chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother here today 07/01/2005 for 4 month immunizations states infant cried for 3 hours non stop past last immunizations.  Mother states she cried every evening for 3 hours for 3 days.  Denies running any fever.  Mother states called doctor, said to watch.
Limbic Seizures later diagnosed as Inflammatory/autoimmune Limbic Encephalitis.
pt states had vomiting and diarrhea after receiving Hep B injection and has had weakness since injection.
orthostaic hypotension; vasovagal syncope: Nausea, pale skin, wavering consciousness, hypotensive; sinus bradycardia; seizure; Hearing loss; Information has been received from the regulatory authority on 18-AUG-2020.   This spontaneous report as received from two healthcare professionals refers to a 12 year old female patient with lactose intolerance, and penicillin allergy.      On 21-AUG-2019,  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1, intramuscularly, lot # R016971, in the left arm), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (dose 1, intramuscularly, lot # 2E3EH, in the left arm) and meningococcal acyw conj vaccine (crm197) (MENVEO) (dose 1, intramuscularly, lot # AMVA12EA, in the right arm) all for prophylaxis.  Three minutes after vaccination the patient experienced a syncopal episode lasting 5 -10 seconds, wavering consciousness for 8 minutes after waking up until the emergency services (EMS) arrived.  Hypotensive from EMS vitals.  Sinus bradycardia on electrocardiogram (ECG) in ER.  Persistent orthostatic hypotension despite 1800 ml of Isotonic fluid boluses (NS) led to pediatrics admission.  The patient was diagnosed with vasovagal syncope.   It was also reported by another healthcare professional (discrepant information) that few minutes after vaccination, the patient and her father walked to consultation window for paperwork.  The patient then went through a seizure for no more than 1 minute.  The patient then woke up, unaware of what happened.  They remained on permanent alert until EMS came.  The patient complained of nausea, hearing loss and was pale. The patient required an emergency room or emergency department visit.   The outcome of the events and the causality assessment between the events and the suspect products were unknown.  As of 28-OCT-2020, all telephone attempts to obtain follow up information had been unsuccessful. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R016971; expirationdate: 22-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
p/ pt recv vax approx 2yr later pt presented w/ 10-12 early, vesicular, chickenpox lesions.
?Moderna COVID-19 Vaccine EUA Sharp pain at injection site first night 2/13/21 Today 2/21 Severe itching, large red round area, hardness and slight swelling  Using anti- itch crème helps
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 48-year-old female patient who received BEXSERO (batch number 16A301, expiry date January 2019). On 8th March 2018 12:45, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 8th March 2018, several hours after receiving BEXSERO, the patient experienced injection site swelling (serious criteria other: As per reporter), neck pain (serious criteria other: As per reporter) and headache (serious criteria other: As per reporter). On 8th March 2018 12:45, the patient experienced faint (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). On an unknown date, the outcome of the injection site swelling, neck pain, headache and nausea were unchanged and the outcome of the faint was recovered/resolved. The reporter considered the injection site swelling, faint, neck pain, headache and nausea to be probably related to BEXSERO. Additional details were provided as follows: The healthcare professional stated that the patient received her 1st dose of BEXSERO in left arm and immediately felt nauseous and faint. The healthcare professional stated that later on 8th March 2018, the patient reported developing a severe headache that involved her head and neck, continued nausea, left arm swollen at injection site that persisted on 9th March 2018 and was described as worse than a day before. The healthcare professional stated patient treated swelling at injection site with a hot compress.
This spontaneous report as received from a physician assistant refers to a 33 years old female patient with amyotrophic lateral sclerosis (ALS). The patient had no drug allergy. The patient was vaccinated with the first and only dose of PNEUMOVAX23 (lot# reported as 0225AE; expired date: 03-JUN-2013) subcutaneously on 19-NOV-2012. No other co-suspects were reported. Concomitant medications included influenza virus vaccine (manufacture unknown), CELEXA, baclofen, lorazepam and "NUEDEXTA". The physician's assistant noted the patient "developed fever, chills, vomiting, as well as redness and swelling at the injection site on 20-NOV-2012." No treatment was given. The present patient status was not recovered. No lab tests were performed. The patient had sought medical attention via calling the office. This same practice had another adverse event with the same lot number and expiration date of PNEUMOVAX23. MARRS# 1211USA009807. Additional information has been requested.
At the time I received the vaccine I was almost 5 weeks pregnant (due date 12/4/21).  On 4/11 I started to have cramping and bleeding and proceeded to miscarry the pregnancy.
This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 26-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (< 46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
By 8:00 that night, I lost the ability to lift my arm and hand. I could not lift it away from my side at all. I had bad pain in from the shoulder to my hand. Through the night the pain starting going across my chest and my back and up into my neck and down my arm, in  a jabbing pain. I could not sleep at all, I went into the ER in the morning, the pain would not stop. I am still fighting with pain my arm and shoulder.
PARALYZED IN THE BED; This spontaneous potential legal report received from a consumer (spouse) via social media (JNJ) through a company representative concerned a male of unspecified age, race and ethnic origin. Initial information processed with additional information received from reporter on 10-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose and start therapy date were not reported, 1 total for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was paralyzed in the bed. Reporter stated that "I would like to share with you what the J&J vaccine has done to my husband. I have photos and all medical reports. He is now paralyzed in the bed. J&J is responsible. You should reach out to me. That shot has destroyed my husband's life our life. Your vaccine is 100% responsible. You deserve to be sued. No one should go thru what we have". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed in the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220514928-Covid-19 vaccine ad26.cov2.s-Paralyzed in the bed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
itching of the site; rash; redness; swelling; A spontaneous report was received from a Reporter  concerning about a female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Calling regarding a rash develop from the Moderna injection for Covid-19 vaccine. It is spreading from the site and is having itching of the site, is redness and swelling. No further details within this voicemail  No treatment details were provided  Action taken with mRNA-1273 in response to the events was not reported.
Stated she had redness and swelling from shoulder to elbow of right arm beginning Friday PM 10/10/03 and continuing through Saturday 10/11/03. Applied ice packs to area.
Got Shingles Vaccine and still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and still got shingles. The patient further stated that it would have been worst without vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
A non-serious spontaneous report of inadvertently administered the entire dose of H1N1 to one nostril was received from a registered nurse/ health professional concerning a 12-year-old female. The relevant medical history was not reported for this patient. On 10-Nov-2009, the patient inadvertently received entire dose of H1N1, Intranasal into one nostril because the divider clip did not stop. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
About a week after my first vaccine, I noticed a pain in my left shoulder near the injection site that felt similar to a shoulder injury I had 3 years ago when I tore my shoulder ligament resulting in a hairline fracture in my humerus. I thought it was just swollen from the shot in my muscle and would go away in a week or so. 5 weeks later, I am experiencing pain in my shoulder that feels exactly like my injury 3 years ago.  Can't lift my arm, can't pull up my pants or put my seatbelt on, have difficulty putting my arm in a sleeve when dressing, have significantly reduced mobility in that arm and it has not gotten any better.  Seems worse. Haven't seen a doctor yet. Still hoping it will get better and not sure which doctor to see.  Trying to find out if this was caused by the vaccine injection before deciding if I should see my internist or shoulder doc.
The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for 15 minutes per pre-vaccination screening, and was discharged to home at 1421 pm without incidence with her spouse who was discharged at 1435 pm.  At approximately 1445, the spouse states that  the patient lost consciousness in the vehicle and that he panicked and brought her back to the clinic site because he couldn't remember where the hospital was.  The patient was found to be sitting in the clinic alert and oriented, pale, diaphoretic, and nauseated.  Vital signs were checked at 1457 with B/P of 124/71, O2 sat 99%, HR 80, and blood glucose of 149.  After being monitored for 15 minutes in her vehicle, the patient stated she was feeling better and was escorted to the restroom via wheelchair.  The patient stated that she felt like she could go home but was advised to call 911 immediately if symptoms returned or she started having any other reactions.  The patient and spouse both verbalized understanding and agreement.
Myalgia, Arthralgia & NauseaVomiting Narrative: Day1-Injection site pain Day 2 & 3-Nausea and muscle aches/pain.
Initial unsolicited report received from other non-health care professional on 15 July 2016. This case involves a 16-year-old female patient who was vaccinated with a first dose of MENACTRA (Batch number: U5180AA, expiration date: 22 January 2017, dose, route and site of administration was not reported) intramuscularly in left deltoid on 14 July 2016. Patient's illness at the time of vaccination was none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were unknown. On 14 July 2016, five minutes following the vaccination, the patient fainted and she sustained a contusion from hitting the back of her head and the patient also had nausea and headache 15-20 minutes later. On 15 July 2016, one day post vaccination; the patient had temperature (100 Fahrenheit). Lab data and corrective treatment was not reported. The patient was not yet recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event: sustained a contusion from hitting the back of her head (Bruise of head). List of documents held by sender: none. Sender's Comments: Patient had received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and fainted after 5min which lead to contusion over back of head associated with headache and nausea, patient also had fever next day. Faint and fever are listed, while injury to head is unlisted and it is sequel to faint. Additional medical history, concomitant medication, infectious history, past vaccination history and its tolerance are needed to further assess the case. Based on the available information role of vaccine cannot be assessed.
Starting 06/30/2022 at around 03:00PM I started coughing which progressively worsened. By 06:00PM I felt feverish and took my temp which was over 99F and the cough was worsening. So, I decided to take an at-home COVID-19 test which was positive. I called a local medical center which prescribed me the antiviral. I picked it up the next day. Overnight I had general malaise, runny nose and cough. The next day I felt feverish and took some TYLENOL, and I started the antiviral around 10 or 11AM. I had a hard time sleeping, dry cough, dizziness, low blood pressure and general malaise. These symptoms continued to progress to the point where I had to increase the amount of trazodone I took to sleep and, even then, I was still waking up more than normal. The fever stopped after 2 days. The other symptoms slowly tapered off. I have not had a sense of smell for years but I can taste things. Since starting the antiviral everything has tasted bitter and my mouth remained bitter 24/7 until about 2 days after I stopped the antiviral. I am back to my normal sleeping patterns; however, I am still quite fatigued and am not at my normal energy levels and am having a hard time getting motivated to do things.
Within 15-minutes of vaccination, the patient reported that their "arm was getting tight and tingling". EMS evaluated patient on-site. Patient was hypertensive (160/86), but otherwise vitals were WNL. Patient refused transport to hospital.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-APR-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL- 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
On 08/23/2022 I started with a sore throat; ear clogged; low grade fever of 99.00; sweating. I took a test it 100.1 degree fever. On 08/24/2022 in the morning I had sore throat; fever of 99.00; I felt achy all over my body and headache. I called my doctor's office and told my doctor about the symptoms I was experiencing. She send PAXLOVID for 5 days to the pharmacy. I started taking it from last night 08/24/2022. This morning I felt nausea and fatigue. No temperature and no sore throat. I will have a tele health with my doctor today and I will discuss my COVID-19 symptoms as well just to see if everything is going the right way. I am recovering now from COVID-19.
SON OF PATIENT CALLED TO CANCEL 2ND DOSE APPOINTMENT STATING PATIENT HAD STRANGE FEELING FROM HIS SHOULDER TO HIS HAND IMMEDIATELY AFTER VACCINE, THEN 13 MINUTES LATER HAD TINGLING IN HIS FACE AND NUMBNESS IN HIS TONGUE. HE WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS UNABLE TO CONSUME WATER BECAUSE OF ADVERSE EFFECTS
PATIENT BECAME VERY DIZZY AND NAUSEOUS THE FOLLOWING MORNING AFTER VACCINATION. PATIENT STATES SHE IS HAVING A HARD TIME PICKING UP HER HEAD.
Raised rash around injection site. Urticarial. Hives on left arm/chest and swelling of left hand.
Flu like symptoms, severe headache, diziness/lightheadness,chills and body aches Fatigue, diahrea, swolen lymph nodes
Redness of arm raised; Warm to touch; Swelling; redness raised; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised). At the time of the report, VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Benadryl and prednisone. No concomitant medications were provided by reporter.
1 minute (approx) after injection client stated she felt nauseous. Brought trash can to her. Says she is hot, got cool cloth and applied to forehead. Client drew arms to chest and started slumping in chair. Help summoned. Client pale and diaphoretic. Thready pulse, unable to get B/P reading. Ammonia inhalant under nose; client stirred a bit. Helped to floor to lie down. HR 72, 80/52 B/P. Dr. assessed client, monitored till recovered.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was administered the first dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly in February of 2007, the second dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly in April of 2007 and was in the office on 14-MAR-2013 to receive a third dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly. No adverse effect reported. No concomitant medication was reported. Additional information is not expected.
Hard, itchy, red circle around injection site about the size of a silver  dollar since the morning following shot and continues still today
Arm Swelled up and had the taste of metal in my mouth - went away after about 2 hours
Broke out at injection site (left leg) with fluid-filled blisters on 3-15-2007.  low fever.  think it is at injection site of Varicella.
pain at injection site, trouble sleeping, nausea/vomiting a little after 12 hours of getting vaccine
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous, anatomical location were not provided). On 17-MAY-2013, the patient experienced a 4 inch circle of redness on her arm (unspecified site). The patient received BENADRYL for treatment. The outcome of 4 inch circle of redness on her arm (unspecified site) is unknown. No reporter causality provided. Additional information has been requested.
Hives on arm injection received this developed respiratory distress within 2 hours of injection. ICU at hospital. 8/29/07-records received for DOS 8/7-8/9/07-DC DX:Asthma, unspecified. Nonspecific skin eruption. Adverse effect diptheria vaccine. Adverse effect tetanus vaccine. C/O arm swollen at injection site, rash was itchy, chest tightness and SOB. Perioral paleness. No cough no wheeze.
2 expired doses of tenivac were administered today 9with no reported adverse event); Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 year old female patient who was administered expired doses of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 23-Jan-2023, the patient received an 0.5 mL dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength - unknown, frequency - once (1x), lot U6922AA and expiry date - 21-Jan-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event) (expired product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.