen in ER on advice of nurse consultant.  Blood work normal; Sunday rash generalized; IV antibiotics @ ER; both Sat & Sun. WBC elevated  2/18 rash fading/ 2/19 child normal.
leg cramping; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier: US-PFIZER INC-2021376708 (pfizer).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "leg cramping".  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
injection given. immediately afterwards she experienced a syncopal episode lasting approx. 1 - 2 mins. patient was given juice and monitored for 15 mins.
Information had been received on 06-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 28-OCT-2013 at a family physicians office, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016, patient was admitted to a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms and complications. The patient remained in the hospital until 06-APR-2016 for treatment of zoster and complications attributable to shingles. Upon being discharged, patient was evaluated by a nurse practitioner who noted that patient had received inpatient medical care for her extensive blistering rash across her body, which was diagnosed as severe herpes zoster in two dermatomes. Patient was sent home with a PICC line which administered antiviral medications until it was removed on or about 08-APR-2016. Patient was also diagnosed with post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to zoster infections (onset date not reported). Patient has been prescribed LYRICA, methotrexate and acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, severe herpes zoster in two dermatomes requiring a PICC line/complications attributable to shingles was determined to be a medically significant event. Additional information has been requested.
1 week after receiving Moderna vaccine, noticed red, defined bump about 1/2" diameter  about 1" above the site of injection.  Several hours later, bump became sore and itchy.  Several hours after that, itching and warm to touch in 3 areas around the deltoid area.  By 5 hours after initial sensation of bump,  a 3 inch diam of erythema, and itchiness.  Also during that period of time had some sneezing and  runny nose. By the 13th day, the area is not swollen, but there is a ring of erythema about 6" long. on the deltoid/bicep area.  No itchiness, but is a bit tender at site of initial injection.
About 24 hrs after - swollen, red reaction continued to grow - burning sensation - itching sensation. Hot/cold flashes, light-headed, dizzy, severe flu symptoms, nausea throughout next 2 days, local reaction feels hot to touch and continues growing, starting to warp around bicep 6-7" long - 3-4 inch wide.
Approximately 1-2 minutes after injection patient says she  felt hot her hands went numb and she felt a thickening in her tongue and throat
pt recvd vax & several days p/vax pt exp a rash on face, neck, & arms, & mild swelling;pt was visited by MD & is recovering;
From top of shoulder down to elbow on arm, pt had redness, swelling, and warm skin, 2 days after shot.  Pt advised to take antihistamine per MD.  (on left arm where KINRIX imm. had been given).
No adverse event; possible administration of Moderna monovalent booster instead of bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster).    No concomitant medication was provided.  It was reported that patient had received a Moderna COVID-19 booster on 5 Sep 2022. However, it was incorrectly recorded as a Pfizer booster on her vaccination card by the provider.  Treatment medication was not provided by the reporter.
Shot given 5/1/15. Mom noticed night of 5/2/15 a small reddened area on right thigh. Area continued to get larger over next couple days. Brought into clinic on 5/7/15 w/5x6 cm circular reddened area to right thigh. Reddened, raised, hard to touch, warm to touch, tender. Given oral antihistamine and oral steroid rx. Will call if not better.
Within 1/2 hour he began vomiting and unresponsive to his name, commands, etc. He was later diagnosed with autism. He lost all his speech and ability to interact with others. 60 day follow-up 02/17/2004: Patient was diagnosed with autism in June 2003. He has regained only minimal speech and has no conversation type speech.
pt seen in hosp ER 8 hrs p/shot #2; c/o tonic-clonic movements x 3 mins; no fever since shot; w/u in ER neg; pt looked well; d/c home;
About 2 hrs felt itching all over body, and following morning  the injection site was red, swollen, itchy. Skin still itchy, but no hives
Information has been received from a physician concerning a 17 year old female who on 03/02/01 was vaccinated with varicella virus vaccine live. About a week or later the pt developed a rash on her left buttock, back and left leg. The rash was described as raised red papules that were like insect bites. The rash was not at all vesicular in nature. The physician reported that the rash resolves completely within a week or so, but returns up to twice a yr. No Tx was required. The physician had no other available information. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Teeth chattering chills Low grade fever Headache  Body & Joint Pain Extreme Fatigue  Bad Dreams  Started about 12 hrs after vaccine  Lasted 24 -34 hours.  Had to miss work 1 day. Felt totally fine afterwards.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patients were vaccinated with doses of improperly stored, oral ROTATEQ (dose and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Large area of erytheima & edema & pain (10 cm diameter) ice, BENADRYL, TYLENOL/ALLEVE for pain
This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th December 2021, the patient received Shingrix. On 7th December 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine yesterday and in afternoon the patient had fever 100.7 degree. The follow-up could not be possible as no contact details were available.
soreness and a bump/lump at the injection site, 2 in bruise formed the next day, persisting 1+ wks after vaccination
Patient developed HA, abdominal "soreness" & bloating, "stabbing" pain in her joints. Developed a fever in the PM. No temp taken, sx lasted 3-4 days. Pt reported she took Ibuprofen without relief. Stated she felt generalized achiness with previous rabies shot, but this time sx were more severe. Gave Pt final dose of rabies post exposure vaccine on 7-9-12. Advised to take ibuprofen prophylactically & will call Pt in 1-2 days to health status 9-11-12 T.C to Pt. Pt reports mild sx with last rabies injection slight HA, mild abdominal soreness & some joint pain. Will consent one more phone f/u to ensure sx have resolved 7/16 T.C. from Pt. Pt stated is "fine" now. No future f/u.
Inappropriate schedule of vaccine; soreness; couldn't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, mobility decreased and drug dose administration interval too short. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose 58 days ago from the reporting dtae and went to the pharmacy to get the second dose two days shy of the 60 day minimum recommendation, which might led to shortening of vaccination schedule. The patient never had a sore arm like with the first dose of Shingrix. He couldn't lift his arm at all after the vaccination.  The issue resolved after 1.5 days. The patient reported that he was in shape guy and his arm was very sore. The patient does not want follow-up.
Case number PHEH2014US015698 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
PATIENT RECEIVED COVID-19 VACCINE ON  Dose 1 date: 04/17/2021,  Dose 2 date: 05/08/2021, AND TESTED POSITIVE TO COVID ON 8/31/21
Information has been received from a health professional concerning a female pt who on 30Aug04 was vaccinated with a dose of varicella virus vaccine live (lot 642633/1315N). Subsequently the pt experienced an episode of asthma. It was reported that the child was treated with prednisolone sodium phosphate (Orapred). Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Pt experienced localized reaction to vaccine in left deltoid approx 2-4 hrs after admin on 7/25/12 including pain, redness, swelling, itching.
Severe cramping, diarhea, pain, crying, lethargy, fever, inability to sleep
Initially sore arm next day.  30 hours after, extreme fatigue.  36 hours after, stomach pain and severe nausea.  On day 14, I started taking Zofran for nausea Nausea has lasted for 2 weeks, impacting ability to work and do normal daily tasks, intermittently .
dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech, lot EL1284), via an unspecified route of administration in the left arm on 06Jan2021 10:30 at single dose for Covid-19 immunisation. The vaccine was administered in a hospital. Medical history included high blood pressure, asthma, neuropathy, hypothyroid. The patient was not diagnosed with Covid-19 prior to vaccination. She had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carvedilol, fluoxetine, levothyroxine sodium (LEVOXYL) and gabapentin. The patient previously took FLAGYL (metronidazole benzoate), PERCOCET (oxycodone hydrochloride;oxycodone terephthalate;paracetamol), dilaudid and had drug allergy. In the morning after vaccine (07Jan2021 08:30), she woke with mild dizziness and it was continuing through the morning so far. The outcome of event was not recovered.
Presented on 9/15/05 with c/o rash to the L arm s/p smallpox vaccination. Dx. erythema multiforme vs contact dermatitis. Given order for Periactin 4mg tid and Hydrocortisone Cream 1% tid.
Patient reports waking up in the early morning hours with pain in center of chest and between shoulder blades. She felt like her throat was closing up, unable to take a deep breath. Dizziness, feeling faint and heavy arms also reported along with headache. Her husband gave her acetaminophen and shower and ice pack and she returned to sleep. Upon waking in the morning, she felt fatigued and arms ached "like she had been doing push ups" The pain in her neck and chest heaviness persisted. She made an appointment for later in the day with her PCP and was promptly sent to the emergency room for further evaluation. X-rays and labs were drawn.
I noticed a scab on my scalp that wasn't going away. I went to the Dermatologist, and they did a biopsy and determined the Basal Skin Cancer. Then she told me I have another spot on my temple. They are performing Mohs surgery to remove one spot today and in one month they remove the other.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 15 months female patient who received 0.5 ml fourth dose ACTHIB lot number for lyophilized powder UI797 powder and expiry date 06 July 2018 and diluent lot U5858BA, expiry date 28 June 2018 (frequency once and site of administration were not reported) intramuscularly on 02 July 2018. Concomitant vaccines Hep A and Dtap. It was actual medication error due to Expired vaccine used as she administered ACTHIB lyophilized powder with the diluent before recognizing the diluent expired. 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.
Acute chest pain, multiple short episodes of stabbing pains in my left side(near heart), tightness in the chest and area. Increased anxiety/anxiety attack.
I tested positive for COVID-19 on 04/18/2021. My symptoms was mild. I did have a fever 100.5 for 2 days, felt fatigue, drain, bodyache and cough. I lost my taste and smell for about 3 month. As of today I still only have about 50% of my taste and smell. An then after dose 2 vaccination,  My dermatologist diagnose me with Skin Cutaneous T-Cell Lymphoma on 03/04/2022. The doctor was unsure if it is caused by the vaccine.
PAIN; BODY ACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pain, and body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache and pain was not reported. This report was non-serious.
Dose 1-No smell/ no taste 24 hours Dose 2-No smell/No taste-today is day 11
Gave pt injection. 6-21-10 - mother states he had sore leg, 3" dia red, hot, spot where injection was given. She took him to see Dr. the Thursday following about (3 days later) Dr gave him antihistamine. She said red gone but bruised.
Red rash started 5 hours after injection. It started as the size of a thumb print and was hot to the touch. It grew over the course of a week to the size of a hand print and was extremely swollen and bright red. Parts looked like fever blisters.  I reported both times I had this reaction to the first 2 covid shots. I did not however report that I got the same rash when I got my flu shot 1 week before (11/15/2021) received the booster shot. I have never had a rash with any vaccine before so this was a bit alarming.
pt recv vax 10APR96 & 13MAY96 pt broke out w/a rash described as chickenpox;
Vaccines were administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 20 years and 1 months.  No concomitant medication was provided.  It was reported that there was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot # L018351 expiry date: 11-AUG-2017 and lot L024993 expiry date: 17-OCT-2017) for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours. The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006420: US-009507513-1612USA001439.
Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102M20A) for COVID-19 vaccination.     The patient's past medical history included Convalescent plasma transfusion in December 2020.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 02-Jan-2021, CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.