chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax;lt knee very swollen & bruised; 2jun95 swelling down & lt knee hard to crawl; 15jun95 swelling almost undetectable by therapist & no physical problems;
Vax on 11/4/99. 12/1 soreness continued in L arm. Unable to sleep on L side. Unable to lifr arm over head.
Four large patches of hair have fallen out (Alopecia Areata) since date of third (booster) dose of Pfizer COVID-19 vaccine.  Hair loss discovered on 3/17/2022 and has worsened since that date.  Approximately 50% of my hair is now gone; have never had occurrence of AA in the past
Believed to be shingles; Burn on back; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and burn of unspecified degree of back (any part). On an unknown date, the outcome of the shingles and burn of unspecified degree of back (any part) were unknown.   It was unknown if the reporter considered the shingles and burn of unspecified degree of back (any part) to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The visitor did not provide additional demographics details. The reporter asked the nurse to look at a burn on patient's back which was believed to be Shingles. The reporter knew generally wait until illness/infection resolved but it was not disclosed. The reporter did not disclosed patient's symptoms until after receiving the vaccine. The reporter thought it was a burn but the provider believed it was Shingles. The reporter consent to follow up.
feeling extremely nauseous; My arm was sore; Headache; Slightly tired; Little dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Reason for no lot number: of Covid-19 Vaccine: It just say Pfizer INC it's hard to read it, this is 0 crossed out EN0142. The patient didn't know what looking at, thought it says E and O or E21042 Pfizer INC.), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced feeling extremely nauseous, arm was sore, headache, slightly tired, little dizzy, all in Jan2021. The patient received this first dose of the Covid-19 Vaccine on 05Jan2021, the patient had been feeling extremely nauseous yesterday and today but after the vaccination the arm was sore, the patient had a headache and slightly tired but did not feel nauseous at all but the patient was feeling extremely nauseous yesterday and today and a little dizzy was that the common side effect and should have subside. The outcome of all the events was unknown.  Information about Lot/Batch has been requested.
Headache , dizzy. Blurry vision, muscle aches, hard to move right arm next morning after injection, nausea, light stomach cramps,fatigue and weakness, low grade temp on the night of the 31st,slight sore throat.
weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 25-Mar-2021, the patient experienced ASTHENIA (weak). At the time of the report, ASTHENIA (weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
11:30 am - Hives and swollen hands, feet and knees.  Gave Benadryl (No change) around 5:30 pm.  Went to hospital per doctor's instruction (7:00 pm).  Shot of Epinephrine around 8:30, slight reduction of swelling.  1 dose of Hydroxyzine at 12:00 am.  Another dose at 9:00 am.  Saw doctor at 11:00.  Gave Prednisolone at 1:00 pm and Allegra at 7:00 pm.
hurt from top of head to feet for one day; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 29-Nov-2020.  This case involves a patient of unknown demographics who had hurt from top of head to feet for one day (pain), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had hurt from top of head to feet for one day (pain), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This non-valid spontaneous report was received from a nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. From 30-JAN-2018 to the time of this report, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route of administration, and anatomical location were not reported), both administered for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. The report was due to a digital data logger. Regarding GARDASIL 9 temperature excursions: The lot # N021571 with expiration date 29-APR-2020 had a storage temperature of 35.80 Fahrenheit (degree F) for a total time frame of 0.45 hours. The lot # N021733 with expiration date 01-FEB-2020 had a storage temperature of 35.90 Fahrenheit (degree F) for a total time frame of 0.45 hours.
muscle spasm in affected arm x 1 week, chest pressure and shortness of breath x 6 weeks and ongoing interfering with ability to function as normal.
Information has been received from a registered nurse referring to two unspecified patients of unknown age and gender. On 09-MAY-2016, the two patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017, dose and route not provided) (incorrect product storage). No adverse effects were reported. GARDASIL 9 Lot: L014415 Expiration date: 25-JUL-2017. Sterile water diluent Lot: L051109 Expiration date: 25-JAN-2018. Temperature: 47 F. Time frame: 144 hours. Previous excursion: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Flu Like symptoms. Severe fatigue for full 24 hour period. Had nausea when trying to eat. I could not eat for over 24 hours. I had fever as high as 101.3F. Also, had chills. Symptoms better after 24 hours with loss of appetite still present. Temperature at 98.0F as of 3-22-21.
Patient woke up the next morning covered in hives. She has not changed anything in her normal routine including bath soap, laundry detergant, food and drink.
14 yr old attendee departed after 15 minute observation period but returned at 27 minute mark (post vaccination) with nasal bleeding.  Applied ice pack and bleeding stopped at 37 minute mark.  Able to ambulate and departed again at 47 minute mark.
12 hours from vaccination developed diffuse rash to trunk - has progressed in 36 hours to full body macular, beefy red blanching erythema with several hive like lesions to shoulders and neck - involves palm & plantar aspects of feet & given MEDROL dose pak; hydroxyzine pamoate.
Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with Nijmegen breakage syndrome (NBS) (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1911USA008596:
This spontaneous report as received from a physician's assistant, via a company representative, refers to a female patient of unknown age, who "last week", on 04-JUN-2013 was vaccinated with a dose of ZOSTAVAX (dose and route were not reported). Concomitant medications were not provided. The last week, on 04-JUN-2013, the patient had an injection site reaction after receiving the ZOSTAVAX. The physician's assistant noticed a shingles like rash around the injection site. The outcome of shingles like rash around the injection site and injection site reaction was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Felt intense pain at injection site.  Pain rendered shoulder and arm very weak.  Severe bruising soon followed.  Loss of range of motion occurred within 1-2 days after injection.  Shooting pain and sharp pain occurred within 1-2 days of injection.  MRI was performed 3 weeks after the injection.  Revealed bursitis and inflammation of tendons.  Started physical therapy approximately 8 weeks following injection after seeing an orthopedic physician.
Bad taste in mouth. Gave water since no swelling or breathing issues. Stayed on site for 30 minutes. Went home.
Pt said she awakened 5/19/11 and had lesions along her vaccinated arm. Pt called pharmacy on 5/25/11.
Pneumovax given 11-10-05 developed redness around injection site, hives chest, neck, stridor, itching eyes, nose, throat. Pt self medicated with Benadryl. Seen 11/11/05 at PCH. Rx Medrol dose pack.
This prospective pregnancy case was reported by a physician and described the occurrence of drug exposure in utero in a female neonate subject exposed to FLUARIX, (GlaxoSmithKline) and INFLUENZA virus vaccine (manufacturer unspecified; unknown) taken by the pregnant mother.  Concurrent medications included Prenatal vitamins and an epidural.  On an unspecified date, the mother of the subject received an INFLUENZA virus vaccine (manufacturer unspecified; unknown).  On 20 October 2009 at 14:46 the mother of the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm).  This was considered to be an extra dose of INFLUENZA virus vaccine.  The baby experienced drug exposure in utero.  The mother's date of last menstrual period and estimated date of delivery were not provided.  The subject was exposed to FLUARIX and INFLUENZA virus vaccine during the first trimester.  The outcome of the pregnancy was unknown.  After administering FLUARIX, the physician was informed by the mother of the subject that she had already received a flu vaccine from her primary physician.  The mother of the subject was seven weeks pregnant.  No adverse reactions were noted at the time of reporting.  Follow up information was received on 23 November 2009 via the reporting physician.  The physician reported the mother of the subject's date of last menstrual period was on 01 September 2009 and her estimated date of delivery was 08 June 2010.  The physician reported the conception was normal and did not involve in-vitro fertilization.  No complication was noted with a viable pregnancy at 11 weeks.  At the time of reporting, the physician did not consider the events to be serious.  Follow-up information was received on 24 August 2010 via a Pregnancy Outcome Form.  On, at 40 weeks gestation, the female neonate was delivered via immediate emergent cesarean section due to bradycardia during epidural placement.  It was noted that the fetus was previously healthy.  The neonate was hospitalized.  Weight was 3901 g, length of 46.5 cm and a head circumference of 35 cm.  APGAR scores at 1 minute and 5 minutes were 01 and 04.  No defects were noted.  This baby case, A0813153B is linked to mother case, A0813153A.
Severe side effects including chills, fever, headache, fatigue, diarrhea, loss of appetite, runny nose
Information has been received from a 67 year old female consumer with hypertension and high cholesterol and a history of cancer who on 04-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included Synthroid, "extenddryl", Diovan, Arimidex, ezetimibe (+) simvastatin, Toprol XL Tablets, alendronate sodium, sulindac. Estring, chromium picolinate, ascorbic acid/vitamin B complex, calcium (unspecified) (+) vitamin D (unspecified), magnesium (unspecified), potassium gluconate, omega-3 marine triglycerides, minerals (unspecified) (+) vitamins (unspecified) (Centrum Silver) and "glucosoveen condroiten". On 06-APR-2007 the patient experienced injection site swelling. The site was a little tender and warm. Medical attention was not sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. There was no illness reported at the time of vaccination.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. On 06-Apr-2007, the patient experienced injectjion site swelling. The site was a little tender and warm. It was also reported that the patient experienced minimal itching and redness at the injection site which the patient reported by phone adn was not seen in the physician's office. Medical attention was not sought. At the time of the report, the patient had recovered from the events on an unspecified date. There was no product quality complaint involved. Additional information is not expected.
NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and auras with migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) cleared of blood clots, Ophthalmological examination (NR: not provided) clear eyes, and Screening test (NR: not provided) clear stomach, carotids were clear. On 09-APR-2021, the subject experienced mild sore arm. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbness of extremities. On 10-APR-2021, the subject experienced tingling of extremity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of extremities, and tingling of extremity on APR-2021, and mild sore arm on 11-APR-2021, and the outcome of tiredness was not reported. This report was non-serious.
eye socket pain; vision changes, including a dark area in her left vision field/eye vision began to see "fireworks'; left-sided jaw pain; tenderness of scalp; temporal daily headaches; numbness on left jaw; optic nerve stroke; lost total vision in her left eye; Optic nerve swelling in her left eye; This case was reported by a lawyer and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 15th November 2018, the patient received Shingrix (unknown). On 9th December 2018, 24 days after receiving Shingrix, the patient experienced optic nerve edema (serious criteria GSK medically significant). On 7th January 2019, the patient experienced loss of vision (serious criteria GSK medically significant). On 9th January 2019, the patient experienced optic nerve infarction (serious criteria GSK medically significant). On 21st January 2019, the patient experienced aching eye socket, scalp tenderness, temporal headache, numbness and sleep disorder. On an unknown date, the patient experienced visual disturbance. On an unknown date, the outcome of the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder were unknown.   It was unknown if the reporter considered the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder to be related to Shingrix.  Additional details: On or about 18 July 2018, plaintiff received the first dose of the Shingrix vaccine and about 15  November 2018, Plaintiff received the second dose of the Shingrix vaccine. Shortly after receiving the second dose, Plaintiff began noticing vision changes,including a dark area in her left vision field. On or about 9 December 2018, Plaintiff went for her annual eye exam. Optic nerve swelling in her left eye was found and an urgent referral was made to an neuroophthalmologist. After more testing was done, her left eye vision began to see fireworks and she experienced eye socket pain. She was told that the vaccine was so new that there were not any guidelines available for treatment. On or about7  January 2019, Plaintiff lost total vision in her left eye which was not recovered. On 9 January 2019, she was seen by Dr. and it was thought she had an optic nerve stroke. On 21 January 2019, Plaintiff began to experience new symptoms including tenderness of scalp, temporal pain While sleeping, numbness 0n left jaw, and temporal daily headaches. The plaintiff had left side jaw pain which was not recovered. These symptoms continued and it was opined by the medical professionals that the symptoms were a direct result of the Shingrix vaccine. Plaintiff to this day still experiences left-sided jaw pain, left-sided eye socket pressure, frequent headaches, and has permanent Vision loss in her left eye.
Around approximately 9:30PM on April 10th, I started to experience chills that got progressively worse throughout the night. No amount of layers seemed to help.  Approximately 30min later I began to have a fever and a rapid heart beat started which led to chest pains . The chest pains subsided throughout the night, but the fever and chills lasted to around 11:00 AM, April 11th. I also had a bad headache from approximately  7AM to 10AM. Theses symptoms stopped around 11:00AM April 11th. Around 12 hours later I started experiencing chills and a fever again, however, these symptoms were less severe than the night before and subsided throughout the night.
Swelling of injection site, red and tender. Frequent urination and incontinent for a brief period of time; 2 1/2-3 months.
This spontaneous report as received from a pharmacy intern refers to a female patient of unknown age. Medical history and drug allergies/reactions were not reported. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J005719 exp date 13-AUG-2014 (dose and route not reported). Concomitant medication were not reported. On 11-OCT-2013, about 1/2 hour after receiving ZOSTAVAX at the injection site under the skin there was a big, red "blob", the size of a plum. The patient sought for medical attention (phone call to pharmacy). No treatment was given for the event. The outcome of the event was reported as not recovered. Additional information has been requested.
Patient received her first dose (monovalent) on 4/18/2023 and was scheduled 3 weeks (21 days) for her second dose. During this time, the monovalent was pulled from the inventory as directed by hospital pharmacy and FDA. Patient arrived at the clinic on 5/9/2023 for her second dose of the primary series and was given the bivalent formula. Now her chart indicates these two doses were given too close together and she is supposed to be actually due for her second dose (booster) for 7/4/20. No reported adverse effects or injury as a result.
Information has been received from a nurse practitioner concerning a 7 year old white male with IgA deficiency who at one year old was vaccinated with varicella virus vaccine live (0.5ml, SC). There was no illnesses at the time of vaccination. It was reported that now the patient broke out with chicken pox about 100 lesions of which only 12 were vesicular. Unspecified medical attention was sought. No product quality complaint involved. Follow up information received from a licensed practical nurse indicated that on 5/8/04, the patient developed chicken pox of over 150 pox. The patient recovered on 5/13/04. No additional information is expected.
Immunized at 9:15 AM- no symptoms, 2-3 episodes of palpitations throughout the day, resolved spontaneously; 9:00 PM chills and palpitations lasting approximately 1 hour- resolved spontaneously with no further symptoms outside of a sore (expected) injection site.
Information has been received from a registered nurse, for VARIVAX (Merck), a pregnancy Registry product. It was reported that on 30-AUG-2006, a male baby born on 10-MAY-2007 (birth weight 7 pounds 10 ounces) was exposed in utero to a dose of VARIVAX (Merck) (Lot #652664/1033R) and MMR II. The nurse reported that the baby was born 2 weeks early. The baby was born without a rectum. The baby then had hyposodiumia secondary to surgery so he was in the ICU for 1 week. Slight hydrocephaly was noted, along with auto temp regulation problems. During pregnancy, it was noted that the mother had high stress. She is a single mother G4P3 prior to delivery. She was in school and worked. Infidelity with husband was noted. No other medications were used during this pregnancy. Anorectal disorder and hydrocephaly were considered to be congenital anomalies. The mother's experience has been captured in WAES0610USA10729. No additional information is expected. This information was originally reported in WAES0610USA10729 which was sent on 16-AUG-2007.
5/13/09 Per nurse child was seen today by N.P. and had an "erythema , macular rash" on entire trunk (front & back) and forehead. Rash started on 5/13/09 along with symptoms of fussiness and anorexia. No fever. No other symptoms. Child was diagnosed as having a vaccine reaction. Will follow up with family in one week to check on status of child. 5-21-09 T.C. to family. Per dad, child is fine now and rash resolved on 5/14/09. No further follow up.