chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One child's father said his child dropped dead after getting 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "One child's father said his child dropped dead after getting 2nd dose.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical Course: It was reported that reporter had a product complaint. Pfizer was using social media and trying to get parents to get 5 year olds vaccinated. Reporter had several children in the (name-withheld) die after getting the doses. There was not news coverage, and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. These are young healthy children. Reporter did not have any specific information to provide on any of these children to complete a report for.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: One child's father said his child dropped dead after getting 2nd dose.
This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female patient who received KINRIX (batch number F43Z7, expiry date 31st October 2016). On 6th November 2014, the patient received KINRIX (unknown) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 24th February 2015. The patient received KINRIX at week 24 of the pregnancy and during the second trimester of pregnancy. On 6th November 2014, an unknown time after receiving KINRIX, the patient experienced vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing. Additional details provided: KINRIX was administered inadvertently instead of BOOSTRIX. KINRIX was not indicated for use in adults.
feel awful; body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th February 2020, the patient received the 2nd dose of Shingrix. On 21st February 2020, 1 days after receiving Shingrix, the patient experienced feeling bad, general body pain and fever. On an unknown date, the outcome of the feeling bad, general body pain and fever were unknown.   It was unknown if the reporter considered the feeling bad, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine and felt awful and also experienced fever and body aches. The patient wanted to know if there was something that he or she could do to alleviate the side effects like use of pain killers, food or water. No other information was reported.
(R) thigh - 8 cm x 8 cm red, indurated, warm area.
26 year old man without prior history of smallpox vaccination reported rash (onset date of 16-June-2008 approx). Subject was hospitalized briefly (no dates provided.) Lab testing: virus isolated by tissue culture, PCR testing of isolated virus identified orthopox/vaccinia, DNA sequencing by CDC reportedly indicates strain is ACAM2000 strain.  Case is linked to 3 other contact transmission cases all of which are members of the same facility.  There has been no identification of further transmission of any of these cases to family members or other close contacts. The source case has not yet been identified but the investigation is ongoing.
Evening of 6/16/14, pt developed a rash on his buttocks. Area was red with blisters. Area measure 6x3 in. Rash developed after receiving the PCV-13.
93 y/o with complex medical history (severe COPD on oxygen, diastolic CHF, CKD3, myelofibrosis, marginal zone lymphoma of spleen with recent progression and no active treatment, chronic anemia, afib, CAD, pulmonary artery hypertension, h/o bladder cancer, hypertension, hypothyroidism, h/o bilateral PE, sick sinus syndrome s/p pacemaker, h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea, most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis, and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms:  & cardiac arrest Treatment:
Fully vaccinated with Moderna x2 and Pfizer x 1. Tested positive for COVID on 02/06/2022. Admitted to hospital on 02/23/2022. Expired on 03/04/2022 while still hospitalized.
Information has been received from a company rep concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that he may have a vaccine failure. No product quality complaint was involved. No further information is available.
left arm was very sore at injection site; a hive type rash appeared on left forearm; pain radiated throughout my entire arm; more hives appeared on upper arm. The hives were very tender.; diagnosed the rash as shingles as a result of the covid vaccination; This is a spontaneous report from a contactable consumer (patient).   A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 24Sep2021 16:00 (Lot Number: 30135B4) as dose 2, single for COVID-19 immunization (at the age of 57-year-old). Medical history included known allergies: sulfonamides. Concomitant medications included fish oil and zinc. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 31Aug2021 16:00 (Lot Number: FE3183) as dose 1, single for COVID-19 immunization (at the age of 57-year-old). No other vaccine in four weeks and other medications in two weeks included Multi vitamin. No COVID prior vaccination and not tested for COVID post vaccination. On 25Sep2021 16:00, 24 hours after injection, the patient's left arm was very sore at injection site, a hive type rash appeared on left forearm, pain radiated throughout her entire arm, more hives appeared on upper arm. the hives were very tender and diagnosed the rash as shingles as a result of the COVID vaccination. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with Acyclovir 800 mg as a therapeutic measure of all the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Immediately limbs felt heavy and weak. Minor Covid symptoms became severe and have experienced muscle weakness, nervousness, jittery, fatigue, and muscle aches/cramps. Received regeneron 5 weeks ago; symptoms still persist 24/7.
shivering, sweating, fatigue, severe dizziness, collapsed 3 times in 24 hours, hurt  myself when I fell and can't walk now. Called Dr., the nurse I spoke with said the Doctor said she has heard of this and it will go away in 2-3 days... would have been even worse if my husband hadn't been home (he often travels for work).  Can't do anything without him because of the injury.
I got so sick for at least a week after each; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: ILLNESS (non-serious), outcome "unknown", described as "I got so sick for at least a week after each".  Additional information: I have had 3 covid-19 vaccinations. I got so sick for at least a week after each. Must I have another shot?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219751 Same patient, different dose, same event;US-PFIZER INC-202300219752 Same patient, different dose, same event;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. No treatment medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. This case contains information for the 92nd of 190 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
Case number PHEH2014US019164 is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 59 year old male patient. His medical history and concomitant medication were not reported. On 18 Sep 2014, he was inadvertently vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly at a dose of 0.1 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with approximately 20-30 lesions. Pt was treated with Benadryl and Aveeno.
high grade fever 34 hrs post vaccine up to 104 for next 3 days , followed by  diarrhea  -on day 3 requiring ivf  ( 3 liters)due to hypotension( I did not take this day my antihypertensives )  On day 4 low grade fever followed by resolution  and loose stools continued through day 6.
After receiving the Meningococcal A,C,W,Y vaccine in their upper left arms, both of my children went into distress and passed out. Their temperatures spiked, extreme sweating ensued, and cold clammy like conditions were evident. Their blood pressure, hear rate, and pulse dropped to half the normal rate. Cold compresses were given and all vitals were monitored in the doctor's office for 90 minutes.
Chicken pox like symptoms, pimple-like boils, VERY itchy, lumpy under skin even on muscles, scaling, slight infection and no healing where spots were scratched.
Pt came to office on day 8 post vaccine with fever, fatigue and poor po intake and rash.. Fever at that time were up to 102.5.  Per MD likely post MMR vaccine rash.  That same afternoon 430pm pt had febrile seizure. Pt taken to ER Chest xray clear,  labs were drawn, WBC slightly high, and BMP showed mild dehydration. Bolus given. Covid test negative. ER also felt fever and seizure is from MMR vaccine.    Per mom pt is doing well today with no fevers.
Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
Event: Allergic reaction on 3/24. The injection site began to itch around 9:30pm after taking a hot shower. Approximately 10 minutes later the injection site area swelled and became "hard" to the touch, then turn red, hot, and tender to the touch. The area affected was approximately 3 inches wide and 4 inches long - it covered the upper arm (deltoid muscle area). Within 5 minutes the itching sensation spread over the upper back on the left side and to the left side of my neck. Approximately 20 minutes later my bottom lip on the left-hand side swelled slightly and turned red and I had a slight difficulty swallowing. My breathing was not impeded. The reaction did not progress further (I had taken allergy medication to stop any further reaction). By 11pm the difficulty swallowing disappeared and the swelling in my lip reduced. By 5:30am I had no trouble with swallowing and there was no facial swelling. The swelling in my arm was reduced by half - although it was still warm, sensitive, and itched. Throughout the day (on 3/25) the swelling and redness at the injection site reduced. Two days after the start of the event, the area is still warm to the touch and will itch on occasion as will my lower left lip.  Treatment: as soon as I recognized it was an allergic reaction, when the area swelled, I took half a Wal-Zyr 10mg tablet (so I took 5mg of Walgreen's generic brand of Zyrtec) - approximately 9:45pm on 3/24. I took the other half (5mg) of the tablet at 5:30am the next morning on 3/25. No additional medication has been taken since.  Outcomes: The reaction was managed with the Wal-Zyr medication. Currently the injection area is slightly warm and itches on occasion, as does my lower left lip. There has been no change in this condition in the past 20 hours.
Flucelvax vaccine administered to one patient following temperature excursion of 60.8ºF for 18 hours; Flucelvax vaccine administered to one patient following temperature excursion of 60.8ºF; This spontaneous case was received on 26-Oct-2021 from other healthcare professional via The Regulatory Authority (reference number: SEQW21-04597) and concerned a 45-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, Flucelvax Quadrivalent vaccine (influenza vaccine, subunit influenza virus vaccine polyvalent) was exposed to  temperature of 60.8 degrees of Fahrenheit being the highest temperature reached for 18 hours (explicitly coded as 'Product storage error temperature too high'). This was a first excursion. The batch number reported was 308520 and expiry date was 30-Jun-2022.   On 26-Oct-2021, an unknown amount of time after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) (explicitly coded as 'Product administration error') as an influenza prophylaxis. No corrective treatment was applied.  At the time of initial reporting on 26-Oct-2021, no adverse events observed after Flucelvax Quadrivalent administration.  The reporter assessed the event as non-serious.  Company comment: Flucelvax Quadrivalent was exposed to temperature of 60.8 degrees of Fahrenheit being the highest temperature reached for 18 hours. On 26-Oct-2021, an unknown amount of time after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. No adverse events observed after vaccine administration. Product storage error and product administration error are assessed as unrelated per company's conventions.; Sender's Comments: Flucelvax Quadrivalent was exposed to temperature of 60.8 degrees of Fahrenheit being the highest temperature reached for 18 hours. On 26-Oct-2021, an unknown amount of time after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. No adverse events observed after vaccine administration. Product storage error and product administration error are assessed as unrelated per company's conventions.
This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. A patient (age, gender, race unspecified) received PREVNAR 13, on an unknown date, at an unspecified dose. Relevant medical history, concomitant medications and past product history were unknown. On an unknown date, following administration of PREVNAR 13, the patient developed pain at the site of injection. At the time of this report, the patient outcome was unknown. Follow-up attempts completed. No further information expected.
Almost immediately after vaccine, patient reports feeling light headed and clammy. BP 120/78, HR70, RR20, O2 Sat 96% on room air. Pt given water and placed in supine position with feet elevated. Pt recovered after 30 minutes of observation
pt recvd vax & arm tender; swollen & red fr inj site to elbow;no fever,rash, n/v, erythema over biceps & part of triceps; tx w/ hydroxyziine prn itching;
This spontaneous report was received from a medical assistant and refers to unknown patients of unknown age and gender. There was no information regarding the patients' concurrent conditions, medical history and concomitant medications. On an unknown dates, the patients were vaccinated with eight improperly stored doses of ZOSTAVAX lot # M015925, expiration date 15-JUN-2017 and lot# M041510 expiration date: 27-JUL-2017 (dose, routes of administration were not reported) for prophylaxis. The vaccines were exposed to multiple above range, defrost cycles. The medical assistant did not have access to the temperature and time frame information at the time of the call. There was no previous temperature excursion. Digital data logger was involved. There was no adverse reaction. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007779:
Received flu vaccine 10/21/2005 left arm. irritation, pain, itching to area x 2 days. Local reaction to flu vaccine, now with possible cellulitis.
Severe weakness in legs, sore calves, balance, rapid heart rate, shallow breathing,  fever, feeling, flushed, feeling  dehydrated , shivering
Patient arrived for Moderna Booster at 1530. Reports hx of "mild throat swelling" after first shot that resolved with liquid Tylenol. Received second dose without complication. Cleared by HCP to receive booster.  At 1544, pt complained of slight throat tingling and requested Benadryl. Provided 50mg Benadryl. Counseled to avoid driving, operating heavy machinery, or anything requiring concentration due to sedating effects. Monitored closely for additional 25 minutes with complete resolution of symptoms. Pt left accompanied by partner and was instructed to seek emergency services if his symptoms recur.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, c/o fatigue,injection site warm,reddness and swelling. Told to follow up with primary care physician if no improvement Narrative:
Headache, muscle stiffness/pain starting in neck and going throughout body, rash on arm.
lymph edema of the arm; No other details provided; 17DEC94 No response to f/u request;
4 hrs p/recvd vax c/o h/a, began to vomit w/stomach cramps; t102, lethargy;
Breakthrough case admission after 5 vaccines Moderna 1/20/21 Lot# 029L20A;  Moderna 2/17/21 Lot# 024M20A;  Moderna 1/6/22 Lot# 033H21A;  MOderna 4/28/22 Lot# 048L22A;  Moderna 11/10/22 Lot# 014H22A
HIVES AND SEVERE ITCHING.  SELF MEDICATIONS BENADRYL.  DOCTOR PRESCRIBED MEDICATION.
Information has been received from a healthcare worker concerning a patient of unknown gender and age. On 17-AUG-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004483 and expiration date: 16-AUG-2015; dose, route and frequency unspecified). No adverse events were reported. Additional information has been requested.
On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minutes. When the vision was restored, I had a frontal headache.
Cold like symptoms started 3 days (March 14) after shot. Reached fever of 102 on March 18 through the 20th, went to urgent care for help. Chronic cough, chest pain, shortness of breath, dizziness/lightheadedness, sinus headache and severe fatigue/weakness has continued ever since. Prescribed prednisone, albuterol inhaler, and cough syrup and antibiotics. No improvement. Went to ER April 3rd and 4th due to worsening condition and follow ups with primary doctor April 6th and 7th. Prescribed Doxicyclene and Simbacort.
On 06/01/17 patient received 2 vaccinations. BOOSTRIX (NDC 58160-0842-52) in his right arm (upper IM) and HAVRIX (NDC 58160-0826-52) in his right arm (lower IM). Patient wanted both shots in one arm as he was also getting an allergy shot after the vaccines. All shots were given under the IMZ standing order physician. Patient came in on 06/04/17 complaining of soreness and a lump in his right arm. Pharmacist spoke to patient and advised him to continue taking Tylenol as there is no evidence of an allergic reaction and the lump was 6 to 8 inches below the injection site which is most likely not due to the injection.
No additional AE reported; a dose of PROQUAD was administered to a 13 year old patient on 14Sep2022; This spontaneous report has been received from a registered nurse regarding a 13-year-old adolescent of unknown gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 14-SEP-2022, a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, therapy type, route, lot#, and expiration date were not provided) was administered to the 13-year-old patient for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
flu days; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient stated that could get the flu days after he/she got the vaccine for shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.