chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister. The patient was treated with acyclovir. On an unknown date, the outcome of the injection site pain, ringing in ears, nausea, difficulty sleeping, shingles and blister were not recovered/not resolved and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, ringing in ears, nausea, difficulty sleeping, shingles and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a Retired Nurse. The batch number was updated from 2YN45 to 2YN4S as per sales data sheet. The patient received SHINGRIX vaccine and it was painful during administration. That night she had difficulty falling asleep. Later in the night she developed a sore arm at the injection site, headache, nausea, and ringing in her ears. The ringing in her ears went away and returned in the morning. At the time of this report, her arm was still sore and she feels nauseous. The patient stated that she has developed a small patch of blisters above her left buttock area that appears to be a shingles outbreak. At the time of this report, the patient was taking acyclovir prophylactically and will see her physician next week. At the time of this report, the patient was concerned because she was taking acyclovir for herpes suppression and just read information that this medication could reduce the effectiveness of the SHINGRIX vaccine. The patient stated, the headache had resolved, other reported events remain. The patient gave consent to contact the safety physician and provided contact details for the same.
acute onset of myalgia migrating from lt foot to lower back;seen in ER w/complete workup done;all tests negative;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm, as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: About 3 days later started having running nose and positive test; (May2022) Positive, notes: Runny nose and some congestion has continued day about day for now 4days. No other symptoms and am testing positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 17May2022, Treatment stop date: 21May2022, Indication: Treatment of COVID-19. Adverse event: After about 3 days of Paxlovid symptoms went away. Finished treatment on 5 days. No symptoms. About 3 days later started having running nose and positive test. Runny nose and some congestions have continued day about day for now 4days. No other symptoms and am testing positive. It's been 12 days since I tested positive and got on Paxlovid 10 days ago. Was fully vaccinated with 2 boosters. This is clearly the rebound effect I've been reading about. Adverse event start date: 25May2022. If patient recovered: Recovering If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 2/20/98; on 2/25/98 pt exp abscess in LA; tx=hot compresses
Localized erythema right upper outer arm within 6 hours of MENVEO injection with noticeable swelling, warmth, increased redness over next 24 hours. No fever, chills, facial swelling, cough, respiratory distress.
Pt's right arm became swollen to elbow, 3.5" greater than left arm, from vax given 10/22/01. Temperature was 99.2. Pt had redness near elbow. Doctor ordered Medrol dose pack and swelling was down on 10/24/01.
Swelling in face and lip, chills, coughing, rash all over entire body, itching
Hospitalization: 10/3/2022 - 10/12/2022 Presentation to the ED: WORSENED AMS.  COVID + date: 10/12/22. Treatment: none specific to COVID. Discharge to: SNF (Skilled nursing facility).
1/11/21 received vaccine and had foggy brain, headache, lightheaded, dizzy, achy, nausiated, extreme weakness 1/19/21, 8 days later developed the above symptoms in addition to a reaction at the injection site, left upper arm extremely swollen, welt, hard, hot, raised, itchy that lasted another 7 days
shortness of breathing; fever; cough; soreness; blue lacy rash on the arms and legs; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced for almost 10 days after getting the first dose of the vaccine. The patient got all the symptoms like fever, cough, soreness, shortness of breathing, diarrhea and blue lacy rash on the arms and legs. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT CALLED AND REPORTED THAT 30 MINUTES AFTER ADMINISTRATION OF THE FLU VACCINE SHE HAD BROKEN OUT INTO HIVES, AND TODAY (ONE DAY LATER) SHE IS HAVING A HEADACHE AND A FEVER.
Left upper arm redness and swelling at site of vaccine, no rash, no tongue/throat swelling.
Pt. reports reaction started around 10 PM last night with swelling (65 mm x 60 mm), pain, itchy, very hot to touch and painful to touch. Sx of bursitis. Will treat with ZYRTEC, ZANTAC and prednisone.
Burning and paralysis of left side of body from head to toe, but seems to be concentrated in left arm and hand. Constant fatigue. Dizziness, overall weakness, left big toe painful,  vision impairment,  loss of muscle, appetite, muscle mass
Headache and sore arm for about four hours that first night. Resolved that night with ibuprofen. Headache from the 10th - 17th. It did not resolved with ibuprofen. Had a COVID test on the 16th.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-JAN-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) of lot # K009473 and dose 0.5 ml, subcutaneously (indication was not reported). The expiry date of the particular lot of PROQUAD (Merck) was given as 03-JAN-2016. No adverse effects were reported. No further information was provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
The patient spoke to us on the phone today and stated that she still has slight soreness in the arm that the vaccine was administered to. She states that it is not painful but that when she moves it a certain way she does feel some soreness.
Low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in right arm on 24Jan2021 10:30 AM (at the age of 54-year-old) at single dose for COVID-19 immunisation in Public Health Clinic/Veterans Administration facility. The patient's medical history included high blood pressure, anxiety, bipolar. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL); the patient received all the drugs within 2 weeks of vaccination. The patient previously took phenytoin sodium (DILANTIN), levofloxacin (LEVAQUIN), hydrocodone bitartrate, paracetamol (VICODIN) and experienced drug allergy for all the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 24Jan2021 16:00, the patient experienced low grade fever 99.5. The patient underwent lab tests and procedures which included body temperature: 99.5 (low grade fever 99.5) on 24Jan2021. The event was considered as non-serious by the consumer. The patient was treated with Tylenol for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Information has been received from an office manager concerning a female who on 29-SEP-2006 was vaccinated with a dose of Pneumovax 23 (lot# 650644/0004F).  Concomitant therapy included ARIMIDEX, FLONASE, LORTAB, MS CONTIN, SYNTHROID and trazodone HCl.  On approximately 30-SEP-2006, the patient developed redness, swelling and pain at the injection site vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
LN swelling under L axilla that evening.  On 1/7/2021-swelling and hives under chin then redness in left arm
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
Ovarian cancer; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CANCER (Ovarian cancer) 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced OVARIAN CANCER (Ovarian cancer) (seriousness criterion medically significant). At the time of the report, OVARIAN CANCER (Ovarian cancer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given. No treatment information were given. Caller reports that their sister got diagnosed with ovarian cancer 6 to 8 months after receiving the Moderna Covid-19 Vaccine.  Company comment: This case concerns a female patient, unknown age, with no reported medical history who experienced the serious, unexpected event of ovarian cancer 6-8 months after unspecified dose of mRNA 1273 vaccine. Information on clinical course was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no reported medical history who experienced the serious, unexpected event of ovarian cancer 6-8 months after unspecified dose of mRNA 1273 vaccine. Information on clinical course was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
her cheek and her lip numb; her cheek and her lip numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (her cheek and her lip numb) and HYPOAESTHESIA (her cheek and her lip numb) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (her cheek and her lip numb) and HYPOAESTHESIA (her cheek and her lip numb). At the time of the report, HYPOAESTHESIA ORAL (her cheek and her lip numb) and HYPOAESTHESIA (her cheek and her lip numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Clinical administered ZOSTAVAX in error, was to receive varicella, physician contacted mother and advised may get chickenpox or rash and to continue to monitor. Provider f/u w/mother next morning no sym or adverse reactions noted.
body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sweats; chills and sweats; sore at injection site; lost sense of smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), intramuscular in left deltoid on 23Jan2021 15:35 at SINGLE DOSE for covid-19 immunisation. She typically got sick when she got the flu vaccine or any vaccine in general for immunization, she got deathly sick. She always got the flu after getting the flu vaccine. She did not get the flu shot this year and she did not get the flu. She did not know the name of the flu vaccine or any vaccine that she was referring to and she did not have lot number to provide. Other medical history was reported as none. There were no concomitant medications. Relevant Tests were reported as none. The patient experienced lost sense of smell on 23Jan2021 with outcome of not recovered, feeling really tired on 24Jan2021 with outcome of not recovered, chills and sweats on 24Jan2021 with outcome of recovered on 25Jan2021, sore at injection site on 24Jan2021 with outcome of not recovered, body aches and Shortness of breath on an unspecified date with outcome unknown.  Details were as follows: the patient had a list of the expected side effects and she did not see loss of sense of smell on the list. Reported she completely lost her sense of smell, she cannot smell anything at all. She was asking if she should be concerned. On Friday prior to getting the vaccine she could smell everything. She thought the loss of smell started Sunday, reported it may have started Saturday (23Jan2021). She noticed when she put her body spray on Sunday and she was washing her hands that she could not smell. She can taste fine. She can handle the body aches and all the other stuff. She clarifies she was experiencing body aches, she was feeling really tired, fatigued. She was feeling better. She could not call earlier because she was so tired. She had the chills and sweats that started Sunday evening and recovered today (25Jan2021). Reported her sheets were drenched with sweat when she woke up. She did not have a fever. She thought most of her side effects started Sunday night. Reported the injection site was sore and that started the day after receiving her injection, it was still sore. She did not go to work today (25Jan2021). She felt like she had shortness of breath but she was checking her oxygen level and it was fine, stated it just felt like she was short of breath and it was ongoing and persisting. No additional vaccines Administered on Same Date. The events did not require a visit to Emergency Room and Physician Office.
Back pain and abdominal pain/discomfort/reflux. All started the day after vaccine.  I?m still experiencing these symptoms even 6 weeks post vaccine, some days are worse than others.  I?ve taken Motrin and reflux medication as needed. I?m planning to see a doctor for my stomach this next week. I?be also started seeing a chiropractor for my back pain.
Erythema and exanthem at sight of shot on left arm/identical to varicella zoster with discrete vesicles on erythematous base painful and burning with constitutional symptoms of nausea and malaise/ no fever.
Pain, deltoid with erythema and mild induration. One area of pimple. (Left deltoid) Pt was seen next day at health center and told to treat symptomatically.
Two-dose varicella vaccine recipient diagnosed with herpes zoster at the hospital on 04/06/2014. Painful rash on right arm - back/arm pit crease, spread to hand. Rash onset 4/1/14. Not hospitalized. No history of varicella. Lasted <4 weeks. Also reported slight fever and vomiting. Treated with antivirals- name of meds is unknown.
102 fever; chills; night sweats; extreme fatigue; brain fog; sore muscles and joints. Started 12 hours after injection. Resolved between 11am-2pm ET on 3/21, so lasted less than 24 hours before resolving.
generalized itching 24 hrs p/1st vax; 72 hrs later had nausea, vomiting, fever <100 & a resp infec, poss viral infect; 19FEB92 f/u recovered
This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose on 05Jan2017 for immunisation. The patient medical history was not reported. Concomitant medication included hydrochlorothiazide, losartan. The patient experienced pain in arms started probably about a week after vaccination in Jan2017. The pain started probably about a week after she got vaccinated, it was mild in the beginning and she just figured it was just going to go away and then each week it was getting worse all the time. Then one day in Jan2017 she felt like her arm was just about to burst with all this pain with outcome not recovered. She experienced red face in Mar2017 with outcome not recovered, bruising around where they gave the shot on an unspecified date and it lasted almost 2 months with outcome of unknown. She went to her doctor 2 weeks before and he could not find anything, he sent her to hospital to get X-ray and an ultrasound to make sure that she did not have blood clot and in order to find out what is going on.
One hour after IM injection, pt with c/o weak legs, headache, nausea. Pt ate lunch and symptoms improved.
Mild Itchy around the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Mild Itchy around the site of the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZC ZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Mild Itchy around the site of the injection). At the time of the report, INJECTION SITE PRURITUS (Mild Itchy around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.
From initial information received on 22Oct03 from a health care professional regarding an adverse event occurring, it was reported that a 61 year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1137HA, administered IM in the left deltoid on 10Oct03 at 11:30AM. Eight days later, on 18Oct03, the pt developed pain in both axillary areas. The areas were sensitive to touch. Reportedly the pt recovered from this event. From additional information received on 05Feb04 from a health care professional, it was reported that no additional information was available for this case at this time. No further information is anticipated, this case is considered closed.
tired; lightheaded; This is initial spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient received the COVID-19 vaccine last Wednesday on 03Feb2021. He was fine for a few days after it and then starting about 2 days ago and including today, he had become quite tired in Feb2021. He had been a little lightheaded (Feb2021) but more so very tired. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Febrile seizure approximately 8 hours following administration of Flu vaccine. Highest fever 103 F. 12/29/06-records requested and received DX: Febrile seizure. FMH: febrile seizures on both sides of family. Temp in ER 103.1.  URI.
employee of facility.  she came to work and was sitting in locker room and noted by another employee to be hyperventilating/shaking. Coworker got nursing staff who went in to assess her. Employee stated she had been having chest pain on and off for the past few days and that her PCP suggested getting tested for covid. She was again complaining of chest pain, stating she can't breath, and became very anxious. BP was high, HR was in 170's, oxygen was 87. Applied O2 via nonrebreather, contacted EMS. At time of EMS arrival employee fainted x 2 and went into asystole. CPR performed for almost an hour before time of death was called.  medical examination performed post death and determined she had a pulmonary embolism.
Patient states that her RIGHT Arm has been hurting since the administration of the Shingrix vaccine. Pharmacy records indicate that shot was given in left arm.
Extreme, large, painful hives all over body including face, palms of hands and soles of feet, hot to the touch, very itchy. Patient continued to be able to breathe.
fever (102.4°F); Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: 102.4 (High) 102.4 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Breakthrough Case of COVID-19; I don't know if this was related but the night before I tested positive I had a sore throat, but the morning I tested positive, I was feeling feverish and was really tired, and I called my Dr.  and I was advised to rest and then the second day, I was having difficulties breathing and I called the Dr. office back and she suggested taking Mucinex and that made me feel a lot better.  The next day I was coughing a lot and a sore throat, but my breathing was getting better and after that my symptoms started getting better over the next few days but I was just very tired like more tired than normal but I am feeling better today.
Vaccine administered after the cut-off time (6:00am). No adverse events, symptoms or any evolution have been reported by the patient after administration of the vaccine so far.