chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a currently 6 year old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-APR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD recombinant Human albumin (rHA) or human serum albumin (HSA) of lot # N015623 with an expiry date of 15-NOV-2018 (Strength, frequency, route and anatomical location were not reported) for prophylaxis. On 03-APR-2018, a 11 minute temperature excursion of -13.3 degrees Celsius occurred as advised by the nurse. All other temperatures were in range and average temperatures remained stable. The vaccine was in the freezer at the time of excursion. The nurse advised that this was a "supported temperature excursion" since it was between -10 and -14 (Units unspecified) for a period of 11 minutes and that the supply could remain in stock and was viable. No previous temperature excursion occurred. No adverse vaccine reactions were reported. The call was because of a data logger. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter.
Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report.  Information on the lot/batch number has been requested.
TEMP 103.4, LETHARGIC, RED SPOT 1/2 INCH DIAMETER ON LEFT LATERAL THIGH.
started walking funny/cannot walk properly/cannot walk unless he has a cane; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (started walking funny/cannot walk properly/cannot walk unless he has a cane) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21 and 024M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), OMEPRAZOLE and PANTOPRAZOLE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced GAIT DISTURBANCE (started walking funny/cannot walk properly/cannot walk unless he has a cane). At the time of the report, GAIT DISTURBANCE (started walking funny/cannot walk properly/cannot walk unless he has a cane) outcome was unknown.     Action taken with mRNA-1273 in response to the events was not applicable   Concomitant medications includes Bromphen/pseudo/dextro HBR syrup No treatment medications provided
Enlarged area around injection site, very red and warm to the touch, appeared to be about 5 small vesicles in the center of the area.
I was encouraged by my children's Pediatrician to inform you of my adverse reaction although it did not cause me to go to a medical facility. I became numb on the left side of my face(same side as injection site) a half hour after my first dose. There was no facial drooping. I went to work and noticed the numbness wore off after a few hours.  When I had my second vaccine shot I informed them beforehand and they monitored me for 30mins after. The numbness was immediate on the left side of my face after receiving my second shot and I also felt it more in my arm this time as well. No facial droop or other issues other than the annoyance of the numbness but the numbing feeling lasted for 3 days this time. I did not seek medical attention as it was just annoying and since it wore off the first time assumed it would this time.
This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 17-JUL-2014 at 04:15 AM was vaccinated with an improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. This is one of several reports received from the same source. Additional information is not expected because all follow up information was received.
Vaccine received on 12/14/2021.  He woke up on 12/15/2021 with a very hot, tender, slightly swollen hard lump (3") where his Pfizer Booster vaccine was given the day before with tender axillary lymph nodes.  Of note - he had received the Moderna vaccines on 3/27/2021 and 4/27/2021.
Event occurred after second dose. 87-year-old male presents emergency department today for chief complaint of weakness. On tylenol. Still Inpatient
vaccine administered approximately 10:30am on Oct 15,2007.  By evening, fatigue, aches, sore throat and hoarse cough set in.  Approximately 2am, awoke with chest pain, tingling - took aspirin.  As of 8am, Oct 18, still fatigued, hoarse cough with some phlegm, aches persist.
Headache, Sedation, Arthralgia, Fever, NauseaVomiting, Sweaty, Shaky, Narrative:  Received 2nd dose of 0900 2/3/21 and by lunch time appeared grey and clammy. Noted fatigue x 48 hours and felt sweaty and shaky. Fever up to 102. Additional symptoms included nausea, headache, and arthralgias in hips and shoulders. Symptoms started to improve by 2/6/21 and resolved by 2/7/21. Missed work x 2 days. No known prior COVID infection.  Other Relevant History:
Local Health Department used expired vaccine for 11 patients. Vaccine: FluMIST manufactured by MedImmune. Lot: YK2014, Expiration date: 1/8/12. 5 patients were given vaccine on X/X/12 (1 day after expiration); 1 was given vaccine on X/XX/12 (2 days after expiration); one was given vaccine on X/XX/12; the others were given the vaccine after that time. All patients were contacted and given opportunity to be revaccinated. Expiration dates are now being more closely watched with expiration date in computer and monitored. All vaccine is tagged if close expiration date. (This was already being done, but somehow this vaccine was not caught in time.).
Patient is a 25M His last visit was 10/7/2020 Today he reports by doxy virtual visit with concerns for HPV vaccination. "the next day after I got it I had nausea, headache and malaise". He references the first week of October. Daily headache, nausea, mild vertigo lasting up to all day without fever. COVID testing completed 6 days ago was negative with a saliva test ("for asymptomatic people") Today - "is the best I've felt over the last month. No fullness to the abdomen or sensation that he cannot take a deep breath. There may be arrhythmia but no heart pain. Denies weight gain or loss.
Headache; Heat in my body; Very tired; tiredness; This is a spontaneous report from a contactable consumer or other non-health care Professional (Patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on 20May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I had the vaccine Thursday last 3 days ago or 4 days, last Thursday I feel like just I feel like very tired on 21May2021 and some headache on an unspecified date, is that normal. Heat in my body on 21May2021. Consumer stated if its gonna go away, at the beginning there is nothing now it starts to feel like two days ago it starts to feel like heat, some heat in my body, now I feel like tiredness last two days. The outcome of event was unknown.  Information regarding lot/batch number has been requested.
increased heart rate; headache; nausea; palpitations; shortness of breath; flu-like symptoms; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not providded), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is being treated for hypertension and hyperlipidemia. Patient had COVID-19 in Jun and still has lost sense of taste and smell with fatigue and headaches lingering. It was reported that after the first dose of BNT162B2, she had mild flu-like symptoms, headache and swelling at injection site. Symptoms lasted 2-3 days. On an unspecified date patient took the second dose and had experienced more significant flu-like symptoms with headache and nausea as well as increased heart rate and palpitations with shortness of breath. The flu-like symptoms lasted 24+hours but the heart rate variability for one week but is decreasing. The patient underwent lab tests and procedures which included hear rate: increased on unspecified date. The outcome of events increased heart rate was recovering and outcome for all other events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
The patient first received her Pneumovax in her right arm, followed by the flu shot in her left. On the Pneumovax shot, I hit the patient's bone, withdrew slightly, and then injected.Two to three minutes after administration of both vaccines, the patient complained that she felt "funny." She tried to stand and found that she could not. I encouraged her to sit back and do her best to relax. Her breathing grew rapid and labored, and her face and chest grew flushed. Her son reported that she has been having more frequent panic attacks as of late, which could have exacerbated the situation. She complained of shortness of breath and that she "couldn't breathe", but denied symptoms of tongue swelling or feeling like her throat was closing. The patient also wasn't exhibiting any outward signs of anaphylaxis, with no swelling of the face or lips noted. An Epi-pen was procured as a precaution but not administered. Emergency services were called at the request of the patient's son due to her continued shortness of breath and anxiety complicated by underlying heart issues, including the presence of an internal pacemaker. Within a few minutes, the patient's color had returned to normal although she continued to have a rapid respiratory rate. This was eased in part by the patient's son getting her home oxygen from their vehicle, which was administered via her nasal cannula. EMS arrived within 15 minutes of incident onset. By that time, the patient had been able to stand and use the restroom with assistance from her son. EMS staff took the patient's vitals and found her blood pressure and oxygen saturation to be within normal levels, and the patient reported feeling much better. The entire incident lasted approximately 30 minutes, and concluded with the patient declining EMS transport to the hospital and returned home with her son.
HE DEVELOPED A SEIZURE DISORDER 2 WEEKS AFTER HIS FIRST MODERNA VACCINATION AND WAS HOSPITALIZED FOR 3 DAYS AT HOSPITAL.
Moderna COVID-19 Vaccine EUA: chills lasting 6 hours, fatigue lasting 1.5 days. Took a total of 4 tylenol over the course of 1.5 days. Tylenol greatly reduced chills and fatigue.
pt admitted to hosp with increasing SOB, productive cough; found to be hypoxemic; chest x ray shows diffuse parenchymal disease; placed on BiPAP; given antibiotics, decadron, remdesivir; acute renal failure; sepsis; intubated due to worsening condition; discussed with family the plan of care and family decided to extubate pt; pt died in the hospital
Got 2 doses within 24h of birth; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-day-old female patient who received HBV (Engerix B) (batch number Zp72s, expiry date 15th December 2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 20th December 2022, the patient received the 2nd dose of Engerix B (intramuscular) .5 ml. On 20th December 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment:  The reporter reported that the infant patient got 2 doses of Engerix B within 24 hours of birth. He didn't report any adverse reaction to these vaccines. Did not consent to follow-up. No follow up to HCP. Additional supportive information: The patient received 2 doses of Engerix B vaccine within 24 hours of birth, which led to overdose.
Itchiness; Big red well; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Big red well) and VACCINATION SITE SWELLING (Swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012E21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and LISINOPRIL for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Big red well) and VACCINATION SITE SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Big red well) and VACCINATION SITE SWELLING (Swelling) 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.
No additional AEs were reported; patient received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 21-OCT-2022, the patient was vaccinated with following improperly stored vaccines: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dose, lot # U039951 with expiration date 22-JUN-2024, for prophylaxis (exact dose, route of administration and injection site were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot # 1912561 was confirmed to be valid, with expiration date 10-DEC-2023, administered orally for prophylaxis (exact dose was not provided) (product storage error). The vaccines were improperly stored for 15 minutes in the temperature of 34.9 degrees Fahrenheit (F). It was unknown if data logger was used to capture the temperature excursion. There were no previous temperature excursions. No additional adverse events were reported (no adverse event).
metallic taste in her mouth; arm pain; feeling fatigue; hematoma/bruising; shooting pins on my fingers; hematoma; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma) and PAIN IN EXTREMITY (arm pain) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue). In November 2021, the patient experienced CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers) and HAEMATOMA (hematoma). At the time of the report, DYSGEUSIA (metallic taste in her mouth), CONTUSION (hematoma/bruising), PARAESTHESIA (shooting pins on my fingers), HAEMATOMA (hematoma), PAIN IN EXTREMITY (arm pain) and FATIGUE (feeling fatigue) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Lesions on bilateral hands and elbows. Patient had c/o urticaria. Treated with Benadryl for urticaria.
Acute myocarditis with markedly elevated serum troponin (peak hs-Troponin I 21,818 ng/L) and abnormal ECG changes. He was transferred to hospital for emergent cath amid concern for possible STEMI, which showed no coronary artery disease. Echo showed normal LV function. Cardiac MRI demonstrates myocardial edema consistent with myocarditis. He was treated with corticosteroids for presumed vaccine-associated myocarditis.
started w/ redness upper L arm, just below site of vaccine, approx 3x4inch redness, with itching and mild swelling.
This spontaneous report was received from an office coordinator referring to a 14 month old patient of an unknown gender who on 22-APR-2013, was vaccinated with a dose of (Merck) PROQUAD (supplied lot # H015779, expiration date, 25-JAN-2014) and with a dose of (Merck) VARIVAX (supplied lot # H018423 expiration date, 08-OCT-2014) on the same day. No adverse effects reported. Additional information has been requested.
I had breast cancer surgery Dec. 2020 and had my lymph node removed. After booster shot I had a swelling and a lot of soreness in the area the lymph node was taken out. Should have had shot in other arm.  Lasted about 5 days.
LEFT SIDE OF FACE STARTED HURTING; THROAT TIGHTENING; CHEST HAVING CONSTRICTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced left side of face started hurting. On SEP-2021, the patient experienced throat tightening. On SEP-2021, the patient experienced chest having constriction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left side of face started hurting, throat tightening and chest having constriction was not reported. This report was non-serious.
Immediate redness in arm at injection site, tender to touch,  swollen and hot.   Day after vaccine- severe chest pains and stomach pain lasting for 4 days. Heaviness on chest.  Blood pressure was OK.   Random stabbing in foot as if someone put a needle in the top of the foot.  All of which is now gone.   Feb 4, approx 1 week after injection,  there is about a hard lump at needle site.  Pt describes a similar to mosquito bite,  very itchy.  Red area of skin approx 2 inch diameter, visible raised lump hot to the touch
Starting on 05/05/2022 I got a sore throat and it was sore the next morning. I tested myself on 05/06/2022, and I was positive. We had a sore throat and mild nasal congestion. On 05/07/2022, I had a telehealth visit with a HCP and they sent over an rx for Paxlovid. I started it that Friday and at that point I probably was starting to feel better. Once I started the Paxlovid, then I got better very quickly. I still have some sniffles but I think its just allergies at this point.
ARM WAS SORE, SWOLLEN AND WARM AFTER 8 TO 12 HOURS.
the covid 19 vaccination was improperly diluted. the manufacture recommends getting revaccinated. patient was made aware of the situation.
Cortical sinus thrombosis with intracerebral hemorrhage, seizures. Admitted to ICU.
PATIENT HAD PFIZR  Dose 1 date: 12/29/2020  PFIZER,  Dose 2 date: 1/19/2021 PFIZER, AND TESTED POSITIVE TO COVID.
Temperature about 24 hours, joint ache, headache, right side of neck hurting, injection site left arm.  12/11/03: Developed hoarseness which lasted till 12/25/03 or there about.
Pain at injection site, muscle achiness, radiates from bicep to pectoral muscle. Warm to touch. Discomfort lasting up to 5 days.
developed red, raised, inflamed area at injection site. Applying Altabax 1% ointment to area twice daily for 5 days.
Injection site red, swollen and warm to touch  starting on day 6 after vaccination was given
Information has been received from an investigator regarding a 15 month old female who received her third dose of Prevnar as part of a safety post marketing trial on 08/30/2001. On 02/19/2002 at 21 months of age, the pt was diagnosed with periorbital cellulitis. Serotype 19A was isolated. The investigator considered this event possibly related to vaccine administration. The medical monitor's assessment is unknown.  Relatednes Assessment: The investigator and medical monitor considered periorbital cellulitis, drug ineffective and pneumococcal bacteraemia not related to the study product.
Fever and chills in the early hours of 1/21 (3:00-4:00am) Extreme nausea the morning of 1/21 (around 7-8am) I also had bad stomach cramping and felt dizzy  I slept for about two hours and the symptoms subsided, but I am still having intermittent nausea
she had mild symptoms, chills for about a half an hour and that was it; This is a spontaneous report received from a contactable female consumer. This consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Historical Vaccine (1st dose) include Covid-19 immunization. The patient experienced she had mild symptoms, chills for about a half an hour and that was it on an unspecified date. The outcome of the event was resolved on an unspecified date.
Patient received high dose flu vaccine and developed a rash on his back within minutes of administration. Unclear if rash was the result of the vaccine. Patient has no known drug allergies. He had no swelling of the throat. He was assessed by a medical resident who ordered topical hydrocortisone 1% cream. The rash resolved without any complications.