chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Menactra 08/10/2005 4:30pm. Woke 08/11 at 11am with headache, nausea, stomach ache. Mom thought speech slurred. Lasted approx 30-60 min, triage RN did't appreciate slurred speech.
Redness, swelling, itching, warmth at injection site. Physician prescribed MEDROL DOSEPAK.
Body aches, fever, high blood sugars, diarrhea & extreme nausea-could not eat or drink for 2 days No clotting during menstrual cycle, EXTREMELY heavy and long flow
sore arm/aches and pains; diarrhea; tired/extremely tired; chills; fever 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101.         No concomitant medication included.   This case was linked to MOD-2021-182959 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-jun-2021 , event outcome and treatment were updated.
On 6-21-2022, I started having fatigue, leg weakness and aching, headache, body aches and chills. The next day, I had a temp of 100.3 so I took tylenol. I called the doctors office and went in that afternoon to test for Covid19. They tested me for the flu and Covid19. The rapid testwas negative and they sent the test off for a PCR. There were no medications prescribed and they told me to alternate tylenol and aleve. My fever broke on 6-23 and I started to feel a little better. I was feeling alot better by 6-24. The PCR came back positive on 6-25-2022. The doctors office called me back on 6-27 to tell me the PCR was positive. I am recovered now and I am reporting my breakthrough case of Covid19.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: blood  clot-Severe, Systemic: Joint Pain-Medium, Additional Details: Patient went to ER, diagnosised with clot and infection. Given antibiotics and xarelto.  patient still having pain/uncomfortable in left arm. Tried to submit prior site not working
Patient sleepy after shot at 2 months of age.  Birth apgar 9, although development delayed after 3 months of age and diagnosed with mild form of cerebral palsy by Dr., neurologist, at 9 months of age. At that time (2 months of age), we did not see a pertussis connection because were told that a bona-fide reaction was marked only by fever.  However, at 11 1/2 months of age, Dr. argued with patient's mother over administration of Pertussis vaccine as mother had learned from other parents of cp victims that Pertussis should never be given to children with neurological problems.  Dr. argued that neurologist said it was safe because pt had non-progressive encephalopathy. Another dose of Pertussis was then administered two weeks before patient's 1st birthday.  Pt developed jerking spells within the week after shot and taken to neurologist and diagnosed with infantile spasms.  EEG showed no seizure disorder present before the shot was given.  Pt could suddenly no longer scoot on floor or smile.  He became lethargic and dull in reflexes and cognitive ability.  His cerebral palsy immediately became severe, with mental retardation, and remained so until his death at age 17.  Since the last pertussis shot, his jerking spasms were uncontrollable by any anti seizure medication on the market.
Have not had a menstral cycle since getting the vaccine and prior to vaccine I have always been regular.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 4:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 4:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 24.87 for dose administered on 27-Feb-2021 and 24.95 for dose administered on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33, 34 and 35 degrees Fahrenheit from 09:00 AM to 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. 20 vials moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 9 am to 10 am. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. 20 vials moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.
Injection site is sore and slightly red. Sore lymph node in right arm above injection site
Mother reports quarter size redened area at injection site the evening of flu vaccine administration.  Reports child was irritable and fussy.  No reported fever until 10/30/08.  Redness and swelling continued and was seen by local physician on 10/31/08 with fever 101 with Tylenol.  Redness reported from shoulder to elbow.  Physician started benadryl 4time per day.
Child received vaccines on 12-9-09 at health department for one week child c/o not being able to bear weight on right leg was seen at BRP on 12-17-09. Dx contusion of right thigh. F/u if no improvements.
Approximately a week after vaccination, developed vision problems with blue lights in right eye, followed by deteriorating vision 7 to 10 days after vaccination. 03/09/2021 was diagnosed with central retinal vein occlusion.
Patient stated that 2 weeks after receiving 2nd dose of Pfizer vaccine, she developed Shingles. Patient stated that she saw her doctor to be treated for shingles. Patient was prescribed anti-viral medicine and Gabapintin. Patient states that she still has shingles.
Red, raised welt, warm to touch 3 1/2 by 4 inch. Treatment, ice and Motrin. Cleared up 06/09/02.
This spontaneous case was reported by a pharmacist and describes the occurrence of IMPLANTABLE DEFIBRILLATOR INSERTION (Defibrillator put in after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPLANTABLE DEFIBRILLATOR INSERTION (Defibrillator put in after vaccination). The patient was treated with Surgery for Implantable defibrillator insertion. At the time of the report, IMPLANTABLE DEFIBRILLATOR INSERTION (Defibrillator put in after vaccination) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.
This spontaneous report as received from a healthcare worker refers to four patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 10-AUG-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Not walking on leg, vomited x2 nite of 19JUN, temp 103F, wakeful through the night; 3 prior DTP;
First dose was a 103 fever and body aches, chills, overall fatigue.   Second dose I was paralyzed for 2 hours about 12 hours after the injection.  Also had 103 fever, chills and body aches with overall fatigue.  I had a rash for a week following the second dose.  The 3rd dose I became anaphylactic allergic to soy, peanuts, lima beans and peas.  I never had a food allergy before.  I ate peanut butter and my lips swelled.  As the week went on every time I ate soy or peanuts the reaction worsened until my face swelled and tongue and lips went numb.  I now have an epi pen and avoid soy and peanuts.  I also had a fever, body aches, fatigue and chills with my 3rd dose.
pt recv vax 21APR94; pt devel a rash & a fever; No further info is available;
This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M038856 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M038856 was stored in the range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. No previous temperature excursion. The call was not because of a "data logger". This is one of the several reports reported from same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA010627.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in September 2015, the patient received the first dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported) and then on 14-NOV-2016, the second dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported) was administered. No adverse effect was reported. Additional information has been requested.
Patient reported that she experienced red blistery rash on Left upper arm.  Bumps developed 3-4 days after vaccine administered.  The red bumps turned in to blistery bumps that were itchy and at times pain "shot through the area on her arm".  Within a week, the bumps had dried up.
patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; patient got the first dose of the COVID vaccine on 18Dec2020/was positive via COVID PCR test on 26Dec2020; had a COVID exposure on 23Dec2020; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medication included chemotherapy. It was reported that patient got the first dose of the COVID vaccine on 18Dec2020 and then had a COVID exposure on 23Dec2020 and was positive via COVID PCR test on 26Dec2020. It was mentioned that patient is a chemotherapy patient. The patient was given the antibodies for COVID on 28Dec2020 and the patient is currently doing well. Reporter's question was that the patient was scheduled to get the second dose of the vaccine on 08Jan2021 and the reporter is wondering if given this patient's situation, is it safe for the patient to receive the second dose or if there are any recommendations on when the patient should receive the second dose. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and SARS-CoV-2 test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
This spontaneous report was received from a lead researcher in the development of the HPV vaccines via online article and refers to 44 female patients of unknown age. The patients medical history and concurrent condition were not reported. The reporter had announcement at the 4th Conference on Vaccination that GARDASIL should not be used. The reporter explained in her presentation that the cervical cancer risk was already extremely low, and that vaccinations were unlikely to have any effect upon the rate of cervical cancer. In fact, 70% of all H.P.V. infections resolve themselves without treatment in a year, and the number rises to well over 90% in two years. Reporter also mentioned the safety angle. All trials of the vaccines were done on children aged 15 and above, despite them currently being marketed for 9-year-olds. So far, 15,037 girls have reported adverse side effects from GARDASIL alone to the Vaccine Adverse Event Reporting System (V.A.E.R.S.), and this number only reflects parents who underwent the hurdles required for reporting adverse reactions. At the time of writing, 44 girls are officially known to have died from these vaccines. The reported side effects include Guillain Barre Syndrome (paralysis lasting for years, or permanently- sometimes eventually causing suffocation), Lupus, seizures, blood clots and brain inflammation. Parents are usually not made aware of these risks. The outcome of Guillain-Barre syndrome, noninfective encephalitis, thrombosis, seizure and systemic Lupus erythematosus was fatal. Causality was not provided. Additional information has been requested.
allergic reaction; hives; This is a spontaneous report from a contactable consumer. (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the Covid vaccine last week and she think she was having like a slight allergic reaction like hives and stuff on an unspecified date. The outcome of events was unknown.  Information about lot/batch number has been requested.
Yesterday, client noticed an itchy, rash on her right arm, where Varicella vaccine was placed on 3/26/2012. It an intact raised reddened round area 40mm X 50mm in diameter.  She complains of discomfort and itching sensation. When asked, she denied any respiratory symptoms and did not notice the skin irritation right away.  When she looked at it in the mirror, she was surprised how large it was.
Redish/pinkish/hot rash; Soreness returned; A little itch; Tenderness/soreness (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Soreness returned), VACCINATION SITE PRURITUS (A little itch), VACCINATION SITE PAIN (Tenderness/soreness (at injection site)) and VACCINATION SITE RASH (Redish/pinkish/hot rash) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (A little itch) and VACCINATION SITE PAIN (Tenderness/soreness (at injection site)). On 01-May-2021, the patient experienced LIMB DISCOMFORT (Soreness returned). On an unknown date, the patient experienced VACCINATION SITE RASH (Redish/pinkish/hot rash). At the time of the report, LIMB DISCOMFORT (Soreness returned), VACCINATION SITE PRURITUS (A little itch), VACCINATION SITE PAIN (Tenderness/soreness (at injection site)) and VACCINATION SITE RASH (Redish/pinkish/hot rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome of the event is updated
Pfizer 3/3/21, 3/24/21, 10/23/21. Positive on 10/20/22
Information has been received from a licensed practical nurse concerning a patient who in the last month (approximately in September 2009) was vaccinated intramuscularly with 0.5 ml of PNEUMOVAX 23 (Lot # 663126/0464Y). According to the reporter in the "same day as vaccination or the following day" the patient developed an injection site reaction. The affected area was red, painful and very hot. The patient recovered on an unspecified date. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Approximately 5-7 days post vaccine, patient developed herpes zoster with left eye keratitis.  Patient required antirviral oral medication and ophthalmologic treatment for the keratitis.
Immediate local pain at injection site with weakness in left arm. This was so bad that patient had difficulty sleeping or carrying things using left arm. This lasted 4 days. No treatment. Patient had not had a tetanus shot since 7 years old.
Patient was given 1 dose of Dtap instead of 1 dose of Td vaccine.
ACHINESS IN ARM WITH FIRST COVID VACCINE; LIVER NUMBERS WERE ELEVATED; This spontaneous case was reported by a consumer and describes the occurrence of LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED) and VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE). In 2021, the patient experienced LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED). In 2021, VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE) had resolved. At the time of the report, LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. The action taken for Humira was unknown.  On 29Nov2021, the patient received Tozinameran (Pfizer Biontech Covid-19 Vaccine) for COVID-19 vaccination via intramuscular route as booster dose. The causality between co-suspect Humira and event Liver numbers were elevated was provided as not reported and dechallenge was N/A. The causality between co-suspect Humira and event Achiness in arm with first COVID vaccine was provided as not related and dechallenge was N/A. No treatment medication was reported.   This case was linked to MOD-2022-577125 (Patient Link).
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest temperature excursion lasted 168 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperature of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Had TIA,  Increased Blood Pressure, Patient reported body weakness, Difficulty standing, Disorientation, Difficulty walking
I started to have some chest pain intermittently which was coming and going on occasion. It was underneath my left breast. It was happening about two times a week and then it was I thought it was heart related but after testing it has been confirmed that it was not cardiac related. It has been present for six weeks and I still get the chest pain so bad that it wakes me up at night.