chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative and through an unspecified reporter of an online post. The post refers to a 15 year old female patient, whose current conditions and medical history was not known. On an unknown date the patient was vaccinated with GARDASIL (dosage details and lot number were not reported). Concomitant medications were not reported. On an unknown date, as the patient was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she had been taking to try to control the seizures caused her to develop kidney stones. Patient was rushed to the emergency room and was hospitalized. The outcome of the events was not known. Kidney stone was considered to be not related to GARDASIL since it was due to the medication that the patient was taking for seizures, while causality assessment for seizures and abdominal pain was not reported. The physician was concerned about GARDASIL due to this online post as he had vaccinated his wife, daughter and his patients. The reporter (from the online post) considered the events to be serious due to hospitalization. Upon internal review, seizure and kidney stone (nephrolithiasis) was considered to be medically significant. The case is linked to 1605MYS009749 (same reporter). Additional information has been requested.
I have a rash that goes all the way down my arm.  You people said this vaccine was safe.  I don't believe it is safe.  I dont have health insurance.  Are you going to help me.  I am going to get an attorney.  What you are doing is not right.
Within 4-6 hours 2-month-old developed after Rotavirus fever, vomiting and diarrhea.  This continued for 3-4 days, not dehydrated.
Upon giving vaccinations, pt was standing for 5min before he fainted and fell to the floor. Pt came to and was oriented x3. Pt then threw up and began to feel dizzy again. Pt was unable to stand he was so weak. EMS was contacted and checked pt out. O2 was adminstered. Pt was cleared to go home.
Pt reported redness and warmth in the area of injection on Friday, 10/23/20. She did go to an urgent care for eval and was not thought to be cellulitis given the redness and induration was  approximately 3 cm down from the area measuring 4 cm x 3 cm without evidence of streaking or warmth. She was advised to apply ice and use an additional antihistamine such as Benadryl. Pt states today, 10/25/20, that she only used ice and the area "is clear now"
Pt had a syncopal event with hypotension and subsequent bradycardia after venipuncture.
10/11/09 awoke with severe pain and weakness in Right deltoid.  Significant Pain and weakness continued for 2-3 days.  Then the pain decresed to moderate lasting 2 -3 weeks. Pain and weakness continue today when raising right arm. She is able to lift the same amount of weight with both arms but the right arm tires easily and she is unable to perform as many reps with the right arm.
Pt. reports today that she felt some discomfort at injection site for "some time" after receiving the vaccine.  Since then she has intermittently ( 6-8 times in 8 months) felt itching/discomfort at the site.  Yesterday she experienced the itching and noticed that there is a small lump (dime size) under the skin at the site.
Penis swelling; Scrotum swelling; Groin swelling; A spontaneous report was received from a  Consumer  concerning a  97 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as penis and scrotum  swollen and groin swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced the events list (verbatims) as penis and scrotum  swollen and groin swelling.   Laboratory details not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was <resolved, resolved with sequelae (include sequelae not provided)>.
Severe headache, fatigue, nausea, sleepy, fever, body aches I took some Ibuprofen for the first 3 days with no relief and finally just stopped taking it because it wasn't helping at all.  I am on day 8 and my headache is still present although it is mild now.  I still have fatigue and feel sleepy all of the time.
Morning after vaccination, mom called to report son had awoken chills & felt warm to touch. Also c/o abdo cramping pain. No N, V, D. Advised to give TYLENOL.
This case was reported by a healthcare professional and described the occurrence of a 27-year-old female subject not responding to therapy following vaccination with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  In 2001 the subject completed the three dose series of hepatitis B vaccine (unknown).  At that time, the subject's titer test was positive for protection from hepatitis B.  Approximately 6 years after completion of the hepatitis B series, the subject was tested again and showed a lack of immunity to hepatitis B.  At the time of reporting the outcome of the event was unspecified.
Red, warm and induration starting around 6pm on 1-2-15. Tender to touch. Location site LVL.
Suspected Covid-19/strong covid-19 positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Suspected Covid-19/strong covid-19 positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for Prophylactic vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Breast cancer, Arrhythmia cardiac (NOS) and Allergy.   On 09-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (Suspected Covid-19/strong covid-19 positive) (seriousness criterion medically significant). At the time of the report, COVID-19 (Suspected Covid-19/strong covid-19 positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) faint Positive and positive (Positive) strong Positive.         Concomitant product use was not provided by the reporter.   On an unspecified date in 2022 (Day 11 after Paxlovid) started Covid-19 symptom (headache, sore throat, aches and pains with cough and wheezing. On same day patient had very strong positive home Covid-19 test. On 05-Jun-2022, the patient received steroids (Intravenous, oral and inhale:) for Covid-19 infection.  Company Comment: This is a spontaneous case concerning a patient of unreported age and gender with no relevant medical history, who experienced the unexpected serious AESI of COVID-19 five months after the administration of mRNA-1273 vaccine (dose number in serie 2). Patient previously vaccinated with COVID-10 Janssen´s vaccine (dose number in serie 1) approximately 8 months before Moderna vaccine. Patient was treated with NIRMATRELVIR, RITONAVIR and steroids (intravenus, oral and inhaler). The outcome is reported as not recovered. It is noted interchange of vaccine product in this case. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unreported age and gender with no relevant medical history, who experienced the unexpected serious AESI of COVID-19 five months after the administration of mRNA-1273 vaccine (dose number in serie 2). Patient previously vaccinated with COVID-10 Janssen´s vaccine (dose number in serie 1) approximately 8 months before Moderna vaccine. Patient was treated with NIRMATRELVIR, RITONAVIR and steroids (intravenus, oral and inhaler). The outcome is reported as not recovered. It is noted interchange of vaccine product in this case. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient reported fever of 100 degrees and had a large, red swollen area on arm where both vaccinations were given. Patient will follow up with PCP regarding the event.
I had very large hives, with swelling, on the inside of both of my thighs. Dr. had me take extra Xyzal, total of 4 per day. The hives were gone within 2 or 3 days. My arm stayed sore and swollen for 2 weeks. I also had an all over flushed feeling with redness to my face.
I experienced general arm pain and swelling at the site of the injection fairly immediately and typical flu like symptoms beginning approximately 24 hours after my 2nd Moderna Booster.  The flu-like symptoms laster approximately 36 hours and after recovering I was left with a lingering fatigue.  On Sunday 4/3/22 I experienced mild, brief chest pain at approximately ten AM - it left quickly and I felt unconcerned as it left within 15 or so minutes on its own.  I went to the gym at 3 PM the same day planning to jog on the treadmill for 30 minutes as I often do.  I felt fatigued so started at a 2.0 MPH walking speed.  Within ten minutes I was struggling as if I was walking up a steep hill (treadmill was completely flat).  I continued for another ten minutes and became quite distressed as I was having tremendous difficulty catching my breath.  I laid down on a bench for about 20 minutes until a friend drove me home.  I recovered except for still experiencing lingering fatigue and I had little appetite.  At ten PM i was sitting in bed and realized I was once again having chest pain - it was stronger than before and I was quite concerned, so I checked my blood pressure using a home monitor - it was 176/110.  I phoned a friend to take me to my local ER Health Hospital as I feared I was having a heart attack!  I was evaluated and kept in the ER for 17 hours before being placed on a floor.
Aching, headache, swelling/tenderness at site, swelling to left eye  16 hours later.  Extreme fatigue and restlessness.
Lower left back pain into my left hip; joint pain in hands and feet; body aches (but no fever)
Patient reporting hives all over body, and swelling. Got worse, went to ER and was prescibed steriods, patient states that hives are coming back even with medication. Reporting headaches as well.
51-year-old male presents to the clinic after experiencing lightheadedness and malaise after receiving his second COVID vaccine today.  He is not diabetic, but failed to eat any food prior to his arrival.  Therefore, he is unintentionally fasting.  Patient has been dealing with COVID long hauler syndrome.  Other than Benadryl for seasonal allergies, no new medications.  He took all of his prescription medications today.  Patient was observed, condition improved, and he was advised to drink more water, eat some food, and return for any recurrence of symptoms.
As bad as flu after first dose, aches, pain all over especially knees and groin area. Hard to breath at times as I have bad cough/fluid in lungs though not bad enough to require medical attention. Headache, fatigue I am currently on  day2 of feeling like this. Note: this is not life threatening I justed wanted to provide honest feedback to you on my side effects. Advil/Tylenal does help a bit
Rash on both arms, recommend hydrocortisone 1% cream if not effective recommend patient call his MD.
Rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014A22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient never diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Rash all over (Patient applied several topical ointments but rash was not better appeared after first vaccine.) since 11-Feb-2021. Concomitant products included ATORVASTATIN for Prophylaxis.   On 02-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced RASH (Rash). On 07-Nov-2022, RASH (Rash) had resolved.            On 11-Feb-2021 at 02:30 PM, the patient received dose 1 of Moderna vaccine with batch number 010M20R in the arm, on 11-Mar-2021 at 02:30 PM, the patient received dose 2 of Moderna vaccine with batch number 026A21A in the arm and on 29-Dec-2021, the patient received dose 3 of Moderna vaccine with batch number 032A21A in the arm.  The event was not caused patient to seek medical care. It was unknown if there was any other potential cause. The patient was not experienced similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-669152 (Patient Link).
This spontaneous report as received from an officer manager referring to a currently 1 year old male patient. No information was provided regarding the patient's medical history and concurrent conditions. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 06-APR-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and anatomical location and route of administration were not reported)  lot # M046004, expiration date: 18-NOV-2018 indicated for prophylaxis. The vaccine had not had any previous temperature excursions as recorded by a data logger. On an unknown date, VARIVAX had temperature excursions of   -14C to -10C  for a time frame of 7 minutes which was called by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA000841: US-009507513-1805USA000923: US-009507513-1805USA000922: US-009507513-1805USA000928: US-009507513-1805USA000925: US-009507513-1805USA000927: US-009507513-1805USA000921: US-009507513-1805USA000924:
I had COVID-19 in July of 2020. I have Long-COVID symptoms since then. After getting the first dose of the vaccine I had serious side effects. I was advised to wait an extra two weeks to get my second dose. After getting the second dose of my vaccine, within 15 minutes of the shot I had Tremors in my legs. I could not get out of bed the next day and I need help dressing. I was very weak, and I went to the COVID-19 clinic, and I was tested. It was negative. I got a lump in my right arm inside my elbow where it bends. I had a history of Lymph Node removal in the past. I was sick for seven days and I had muscle twitching, insomnia, and neuropathy in my feet. My COVID-toes started to return. I had severe cramping, spasm, left sided abdomen pain. I was having breathing issues and heaviness in my chest. After 7 days some of the symptoms improved but I was still fatigued, and I had the lump in my arm persisting. I got a mammogram and there was a lump under my right arm. It was suspected that I had a blood clot in my armpit, but it was ruled out. It has been 3 months and I have hair loss and a Biopsy in my hair. It is almost as if my COVID Symptoms. I have a sore on my abdomen which has been there for 2 months. I consulted a Dermatologist, and it is unidentified. My blood work shows elevated inflammation markers. I still have insomnia and I have a persistent cough.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-APR-2011 the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2015, she was treated by a physician at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Pt exp tenosynovitis & a fever following vax; No further details were provided;
autoimmune type issues; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune type issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. GH9693) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune type issues) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (autoimmune type issues) had not resolved.            No concomitant medication information was provided.    It was unknown if the patient experienced any additional symptoms/events.  No treatment drug information was provided. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of autoimmune disorder. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID-19 vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. It was reported patient had autoimmune type issues. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
PATIENT CALLED THE PHARMACY 4/20/19 STATING SHE IS HAVING A REACTION TO THE VACCINES SHE RECIEVED ON 4/18/19. SHE IS HAVING ARM SORENESS, CHILLS, AND FEVER. SHE IS TAKING IBUPROFEN TO TRY TO GET RELIEF. SHE IS NOT HAVING DIFFICULTY BREATHING. WHILE IT IS HARD TO TELL WHICH VACCINE CAUSED THIS, THIS REACTION COULD OCCUR WITH EITHER ONE. PATIENT WILL CONTINUE TO MONITOR HER SYMPTOMS.
Pt recvd Engerix-B on 29JUL91 @ 230PM, & @ 340PM that same day, exp rise in temp, malaise, fatigue, nausea, chills, h/a, myalgia, tingling in one hand & inject site pain; Hospitalized due to severity of sx;
patient is feeling like someone punched her arm; feels like its a big bruise; 3x2inch patch of deep red skin; little bump underneath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), GLIMEPIRIDE, BUMETANIDE, VENLAFAXINE, MONTELUKAST, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), CARVEDILOL, LEVOTHYROXINE, LORATADINE, FAMOTIDINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath). At the time of the report, PAIN IN EXTREMITY (patient is feeling like someone punched her arm), CONTUSION (feels like its a big bruise), ERYTHEMA (3x2inch patch of deep red skin) and SWELLING (little bump underneath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that it doesn't seem like they gave it to her in the upper should (deltoid) they gave it in the middle of her arm near the elbow. No treatment medications were provided.
Presented to ER w/rapid heartbeat, felt faint, & had shaking @ approx 7PM on 12AUG91; Stated ECG did not reveal abnormal heartbeat; States given sedative & tested for TSS since menses on;
The symptoms began the same day. It felt like something was poking lungs and bronchial area. I was fatigued which initially went away but the poking sensation in still there. I thought that it was a fibromyalgia flare but that was ruled out. I saw Dr. after I took my 2nd dose and had the same symptoms. I was given a nebulizer for breathing because I also contracted covid.
Hives and itching on my behind. woke up at about 2:00AM itching so bad I could not deal with it, hives on my stomach, breast, behind,groins, hands and feet itching, went to ER around 2:30AM.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. Their concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M033905 with expiry date 20-JUL-2018 (exact dose and route of administration were not reported). The administered doses were exposed to the temperature between 6 and 14 degrees Fahrenheit for 1 hour and 10 minutes and to the temperature between 15 and 46 degrees Fahrenheit for 2 hours and 10 minutes. Previous temperature excursions included exposure to the temperature between 15 and 46 degrees Fahrenheit for 10 hours and 40 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.