chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 65 year old female with SULFONAMIDE allergy who on 26-JAN-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX in the arm. No lot number was provided. Concomitant vaccine included ZOSTAVAX (Merck) (MSD) on 26-JAN-2009. Other concomitant therapy included estrogens (unspecified) and vitamins (unspecified). On 26-JAN-2009 the patient experienced pain at the injection site. The patient sought medical attention. "Routine labs" were performed. Subsequently, the patient recovered from injection site pain 2 day after administration, on 28-JAN-2009. Additional information is not expected.
Approximately 1 week after the shingles shot that my right arm felt numb from the tip of the shoulder down approximately 6 inches on my arm, right around the area I received the shingles shot.  It has also had periodic itching, and when I scratch there I can feel the pressure of scratching but not the actual scratching like I do on all other parts of my body
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Live significant follow up appended : reporter information, lot no, expiration date were updated .
On day 2 extreme tired, low grade fever 99.2, chills, lack of appetite. Left arm hot to touch, red. Day 3 lymph nodes under left arm were enlarged and swollen (palpable), extreme pain couldn't lift arm, chills and sweats. Day 4 lymph nodes still swollen and palpable but can lift arm to shoulder height, still lethargic. Left arm is still hard, red and hot to touch area has gone from size of golf ball to the size of an orange.  Day 5 Lymph nodes are no longer palpable but still very sore. Left arm has gone from size of orange to cover most of upper arm still red and hot to touch. Day 6 Left arm is still red and covers most of upper arm not as hot. Day 7-10 left arm begins to fade redness and is now itchy. Day 12 back to baseline in all areas.
Approximately 2.5 weeks after I suffered from Vertigo.  Dizziness, vomiting, Symptoms lasted approx one week.
Injection site swelling approx: 1 hrs after vaccine and onset of headache. Approx: 2-3 hrs after arm swelling (with heat and redness) spread to most of upper arm into shoulder, along with continued headache, fatigue and joint pain. Most of these symptoms continued along with on and off chills and low grade fever (99.1 normally run about 97)and became worse in intensity overnight and all of May 5 with slight pain into front upper right chest area. I took 2-500 mg acetaminophen tabs an hour after the onset of symptoms and then in the AM with little relief. Drank lots of water but had little to no appetite (mostly had broth). May 6 most of the joint symptoms subsided but for lower back pain along with the arm swelling. I've iced the area on and off as the symptom persisted. As of the filing of this form May 7, I still have fatigue and the arm swelling which has been itchy in both situations (I've used topical Benadryl and tabs to combat that reaction) and continue to ice it.
large area of intense swelling; large area of intense redness; large area of intense pain; very itchy; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, 2 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, localized erythema, pain localized and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix 4 days ago the actual injection site was not sore at all but two days ago a large area of intense redness, swelling and pain well below the injection site (at least 3 inches below) developed. It covers a large swath of arm going almost all the way around patient arm above patient elbow. It was also very itchy. Other side effects were manageable but this one was concerning in lie of 2nd injection in a few months.
given bivalent COVID 19 booster for dose #1 of primary series. CDC site recommended giving correct primary dose. Patient informed of situation and agreed to receive second injection as suggested. instructed to return for further vaccines
Fever spike 102.1,  lethargy, refusal to eat, drink and take medication; sent to  ER on 1/30/21; COVID tested (negative) returned home same day.
This spontaneous case reported by a nurse, describes the occurrence of accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 018F21A) for COVID-19 immunization. Concurrent medical conditions included being immunocompromised. On Jan 28, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 0.25 milliliter. On Jan 28, 2022, patient experienced accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead). At the time of the report, accidental underdose (immunocompromised patient supposed to get third dose but given half dose of 0.25mL instead) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
After receiving the COVID-19 vaccine the patient was waiting in the store after the shot and was walking around. He had gotten dizzy while walking in an aisle, and lost his balance and fell.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of M-M-R II (therapy type, dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information and which were supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician, referring to three unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ administered orally (strength, dose, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccine had an unspecified temperature excursion (reported as greater than - 70 Fahrenheit (F) and below of 32 F) with a time frame of 40 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004743:
FLU; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported (formulation, expiry date, strength was unknown) via unknown route in unknown administration site for Flu vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLU).  At time of reporting, the outcome was Unknown for the event flu.
Patient stated that she has hives on her arm. Patient stated that she is allergic to latex and they put a band aid on her arm and the provider stated that the band aid was latex free. The hives are very itchy and red.
Extreme fatigue and sleepiness in the afternoons for 4-5 days Daily headaches starting on day 2 till day 13 of the 2nd dose of Pfizer Migraines on day 4 and day 12 - painkillers did not work
Swollen red R upper area > resolved w/ Benadryl and 1 1/2 days of Prednisolone. Seen at urgent care.
I got my flu vaccine at the pharmacy dept of a grocery store. I left right away & before I got out of the door my arm started itching. By the time I got home my arm was swollen & very painful. I had a large swollen area of about 3" by 5" an my arm was red & hot to the touch.  The pain & swelling lasted about 10 days. On 10/14 about 6 p.m. I started running a fever and had cold symptoms for 48 hrs. After that I felt better.
Vesiculopapular lesions around neck 0.5 -1 cm diameter  itch began 2.5 weeks after vax. No systemic symptoms.
feeling tired for a day after her first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired for a day after her first dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (had lung issues). Concomitant products included GUAIFENESIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (feeling tired for a day after her first dose). On 20-Jan-2021, FATIGUE (feeling tired for a day after her first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Asthma medications for lungs. Treatment information was not provided.   This case was linked to MOD-2021-387215 (Patient Link).
I got two shingle shots and still got the shingles / Suspected vaccination failure; I got two shingle shots and still got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Developed cough, fatigue, congestion 7/1/21. Symptoms fully resolved by 7/12/21.
COVID/related - COVID toes - peritonitis - caused by many different causes - an immune response - it only appeared on my toes. On my left foot first with a rash and prominent blood vessels appearing purple. It then went to my right foot which my big toe and my next three toes next to it turned glowing bright red and swelled up and hurt a lot. And it was itching. And then that eventually turned purple. I immediately started searching what it might be. I contacted Medical Clinic and told me doctor and they said I did not need to come in unless it got worse. I talked to Dr. during the course of it all. I talked to a Dermatologist on June 15. She confirmed the diagnosis. And told me to keep using the cream. OTC - Hydrocortisone cream - 1% and that took away the itching as I kept using it. It was generic brand. The initial pain receded after a a couple or three days. The discomfort (from the swelling) and the itching lasted a long time. My time for ultimate resolution was 62 days that it took. Over production of Interferon 1 and Adam 17 - that is what they are saying that causes it. I had no COVID positive test. I had a negative PCR test (April 19th, 2021). I only had the "COVID toes" and no other symptoms. Note: Exposed to a virus on May 12th. I was sitting in place was coughing and sneezing and refusing to wear a mask.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a adult female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12the June 2016). On 15th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site redness, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site warmth and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient ws in the early 30s. The reported injection site of FLUARIX was left deltoid. The patient experienced swelling, pain and redness at the injection site a couple of hours after receiving a FLUARIX injection. The injection site was also warm to touch. The reported reactions were improving on the day before the time of reporting, but the reporter had not seen the patient on the day of reporting. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133985, US2015GSK133986, US2015GSK133988 and US2015GSK133984).
Fever, shakes, joint aches- all joints, headache, vomitting (mainly dry heaves), and inability to breathe. Had to call ambulance to get to hospital as I could not get up off the floor.
Very sudden onset of Hugh fever 103.9 and uncontrollable shaking and shiver as well as complete feeling of being totally out of it.
AWFUL METALLIC TASTE IN MOUTH; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced awful metallic taste in mouth, chills, fever, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient recovered from fever, and the outcome of chills, muscle aches and awful metallic taste in mouth was not reported. This report was non-serious.
Swelling and redness left upper arm, itchy, parent applied cool compress, used BENADRYL x 24H.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-JUL-2016, the patient was vaccinated with a dose of improperly stored VAQTA "10Pk 50U/1ml SD Llok w Caps Adult" with lot number L031196 and expiration date of 05-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the highest recorded temperature of 47 (8.333333333 Celsius degrees) for 24 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
So, a few days after the vaccine, I developed a rash on my arms and face. I did a telehealth visit and the Physician prescribed an oral steroid and a cream for diagnosis of contact dermatitis. The cream is Triamcinolone Acetonide and I do not remember the steroid, but I took it for approximately 2-4 days and within that time the rash cleared up, with the medications.
Very swollen and sore lymph node (Supra clavicular) on the left side below my neck.
This spontaneous report was received from a physician refers to a female patient (age unknown). In approximately February 2012, about a year ago, the patient was vaccinated with first two doses of GARDASIL (120 micrograms) (lot number, dose and route were not reported) as prophylaxis. On approximately 13-FEB-2013, the patient was vaccinated with third dose of GARDASIL (120 micrograms) as prophylaxis (lot number and route were not reported). No adverse effects reported. Additional information has been requested.
Right sided facial swelling that extends from Jawline into neck. Also noted with redness to facial area. Onset 2/10/21 with worsening today 2/11/21
pt recvd vax & was fussy at 6pm; pt was screaming w/ t 103; apap would not bring t down; pt would not eat or drink; leg 4 x nl size; 13oct94 pt was fine;
No adverse reaction.  Doses given too close. 2/26/2021 and 3/18/2021.
On approximately 07/15/2022, in the morning, we noticed a white spot, about the size of a nickel, at the injection site. We showed the doctor at his well check-up in August. We thought it may be a fungal infection, we put cream on it, and it is still there. I showed it to the doctor again last week.
administration of FLUBLOK to a pediatric patient with no reported adverse event; Expired vaccine administered with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 8 years old male patient who experienced administration of flublok to a pediatric patient with no reported adverse event and expired vaccine administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2022, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength not reported; lot QFAA238 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 22-Oct-2022, (latency: same day) there was administration of flublok to a pediatric patient with no reported adverse event (product administered to patient of inappropriate age) and expired vaccine administered with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.; Sender's Comments:  01335662:
A physician reported that a 12 month old female received her 1st dose of Prevnar, as well as, varicella, measles, mumps and rubella and hepatitis B vaccines on 9/29/00 and within 1 to 5 days, post vax, developed fever of 103F and a rash. The physician indicated that the pt developed a rash from the MMR vaccine.
her veins were swollen and she had blood clot.; her veins were swollen and she had blood clot.; severe earache; severe headache; her mouth and throat were on fire.; her mouth and throat were on fire.; This is a spontaneous report from a non-contactable consumer (other HCP) via medical information team. A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route of administration on 09Mar2021 as single dose for covid-19 immunisation. Reportedly, patient got the first dose of the Pfizer COVID-19 vaccine on 09Mar2021. After that, she had developed severe earache, severe headache, her mouth and throat were on fire. Few days later, her veins were swollen and she had blood clot. She was also afraid to take her medication, Eliquis, since there may be more adverse events from that medication. Patient was scheduled for her second shot of the Pfizer COVID-19 vaccine today, 20Mar2021. She was told that the adverse events after the second dose of the vaccine are worse than the first dose. She has also read that people die from the vaccine. She wants to cancel her appointment today. She wanted to know if the vaccine would be 80-85% effective after a single dose. She wanted to know if she would be ok with just one dose of the vaccine. No PQC was present. The outcome for the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of thrombosis and other events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I had cold symptoms - runny nose, cough, laryngitis - no fever. Urgent care said I had an ear infection, a little bronchitis -