chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as over three years ago), the patient was vaccinated with a first dose of GARDASIL 9 (lot # and expiration date were not reported) prophylaxis. The patient missed two doses of GARDASIL 9. There was no adverse effects reported. Additional information has been requested.
body ache; feel like head was going to blow up; eye were hurting; fingers felt like I had electricity was pounding through my fingertips; intense headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), HEAD DISCOMFORT (feel like head was going to blow up), EYE PAIN (eye were hurting), PAIN IN EXTREMITY (fingers felt like I had electricity was pounding through my fingertips) and HEADACHE (intense headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for an unknown indication.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN, POTASSIUM, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (intense headache). On an unknown date, the patient experienced PAIN (body ache), HEAD DISCOMFORT (feel like head was going to blow up), EYE PAIN (eye were hurting) and PAIN IN EXTREMITY (fingers felt like I had electricity was pounding through my fingertips). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body ache), HEAD DISCOMFORT (feel like head was going to blow up), EYE PAIN (eye were hurting), PAIN IN EXTREMITY (fingers felt like I had electricity was pounding through my fingertips) and HEADACHE (intense headache) outcome was unknown.            patient take Oregon Probiotic, Losartan 50mg, Potassium, Nexium, Hydrochlorothiazide 12.5mg, Calcium plus vitamin D3, Atorvastatin, Benadryl at night and Flonase nasal spray as a Concomitant medication.   This case was linked .
14-year-old male presents to the emergency department 4 days after his second Covid vaccine.  Initially after the vaccine he had some generalized fatigue and nausea but yesterday started experiencing some chest tightness lasting up to 4 minutes.  He also feels an irregular heart rate or like his heart is bounding.  He also had some generalized bilateral neck stiffness.  This is all resolved currently.  He did vomit 1 to 2 hours ago.  No fevers or chills.  No cough or cold symptoms. ECG shows normal sinus rhythm with ST 1 box upsloping elevation V3 through V6.  Initial troponin is elevated at 2.6.  Attempted to consult  cardiologist  and they recommended pediatric cardiology consultation.  Spoke with Dr. .  She recommended admission with trending troponins and Motrin.  She says they typically do echocardiogram and if normal then cardiac MRI.  Spoke with Dr.  in the  ER and they graciously accept patient in transfer.
fever noted on 24MAY98 then erythematous patchy macular rash noted to upper area which became confluent by 28MAY98;pt devel same rash to abd, chest & back then to thighs progressively by 28MAY98 rash is few & scattered;
Moderna COVID-19 Vaccine- 2nd dose after ~15 hours: Fever up to 100.6, chills, body aches, headache, and light-headedness. Fever persists >9 hours. injection site soreness within hours that persists.
Information has been received from a registered nurse concerning a 4 year old female with no known pertinent medical history or drug reactions/allergies who on 13-Aug-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot# 660082/19770) 0.5ml SQ in her left deltoid. Concomitant therapy included MMR-II (MSD). On 15-Aug-2008, within 48 hours of the vaccination, the patient developed a 2 inch diameter warm, tender, pruritic and red raised local reaction at the injection site without significant induration. The nurse requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and research was released. This is one of several reports from the same source. Additional information has been requested.
Other sister in law had a rash after the second shot; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date reporter's other sister in law had a rash after the second shot. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076605 same drug/event, different patient
the area is slightly swollen; Discomfort on my left arm pit; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 17May2021 09:15 as dose 2, single, and then dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation administered in Hospital. Medical history included none. The concomitant medications in 2 weeks were not reported. The patient reported, discomfort on her left arm pit (the area is slightly swollen) on 18May021 07:00. This happened on her first dose too. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 21Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.   Follow-up attempts completed. No further information expected.
4am  (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting  11am( out of bed)  needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking  9pm  to bed  8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP  1130 Arrived at hospital ER and was subsequently diagnosed and admitted  with a cerebellar stroke
Blood clot - cephalic vein thrombosis/DVT in left arm. On August 14, I began feeling soreness in my left arm,  at the injection site. On August 15 I began feeling a pain below the injection site on my bicep area.  It was very sore but my skin was not exhibiting any redness. August 16 and 17th the pain intensified and a large red Blotch in the area begin to appear and grow over the course of the two days. The pain intensified and I couldn?t even touch the area without it being incredibly painful. August 18 I went to the emergency room, and was diagnosed with Cephalic vein thrombosis.
Headache EXTREME PAIN AT INJECTION SITE, CHILLS, JOINT PAIN, BODY ACHES EMPLOYEE STATES SHE IS IN MORE PAIN AFTER VACCINATION THAT SHE WAS WHEN SHE HAD COVID
Patient received Pfizer Covid-19 pediatric (5-11yo) dose instead of >12yo dose.
Local rxn both sites - Erythema no fluctuance. (R) arm ~2-5cm; (L) arm ~8cm. TX - BENADRYL + TYLENOL.
Case number PHEH2013US020522 is an initial spontaneous report received from a nurse on 30 Sep 2013 with a follow up information received from a nurse on 04 Feb 2014. This report refers to a 21-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) in the deltoid which was placed room temperature on 26 Sep 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine in shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error. Follow up information received from a nurse on 04 Feb 2014: Site of vaccination was updated.
itchy rash legs and arms, torso, scalp, cheeks, groin x 1 wk
Vaccine administered to a 14 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B12A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  The patient did not have any side effects.  Treatment medications was not provided by the reporter.
Pediarix, Hib and Prevnar was given at the age of 1 month old.
We asked the patient if she wanted her second shingles shot and patient proceeded to show us her dark spots all over her hands, arms, and her belly. Patient says that the day after she received the shingrix and prevnar 20 (7/31/2022), she broke out in a rash over her hands, arms, and belly. She went to the doctor and was told it was an allergic reaction to the immunizations. When we spoke on 3/19/23 she says the rashes were red and they darkened to the darkened spots currently all over her hands, arms, belly. We are not sure what or how the patient was treated by the provider as we did not know about the incident until about 7 months after it occured.
POST VACCINATION SYNCOPE. DID NOT FALL, LOWERED TO GROUND. QUICKLY ALERT AND ORIENTED, ASSISTED TO WHEELCHAIR. WHILE WAITING FOR COT HAD ADDITIONAL SYNCOPAL EPISODE, NAUSEATED. MONITORED FOR 25 MINUTES AND SYMPTOMS RESOLVED.
haven't had a shot for over 20 years as patient was allergic to them; Initial information was received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced haven't had a shot for over 20 years as patient was allergic to them (allergy to vaccine) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious haven't had a shot for over 20 years as patient was allergic to them (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
4/27/01, here at clinic with right leg pain and small mass 1.5" X 2.25" and warm to touch. Also swollen and has a fever of 101F.
Moderna vaccine administered to pregnant patient; Achy; Tired; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient), MYALGIA (Achy) and FATIGUE (Tired) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Aug-2020 and the estimated date of delivery was 21-May-2021. On 07-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient), MYALGIA (Achy) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 07-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Moderna vaccine administered to pregnant patient) had resolved. At the time of the report, MYALGIA (Achy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concurrent medications usage has been not provided by the reporter  No treatment were medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Updated Patient's Age from 37 Years to 27 Years
has not received dose 2 yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25 February2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the concerned patient.  The age at vaccination was not applicable to this report. The patient stated she had received dose 1 of SHINGRIX.  The patient had not received dose 2 yet which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Rash broke out in flat rashes in the back of his neck and right ear; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an infant patient who experienced rash broke out in flat rashes in the back of his neck and right ear (rash), while he/she received vaccines HEPATITIS B VACCINE, PREVNAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in the right thigh, a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in the right thigh and a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in the right thigh.  On an unknown date, the patient developed a non-serious rash broke out in flat rashes in the back of his neck and right ear (rash) 15 min following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVNAR 13 and HEPATITIS B VACCINE.  Other relevant tests were not reported.  Final diagnosis was rash broke out in flat rashes in the back of his neck and right ear.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the event.  Information on the batch number was requested  List of documents held by sender: none.
Case number PHEH2012US007061, is an initial spontaneous report received from a physician on 28 Mar 2012: This case refers to 18-years-old female patient. She was received only Men A liquid conjugate component of MENVEO vaccine (batch number: A10061) at dose of 0.5 ml intramuscularly, reconstituted with a sterile water instead of Men C, Y, W-135 liquid conjugate component on 28 Mar 2012. No adverse reaction had occurred following this maladministration error.
The patient experienced chest pain in the setting of ECG changes (see below) and elevated troponin concerning for myocarditis. The chest pain resolved within 24 hours and troponin down trended.
patient was administer 0.2ml of pfizer 5-11y vaccine undiluted, resulting in a higher then recommended dose
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 12-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
pt recv vax & devel an inj site rxn characterized by edema & erythema;pt became lightheaded 9 hr p/vax had a syncopal episode, fell & struck head;pt recovered;
Diarrhea; Upset stomach; Low gradefever; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6208), via unspecified route of administration in left arm on 16Mar2021 at 11:45 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), depression and fractured arm and leg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: em9810), via unspecified route of administration and in left arm on 05Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient had no known allergies. Concomitant medications included LIPITOR, gabapentin (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and blood pressure medications (unspecified); all for unknown indications from an unknown date. Prior to vaccination, the patient had no symptoms associated with COVID-19. Since vaccination, the patient was not tested COVID-19 positive. On 16Mar2021 at 15:00, the patient experienced diarrhea, upset stomach and low grade fever. Therapeutic measures were taken as a result of diarrhea, upset stomach and low grade fever and included treatment with IMODIUM AD and TYLENOL from an unknown date. The clinical outcome of diarrhea, upset stomach and low grade fever were not resolved.   No follow-up attempts are possible. No further information is available.
Sudden infant death several days after receiving 4 month vaccine series Became fussy and developed raspy breathing in the days following the vaccine administration
Patient complained of Headache, Chills, Shallow Breathing, Body shakes, Body aches.
Injection site pain, arm pain extending down to the hand, swelling and welps, difficulty breathing, dizziness, ringing of ears
FLUZONE HIDOSE administered 10/18/16. (L) upper arm became itchy at 7-7:30pm and this continued throughout night. Large area of redness noted on (L) upper arm (underside of arm) Pt. going to see MD today.
A spontaneous health professional report from a regulatory authority in an article. Vaccine Adverse Event Reporting System (VAERS), July 2013-April 2014, concerns a 7 year old female. The patient's medical history included subacute sclerosing panencephalitis (SSPE). No concomitant diseases and concomitant medications were reported for consumer. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date, and 64 days later she required hospitalization for 16 days for changes in mental status and progression of SSPE. The patient died from an unknown cause on an unspecified date. The report did not describe whether an autopsy was performed. The reporter assessed the death to be serious by the criterion of death.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2019, 17 days after receiving SHINGRIX, the patient experienced blister, rash and chest pain. On an unknown date, the patient experienced shingles, injection site pain, headache, influenza-like symptoms and pain in arm. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, blister, rash and chest pain were unknown and the outcome of the injection site pain, headache, influenza-like symptoms and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, headache, influenza-like symptoms, pain in arm, blister, rash and chest pain to be related to SHINGRIX. Additional information was provided as follows: The reporter was reporting adverse event for her husband. The patient received a dose of SHINGRIX and experienced pain at injection site, headache, flu like symptoms, and sore arm. Everything lasted for one day except the sore arm which lasted for about 3 days. About 2 weeks post vaccination the patient experienced a rash, blisters and chest pain from rib cage to the neck and to the back area. He went to the doctor right away on 16th January 2019. He was then diagnosed with Shingles and he was started on antiviral medications. Consented to follow up was provided. No further details were provided. This is 1 of the 2 cases reported by same reporter. There is an inconsistent information provided by the reporter with respect time to onset. As per reported statement (About 2 weeks post vaccination) it is 14 days for a rash, blisters and chest pain; however, as per narrative description (He went to the doctor right away on 16th January 2019) it is 17 days. As the patient went right away to the physician after experiencing the adverse events the time to onset has been kept according to it.
Localized erythematous nonblanching papules/macules surrounding area of vaccine site.