chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen from hip to toe w/golf ball size lump w/red sploches around site; DPH & Epi given;
fluttering issues; heart racing; attributed by the cardiologist to stress, anxiety and dehydration; attributed by the cardiologist to stress, anxiety and dehydration; attributed by the cardiologist to stress, anxiety and dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown", described as "fluttering issues"; PALPITATIONS (non-serious), outcome "unknown", described as "heart racing"; STRESS (non-serious), ANXIETY (non-serious), DEHYDRATION (non-serious), outcome "unknown" and all described as "attributed by the cardiologist to stress, anxiety and dehydration".  Clinical course: The reporter stated her 19-year-old daughter got the Pfizer BioNTech COVID-19 vaccine in May2021 and had some heart racing and fluttering issues that were not immediate after the administration of the vaccine. These symptoms, that happened when the reporter's daughter was 17-year-old, were attributed by the cardiologist to stress, anxiety and dehydration however, reporter stated that upon checking the VAERS reports, the lot numbers that her daughter was administered (EW0170 and FK9729) counted more than 3000 reports of side effects while her mother-in-law three lot numbers had only 124 reports. She now had learned to manage the anxiety a lot better, she was drinking the water she should, and she was still having these problems. Caller also stated, "Your fact sheet should be more factual."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046062 same patient/vaccine/event, different doses;
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that the Date the vial was initially stored in the refrigerator was on 01-Dec-2021. It was reported that vial did not undergo any temperature excursions. No treatment information was provided.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that the patients have usually been okay with the first dose but experienced flu like symptoms for 2 to 3 days with the second dose. This case has been linked with US2018GSK154782, reported by the same reporter.
Pt. received vaccine and immediately after was fine. Approx. 1-2 min. after pt. checking out and fainted hitting head on side of wall. Pt. remained lying for a few minutes. Able to describe what occurred, name, date, etc. Pt. sat up and fainted again. Pt. B/P stable. Pt. remained in supine position for 10 min before sitting for 10 more min and then moved to exam room. Vomited x1. Pt received PO fluids, ice packand rested. No subsequent HA in office or bleeding. In office 60 min. Advised to call back if any changes and to rest. Pt. felt normal when left. MD immediately notified and present. Examined pt. Made note in chart for pt. to have subsequent vaccines administered while lying down and to remain seated for several min after.
Patient had an approximately one minute tonic clonic seizure associated with a temperature of 102 degrees F.  Patient recovered and has not had a fever or seizure since.  Patient went to emergency department last night, but did not stay because of the wait.  Patient was evaluated in the office this morning (6/13/2008) and was found to be in good health.  He was to follow up with a pediatric neurologist to confirm the suspected diagnosis of febrile seizure.  He was instructed to call our office as needed for any further concerns and to proceed to the emergency department if any further seizure activity.
Discomfort/pain in left shoulder at site of injection beginning approximately 10 hours after receiving shot; Muscle and joint discomfort/pain throughout back, shoulders, and legs; Abnormal smell/taste in back of nose/mouth; These effects continue through the day following the injection.
Patient experienced disturbed sleep for several days after varicella. She was unable to nap and was up every hour during the night for 2 days.
Mild Nausea, dry mouth, muscle tenderness near injection site and muscle stiffness in the entire arm
I was tired immediately and slept for about 16 hours. Then I went to work and felt fine. On the third day I got suddenly I?ll. I was sweating  profusely, had severe stomach pain and diahrrea and was weak, dizzy and tired.
This is a 53y.o. male with past medical history for TIIDM, HTN, OSA on CPAP, arthritis, presents to ED with complaints of lower abdominal discomfort with assocaited nausea/vomiting x4 days. Patient states that he has not been able to tolerate any PO intake with minimal solid or liquids consumed over the past 4 days. Denies any chest pain, shortness of breath, productive cough, fever/chills. Patient denies prior CV 19 viral infection and reports completion of his COVID-19 vaccine series, however believes he was exposed at his current job. Of note, patient currently is on no diabetes regimen, despite A1c being 9.7% on most recent labs in June. Patient is also on a multidrug, anti-hypertensive regimen with previous echocardiogram in 2019 demonstrating changes consistent with hypertensive heart disease LVEF 60% with indeterminant left ventricular diastolic function. Patient does not follow with cardiology, states that his PCP currently manages his anti-hypertensive regimen.    In the ED, Vitals on arrival of T 97.8°F, BP 137/88, HR 84, RR 20, SpO2 100% on room air. Labs remarkable for Plt 405 on CBC, Cr 2.36, Glucose 187 on BMP. UA contaminated. Ultrasound kidney and bladder to evaluate for hydronephrosis and obstruction without significant change from CT abdomen and pelvis showed no acute intra-abdominal or pelvic process with noted hepatic steatosis, prostatomegaly and a stable left adrenal adenoma. Patient received IV Zofran ×1 along with a 1 L 0.9 and a bolus. At time of exam patient's nausea and vomiting resolved and no further episodes of nonbloody nonbilious emesis since admission, continued bilateral lower abdominal pressure was noted. For allergy consulted for further evaluation.
Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza (Afluria) (Dose no: 1, route: Intramuscular) on 09-Nov-2021, Zoster (Shingrix) (Dose no: 2, body site: left deltoid, route: Intramuscular and lot no:D4CZ3) on 21-Dec-2021. Past adverse reactions to the above products included No adverse reaction with Influenza (Afluria) and Zoster (Shingrix). Concurrent medical conditions included Allergy to metals (Allergy to Iron), Pulmonary hypertension since 20-Nov-2018, Heart failure since 26-Jun-2019, Atrial fibrillation since 08-Nov-2018, Vitamin D deficiency since 09-Nov-2018 and Hypokalemia since 27-Aug-2020.   On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Jul-2022 at 1:33 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo temperature excursions. The patient did not report any adverse events. 6 patients on 05-Jul-2022, 6 patients on 06-Jul-2022, and 3 patients on 07-Jul-022. No treatment medication were reported.
No additional adverse effects were reported in fue patient.; Patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On an unknown date in January 2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), (lot No. S024369 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 06-AUG-2021, but upon internal validation established as 08-JUN-2021) for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with diluent MRK (lot number and expiration date were not reported).    The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F (-14°C to-10°C) (9.8F) degrees Fahrenheit for 2 hours, as recorded by a data logger. There was no adverse event reported in the patient.
Infant received multiple parenteral vaccines as well as oral Rotateq at his 2 month visit; time administered between 10-11 am. No reaction while in the pediatricians office, but by 5 pm was noted by mother to have progressively increased drooling and prominent tongue swelling, requiring an Emergency Room visit at 7pm where he was treated with oral steroids in the ER followed by 4 daily doses of Orapred. Mother notes resolution of tongue swelling by day 2-3. No hives or local reactions at the sites of the parenteral vaccines were noted at any time. 11/27/07-records received for DOS 8/16/07-Status post possible reaction to immunization condition much improved. Evening of injection tongue protruded, lower lip swollen. Low grade fever.
Elevated heart rate exceeding 112 BPM and having spikes of up to 200 BPM, and an average of 139 BPM. Patient took deep breaths through his nose, then exhaled through his mouth which brought his heart rate down to 75 BPM average.
Complaint of dizziness and weakness after administration. This morning she reports feeling better but not 100%. Denied wanting to see a physician for treatment.
Patient fainted upon receiving the vaccine. Her body also shuddered. I used two ammonia inhalers and she responded.   Patient mentioned both her hands were numb, then tingling. Her  mother massaged her hands. She stayed for observation for 40 minutes. She left with both her mom and dad. She said she felt ok. I called her the same evening to check in. She had a nap and said she felt fine.
About 2 months after injection, a small blister developed that was itchy. Continue to be itchy intermittently now for 2 months since it developed.
Body aches, severe headache 24 hours after injection. Headache severe, went to ER for Lumbar Puncture & CT of head (both WNL per patient). 7/5/12 states headaches (migraines) now once every 5 days, but they were daily.
Patient received vaccines at 11;35 am once she stat down post vac area she begun to feel dizzy.
Redness in arm; Hot arm; Itching arm; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th August 2019, 7 days after receiving Shingrix, the patient experienced erythema of extremities, extremities hot feeling of and itchy upper limbs. On an unknown date, the patient experienced pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pain in arm, erythema of extremities, extremities hot feeling of and itchy upper limbs were recovering/resolving.   It was unknown if the reporter considered the pain in arm, erythema of extremities, extremities hot feeling of and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in left arm. The patient experienced sore arm for about 5 days after receiving the 1st dose of Shingrix vaccine.  On 5th August 2019, the patient experienced red, hot and itchy arm right below the injection site.  The patient applied topical Benadryl and also took a Benadryl. It was now getting better.  The reporter did not consent to follow up. No further details were provided.
dies at campus after the game; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves a 19 year old patient of unknown gender who died at campus after the game after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date it was reported that the patient died at campus after the game (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal)   Action taken was not applicable.  At time of reporting, the outcome was Fatal   It is unknown if an autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022: This case involves a 19 years old and unknown gender patient who died at campus after the game after receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any concurrent conditions, medical history precludes comprehensive case assessment.; Reported Cause(s) of Death: dies at campus after the game
Rash at injection, approx 2", very red, slightly tender and itchy, firm and slightly raised.  Slight improvement today, day 3.
received Moderna vaccine and he's 12 years old; a golf ball size knot that is all red at the injection site; a golf ball size knot that is all red at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna vaccine and he's 12 years old), VACCINATION SITE MASS (a golf ball size knot that is all red at the injection site) and VACCINATION SITE ERYTHEMA (a golf ball size knot that is all red at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna vaccine and he's 12 years old), VACCINATION SITE MASS (a golf ball size knot that is all red at the injection site) and VACCINATION SITE ERYTHEMA (a golf ball size knot that is all red at the injection site). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna vaccine and he's 12 years old) 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.
severe diarrhea for first week,  moderate diarrhea for second week, chills for two days, malaise for first week, lack of appetite. Urgent Care and Primary Care doctor visits suggested adverse vaccine effect most likely.  Complete recovery
This spontaneous report as received from a pharmacist refers to a 60 year old female (non pregnant) patient with no drug reactions or allergies. The patient's concurrent condition included diabetes. On 25-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administration at dose 0.65 ml subcutaneously (lot # K003604 with expiry date: 20-MAR-2015). Concomitant therapies included an unspecified insulin, NEXIUM. hydrochlorothiazide (manufacturer unspecified), ramipril (reported as "ramopril"), verapamil (reported as "verapimil") and CRESTOR. The pharmacist stated that the patient was also taking amoxicillin as treatment at the time of injection but not to treat injection site reaction. Reason for amoxicillin treatment was unspecified. On 26-AUG-2014, after receiving the vaccine, the patient had swelling at the injection site "about the size of a baseball" with redness. The patient did not seek medical attention. The outcome of the events was reported as recovered approximately on 02-SEP-2014 (reported as "about a week later"), without treatment. No laboratory test were performed. The relatedness between the events and ZOSTAVAX was not reported.
Orange sized hot, painful, red, and hard injection site; Injection site hot; Injection site painful; Injection site hard; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 26th November 2021) for prophylaxis.   On 14th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site pain and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site pain and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination with dose of Shingrix, the patient had orange sized hot, painful, red, and hard injection site. The reporter consented to follow up.
No adverse effects; incorrect product storage; This spontaneous report wsa received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medican history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 29-JUL-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis, lot #R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse event was reported.   The temperature excursion was reported as above 47°F/9°C (9.9°C) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported.   No digital data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1908USA001033:
after contacting her , she came back to the pharmacy and talked to me, but has not mentioned any side effects at this time it is around 6:45p.m.
At or around the injection site - red circle and swollen. Red circle grew to about 2.5 in in diameter. It was slightly itchy, but no soreness or pain. Adverse effect began 8 days after injection.   Treatment: hydrocortisone cream 1% applied 2x/day for 2 days.   Outcome: I stopped the cream after 2 days because the redness and swelling were gone.
I contracted Covid on 1/24/2022. I had bad body aches and flu like symptoms. Cough, mucus, and sore throat. Nausea and vomiting would come on some as well. The chills were very bad as well. Today I still have a cough and bad mucus.
Within six months of receiving the vaccine, the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm.; Within six months of receiving the vaccine, the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history.   On 01-DEC-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at an army clinic for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes zoster) (dose, administration route, anatomical location lot # and expiration date were not provided).  Within six months of receiving the vaccine (In June 2016), the patient suffered a painful outbreak of shingles and rash in his forehead. Shortly thereafter, patient had multiple outbreaks of shingles including cellulitis of his right upper arm. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries, also reported as serious, progressive and incurable injuries. The reporter considered cellulitis and shingles to be related to Zoster Vaccine Live(ZOSTAVAX).    Upon internal review, the event of cellulitis was considered as medically significant event.
8 hours post-vaccine, experienced rather severe chills and fever spiking around 101.5, restless sleep, aches, pains, slight headaches all lasting around 24 hours.
Developed a redness around vaccine site a few days after injection.  The reaction is resolving on its own.