chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-4410. Initial case report received from a consumer on 07 NOV 2009. A male patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on 12 OCT 2009. The patient experienced mild body aches and stiff neck on 13 OCT 2009, one day after the injection. The patient recovered.
2.75 x 1.75  CM  RED  HARD AREA  AT  INJECTION SITE
soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 26-Mar-2021, PAIN IN EXTREMITY (soreness in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Event outcome provided and Second dose details
FLU LIKE SYMPTOMS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms. This report was non-serious.
no additional AE; 1st dose of MMR II 08/24/2006 and patient's date of birth is 08/29/2005, the 2nd dose was given 08/17/2010.; This spontaneous report was received from a medical assistant and refers to a 11-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-AUG-2006, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot# reported as 095R, but upon internal validation verified to be a non-valid lot# (formulation, dose, route of administration, expiry date were not provided) for prophylaxis. On 17-AUG-2010, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, dose, route of administration, lot # and expiry date were not provided) for prophylaxis (inappropriate schedule of product administration). There was no additional adverse event reported.
Chills; Low fever; Joint pains; Muscle aches; Mild nausea; Fatigue; Injection site pain; headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 30Apr2021 at 16:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included colecalciferol (VITAMIN D3) and multi vitamin GUMMY; both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 05:00, the patient experienced chills, low fever, joint pains, muscle aches, headaches, mild nausea, fatigue and injection site pain. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, low fever, joint pains, muscle aches, headaches, mild nausea, fatigue and injection site pain were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
injection site was bleeding; wondering if the full dose was received or should get another vaccine; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support. A contactable consumer reported for a unknown Patient.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had injection site bleeding and patient wondering if the full dose was received or should get another vaccine. It was reported that, It was reported that a patient did not receive the covid-19 vaccine at pharmacy, after patient received the vaccine, the injection site was bleeding and had clear fluid, patient is wondering if the full dose was received or should get another vaccine. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Zostavax (0561Y/4131x)administered on Tuesday, 7/21/09 to LA without incident.  Pt. called office on 7/27/09 reporting sore & swollen Lt shoulder joint in the middle of the night on Saturday, 7/25/09.  States it's a "wrenched joint" feeling when she lifts her arm.  No redness, lump or itching.  States site is swollen but "not bad".  Pt. states she can't think of anything she's done that would account for that pain.  Recommended ice pack & stated I would follow up.  On 7/29/09, called pt. who states that her arm was really bad yesterday but is a little better today.  States that it seems to be "joint" pain. She states that she is regularly icing site and that seems to help.  She does not wish to go to PCP as "what are they going to do about it?" States she is taking aspirin and aleve & applying ice.  States "I honestly feel it's better today than yesterday."  Will continue to follow up w/patient.
Really messed up her cycle; Clarified she is losing a lot of blood and never ever experienced it before the COVID shot/ bleeding more than 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 31Oct2021 as dose 1, single (Lot number: 30145BA) at the age of 31 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "not recovered", described as "Really messed up her cycle"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "Clarified she is losing a lot of blood and never ever experienced it before the COVID shot/ bleeding more than 7 days".  Additional Information: She did not have any prior vaccinations within 4 weeks. Ever since she got the COVID shot against her will, it was for her job to keep her job, it has really messed up her cycle. Her cycle usually comes on for 5 to 7 days. She was bleeding more than 7 days, might be up to 14 days or more. It did not start to happen until after she got the COVID shot. She did not have any investigations.
child began to shake uncontrollably /w crying & fingers became blanched approx 1 hrs /p immun.
New onset of migraine headaches with nausea, vomiting, photo and phonophobia 3 days after vaccine administration. No history of migraines perviously
pt devel an inj site rxn characterized as red, raised, painful & warm area around site, day p/vax;this is one of three patients from this site who exp the above reaction coincident w/the use of lot number 4958068;
Burning pain immediately after injection.  Pain and redness has persisted.  Pain in the left arm radiating down the arm in the elbow, forearm, and wrist.  Tingling sensation in the pinky and ring finger.  Burning pain and ache in the left arm.  Feeling of burning and cold felt in the arm.
2 syringe breaks of VAXNEUVANCE following administration that was reported in a PQC case on 08/02/2023; 2 syringe breaks of VAXNEUVANCE following administration that was reported in a PQC case on 08/02/2023; No other AE; This spontaneous report was received from a physician assistant and refers to unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, patients were vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). It was reported that 2 syringe breaks of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) following administration (poor quality device used, syringe issue). The reporter confirmed there were no injuries and no symptoms reported (no adverse event).  This is a non-valid report due to lack of patients' identifiers.
Achy body, backache, neck ache, weak, low appetite, losing weight, no energy
Local symptoms- pain-discomfort. General symptoms-chills, fever, headaches, muscle pains, fatigue. Narrative:
1. This case meets vaccine breakthrough review criteria. 2. Patient is asymptomatic.  Per chart notes, had cold like symptoms two weeks prior with loss of taste/smell.  Symptoms have resolved.  Admitted for L&D, uncomplicated delivery. 3.  No chronic conditions/PMH.
This case was reported by a physician and described the occurrence of injection site stinging in subject of unspecified age and gender who was vaccinated Havrix (GlaxoSmithKline). Concurrent vaccination given on the same day as Havrix included varicella virus vaccine. On an unspecified date the subject received unspecified dose of Havrix (unknown). Less than one day after vaccination with Havrix, the subject experienced injection site stinging. At the time of reporting the outcome of the event was unspecified. The reporter stated that this events had occurred in an unknown number of patients of all ages and with multiple lots of Havrix. It was questioned if the Havrix involved was the preservative-free formulation.
bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was soreness; bleeding from where the nurse injected her; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration injected into right arm on 24Jan2021 at 05:45PM or 05:44PM at single dose for COVID-19 vaccination. Medical history included Graves' disease, she was diagnosed in the 1980s with Graves' disease, which became Hashimoto's so she took Synthroid, because she believes it switched from hyperthyroid to hypothyroid, and Lichen sclerosus. Concomitant medication included levothyroxine sodium (SYNTHROID) for Graves' disease and Hashimoto's, furosemide, and fluocinolone acetonide for Lichen sclerosus. On 24Jan2021, the patient experienced bump in the arm, She said that the bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle, at its largest it was bigger than a half dollar, now it's a quarter. She said that they did no treatment, there was soreness, but it has not required treatment, the discomfort was bearable. She said after she was given her shot she was bleeding nurse from where the nurse injected her, she sometimes did that, it was not related at all, blood dripped down her arm, she had to wipe her arm. The outcome of the events was unknown. She said she would like to know if Pfizer had info information about whether she should have her supplements, like Vitamin B, C, D and her Furosemide, and whether she could have Zinc or Magnesium as well.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the information available a possible contribution of the vaccination with BNT162B2 towards the onset of vaccination site bleeding cannot be fully excluded.
Right eye lid and under eye was red and swollen. She said there was a rash on her forehead that had pretty much gone away-just a little red but no rash
Patient stated had pain following administration 10/7/22 and that had improved symptoms but "throbbing" at site still 10/17/22.
The patient did NOT experience any adverse reactions.  The vaccine was given after the beyond-use-date.  The medicine was contained in the original vial in the refrigerator (~41'F).  The vaccine was drawn and administered immediately after.  The manufacturer recommends the diluted vaccine is good for up to 6 hours after dilution.   After detailed conversation with the Pfizer manufacturer and CDC,  it was determined that the vaccine within the vial has maintained physical stability within the parameters mentioned and the patient would not need to repeat the dose.
Initial unsolicited report received from a healthcare professional via health authority (under reference number: 730388) on 03-Apr-2018. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUBLOK QIV in the right arm and PNEUMOVAX in the left arm (batch number, expiry date, dose, dose in series and route of administration were not reported for both the vaccines) on 01-Dec-2017 at night. The patient was vaccinated with a dose of FLU SHOT on an unknown date of Oct-1987 and also with STEROID SHOT on an unknown date (three weeks and one day before PREVENAR 13) for back pain. Patient had a medical history of fibromyalgia and back pain on an unknown date. Concomitant medications was not reported. On 01-Dec-2017, on the same day following the vaccination, the patient experienced that her left arm from the almost top of the arm to her elbow was red, hot, swollen and I couldn't lift it, had chills-did not eat supper for two days-felt queasy. Patient's Lab data was reported as none. Patient received BENADRYL to take about a week for all the red to go away, CALCIUM, VITAMINS, PANTOPRAZOLE and ADVIL as a corrective treatment. On an unknown date, the patient was recovered/resolved from all the events. List of documents held by the sender: None. Addendum 28 Dec 2018: Amendment: Upon second medical examination of the case during internal review, a significant correction was performed on 28-Dec-2018 to amendment product code of suspect product from FLUBLOK TIV 528 to FLUBLOK QIV 529.
got Bell's palsy within a day or two after I gave the flu shot a few years ago; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a adult patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a week after receiving Influenza vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Influenza vaccine.  Additional details were provided as follows: The patients was 65 years old at the time of reporting. The case was reported by a physician during a Medical information chat. More than 12 to 13 years ago the patient received flu shot and got Bell's palsy within a day or two after the vaccination. The reporter had no vaccination records.
Pt recvd 3rd dose of Hep B vax 11SEP91 later that day pt devel hives over entire body; On 12SPE91 exp nausea, stomach cramps, dizziness, myalgia & diarrhea; pt tx DPH;
Patient died suddenly and unexpected the day after her second Moderna booster shot.  She had reportedly been feeling unwell with symptoms including grogginess and headache prior to her sudden  death.  She was found unresponsive in a chair approximately 20 minutes after last known alive, and resuscitative efforts were unsuccessful.  She had reportedly gotten the booster in the afternoon, and was pronounced deceased the evening of the following day.
When talking to the patient to remind him it was time for his second dose he mentioned that with the first dose around 4 to 5 days after the vaccine he experienced what felt like a heavy chest and hurt to breath when he took deep breaths.
Pt began to act tired, vomited at home. mom took pt to ED because pt was "not acting right". Pt vomited twice in ED but was otherwise normal. Zofran given, pt discharged to home. pt vomited once in am on 6/24/16, tolerated pedialyte the rest of the day. As of 6/28/16 pt has totally recovered and is fine, per mom.
Pt seen on 3/21/14 - received PEDIARIX on 2/14/14 - small red mark at injection site, large bump noted there on 3/20/14 - not red or hot to touch but tender. Exam 3/21 showed 1.5 x 2.5 inch cystic lesion that transilluminated with 0.5 cm purple macule with punctate center.
Flu-like symptoms, sweating, chills, nausea, passed out twice during the first few hours after the onset of symptoms. Upset stomach, vomiting in the night. Felt better the next day and by the third day after the onset of symptoms felt recovered.
Narrative:  Patient received influenza vaccine 10/29/2020. Patient called 1/13/21 to confirm PCP appointment next day. AE for influenza vaccine with symptom "lip swelling" was added to chart the same day. No documentation of timing or event in medical record. Per PCP note 1/14, no recent hospitalizations and no new medical issues at that visit.
102 degree fever, muscle aches, headache and earache lasting about 36 hours after onset of symptoms. Tylenol helped control symptoms
3RD DOSE OF PFIZER COVID VACCINE GIVEN 12/23/21, LOT #FG3527; pt brought to ED with c/o SOB with exertion and increasing weakness; bradycardic in ED; EKG showed sinus bradycardia with first degree AV Block; elevated troponin; pt's condition worsened; acute encephalopathy with an increase in lactic acid; found to be Hepatitis A positive and COVID positive; PEA arrest while at dialysis; CPR and defibrillation; ROSC achieved; transferred to ICU; DIC dx with worsening platelets; refused blood products due to religion; became intubation only; pt's condition worsened with arrhythmias and drop in platelets; pt passed away in the hospital
Immunization error occurred at a Bi-monthly vaccine clinic inside .   is currently residing at this   and he filled out a pre-vaccination checklist per protocol and checked NO to all questions on checklist including "have you had a previous dose of COVID-19 vaccine."  We administered 0.5 mL Johnson and Johnson COID-19 vaccine IM in right arm  05-04-21.    He was monitored for 15 minutes  and left without incident.   When I went back to pharmacy to document vaccine I then discovered record of J & J previous given on 03-09-21.    I filled out occurrence report and notified clinical super visor at .
Sudden deafness; A spontaneous report (United States) was received from a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden deafness/sudden hearing loss  The patient's medical history, was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prednisone,mycophenolate mofetil,hydroxychloroquine sulphate and lisinopril.  On 04 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:0271921a ) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 16 Mar 2021, after receiving the first dose, the patient experienced complete hearing loss all at once in right ear. She was diagnosed with sudden deafness on 23 Mar 2021. Treatment medication included unspecified steroid shots in the ear drum.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event sudden deafness was not resolved at the time of this report.; Reporter'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.
Severe chest pain, extreme inflammation of heart, increased glucose levels, pancreas started to shut down.
Deep Vain Thrombosis left leg. Pulmonary embolism. Treatment  - Blood thinners.
Patients grandmonther called on 10/30/13 stating her grandson had been having a little rash that comes and goes and appears at various locations of the patients body. The patient vomited 3 times only yesterday but was acting normal nothing else appeared wrong. The patients appetite has dimished some. No high fever reported. The patient does not have a problem with itching as far as the grandmother can see.
I had a breakthrough case of Covid had mild covid symptoms for about a week, the I contracted Covid was down for two weeks scratchy throat cough runny nose and fever labored breathin. Was prescribed Paxlovid.
High fever x2-3 days, developed oral cold sores on lips and surrounding skin. Treated with Acyclovir ointment, condition appeared to get better, but worsened considerably 10/25/2021. 10/28/2021 PCP prescribed Triamcinolone 0.1% ointment and round of oral Valtrex. Swelling, redness, sores grew worse. Medications halted 10/31/2021. 11/11/2021 Dermatologist tested skin for HSV and fungus, tests were negative. Symptoms persisted on and off thru December 2021 and finally went away early 2022.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site wheal, pain, chills and injection site burning. On an unknown date, the outcome of the injection site wheal, pain, chills and injection site burning were recovered/resolved. It was unknown if the reporter considered the injection site wheal, pain, chills and injection site burning to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The events lasted for two weeks, then resolved.
Gagging and nausea. IM Zofran 4mg given by EMS.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.