chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heptatis A infection; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of hepatitis a in a male patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult and Havrix adult at an unknown dose. On an unknown date, several years after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced hepatitis a and incomplete course of vaccination. On an unknown date, the outcome of the hepatitis a and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the hepatitis a to be related to Havrix adult.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine years ago and experienced hepatitis A. Till the time of reporting the patient had not received the booster dose, which led to incomplete course of vaccination. The patient stated that the health department told her to just get the booster vaccination, but the centers for disease control (CDC) told to get the Havrix series again. This case has been considered as medication error associated with adverse event. This case has been linked with case US2019158421, reported by the same reporter.
mild muscle and joint pain; mild muscle and joint pain; low grade temperature; severe migraine; This is a spontaneous report from a contactable consumer (patient) reported unspecified age and gender received first dose of of BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot Number were not reported, Expiration date: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. Medical history included autoimmune disorder, three auto immune disorders, hasimoto's, raynaud's and another that hasn't been given a name, raynaud's phenomenon. The patient's concomitant medications were not reported. The patient experienced mild muscle and joint pain (arthralgia, mild muscle and joint pain (myalgia), low grade temperature (body temperature decreased), severe migraine (migraine). The outcome of events were unknown.  Information on the lot/batch number has been requested.
I now have major tinnitus.  It is so annoying!! From what I've researched is that it's from inflammation in a spot in my brain. I'm also having headaches most evenings. Haven't found anyone to help me yet.
It started with a sinus infection in my nose and fatigue. We were traveling and I took a test and tested positive for COVID-19. I talked to a doctor through telehealth, and she prescribed me PAXLOVID, and I started feeling better. I rebounded a couple of days later after I finished the PAXLOVID, and I had the same symptoms but with a cough. I took ROBITUSSIN for the cough. It took me 2 weeks until I tested negative. I am still tired and can't exercise like I use to.
This spontaneous report was received from a health professional referring to an unknown number of patients of unknown age and gender. On an unspecified dates in March 2015 (reported as "between 19-MAR-2015 - 23-MAR-2015"), the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ (lot# K023535; expiration date 22-MAY_2016) dose was not provided. No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Severe hives from head to toe that persisted for 72 hours roughly 7 days post vaccine. Was given a steriod injection by my PCP which helped tremendously as well as a daily antihistamine
His arm was tingling immediately after; He woke up in the middle of the night sweating; Body aches; Vomited; He was feeling fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (His arm was tingling immediately after), HYPERHIDROSIS (He woke up in the middle of the night sweating), PAIN (Body aches), VOMITING (Vomited) and FATIGUE (He was feeling fatigue) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PARAESTHESIA (His arm was tingling immediately after), HYPERHIDROSIS (He woke up in the middle of the night sweating), PAIN (Body aches), VOMITING (Vomited) and FATIGUE (He was feeling fatigue). At the time of the report, PARAESTHESIA (His arm was tingling immediately after), HYPERHIDROSIS (He woke up in the middle of the night sweating), PAIN (Body aches), VOMITING (Vomited) and FATIGUE (He was feeling fatigue) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information was received on 16-Jun-2021. The outcome of the events Body aches, fatigue, night sweating, arm tingling immediately and Vomiting was updated to recovered. Narrative updated.
I got a COVID positive test result 24May2022; I got a COVID positive test result 24May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 16:00 as dose 1, single (Batch/Lot number: unknown) and on 05May2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "HypoThyroid" (unspecified if ongoing); "I lost my sense of smell near the start of the pandemic", start date: 2021, stop date: 2022, notes: lost my sense of smell near the start of the pandemic. I have my sense of smell back. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "I got a COVID positive test result 24May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: I got a COVID positive test result 24May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported patient had sense of smell back which was a very positive result. It had been gone for over a year. she was given the Paxlovid from 24May2022 to 26May2022, because got a COVID positive test result 24May2022. However, she lost sense of smell near the start of the pandemic and never got it back. Maybe she had COVID back in then and didn't know it. After day 1 of the Paxlovid treatment, she was suddenly inundated with smells and scents she thought she'd never smell again. It has been so surprising and weird felt she needed it o share this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I woke up the morning after my second Shingrix shot with a burning/tearing sensation in my left shin when my leg rubbed against the mattress as I moved my leg in a forward motion getting out of bed. Simply touching my leg does not hurt and I can even gently punch my leg and it doesn't hurt; it's the motion of pulling the skin towards the outside of my body that causes the pain. The pain does not feel skeletal, muscular, or on the skin but because it felt like a tear below the skin, I went to my orthopedic specialist to see if he could diagnose the issue. I kept my PCP abreast of the appointment and the outcome. Dr ordered an x-ray of my leg and conducted a physical exam; these occurred on September 16, 2022. Neither the x-ray nor the physical exam revealed any breaks in the fibula, nor were there any signs of muscle tear or other issues. He stated that although my specific symptom of the burning/tearing sensation in the left shin are not listed as side effects, he knew of another patient who experienced something similar following a Shingles vaccine (I don't know if it was also Shingrix). He said that patient's symptoms subsided in time but came back worse after the patient developed COVID. Dr. prescribed Meloxicam to help alleviate pain until the condition rectifies and asked me to contact him if it does not. He was up front with me and said that there "is no scientific backing" for his assessment of pain in my peroneal nerve due to the vaccine but in the absence of any other typical cause (all ruled out via the x-ray or physical exam) combined with a previous patient experiencing the same thing, he believes my pain is indeed the result of my body's reaction to the second Shingrix shot. So while we cannot definitively say that the pain is caused by the vaccine, we have ruled out all other known possibilities, therefore I wanted to report this event just in case.
On April 12th I started getting mild headaches.  On April 14th, I was freezing cold and wrapped in a blanket.  That night it went completely away and now I?m fine. Just reporting that after 11 days after the second Moderna shot I had symptoms.
AREA VACCINATED IS SWOLLEN, REDDENED, AND HARD TO THE TOUCH.
high fever; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported for a patient that:  This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced high fever and headache. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
pt states feels dizzy about 5mins p/vax; Epi & DPH given pt was referred to hosp
29 y/o F dependent spouse with history of atopy referred by Dr./OCC HEALTH to healthcare center for evaluation & documentation of onset of swelling of throat with difficulty swallowing & coughing paroxysms about 4 to 5.5 hrs s/p receipt of Tdap (LUE) & IM Seasonal Influenza (RUE) on 16NOV12. These immunizations were required in order for her to volunteer.
11-3-09 Rash - 6-8 hr later. 11-4-09 headache, took BENADRYL - got OK - jerky legs, yellow spot in front of eyes. 11-6-09 knot in roof mouth, spot worse. Rt side face went numb, legs started jerking. To Dr's office - "facial paralysis right side - hosp to monitor - increased BP then bottom out - on BENADRYL. 11-7-09 discharged stayed on BENADRYL. 11-11-09 CT scan allergic reaction Dr. feeling back in face. 11-12-09 Back at work - no numbness, no jerky legs still has headache relieved with meds.   11/13/09 History and Physical received for DOS 11/06/09. Final DX: Angioedema and possible reaction to the flu vaccine. LC   Pt developed a yellow spot in R eye, upper respiratory congestion, rhinorrhea, and not feeling well.  The next day Pt developed big white yellowish spot in R eye, swelling of upper R eyelid, numbness and tingling around the R side of lip and legs, headache, and felt nervous and jittery. After the review of HEENT Pt had headache, some dizziness, paresthesias around lip, and swelling above the R eye. Upon examination, both legs were notably jittery and nervous-feeling.  The Pt was sent to the hospital for further observation and discharged on 11/07/09 in good condition with only some headache.  The physician believes that the Pt's swelling was possibly due to an allergic reaction to H1N1 vaccine.   11/25/09 Discharge summary recieved for DOS 11/06-11/07  Final DX: Angioedema w/some transient visual disturbance changes felt r/to allergic reaction Hospital course as stated above. D/C to home. Tingling almost resolved, angioedema resolved. No HA, moving well. Finish Tamiflu.
Developed flu-like symptoms including:  101F fever, chills, body aches, increased heart rating (100bpm resting).  The next day, the flu-like symptoms subsided, but general fatigue set in.  Day 3, fatigue began to subside, but now dizziness and clamminess persists.  Overall, I would like symptoms of flu-like, body aches, and dizziness to be added to the database.  As a point to note (not addressed in the questionnaire), I naturally recovered from Covid in February 2021, but had to get vaccinated due to employer requirements.  I believe I have natural immunity, and the shot hasn't improved that but may be the reason for these side-effects.
Fatigue, nausea, diarrhea & tachycardia 48 hrs post second COVID vaccine.
Itchy lump at injection site on 08April2021; Noticed larger lump like a large mosquito bite (3 cm x 4 cm oval), redness on 09April2021
Patient administered vaccination which had been stored in refrigerator for 5 days past expiration date of 10/17/2021. No disruption in storage, handling or cold chain.  Agency contacted and advised to reach out to Moderna. Moderna did an analysis of the vials associated with our storage excursion. The vaccine administered on October 22, 2021 from lot number 033B21A maintained activity necessary to protect against the SARS -Cov2 virus at time of administration.  Patient notified, no adverse side effects noted. Next dose scheduled for 11/19/2021.
severe  nerve pain in my left leg hamstring area and top of my left foot.  After 2nd vaccine, severe nerve, hip pain which caused me to limp for 5 days.  Severe uterus pains.  Severe foot cramping which knarled my toes and lasted for 8 hours straight.  Groin pain on both sides.  Whenever I get these pains, I feel the injection site muscle tingling.
Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats
Fever 101.2, severe headache, and nausea/vomiting the morning following the vaccination.  Fatigue, but no fever, headache, or nausea the second day after the vaccination.
DTaP vaccination given 1-24-06 in right upper arm. 2-5-06 patient noticed lump in the area of the injection. 3-1-06 patient noticed lump was red and tender. 3-16-06 he sought further medical evaluation. Round mass in right upper arm area 2cm diameter palpable, 1 cm area of erythema overlying mass. Warm compresses and antibiotic ointment administered daily. Rechecked 3-22-06 mass was 3cm and erythema 2 cm. Afebrile. Started on Duricef 500mg bid for 10 days. Incision and drainage of mass was done 3-22-06. Purulent material expressed and sent for culture. Cyst like capsule also removed. 3-30-06 well healed incised area right upper arm. Asymptomatic.
VARIVAX right thigh 10/15/12. Local erythema that day. Diffuse urticaria 10/16/12.
No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that rotavirus vaccine, live, oral, pentavalent (ROTATEQ), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2012USA002962:
Interchange of vaccine products; Revaccination with different COVID-19 vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In 2022, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In July 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant product use was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  The primary reporter did not have the lot number information, because the information was not available in the patients file.  The reporter's causality for the event of COVID was not provided for Humira and possible for Pfizer Biontech COVID-19 Vaccine.  Company comment: This spontaneous case concerns a 76-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Additional vaccination with Pfizer COVID-19 vaccine could be a confounding factor. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Additional vaccination with Pfizer COVID-19 vaccine could be a confounding factor. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The pt developed fever later in the day following vaccinations, which continued daily ranging from 101-103. Patient also experienced decreased appetite, but denies any other complaints. Patient was brought in by parents and was examined by Dr. Following examination and blood work for prolonged fever, differential diagnosis would be a coincidental viral illness starting either at the same time or contiguous to the immunizations versus a prolonged fever from immunizations. Due to low white blood cell count and prolonged nature of fever, Dr. determined fever is likely related to a new seperate viral illness and was discussed with family. Patient parents were advised to treat with Tylenol or Motrin for pain or fever.
Pt was in pharmacy at bedginning of the year ( 2008 ) and reported a red spot at the injection site. Returned in July this year and showed the pharmacist a persistant red spotting at the injection site. Pt was instructed to seek medical help.At this time we are not aware of treatment, diagnosis.
Welts on back and around eyes. Began about 1 1/2 to 2 hours after vaccination
"A mother reported that her 2 month old daughter received Rota Shield, MMR, IPV and DTP vaccines in June, 1999. Within 2 days, the infant developed brown, watery diarrhea. She was seen by the physician, who instructed her mother to change the infant's formula to soy. The infant was unable to tolerate the soy formula and was restarted on the previous formula. The diarrhea persisted. On 8/2/99, her formula was changed to a different brand of soy. As of 8/3/99, the diarrhea persisted and the mother stated that her daughter may be experiencing abdominal discomfort."
Patient is having muscle pain in both arms and her neck since the second vaccination. She says her right hand goes numb, and both grips are intermittently weak. She says she has gotten sharp stabbing pain in left arm, (shot was in right). Has indicated that it doesn't seem to be resolving. I told her to go see her primary and that we would notify the "CDC."
Developed, cough swelling of throat, mouth, SOB. Treated in Emergency Room - SOLUCORTEF, BENADRYL, PEPCID.
Aside from a very sore left arm for two days after vaccination, a more serious symptoms began on Thursday morning around 6:00 am, January 28th 2020, and the lower right side of my face started swelling and numbness followed. Also I felt some pain and have lost movement on the right side of my face. It looks like I had a stroke. Upon research, I came across Bell's Palsy and its the closest description to what I am currently experiencing. In the last two days, the swelling has subside and it's a little bit better, however, my face is still compromised.
pt recvd vax & 2 hrs later grandma called stated unable to keep pt awake; t104 ax; MD told family pt had underlying ear infection, unk to family when pt recvd vax caused fever to be accentuated;
Patient received the flu shot at 10:10 AM on 1/24/11. It was his 2nd dose this year. About 15 min. after receiving it he broke out in hives on his forehead & on his chest. No SOB. He was given BENADRYL 25 mg po with improvement in hives.
Received vaxx and immediate wheal and diffuse redness over upper arm. Benadryl 50 mg, liquid given at 4:20 PM per physician. Ice applied. Mother requested observation 20 more minutes. Redness decreased. No respiratory problems. Redness was present with diffuse erythema at site when pt left.
At 11:25 am patient reports complaint of "itching" that started on her left hand and spread throughout her left arm, to her back. Patient was escorted to triage area to be evaluated by medical team and observation clinical supervisor. After assess patients left arm, hand, and back and no signs of irritation or rash were present (as reported by the medical team.  Patient given 25mg of diphenhydramine by mouth at 11:35am. Patients vitals at 11:35am- Temp. 97.6f - B/P: 129/88 - Pulse 71, Resp: 16 -  Patient reevaluated at 11:50am with patient reporting a decrease in itching. Patient cleared to leave triage by medical team.
Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL.  The physician reported that the patient had a "positive pap smear after completing her GARDASIL series" (date not reported).  At the time of reporting, the patient had not received any treatment or additional testing in regards to this incident.  It was unknown if the patient sought medical attention.  Outcome was not reported.  Additional information has been requested.