chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sleepy; lethargic; kind of confusion; itchiness; soreness; headache; chills; joint pain; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-126334) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness) and PAIN (soreness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (very sleepy), LETHARGY (lethargic), CONFUSIONAL STATE (kind of confusion), PRURITUS (itchiness), PAIN (soreness), CHILLS (chills) and ARTHRALGIA (joint pain) had resolved and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications reported.
High Fever and Pain. Could not work the rest of the week. Over next 4 months kept getting very sick-infections-ears, eyes, throat, sinus, bronchitis, all more than 1 time. Had stiff necks. Developed bone pain in shins-then hip that broke at age 21 due to fibrous dysplasia. Then I had other bone pain- wide spread. Eventually Vitamin d helped but in the process was given all kinds of drugs thru health Center. I had transferred there and was an honor student-the vaccine paperwork was submitted to Health center. I developed anorexia, all my teeth became loose and creeked (this got better), became depressed. Had adverse reactions to treatment and bone scans. Fosamax was one of the drugs and Lodene XL another. I was treated for severe VitD deficiency at 50 000 IU weekly that finally helped 2 years in trying to get help. But then it was upped to 100k and I had something like a stroke and have never been the same person--went from honors to not being able to count or recite the alphabet and had to relearn basics--withdraw from college where I was engineering major. I repeated told doctors that I got sick and had been sick since I had the vaccine and they dismissed my complaint as nonsense. Recently I have been having bizarre symptoms and have found I have corroded dental fillings that may be the issue--reading about mercury and vaccine--I know for an absolute fact that my health demise--physical and mental was from the vaccine and not coincidence. Back then I got so depressed and was in so much agony I tried to end my life--so it is life threatening especially when doctors would not own up to what the problem was. It left me feeling like pain and bizarre health-kidney pains/stones were all in my head. I was treated with drugs for pain and biophosphonates that made me very ill. I was dx'd with post traumatic stress disorder causing my pain 20 years after domestic violence- instead of helping me with reaction to vaccine by one. Another was going to give me an artificial hip--but coudln't tell me how that would help my shin and arm pains. Had lymph nodes in leg removed toward the end as they were very swollen--a biopsy was supposed to be done but wasn't. The cost of all that I was put through for medical-that didn't help was unbelievable and then my insurance wouldn't cover so had to apply for hospital welfare to pay for some and let the rest destroy my credit. I ended up dropping out of college because I couldn't remember anything that I'd learned and I'd been Phi Betta Cappa, Presidents list and Deans list. To this day I believe vaccine ruined me--how I was able to function and think--I have recovered to an extent but I am not the same. I became disabled in 2013- due to unpredictable health-anxiety and employment problems.
This spontaneous report as received from a medical assistant refers to an unknown number (out of 6 patients) patients of unknown age and gender. The patient's medical history was not reported. On 03-JUN-2014, the patients were vaccinated with doses of improperly stored liquid PEDVAXHIB (lot #J013944, expiry date 13-AUG-2016, 0.5 milliliter(ml) intramuscular (IM) that had been exposed to 30 Fahrenheit (F) for less than one hour, rather than the 16 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an unspecified dose of improperly stored PROQUAD (recombinant human albumin (rHA), lot number R006217, expiration date 28-AUG-2019, route of administration was not reported) for prophylaxis. It was reported that sterile diluent (lot number and expiration date were not provided) used for reconstitution of the vaccine was not improperly stored. The vaccine was stored in temperature between 15 and 46 Fahrenheit degrees for 3 hours 30 minutes (date unspecified). Previous temperature excursion was recorded in temperature range of 15 to 46 Fahrenheit degrees for 1 hour 30 minutes (date unspecified). A Digital Data Logger was involved. No adverse effects were reported. This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA005807:
On 2/17/00 and 3/8/00 the pt developed chickenpox. The pt's physician did not want to see her the first time because she was so infectious. On the first breakout the pt had 65 pox and on the second breakout 15 pox. The first breakout completely healed. On 3/9/00, the pt was seen by a physician. Follow up data states the patient was seen by a physician on 03/09/2000 for a non-varicella viral rash. The patient was treated for a viral rash only. Additional information has been requested.
Redness, swelling, induration, itching entire (L) upper arm from shoulder to elbow - almost circumferential.
woke from nap w/fever of 102-103; mom sponged every 2 to 3 hrs for next 24 hrs; pt was given APAP ever 3 hrs for next 4 days; MD contacted & thought it was probably the shots but did not exam pt;
Little out of it in her head, very quick surge of pain on her left leg which is repeating; Left nose congestion; Left side of the face being numb; Eyebrows were kind of very heavy; Muscle aches; Temperature little high, heat was radiating to back of her head; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left nose congestion/ nose congestion, left side of the face being numb/ Hypoesthesia, eyebrows were kind of very heavy/asthenopia , little out of it in her head/adverse reaction, muscle aches/ myalgia, temperature little high,heat was radiating to back of her head/ pyrexia.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:016B21A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high. Treatment for events included diphenhydramine HCl, acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high were considered unknown.; Reporter'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.
Myalgia, Arthralgia, Fever, pain, swelling and warmth at injection site Narrative:
Information has been received from a physician concerning a 9 year old male who in approximately 2000, "8 years ago", was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck). On 12-Aug-2008 the patient came to the office with a case of shingles. At the time of this report, the patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX lot # reported as M376655, expiration date 29-NOV-2017 (dosage and route were not reported) for prophylaxis, which  was exposed to temperature excursion of 47°F to 77°F for a time frame of 4 hour. There was a previous temperature excursion with a temperature of 15°F to 46°F for 6 hours. There was no data logger reported. No adverse effects reported. The vaccine was reconstituted with properly stored sterile diluent (MERCK) lot # K026802, expiration date 21-OCT-2017 (dosage and route were not reported). Lot number M376655 is an invalid lot number for ZOSTAVAX.
Patient complained the day after the vaccine that the site of the injection is red and swollen, and she has headache and feels nausea. Patient is advised to take BENADRYL and apply cold/ice to the site of the injection. Monitor the adverse and seek medical assistance if the symptoms not resolved.
In on 9/6/11 - rcv'd vaccine, tolerated vaccine at first, swelled up soon after to (R) upper arm (shoulder), approximate size of gold ball, hard/red/tender to touch x 4d, symptoms now improving 9/12/11, still with noticeable knot - resolving.
Patient said she started itching from head to toe the evening after getting the vaccination.  the itching comes and goes. There is no rash, swelling, or SOB.
Swelling in arm achy -> after 2-3 days achy from hips up fatigue after 2 weeks still achy & fatigue. Going to Dr today 11/7/11.
PATIENT REPORTED FEELING FLU LIKE SYMPOTOMS DAY AFTER INJECTION WHICH WAS EXPECTED.  HOWEVER STARTING SUNDAY EVENING HE BEGAN TO HAVE PAIN IN HIS LEFT AREA OF HIS NECK.  THAT PAIN THEN BEGAN TO RADIATE DOWN TO HIS LEFT SIDE.  THE PAIN BEGAN TO GET MORE INTENSE TO WHERE MONDAY EVENING HE WAS HAVING DIFFICULTY TAKING A DEEP BREATH.  MONDAY NIGHT HE WAS UNABLE TO SLEEP DUE TO PAIN AND SHORTNESS OF BREATH.  TUESDAY MORNING HE CONTACTED DOCTOR AND THEY SENT HIM FOR CT SCAN.  THE SCAN SHOWED A PULMONARY EMBOLISM IN HIS RIGHT LUNG WITH EFFUSION SHOWING IN LEFT LUNG.  THE ONLY THING DIFFERENT PATINET DID DURING THIS TIME IS GET THE SHINGRIX VACCINE.  DOCTOR THEN PUT PATIENT ON ELIQUIS FOR TREATMENT.
After the nurse administered the vaccine and left the room, I turned to my daughter to see if she was ready to go. The look on her face was very strange and I could see the color literally drain out of her face. I spoke her name and she began gropping for me, saying mommy where are you? I can't see you! I can't see! Then she started gagging and I grabbed a garbage basket just in time for her to vomit in it. Her sight began to return but her color did not. By this time the nurse came back looking for us. I explained what had happened and she had my daughter lye down with a cold wash cloth on her head. Another nurse and a doctor appeared in the door to see what was going on. Though none of them seemed all that concerned about this event, I feel this needed to be reported. This is not a normal reaction of the body to a medicine unless what is being put into the body is toxic. My daughter had temporary blindness and vomited.  My daughter has always had reactions to every vaccine she has ever received. She would spike high fevers between 103-105, have tenderness, swollen area of shot, and within two or three days would have cold/respitory symptoms, but nothing had prepared me for what I would experience in the office on this particular day.
Dizziness, Headache, NauesaVomiting, MULTIPLE DVTS LEFT LEG; "FOGGY BRAIN' Narrative: EMPLOYEE STATES: multiple deep vein thrombosis in left leg documented by imaging and follow up by specialist symptoms are better but still on medication: Xarelto 20mg x 6 weeks then 10mg x 6 months other side effects: headache, nausea, dizziness, and foggy brain for a few weeks post 2nd dose symptoms have mostly subsided
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient experienced redness and swelling at the injection site. The patient contacted the office to seek medical attention. This is one of 4 reports from the same source. No further information is available.
A report was received from a regulatory authority on 11/25/02 concerning a 54 year old male vaccinee who experienced a cold (3 days post vaccination), muscle pains (7-10 days post vaccination), decreased urinary output (9 days post vaccination), diagnosed as rhabdomyolysis with acute renal failure after receiving the Fluvirin vaccine on 10/18/02 which involved or prolonged hospitalization, involved persistent or significant disability or incapacity and was medically significant. The vaccine had a history of deep vein thrombosis, inferior vena cava obstruction, hypertension, renal allograft and end stage renal failure. The vaccinee was receiving ciclosporin, prednisolone, sirolimus, atenolol, doxazcsin, simvastatin, omeprazole and warfarin concomitantly. On 10/21/02, the vaccinee experience cold symptoms. Seven to 10 days later the vaccinee had muscle pains and on 10/27/02, decreased urinary output. A renal biopsy was performed and nothing abnormal was detected, that is, no rejection of the allograph. A diagnosis of rhabdomyolysis with acute renal failure in the transplant kidney was made which required dialysis treatment. The vaccinee had not recovered. There was insufficient information to determine the reporters causality assessment.
Patient anxious complained of arm pain with injection and approximately 3 minutes later patient  had loss of consciousness for approximately 2 minutes.  BP low normal 108/60. Patient pale, diaphoretic and cool to touch, Patient assisted to stretcher and on monitor and found to be bradycardic HR as low as 38 . CODE team arrived and within 5 minutes patient back to baseline
Administered vaccine past the published expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on 30September2021.  No treatment medications were reported.
Needle was not tightly fastened to syringe and vaccine leaked out when being administered into the patient's left arm. A full dose was administered into the patient's right arm.
cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219; HDL increase; lower triglyceride levels; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, 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 experienced BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels). At the time of the report, BLOOD CHOLESTEROL DECREASED (cholesterol levels were significantly low/lower cholesterol levels in 20 years/overall cholesterol went from 237 down to 219), HIGH DENSITY LIPOPROTEIN INCREASED (HDL increase) and BLOOD TRIGLYCERIDES DECREASED (lower triglyceride levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: 237 (High) High and 219 (Low) cholesterol levels were significantly lower than before. On an unknown date, Blood triglycerides: down (Low) low. On an unknown date, High density lipoprotein: increased (High) High.         No concomitant medications were provided. No Treatment medications were reported. Patient also went through Lipid Panel Test which resulted into lower cholesterol levels than before.   Reporter did not allow further contact
Dizziness, blurred vision, hot/cold, nausea, Vertigo;  Dizziness, blurred vision - lasted 45 minutes.  4/29/21 - typical side effects today except for pain behind eyes with headache.
Redness and swelling localized to left upper thigh starting within 12 hours of injection.
Two days after receiving the vaccine patient experienced flu-like symptoms, body aches, nausea, and swollen lymph nodes in the armpit.  The next day she had eye and jaw pain, and burning up and down her arm which she believes is the start of shingles
Increased heart rate, dizziness, low-grade fever, near fainting spell, flush cheeks, muscle pain (arm, shoulder and back), and loss of ability to focus (went home from work).  Significantly elevated tinnitus symptoms as well.
I was diagnosed with Covid on 2/12/2021 and my entire family also got Covid.
1 seizure on Monday 12/15/03 and then one on Wednesday 12/17/03 at 10 AM. Hospitalized on 12/17/03 and was released 12/19/03.
Information has been received from a female consumer concerning her 73 year old husband with a "heart disorder" who on 03-DEC-2007, received a 0.65 ml. intramuscular dose of Zostavax. It was indicated that the patient had a cold at the time of the vaccination. Concomitant therapy included an unspecified medication for his "heart". Additional information from the reporter indicated that on an unspecified date since receiving the vaccine, that the patient developed a cold, and unspecified bronchial problems. The patient developed pneumonia and on 26-JAN-2008 was hospitalized. At the time of this report the patient was still hospitalized. A product quality complaint was not reported. This is one of two reports from the same source. Follow up information has been requested.
3:30 pm Received the vaccine 3:40 pm Lost vision, gained a loud ringing in the ears, hands went numb, and passed out for over a minute 3:45 pm Vision was regained, hands were still numb and I could not hear due to the loud ringing in the ears 3:55 pm All Symptoms subsided, went to urgent care and I checked out
pt recv vax 13JUN95 & 0n 2FEB97 pt devel 10 to 15 lesions but no fever;on 7FEB97 presented to a MD;f/u info reported that the pt subsequently recovered;
Leukemia, AML, He is day ~21 Decitabine and day 14 VEnclexta for now confirmed t-AML. NGS and cytogenetics returned complex cytogenetics with RUXN1-MECOM fusion t(3;21) TET2 x 2 DNMT3A and RUNX1 genes.  THis is all c/w treatment-related AML.  Besides fatigue and minimal nausea, he has no focal complaints.  No fever, on LVQ ppx due to severe NTP.
Pt. was given Daptacel instead of Adacel. Pt was called 8/30/07 and asked if she had any problems with her arm or health after injection. She said she had no problems; her arm had no bruise, bump or soreness and she felt fine.
Fatigue, headache, nauseousness, overall aches and pains. Started on 3/7/21 and still present 3/14/21.  3/7 - slept for 12+ hours.  Headaches are daily.  Nauseousness was stronger on 3/7, 3/9, and on 3/13 (where I ate something in the morning and I vomited everything up).  Eating usually very light during morning hours (where I felt most nauseous).
Severe headache, current fever of 101.5, nausea, severe pain at injection site
The morning of May 13, 2022 I had a stuffy sinus cavity. Then in the early afternoon I had extreme fatigue. I thought I might have Covid. I took an at home Covid test and it was positive. I called my doctor, and they recommended that I go to the ER. I was seen in the ER, and all my vitals came back fine. They didn't do another Covid test, but they said my symptoms were similar to Covid. I was prescribed Paxlovid for 5 days. I picked it up the next morning. I finished the last course on May 18th. I'm not fully recovered yet. I still have a little fatigue. I have been isolating myself. I hope to end the isolation on May 23rd.