chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 to 02-APR-2016, the patients were vaccinated with an improperly stored doses of VAQTA (pediatric dose with lot # L007559, expiration date 01-JUN-2017; lot# L028666 with expiration date 04-NOV-2016; adult dose with lot# L027735, expiration date 12-JAN-2017; lot# M009786 with expiration date 26-MAY-2017; dose, anatomical location and route of administration were not reported). It was reported that an improperly stored sterile diluent (lot# K023007 with expiration date 24-SEP-2017; lot# L017417 with expiration date 02-FEB-2018; lot# L015432 with expiration date 24-JAN-2018; lot# reported as L03221 expiration date was not reported; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 was verified to be an invalid lot# for sterile diluent. This is one of several reports received from the same reporter. Additional information has been requested.
Extremely painful shoulder pain started initially, then broke out in a rash over entire body. Wheezing on day 4, given a steroid injection and oral steroids x 5 days with Benadryl and hydroxyzine as well.   To dermatologist today and given triamcinalone ointment and other ointment for face. Rash continues today. Have been to urgent care 3 times and finally was able to see dermatologist.
Woke up with severe headache/migraine  6am 12/18/05 (forehead and behind eyes); to urgent care about 2pm 12/18/05; to ER 12/24/05 treated with Compazine and Benadryl by IV, given Rx for pillform; came down with flu 12/26/05 vomiting 6-8 times between 7:30 & 10am 12/27/05.  Saw Dr on 12/29/05 for migraines.
Arm blew up; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Arm blew up) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (booster) and flu. Past adverse reactions to the above products included No adverse event with Pfizer and flu. Concurrent medical conditions included Egg allergy.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm blew up). At the time of the report, LIMB DISCOMFORT (Arm blew up) had resolved.            Concomitant medications were not reported.  They put ice on patient arm and next day arm was okay. Treatment medications were not reported.
The patient had noticed moderate arm soreness starting the day following the immunization, and she stated it worsened going into the next day. She also stated that the same arm was feeling weak. It was tender to the touch, and she had at red spot at the site of the injection as well as 3 other red spots about 3 inches from the injection site that were about 1/2 inch each in diameter.
Patient is 74 years old female with PMX. of HTN, HLD, DM, obesity, RA came to hospital for Regeneron infusion, found to have hypoxia with O2sat at low 80's and was sent to ER without infusion Patient reported that 1 week ago she began feeling ill with cough and bodyaches. Yesterday she developed fevers and felt generally weak She has no report of chest pain, being lightheaded or SOB. She took a home COVID test yesterday and was positive. Patient was referred today for the infusion. While being triaged, patient was found to be hypoxic. There has been no report of vomiting or diarrhea.
Fever, rash face, neck, chest, legs, hands, sore throat, See attached office notes and Hosp D/C. DC Summary 11/18/-11/19/06. DC DX Streptococcal pharyngitis, leukocytosis, disorder volume depletion, dehydration. Chronic ITP with complaints of fever, sore throat rash and petechiae s/p splenectomy prior to vaccines
Swollen lymph node under left arm, about the size of a plum, no treatment.
3 days after booster, developed chest pain, elevated cardiac enzymes, elevated ESR & CRP, suspected vaccine mediated myocarditis
Pt woke with extremely sore upper right arm radiating down inside arm to hand some mild swelling no redness, no fever, pt had a hard time moving her right arm abduction and above her head, pt was evaluated next day / Pt applied ice, took Tylenol and Vicodin prn.  Some improvement 8/11 then reoccuring pain 8/12, not as severe as intial pain, pt did rest, ice, Tylenol and physical therapy started for prolonged muscle pain 8/24. Pt is 80% better at this point cont. PT and home exercises, no longer taking Tylenol or Vicodin, is continuing PT 1-2 times a week, no longer pain with most ADLs.
Pt received the first dose of Pfizer BioNTech Covid 19 Vaccine (LOT# EW0179, exp. 8/2021) at 1024. At approximately 1440 patient reported to ancillary staff  that she received the first dose of Sinovac Covid 19 Vacccine in on 3/21/2021. Situation elevated  to supervisors.  Patient advised to finish series and return for her second dose of Pfizer BioNTech Covid 19 Vaccine in 28 days.
Pt rec'd TD injec 29MAY91-pt called back on 6JUN & 10JUN to c/o lt arm being very sore & weak since inject;
The vaccinating nurse reported that within 15 seconds of being vaccinated the patient states she needed to lie down and then slumped with apparent loss of consciousness.  She was pulled to the floor by her companion, possibly hitting her head. She awoke, according to the nurse in about 45-60 seconds and shortly after was A&Ox4, moving all extremities. BP 127/84 P68 O2- 98%  She was placed on a board and transported to ED for possible head injury  The patient arrived fully alert and did not report previous episode of vasovagal syncope.  After she had the incident her mother stated she had had such an episode at age 10 with a vaccine.
Fatigue starting at 17:00,  lasting until 12:00 the next day. fever starting at 19:00, fever rose to 100.6 before taking Tylenol, did not return after medication wore off. Headache starting at 21:00, lasting until 12:00 the next day.
Left arm started itching a few minutes after injection,  slight redness appeared although only where patient had scratched.  Back also started itching no rash. Complained of burning sensation in legs.  Denies shortness of breath, difficulty swallowing, no swelling in tongue or throat.  BP- 124/79, p-93, O2sat-97% Given SL Zyrtec 10 mg at 5:30 pm.   Did notice slight decrease in symptoms within 10 minutes however symptoms persisting.  Given 50  mg IM Benadryl (RFA) at 5:40 pm .   5:44 pm- BP-112/73, p-85, O2sat- 98%  Discharged home with mother at 5:50 pm, given ER precautions- seek immediate care if shortness of breath, trouble swallowing, swelling or worsening in any way
Pt reports onset of dizziness, chest tightness, shortness of breath that started acutely 45 minutes to 1 hour after receiving her second Moderna vaccination on 2/24/21.  She reported that she was told by her employer that the symptoms were due to the Moderna vaccine.  She reportedly developed fever and some throat discomfort as well.  Symptoms became persistent and disrupted sleep and was unable to work.  She sought medical attention in the ER for persistent symptoms on 2/26/21.  Extensive workup was essentially normal.  She received Zofran, Decadron, IVFs, and Albuterol inhaler while in the ER.  She reported improvement in her chest tightness and SOB after Albuterol.  She was discharged home with instructions to f/u with her PCP in a couple of days for recheck.
Marked swelling, redness, induration of left arm around injection site and enlarging for 24 hours.
Pt recvd Hep B vax/MMR on 5AUG91 & on 26AUG91 devel rash on face & neck which persisted for 24 to 48 hrs; No further details were provided;
Recurrent sinusitis, recurrent headache, and persistently elevated blood pressure above baseline. Continues at date of reporting
Since the 2nd shot I have had racing, pounding vibrating heart and fluttering heart it has continued for months.  I have never experienced this before.  I have been through an EKG, Echo cardiogram, Stress test and am now scheduled for angioplasty surgery.  Prior to this healthy active 59 year old no issues.
unconsolable crying for 5 hrs; treated w/APAP w/resolution in 30";
Weakness persisting in her left arm continuing 12 days post administration. Initial pain greater than usual upon administration.
Headache, Myalgia, Arthralgia, chills, flushing Narrative: The morning after receiving the vaccine, patient reported having a headache, body aches, and alternating between feeling warm and cold. He took 650mg acetaminophen one time.
Redness, warmth, swelling, some pain within 24 hrs of vaccine (R) arm.
About 30 minutes with DTAP/IPV/Hib-HepB/Prevar baley, who immediately feel asleep with the shot, arrival at home. Parents found her to be limp and were not able to awaken her for aleast 2 minutes even than continued to sleep for most of that day.
Arm started to get sore in my muscles on front and back of arm. Pain in using and raising my arm. Pain is still present as of today Took Ibuprofen, tried BLUE-EMU. Some headaches not all the time.  I usually don't get headaches. Pain is from my shoulder to my elbow. How long are these systems suppose to last?  They do not subside and gets worse as I use my arm.  Hard to raise my arm shoulder high or above. Have not been to the doctor yet because I didn't think that there was anything to be done.
Dizziness and Vertigo~20 minutes after shot Nausea + Dizziness and Vertigo~30 minutes after shot  Nausea + Dizziness + itchy throat ~35 minutes after shot  Nausea +Dizziness +itchy throat + trouble breathing ~40 minutes after shot Nausea +Dizziness +itchy throat + trouble breathing + numbness in legs and arms ~43 minutes after shot  Nausea + Dizziness continued for 10 days with bouts of trouble breathing. Itchiness all over body started about 3 hours after shot. Continued for about 7 days, responded to small doses of benadryl.
The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JUL-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2016, the patient was treated by a physician for a severe vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 29-SEP-2016, the patient was inadvertently vaccinated with a third dose of PEDVAXHIB (strength, dose, frequency, route of administration, lot number and expiration date were unknown). There were no concomitant therapies nor adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Projectile vomiting and rectal fever of 101.7  the night of the vaccine. Crankiness and decreased appetite for about 4 days following vaccine. Hard lumps in thighs at injection sites which appeared to be painful and cause discomfort when touched.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported. No treatment information was reported.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 18-APR-2012, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route and site of administration, lot # and expiry date unspecified). No concomitant medications were reported. The nurse reported that the patient came to the office and would like to receive the second dose of GARDASIL on 30-APR-2015 (reported as "now"). No adverse symptoms were reported. Additional information has been requested.
p/vax pt devel rash on abd & back;had large whelp-looking spots although not raised;lasted 2-3 days;went away w/o other sx;no fever;
A-fib alerts from my fitness/health tracking device.; heart palpitations/Sleeping HR of 102-133; Left arm and chest pain.; Left arm and chest pain.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Jul2021 10:30 (at the age of 59-year-old) (Batch/Lot Number: GW0198) as dose 1, single for covid-19 immunisation. Medical history included gastritis. The patient was not pregnant. Concomitant medications included omeprazole magnesium (PRILOSEC) and colecalciferol (VIT D) which were her medications in two weeks. The patient previously took amoxicillin and experienced allergies.  The patient had no other vaccine in 4 weeks. On 18Jul2021 at 12:00, the patient experienced heart palpitations and a-fib alerts from her fitness/health tracking device, and left arm and chest pain. On 19Jul2021, the patient experienced sleeping heart rate (HR) of 102-133. There was no treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not covid tested post vaccination. Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt recvd 1st dose of Recomb on 25JAN91 & devel severe shoulder pain;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX "did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-SEP-2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
pt had a localized red rash around inj site of varicella then dissipated w/in 2min;
Profuse sweating, light headed, hard to hear, almost fainted within minutes of receiving the shot.  Was fanned, given orange juice and a cool towel. After 30 minutes I felt okay to leave the pharmacy.  Felt lightheaded the rest of the day and really out of it. Developed a fever later that evening that ran throughout the night.  Loss of appetite for 3-4 days.  Diarrhea on day 4.  Pain in arm at injection site for 4 days.
Administration error: gave 12+ age vaccine instead of the 5 to 11-year-old vaccine.
WAS LESS ACTIVE, SLEPT MOST OF THE TIME, COMPLAINED OF BACK PAIN ON THE DAY AFTER VACCINATION ON 10/22/2021; WAS FOUND UNRESPONSIVE/DEAD ON 10/24/2021.
neuropathy; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered neuropathy (neuropathy peripheral). As a result of these symptoms, she was seen and treated by medical providers and was still under their care. As a direct and proximate result, her symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient' condition. As a result, she sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for neuropathy peripheral was not recovered due to ongoing treatment.   Upon internal review, the neuropathy peripheral was considered a medically significant event.  The neuropathy peripheral was a disabling event.
Information has been received from a medical assistant referring to an patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 03-DEC-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot # 1586751, expiration date: 16-FEB-2021, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Maximum fever of 103.3.  Sweating, shivering chills, profuse  watering eyes and nose.
Extreme vertigo and headache  3 days after vaccine. I had headache, extreme fatigue, body aches, dizziness and chills for 24 hours after vaccine. Then felt ok. Work up on March 2 with extreme vertigo and exploding headache.
Neck pain, vomiting, stabbing head and stomach pain, dysplasia, loss of weight. agitation, numbness in arms and legs.
The day after the vaccined was administered, patient was unable to produce any saliva and inside of cheeks were red, swollen. This lasted 3 days. After that, patient experienced headaches, nausea, cough that stopped on 10MAR21. Patient had no symptoms of illness prior to vaccination on 24FEB21, on 04MAR21 patient tested positive for covid-19.
My first symptoms began two days after my second Pfizer injection and included lightheadedness, fatigue, and muscle cramping in my back and neck. Three days after my second injection I was experiencing nausea, vomiting and diarrhea. I could not successfully retain food, only clear liquids (solid food or liquid nutritional supplements were immediately vomited). By day seven my diarrhea was clear and/or mucous. By day eight and nine post second injection my diarrhea was a clear yellow tint and had pink colored tissue in it resembling grapefruit pulp and a little bit of blood as well. During this period I was experiencing intense stomach cramping that felt as if taking blows to the abdomen and also felt extremely light headed. When laying down it felt as if I were falling through the mattress and also felt an indescribable feeling of impending doom. I made a slow recovery after that and experienced intense abdominal pain and diarrhea if I exerted any significant energy or ate any more than small amounts of simple foods or drank any alcohol. I did not fully recover until about three months after receiving my second dose of the Pfizer injection.
p/vax pt exp rash; itching; T101 x2 days; cough x2days; gave atarax
diarrhea; bowel movement; cramping; fatigue; his left arm swollen; pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his left arm swollen), PAIN (pain), DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement) and ABDOMINAL PAIN (cramping) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL TARTRATE (LOPRESSOR), AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LOSARTAN POTASSIUM, ATORVASTATIN, DIAZEPAM (VALIUM), TAMSULOSIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain). On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. On 23-Feb-2021, PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain) had resolved. At the time of the report, DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 25Feb2021, he had diarrhea, bowel movement, cramping, he went 4 times to the bathroom in 4 hours and it is semisolid.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up information received on 28-APR-2021, added, patient requested no further follow-up On 11-May-2021: Follow-up information received on 11-MAY-2021, added Email ID. Patient stated that he is doing much better past 3 weeks. Outcome of all the events updated to recovered or resolved.