chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain from broken teeth; This is a spontaneous report from a contactable physician. A 79-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported that patient received both doses of the Pfizer BioNtech covid 19 vaccine last on 07MAR2021, seeking information on when he can get the third booster dose as he had various health issues, namely pain from broken teeth that he needs to visit his dentist to have fixed. The outcome of the event was reported as unknown.
Initial unsolicited report received from a nurse (Nursing Supervisor) on 26-Jun-2017. This case involves a 54-year-male patient who was vaccinated with a first dose of ADACEL (Batch number- C5216AB, expiration date- 06 Jun 2019, dose, dose in series and route of administration were not reported) in left deltoid on 21-Jun-2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as none. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations were reported as none and concomitant medications were not reported. On 23-Jun-2017 morning, two days following vaccination patient experienced nausea, vomiting, body aches, fever and chills. On an unknown date following vaccination, patient returned to office and there was quarter size reddened area that is firm to the touch and mild painful. The patient needed ER / doctor visit on an unspecified date. It was reported that patient was advised to take over the counter pain medication, rest and apply ice. Laboratory investigations was reported as none. On an unknown date patient was recovered from all the events only vaccination site inflammation was not recovered. List of documents held by sender: none.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm; cannot raise it), PYREXIA (fever), FATIGUE (zero energy) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm; cannot raise it), PYREXIA (fever), FATIGUE (zero energy) and HEADACHE (headache). At the time of the report, PERIPHERAL SWELLING (swollen arm; cannot raise it), PYREXIA (fever), FATIGUE (zero energy) and HEADACHE (headache) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided.
A non-serious spontaneous report of administration to a 54 year-old was received from a 54 year-old female consumer subsequent to FLUMIST. The patient received FLUMIST (date not reported). The consumer reported that she received FLUMIT at her church and later discovered that FLUMIST was only indicated up to age 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
had both shot, broke out with shingles/suspected vaccination failure; shingles, right side of face; extreme pain; feels like face is on fire; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In May 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had both Shingles shot, but last week he/she broke out with shingles on the right side of face. The patient do believe if he/she had not had the shots it would be much worse than it is. It was extreme pain, very painful. At times it just feels like his/her face was on fire. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
PATIENT HAD BEEN INITIALLY VACCINATED WITH THE MODERNA COVID-19 VACCINE (PRIME DOSE); PATIENT RECEIVED PFIZER-BIONTECH COVID-19 LOT# EN6199 | EXP: 06/2021 IM INJECTION TO LEFT DELTOID AS THEIR SECOND DOSE (BOOST DOSE) ON 03/19/21 AT 17:30; PATIENT MONITORED FOR 30 MINUTES S/P INJECTION AND PATIENT DENIES ANY C/O  PAIN, DISCOMFORT, ANY AND ALL OTHER S/S AT THIS TIME;  RN WILL CONTINUE TO FOLLOW UP WITH PATIENT QDAY FOR NEXT 14 DAYS; PATIENT GIVEN COPY OF EUA FACT SHEETS FOR BOTH MANUFACTURERS AS WELL AS MEDICAL CONTACT INFORMATION; PATIENT DEMONSTRATES AND VERBALIZES UNDERSTANDING.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FF8831) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "hashimoto's thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfa Drugs; "Known allergies: SUlfa drugs" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfa Drugs. Concomitant medication(s) included: INSULIN; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive; (29May2022) Negative; (10Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks. Product- COVID 19 Treatment, Brand: Paxlovid, Treatment start date- 25May2022, Treatment stop date- 30May2022; Novolog. I tested positive for COVID19 on an at home test on 25May2022. I have Type 1 diabetes and consulted with endocrinologist who prescribed Paxlovid. I took the full course and followed CDC guidelines on masking/isolation. I recovered, and tested negative on 29May (Day 4). I remained negative on subsequent tests through Day 12 (the last day I had tested prior to 10Jun2022). On Day 16 or 10Jun2022, symptoms returned and I tested positive for COVID19 again.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Within 2-3 hours after receiving the Rotateq vaccine, she got serious vomiting and diarhea and began to cry and scream uncontrollably.  She seemed to have extreme discomfort in her stomach and/or digestive system.  She became exhausted from the pain and sleeplessness.  Her gas seemed to build over the next two days.  By the end of the second day, my pediatrician's nurse on call advised me when I called in with the symptoms to take her to the emergency room.  At the emergency room, a number of tests were done, including an x-ray to test for intrussesesion (spelling is wrong, I know).  The x-ray showed that her intestines looked fine but that her whole digestive system was filled with major amounts of gas that was causing extreme bloating.  She had a hard time getting the gas out.  I was told the only thing we could do for her is give her mylicon and continue to burp her constantly.  She had severe stomach problems for the next 2 months, and she didn't return to what I would consider to be normal or healthy or pre-innoculation condition until about 4 months later when she was 6 months old.  She is otherwise a very healthy and strong girl and has had no problem with any other vaccine.  I knew that all of her symptoms began right in-time with the vomiting and diahrea 2-3 hours after the vaccine.  There were no other dietary or lifestyle changes that can account for her sudden decline in digestive health.
Felt tachycardia. This resolved without intervention in a few minutes. HR 77, O2 99%, BP 126/78
Difficulty breathing, wheezing, weakness all over, dizziness, muscle aches, fatigue and nausea.
Patient reports itching, and hives. Epi Pen administered and patient escorted to the ED She did receive epi prior to arrival but required no epi in the ED.  She received corticosteroids.  She was monitored for period time with no deterioration of symptoms. She is discharged stable condition she will complete prednisone and use Benadryl as needed
Every time I breathe I have pain; Soreness in arm; Has asthma; When moving around more noticed being winded/ thought I slept wrong; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong). At the time of the report, DYSPNEA (Every time I breathe I have pain), PAIN IN EXTREMITY (Soreness in arm), ASTHMA (Has asthma) and FEELING ABNORMAL (When moving around more noticed being winded/ thought I slept wrong) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sore Mouth; STOMATITIS; This spontaneous case was reported by a physician and describes the occurrence of ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) in a 52-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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS). At the time of the report, ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) to be probably related.    Concomitant medications were not provided. Treatment information was not reported.
Patient stated she felt faint and dizzy.  Nurse stated that the patient looked sweaty and pale but did not actually passout.  PT also said she felt sick to her stomach but did not vomit.
No known adverse reaction. Vaccine expired 8/31/2022, but erroneously administered on 9/1/2022. Parent contacted. Recommended revaccination.
Dizziness 4/30 0400 -> resolved "late afternoon". Increased BP.
Red patch on area of arm where shot administered appearing 10 days after 1st dose of Moderna Corona virus vaccine
Within 24 hours developed burning/ redness at injection site. Then blisters developed. Called MD 10/18/04 and Prednisone oral prescribed x 6 days and Triaminoclone cream. Blisters and swelling from shoulder to thumb progressed. Client not seen by doctor until 11/10/04. Health department notified 11/15/04.
pt recv vax 3MAY96 & w/in 15min pt exp scratchy throat & throat tightness;pt has taken DPH tablets & is exp some relief;pt will contact MD;
Patient present with left wrist joint pain, and ankle pain and stiffness.  Left wrist pain with a relatively sudden onset, approx 12 hours after injection site.  The pain is located at the entire wrist but is worse just below her thumb. This has been continuous since the vaccine and has not subsided for the past 7 weeks. She describes the pain as sharp and radiating to forearm and often feels a clicking or feels like the joint is stuck. Aggravating factors include lifting her new born child and is worse at night time.  She has not tried taking pain medications for it at this time, but has tried ice, which does not help with the pain. The pain is so severe at time's that she worry's she may drop her child. Ankle pain and stiffness lasted for approx. one week and has subsided at this time.  Denies prior injurys.
Administration Error - undiluted vaccine administered.  Patient received one undiluted dose of Pfizer-BioNTech vaccine (0.2ml).  Provider who administered dose did not add the 1.3ml diluent to the vial.  Therefore, the administered dose was incorrect.    The error was noted 5+ hours later.   At the time of administration and prior to leaving clinic, patient was asymptomatic.
only time ever got the flu; Initial information received on 24-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves patient who experienced only time ever got the flu (influenza) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious only time ever got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event (only time ever got the flu).  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Chest flushing and gagging 25 minutes after initial dose.  Symptoms were reported by patient and husband to be consistent with previous episodes of "chemical sensitivity" that have not required epinephrine.  Pt was given benadryl PO and transported to ED for EMS.
p/pt recv vax seen in MD office w/lt arm red & swollen size of nickle; no fever; no neurological sign rpt; parents says it grew to size of half dollar; subsiding now;
Less than 48 hrs after admin of vaccine fevers 103.5. Lethargy - unable to walk - developed neck and back pain. Seen in ER - for meningitis; Sx D/C after spinal tap 2/1/18 admitted to ER due to having seizure. EEG normal. As of 2/7/18 doing better.
Chief Complaint  To rm 6 per EMSwith decreased responsiveness  History of Present Illness  79-year-old demented and mostly nonverbal female nursing home patient who has presented to the ER this evening with altered mental status and decreased responsiveness.  She was brought to the ER after staff reported some concerns.  She was treated earlier this month for a pansensitive E. coli UTI.  Urinalysis this evening demonstrates persistent pyuria, although bacteria were negative.  Also interestingly, she has tested positive for COVID-19.  She was fully vaccinated earlier this year with Pfizer vaccination series x2.  Her daughter, present in the room, states that she has not received the booster shot as of yet.     There were some reports of possible perioral cyanosis at the nursing facility.  According to the ER physician, obtaining an accurate pleth on the SPO2 monitor was somewhat difficult.  She is presently at 100% SPO2 on a liter of oxygen.  A chest x-ray was obtained which does not reveal evidence of pulmonic infiltrate.  She was given IV fluids after her lactic acid level returned at 2.4.  She has also been given Rocephin.   Patient will now be admitted to the hospitalist service for continued evaluation and management of presenting conditions.   PLEASE NOTE THAT COVID BOOSTER VACCINEWAS PULLED FROM REGISTRY.
cramping; diarrhea; fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Nov-2023, the patient experienced MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), FATIGUE (fatigue) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No Concomitant medication was reported.  Events occurred within 6 hours of receipt of vaccination. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
legs swelled a lot; pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs; couldn't move her ankles; hard to move them; sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened). At the time of the report, PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened) outcome was unknown.            Concomitant medication not provided by reporter. Patient went to the emergency room twice and the doctor did not seem to understand the issue. Treatment information not provided by reporter. The Patient states the pain is strong that the patient is trying to look for an alternative,  .
Rash on L arm, red, slightly raised approx. 3" in length; 1" wide. Pt states "its getting better". Site of SC polio injection in back of arm.
Pt recvd vax & exp diarrhea & stomach cramps; sx lasted 24-48 hrs; treated w/ rest & adequate fluids;
Shots given at approx. 1000 AM.  Baby wouldn't stop crying.  Mom called at 1545.  Tylenol infants given at 1130 and 1530.  No rash.  No swelling.  Pink at shot sites.
Patient had a hard red lump on left deltoid. Tried using warm wet compress to help with no success. Patient was seen in ER 3 days later for cellulitis and started on KEFLEX.
My daughter was given the final GARDASIL shot, for a month or so after she suffered from migraines and body aches.  8/12/08 Reviewed PCP medical records of 10/9/2007- 4/25/2008. FINAL DX: none provided. Records reveal pt c/o of cough, sore throat & possible dyslexia on 10/9/2007. Dx w/URI.  Had right ankle sprain 11/2007.  Dx w/URI on 12/13/2007.  HA & cough 1/2008, injured wrist at school & went to ER 2/08 where dx w/wrist sprain, continued w/intermittent but almost daily HA & stomach ache, allergies.  On 4/18/08 dx w/HA & allergies.  Referred to Neuro & Ophtho, both exams (-).  Developed cough & nosebleeds w/sneezing.  Dx w/sinusitis. VAX: HPV #3, lot #1968U given IM LA on 4/18/2008; HPV #2, lot #1062U given on 12/13/2007 IM LA; HPV #1, lot # 0522U given on 10/9/2007 IM LA; & Fluzone #2437AA given 10/9/2007 IM RA.
During a mass Flu Clinic for adults and children, I gave "FLUARIX" to a child meant for adults 18 years and older by mistake. No known adverse events.  Follow-up - No adverse events occurred.
Developed stomach cramps and discomfort. Proceeded to vomit and empty stomach. Waited a few hours and then diametric and another vomiting episode.
Pt. states that after receiving the 1st dose of J&J 07/31/2021, started experiencing symptoms 08/05/2021 of severe inflammation in the right leg (prior removal of varicose veins), Recommendation for no other vaccines due to possible blood clotting.
Modern a COVID-19 Vaccine EUA On the 9th day after vaccination, my left arm had a 2 red swollen  rashes below the injection location. It was very itchy and tender. I did not take any medication. The discomfort lasted 2 days and the redness and swolleness  was gone 3days later.
Severe ear pain on the right side. Tender scalp.  Visited the ER and urgent care to get pain relief.  Prednisone was prescribed and helped ease the pain bug pain is still persisting after medication was consisted.  Went to the ENT and am following up with sinus catscan, chiropractor, dental specialist, allergy treatment, and neurologist.