chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Around 9:00 PM after injection, complained of severe pain in arm around injection site. Gave Children's MOTRIN. Awoke 8:30 AM with 101 fever, red and swollen 3" mound around site. 12:00 PM gave 1/6 dose of MOTRIN (felt nausea). 2:00 PM gave remaining dose MOTRIN, fever reduced to 99. Iced bump.
Pt has called office to report reaction after vaccination. Pt. reports that approximately 30 minutes after vaccination (she was already home), she became very itchy, all over. She then noted her lips were numb. Her throat was itchy and then felt to be swelling. She did not have trouble breathing, but did feel it was difficult to swallow. Pt did take benadryl which helped lessen the reaction. After the benadryl wore off, the symptoms would return. She took the benadryl every 6 hrs for 24 hours per patient until symptoms resolved. She did also develop flu-like symptoms the evening of the vaccine, which persist still 3/15/21. She did not go to the ER or to see a doctor through this. Patient questioning taking second vaccine - advised to speak with her PCP.  After speaking with PCP, patient is opting out of second vaccine.
Right shoulder progressively got more and more sore, two days after injection I am unable to move my right shoulder in certain positions. There is a dull ache with bursts of excruciating pain with movement.
Pt presented to our clinic as a new patient on 11/12/21. Our clinic does not administer Covid vaccines.   Pt received 1st Pfizer Covid vax 10/18/21, no adverse effects. She received 2nd dose 11/6/21, then a few hours after admin she stood up quickly and almost fainted- dizzy with tunnel vision; she did not lose consciousness or fall. The next day she had a similar episode but instead of tunnel vision she decreased hearing. Pt has never had these symptoms before or since. At time of clinic visit on 11/12/21 pt did not have any further symptoms.
I have been hurting constantly since my 1st vaccine on March.23,2021...For a couple of days afterward I had achy flu-like symptoms all over my body which seemed to subside by days 3 & 4, Then I started having shooting pains between my shoulder blades that felt like I was being stabbed. My flu-like aches sky-rocketed until I had to start sitting perfectly still - any movement at ALL caused me wrenching, agonizing pain.  I thought I might be having a heart attack! I went to my Doctor - on Monday.  My BP was really good,  my heartbeat was strong,  my lungs were clear except for a touch of wheezing due to asthma, etc.  Right after this visit I got in my car to drive home, and I could hardly move! Same thing happened last week after a GYN appt... Could hardly drive home! Two weeks ago I came home hurting with acute pains and I was laboring to draw my breath...  Then the pain was so strong that I had to sit it n the same spot for 3 hrs unable to move!
pt recvd vax 17NOV95 & 1DEC95 pt noticed 1 lesion on lower extremity;# of lesions had gradually inc & now had several hundred;1DEC95 MD nicked hand while performing surgery & had cellulitis around it;extensive vesicular lesions
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 71 years 6 months.   No concomitant medication information was provided.  It was reported that the vaccines were administered beyond use date after the thaw process. Patient got Moderna. Reporter stated that there were no reports of any reactions after the administration of vaccines.  No treatment medication were provided.
Pt was seen in clinic on 08/14/23 for a blood draw and vaccines. At the time of the appt., she reported not being pregnant and did not plan on becoming pregnant in the next month. She was given Energix B, MMRII, and Varivax on 08/14/2023. She returned to clinic on 09/15/23. During this appointment. she informed RN that she had been nauseous and fatigued since her last appt. and had missed her period on 08/22/2023. She was advised to take a pregnancy test to rule out pregnancy before any further vaccination. RN spoke with pt. on 09/19/23 and she informed RN she had a positive pregnancy test on 09/16/23 . She is not reporting any issues at this time with her pregnancy. Reports she has not seen OB GYN regarding this pregnancy but is scheduled for her first visit in December 2023.  Reporting due to potentially being pregnant at time of vaccination/pregnancy occurring within 28 days post live vaccine administration.
pt recvd vax 23NOV93 & w/in 24 hrs alleges that exp intermittent pain in face; tingling sensation in face, neck, & down arms; next day hand tingling in legs; 2wks later sx worsening; has hx of GBS 6 yrs ago;
Blood clots in the legs and lungs; he passed out and still currently admitted in hospital; Blood clots in the legs and lungs; 2nd dose given 2 weeks from the 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clots in the legs and lungs), LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (2nd dose given 2 weeks from the 1st dose). On 22-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood clots in the legs and lungs) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 22-Apr-2021 due to DEEP VEIN THROMBOSIS, LOSS OF CONSCIOUSNESS and PULMONARY EMBOLISM. On 19-Mar-2021, PRODUCT ADMINISTRATION ERROR (2nd dose given 2 weeks from the 1st dose) had resolved. On 22-Apr-2021, LOSS OF CONSCIOUSNESS (he passed out and still currently admitted in hospital) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots in the legs and lungs) and DEEP VEIN THROMBOSIS (Blood clots in the legs and lungs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. Patient reported that he had diagnosed to have blood clots in the leg and lungs and had unspecified procedure. Patient reported that he was given a unknown medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the reported drug administration error (2nd dose administered 2 weeks from 1st dose) may remain a confounder.
Information has been received from a registered nurse concerning a 6 year old female with unspecified food allergies who on 6/29/98 was vaccinated with the second dose of varicella virus vaccine live. There was no illness at the time of vaccination. The RN reported that on 9/23/03, at 9:00, the patient developed varicella. It was unknown if medical attention was sought. On 9/30/03, the patient's varicella resolved. Additional information has been requested.
Headache, Myalgia, Fever, Diarrhea, arm pain on vaccine side Narrative:
Systemic: mentioned a fear of needles after talking with the patient-Mild, Additional Details: 2/20/21 app 11:45am received his second COVID vaccination. He was seated for 20 minutes after his shot.  He described himself as feeling nauseous, sweaty, and \"pale\".  He went out for 20 seconds, when his coworker called his name.  He quickly responded.  He was then walked to the RN office of the facility.  She took vitals BP 148/82, 58 heart rate, 99% pulse ox. He started back\r\nto work. At 3 pm I checked in and he responded he was feeling fine.
This spontaneous report as received from a Registered Nurse refers to a 11 month old female patient. On 12-AUG-2004 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot number not reported). The outcome was unknown. Additional information has been requested.
Patient developed a systemic rash 7 days post vaccination. Rash was concentrated in trunk area, but also was present on upper and lower extremities. There was a very small area of rash on one of the patient's ears. The injection site (approximately 1 inch above elbow area according to patient) was red and swollen, as was the patient's elbow. Once the patient realized that this may be an allergic reaction she took BENADRYL to help resolve the symptoms, which worked well for the patient. The symptoms were gone 3-4 days after onset.
I received my first Covid-19 Moderna injection and felt slightly groggy and tired as the day progressed. Just before bed I noticed my arm was quite sore and I still felt tired and slightly light headed. The next day (Feb 4) I had a very sore left arm at the injection site but felt good otherwise. I came home from work and took one 200mg Ibuprofen as my arm was still quite sore. The following day (Feb 5) my arm pain subsided but I still felt light headed during the evening. I am writing this on Feb. 18th and each day I have bouts of being light headed and have difficulty concentrating. There is no real pattern to what time of day I get the symptoms. I do not have the classic headache but definitely feel pressure in my head and behind my eyes. I also find that I wake up after a full nights sleep and feel not well rested. I spoke with my doctor last week and he suggested I give it until this week to see where things are at. I plan on contacting him soon to schedule an appointment to discuss my symptoms more. Before getting the vaccine I did not have any of these symptoms as I describe.
Initial misuse report received from a healthcare professional on 25 April 2014. The patient had received FLUZONE intradermal expired on 19 April 2014. No adverse event was reported. List of documents held by sender: none.
Patient described swelling in throat (2/10) 16min following receipt of vaccine. POD staff administered diphenhydramine liquid 36mL/90mg PO at 11:43am. Patient requested transport to nearby ER at 11:52am via ALS; at 12:00pm the patient declined transport/medical care and stated he was feeling better.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, pain at the injection site Narrative:
Side effects began the next day after receiving the vaccine: aches, nausea, vomiting, headache. Spent the day in bed, and felt better by the next day.
Day after 2nd shot  fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable.  Able to drink, normal stool, no other symptoms
Narrative: "I can't get a deep breath, I am tired" "I'm not the same person after the vaccine"
Adverse skin reaction at the injection site in the upper left arm. 3inch by 4 inch red splotch, mild swelling, skin burning and discomfort. Appeared approximately 12 hours after receiving second dose of Moderna. Redness, swelling and discomfort have begun to lessen approximately 26 hours after onset.
16 days post vax, the pt developed chickenpox with about 15 lesions. The pt also experienced a bad cold.
This spontaneous report was received from a physician via a company representative concerning a 2 month old female patient with no pertinent medical history and no drug reactions and allergies. On 14-OCT-2013, the patient was vaccinated with an expired dose of 2 milliliter (ml) (first dose) of ROTATEQ (lot number and expiry date were reported as H010690 and 05-OCT-2013 respectively), orally. There were no concomitant medications. On 16-OCT-2013 (also reported as today), the patient experienced vomiting. Physician reported that no treatment was given due to the patient vomiting and no lab or diagnostic studies were performed. The outcome of vomiting was unknown. The relatedness was unknown for ROTATEQ. Additional information has been requested.
I received my second Moderna booster for COVID-19 on 5/14/2022. On 7/22/2022, I took a home test for COVID-19 that yielded a positive result. I had a headache, sore throat, and cough. I had a telehealth visit with my doctor and was prescribed PAXLOVID, which I started taking that evening. I took the PAXLOVID for the recommended 5 days. When I started taking the PAXLOVID, the aforementioned symptoms gradually diminished. During my illness, I generally felt shaky and weak throughout my whole body; after I began the PAXLOVID, this particular symptom diminished and was gone by 7/23/2022. The headache went away on or about 7/25/2022, but it returned on or about 8/1/2022. On 8/2/2022 , I had another telehealth visit with my doctor, because the headache, cough, and sore throat were rebounding. This time around, I was prescribed doxycycline, which I started taking that evening. On 8/4/2022 I saw my doctor in person, so she could examine my breathing. She told me that she detected a little bit of a noise in the lungs that was considered anomalous. She advised me to continue taking the doxycycline until it was gone, and she said that she believed my respiratory function would improve quickly as I took the medicine. I finished the doxycycline on 8/15/2022 or 8/16/2022. I took a home test on 8/16/2022 and got a negative result. That was also the first day that I had had without coughing since my illness began.
C/o dizziness fingers feeling cold feeling weak after vaccination.  EMS called to evaluate.
ON 12/24/20 AT 7:30PM, DEVELOPED SORE ARM, SWOLLEN ARMPIT, FEVER OF 103.1, SHORTNESS OF BREATH, AND HEADACHE. LASTING 4 DAYS BEFORE RESOLVING. SEEN IN URGENT CARE.
did not sleep much the night; fever; body aching; vomiting; injection site is red; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (injection site is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (did not sleep much the night), PYREXIA (fever), MYALGIA (body aching), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103 degree f High.         The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Patient experienced itching and was administered 25 mg benedryl by mouth. She was observed in waiting room for 30+ minutes.
Cold chills for 16 hours, then sweats with temp, headache, terrible back pain, slept a lot. Shot at 10:30am on 1/27 - chills started at about 8pm til noon on 1/28. Everything else started during the night and I felt better about 3:00pm on 1/28.
When reconstituting MMRV Vaccine it was reconstituted with the Menactra vaccine solution rather than sterile water diluent. Therefore the MMRV and Menactra was administered as a combination IM shot to the youth. YOuth was observed in the clinic for 20 minutes no adverse reactions noted by pediatrician or nurse,
Started with tingling in right arm & fingers. Spitting up phelm than vomiting & diarrhea. Extreme weakness, fever & chills.
Approximately 3 minutes after receiving vaccine, client complained of feeling light headed and was pale. He was assisted into Trendelenberg position. Ice pack placed on forehead, apple juice offered and consumed by client. Did not lose consciousness. Monitored thirty minutes and discharged home-ambulatory.
No additional adverse event; Medical Assistant calling to report adverse event for VARlVAX that was administered after improperly stored; This spontaneous report was received from a certified medical assistant regarding a patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# T027303, expiration date 12-AUG-2022, given as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (average temperature: 8.5 °F) for 0 hours, 18 minutes and 0 seconds; and of 6°F to 14°F (average temperature: 11.9°F) for 1 hour, 0 minutes and 0 seconds. The cumulative timeframe was 1 hour and 18 minutes, with no previous temperature excursion. No further information given, and no additional adverse event was reported (no adverse event).
Sore arms; Headaches; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), HEADACHE (Headaches) and MYALGIA (Muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arms), HEADACHE (Headaches) and MYALGIA (Muscle aches). At the time of the report, PAIN IN EXTREMITY (Sore arms), HEADACHE (Headaches) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
This spontaneous report as received from a a male patient of unknown age regarding himself. On an unknown date the patient was vaccinated with PNEUMOVAX23, subcutaneous. The patient reported that he "received 2 subcutaneous injections of PNEUMOVAX 23 (dates unknown)." The patient also reported that he has developed "aches all over the body" after receiving the second subcutaneous injection site of PNEUMOVAX 23 (date unknown). It is unclear as to whether the patient received these 2 injections at the same time. All dates are unknown. The outcome of aches all over the body is unknown. Causality was also unknown. Additional information is not expected.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 24-MAR-2015 the patient was subcutaneously vaccinated with 0.5 ml of (Oka-Merck) PROQUAD (lot # reported as K023364, expiration date 20-MAY-2016), which was exposed to -11.5 Centigrade 2 hours and 10 minutes. No adverse effects were reported. Additional information has been requested.
The evening of his morning shot he began to have back pain up between his shoulder blades. Describes it as burning, his "skin hurts" is uncomfortable when touched, leaning against a chair or even when his t-shirt rubs against it.  Three days later and it still hurts.