chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse, who reported on behalf of her 3-year-old daughter. A 3-year-old female patient was administered a dose of PREVNAR 13 by unspecified injection in the left thigh on 16May2011. Relevant medical history was none. Relevant concomitant medications were none. On 16May2011, at 22:30, the patient experienced fever and chills. On 17May2011, she experienced vomiting and fever which she mentioned to be 101.1 degrees. Therapeutic measures taken in response to fever and chills included treatment with TYLENOL and MOTRIN. Relevant lab data included body temperature of 101.1 degrees (unspecified) on 17May2011. At the time of this report she had not recovered from the events.
Itchy but more biting sensation rash  and hives all over including hands and feet. This lasted for 2-3days.  Benadryl PO helped but as soon as Benadryl wore off the rash/hives came back.
Severe lightheadedness within 15 minutes of ZOSTAVAX administration. Paramedic took vital signs + blood sugar (all WNL). Pt refused work up at hospital + would contact primary care physician.
"Covid-arm": hives, rash, redness, itchy, slight pain.  Started below the injection site on upper arm 1 week after receiving first dose.  Got larger and migrated to other parts of upper arm.  Have had this 6 days now and it is still there.  It has migrated lower and further back, but is still very red and itchy.
staff person given only the DTAP, without HIB to patient; Initial and Live follow-up information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who received, 0.5 ml dose DTAP portion without HIB portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Formulation: unknown, lot: C5427BA, expiry date: 13-OCT-2019) via intramuscular route in left thigh on 11-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate reconstitution technique (staff person given only the DTAP, without HIB to patient)  It was unknown whether the patient had any adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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 document held by sender: none.
Information has been received from a physician concerning an 8 year old female child who in approx. 1998 was vaccinated with 1 dose of varicella virus vaccine live. In approx. 3/00, the pt experienced a severe case of chickenpox, it was noted to be a "pretty bad case" and that she had "chickenpox on her chickenpox". The pt was not known to be immunocompromised. The physician considered hospitalization. Additional information has been required.
This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2019, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N0306956 and expiration date: 25-AUG-2019) single dose, once, orally, for prophylaxis. The administered doses of the vaccines experienced a temperature of 50.92 Fahrenheit for 20 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.
The first dose of the vaccine was given on 2/16/21 - he vomited at clinic, felt lightheaded, and was brought to the urgent care and observed, given 50mg IM diphenhydramine. all sx resolved. No sx airway swelling or respiratory sx. VS wnl. He was discharged and given PO benedryl TID for 48h. Since pt had reaction but was not clearly allergy/anaphylaxis, recommended ok to give second dose - but to give in urgent care in monitored setting. Second dose given 3/18/21. within 5-10 min of vaccine administration, patient began vomiting. He was treated with 4mg IM Zofran, then another 4mg IM Zofran (8mg total) and 50mg IM diphenhydramine. All sx resolved. No airway swelling or respiratory sx. VS wnl. Pt was stable, discharged from urgent care. Gave 50mg PO diphenhydramine x 24h.
sharp pains on left side of chest/ when taking a deep breath there is a little soreness right below the ribcage; received shot and felt soreness/like with a tetanus shot; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at site of left arm at 09:00 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included colitis (in remission right now). There were no concomitant medications. The patient received shot and felt soreness on 29Dec2020, had sharp pains on left side of chest on 30Dec2020, and when taking a deep breath there is a little soreness right below the ribcage. Clinical course: patient got the vaccine on 29Dec2020 and felt soreness, like with a tetanus shot. On the 30th2020 he was kind of sore and then by midday all of a sudden felt the sharp pain in his chest, and once in a while when taking a deep breath there is a little soreness right below the ribcage. He went to the emergency room on 01Jan2021 and they first did the EKG, then the X-ray and they both were normal. To rule out pulmonary embolism they did CT scan and that was all fine. He also just wanted to rule out heart or lung problems since he is pretty healthy. He did not receive any other vaccines the same day and none 4 weeks prior. Vaccination facility type in hospital. The outcome of events was unknown.
Hives all over body, throat swelling and itching.  Benadryl 50mg given.
Pfizer 8/7/21 and 9/1/21. Positive on 1/26/22
At about 12 hours after injection I started running a fever of 102ºf  that lasted 24 hours some times it would spike up to 104ºf. Had a headache that lasted 2 days soar muscles and joints over entire body skin all over turned red. Had no appetite. 30 hours after injection I broke out in a rash all over my chest and back. A very very bright patchy rash.
I felt like I got sicker the more I laid down; feel like I have the flu; I threw up all the water I had; can't eat anything because of the nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I felt like I got sicker the more I laid down), INFLUENZA LIKE ILLNESS (feel like I have the flu), VOMITING (I threw up all the water I had) and NAUSEA (can't eat anything because of the nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (being positive) in December 2020. Concomitant products included PIOGLITAZONE HYDROCHLORIDE (ACTOS), FUROSEMIDE, LEVOTHYROXINE, LOSARTAN, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), OMEPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERTRALINE, TICAGRELOR (BRILINTA), VITAMIN D3 and REPAGLINIDE (PRANDIN [REPAGLINIDE]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (I felt like I got sicker the more I laid down), INFLUENZA LIKE ILLNESS (feel like I have the flu), VOMITING (I threw up all the water I had) and NAUSEA (can't eat anything because of the nausea). At the time of the report, ILLNESS (I felt like I got sicker the more I laid down), INFLUENZA LIKE ILLNESS (feel like I have the flu), VOMITING (I threw up all the water I had) and NAUSEA (can't eat anything because of the nausea) outcome was unknown. Not Provided      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.   No treatment information was provided.
pt recv vax 8JUN95 & p/pt brother recovered from chicken pox & then pt devel chickenpox;
resting heart rate at 138 when waking up, resting heart rate at urgent care 124. Continuing to have a racing heart rate at random resting times. Will be making an appointment with a cardiologist for further testing.
This case was reported by a healthcare professional (office manager and nurse) and described the occurrence of convulsion in a 24-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included Tdap; GlaxoSmithKline; unknown; right deltoid given on 15 June 2013. On 15 June 2013 at 10:30 the subject received 1st dose of HAVRIX adult (intramuscular, left deltoid). On 15 June 2013, 10 minutes after vaccination with HAVRIX adult, the subject experienced convulsion, bleeding from inside ear, fall, hit head, concussion, and brain hemorrhage. The nurse reported that the subject "was rubbing his left arm and started to fall forward and then fell backwards and hit his head on the floor." Per the nurse, the subject then "experienced convulsions" and "blood came out of his ear." The subject was "hospitalized for 2 days, and 1 day was spent in the Intensive Care Unit." The subject was diagnosed with a severe concussion and minor brain bleed per the nurse. The nurse suspected HAVRIX "because of the issues they have been encountering within the past month after administering HAVRIX" (see case A1032762A). The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were improved. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
tested Covid19 positive; tested Covid19 positive; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 or 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 05Jan2021 or 06Jan2021 and then 2 weeks later tested positive for COVID in Jan2021. The patient asked how long he was supposed to wait for the second dose. It was just a mild case and he has already recovered the few days in Jan2021.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for "tested Covid19 positive".
Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet.  At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath.  I was surprised at how fast and furious this came on.
Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke during the night.  Sunday & Monday still feel out of sorts. Temp normal but blood pressure on lower side. Reports today still feel unwell; injection site slightly warm, feeling light-headed, slightly nauseous, headache, again lower BP.  Took 2 Tylenol @ 4pm.
I felt a sharp and burning pain immediately while receiving the injection, since then I've had severe arm pain that radiates to my neck and shoulder. I had to go to the ER for the pain and was informed that the vaccine shot could have triggered a flare-up in my arm. Since then I have had non-stop arm pain and a minimum range of motion.
ITCHING,RASH AND HIVES ON THE BACK,UNDER ARM, LEGS...SYMPTOMS COME AND GO
no adverse event; MMR II, Varivax, Vaqta and prevnar 13 intended for a 12 months pediatric visit were inadvertenly administered to a 6 month old; This spontaneous report was received from a registered nurse referring to a 6-month-old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On 22-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) one injection, lot # T000890 that expires on 01-JAN-2022, for prophylaxis (dose, route of administration, lot number and expiration date were not reported), varicella virus vaccine live (oka/merck)(VARIVAX) one injection, lot # T028309 that expires on 20-AUG-2022 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) , hepatitis a vaccine, inactivated(VAQTA) one injection, lot # T023913  expiration date reported as 20-AUG-2022, but upon internal validation established as 31-MAR-2022.)(dose, route of administration, lot number and expiration date were not reported) and pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) one injection, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) intended for a 12 month pediatric visit but was inadvertently administered to the 6 month old patient.  It reported that the patient was not exhibiting any adverse symptoms at the time of the call.  No additional adverse event was reported. No product quality complain. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT TIBIAL VEIN ACUTE DVT OF LEFT PERONEAL VEIN
Flu-like symptoms, severe headaches and low fever of 99.5 and persistant cough. Worsened on 2/11/2000 through 2/14/2000. Saw doctor on 2/11/2000 for cough and was prescribed cough syrup with codeine. Used double doses of Excederin for headache, still coughing at this time. Only had flu-like symptoms with slight nausea for 1 1/2 days with #1 and #2 shots.  Follow up 06/05/2000: "Patient recovered from adverse event. "
About a month after second Moderna shot, I developed pulsatile tinnitus in the right ear that persists to this day.
10:25 - Pt compalins of tingling in mouth. Will continute to monitor. Initate VS. Lung sounds clear. 10:40 - Pt speech is muffled. Tongue minimally swollen.  10:41 - Benadryl 25 mg IM RA administered. 10:45 - Patient reports resolution of tingling in mouth. Tongue swollen resolved. 10:55 - Patient left.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (strength was unknown) (lot# M034856 and expiration date 27-JUL-2018) subcutaneously for prophylaxis. The MERCK STERILE DILUENT was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 07-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
"Covid arm" itchy red rash covering most of outer, upper arm around vaccination site.  Appeared 9 days after 1st vaccination. Slowly fading, but still itches a bit a full week later.  Also had slight chills in the evening the day of the shot and felt chilly the next day.
HAD SYNCOPAL EPISODE, FELL TO GROUND STRIKING HEAD, HAD CT SCAN OF HEAD.
I was in AFib (atrial fibrillation) 3 years ago and was treated with an ablation - 7/16/2018.  Afterwards I would occasionally feel an irregular heart beat. I had my first Covid 19 vaccination on 01/15/2021 - Pfizer-BioNTech - lot # EL1284 My second Covid 19 vaccination was on 02/05/2021 On about 02/19/2021 and many times after I was feeling an irregular heart beat. My doctor says I am in AFib again and I am scheduled for another ablation in July, 2021. Is it possible that the Pfizer-BioNTech Covid 19 vaccination caused the current AFib (my doctor thought so) or is it a coincidence ?
This spontaneous report as received from a nurse refers to 11 patients (also reported unspecified patients) of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. The reporter stated that patients received unspecified doses in M-M-R II (lot # L001336 with expiry date 13-JAN-2017, lot # K018965 expiry date 15-OCT-2016, lot # K004949 expiry date 04-APR-2016, lot # K024038 with expiry date 26-NOV-2016) immunization series that were improperly stored at temperature of 71 degrees F for a time frame of 40 hours (incorrect product storage). Previous temperature excursion was reported, reporter stated the time and the temperature was cumulative information from early January 2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Severe muscle pain and joint pain in right arm swollen right arm. Severe Pain lasted 3 days and then pain which is still in upper arm in muscle and shoulder and on muscle in back of neck. Took Tylenol and ice packed the area. Went to Instant Care and doctor gave me prescription for pain meds and told me to continue to ice pack, this was on Feb. 18, 2015.
diluent only administered; diluent only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 15-month-old male patient who received MMR (Priorix) (batch number CT34G, expiry date 26-DEC-2025) for prophylaxis.   On 28-JUN-2023, the patient received Priorix. On 28-JUN-2023, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: diluent only administered) and inappropriate dose of vaccine administered (Verbatim: diluent only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received only the diluent portion of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Blood pressure jumped high. Heart rates speedy over 100 beats/min. Dizzy all the time. Constantly coughing.
She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 025A21A and 030L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Vegetable allergy (mushroom allergy), Penicillin allergy and Drug allergy (Paxel).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748145 (Patient Link).
This spontaneous report as received from a medical assistant refers to multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (Lot # L037921 and expiration date: 31-MAY-2017; Lot # L035636 and expiration date: 21-MAY-2017), orally (dose not provided). Concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 31.5 F for 3.5 hours. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same source. Additional information has been requested.
Extreme Fatigue starting day of shot + following day; went to bed @ 6 PM. Arm sore (injection site); some shivers; felt headache like fever but did not have latter. *For more than a week, my chest felt like it was being sat on + breasts were sore especially on right side. (July breast MRI normal). Last side effect was unusual prompting me to call provider + breast center  Do not have specific details like manufacturer, lot #, route, usually this isn't given to patients. Took time to contact my primary care provider, Dr., since she ordered taking SHINGRIX new series. (I had the old shingles shot some years back) This new incarnation was to provide better protection. Because the soreness was also in chest/breast area ofF + on for over a week, called my provider @ Breast Institute. Recent July MRI showed normal. Thank you!