chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Rash was warm to the touch; Rash was the size of a softball; Rash on her left arm; Rash was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm), RASH PRURITIC (Rash was itchy) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives from  other sources.). Concurrent medical conditions included Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball) and RASH PRURITIC (Rash was itchy). 29-Oct-2021, the patient experienced RASH (Rash on her left arm). On an unknown date, the patient experienced FATIGUE (Fatigue). In November 2021, SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm) and RASH PRURITIC (Rash was itchy) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient received first booster on 27-Oct-2021.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-546786, MOD-2022-546924, MOD-2022-546935 (Patient Link).
I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the front of my left shoulder that went about halfway down my left arm. Additionally, I couldn't breath - it was very painful to attempt to fully fill my lungs. This condition lasted for about 45 minutes as I tried changing positions in bed to make the pain change (either worse or less) but it was consistent and would not go away.  At that time my wife and I thought I may have been having a heart attack so we went to the Emergency Room.
Pain at injection site, itchy, redness, swelling, radiated into joint pain, acute SOB.
Psychological and physical symptoms both.  Brain fog, fatigue, anxiety, depression, skin rash, heart arrhythmia, difficulty concentrating, short term memory issues, lack of motivation.  Suicidal thoughts, impulsive thoughts.
Severe headache/Migraine; Feels like tension inside the head; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO150) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prenatal vitamins (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 07:00, 7 days after the shot, the patient experienced severe headache/migraine that lasted for 2 days straight. The patient felt better on 14Apr2021 but still had mild discomfort which felt like tension inside the head. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events severe headache/migraine and feels like tension inside the head which included treatment with pain medication but that did not help. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe headache/migraine, feels like tension inside the head were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
The immunization that was suppose to be given was a prevnar 13 but a prevnar 20 was given instead.  It was given in his arm which became sore and had a lump right away and it continued to have this symptoms for at least 10 days
she has an infection employee; This is a spontaneous report from a contactable other HCP (director of patient services) reported for a 58-year-old female patient. A 58-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/lot number: EW0196, Expiry date: unknown), via an intramuscular route unknown site on 29Jul2021 (age at vaccination: 58-year-old), 0.3 ml as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced infection. The patient was scheduled to receive second dose on 09Sep2021 (over 4 weeks after the first dose). The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
vaccine administered  IV not IM; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a Patient via interactive digital media. Shingrix vaccine was administered and went IV (Intravenous) not IM (Intramuscular). Additional Supportive Information: Shingrix vaccine was administered and went IV (Intravenous) not IM (Intramuscular),which led to intramuscular formulation administered by other route. The follow up would not possible as no contact details were available.
PAIN AT INJECTION SIGHT THAT SUBSIDED AFTER A FEW DAYS.  RECIEVED FIRST MODERNA VACCINE ON MARCH 2.  MARCH 7 DEVELOPED ITCHING BURNING AND RASH 3"X2" APPROX. AT INJECTION SITE ON LEFT ARM.  CAN NOT RECIEVE VACCINE IN RIGHT ARM DUE TO BREAST CANCER LYMPH NODE REMOVAL. RASH IS STILL PRESENT AND ITCHING SWOLLEN ON MARCH 11 TO DATE.
Approximately one hour after receiving the vaccine, patient became light headed and dizzy. The following morning (11/29/16) patient experienced severe body aches, exhaustion, and a fever of 102 degrees. As a result, patient missed a day of work. By the third day (11/30/16) patient was no longer experiencing a fever.
This case was reported by a nurse and described the occurrence of swelling injection site in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject had no known drug allergies. On 12Sep05 the subject received 5th dose of Infanrix in the left leg (AC14A006BA). On 12Sep05, the subject was also vaccinated with inactivated poliomyelitis virus vaccine (Ipol) in the left leg, measles, mumps and rubella virus vaccine (MMR II) in the right leg. At an unspecified time following the administration of Infanrix, on or after 12Sept05 and on or before 15Sep05, the nurse reported that the subject experienced, a large swollen area at the injection site (in the left leg) the size of a small grapefruit that was red and warm to touch. The subject was seen at a physician's office. The events resolved on an unspecified date on or after 15Sept05 and on or before Oct 2005.
Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
Pneumonia PS23 with PS13 administered this time last year no side effects. My right arm and face broke out in hives, bumps and blisters. My eyes were very swollen and skin damage to my nose chin and eye area. The skin became hardened swollen and red.
fever, chills, aches, low oxidation, arm swelling and pain, lack of appetite
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 31-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX with expiration date of 30-DEC-2016 (dose, frequency, route, anatomical location and lot number were not reported) for prophylaxis (expired product administered). No adverse effects were reported. Additional information has been requested.
therapy non-responder  This case was reported by a consumer and described an adult female subject who did not respond to immunization to the hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) immunization series. The reporter is the subject.  A physician or other health care professional has not verified this report.  There were no concurrent medications.  On an unspecified date in October 2005, the subject received the 3rd dose of Engerix-B.  On an unspecified date in November 2005, one month after vaccination with 3rd dose Engerix-B, a hepatitis B surface antibody titer was negative. Reporter received via Merck & Co., Inc.
Erythema, induration right medial thigh developed slowly over a period of 24 hours post-vaccination
Received smallpox vaccination and progressed as expected without adverse reaction.  28 May 03 developed a 2-3mm pustule immediately adjacent to the original smallpox vaccination site.  Site itched and was associated with headache.  Site progressed to scab and healed.
A nurse reported that several patients developed red rashes at the injection site within 24 to 48 hours of receiving the injection. No further information is available at the date of this report. Additional reports will be generated when identifying information is available.
on 9/3/2020 patient presented to the pharmacy with red swelling around the injection site that expanded to about the size of an orange and patient stated it hurt a little. patient got vaccine between 7-11am on 9/1/2020 and she got symptoms on the morning of 9/3/2020.
Pt had h/a, chills hospitalized 2 days; arm swollen around sleeve, arm feverish, broke out-red & angry looking;
Patient called from work approximately 3 hours post-vaccination with symptoms of chest pain, shortness of breath, vomiting, and UE paresthesias. He proceeded to have a syncopal episode and 911 was called by his co-workers. Pt regained consciousness prior to EMS arriving. He reported feeling nauseated and was found to be hypertensive. He was given Zofran, which helped with his nausea. His blood pressure normalized. Patient felt better and declined any further evaluation or treatment, including declining transfer to ED.
Expired havrix vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient inadvertently received an expired dose of Havrix vaccine. The reporter consented to follow up. Follow-up via email would be okay. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Information has been received from a physician concerning a 9 month old female infant who on 26-MAY-2010 was inadvertently vaccinated with a dose of VAQTA (lot # 667009/0095Z) instead of hepatitis B virus vaccine due to human error. This was not a PQC. No adverse symptoms noted. Additional information has been requested.
The physician did not experience any symptoms; Physician inadvertently had PROQUAD sprayed in her eye during and administration to the patient; Physician inadvertently had PROQUAD sprayed in her eye during and administration to the patient; This spontaneous report has been received from a registered nurse, concerning a female patient of unknown age, who was a physician. Her concurrent conditions, medical history and concomitant medications were not reported.   On 23-JAN-2020, the physician inadvertently had measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) sprayed in her eye during an administration to a patient (lot # S013711 and expiration date on 31-NOV-2020). The physician did not experience any symptoms. No product quality complaint was involved.  Since the patient did not get a full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), case # 2001USA008752 was also created.; Sender's Comments:  US-009507513-2001USA008752:
17th - Sore throat started that evening and overnight that night. That went away. Within 24 hours, I had leg pain. Overnight on the 18th, I could crawl but I could not walk or stand. I was able to manage to get around with husband's care. I called the doctor: Diagnosed as Degenerative Joint Disease - Osteoarthritis - she said she saw this - major inflammation in my joints. She didn't know I that I had had a diagnosis for that years ago. At that time, they weren't concerned with breakthrough cases. )Our county currently has 28% breakthrough cases now but at that time they weren't aware of it. So I wasn't tested for COVID.) I came home and started my  at-home physical therapy routine again - then on day 10, it disappeared just like a cold would disappear. I also had visual migraines again at that time. Those symptoms lasted a couple of days. On the 24th, I had four visual migraines in one day; day 5 - had another one and by day 10 everything cleared up with the 9th being the last day  that being the last visual migraine . It was like having a cold in my joints - it was all the old injuries inflamed - bad knee on one side and bad foot on another side - major inflammation. My vitals looked fine when I went into the doctor. My pulse was 85 at the time of the exam.  She said to go home and take care of myself.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025O20A) for COVID-19 vaccination.     The patient's past medical history included Social alcohol drinker (couple drinks a week) and Pregnancy (No complications reported, live, full term birth). Concurrent medical conditions included Drug allergy. Concomitant products included FISH OIL and CIMETIDINE HYDROCHLORIDE (TAGAMET [CIMETIDINE HYDROCHLORIDE]) for an unknown indication, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE].    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Feb-2021. On 02-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 02-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Glucose tolerance test: unknown Did not provide test results.. In June 2020, Pregnancy test: positive (Positive) positive. In June 2020, Ultrasound foetal: unknown Did not provide results of "ultrasonds" but stated she had 3 some were around June 2020..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Previous pregnancy end date was 06 Jun 2021 and outcome of the pregnancy was live birth without complications.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This spontaneous report as received from a nurse refers to a 60 year old female patient with no medical history.  On 06-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006832, exp date: 14-SEP-2014) subcutaneous. Concomitant therapies included verapamil, aspirin, NASONEX and triamcinolone. The nurse was reporting that a patient developed redness, swelling, and itching at the injection site after receiving a dose of ZOSTAVAX (in approximately December 2013). The nurse also mentioned that the patient developed glaucoma while taking amitriptyline in the past (captured in MARRS# 1312USA011131). There was no laboratory studies performed. Patient sought medical attention by calling the office and was given no treatment for AE. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
AS soon as the vaccine was given, a hard lump developed under the skin and kept growing. The area bruised and got hot after about 20 minutes. I spoke with the nurse and they may see her if it continues to be bothersome. The patient went home to put ice on the area.
At about 3 pm the day after I got the vaccine (26 hours later) I started crying and realized I was exhausted. I laid down to rest, and 5.5 hours passed. I got up around 830 pm, and my forearms itched. I checked and they were covered in red bumps that hurt. I took benadryl over the course of the following 2 days and saw no improvement. I have co rated my doctor, their soonest appointment is next Thursday. If the condition doesn't improve by Sunday, I will be going to an Urgent Care place.
first shot was fine second shot next day pt. began having a red swollen tongue ,multiple blisters small to medium size, skin irritation in mouth.
I received an allergic reaction to my shampoo after receiving my first COVID-19 shot. I shampooed my hair the Saturday after my first COVID-19 vaccination without any problems. When I shampooed my hair the weeks afterwards, I had an allergic reaction to the shampoo. I itch in my scalp, face, arms, and legs whenever I shampoo my hair. I went to an allergist in May 2021 and he was unable to determine the allergens. I went to 2 dermatologists this year (Jan 2022 and April 2022) and the second dermatologist discovered all of my allergens (coconut, nickel, gold, fragrance,  propylene glycol, formaldehyde resin finish). I had allergy blood tests and patch testing in 2021 and additional patch testing in 2022. Currently I had to change all of my soaps, clothing, shampoo, conditioner, lotion, etc with those allergens.
From about 4:30 -8 pm that evening my head felt confused. When I would look at a list it appeared out of order but when I looked at it later it was in order. It felt like I didn?t have control of what was going on in my head.
Complained of pain and swelling left upper arm.  Diagnosed with Cellulitis.  Treated with Augmentin, Ibuprofen, and cool compresses.
This spontaneous report as received from a pharmacy technician refers to a 7 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
pt recv vax 14JAN98 & the next day mom told MD that pt had a limp tongue when feeding today 15JAN98; A report from a manufacturer lab (8-98041-014L) regarding events. "One day following receipt of HIB-Titer, DTaP and IPV (Connaught) vaccines, this infant's mother reported that the infant developed abnormal tongue movements. His tongue then went limp. The infant was seen by a nurse practitioner, who noted an excessive amount of saliva present; however, the tongue appeared mid-line and was moving normally." Follow-up #1 (18-Jul-2002): During internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added saliva increases).
In my first dose, I am having fever, headache, body aches, nausea, dizziness and bleeding from my menstrual cycle has increased a lot.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of VARIVAX (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 5 and 14 degrees Fahrenheit for 60 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for contact with the reporter was given. Sender's Comments: US-009507513-1702USA006714: US-009507513-1702USA006713: US-009507513-1702USA006711: US-009507513-1702USA006712.