chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pale, clammy, diaphoretic associated with vomiting and near syncope 12 hours status post vaccine.   Then within 24 hours post vaccine developed burning in chest.   36 hours post vaccine severe chest pain.  Described as elephant on chest radiating down left arm to left jaw associated with paleness and diaphoretic.  Hurt to take in deep breath and pain worsened upon lying down.  Relieved with motrin 800 mg.  I continued motrin every 6 hours until I could follow up with cardiologist on Friday 01/29/21.  EKG showed ST elevation in all leads.  Stat echo was performed at facility.   Diagnosed per doctor with acute Pericarditis.   Started on Colchicine 0.6mg twice daily X 10 days.  Other doctor followed up and continued Colchicine 0.6 mg x 90 days.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
ON  10-22-07 PATIENT'S MOM SAID THAT 6 HOURS AFTER SHOT ON 10-08-07  HAD TEMP OF 104, GAGGING AND SAID THROAT WAS CLOSING.COULDN'T MOVE HIS BODY ,VOMITED AND SAID HE WAS PASSING OUT.HE WAS TAKEN TO THE EMERGENCY ROOM.THE MD SAID HE JUST HAD A FLU AND WAS DISCHARGED NEXT MORNING, NO MED WAS GIVEN
Later that night he got vertigo he had a spinning sensation and was unable to stand. He has heart palpitations, a rash and swollen lymph node under left arm. Under heel of left foot has become numb. He went to the dr who dx him with vertigo and high blood pressure.
This spontaneous case was initially received on 02-OCT-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Medication error (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage. Company's evaluation and comment: Seriousness criterion/criteria: Non serious.
A week and half later, I started having SOB and my heart rate would go really high. I went to the ER. They did Echocardiogram, MRI, EKG, and CT scan. They found that my aortic valve was not closing. They said that the vaccine could have irritated the valve. I winded up having surgery.
After first shot in April , I had a stomach ache and diarrhea but it went away relatively quickly. Within a few weeks I noticed occasional muscle twitches in my legs but nothing to cause me concern. After the second vaccine in May, I had a severe stomach ache below the rib cages. Around 3:00AM I had a severe stomach ache, felt chills one minute, then I was hot, and sweating. This event passed and I I thought I recovered but two to three weeks later (around May 31st) I was experiencing twitching all over my body along with two to three weeks of diarrhea (unlike anything I ever experienced. For one week, it was extremely intense and I went from weighing over 185 pounds to around 170ish. After the diarrhea event, I continued to experience anxiety, erratic blood pressure and then the first panic attack of my life.  I believe my eosinophil levels were much higher than any prior blood tests as well. The diarrhea went away but I continue to experience elevated anxiety and I am now experiencing neurological sensations. My  head burns and sometimes feels numb. My hands are always abnormally cold.
Herpes zoster without complication. Treated with valacyclovir 1000 mg TID for 7 days. Due to excoriations over affected areas, patient also treated with keflex 500 mg 4x daily for 7 days.
On December 2, 2022, I started getting dizzy and felt like I wanted to throw up, vomiting, diarrhea. I lasted for two hours before I could sleep for a bit, then my daughter took me the local urgent care. I was tested for COVID-19 and Influenza A and B both tests came back negative. They told me to go to the emergency room to get more test run. I went to the emergency room, where they ran a CAT scan, EKG the test was negative. I was advised to go home and rest. I made an appointment with PCP, that was cancelled. I went back to the urgent care on December 21, 2022, were I tested positive for flu. Once I recovered for that I got ill again and tested positive for COVID-19 on January 19, 2023. I finally made an appointment to see an ear nose and throat specialist. Upon her examination, she felt that I may have Ménière's disease. I have seen an audiologist; I was fitted for hearing aids that have helped improve my health. I have changed my diet to low sodium, the vomiting is gone as well as the diarrhea. I do have slight dizziness but that is not as bad as it was, it is more controlled.
Fast heart beat; Dizziness; Off balance; Hot flashes; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), HEART RATE INCREASED (Fast heart beat), DIZZINESS (Dizziness) and BALANCE DISORDER (Off balance) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HOT FLUSH (Hot flashes) and DIARRHOEA (Diarrhea). On 05-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart beat) and DIZZINESS (Dizziness). On an unknown date, the patient experienced BALANCE DISORDER (Off balance). On 04-Mar-2021, HOT FLUSH (Hot flashes) and DIARRHOEA (Diarrhea) had resolved. On 07-Mar-2021, HEART RATE INCREASED (Fast heart beat) had resolved. At the time of the report, DIZZINESS (Dizziness) was resolving and BALANCE DISORDER (Off balance) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Fainted; Vomited; Ringing in ears; Injection site was slightly sore; Sore throat; Hoarseness; Dry eyes; A spontaneous report was received from a consumer, concerning herself a  71 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainted/Syncope, Vomiting, Ringing in ears/, injection site was slightly sore/Vaccination site pain, Sore throat, Hoarseness, Dry eyes.  The patient's medical history was not provided, concomitant medication was not provided by reporter.  On 14Jan2021, prior to the onset of events patient received her first dose of two planned doses of mRNA-1273 (lot number: 028L20A) via unknown route on right arm for COVID-19 infection prophylaxis.  On 15 Jan 2021 she experienced fainted, She was taken to the Emergency Room by ambulance. She was vomiting in route to the hospital. She also complained that she had ringing in her ears, & admits that she still had it. At the hospital, they performed a CAT scan & a MRI of her "stomach." They wanted to admit her, but she was fearful she would contract Covid during her hospital stay. The injection site was slightly sore. She admits she developed a sore throat & hoarseness that day, & has I've had it since then. On 01March 2021, her eye Dr diagnosed her with dry eyes. The seriousness for fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness considered as hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness, Dry eyes was unknown at 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 these events, a causal relationship cannot be excluded.
I missed the time frame for the 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st of Shingrix on 17th September 2021).   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 Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The case was reported via interactive digital media. The patient got the ZOS (herpes zoster recombinant) Shingrix and missed the time frame for the second dose. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
I was traveling out the country a few days before on 12/17/2022. That was a Saturday, between Monday and Tuesday I was feeling not well in the middle of the night. I had chills and vague nausea. Throughout that day I continued to feel unwell and super tired and chills and extremely nauseous. That night I had a fever of 100. That 12/21/2022 I took an at home COVID-19 test it was positive. I had a higher fever of 102. I slept until 3 days and nights. I took ALEVE every 12 hours for two to three days. On that Friday I guess was the 23rd, I talk to my doctor and told her my fever was going down and the nausea was gone. It was going up and down that day. They went through my health status and saw it being mild to moderate to prescribe PAXLOVID and fill it if I felt worse. I did not feel worse, but I wanted to take it to prevent long COVID-19. I knew I was getting better by that Sunday maybe, because I was unable to slept.
Approx 2 days (9/11) after Tdap patient experienced swelling in her right leg that continued to get worse into evening of 9/11. Patient states that she iced her leg and the swelling went down somewhat but came back the next day and the day after thru today 9/14 where she is still experiencing swelling but to a lesser degree.
Tingling numbness in right arm.  Arm goes to sleep.  Started to occur at night 3 weeks after completion of second dose.  04/28 arm continues to feel tingly during the day.
Within 1 hr of 2nd shot, experienced tingling/numbness in both arms&hands&right thigh, in addition to heaviness in left arm. All day Sat had dull headache. Woke up Sunday morn with splitting headache, nauseous, dizzy. Checked BP it was 140/90 (for me anything above 130/80 gives me headaches, my typ high is 124/78). Then experienced tingling&numbness on both sides of face, upper back of head, hands, fingers, and legs. Numbness came and went. Monday afternoon walked up 3 flights of stairs (which I've been doing every day for almost 1 yr), but now experienced shortness of breath, heart palpitations. within 1 hr my entire face/back of head was numb, felt pressure in both of my ears, and both my hands, right leg became partially numb. Went to ER in evening since numbness persisted on/off, especially in face/head. Doc told me my potassium was a bit low & minor dehydration. Got cat scan & EKG--all ok. Was given potassium pill and fluids. While I was waiting, my entire right side (arm/face/legs) became numb for ~1 hr, then lessened up, and moved to left side. Was discharged, but continue to experience "rolling" numbness all over my body--mostly face/back of head, hands/fingers, and legs--but it's now also affecting  lower back of head, and upper front & lower back as of Tuesday morning. Some heaviness in both arms, but again on/off. Haven't had another high BP episode from what I can tell. I've never been completely paralyzed per se, but simply tingling/partial or total numbness for long periods of time in all the above mentioned areas.
Vaccine had expired from being pulled from the ultra freezer just the day before the vaccine was given.
the patient was administered a properly stored but expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-DEC-2019, the patient was vaccinated with the first dose of a properly stored but expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N001533 and expiration date 16-OCT-2019 (dose, frequency, route and anatomical location were not provided) for prophylaxis.
immune-suppressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002689 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNOSUPPRESSION (medically significant), outcome "unknown", described as "immune-suppressed". Additional information: On 20Jul2022, it was reported that the patient started treatment on an unspecified date with Pfizer Biontech Covid-19 Vaccine. It was reported that the patient experienced immune-suppressed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Local symptoms: Pain-discomfort. General symptoms: Chills, headaches, joint pains, muscle pains, fatigue. Narrative:  Other Relevant History:
Vaccine was reconstituted incorrectly with only 0.8ml of sodium chloride instead of the required 1.8ml. Patient received more than double the dose on Saturday 07/10/21. I spoke with her on Sunday 07/11/21 at 4:57pm and she stated that she was doing fine though had a slight headache and some fatigue. I told her what happened and explained that she could have a stronger immune response due to the higher dose. I asked if I could call her back later this week and she said Thursday afternoon 07/15/21 would be fine.  I will check in with her at that time to determine whether she has had any further effects. Her primary care provider has been notified of the incident.
Faintness on Standing; Back Ache; Fever 100.2 F; Chills; Sore Injection Site; A spontaneous report was received from a Nurse concerning a 52-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced events Faintness on Standing/Dizziness, Fever 100.2 F/ Pyrexia, Chills, Back Aches/ Back pain, Sore Injection Site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: Unknown), via an unknown route for prophylaxis of COVID-19 infection.  On 03 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot/Batch number: 029L20A) via intramuscularly in the Deltoid Muscle for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient had Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site. Treatment information for the events was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site, was unknown in Feb 2021 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 events, a causal relationship cannot be excluded.
Child received her first Covid vaccine when it was noted that she had received 0.2 ml of the 5yr-<12 yr vaccine instead of the 6 mo -4 yr vaccine.
Initial report received from a healthcare professional on 07 November 2013. A 15-month-old patient received last year's FLUZONE 0.5 ml. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
pain as like it is broken, can barely lift it; cannot sleep well from the discomfort; sweats and has clammy skin; Bad injection site pain in the left arm; patient received a dosde of Adacel at Gestation age: 30 weeks; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 32 years old female patient who experienced pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at Gestation age: 30 weeks on an unknown date.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The events occurred at 30 Weeks of pregnancy.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Epilepsy and was taking KEPPRA. The patient previous pregnancy/ies details not reported.   No concomitants reported.  On an unknown date (over 9 days ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6272AA, expiry date: 26-Apr-2021, via unknown route in the left arm.  On an unknown date, the patient developed a non-serious pain as like it is broken, can barely lift it (injected limb mobility decreased), cannot sleep well from the discomfort (poor quality sleep), sweats and has clammy skin (cold sweat) and bad injection site pain in the left arm (vaccination site pain), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was injected limb mobility decreased, poor quality sleep, cold sweat and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from the events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
No additional adverse events; Administration of expired ROTATEQ; This spontaneous report was received from a licensed practical nurse referring to a 2-month-old patient of unreported gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided.    On 04-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (expired product administered) (lot number T033812, expiration date 29-DEC-2021; dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. Nurse inquiring viability of expired dose.     No product quality complaints reported and no additional adverse events (no adverse event) were reported.
SkinRash & ErythemaMultiform Narrative:  Itching of scalp, slight redness attributed to scratching by employee, no wheals or blisters
gave some doses of ActHIB to patients without the dilulent, did not use the supplied 0.4% Sodium Chloride diluent, used sterile diluent instead; Initial information received on 08-Jul-2019 and additional information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA188132 and 2019SA188109 (same reporter).  This case involves a 19 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-JUN-2019) via intramuscular route in the right thigh (reported as right leg)  on an unknown date of March or April 2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution. The girl that had given the shot did not use the supplied 0.4% Sodium Chloride diluent that was in the box. She used sterile diluent instead. The one in the box was supposed to be used.  It was unknown whether the patient experienced any adverse event post vaccination.  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 Directive and Module VI of the Practices. 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.  List of documents held by sender: none.
This spontaneous case, initially received on 07-Sep-2018, reported by a pharmacist and concerns a 65-year-old, elderly, male patient. On 07-Sep-2018, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195124, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). On the same day, the patient also received the non-company suspect ZOSTAVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was observed for 10 minutes and did not experience any adverse events. This case '201803759' was linked to 201803758, reported by the same reporter. The reporter assessed the case as non-serious.