chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little pimply /all over her body / the are increasing in number; itchy blisters all over her body / the are increasing in number; itchy blisters all over her body; felt like she had the flu; every joint in her body hurt; This case was reported by a consumer and described the occurrence of influenza like illness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020, no complications).   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced influenza like illness and joint pain. On 2nd December 2020, the patient experienced pimples, blister and pruritus. The patient was treated with ibuprofen. On 30th November 2020, the outcome of the influenza like illness and joint pain were recovered/resolved. On an unknown date, the outcome of the pimples, blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, joint pain, pimples, blister and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the 2nd dose of Shingrix and on the next day, she felt like she had the flu and every joint in her body hurt. The patient took ibuprofen and felt better on 30th November 2020. The patient started noticing 4 days after receiving Shingrix, little pimply, itchy blisters all over her body they were increasing in number as the days go on. The patient did not currently have a primary care physician. The reporter did not consent to follow-up.
Constipation for 7 days... there was one release at day 7, but now is constipated going on day 4.
Patient reported two days after vaccination hives around vaccination site. Patient was offerred an immediate appointment with our physician, he refused medical treatment.
Information has been received from a 19 year old female patient who on 27-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 27-JAN-2009 after she received the vaccine she fainted immediately.  As she was coming to she could hear the nurse yelling that she was having a seizure and she then fainted a second time.  She came to and fainted a few more times, then she went to the emergency room in an ambulance.  She was not admitted to the hospital and was released a few hours after she had received the vaccine.  On 27-JAN-2009 the patient was recovered.  Patient sought medical attention was at emergency room.  The patient considered seizure and fainted was determined to be other important medical events.  No further information is available.
Employee had softball size area around the injection site that became hot, swollen, itchy for three days after injection was received.
02/27/2001, vesicles noted with discomfort. On 3/3/01, vesicles dried. MD confirmation.
Patient presented to the pharmacy 3/26/21. Patient reports woke up this morning & showered then discovered reaction. Red/swollen inner aspect of left deltoid. Warm to the touch. Sensitive to the touch/pressure. Approx 4in. Marked area for patient and recommended follow up with provider. No history of pneumovax per patient.
Adverse event: development of hives, rash, and dermatographia over entire body 10 days after 2nd Moderna shot. Hives and rash subsided after 7-10 days; dermatographia remains. Allergist MD prescribed daily fexofenadine (Allegra). Symptoms are manageable and less severe with fexofenadine usage. Bloodwork ordered by Virant shows possible thyroid disease but inconclusive.
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 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022 at 1:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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 46.33.  Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-April-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-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
blood clots in both legs; severe pain in both his legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in both legs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008D21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROMBOSIS (blood clots in both legs) (seriousness criterion medically significant) and PAIN IN EXTREMITY (severe pain in both his legs). At the time of the report, THROMBOSIS (blood clots in both legs) and PAIN IN EXTREMITY (severe pain in both his legs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment included Eliquis (apixaban) for three months. Reportedly, the patient was put on apixaban 2 tablets every morning and evening for 14 days and will then take 1 tablet every morning and evening for a total of 3 months. He does think that the medicine is helping.  Patient stated that he never had blood clots before and suspects that it was from the shot.; Sender's Comments: Very limited information has been provided at this time. Further information has been requested. Based on the current information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Arthritis flares started about a month after my second Pfizer vaccine. I never had them before.
Patient reports waking up the following morning with leg cramps, malaise, fatigue, feverish (subjective). Patient noted darker urine and abdominal pain starting on 8/18/21.
Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated on her right arm with a first 0.5 mL dose of GARDASIL (LOT# not reported). Right after injection, the patient experienced numbness on her right side of the body that lasted one day. Unspecified medical attention was sought. The patient did not want to receive any more doses of GARDASIL. No further information was provided. Additional information has been requested.
1-2 weeks after vaccination patient began having multiple joint pain and exacerbation of asthma. Continues to have these problems and does not feel well at all.
congestion, cough, fatigue, headache, muscle/body aches, nausea, loss of taste/smell, sore throat, runny nose
Severe back pain began within about 5 hours of receiving vaccine.  Back pain and left side pain continued overnight.  Felt unable to move in the morning, severe head- and neck- ache which took about six hours to mostly resolve.  Side and lessened back pain continued for approximately a week; emergency room visit on 8-18-19, CT abdominal scan showed nothing; normal WBC count, not a recurring UTI.
Right arm rash, itchy welts, short of breath, lips and tongue started to swell.  Spoke to a Doctor and took 2 Benadryl tabs (25mg tabs) orally and used her sons inhaler (Proventil).  Then sysmptoms subsided.
4 hrs after getting pneumonia injection right arm -swelled to twice the size, pain was excruciating x 3 days.
patient sates upper shoulder pain for the past 2 months and has difficult time with arm mobility. went to doctor today and was prescribed prednisone and physical therapy
Patient presented  requesting a Moderna vaccine and stated he had not receive any previous COVID vaccination as well as signing a registration form that denied previous vaccination. Upon searching for his vaccination history his previous record was not found, due to the addition of Sr. to his name.  It was when the vaccine was being entered, and after the Moderna vaccine was given, that the error was discovered, and that the patient did receive two previous Pfizer vaccines. Patient was contacted by  phone 72 hours later and had no adverse effects.
Patient reports rash on front of both lower legs and stomach the day after receiving second dose of Pfizer vaccine. Treating with topical hydrocortisone cream.
Information has been received from a physician concerning a 14 year old female who in approximately December 2006, " a few weeks ago," was vaccinated with a dose of Gardasil (yeast) (lot#654885/1424F). Subsequently, "after her first shot" the patient developed hypertension. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Severe panic attack approximately 45min after receiving vaccine.  I felt fine when I left the clinic after my vaccine.
Patient developed hives 5 hours after vaccination.  He went to see a physician assistant who prescribed and administered a steroid shot.
This spontaneous report was received from a licensed practical nurse referring to a 4 month 23 days old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 29-OCT-2013, the patient was vaccinated with the 1st dose of VARIVAX (Merck) (lot # and expiry date not reported) at the mentioned age. No adverse effects were reported. Additional information has been requested.
starting day and a half after the shot was given on her left arm, She experiences Stiff arm -> patient had hard time lifting her left arm over her head.  Still painful to lift and it hurts to lay on bed with her left arm side down even till month later 11-8-09
Mixed series Received Janssen 3/28/21 - lot 1805022, left deltoid
After the first dose I was sick as expected with a sore arm, fever, etc...  After the second dose I got really sick. I had flu like symptoms for about a week or so. Then I had issues breathing , chest pains, and my legs were really sore. I had developed new blood clots in both legs, superficial and deep vein. I did not have a heart related chest pain though. I continue to have these issues right today.
Feeling Sick; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), PYREXIA (Fever) and FATIGUE (Tired) in a male patient of an unknown age 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 08-Jun-2021 at 5:00 PM, the patient experienced MALAISE (Feeling Sick), PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, MALAISE (Feeling Sick) outcome was unknown and PYREXIA (Fever) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Two brothers and her mom of reporter received Moderna vaccine.   No concomitant medication was reported. The treatment information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: NNI
Allodynia (skin sensitivity) all over but especially noticeable on my left thigh; In addition to the usual fever (100.7); Joint aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and Raynaud's. The patient had history of known allergies reaction to some detergents and medical tape adhesives (with prolonged exposure). Concomitant medications included erenumab (AIMOVIG), estradiol (DIVIGEL), progesterone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and baclofen (BACLOF); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. She also received estrogen gel (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced allodynia (have been using that medication every day for years). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 15:00, in the afternoon of the day after receiving second COVID dose, the patient experienced in addition to the usual fever (100.7), joint aches, fatigue and had allodynia (skin sensitivity) all over but especially noticeable on left thigh at the exact location the patient had applied an estrogen gel (hormone replacement) early that morning. The patient had been using that medication every day for years and had never had that feeling any other time. The patient got allodynia when she had a bad migraine, so she recognized it, but never before had it been more intense in one particular area of her body, and the patient did not have a bad migraine at the time so it was not migraine related. The patient had read that there had been reports of women having more reactions to the vaccine than men, and thought might be useful to know that the patient had this reaction in the exact spot where she had applied estrogen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of allodynia (skin sensitivity) all over but especially noticeable on my left thigh, fever (100.7), joint aches and fatigue were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 16-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011188:Original Case : 1809USA010671; US-009507513-1809USA011189:Original Case : 1809USA010671; US-009507513-1809USA011186:Original Case : 1809USA010671; US-009507513-1809USA011190:Original Case : 1809USA010671; US-009507513-1809USA011184:Original Case : 1809USA010671; US-009507513-1809USA011185:Original Case : 1809USA010671.
I experienced a breakthrough case of COVID-19 on 12/13 with headaches, coughing and congestion. I tested negative on 12/25 and on 12/31 I tested positive again.
Has had constant headaches, fatigue, tremors and tingling in legs and arms, temporary paralysis.
Information has been received from a medical assistant refers to a 13 year old female patient with wheezing. The patient had no drug reactions/allergies. On 12-JAN-2015 the patient was vaccinated with the first dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017, 0.5ml, intramuscular in the left arm). Concomitant therapies included PROAIR. On 13-JAN-2015 the patient called office complaining of numbness and tingling of the left arm and feeling anxious. The patient was prescribed BENADRYL as treatment. The patient called back later on 13-JAN-2015 to report she was experiencing numbness and tingling of her whole body, especially her legs and feet. On 14-JAN-2015, the numbness and tingling resolved but the patient had developed a "heaviness and weakness" of her legs. The heaviness and weakness of her legs resolved on 16-JAN-2015. No Lab diagnostics studies were performed. No intervention was given to prevent serious criteria. The medical assistant added that the patient would not be administered additional doses of GARDASIL. The outcome of the event feeling anxious was not reported. Additional information has been requested.
Started throwing up around 10 hours after 2nd shot.  Only lasted about 2 hours
2 seizures: 1 following vitamin K injection on 5/8/08 at hospital.  1 following her 2 week hep B vax at health clinic on.
Information has been received from a physician concerning an approximately 21 year old female who in June 2007, was vaccinated IM with Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Two days after receiving the first dose of Gardasil, the patient developed groin warts.  There is no known history of these warts.  The patient came back in about a month later and was given the second dose of Gardasil.  A few days after receiving the second dose, the patient had a huge outbreak of warts.  The patient was treated with cryotherapy.  The patient did not notify the physician of the warts until the second outbreak occurred.  Medical attention was sought.  The patient's outcome was not reported.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 21 year old female with no pertinent medical history, drug reactions/allergies and no illness at the time of vaccination who on 07-MAY-2007 (also reported as June 2007), was vaccinated IM in the deltoid with a first dose of GARDASIL (lot# 654272/0319U) in the evening. Concomitant therapy included hormonal contraceptives (unspecified). Two days (also reported on an unspecified date in May 2007) after receiving the first dose of GARDASIL, the patient developed groin warts (also reported as vulvar warts). There is no known history of these warts. The patient came back in about a month later (also reported as 09-JUL-2007) was given the second dose of GARDASIL (657868/0523U) IM. A few days after receiving the second dose, the patient had a worse outbreak of warts. The patient was treated with cryotherapy. The patient did not notify the physician of the warts until the second outbreak occurred. Medical attention was sought. The patient's outcome was not reported. In August 2007, the patient had recovered within 2 weeks post treatment. Additional information is not expected.
Noticeable signs after the second (HEP B - DTAP, ROTA.) Rash, increase in crying.  Substantial changes after 6/24/08 shots.  Mouth closed; would not open to eat - "Spacey at times."  Still not chewing 12/09.  Unaware of the reporting system, so that's why this is of date above.  Son still not chewing food at 21 months!!
hives, blisters filled with fluid on both feet , in mouth, arms. diagnosed as bullos pemphigold after results of arm punches done in 2 places on body.
After receiving the COVID 19 Booster shot he experience tooth and shoulder pain. One month later he had a heart attack and died in the hospital on 12/11/2021. My son researched on and saw that the booster can cause a rise in blood sugar levels to go up, thus, causing his heart to be inflamed.
C/O swelling , soreness, and redness to injection site.  States it is still that way 5 days later and itches.  Denies increased in size, denies pus.
This spontaneous report was received from a registered nurse and refers to a 2 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.