chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 60 year old male consumer with high blood pressure, glaucoma and high cholesterol and no allergies who on 16-FEB-2011 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included LIPITOR, DIVON-50, NORVASC and COSOPT. The consumer stated that on 18-FEB-2011 the patient experienced a red spot and lump at the injection site. The consumer reported that it was a "sterlic abscess". The patient would go to follow-up with his physician. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient's red spot at the injection site and lump at the injection site and sterile abscess persisted. The patient did not seek medical attention. Follow up information has been received from a physician and medical records concerning a 60 year old retired male patient with glaucoma, high blood pressure (also reported as hypertension), high lipids, arthritis and a history of zoster vaccination (06-Oct-2009) who on 16-Feb-2011 was vaccinated in the left posterior upper arm with ZOSTAVAX (Merck) (lot # 669191/1456Z, expiration date 28-JAN-2012). On 18-Feb-2011 at 12:45, the patient went to the emergency room with an allergic reaction including a 3 cm (also reported as .3 cm) x 3.5 cm red raised edematous and erythematous area with a 1.5 cm x 2 cm darker edematous and erythematous area on the patient's left posterior upper arm at the injection site, "no abscess" was noted. The patient reported no pain or pruritus. The patient's allergic reaction was also noted as a red blanching rash area on the patient's left posterior upper arm where he had the injection. The patient was treated with KEFLEX. On 21-Feb-2011, the patient was seen in the office. The physician reported the patient had recovered. All available medical records will be provided upon request. Additional information has been requested.
Information has been received from a pharmacist concerning a 78 year old female who on 19-OCT-2007 was vaccinated IM with a zoster vaccine live (Oka/Merck). It was reported that the patient could not sleep and was concerned. The patient had no symptoms at the time of vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning a 69 year old female who on 19-OCT-2007 was vaccinated with a first dose of ZOSTAVAX vaccine (Merck) (Lot # 658604/1088U). It was reported that the patient could not sleep and was concerned. The patient had no symptoms at the time of vaccination. Additional information from the pharmacist indicated that no adverse event occurred. Additional information is not expected.
Terrific headache/bad headache; I got sick last night with nausea; I got sick last night; Feel running fever and right now at 99.2; hot burn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Aug2021 08:45 (Lot number: LD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "low immune system" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0164), administration date: 27Jul2021, for COVID-19 immunization; Pneumonia shot 13, for Immunization, reaction(s): "I had no side effect for the pneumonia shot". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Terrific headache/bad headache"; NAUSEA (non-serious), outcome "unknown", described as "I got sick last night with nausea"; ILLNESS (non-serious), outcome "unknown", described as "I got sick last night"; PYREXIA (non-serious), outcome "unknown", described as "Feel running fever and right now at 99.2"; FEELING HOT (non-serious), outcome "unknown", described as "hot burn". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, nausea, illness, pyrexia, feeling hot.  Additional information: The patient got the shot that day about 8:45, somewhere around there the patient started having terrific headache and got sick last night with nausea, felt running fever and right now at 99.2. The patient was in bed. The patient wanted to know if that was normal. The patient had a low immune system. The patient was running fever right now, got a bad headache, had nausea since last night off and on and hot burn and the patient's head just felt, head hurt but head felt little relaxed. The patient took Tylenol for headache and fever, extra strength. The patient had some lab test done about 2 or 3 week ago.  No follow-up attempts are possible. No further information is expected.
Menstruation- onset approximately 3 weeks early, heavier than normal for first 2 days. Accompanied by severe cramping in lower left and right abdomen, loss of appetite and nausea. Day 3 of menstrual cycle today, now only spotting but severe cramps and loss of appetite and nausea continues.
Sore upper arm at injection site. Arm was slightly sore the day of my original vaccination (3/30), and got worse the next morning. By the evening of the 31st, most pain had subsided, and was completely gone on the 1st. Around the 10th of April, i noticed slight soreness at the injection site once again, which lasted until today, 4/15.  Most soreness is now gone after today.
Huge welp with approx. 50-100 small Blisters which leaked yellow fluid from them and became raw open sore with burning skin. I use triple antibiotic ointment but made it worse.  Took Benadryl. This is the 5th day and it is not healed as of yet.
After administration of Td and Tb medicine for test, RN left room only to hear noise and returned to find client lying on floor between chair and desk, body stiff, hands positioned in fist and pulled back. Heart rate rapid and weak BP (99/50) and pale. Revived quickly with ammonia inhalant. Mother stated client had eaten on grapes at noon and client required juice.
POST VACCINE ADMIN, PATIENT REPORTED HE FELT LIGHTHEADED, QUEEZY, STARTED TO GET TUNNEL VISION. REPORTS HE ATTEMPTED TO GET UP AND LEAVE, AND STARTED TO PASS OUT, COULD NOT REMEMBER IF HE LOST CONSCIOUSNESS, HAD UNWITNESSED, UNASSISTED FALL TO FLOOR, REGAINED AWARENESS, AND GOT SELF BACK IN CHAIR, NOTEABLY DIAPHORETIC AND PALE. STAFF ASSISTED PATIENT BACK TO FLOOR AND RAISED LEGS IN AIR. ASSISTED TO STRETCHER AND PLACED IN TRENDELENBERG, TAKENE TO OBS. STATES RELIEF ONCE ON STRETCHER. ORTHOSTATIC HOTN NOTED ONCE STANDING WITH DIZZINESS REPORTED, ASSISTED BACK TO STRETCHER AND SNAKC/WATER/JUICE PROVIDED. R KNEE ABRASION/BRUSHBURN NOTED FROM FALL, CLEANSED BY ON SITE MD, NO OTHER INJURIES NOTED OR REPORTED BY PATIENT. ONCE S/S RESOLVED AND BP MAINTAINED IN STANDING POSITION, PATIENT ESCORTED TO EXIT WITH NO ISSUES AT 0955.  PER ON SITE MD, CLASSIC VASOVAGAL REACTION, RESOLVED. 0936 LYING BP 106/73 HR 70 RR 18 SATS 100% RA 0940 SITTING BP 118/73 HR 65 RR 18 SATS 100% RA 0942 STANDING BP 110/66 HR 71 RR 18 SATS 100% RA; REPORTS SOME DIZZINESS RETURNED, SAT BACK ON STRETCHER 0948 STANDING BP 98/67 HR 74 RR 20 SATS 100% RA; ASSYMPTOMATIC 0950 STANDING BP 88/58 HR 70 RR 18 SATS 100% RA; REPORTS MILD DIZZINESS BUT IMPROVING 0954 STANDING BP 109/72 HR 75 RR 18 SATS 100% RA; REPORTS S/S RESOLVED, AMBULATING WITH STEADY GAIT AND REQUESTING TO LEAVE, NO FURTHER ISSUES.
shot did ache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot did ache). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she would not know and stated that the immunization shot did ache for a couple of days though. The follow-up could not be possible as no contact details were available.
Hands paralyzed for 4-6 hours, 102.5 temp for 24 hours, delusional, splitting headach for 24 hours.  Tired on 3rd day
Skin itching, multiple hives all over the body - arms, legs, neck, back, waistline, and head.   Consistent rash and itching all over the body with hives - redness, bumps etc.
Hospitalized (1.21.22-1.25.22); COVID-19  positive (1.21.22); fully vaccinated PLUS booster Admission Date: 1/21/2022 Discharge Date: 1/25/2022 Discharge Disposition:  Home without services Active Issues Requiring Follow-up:  CVID: Obtain IgG level on 1/30, goal trough > 1000, results cc'd to Doctor COVID Pneumonia: finish 10-day course of Decadron Superimposed Pneumonia: fungal serology results pending DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Severe sepsis (HCC) [A41.9, R65.20] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID [U07.1] HOSPITAL COURSE: The patient is a 22-year-old female with past medical history of CVID, Kabuki syndrome, and epilepsy presenting with a 1-day history of fever, cough, and multiple seizures.  She was found to be positive for COVID on 01/21.  She was found to be hypotensive, tachycardic, and febrile and was given fluid resuscitation. Chest x-ray showed bilateral opacities with increased opacities on the right.  Procalcitonin was also elevated.  Empiric antibiotics were started for likely superimposed bacterial pneumonia, considering imaging findings, elevated procalcitonin, and patient's history of CVID. CT thorax was obtained which showed bilateral peripheral pulmonary infiltrates with no abscess seen. ID was consulted and recommended fungal serology. For her COVID pneumonia, she was started on remdesivir.  On 01/21, during the night she became hypoxic and required 2 liters nasal cannula.  She was then started on Decadron. Blood cultures were negative. Her respiratory status improved to needing 1-2L NC while sleeping. She also had improvement of her CRP. On 1/23 she did have a seizure that lasted 30-60 seconds witnessed by her mother, who stated that it was similar to the seizures she regularly has at home. She was kept on her home seizure medications with aggressive electrolyte repletion. Due to her immunodeficiency and risk for decompensation, she was kept under close monitoring inpatient while completing her 5-day remdesivir/antibiotic course. She was able to be weaned off of oxygen with no need for oxygen supplement at home.    She was then medically stable for discharge. Follow-up with her PCP was relayed to the patient's mother at bedside and patient's mother voiced understanding.
Mom states "has #2 HPV 1 mo. after HPV #1". Since then c/o belly issues, fatigue - however appt in Aug '14 day rec'd HPV #1 child and parent c/o belly issues and fatigue now mom claims this all happened after GARDASIL #2.
This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a male patient. Weight: not provided; Height: not provided. Drug history included influenza vaccine (non-Seqirus brand, previous year) (reaction: aching in left shoulder/aching left shoulder blade, aching neck, pain radiated from upper chest, left arm could not be raised above shoulder, low grade fever of 99, lethargy, aching clavicle, pain shoulder joint). Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date four days after injection, the patient started aching in left shoulder, left shoulder blade, neck and clavicle (outcome: not reported). Pain radiated from upper chest, shoulder joint, shoulder blade and neck (outcome: not reported). Left arm could not be raised above shoulder (outcome: not reported). Pain scale was 5-6 of 10. Low grade fever of 99 and lethargy was present for 3 days (outcome: not reported). Ibuprofen was used to lessen symptoms. Reporter comments: The healthcare professional considered all events non-serious.
Within 8 days of vaccine began experiencing tingling in fingertips and palms/numbness in fingers both hands. Has become increasingly worse. Numbness spreading to forearms both left and right. Cannot judge grip, drop items in hands. Feelings of pins and needles constant. Triage nurse made appointment for urgent care due to bilateral tingling  which led to visits to Orthopedics;Orthopedics sent to  Blood test show low b12 rating of
Right after vaccine administered bled a small amount and then swelled to a small hard lump. Pt waited in store for 35-40 minutes and looked to have sore arm. Pt only had local rx. After 3 hours- we called pt and swelling was going down.
CHILLS, MYALGIA, ERYTHEMA/SWELLING AT INJECTION SITE Narrative:  SYMPTOMS LASTED 36-48 HRS;  EMPLOYEE MISSED 2 DAYS OF WORK  Other Relevant History:
This case was reported by a lawyer via a statement of injuries, and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose(s) of LYMErix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, joint swelling, headaches, flu like symptoms, possible memory loss, insomnia, rashes, fatigue, tingling in extremities, muscle pain, chills, sweats, vision and hearing disorders, and decreased activities of daily life. The statement of injuries further alleged that the subject also experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMErix including but not limited to those set forth above". At the time of reporting the outcome of the events were was unspecified. Follow up information was received on 30 April 2008 via medical records. On 09 March 2007, the subject experienced injury of the right shoulder and left knee, which was aggravated on 19 April 2007 by lifting a washing machine. Upon initial examination on 29 June 2007, he complained of a pain level of "6" in his lower back and front left leg, with back injury secondary to a fall and/or an "old" motor vehicle accident. It was noted that he had failed prednisone, and medications at that time included Percocet, Ambien, and Motrin as well as propanolol. He also reported a history of tachycardia and a hearing deficit in his right ear, and indicated "MRI reported to have (positive) findings". Percocet was continued for back pain, and he was referred to an orthopedist for knee pain. On 11 September 2007, he was evaluated for a migraine and a four to six week history of joint pain, as well as a history of Lyme disease. He reported that the headache and joint pain were similar to Lyme disease, and Assessment included Lyme disease myalgias and back pain. The subject presented on 31 January 2008 due to neck and shoulder pain. He reported that he had run out of Ambien, and experienced significant insomnia without it. He had discontinued Lyrica, which he had received for treatment of fibromyalgia, due to intolerability. Current problems included hearing loss, as well as tachycardia and benign hypertension. He received a refill of his prescription for Ambien. The event of hearing loss was assessed to be medically significant by GSK. The events of tachycardia and benign hypertension were assessed to be incidental findings upon medical record review.
"hurt to raise the arm"; "soreish arm"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm"). At the time of the report, MYALGIA ("soreish arm") and PAIN IN EXTREMITY ("hurt to raise the arm") outcome was unknown. Not Provided          No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.
At around 6:00 on January 14, 2021 I felt a little tight in chest/throat. The next morning I was very tired. I did run a very low-grade fever.  On the 17th I also had a very bad headache and nasal congestion. Because I am immune compromised, I took rapid  Covid test on the 17th.  prescribed the Moderna vaccine pill Molnupiravir taken for 5 days. It certainly kept things under control. The first day or two on it, it made me a touch lightheaded.  After 2-2 1/2 weeks I did go in for what I believe to be a sinus infection/Plugged ears. I was given Bactrim 7 days and did recover and feeling fine.
Pt felt itching on his right arm 10/3/16 late night when he was sleeping. He scratched his arm and developed rash on his right arm. Rash was about 6mm length when he came into the pharmacy. The rash diminished after he applied the pack over it. The rash was almost gone on 10/6/16.
Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling very tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Feeling very tired). At the time of the report, FATIGUE (Feeling very tired) had not resolved.            No Concomitant medications were reported No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable    This case was linked to MOD-2021-051713 (Patient Link).
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 07-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 had two temperature excursions; one of 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and other one of 888 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Developed syncope about 4 days after vaccination.  Developed concussion symptoms from hitting head.
Initial and follow-up information has been received from a physician and a nurse concerning a 5 year old male patient, who on 03-NOV-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot # 661662/1137X) on his right thigh. The physician reported that on 04-NOV-2008, the patient experienced cellulitis on the right thigh. On 05-NOV-2008, the patient was hospitalized. At the time of the initial report the patient had not recovered and was still in the hospital. In follow-up information the nurse reported that the patient was hospitalized from 04-NOV-2008 to 06-NOV-2008. On 04-NOV-2008, the patient was seen in the doctor's office, because of a red, hot and swollen rash on his leg. He was given AUGMENTIN, but the rash continued to spread. He was sent to the emergency room and was admitted because of the speed the rash was spreading. He was given IV antibiotics and cultures were negative for a reaction to varicella. At the time of follow-up report, the patient was at home and doing better. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 6 year old female patient with asthma and with no drug reactions/allergies. On 06-MAY-2014 the patient and her twin sister were vaccinated with PNEUMOVAX 23 (batch #: H018440, lot #: 0718AE, expiration date: 29-MAR-2014, dose, route of administration, anatomical location not reported) due to "high risk for asthma". Concomitant therapies included albuterol sulfate (manufacturer unknown) and FLOVENT. On 06-MAY-2014 the patient received expired dose of PNEUMOVAX 23. It was also reported that PNEUMOVAX 23 did not have any previous temperature excursions. On 07-MAY-2014, the patient experienced localized swelling and redness at the injection site. There was no laboratory tests performed. There was treatment with MOTRIN and KEFLEX given for the reported events. The outcome of localized swelling at the injection site and redness at the injection site was reported as recovering/resolving. The patient sought medical attention by visit in emergency room and then by follow-up office visit. The relatedness between the therapy with PNEUMOVAX 23 and the events of localized swelling and redness at the injection site were not reported. This is one of several reports from the same source. Additional information has been requested.
1. After I got the first shot, I began having itchy symptoms on my body.  2. After I got the second shot, for the first day, my symptom was nausea. The second day, my symptom was fever.  The third day, hives appeared. It has not gone. I have been taking medications listed below.  a. RA CETIRIZINE HCL 10 MG b. HYDROXYZINE HCL 25 MG c. FAMOTIDINE 20 MG Before I started taking medications mentioned above, my doctor prescribed me TRIAMCINOLONE 0.5% OINTMENT and LORATADINE 10 MG. Unfortunately, these two medications did not improve my symptoms.
covid vaccine breakthrough case  dose 1 Moderna 2/10/21  015M20A dose 2 Moderna 3/10/21  030A21A dose 3 Moderna 11/16/21  005C21A
Soreness of the lymph nodes on the left arm started the day after the shot received.  This morning area under arem was was still sore.  By the after the tenderness was subsiding.
2 month old infant received the above vaccines and within 2 minutes had very red legs and feet and began breaking out in hives to lower torso. Respirations were normal and child was crying. RN administered Epinephrine 0.05 ml IM and called 911. Ambulance came within 8 minutes of the call and took her to ER. Child was given a steroid and BENADRYL and sent home with a steroid per Mom. She followed up with her primary care MD on 07/23/19. He advised her to stay on the steroid for the full course. Feet were still red at the ER. All symptoms had resolved by 7/23/18.
This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 16-OCT-2017, the patient was vaccinated with an expired dose of ROTATEQ lot # M007125 with an expiration date 06-OCT-2017, 2 ml, orally for prophylaxis. Primary reporter denied any adverse effects occurred.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC)