chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional who was informed by a physician's office concerning a 14 year old patient who on unknown dates was vaccinated with a dose of PEDVAXHIB instead of a dose of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. This is an amended report. The number of the patients included in this report was changed from two to one. No further information is available.
shingles; pain; burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a year after receiving Shingrix, the patient experienced shingles, pain and burning sensation skin. On an unknown date, the outcome of the shingles and burning sensation skin were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the shingles, pain and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had an issue for six weeks till the reporting time, with burning and pain.  The patient's doctor said that the patient might had shingles with no rash. The patient wanted to know when the patient would receive second shot. The pain was a little better at the time of reporting, with no rash.  The physician said it could be shingles with no rash. So when was safe to have second shingles vaccine. The patient read that the rash should be gone in order to have the vaccine.
immed p/MMR inject, pt had uticaria @ inject site; pt was sent to MD; cleared up w/o any complications;
mental only, no physical effect.  Disjointed thoughts, incomplete but w/ accurate data, Felt as if no control over mind and losing my mind.
12-24 after vax, pt devel neck pain, stiffness and "hot rashes" at the inject site. This is 1 of 6 pts receiving vax that exp similar rxn.
Extreme exhaustion 4/16/21-4/19/21, ringing in left ear 4/19/21
Pre-Gardasil: Daughter had lots of energy & exceptional immune system (rarely ill, could be around sick people and not catch illness). Very active. After Gardasil: It took a while after the last shot in the series for the issue to take hold and for her parents to notice. Parents at first push it off as a growth spurt. Fatigue to such a level falls asleep in car before and after school--on way to and fro. Lacks stamina she had in past for exercise and sports, no longer enjoys taking part in cross country team.  Low energy.  Eats tremendous amounts, but doesn't gain weight.  Daughter gets sick very easily (catches colds, flu, etc...  Parents can be exposed to same illnesses and do not come down with it.  Before Gardasil, parents more likely to become ill than daughter).  Parents taking daughter in to Drs. about concerns in 2012-2015 (last Gardasil shot in late 2011).  Fainting incident at school.   Very low Vitamin D levels.  Later, blood tests show low white cell count, Epstein Barr, mild neutropena, mono.  Daughter gets ill very easily and is ill often. Chronic fatigue persists.  Daughter no longer goes out for cross country, changes life to accommodate fatigue and compromised immune system.
Palpitations, dizziness, and nausea with associated intermittent tachycardia. Worse with exertion.
Experienced reactions on face -  Papular rash all around the nose and upper lip/papular rash across the bridge of her nose and mouth/small raised areas on her cheeks; similar one on her other arm, she said it itches; had a lot of nausea for 4 days; one little white headed pimple on inside aspect of lower forearm; My face was a lot more pink; very dry flaking skin around the mouth; very dry flaking skin around the mouth; face rash; This is a spontaneous report from a contactable nurse (patient) from medical information team. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 19Mar2021 13:24 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. Medical history included Hashimoto from 1988 and ongoing, esophageal ulcer from 2003, coeliac, gluten allergy; she reacts to things like Gluten, she will break out in hives to things like shrimp, she will get hives, big ones, and gets itchy all over, has allergies to strawberries, oranges, reflux, soy, and eggs allergy, allergic to propylene glycol. Concomitant medications included levothyroxine sodium (TIROSINT) taken for Hashimoto and ongoing; esomeprazole sodium (NEXIUM) taken for esophageal ulcer from an unspecified start date and ongoing.  Historical vaccine included swine flu vaccine (SWINE FLU VACCINE (1976), MONOVALENT), and experienced Guillain-Barre; back in the 80s, the 70s because she graduated in 1978 9as reported). The patient experienced reactions on face; papular rash all around the nose and upper lip/papular rash across the bridge of her nose and mouth/bumps on her cheek, a couple of raised bumps, one on her right cheeks /small, raised areas on her cheeks, similar one on her other arm, she said it itches, had a lot of nausea for 4 days, one little white-headed pimple on inside aspect of lower forearm, face was a lot more pink, very dry flaking skin around the mouth on 19Mar2021 and face rash, less than 48 hours maybe 36 hours after the first dose on Mar2021. The patient underwent lab tests and procedures which included gastroscopy: she did not have ulcers on 2019, sars-cov-2 test: negative on an unspecific date. Therapeutic measures were taken included little steroid cream for little white-headed pimple on inside aspect of lower forearm. The outcome of papular rash, nausea was recovering, itchy rash, dry flaking skin around the mouth, rash was unknown, white headed pimple recovered on an unspecified date in 2021 and other event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got extreme headches, neck pain , lower back pin nausea fever within 24-36 hours of shot. Pt is ok now
Received 1 dose SHINGRIX IM L deltoid -> immediate pain at site, significant for 5 minutes. Body aches began hours later. On AM of 4/6/18, low grade fever, body aches, extreme fatigue, injection site pain; Symptoms helped by several doses of ADVIL 400 mg. We administered 10 other doses of SHINGRIX. Most had injection site pain, some body aches. Another 79 y/o man had same body aches, flu symptoms > 24 hr p vaccine I do not believe GSK's incidence of side effects of 6% is accurate. This vaccine has problems. I would never take another dose and cannot give any more to my patients.
pt recvd vax; red swollen, not at inject site; size of 50 cent piece;
No additional AE reported.; Caller stated the vaccine was administered after expiration.; This spontaneous report has been received from a pharmacist referring to patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 24-AUG-2021, the patient was vaccinated with a 0.5 milliliters (mL) expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot number S025608, was verified to be a valid lot number with an expiration date reported and established as 18-AUG-2021) (dose number, vaccination scheme frequency, route, and anatomical site of administration were not provided) (expired product administered). It was reported that the vaccine did not had a temperature excursion. No additional adverse event (AE) was reported.
Started feeling a burning and painful rash that increased was only getting worse with time. She called her Dr, and was advised to go to the ER. They confirmed that it was shingles and gave her an rx for Valtrex to take 3 times a day for 7 days. It cleared it up.
temporary loss of hearing in left ear; loss of balance; hearing is gradually returning but still not normal.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 ml Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 ml Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 ml Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 ml Moderna Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 ml Moderna Bivalent Booster).    No concomitant medication information was reported. It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised patients. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL. No adverse events were reported. No treatment information was reported.
The night of the vaccination, the pt experienced blood in urine, unexplained hives and rash including red dots on palms of hands, severe ear infection, fussiness, rash around mouth and diaper area. Usually is an extremely happy baby.
Rebound covid after taking 5 days of paxlovid Jul2022; Rebound covid after taking 5 days of paxlovid Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EN6200), in left arm and on 18Mar2021 at 13:00 as dose 2, single (Lot number: EN6207) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid for covid-19 immnization, notes: Antiviral treatment, Treatment start date: 13Jul2022, Treatment stop date: 17Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound covid after taking 5 days of paxlovid Jul2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information included as Patient had taken other medication in 2weeks. Patient had Known allergies.
Abnormal mammogram; Abnormal gland swelling on right side breast; Metallic taste in mouth; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date 08Mar2021 12:15 (Lot number: EN6198) at the age of 64 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Ovarian cancer" (unspecified if ongoing); "Lymphedema" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies to bees" (unspecified if ongoing). Concomitant medication(s) included: FAMCICLOVIR; EFFEXOR; VITAMIN D [COLECALCIFEROL]; VITAMIN B6. Past drug history included: Naproxen, reaction(s): "Allergies". The following information was reported: DYSGEUSIA (non-serious) with onset 11Mar2021, outcome "recovering", described as "Metallic taste in mouth"; MAMMOGRAM ABNORMAL (non-serious) with onset 19Mar2021 13:30, outcome "recovering", described as "Abnormal mammogram"; LYMPHADENOPATHY (non-serious) with onset 19Mar2021 13:30, outcome "recovering", described as "Abnormal gland swelling on right side breast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia, mammogram abnormal, lymphadenopathy.  Additional Information: The patient had metallic taste in mouth starting day 2-and-a-half that continues (recovering). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. Due to abnormal mammogram, the patient had to return. Ultrasound was clean but still saw abnormal gland swelling on right side breast. The patient was administered with the second dose of BNT162B2 (Lot Number: ER8732) on 27Mar2021 at 03:45 PM in right arm. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Had nosebleed one week after first dose. Had second nose bleed four days after the second COVID vaccine. Then had a third nose bleed  six days after the second COVID vaccine. The third nose bleed was so bad that patient had to run to the hospital.
Chills.aches allover. Vomiting although I had only taken metimucil. Arm extremely sore! Dr. told me it was because I had covid19  90 days before. This continued for 24 hrs, except for vomiting. That stopped after first day. Arm sore for a week!!
Patient presented to employee health about 1 hour after receiving the flu vaccine with c/o hives. Denied SOB, wheezing. States her skin felt itchy on R arm, chest, and head. Exam showed red arms and chest without visible wheals; NAD. Given 25 mg oral Benadryl and given another tab to take later. She was recommended to go to ED with any SOB, wheezing, face/tongue/throat swelling, hoarse voice. She agreed.
mild joint pain; felt tired; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 10Apr2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; ARTHRALGIA (non-serious), outcome "unknown", described as "mild joint pain"; FATIGUE (non-serious), outcome "unknown", described as "felt tired".  Additional information:Currently (Withheld) is experiencing a headache after completing the vaccination series and asked if she can take Tylenol or Ibuprofen  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt developed Rotavirus after full series of Rotavirus vaccines. Yellow diarrhea, vomiting, dehydration, decreased appetite, not sleeping, runny nose.
Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of COMVAX injection (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1503USA005652) from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 6 month old male with no pertinent medical history and no drug allergies, who on 16-APR-2010 was vaccinated with the first dose of ROTATEQ (2ml, oral, lot # 665022/1613Y), the second dose on 23-JUN-2010 (2ml, oral, lot 664946/0148Z), and the third dose on 26-AUG-2010 (2ml, oral, lot # 665258/0201Z). Concomitant therapy included vitamins (unspecified). No symptoms after the first two doses. On 01-SEP-2010 the infant experienced vomiting twice with bloody stools. He was seen in office the next day, 02-SEP-2010, very fussy and a hemoccult test was positive for blood. He was admitted to hospital. After testing and exam he was diagnosed with positive intussusception and was transferred during the night to a Medical Center. He had surgical correction with no bowel damage. He was discharged from the hospital on 05-SEP-2010. He was readmitted to the hospital on 07-SEP-2010 with fever and diarrhea and was discharged on 08-SEP-2010. He had a few episodes of diarrhea after returning home, doing well now and eating well. The final outcome is recovered. Intussusception was considered to be an other important medical event by the reporter. Additional information has been requested.
fever; Headache; whole body pain; sore arm; chills; This is a spontaneous report from a contactable consumer. This 55-Years-Old female consumer reported that.  A 55-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3247, Expiration date: unknown), via unspecified route, administered on 27Jan2021 at 02:45 PM (at the age of 55-year-old) as dose number unknown, single for COVID-19 immunization from Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccines received within 4 weeks of vaccination. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Allergies to medications, food, or other products were not reported.  On 27Jan2021 at 10:00 PM, 7 hrs 15 min after the vaccination, the patient experienced fever/chills, headache, whole body pain(light), sour arm. The events assessed as non-serious. The outcome of the events was recovered on 29Jan2021 morning.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected   No follow-up attempts possible. No further information expected.
Approximately one month post vax, the pt experienced bilateral pain in elbows, wrists, and knees. These symptoms were ongoing.  In approximately March, 2000, the pt received his 2nd dose of Lymerix, in addition to the above joint pain symptoms, he now complained of leg cramps in the upper part of his leg. There was no redness, swelling, or heat generated by the joints. In 6/00, he was seen by an orthopedist and diagnosed with tennis elbow, and advised to take ibuprofen and to exercise. In 10/00, the pt still complained of generalized pain. He was seen by a rheumatologist and was diagnosed with joint-muscle pain. The rheumatologist prescribed Vioxx for pain control. Lymerix was discontinued. As of 11/10/00, the outcome of the events is ongoing.
Patient awoke day after receiving HPV with eyes swollen shut, red itchy periorbital rash.  Seen early afternoon approximately 24 hrs after injection.  Eyes open, rash represent with residual swelling.  Rx:  Applications of cold, benedryl or claritin, motrin for inflammation. Photo taken of pt.
This case was reported by a healthcare professional via a sales representative and described the occurrence of pregnancy in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The case was also reported by the subject. Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 March 2008. On 10 April 2008 the subject received 2nd dose of TWINRIX (1 ml, 09:30 am) in the left arm. Approximately two hours after vaccination with TWINRIX, the subject discovered that she was pregnant. Follow-up information received on 08 May 2008 regarding the pregnancy indicated that the subject (the pregnant mother) was 23 at the time of event. Her last menstrual period was 07 March 2008 and expected date of delivery, 18 December 2008. Only one fetus in this pregnancy. The 1st dose of TWINRIX was administered just before or around the time of conception. The 2nd dose of TWINRIX was administered at approximately four weeks of pregnancy. From 04 to 06 December 2007, the subject received ofloxacin, 0.3 percent daily for pink eye. No adverse events were reported as of 05 May 2008. Follow-up information received on 27 March 2008 via a Pregnancy Registry Registration Form indicated that the subject's due date is 23 December 2008. The subject experienced a normal conception and there has been no evidence of defect on prenatal test. The mother has no relevant medical history and no history of previous pregnancies. The father of the fetus has a history of juvenile myoclonic epilepsy. TWINRIX was administered intramuscularly. Follow-up information received on 10 February 2009 via a Pregnancy Registry Outcome Form indicated that the subject gave birth to a premature (36 weeks gestation) male infant on 24 January 2009, via induced vaginal delivery with vacuum extraction. The infant weighed 6 pounds and 13 ounces and was 19 inches in length. It was reported that the subject was on bed rest for 10 days prior to delivery due to preterm labor. Labor was induced due to extreme back pain. The neonate was born with hyperbilirubinemia and lung immaturity. For details concerning the baby case, please refer to A0724362B.
Severe flu like symptoms, Chills, fever, rapid beathing, body aches, headache, fatique for 1.5 days
sore arm/mild body aches; headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired). At the time of the report, MYALGIA (sore arm/mild body aches), HEADACHE (headache) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications were provided by reporter.   This case was linked to MOD-2021-213485 (Patient Link).
pt vax hepta b.  pt ex fatigue, diarrhea, h/a, flu-like illness w/i 24 hrs.