chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; BURNING SENSATION AT INJECTION SITE; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, burning sensation at injection site, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation at injection site, fever and chills was not reported. This report was non-serious.
BODY ACHES; DIZZINESS; CHILLS; HEADACHE; FEVER; NAUSEA; 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 not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, once a total administered on 27-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 (units unspecified). On 27-MAR-2021 18:00, the subject experienced body aches. On 27-MAR-2021 18:00, the subject experienced dizziness. On 27-MAR-2021 18:00, the subject experienced chills. On 27-MAR-2021 18:00, the subject experienced headache. On 27-MAR-2021 18:00, the subject experienced fever. On 27-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, chills, fever, and nausea on MAR-2021, and had not recovered from headache. This report was non-serious.
Migraines quit and haven't come back; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 69-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (In 2004). Concurrent medical conditions included migraine headache (very painful migraine headaches 2-3 times a week) and neck pain.   On 20-JAN-2023, the patient received the 1st dose of Shingles vaccine. On 03-FEB-2023, 14 days after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect (Verbatim: Migraines quit and haven't come back). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter stated that after the bout with shingles he started getting very painful migraine headaches 2-3 times a week.  After having the first of two shingles shots, the patient's migraines quit and had not came back.  The reporter just wanted to let us know and thank you for getting rid of that pain in his head and neck.
Patient given flu shot; 5 minutes later, patient fainted, unconscious for 5 seconds. Patient hit head; EMT called, assessed and cleared.
Female revaccinee with a non-specific generalized rash.  She was vaccinated on February 25.  The following day, she presented to her local ER with an itchy, red, patchy rash over her wrists, hands, upper chest, upper back, neck and upper thighs. A few papular/vesicular lesions were observed on her trunk.  A few additional lesions were noted over the next few days. On March 2, some were unroofed and swabs were obtained for viral culture and PCR. PCR was negative for vaccinia and viral cultures are negative at day 1.  Antihistamines were prescribed with some relief of itching. Her vaccination site showed a major reaction without complications.
Pt. developed a large bump; looked like a small hive around the injection site. After 5 minutes the swelling went down (normalized). Pt. was not worried; was given diphenhydramine 25mg with water. Pt normalized.
Headache, Myalgia, FATIGUE, CHILLS, SITE SORENESS Narrative:
Patient developed baseball size welt on left deltoid, temperature of 103, severe headaches, and sweats/chills/aches. Symptoms lasted for 2 weeks. Patient reported this on 03/15/2011, after symptoms had subsided.
12/03/2009 noted tingling across right upper arm after H1N1 flu vaccination given in right deltoid muscle. Tingling traveled up into right neck and shoulder blade (aching). Reported to doctor, who felt there was arthritis causing an impingement syndrome. 4/28/2010 reported to hospital. Still has right upper arm pain "7"/10 scale.
On 9/13/2010 patient received Flu shot (L) upper arm. On 9/16/10 she developed hives on scalp and trunk in association with redness at vaccine site. She required treatment with Prednisone & ZYRTEC.
Pt developed red, sore area at injection site pt also developed rash on legs. Went to physician and was told she had a mild case of chicken pox. She had papules consistent with chicken pox.
blood came out of the injection site; dose of Engerix-B/ 05Apr2021 / liquid and blood came out of the injection site; liquid and blood came out of the injection site.; This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 5-week-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th April 2021, immediately after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hemorrhage, injection site leaking and accidental underdose. On an unknown date, the outcome of the injection site hemorrhage and injection site leaking were recovered/resolved and the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the injection site hemorrhage and injection site leaking to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a dose of Engerix-B one week ago and a small amount of liquid and blood came out of the injection site. The nurse contacted the CDC (Centers for Disease Control and Prevention) because they were concerned that the patient did not received the full dose, which led to accidental underdose and the CDC recommended to revaccinate. The reporter consented to follow up. For tolerance of revaccinated dose refer case US2021AMR082955.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082955:same reporter
The evening after the Moderna COVID-19 vaccine was given the patient started experiencing chills, shaking, headache, muscle aches and extreme fatigue. The headache, muscle aches and extreme fatigue continued for 2 days after vaccine administration. The patient took tylenol and ibuprofen for his fever and headache symptoms. To date, he is still experiencing headaches. He will be visiting his PCP for his annual 2/26/21 and will bring up the reaction to him for further direction.
I completed my Moderna vaccine series on 2/5/21 to protect myself against COVID-19.  I also tested positive for COVID-19 in mid-December.   This past week I had a menstrual cycle, and I discharged a high volume of blood blots.  I am taking an oral contraceptive and my periods are  are normal frequency, length and flow, until this last period.  The clots could fill an entire maxi pad that needed to be changed every 2 hours, for about 48 hours.  After that single clots were discharged every 2 hours for another 2 days (and still occurring as I write this).  I sent my PCP (an OBGYN) a direct message in patient portal also reporting symptoms.
Pink papular rash on trunk with temp 102.1 week after MMR, speech regression. Diagnosed with autism/LKS at 2 years of age.
son contracted Covid (determined by at-home testing kit); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (son contracted Covid (determined by at-home testing kit)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (son contracted Covid (determined by at-home testing kit)). At the time of the report, COVID-19 (son contracted Covid (determined by at-home testing kit)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient contracted COVID which was determined by at-home testing kit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Patient did not received Booster, but he was scheduled. Company Comment: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (determined by at-home testing). The event occurred approximately at an unknown day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (determined by at-home testing). The event occurred approximately at an unknown day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
AFTER THE FLU VACCINE SHE FAINTED WHILE I WAS APPLYING THE BAND AID. I YELLED HER NAME AND SHOOK HER. SHE AWOKE WITH A JERKING MOTION. SHE SAID SHE DIDN'T KNOW WHO I WAS AT FIRST. BUT WE TALKED FOR 5 MINUTES AND SHE REGAINED KNOWLEDGE QUICKLY. SHE SAID THIS NEVER HAPPENED BEFORE. SHE ALSO RECIEVED HER FLU VACCINE AT THIS LOCATION LAST YEAR 10/5/10. SHE DECIDED TO STAY FOR 15 MINUTES TO SEE HOW SHE WOULD BE FEELING. SHE LEFT FEELING PERFECTLY FINE.
Client states that on 01/18/2021 after receiving the Covid vaccine client started having cramping in Her R-foot.  Finallt was able to sleep.  Went to work that morning having some body aches.  around 9:00 am states she passed out.  Her boss called for the EMT's and they called an ambulance and client was transported to the hospital.  Stayed in the hospital ER all day and returned home around 4:00pm that same day.  She stated that the medical provider said they could find nothing that could have caused the reaction other than she had received the Covid vaccine the day before.
Patient had syncopal episode in back seat of mothers car after vaccine injection.  Nurse in observation noticed patient slumped down in the back seat and asked parent to role down the window. Back door was opened for assessment, upon opening the back door patient was starting to sit up and open eyes.  Respiratory rate and pulse WNL. Patients legs were then elevated and was given fluids. Patient was observed for additional 15 minutes. Parent states she felt comfortable taking patient home after additional observation.
Her arm was sore starting the night of the injections.  She woke up and said her arm was extremely sore and she could barely move it.  She states that she has difficulty moving it or getting dressed
Weird side effects; feels like she has a bad sinus infection; Now she is losing taste and smell.; Now she is losing taste and smell.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.). At the time of the report, FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow up received and additional event added.
8 days after vaccination: sore throat, runny nose, sneezing, nasal congestion, dry cough, tiredness
Vision went off; White tongue; Tongue swelled up; Lip swelled up; Chills real bad; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision went off) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced BLINDNESS (Vision went off) (seriousness criterion medically significant), TONGUE DISCOLOURATION (White tongue), SWOLLEN TONGUE (Tongue swelled up), LIP SWELLING (Lip swelled up) and CHILLS (Chills real bad). At the time of the report, BLINDNESS (Vision went off), TONGUE DISCOLOURATION (White tongue), SWOLLEN TONGUE (Tongue swelled up) and LIP SWELLING (Lip swelled up) outcome was unknown and CHILLS (Chills real bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up received on 04-Jun-2021 contains significant information. Onset date of the events ( Tongue swelled up, Lip swelled up) were added. New events (White tongue, Vision went off) were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient received two flu vaccinations for this flu season with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- US-SANOFI-00361585) and transmitted to Sanofi on 17-Nov-2020.  This case involves a 73 year old male patient who received two flu vaccinations this season, a dose of INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) on 15-Sep-2020 via unknown route and unknown administration site and 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ443AA, expiration date not reported) once via unknown route at left deltoid for prophylactic vaccination on 17-Nov-2020 (extra dose administered).  The patient medical history, past medical treatment, past vaccination and family history were not provided.  The patient did not receive any other vaccinations or medications concomitantly.  It was an actual medication error case due to extra dose administered (latency same day).   At the time of this report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for INFLUENZA VACCINE.
Numbness on right side of my face; Numbness on tongue; Inappropriate route of vaccination; Olfactory (smelling smoke) hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Olfactory (smelling smoke) hallucinations), HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concurrent medical conditions included Environmental allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced HALLUCINATION (Olfactory (smelling smoke) hallucinations). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ). At the time of the report, HALLUCINATION (Olfactory (smelling smoke) hallucinations) had not resolved, HYPOAESTHESIA (Numbness on right side of my face) and HYPOAESTHESIA ORAL (Numbness on tongue) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous), the reporter did not provide any causality assessments.   No concomitant medical information were reported. No treatment information was reported.; Sender's Comments: This case concerns a 42 year-old, female subject, with medical history of environmental allergies and migraine, who experienced the unexpected event of Hallucination. The event occurred approximately 6 days after the first dose of Spikevax. The rechallenge was not applicable as the event happened after the first dose. The medical history of environmental allergies and migraine remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. The event was captured as serious as per IME list, however, reporter and the company physician consider the reported event as non-serious.
No AE; expire dose administered; Information has been received from a medical assistant, referring to a 45 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-OCT-2021, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated(VAQTA) lot # T017179, expiration date on 26-OCT-2021 (anatomical location, dose and administration route were not reported) for prophylaxis. No adverse effects were reported and was stated that the hepatitis a vaccine, inactivated(VAQTA) vaccine had not experienced a temperature excursion.
Support Call Center: Have 24 year old patient who was completing pre-vaccination requirements for upcoming splenectomy on 9/28/2017 (patient has a cyst on the spleen the MD will be removing). Approximately 24 hours later, patient c/o pain and tenderness to left deltoid then redness. Over next 24 hours this reaction worsened and he complained of chills, fever, lethargy and presented to ER on Monday. They reported his rectal temp was 102.4F and his WBC was 24. Dr. admitted him for cellulitis and began treatment with vancomycin. As of 8/22/2017 is WBC count was down to 15 and fever resolved with left deltoid swelling almost gone. He will keep him in the hospital for another 2-3 days on antibiotics tx.
shoulder pain lot of shoulder pain extremely harsh joint pain; swelled up; finger was very sore like arthritis; knee weakness; This is a spontaneous report from a contactable patient. A 72 years old female patient received her first shot of the Pfizer vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. The patient reportedly experienced ailments lot of shoulder pain extremely harsh joint pain, in her arm. Her hands swelled up a little bit, her finger was very sore like arthritis, knee weakness. Ten days after the vaccination the patient still has pain in arm and shoulders Outcome of the events weakness, arthritis and joint swelling were unknown.   Information on the lot/batch number has been requested.
blood platelets went down; dehydration; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: PLATELET COUNT DECREASED (hospitalization), outcome "unknown", described as "blood platelets went down"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydration". The patient underwent the following laboratory tests and procedures: platelet count: blood platelets went down. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congestion, continued to increase. Appointment with NP.  Possibly sinusitis, treated with antibiotics.  Increase cough with thick phlegm. Unable to contact NP regarding increase of symptoms.  Went to urgent care facility and chest x ray was done which showed Cardiomegaly.  Follow up with NP who scheduled a visit with a Cardiologist.  Comparison of last chest x ray was done.
Left arm pain/burning. No redness/warmth/swelling on exam. (L) arm tenderness on exam.
Narrative: 61 y/o male reported to PCP for a scheduled follow up appt. States that he developed hives and itching after receiving his second dose of moderna. States he had no effects after the first shot in mid February. Tool the second shot in Mid march then end of May into June, developed facial swelling and lip swelling and also developed hives on various parts of his body (he took photos at the time and showed them to PCP). He went to an urgent care clinic and received a course of prednisone and hydroxyzine for itching. The symptoms resolved with this combination however the symptoms of itching and welts came back once medication course was completed. He had been using Benadryl over the counter which stopped the itching and firmly believes he is having an allergic reaction to the covid vaccine.
Laryngitis, cough, sore throat, fatigue, diarrhea, nausea lasting over 3 months.