chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of GARDASIL, oral ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot # and expiry unknown) between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse events reported. This case is linked to 1403USA008919, 1403USA008920 and 1403USA005434 (same reporter link). Additional information has been requested.
Twenty-Four Hours after the vaccine I experienced severe headaches, muscle aches, and fatigue including fever 101-102, reducing to moderate levels after 6 hours but persisting for 7 days.  Symptoms varied in  severity over days but significantly impacted ability to work.
Information has been received from a doctor of pharmacy student concerning a 28-year-old female, with no pertinent medical history or allergies, who on 19-DEC-2006 was vaccinated intramuscularly with a dose of hepatitis A virus vaccine inactivated. Concomitant vaccination given on the same day included a dose of DTaP (manufacturer unknown). Concomitant therapy included Ortho-Cyclen. On 22-DEC-2006 routine blood work was performed as part of a complete physical exam. All results were within normal limits except the thyroid stimulating hormone value was elevated to 7.02. Unspecified medical attention was sought. Follow-up is planned with the healthcare provider. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
The patient received her second dose of  Covid-19 vaccine today at 10:18am. At around 10:43 am, the patient started to feel tingling of her tongue.
Site reaction started an hour after leaving appointment. By the next day (5/1/18) per mom the area was very red and warm, with potential for cellulitis if left untreated. No fevers. Normal activity otherwise. Mom came in to have it checked, and NP prescribed KEFLEX x 7 days and gave child 5 mg dexamethasone in Ibuprofen (3.75 ml) as preventative measures.
Patient reports she had some arm pain after the shot, and later developed a flu-like illness with symptoms of chills and body aches. Then about 5 days after the shot, she developed a generalized itchy rash
This is a spontaneous report received from contactable consumer or other non-HCP (parent). A 17-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FE3592), at the age of 17, on Sep 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the flu shot for immunisation, reaction(s): swelling at the injection site; spot gets hot-to-touch. The patient experienced insomnia (couldn't sleep until 4 am), onset Sep 3, 2021, with outcome of unknown. The reporter's son has not had a flu shot in over 6 years. He will swell at the injection site and the spot gets hot-to-touch. He did not, however, have those problems with the COVID-19 vaccine. He stayed at the vaccine van for probably 30 mins to 1 hour. He had no signs of an allergic reaction. He tried to take the flu vaccine without the preservative. The only one he could take was the one that injects into the nose, but they since eliminated that one. That's why he stopped getting the flu vaccine because it got worse year to year. He even tried to take Benadryl as a preventative for anaphylaxis to counteract an allergic reaction to the shot. No follow-up attempts possible. No further information expected.
Within a few hours of shots, he began crying and cried almost non-stop for 4 hours.  Was given po codeine for pain from ER
Within 5 hours extreme soreness at injection site progressing to limited range of motion of right arm. Pt. went to bed woke up about midnight with severe body aches, primarily on right side of neck and right side rib cage. Pt. had severe sweats and body chills for most of night. Experienced generalized fatigue for next 3 days.
8 days later from receiving the vaccine a hot red patch appeared on my arm. Itchy and tender to touch.  I had the same reaction the next day from receiving the vaccine. I got the vaccine on friday 03/19 and I had a hot red patch saturday 03/20 and sunday 03/21 and my arm was very sore.  Starting Monday 03/22 no side effect and no pain until today Saturday 03/27 around 8pm. I felt a shooting pain and when I uncovered my arm i had the hot red patch which it started itching  and is tender to touch
Developed delayed cutaneous hypersensitivity "Covid arm"; Rash on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection). At the time of the report, VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided
About 48 hours after receiving below two vaccines, daycare noted upper right arm was red. Ice applied and improved. My exam reveals very healthy one year old with about 3cm area of non-tender erythema with central induration upper right arm.
Later that evening I started shaking and I ran a low-grade fever of 99-100. I had scalp pain which was the worst, and my hair is falling out and dermatology confirmed that. The shaking was horrible. I'm also getting these blood rushing feelings like my blood is too thick and it's rushing through certain veins and there's a vein on left side of head and I feel it rushing through. I have pain in leg, and I take an aspirin just to be on the safe side. The scalp pain is horrendous, and it hurts to touch the top of my head. The shaking stopped and that was a full week of shaking. I got COVID-19 3 weeks after the 2nd dose as well and tested positive on October 17, and those COVID-19 symptoms started 7 days prior to testing positive and those symptoms were fever, shaking, body aches and pains, sore throat, and an additional cough to the one I already have, a headache, and I smelled ammonia constantly and I would try to eat meat and it smelled like ammonia. After I tested positive for COVID-19, it was a week before my symptoms stopped. The only thing I still have is the blood rushing feeling in veins and the scalp pain. I don't know how to explain the scalp pain, but my doctor did give my fluocinonide ointment to put on my head. I had COVID-19 previously from November 2020-January 2021.
I got the vaccine on Jan 5th. Felt fine that night but the next morning I had an inflammatory response. Every area of my body that I've injured as an adult was swollen and sore. My jaw where I had my wisdom teeth removed last year, my knee that I had surgery on about 2 years ago, any part that had previously had been injured. That night I was tired but felt back to normal on the 7th. On the 13th I went to the gym and did upper body and that night I started to have a reaction at the injection site. On the 14th my arm had swelled significantly and turned bright red, I went to our health clinic and was put on steroids to calm things down. I think exercising my upper body a week after the shot made me have that reaction, like exercising the muscle made the vaccine secrete faster or something.
The patient received a 1st Moderna shot in the community at a temporary immunization clinic.  He was not able to complete the series with the temporary group.  He has since not been able to find a moderna shot to complete his series.  Due to the unavailability of the same product either on base or in the community at the moment, we completed his series on 04/07/21 with the Pfizer vaccine; both us (the clinic) and he (the patient) knowingly completing his series with a different product.   This form is being filed as a requirement of the CDC.
she had tiny little blisters on the inside of her elbow; soreness; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Mar2021 (Lot number: EN6207) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BLISTER (non-serious) with onset Mar2021, outcome "unknown", described as "she had tiny little blisters on the inside of her elbow"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "soreness"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue". The events "she had tiny little blisters on the inside of her elbow", "soreness" and "fatigue" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, pain, fatigue.  Additional Information: It was stated that patient had tiny little blisters on the inside of her elbow at first after her 1st shot of the Pfizer Covid vaccine . Caller stated that the blisters began after she had the first dose of the vaccine in Mar and thinks her dose was on 25Mar or 26Mar2021; states she was thinking by the first week in Apr which was the last time she went off the medication and tried all through the summer to go off of different things and started with steroids and got off those after a month or two and everything came back like the soreness and fatigue and she noticed it started taking a long time to come back and she is getting less of it. Caller stated she can't remember the date of her 1st dose of the Pfizer COVID Vaccine then clarified it was on 19Mar2021. There was no prior Vaccinations (within 4 weeks):  She did knew that her dad had a reaction and it also may be genetic or not but her dad had the reaction that was different but it was a reaction to the Pfizer Covid vaccine also given at the same place as the caller had her vaccine administered.   No follow-up attempts are possible. No further information is expected.
positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), on 15Feb2021 as dose 2, single (Lot number: EM9810), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "oversized bladder" (unspecified if ongoing), notes: oversized bladder; "diabetes" (ongoing); "Blood pressure high" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Reflux" (unspecified if ongoing), notes: Reflux; "Memory Issue" (unspecified if ongoing), notes: Memory Issue. Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus; ARICEPT taken for memory impairment; METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]; LIPITOR; SERTRALINE taken for anxiety; FAMOTIDINE taken for gastrooesophageal reflux disease.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) looks good, notes: every 6 months; SARS-CoV-2 test: (24May2022) Negative; (26May2022) Positive; Vital signs measurement: (2022) Okay. Therapeutic measures were taken as a result of covid-19.
Both eyes became severely red following the injection with it covering the full eye.  In addition, developed significant throat irritation.
pt recv vax 24AUG95; intense volleyball game-very intense emotion status 25 & 26AUG; broke out in hives 26AUG95 over chest, abd & buttocks; took APAP & advil; s/s gone by 27AUG95 noc;
Narrative:  An 80yo male with PMH of Parkinson's Disease, Congestive Heart failure and Atherosclerosis of Coronary Artery without Angina Pectoris Per nurse's documentation - he received Pfizer's Covid -19 vaccine first dose on February 22, 2021 per policy and protocol , without complication No ADE was reported The system shows the patient passed away on March 19, 2021 March 22, 2021 documentation by admin officer of the day does not include the cause of death
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source.
Redness, swelling at injection site, irritation but no itching for 3-4 days. No fever. Red spots stay for 9 days.
Bilateral hands itching followed by raised nodules in the wrist area then all over body leaving dark marks.
Additional micronodule in the mid aspect of the left upper lobe, a left upper lobe micronodule posteriorly, and a punctate micronodule mid aspect of the left lower lobe superior segment.; This is a spontaneous report from a contactable consumer (pfizer colleague) reporting for the patient. A non-pregnant adult female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 23Mar2021 as a single dose for COVID-19 immunisation. Medical history included hypercholesterolemia and on 20Jan2021, lung nodule identified which was ongoing at the time of the report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 04Mar2021 as a single dose for COVID-19 immunisation. On 02Sep2021, the patient underwent lab tests and procedures which included a follow-up computerized tomography (CT) scan for a pulmonary nodule that was identified prior to COVID-19 vaccine on 20Jan2021. On 06Sep201, test results were received by the patient that revealed an additional micronodule in the mid aspect of the left upper lobe, a left upper lobe micronodule posteriorly and a punctate micronodule mid aspect of the left lower lobe superior segment. No additional pulmonary nodularity was identified and the original nodule identified on 20Jan2021 was unchanged. No other abnormalities noted. The patient was not symptomatic. The adverse event did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021 the patient underwent COVID-19 test via nasal swab and the results were negative. The clinical outcome of the event additional micronodule in the mid aspect of the left upper lobe, a left upper lobe micronodule posteriorly and a punctate micronodule mid aspect of the left lower lobe superior segment was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Itchy at the point of injection; Slight rash at the point of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at the point of injection) and VACCINATION SITE RASH (Slight rash at the point of injection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the point of injection) and VACCINATION SITE RASH (Slight rash at the point of injection). On 27-Jan-2021, VACCINATION SITE RASH (Slight rash at the point of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the point of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information added on 24JUN2021 contains non significant information. Patient had concerns about the form and how to provide more information if needed.
pt devel fever, had aching & felt warm;pt got too chilled in freezing weather;had some rash;devel arthritis from sacroiliac on down whole rt leg;had some trouble there for a month;took OTC drugs for arthritis;
Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.   No known health complications.
Patient reported some nausea the next day and pain in her shoulder. On 8/14/20 she received a 5 day course of prednisone. She said there had been some improvement but on 8/20/20 it seems to be worse. She has limited movement of her shoulder and some tingling in her arm. She will continue to seek medical treatment.
Vomiting @ 630PM on 8NOV91, diarrhea, myalgia, dizziness, general weakness, soreness @ site of inject for 2 days;
1st dose Apr2022, 2nd 14nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2022).   On 14th November 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment:  A pharmacist reported that the patient received late 2nd dose. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose later than the recommended interval, which led to drug dose administration interval too long.
sore arm (side of the injection); itchy rashes; could not lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm (side of the injection)), HYPOKINESIA (could not lift her arm) and RASH PRURITIC (itchy rashes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPOKINESIA (could not lift her arm). On 09-Feb-2021, the patient experienced RASH PRURITIC (itchy rashes). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm (side of the injection)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 09-Feb-2021, PAIN IN EXTREMITY (sore arm (side of the injection)) and HYPOKINESIA (could not lift her arm) had resolved. At the time of the report, RASH PRURITIC (itchy rashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Non significant follow up received on 19-JUN-2021, no new information
Information has been received from a consumer concerning her daughter who in 2007 was vaccinated with a dose of GARDASIL. On an unspecified date the patient had been diagnosed with HPV type 16. It was unspecified whether the patient sought medical attention. Upon the time of the report, the patient's present status was unknown. No further information is available.
Intense itching right side of face then moved to palmar surfaces. She then devoloped a macular-papular rash on her legs, then torso. Bottoms of feet itch at night. Pt was   RX'd  Prednisone and HYdroxyzine.
Fever (102) 24 hrs, (99.5) 2nd day  chills, achy muscles, sore arm with redness and swelling and rash around shot area, upset stomach, headache and tired.  Most gone after 48 hours except arm took a few days longer?about 4 days.  Took Ibuprofen
On Nov 5, while doing routine and simple yardwork, I experienced shortness puff breath, fatigue, tightness in the chest, and tingling in my left arm.  On Nov 6, went to urgent care facility; PA did EKG and found no heart abnormally.  He advised to go to ER if symptoms persist or get worse. Went to ER on Nov 8; blood workup, EKG, chest X-ray, and chest CT-scan with contrast showed no heart issues or blood clots in chest cavity.  Discharged from ER and instructed to follow up with PCP. On Nov 9, symptoms persisted, so I called PCP; was indicted to get COVID-19 test, which was negative then further instructed to go back to ER.  Second ER visit confirmed no signs of heat attack. Inducted to follow up with PCP.  PCP appointment on Nov 16 with EKG confirmed no signs of heart attack. Cardiologist appointment on Nov 17 diagnosed pericarditis.