chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 11 month old Asian female with no medical history or allergies who on 11May05, at 10:30AM, was accidentally vaccinated in the left thigh with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650644/0887P). Concomitant vaccine that day, at 10:30AM, included a second dose in the right thigh of Hib conj vaccine (tet toxoid) (Acthib) (lot UE392AA). There was no illness at the time of vaccination. The child has manifested no additional symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the next day after vaccination, on 12May05, the pt developed a fever of 105F for one night. On 13May05 the fever was gone, but she developed a slight rash and started cold symptoms with sneezing, coughing, runny nose and sore throat. After one week the symptoms were gone. There were no lab tests done. The pt recovered before 24May05. Additional information is not expected.
Extremely sick; This is a spontaneous report from a contactable consumer.    A 85-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination 85 years) as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19, Prior to vaccination. It was unknown if patient has been tested for COVID-19, since the vaccination. On an unspecified date in Feb2021 patient was extremely sick.  Treatment received for adverse event was unknown. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection site was red, tender, itchy. Had high temperature, some diarrhea. Little rash around site. S/S persisted about 1-2 hrs, resolved.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about  27-MAR-2008, the patient was vaccinated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JAN-2012, the patient was treated by a physician for painful and blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Chills on day 1; feeling of needles poking at me in night 2; morning of day 3:  bright red rash on my  neck and chest - not painful or itchy
About 10 minutes after receiving the vaccine, Patient began experiencing chest tightness, shortness of breath, and dizziness. 911 was called.  50 mg of Benadryl was given at 11:00, then 1 EpiPen administered at 11:10 when her symptoms worsened. Pulse ox was taken and was 97%. EMT arrived and the patient was transported to a local hospital. The patient reported feeling better when contacted by a site administrator later that day.
Vaccine administered IM route. Per standing order vaccine not to be re-administered. Patient counseled that vaccine does not need to be re-administered.
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unspecified age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 16-MAY-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter (mL), once, lot# X004813, expiration date 28-JUL-2024, strength, route and anatomical location were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 46.74 degree Fahrenheit (F) for 2 minutes (product storage error). There were no previous temperature excursions. No additional adverse events were reported (no adverse event), and no further information was provided.
100.4 fever, chills, headache, body aches, dizziness, light headed, nausea, fatigue started 9 hours after vaccine. All of the previously listed reactions continued the second day, with addition to abdominal pain, cough, slight bloody nose, and ear ache. The third day most reactions were gone except fatigue, headache, done light headedness, some body aches, cough and some ear pain. Today I have a cough, some fatigue, and body aches.
patient states that on october 28 (3 weeks after injection) she started getting rash all over body, soreness and swelling at perceived injection site and cough/tightness in chest
During vaccination, needle came loose and 50% of the vaccine was spilled; During vaccination, needle came loose and 50% of the vaccine was spilled; A spontaneous report was received from a physician's assistant concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and during vaccination, needle came loose (device connection issue) and 50% of the vaccine was spilled (underdose).  The patient's medical history was not provided.  Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date.  On 11 Feb 2021, on the same day as the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 038K20A) in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, during vaccination, the needle came loose and 50% of the vaccine was spilled.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, the action taken with the drug in response to the events was not applicable.   The outcome of the events, during vaccination, needle came loose and 50% of the vaccine was spilled, was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to loose needle for mRNA-1273, lot # 038K20A with no associated AEs.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-DEC-2015, the patient was vaccinated with one dose of improperly stored ZOSTAVAX, lot # L021609, expiration date 10-SEP-2016 (route unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
No additional AE reported; expired dose of PNEUMOVAX 23 was administered to 3 patients; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis (expired vaccine used). There was no additional adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Painful movement, elevated blood pressure, weakness in vaccinated arm. Not red initially, but noted to be red and swollen the following day. Vomiting x 2, flushing. Patient treated with Keflex 500mg BID x 14 days and prednisone 10mg qday x2.
cut the muscle at my face it actually caused an indentation so a piece of my face was taken out and now I've got swelling in that side and you can't see the indentation anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: I have had migraines; "brain tumor" (unspecified if ongoing), notes: I have had brain tumor; "brain surgery" (unspecified if ongoing), notes: I had to get brain surgery 2 time in my brain; "neurological problems" (unspecified if ongoing), notes: I've had neurological problems; "Tumor" (unspecified if ongoing), notes: I had a tumor when I was 18 years old; "seizures" (unspecified if ongoing), notes: suffered with seizures 8 years after that for a period of 12 years; "allergies to medicine" (unspecified if ongoing), notes: I had a lot of allergies to medicine; "arm pain" (unspecified if ongoing), notes: wake up with arm pain; "upset stomach" (unspecified if ongoing), notes: possibly an upset stomach. The patient's concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 2023, outcome "unknown", described as "cut the muscle at my face it actually caused an indentation so a piece of my face was taken out and now I've got swelling in that side and you can't see the indentation anymore".  Additional information: Caller reports that she had vaccine for covid 4 weeks ago as of tomorrow, used to suffer with migraines, wake up with arm pain, possibly an upset stomach, have had migraines it came and gone, have had brain tumor, had to get brain surgery 2 time in her brain and She is just concerned about having the second vaccine, she never meant to have it because she don't wanna have a stroke or anything bad to happen because of the vaccine. She had neurological problems, had 2 brain operations, had a tumor when she was 18 years old and suffered with seizures 8 years after that for a period of 12 years. She had a lot of allergies to medicine. She was just concerned because it cut a muscle at my face and when they cut the muscle at her face it actually caused an indentation so a piece of her face was taken out and now she got swelling in that side and you can't see the indentation anymore. They started out really intense and for a solid week it was didn't leave and they are coming and going like when she was a child cause she suffered with them for 5 years till they found out she had a tumor and there is scar tissue in the area where the tumor was."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
nausea; body and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (body and muscle aches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer stomach (By taking ibuprofen). Concomitant products included LOSARTAN, SIMVASTATIN, FISH OIL and COLECALCIFEROL (D3) for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (nausea) and MYALGIA (body and muscle aches). At the time of the report, NAUSEA (nausea) and MYALGIA (body and muscle aches) outcome was unknown.; 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.
4 hours, post vax, pt had 1 hour of crying then became pale, limp, poorly responding, which lasted several minutes; then remained pale and lethargic for 1-2 hours. Diagnosed with Hypotensive, unresponsive episode
DIZZINESS; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on 06-APR-2021 17:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Severe ringing in my right ear since 04/20 Tuesday noon. Dizziness, Nausea, and Vertigo-like symptoms that lasted rest of the day. I still have constant high-pitched loud sound in my right ear.
Cold sores developed overnight below the right half of my lower lip (itching, burning blisters, weeping). Right side of lower lip has swollen to maximum size (throbbing, red, stretched skin to the size of a grape tomato.) Canker sore developed on the inside of that area, but that may be due to accidentally biting the swollen lip while eating. Ongoing. It may be worth noting that I've only had one cold sore before and it was earlier this year (Feb 2022). So they are not something I experience frequently.
Ringing her ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing her ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing her ears). At the time of the report, TINNITUS (Ringing her ears) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. The patient went to her Ear, Throat and Nose doctor and was told she should get the 2nd dose. This case was linked to MOD-2021-400077 (Patient Link).
My menstrual cycle is not due to begin until March 17, 2021.  I am on birth control and I take it routinely at the same time everyday.  I did not miss a dose, my cycle has never been early like this (maybe a day early.)  I started spotting hours after I received my shot, on March 8, 2021 and now it is a full blown cycle.  This makes my cycle 9 days early.
Subsequently post vax, the pt developed pleurisy symptoms, had low energy level, and felt very tired. She was hospitalized on 6/13/00.  Follow-up dated 6/26/00 from the physician indicated that the pt developed chest pain which lead to the recent hospitalization.
Vaccine was given when it is 4 days after itss beyond-use-date in the fridge
"Caused fibromyalgia to flare up" inducing:  -worsening upper respiratory infection -mouth blisters/soreness with constant drooling -skin burning -shingles outbreak -severe muscle weakness -kidney infection -loss of appetite -diarrhea -severe fatigue
Severe shoulder pain where I received the injection on 4-30-18 and still sore, but improving as of 5-2-18. Muscle and joint pain for 2 days, but now improving, shivering for a day, weakness for 2 days, on 5-1-18 bicep in the arm I received the vaccination started getting very sore and turned red and warm to the touch and is still this way today 5-2-18.
Felt soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt soreness on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt soreness on his arm). At the time of the report, VACCINATION SITE PAIN (Felt soreness on his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna) in an 11-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR4504B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mixed series which patient had received 1st dose Pfizer COVID19 vaccine and 2nd dose Moderna) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that HCP was looking for further information regarding mixing and matching COVID19 vaccines in pediatric patients. HCP refused to provide further information as they did not agree on seeing the event as a deviation as they did not have availability of Pfizer COVID19 vaccines.  Treatment medication was not provided by the reporter.
Pt was feeling sick with tiredness and sinus symptoms before he got the flu shot. The day after flu shot, he had a temperature of 104F, sweating, total body ache and exhausted X 4 days. He was seen at a walk-in medical care center. Missed 1 week of work. Rx'd with Naprosyn; Tylenol and ice. Dx: concomitant Viral Syndrome and a reaction to flu vaccine.
Patient was injected in the right deltoid, and presented with swelling and redness below the injection site and continuing down to her hand.  Two days post injection when the patient returned to the pharmacy,  the redness, pain and swelling were resolving.  The pharmacy contacted her primary physician to advise of the condition, and the patient said she will call her doctor if the condition worsens or does not improve.
Patient presents with vaccine reaction   Had first dose Pfizer COVID vaccine and walked into waiting room for observation and started to feel like drank sometimes warm and then became dizzy shortly after that. Waited a couple minutes in waiting room and then told observer up front what she was feeling. Was asked if wanted a wheelchair to come back to examination room and patient declined and able to walk back down the hall accompanied by her husband.     Denies nausea, abdominal pain, no SOB, no syncope, no recent illness, denies fevers cough, ill contacts   Working wood burning project and was up till 3am and then unable to go sleep yet today. Also has stress with only child with being treated for stage 4 breast cancer   Did eat breakfast around 9am- granola and cup of tea this am. Nothing since then.   Current B/P 164/110 and then 10 minutes later was 150/86. Patient verbalized has history hypertension even with medication. Denies visual changes, denies headaches Vaccine reaction Symptoms resolved. Told patient if start to feel bad again let someone know (husband, COVID hotline, PCP). Increase fluids, discussed sleep hygiene.Patient and/or guardian verbalized understanding
Patient presented who is a former smokerhome oxygen 2-3 lt at night time. She was admitted to the hospital for 3 days with the chief complaint of shortness of breath. She states that she developed cough and shortness of breath about 2 days ago and has been getting worse because of which she came to the ER. In hospital, initially she was on Solumedrol 40 mg every 8 hr>>changed to prednisone 40 mg daily for 5 doses at discharge. Pantoprazole 40 mg daily while on steroids.
in mid May 2021, I began to have heart palpitations, hair falling out, extreme fatigue.  I went to see a cardiologist who put me on a heart monitor, did bloodwork and an echocardiogram.  The blood work showed my thyroid had completely stopped.  In addition, my heart is not coming back to relaxation as fast as it should.  Due to this, I am now on thyroid replacement hormone therapy and take a medication to slow my heart back down.  This occurred after the second Moderna dose.  I have not felt well at all since my second dose, and still am extremely tired, and trying to get my body into some kind of balance.
broke out all over body hives at home  ~8-9 days for hives to resolve pt states she is ok now 7/28/19.