chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 67 year old male with osteoarthritis, rheumatoid arthritis, hypertension and hyperlipidemia and no known drug reactions/allergies, who on 28-Feb-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of PNEUMOVAX 23 (Lot #651320/1008P). Concomitant therapy included LOTREL, LIPITOR, aspirin, METAMUCIL, cod liver oil a multivitamin (unspecified). On 28-Feb-2006 the patient developed redness, swelling, and pain in right arm after receiving the injection there. The patient had decreased range of motion in right arm and unable to fully grip with right hand. It was reported that no fever was present. On the evening of 01-Mar-2006, the patient experienced shaking chills and red blanching rash over his right anterior chest & abdomen. The physician is treating the patient with oral tapering prednisone. The patient's present status was reported as recovering. No product quality complaint was involved. Redness in right arm, swelling in right arm, pain in right arm, decreased range of motion in right arm, unable to fully grip with right hand, shaking chills in the evening and red blanching rash over his right anterior chest & abdomen were considered to be disabling. Additional information has been requested.
pt c/o of weakness in legs and heart palpitations. v/s initiated pt appeared to be tachycardic and hypertensive, monitoring continued , remained hypertensive and tachycardic. pt denied chest pain, blurry vision and headache. No improvement EMS activated. Pt handed off at 18:38 to EMS
STORAGE IN REFRIGERATOR (2 GRADE C - 8 GRADE C) UP TO 30 DAYS.  (VACCINE USED AFTER 10/16/2021)
Around 2 hrs after receiving the Vaccine I began suffering a very bad headache, severe nausea, vomiting, extreme fatigue and weakness, severe body aches, temp between 99 and 100F,  severe joint pain(more than normal for me)
Patient was given dose of 0.5 ml Im of Moderna Vaccine as booster dose.
Mom called to just let us know that patient's arm is still sore.  Mom states patient has to manipulate arm to actually find area where shot was given.  Hasn't really complained about it before today 6/25/01. No redness no fever noted, no swelling either.
Patient's Mom came in with her 12 yr old daughter asking for 1st dose Moderna Vaccine.  Our Nurse said she forgot about the minimum age required for Moderna Vaccine.  Nurse gave a 12 years old female Moderna Vaccine 0.5ml 1st dose today.
The person administering the vaccine gave a 0.5 mL dose of the Pfizer instead of 0.3 mL.
Redness, swelling, heat, mild itching, hardness at injection site Abdominal cramps, nausea, vomiting  Mild fatigue
This case was reported by an unknown source and described the occurrence of reaction gastrointestinal in a female subject of unspecified age who was vaccinated with Hepatitis A vaccine, manufacturer unspecified), Hepatitis B vaccine.  Concurrent medical conditions included celiac disease.  On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), unspecified dose of Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis A vaccine and Hepatitis B vaccine, the subject experienced reaction gastrointestinal.  A female subject with "a kind of" celiac disease reported that she was given Hepatitis A vaccine and Hepatitis B vaccine, which she believed were GSK bran vaccines.  The subject reported that she had some sort of gastrointestinal (GI) reaction.  The subject inquired about GSK vaccines and gluten content.  At the time of reporting the outcome of the reaction gastrointestinal was unspecified.
tested positive for Covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 4 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments:  The patient was reporter's husband. The patient received Shingrix on last Friday from day of reporting and on Tuesday tested positive for Covid. The patient wanted to know if Covid would affect the efficacy of the Shingrix vaccine. Additional Supportive Information: This case was linked with US2022AMR057938, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR057938:same reporter - reporter´s case
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 13-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the PNEUMOVAX had temperature excursions for 2220, 24, 96 and 48 hours with highest recorded temperature of 59.9F (15.5 Celsius), 47.5 F (8.6 Celsius), 47.2 F (8.4 Celsius) and 46.8 F (8.2 Celsius) respectively. The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
My arm was very sore to touch for a few hours after getting the 5th dose of the COVID-19 vaccine. I didn't have any other side effects during the first couple of days. Two days after getting my Bivalent when it got darker in the evening, I started to notice a flasher in my eye. It is a very thin crescent in on the outside of my right eye that flashes on and off. It is not as noticeable during the daylight. I was walking at night, and it was really noticeable that it was difficult to see. I was a little nauseous. It was a little like the Vertigo I have had in the past. It did not improve over the next couple of days and I was afraid I had a detached Retina. I went to an Urgent Care, and I was sent to the ER. I had floaters in my right eye as well while I was there. They were unable to determine the problem and they said my eye was too cloudy to tell. I went to the Ophthalmologist four days after the event started. He said I was at risk of Retinal detachment with my symptoms, but it is still alright. Risk of Retinal detachment. My Ophthalmologist advised that we observe the problem so I will go back to be checked in one one week and periodically after that. I can still see the little floaters after almost two weeks and I can see the flasher at night. I have trouble driving at night because there is a glare around lights at night.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium
Painful left arm within 45 minutes of shot.  Numbness and tingling started later that evening and was especially bothersome and painful the next morning, 10/10/08.  I said to my co-workers that I thought I was having a stroke.  Numbness in chest is significant.  Cannot feel collarbone area on left side.  Calf and thigh of left leg burn and tingle.  Ankles are numb.  Toes are numb, worse depending on foot/leg placement.  5/8/09 neurology records received DOS 10/17/08-3/13/09. FINAL DIAGNOSIS: Acute demyelinating encephalomyelitis (mild) Post-vaccination discomfort, numbness left shoulder. Numbness then spread to left arm, chest and leg. Diagonal diplopia and lightheadedness. Altered sensation to pinprick and light touch - left leg and anterior thorax. Left hip flexor weakness. New-onset headaches several months later. Intermittent arm and leg pain. Weakness noted left leg. Diplopia, hypertropia.
Muscle twitches in the injection site that happen spontaneously through the day still 2 weeks after receiving the vaccine.
sweats appeared with terrible itching; throat closing; sick over 1.5 weeks; nausea; weak; sore arm; day 2 woke up with itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 17Oct2021 as dose 2, single (Lot number: FH8027) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Anatomical site of injection: shoulder, Batch/lot number: 30130BA), administration date: 01Sep2021, for COVID-19 immunization, reaction(s): "Tired". The following information was reported: PRURITUS (non-serious) with onset 19Oct2021, outcome "unknown", described as "day 2 woke up with itching"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 20Oct2021, outcome "unknown"; ILLNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sick over 1.5 weeks"; HYPERHIDROSIS (non-serious) with onset 20Oct2021, outcome "unknown", described as "sweats appeared with terrible itching"; THROAT TIGHTNESS (non-serious) with onset 20Oct2021, outcome "unknown", described as "throat closing"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "unknown", described as "weak". Therapeutic measures were taken as a result of throat tightness.  Additional Information: Dose 1, administered on 01Sep2021, Anatomical site of injection: shoulder, Batch/lot number: 30130BA. Dose 2, administered on 17Oct2021, Anatomical site of injection: shoulder, Batch/lot number: FH8027. No Prior vaccination within 4 weeks. No Concomitant drugs. No Patient's medical history. Comments/Narrative: 1st Pfizer vaccine part A: No reaction, tired after 2 days. 2nd Pfizer vaccine part B: sore arm-day 2 woke up with itching. Day 3 very sore arm of well appeared with terrible itching. Day 3-night time throat closing urgent care said- don't come here- we cannot help you. Go where you got vaccine. Pharm at (facility name withheld) gave the Benadryl and took my report. Sick over 1.5 weeks and weak. Nausea 3 days.  No follow-up attempts are possible. No further information is expected.
14JAN97 c/o abd pain-vomited x 3;then noticed facial rash noted 15JAN97;some swelling lt side around that PM;pt to pvt MD 17JAN97 because of facial rash;
Entire upper arm turned bright red and very hot to the touch. Itched. Redness continued to spread and grow through Saturday evening. Went to ER Saturday evening and left with a diagnosis of cellulitis of the upper arm with a treatment plan of 10 days of antibiotics.
Patient reported feeling warm and flushed.  No obvious rash or redness. Given Benadrly po and observed by paramedic onsite for an additional 30 minutes.  The patient felt better and requested to go home.  Family member present to drive her home.
Patient is having ball like swelling at the injection site in the left arm.  Patient states that there is redness, tenderness and swelling.  Patient states that it started the night of the vaccination 8/12/2022.  Patient came back to the clinic today 8/15/2022.  Patient and MOC state that the swelling has gotten larger.  MOC states that they have tried ibuprofen and that has not helped.
shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 75-year-old patient (pt) of unknown gender. The pt's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in 2016, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at the pharmacy. Subsequently, on an unknown date, the pt was treated by a healthcare provider at the clinic for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): shingles/herpes zoster. The outcome of the shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
On 6/1/2021 patient presented to the Medical Center with C/O chest pain, diaphoresis, and nightmares during his sleep.  Physical exam revealed mild tachypnea.
Sudden onset of lower leg ( shin area) pain similar to a Charlie Horse. Lasted approximately 7 hours. Diarrhea for 2 days
Area of left leg knee to thigh red and swollen at DTaP, HIB, IPV site ice applied, Tylenol given.
Case number PHEH2016US032874, is an initial spontaneous report received from a consumer on 15 Dec 2016. This report refers to an adult male patient. Historical condition included stroke. Vaccination history included administration of seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) which caused dizziness and muscle aches (see case: PHEH2016US033492). Current conditions included cancer. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in Oct 2016. On an unknown date after vaccination, the patient experienced dizziness, was using cane to walk, aches and pains. The patient went to emergency room and was told had sinus infection. The patient received hydration in emergency room. It was reported that the dizziness started after receiving flu vaccine last season and became worse after receiving again in Oct 2016 (date unspecified). The outcome of the events dizziness, aches and pains was reported as condition unchanged and for other events it was not reported. The seriousness of the event sinus infection was not reported and for other events it was reported as serious (disability). The causality of the events was not reported.
Complete cessation of menstruation. Prior to vaccine patient had regular, consistent menses. After vaccine, as of time of reporting menses has been absent for eight months.
BLOOD CLOT IN THE LUNGS; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported that 'JJ shot gave him blood clots on his lungs'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220212243-COVID-19 VACCINE AD26.COV2.S-Blood clot in the lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt recvd 2-1cc injects of Recombivax 28NOV90 & 29DEC90; 30MAY91 recvd Engerix-B pt "did not develop immunity";
1st Pfizer vaccine 10/15/21 few days after 1st vaccine palms developed tiny almost blisters mainly right hand intense itching sensation i notified occupational health and was still advised i had to receive second vaccine in order to be compliant 2nd Pfizer vaccine 11/5/21 my hands continued with reaction to the point my skin started peeling off the intensity of pain became so unbearable i had a heartbeat in palm of hand unable to sleep called in to work at 12/20/21 to seek help went to dermatologist 12/20/21 he prescribed steroids and was unfamiliar with covid vaccine side effects and thought perhaps it would subside with steroids or possibly psoriasis at the same time my right knee swelled however no injury .fast forward another dermatologist stelera did not help currently skyrizi has not helped today my palm has never healed severe painful cracks it limits my daily functions had biopsy and is palmar psoriasis which is life long . i was referred to rheumatologist by orthopedic my large right knee effusion seen on MRI and x-ray 70-80ml of fluid was drained/collected rheumatologist stated i had psoriatic arthritis which is life long. I expressed my concerns for exemption prior to vaccine since I had two autoimmune diseases and Dr. our hospital physician deemed that I be vaccinated and even the second vaccine after expressing reaction concerns. Since this Vaccine my quality of life has dramatically changed pain, physical, emotional, not to mention this will never go away.  I have tried topical cream ,oral steroids', anti inflammatory ,biologics ,have had biopsy's x-rays lab work MRI seen orthopedic rheumatologist and dermatologist along with regular doctor. Im in Healthcare i need my hands and this puts my self at risk for infections with open cracks let alone using my right hand is painful.
Very bad extreme headache firts day slept for hours had. a headache for 2 days.  4/13/2021 Lost feeling in my arm where vaccination was administered lost feeling leftside of face and left foot asleep for about an hour.
Prolonged, Atypical Febrile seizure.  Transported via Ambulance to emergency room.
Insomnia - hard to fall asleep; hard to stay asleep; wake too early; constant exhaustion; periodic dizziness; diminished appetite; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy on an unknown date. Concomitant medications included biotin (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D), curcuma longa (TURMERIC) and silicon dioxide (VIVISCAL); all from unknown dates for unknown indications. The patient previously took Diflucan on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 16:00 the patient experienced insomnia - hard to fall asleep, hard to stay asleep, wake too early, constant exhaustion, periodic dizziness diminished appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with Trazadone 50 mg. The clinical outcome of the events insomnia - hard to fall asleep, hard to stay asleep, wake too early, constant exhaustion, periodic dizziness diminished appetite was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
About 2 weeks post 2nd vaccine; Left deltoid pain radiating through axillary into left breast. Constant left pain/discomfort
The night of the vaccine, 11/02/2021 @ 2:00 AM  I a got really bad headache, nausea,  vomiting . The next day, 11/03/2021 was horrible. I had  fatigue the headache got worse and I pretty much stayed in bed all day.  11/03/2021- I called my doctor, she wanted me to go to the ER and get evaluated and get fluids for the headache. I went to the ER, they did not do any test or labs; they did not do anything. It was a waste of my time. The ER is not informed and not understanding this type of headache from the booster. They tried to treat it with a cocktail that I was allergic to.  I have  never had a headache like this before.  The headache is incapacitating. I am treating it with Tylenol, which is not helping. These headaches from the vaccine are different from migraines or other headaches. I don't get migraines. I never had a headache like this. I am wearing a hat, because it relieves the pressure a little. I feel if I take off the hat my head is going to explode.  If I lay down flat , if I turn my head in any speed, any motion I get dizzy. I get nauseous. It's just a vicious cycle.
HIGH FEVER; EXTREME FATIGUE; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin and aspirin allergy, alcoholic, non smoker, and reye's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 21:30, the subject experienced high fever. On 10-APR-2021 21:30, the subject experienced extreme fatigue. On 10-APR-2021 21:30, the subject experienced sore arm at injection site.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F.  Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, and extreme fatigue on 12-APR-2021, and had not recovered from sore arm at injection site. This report was non-serious.
Patient admitted 7/12/2021 for dysphagia, vaccinated 6/10/2021, tested positive for covid 7/13/2021 Discharge 7/20/2021  Vaccinations: 1st Moderna dose 4/24/21 Lot # 046B21A and 2ND dose Moderna on 6/10/21 Lot #027C21A  Chief Concern, Brief History of Present Illness, and Hospital Course 53 yo gentleman presented with abdominal pain with long standing h/o gut dysmotility. He also tested positive for COVID but was asymptomatic. GI was consulted and his bowel regimen was modified (lubiprostone was added) and he had good response with resolution of his symptoms. He was than discharged to home in stable condition with new Rx for lubiprostone (Amitiza).  He also has a chronic indwelling foley catheter and UA and Urine Cx was positive with no evidence of infection and no LUTS. He was started on antibiotics initially and have been stopped on discharge as he never had any symptoms.  Patient's amitriptyline was also decreased from 50mg to 25mg and suggest titrating this medication as an outpatient to discontinue.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 7/23/21 and the second dose of Pfizer COVID-19 Vaccine on 8/13/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
tired, headache in back of head, dizzy, warm chest, hypertension, evaluated by EMS, transported to ER