chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 32 year old female who in 1998 was vaccinated with the first dose of Hep B. Later that afternoon the pt experienced a 4 - 5 inch wheal at the injection site. The area was raised, inflamed, hot and itchy. There were no systemic symptoms. She sought unspecified  medical attention. A few days after onset, the pt recovered. She did not receive the second dose of Hep B vaccine. No further information is available.
84-year-old female with paroxysmal atrial fibrillation on Eliquis who presented to the ER with complaints of worsening shortness of breath.  She reports that she went to a outpatient clinic and was found that her oxygen level was low so she was sent to the ER for further evaluation.  She is found to be Covid positive.  She reports she received 2 doses of the Pfizer vaccine earlier this year.  She lives alone but reports she was probably exposed because several members of her church had Covid.  She had fevers and chills.  Denies nausea or vomiting.  Denies any chest pain. Patient received Remdesivir, steroids, antibiotics, supplemental O2 (15 LPM non rebreather) CT study 2 days ago showed no pulmonary embolus, bilateral infiltrates consistent with pneumonia?Covid. Patient still hospitalized at time of report.
Patient was erroneously given 0.2 mL dose instead of 0.25 mL dose. No adverse events were noted.
Diarrhea; Dizziness; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A consumer reported for a male patient (reporters' brother) that. A male patient of an unspecified age received dose number unknown of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWO191) via an unspecified route of administration on 15Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea, dizziness, tired in Jun2021. The clinical course was reported as he said he got the shot on last Tuesday and he is still experiencing side effect like diarrhea and dizziness. The clinical outcome of events not recovered.  No follow-up attempts possible. No further information expected.
"I received the shot roughly around mid-day before starting holiday time off.  After I got home I started feeling "not right".  I felt like I was extremely warm and sweating as well as slowly becoming more nauseous.  I believe roughly 4-5 hours after getting home, I began vomiting and diarrhea simultaneously.  My memory of everything else after that started is very fuzzy until the morning I was discharged, which if I remember correctly was 3 days later.  My wife has said that I had a fever and the first 2 days I was in the hospital when she came to visit I was disoriented and "out of it"."
Headache, Myalgia, NauseaVomiting, injection site red, very painful welt Narrative:
Hot tingling sensation moving up my arm to my shoulder and neck. Rash on my arm and shoulder.
Adult Zostrix given instead of Pediatric Varicella vaccine.  Vaccine was given approx. 4:40 PM.  Incident was not discovered until the morning of 01/15/2010. No adverse effects.
ALLERGIC TO HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Idiopathic urticaria, Generalized osteoarthritis and Pancolitis.    No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA). At the time of the report, DRUG HYPERSENSITIVITY (ALLERGIC TO HUMIRA) was resolving.            No relevant concomitant medications were reported.   The reporter's causality for the event of ALLERGIC TO HUMIRA with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Significant follow up received included event verbatim updated.
allergic reaction; Initial information was received on 11-Jan-2021 regarding an unsolicited valid non-serious from other health care professional.  This case involves a patient of unknown age who experienced allergic reaction (hypersensitivity), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient experienced allergic reaction (hypersensitivity).  No laboratory data was reported.  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
Patient reports arm soreness after his HPV vaccine in his left deltoid. He reports feeling a radiating burning sensation down his arm initially when receiving the vaccination. He continues to have left shoulder soreness for about 1 week that seemed to improve, patient reports enough that he did not come back to be evaluated, however times did return prompted him to come in for evaluation. He denies any weakness, numbness or tingling or radiating symptoms at this time. He does does have a dull ache soreness in the lower aspect of his deltoid/upper lateral bicep tricep.
Received pneumovax vaccination on 3/27 in right upper arm. on 3/28 she developed mild local tenderness at the site and was given Ancef 1gm x 1,but there was no evidence of cellulitis and thus the area improved, she was not continued on antibiotics.
I had injection site area pain, and I found there was a pain with as like bruise on the back side of left index finger. I don't have any pain at the injection area. About my index finger, It is getting better, but it has still a little pain and a little blue around the second joint area.
This spontaneous report was received from a nurse and refers to two unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as M038225 with expiry date of 07-SEP-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of >14 degrees Fahrenheit but < 46 degrees Fahrenheit for 120 hours. Data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Arm (site of injection) sore for 48hours; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 05Mar2021, the patient experienced headache which started around 8 hours after the dose and lasted for another 12 hours. On 06Mar2021 at 08:00, the patient experienced arm (site of injection) sore for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event headache which included treatment with Ibuprofen. No therapeutic measures were taken for the event arm (site of injection) sore for 48 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was recovered on 06Mar2021. The clinical outcome of the event arm (site of injection) sore was recovered on 08Mar2021 at 08:00.  No follow-up attempts are needed. No further information is expected.
I got the flu shot on Oct 10, 2012. As of today 11/27/12, my right arm is still not able to move as normal like before. The arm will not able to lift very high or it will be painful when I try to lift high.
Initial unsolicited report received from a physicianon 19 November 2015. This case involves a 78-year-old female patient who was vaccinated with a intramuscular dose of FLUZONE HD (batch number UI436AA, Expiration date 08 April 2016, dose, dose in series, site of administration were not reported) on November 2015 (unspecified date). Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as hypothyroidism, hypertension, and high cholesterol. Concomitant medications were not reported. On an unspecified date, couple of days post vaccination, the patient developed pigmented purpura dermatosis. Patient required emergency room and physician visit. Lab data included complete blood count which was reported as normal. Corrective treatments were not reported. Outcome of events was reported as unknown. List of documents held by sender: none. Follow up information received from a physician on 26 February 2016. No new information reported.
Subsequent to receiving one dose of varicella virus live on 7/25/95, the pt developed full blown case of chickenpox characterized by fever with many lesions all over the body on 4/28/99. Reportedly the pt's mother had shingles approximately one month prior to onset.
Warm feeling and rash on the left side and left upper leg and around waist. Pt stated that rash burn.
Swollen neck/collarbone area; Sore side of neck/collarbone area,; Presence of knots in this area with sore to touch and move neck area/knot under left arm pit with feeling ofsmall knot; Difficult swallowing; Constant headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER2613) via an unspecified route of administration in the arm left on 10Apr2021 at 14:15(at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. The patient previously took Sulphur and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 14Mar2021 at 14:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 17:30 the patient experienced swollen neck/collarbone area, sore side of neck/collarbone area, presence of knots in this area with sore to touch and move neck area/knot under left arm pit with feeling of small knot, difficult swallowing and constant headache. The event resulted in emergency room/department or urgent care. The clinical outcome of the events swollen neck/collarbone area, sore side of neck/collarbone area, presence of knots in this area with sore to touch and move neck area/knot under left arm pit with feeling of small knot, difficult swallowing and constant headache was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
After I got my 2nd dose and I was in the waiting room area, about 5 minutes later, my tongue and throat started to swell and mouth felt fuzzy.  I called the nurse over to take my vitals and my blood pressure was 210/180.  They took me downstairs to the ER.   I was given dexamethasone and other medications and they did blood work.  I was there for about 8 hours.  When my BP stablized,  I was discharged to monitor my blood pressure at home and given a prescription oral steroid pack (don't remember the name).  I followed up with my PCP with a phone consult and was prescribe losartan 25mg once a day for my blood pressure.  I am currently taking half the dosage now.
female accompanied by  her father.  Filled out paperwork and was allowed through by clerical person to receive inj.  Nurse vaccinated client.  Clerical supervisor saw DOB after vaccination completed by nurse and informed her.  Client was kept 20 minutes.  No adverse reactions.  Father informed she was underage and we can not administer her second vaccine and to not get any other vaccines for covid unless notified by us or her personal physician.
Patient had  pfizer vaccine mid September , he reports a headache x 3 days that he treated with tylenol, then about a week to 10 days after began having paroxysmal episodes of vertigo - no neuro deficits at time of exam and no other symptoms aside from one episode of nausea- episodes start with turning head to one side and resolve with changing position
not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
developed a rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, 2 days after receiving Shingrix, the patient experienced rash. On 31st August 2020, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years. The patient received dose 1 of Shingrix one week ago. She states that two days after the patient received the dose they developed a rash that lasted for two days and resolved. The reporter did not consent to follow-up.
Case number PHEH2014US011474 is an initial spontaneous report received from a medical assistant on 05 Jun 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO, (batch number: M13017, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml on 13 May 2014. On the same day evening or the next day early in the morning, he developed cellulitis. On 15 May 2014, he was evaluated by the reporter and was found to have a non-tender non-pruritic warm to touch enlarged abscess in his left arm. The events were reported as non serious. The outcome and causality were not reported.
Pain/soreness in L bicep then bilateral buttock pain overnight that got worse. Was found to be rhabdomyolysis. CK peaked at 9303. Patient treated with IVF and pain control with rapid improvement in CK and improvement in pain symptoms, as well as resolution of AKI and elevated trop. Patients CK was down to 2200 at time of discharge and inflammatory markers had improved significantly.
Itching and swelling in left upper arm as well as warm to the touch - also some discomfort
2 days after shot I smelled something odd. This lasted for 3 days.  I also experienced very painful redness and spots on the left side of my tongue and a sore throat. The pain made it  difficult to eat or swallow.Because I often get canker sores in my mouth, I thought that this might be that but it was different than what I usually get.  I took Benadryl, valacyclovir, Motrin, and rinsed and gargled  with various mouth washes and dry mouth products.. Salt water rinses were helpful. Today is day 5 after shot and my throat is better and tongue is better.
ALLL OVER BODY TINGLING SENDSATATION, RASH ALL OVER CHEST , EARS FELT ON FIRE AND ITCHY SKIN ALL OVER
Patient received DTAP/IPV on left arm. 48 Hs c/o develop swollen and redness on site in small blisters, on site of injection. Today the arm is swollen, mild redness. He had no fever or breathing difficulties.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Twinrix vaccine which was already expired on 01st January 2023. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
Patient reported this information to her teacher and the teacher reported the informaton to HD on 10/5/2023. Since patient got vaccines on 9/27/2023, she stated she develped a strong allergy and missed school on 9/27, 9/28.  She returned to school on 10/2 and reported feeling bad to her teacher.  Teacher stated that patient's face appeared swollen.  The teacher asked patient if she had eaten or drank any new foods, if she had been playing with an animal or was using a new shampoo, soap or fabric detergent or if patient had been gardening at home.  Patient answered No to all questions.  Patient told her teacher that she also fainted at home on 9/27/2023 and hit her head on a chair and remembered waking up and having difficulty breathing.  Patient told her teacher that she crawled to  her night stand and grabbed a glass of water.  Patient stated that the water helped her.  Patient asked teacher if she could leave school on 10/2 due to body itching and feeling dizzy.  Patient started taking Benadryl every 8 hours and Bendadryl ointment and started to feel better.  On 10/5/2023 patient told her teacher that if she didn't take the Benadryl she felt her skin allergy and itch would come back.  After incident was reported to HD by the teacher, Public health nurse instructed teacher that patient should follow up with a health care provider and should take vaccine records with her to her appoinment.  Teacher stated she would help patient get and appt with a health care provider.
This spontaneous report was received from a nurse referring to a 27 year old non-pregnant female patient with neither pertinent medical history nor drug reactions/allergies. The patient was not taking any concomitant medication. On 06-MAR-2017, the patient was vaccinated with GARDASIL 9 (lot # M037770, expiration date 01-JUN-2019) for prophylaxis (dose and route of administration were not reported). On the evening of 06-MAR-2017, the patient reported experiencing fever (100F taken orally) (pyrexia), confusion (confusional state), tiredness (fatigue) and bumping into things (coordination abnormal). No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. Causality relationship between the events and GARDASIL 9 was not reported. No product quality complaint was involved. Additional information has been requested.
PAIN IN UPPER LEFT ABDOMEN ALONG WITH PAIN IN LEFT MID BACK REGION STARTING ON 10/29/2012. SHINGLES BREAK OUT BEGINNING AT 9PM ON 11/8/2012 WITH FULL RASH ON LEFT SIDE STOMACH AND MID BACK ON 11/09/2012 ALONG WITH RADIATING NERVE PAIN IN THE AREAS OF RASH.
Woke up with extreme dizziness the morning following injection.  Caused me to fall in my bathroom.  At injection site on left arm, a scaly, itchy, and burning rash appeared about the size of a dollar bill.
Headache, chest pain, shortness of breath, right arm pain on the same side as the injection.
Repeated shaking with chills, headache, nausea and vomiting, muscle/joint aches, fatigue, fever.