chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got shingles; Rash; Painful; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles in January and got over them). Previously administered products included shingles vaccine (received original vaccine many years ago of reporting date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash and pain were unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the original vaccine many years ago and It was supposed to be lifetime but patient got shingles in January and it got over them. The patient was about to get the first of 2 injections of Shingles vaccine and which was said to be lifetime.  Doctor reported that would not be lifetime.  The patient stated, it was on calendar that, six weeks later on Tuesday, the second dose should be administered but the patient got shingles on Monday, day before vaccination. The patient experienced not a big breakout rash but still it was painful.  The patient guess that vaccine reduces the severity but not the shingles and thus advices to get the vaccine as it reduce the severity and it was worth it.
Somewhere between Hep A (1st shot given) & MMR (2nd shot given) vaccination, on left thigh, patient appeared to have an approximately 5-10 second "episode." Vocalizations and movements stopped. Her eyes were open and appeared fixed and glassy. Afterward, she returned to previous behavior.
Developed a rash (approximately 3 inches in size)at the injection site.  Also suffered from fever, headaches, and lightheadedness.
Pharmacy called patient to remind her to come for her second COVID vaccine. Patient said she did not want to get second vaccine yet because she had a reaction. She said that she got "COVID arm" a large red patch that was itchy appeared on her arm near the injection site. Patient also said that later on she felt that she had trouble breathing. She took benadryl to treat the symptoms. She said she experienced anaphylaxis in the past and  felt that if she did not take benadryl she may have went into anaphylaxis.
In 2008 I got the 3 doses of GARDASIL to prevent HPV, since I had not become sexually active. During that first year, I started to see changes in my vulva, skin growths appeared and began to grow. I had witness the changing process but failed to mentioned to my doctor since, I had not become sexually active. Then I began to have a series of pulmonary illnesses to the point that I was hospitalize twice and given pulmonary therapy and a prolong steroid therapy which caused other health problems, such as weight gain. Also I got gastric and biliary reflux, IBS, began to have problems with hemorrhoids and varicose veins, and joint pain and problems which included severe back pain that needed hospitalization. I began sexually active in 2011, only one partner, one sexual encounter since. In 2015, I got my first pap smear, and the doctor saw the growths. I mentioned those appeared right after I was vaccinated, and he urged me to have them removed. I went through an extremely painful electrocautery. And now after the diagnosis came positive for condylomas; I am undergoing emotional distress, anger and helplessness because the vaccine I thought will prevent an illness actually infected me with it. Now, I have to deal with living with a venereal disease, the insecurity that brings on a possible relationship, or having regular check ups to watch out for more condylomas to appear again, and undergo an extremely painful and costly procedure to have them remove. Also I have to consider a possible transmission to my child if I get pregnant. GARDASIL should be taken out of the market. It is shameful that the FDA permits it to be on the market and Merck can ruin the lives of so many young girls, and women around the world. Take the responsibility!
Pt was administered an expired dose of Varivax.  Parents of patient to be notified, no adverse reaction seen at clinic.
I fainted; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 12:45 as a single dose for COVID-19 immunisation. Medical history included allergies to Penicillin. The patient was not pregnant at the time of vaccination. The patient has not had COVID prior to vaccination. Concomitant medication included etonogestrel (NEXPLANON). The patient has not had any other vaccine in four weeks. The patient fainted on 21Apr2021 17:00. No treatment was given in response to the event. The outcome of the event was recovering. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received his Janssen COVID vaccine and was waiting his 15 minute wait. He stood and reported feeling light headed , faint, pale, and diaphoretic. Patient was lowered to the floor, feet elevated, ice pack applied to neck, and vitals taken. BP 126/72, O2 sat 98%, Pulse 70. Monitored patient for an extra 25 minutes. Vitals stable BP: 127/74, O2 sat 98%, and Pulse 71. Patient discharged to home and feeling back to normal. Patient states that he had gone out the night prior and had a few drinks and did not eat breakfast prior to coming for vaccine.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 31-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of bilateral conjunctivitis in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). The FLULAVAL expiration date was reported as "2008/2009". On 11 November 2008, 1 day after vaccination with FLULAVAL, the subject experienced bilateral conjunctivitis and swollen eyes. The healthcare professional reported that a subject received FLULAVAL and woke up the following morning with swollen eyes and bilateral conjunctivitis. She was evaluated by and ophthalmologist because they thought it might be caused by allergies; however the cause could not be determined. At the time of reporting the outcome of the events were unspecified.
This spontaneous report was received from a nurse concerning a 5 years old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot number M035688 with expiration date of 10-AUG-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M035688 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger and the lot had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. 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-009507513-1701USA009503: US-009507513-1701USA009504:
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was reported that the vaccines were stored in freezer, they took out one to two vials and placed in fridge each day as needed.  No treatment drugs were reported
TODAY PATIENT'S MOTHER INFORMED ME THAT PATIENT HAS DISCOVERED THAT SHE IS PREGNANT.  SHE THINKS HER LAST MENSTRAL PERIOD WAS IN DECEMBER 2008.
This spontaneous report as received from a registered nurse refers to a 17 month old male patient. Patient's medical history was not reported. On 07-JAN-2014 the patient was vaccinated with one dose of (Oka/Merck) PROQUAD (lot #: J002302, expiration date: 22-AUG-2014, dose, route of administration, anatomical location not provided). On 29-APR-2014 (also reported as: "2 days ago") the patient developed chickenpox. The patient had no fever. The outcome of the event was unknown. Patient sought medical attention (unspecified contact). The relatedness between the event and the therapy (Oka/Merck) PROQUAD was not reported. Additional information has been requested.
Headache began immediately after shot. Violent chills and shakes, fever started 6 hours after. Fatigue, headache, muscle aches, fever lasted for 24 hours
Four weeks after send dose of Pfizer experience Stroke-like symptoms such as numbness  on left face, arm and leg; confusing head; sharpness of skin sense declined. Hospital ED, did multiple tests including MRI.
have developed swelling of my lymph nodes/lymph node in her left neck is very swollen; dizzy; dried up her mouth; It seems to be getting worse. It seems like the swelling is traveling up on her neck getting closer to her ear lobe; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 06Mar2021 08:30 (at the age of 69-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included anxiety. Concomitant medications included clonazepam (KLONOPIN) taken for anxiety, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no adverse events following prior vaccinations. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in right arm on 13Feb2021 (at the age of 69-year-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient had developed swelling of my lymph nodes/lymph node in her left neck is very swollen, and also experienced dizzy and dried up her mouth, where it seems to be getting worse. it seems like the swelling is traveling up on her neck getting closer to her ear lobe. The patient visited physician office regarding the event. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result, mammogram: negative result. The outcome of all the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Symptomatic cough; got really sick with fever; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Symptomatic cough) and PYREXIA (got really sick with fever) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032230) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Symptomatic cough) and PYREXIA (got really sick with fever). At the time of the report, COUGH (Symptomatic cough) and PYREXIA (got really sick with fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  There was a total of 97 doses consisting of 9 half boxes of vaccines in the vial.  it was reported that one resident that got really sick with fever, symptomatic cough. This was started 48hrs after adiministration.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750249, US-MODERNATX, INC.-MOD-2023-750488, US-MODERNATX, INC.-MOD-2023-750486, US-MODERNATX, INC.-MOD-2023-750485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750249:Same Report US-MODERNATX, INC.-MOD-2023-750488:Same Report US-MODERNATX, INC.-MOD-2023-750486:Same Report US-MODERNATX, INC.-MOD-2023-750485:Same Report
TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-913) was received from a consumer on 17-Apr-2019. It describes a 20-year-old female consumer who "took two unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took two unrefrigerated doses of Vivotif on 14-Apr-2019 and 16-Apr-2019, respectively.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
The pt became very fussy around 1:00 PM on 10/29. He would not open his eyes, was very limp and left leg would shake uncontrollably. He had a blood blister on the right side of tongue. The pt was taken to the ER.
This spontaneous report was received from a physician referring to 9-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 till 12-MAY-2017, the vaccine was exposed to various temperature excursions ranging from 47 degrees Fahrenheit (F) to 49 F for the period of up to 16 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012766:
Information has been received from a registered nurse concerning a 56 year old female who on 09-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 660685/0619X). On 10-OCT-2008 the patient experienced nausea, a large injection site reaction, the arm was red swollen, sore, warm to touch and flu like symptoms. Subsequently, the patient recovered on unspecified date. This is one of several reports from the same source. Follow up information was received from a registered nurse. It was reported the patient with Parkinson's disease and osteoporosis was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX 23 vaccine on 09-OCT-2008 at 2:41 pm. On 10-OCT-2008 the patient's right arm was red swollen, warm to touch and tender. The patient had "flu like symptoms" for two days following injection. No further information was available.
Screaming spell - symptoms. Give patient TYLENOL every 4-6 hrs-prn-for pain.
Pfizer-BioNTech COVID-19 Vaccine:  About 15 minutes after vaccination, patient started to feel that there is a lump in his throat and both hands had tingling. Paramedic was on site and put patient on EKG monitor and observed patient for 20 minutes. The patient left the site independently and stated no further issues.
This spontaneous report as received from a registered nurse refers to a 2 months old patient of unknown gender. The nurse reported that on 29-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ, (lot #J005073) expiration date: 17-SEP-2014. Route and dose were not reported. On 14-MAR-2014, the patient received the second dose of ROTATEQ, (Lot # J008735), expiration date: 24-MAR-2015. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
NO ADVERSE EFFECT REPORTED; 21 year old patient received one dose of pediatric formula VAQTA; 21 year old patient received one dose of pediatric formula VAQTA; This spontaneous report was received from a medical assistant refers to a 21 year old patient of unknown gender. Information on patient's medical history, drug allergies/reactions, concurrent conditions and concomitant therapies were not reported. On 23-MAY-2019, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unspecified units) (lot # R035227, expiration date: 01-JAN-2020) via intramuscular route for prophylaxis. On 23-MAY-2019, patient received one dose of pediatric formula (incorrect dose administered) (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of event was unknown. No product quality complaint involved in this case.
C/o tachycardia (HR 120's), throat tightness, tongue felt "funny" started 30 minutes after vaccine, lasted 2 hours. Took 25 mg BENADRYL.
Sore arm; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2021, 30 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient's husband reported the case. The  patient received shingrix vaccine and she had a sore arm afterwards (no date provided), which had since resolved. The patient also developed shingles along her lower back. The patient currently taking Valtrex to treat the condition. The reporter did not consented to follow-up.
General aches and pains began 36  hours after injection and lasted approximately 24 hours.  It felt as though every arthritic joint was inflamed.  I used heating pad to relieve pain and felt normal the next day.
Staff member (who received vaccine) presented with no immediate adverse event but after a few minutes of receiving the vaccine developed nausea and abdominal cramping; and did not feel comfortable getting up.; received 50 mL of Benadryl.; presented with new headache.  Was unable to take BP due to staff member unwilling to take off sweatshirt. Pulse and O2 (97-98%) stayed steady throughout. Was observed for 30 minutes and to  persistent nausea was transported to local emergency department.  Staff member did not present with any respiratory issues.
Pt was given and injection of DTaP and IPV on 10/26/99. Pt returned to office on 10/28/99 with local reaction of erythema and induration.  15 x 11cm erythema and 3 cm of induration @ site.  Tx: ice to site and Benadryl.
Pt recv vax in 1994; within 12 hr pt exp uncontrollable crying & hives, itching & wheal at site after tetanus toxoid test
shingles rash that caused severe pain; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around December of 2007, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around December of 2009, the pt was diagnosed with Shingles, which lasted several weeks and caused severe pain; the shingles rash continued to occur approximately every six months. As a direct and proximate result of the company's defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Outcome of the event was not provided and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered rash to be a disabling event