chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). In November 2018, less than a month after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient's mother reported that approximately 2 weeks ago from the reporting date the received BEXSERO and experienced arm pain. The reporter reported that there was no sign of swelling or redness just pain in the arm. The reporter gave consent to follow up.
High fever started on Wednesday then turned to a cold on Friday by 3 am on Sunday I woke up to her crying because her eyes was closed shut due to excess mucus from her eye.
This is a spontaneous case, initially received from other health professional (nurse) on 07-Feb-2018, concerning a 57-months-old, child male patient. On 06-Feb-2018, the patient (under 5 years of age) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left vastus lateralis, batch number: XF35009, expiry date: 30-Jun-2018). The reporter assessed the event as non-serious. Significant follow up received on 26-Mar-2018: This case was considered as lost to follow up. Hence, no amendment was done in the narrative.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's friend. The case has been linked to the case US2019127843, reported by same reporter.
This spontaneous report as received from a doctor of pharmacy refers to a two patients of unknown age who on 18-JUL-2012, were vaccinated with a dose of VARIVAX (Merck) (lot number 669557/1700Z, Exp. Date: 12-SEP-2012, also reported as 09-DEC-2012) (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Pt arrives with URI. pt got covid last week at Bingo. Pt has steadily gotten worse in the last week. He has lost sense of taste and smell, has a cough feels very little short of breath, denies chest pain, denies headaches, denies nausea vomiting diarrhea.  Patient has had the Covid vaccine.  Patient has had a stroke in the remote past that has left him with some mild right-sided weakness.  Patient denies history of MI.  Patient has not been seen for this or been on any medications yet, I am not sure that his event has a positive. Associated Symptoms: cough, shortness of breath, URI symptoms o History of Present Illness  This is a 78-year-old male with significant past medical history of hypertension, diabetes and hyperlipidemia that presented to the hospital with chief complaint of progressive worsening dyspnea over the past several days.  The patient started feeling sick last week Wednesday, about 8 days ago.  He had significant chills while he was at bingo, he started to get worse from there.  The patient states that he had no appetite, lost taste and smell.  The patient had intermittent fevers and chills, with diuresis.  The patient had a severe cough, felt very weak and fatigued.  He states that he did not get up to walk for several days.  The patient then started to develop significant dyspnea, he called his neighbor today who then called 911.  The patient denied any significant chest pain, nausea or vomiting.  He states he has not been eating or drinking very much at all.  The patient does live alone..  He denies any abdominal pain, diarrhea, lightheadedness or dizziness.  The patient denied any chest pain,, lightheadedness or dizziness.  He denied any palpitations.  The patient denies any history of CKD.  Patient states he really has not been taking his home medications as he has not been feeling well.  Denies any dysuria, hematuria urinary frequency.  The emergency room, the patient was found to be severely hypoxemic on room air he was titrated up to 7 L of oxygen.  The patient had a chest x-ray which looked like old pneumonia.  He had acute renal failure.  When he got to the med surge floor the patient had to be rapidly titrated up to 15 L high flow nasal cannula as well as a nonrebreather mask to maintain O2 sats above 90%.  The patient currently is dyspneic and having mild conversational dyspnea.
Pt. received Moderna vaccine at 10:45a.m. ten minutes later pt. started complaining of pain behind both ears.  Pt. denied chest pain, SOB at the time.   Pt. remained in the office.  Approximately thirty minutes later, pt. developed chest pain on the left side.  EKG was attempted but could not be performed due to pt. stated it was his chest was hurting when he laid back. Pt. was given 2 liters of Depo Medrol IM and placed call to 911.  EMS arrived within fifteen minutes.  Pt. was transported to ED.
Client c/o difficulty breathing and anxiety, duration 5 minutes, one week after first dose. States "felt weird" and "had to take mask off to breathe".
Patient becoming dizzy and state mental changes after leaving clinic and after stopping at pharmacy, hitting gas instead of brake and had profuse bloody nose, patient taken to ER and needed packing to stop. CBC, PT/PTT, CMP normal.
With 2nd dose, hives on other parts of my body, severe on back. Received cortosone injection at urgent care and am now on methylprednisone pack from primary doctor. Still active 2/16/21. Took benedril on own for first 2 days. Highly allergic only to insects.
Felt like she had the flu for one week.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.) 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 April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Document Attached for Initial Report, Non significant Follow up
Case number PHEH2012US010859 is an initial spontaneous report received from a nurse on 24 May 2012: This case refers to 20-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10053) intramuscularly, without reconstituting with Men A component on 24 May 2012. No adverse reaction had occurred following this administration error.
On Wednesday, April 5th, 5 days after DTapP vaccination, patient suffered from a seizure.  The seizure lasted for approx. 3-4 minutes.  Her temperature was taken immediately following the seizure and it ranged from 98-99 degrees.  She was taken to the ER and several tests were taken to determine the source of the seizure.  She was hydrated and given a Tylenol for a low-grade fever of 99 degrees. Her temperature was low-grade for the remainder of the day. After all tests showed that everything was clear and was released.  The following day during a check up with her pediatrition, she was experiecing a fever, very lethargic and was found to have some kind of throat soreness.  The Dr. observed her for 12 hours while she was being hydrated to make sure a fever didn't spike and cause another seizure. At the examination the following day, she seemed to be back to her cheerful self and was sent home.  No other reactions were seen after this.
Arthritis; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Lot number: HG2282) at the age of 64 years, in left arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "Heart attack" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization; Bnt162b2 (Dose 4), for COVID-19 immunization; Bnt162b2 (Dose 5), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered"; ARTHRITIS (non-serious) with onset 06Oct2023, outcome "not recovered". The events "arthritis" and "pain" required physician office visit. Additional information: patient had six Pfizer shots since the pandemic, and she had been fine after all of them, except for this last one, patient now have Arthritis okay and it came on exactly on the 10th day after she had gotten a shot and she was talking, she had been in pain for 28 days. Patient went to the doctor on Monday but she had been in pain for. Patient did not have Arthritis before. Patient had the Flu (Unspecified flu shot) and the RSV (Unspecified RSV vaccine) two or three weeks prior.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
swollen eyelids w/sore erythema, both eyes 2hr p/vax
Tested positive for COVID-19 after the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) (seriousness criterion medically significant). At the time of the report, COVID-19 (Tested positive for COVID-19 after the first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event "COVID19 +" , a causal relationship is unlikely related; 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 "COVID19 +" , a causal relationship is unlikely related
Clinic did not ask me to wait 15 to 20 minitues. Passed out 10 minutes after injection. Rolled car 3 times.
Approximately 24 hours after the injection, my eyes began to itch and swell shut.  This was the exact same reaction as last year, however, I had a different flu injection last year - the one recommended for seniors.  I went to the ER as that was the only doctor available, who gave me a prescription for dexAMETHasone, which I took for two days and my eyes returned to normal.
Had 1st anthrax vaccine at 13:00 on 12/3/02. Experienced nausea at 13:30. Developed pruritic macular rash on entire body with onset of facial/neck swelling and tightness, mild shortness of breath - did not seek medical care - took Benadryl and fell asleep - symptoms resolved next day.
Fever of 101 degrees, Headaches and entire body aches for three days on both shots. Felt like the Flu.  The second shot 20 hours after I began convulsing  and shaking uncontrollably.  In addition I started to feel very cold at this time. Then Became nauseated.  Held off vomiting as long as possible.  When I went to walk it was almost impossible.  After vomiting about six times over a period of time I made way back to the couch where I laid until my convulsions began to subside along with nausea and the feeling freezing.
Itchy rash started 24 hours ago after doses of VARIVAX #1 3/28/02 and #2 3/28/07
This spontaneous report has been received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On unknown dates between 20-DEC-2016 and 02-FEB-2017, the patients were vaccinated with improperly stored PNEUMOVAX23 (0.5 ml, once) via intramuscular route for prophylaxis. Nurse reported that the vaccines were exposed to 50.9F temperature for 6 hours on 20-DEC-2016. There were no previous temperature excursions. Data Logger was involved. Nurse also mentioned that the refrigerator was small and did not stored many products, so the lots may have varied and were specific to patients. No adverse effects were reported. Additional information has been requested.
Above vaccine given 930A ON 9/1/21 ANd VAcciNe expired 8/31/21 Reported to Moderna awaiting further instruction.
Extreme dizziness, weakness, disorientation, ringing in ears - for 3 days - no treatment.
About 60 minutes after receiving the vaccine, I developed a rash/hives on my face, neck, chest and arms. This lasted for about 20 minutes with no treatment. I took a Benadryl by doctor instruction a few hours after the reaction.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm 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). The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red and swelling legs, hives, itching, redness on throat with swelling and now bruises
I have trouble swallowing solid food. Specifically, after chewing the solid foods finely (i.e. eggs, spam, meat, edamame), the throat will not swallow. It just feels like the throat forgets how to swallow, which should have been a natural response normally that does not require conscious thinking. If I forcefully swallow it, it feels like the food did not go down well and some pieces were stuck in the trachea and I want to spit out mucous. When I spit out, there were nothing strange, mainly just saliva. I had no issue swallowing liquid or soft foods (i.e. yogurt and steamed egg). I do not feel pain or swollen on throat but do sometimes feel there was something at the back of the throat. But again when I spit out mucous there was nothing abnormal. I went to the student health center and they did not find any abnormal in the throat, only seemed a little red but nothing abnormal.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 09:30 as dose 1, single (Lot number: EM981), in left arm, on 26Feb2021 at 09:30 as dose 2, single (Lot number: EN6201), in left arm, on 12Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 27May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received covid treatment with Paxlovid treatment start date-26Jun2022, treatment stop date-29Jun2022, Lot number: G8236, Indication: Treatment of covid-19.  No follow-up attempts are possible. No further information is expected.
Rt lateral thigh 15 x 30cm erythema and induration that is hot to the touch, dx is cellulitis, cool pack to affected area, deflex 250mg/5cc 6cc po qid x 10days.
On 11/14/00, this 52 year old female received a Fluvirin vaccination at her local drugstore. "A few days later", she developed bilateral soreness/weakness of her shoulders. She also noted a rash on her right hand and on bony prominences; "knuckles, ankles and elbows". The dx of "dermatomyositis" has been made. Pt states that "dermatomyositis is sometimes involved with cancer", but that her tests have all been negative for malignancy. Additional information has been requested. The follow up received on 3/22/01 states "dermatomyositis, muscle weakness, muscle soreness, and rash (November 2000)."
Information has been received from the authors in a published literature regarding to a patient of an unknown age and gender enrolled in a study. The subject's current condition included human immunodeficiency virus (HIV) infection. Medical history was not reported. This was a clinical trial, the patient was randomized in a 1:1.5 ratio to the immediate and delayed vaccinations groups (Immediate group and Delayed group, respectively) by a computer-generated random list. The 1:1.5 ratio was chosen to account for the likelihood for increased rate of lost to follow up in the Delayed group. Those in the Immediate group received, on an unknown date, pneumococcal vaccine (Manufacturer unknown) (dosage, route, lot# and expiration date were not reported) at the time of enrollment and placebo 9-12 months later. The Delayed group received placebo at the time of enrollment and pneumococcal vaccine (Manufacturer unknown) 9-12 months post-enrollment (after 6 months of antiretroviral treatment (ART)). All participants were followed up 1 month (4-6 weeks), 6 months (+/-1), and 12 months (+/-3) after each intervention. The authors reported that on an unknown date 7 subjects were hospitalized with diagnosis of pneumonia. One case was confirmed as pneumococcal pneumonia (a patient randomized to the Delayed group and prior to PPV23 administration). The outcome of Pneumonia pneumococcal was unknown. The investigator considered Pneumonia pneumococcal to be related to Pneumococcal Vaccine (Manufacturer unknown). Additional information has been requested.
Patient received the Moderna vaccine at the at of 17 years and 8 days, vaccine is recommended for individuals 18 years and older.  Attempted contact to mom to see if patient is having any adverse reactions to vaccine outside of side effect potentials as noted on the EUA education provided at the vaccine clinic. There was no answer by mom, will attempt to call again on 3.19.2021.
dose that was expired on 11/9 was given on 11/10, Moderna was contacted and the dose was found to effective
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose, route and lot number unknown). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date in 2013 the patient experienced death, following unspecified surgery. The pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013 and was inquiring about the 3(three) vaccinations that the patient had received. The physician stated that the patient had exhibited a fever. A request was made for the patient's Primary Care Physician's, name and contact information. A request was made for a copy of the patient's Death Certificate and/or Autopsy Report. The pharmacist stated that there were several physician's involved with the patient's case. The pharmacist refused to give any information and stated that the patient's information was being handled by Clinical Risk Management for Pharmacy. Relatedness between vaccination with ZOSTAVAX and death was not reported. Upon internal review surgery was considered medically significant. Additional information has been requested.
Pt recv vax on 10/31/98; on same day pt exp hives over body w/itching x 4dy; tx=Caladryl lotion, Benadryl, Benadryl cream
10 minutes, post vax, pt had syncopal episode with fall from standing position, striking her head (posterior) on the floor. Pt initially unresponsive with eyes open X 30 seconds. Pt had erythematous rash (papular patches) on left upper extremity where IZ was received and around eyes and mouth. No respiratory problems. Child was monitored an additional hour and Benadryl. Rash present when she left but had decreased.