chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19 after first dose; Missed second dose (beyond 42 days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medications were provided. Treatment medications were unknown.
Patient received a flu vaccine at the 10/21/22 vaccine clinic. She felt pain at the time of vaccination from the site of injection to the tip of her thumb. Patient's mother, observed the bandage was placed at the top of Patient's shoulder towards the front of her body. Patient reported a dull pain when her arm was held down, was unable to wash or brush her hair and experienced pain worse with movement from her neck to her fingers Patient's mother took her to the pediatrician when pain was unrelieved by ibuprofen/naproxen and Patient lost the ability to place objects into her pockets. Patient's pediatrician diagnosed Patient with a syndrome caused by improper vaccine injection technique and referred her to a neurologist.
pt recvd vax; 3 hrs later, exp bilateral 7cm erythema; tx ice packs; resolved;
Child in school nurse office-phone call from RN- states "big wheel- she can put 4 fingers over to cover diameter-appears red raised - slightly painful to touch. States pain started 10-21-08 with stinging. Slept all day after school on 20th and ran low grade fever.
9-4-21 Within an hour of the vaccine, my left shoulder near the injection site was hurting. By the evening , the area of pain grew.  9-5-21 my arm hurt down to my fingers by 8 am. Around 6:09 pm, I felt tired. By 10 pm I was overwhelmingly tired and a headache was forming.  It?s currently about 1240am and I?m trying to sleep, but the headache is terrible and my left arm is very sore and burning. My temperature is normal for me, reading 96.9 F.
The morning following injection I developed a fever that lasted 3 days and reached 101 degrees F.   My left arm was sore, red and swollen. I felt light headed on day 2 and the soreness and swelling of my arm at the injection site had increased. On day 3 the fever was reducing and swelling and redness were at their peak.
Vertigo/room felt like it was spinning; foggy headedness; body aches; Headache; Dizziness; feeling disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DISORIENTATION (feeling disoriented), VERTIGO (Vertigo/room felt like it was spinning), FEELING ABNORMAL (foggy headedness) and MYALGIA (body aches) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIZZINESS (Dizziness), DISORIENTATION (feeling disoriented), MYALGIA (body aches) and HEADACHE (Headache). On 21-Apr-2021, the patient experienced VERTIGO (Vertigo/room felt like it was spinning) and FEELING ABNORMAL (foggy headedness). The patient was treated with DIMENHYDRINATE (DRAMAMINE) on 02-May-2021 for Adverse event, at an unspecified dose and frequency. On 21-Apr-2021, DISORIENTATION (feeling disoriented), MYALGIA (body aches) and HEADACHE (Headache) had resolved. On 22-Apr-2021, DIZZINESS (Dizziness) and FEELING ABNORMAL (foggy headedness) had resolved. At the time of the report, VERTIGO (Vertigo/room felt like it was spinning) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Maculopapular rash on body and extremities, itching. Treatment: ZYRTEC 10 mg, 1 tab PO daily, and BENADRYL.
From telephone contact received at manufacturer on 8/19/02, it was reported that 16 month old twin females with bat exposure on 8/10/02 received RIG and rabies vaccine on 8/14/02. Pt's mother reported that 30 hours after vaccination, pt awoke during the night, dazed, arms and legs flaccid for about 30-40 minutes and low-grade fever. Pt was vaccinated at hospital. From follow-up telephone contact to hospital on 8/20/02, additional info received: "One twin received RIG 180 units left thigh, rabies vaccine 1cc right thigh on 8/14/02, no lot # recorded. On 8/17/02, twins returned to ER for second injections of rabies vaccine. At 13:26PM, pt received 1cc rabies vaccine in right upper leg (lot U0595, expiration date 8/28/04). No adverse reaction reported on either twin. Mom is not sure if a bat bit children. The other twin received 180 units RIG in right thigh on 8/14/02 and 1cc rabies vaccine in left thigh on 8/14/02 and on 8/17/02 1cc rabies vaccine in right upper leg, same lot as sister U0595. Twins are to return on 8/21/02 to receive next doses. Hospital staff to inquire about the reported adverse event after the first dose and notify us with the information. Twins were to return on 8/21/02 for next series of injections, but as of 8/22/02, 16:00 had not returned. No hospital record for adverse event that mother has reported. Hospital was unable to confirm adverse event report."  Linked with case U2002-00646.
Patient began experiencing extreme fatigue, increased frequency of urination, numbness and tingling in fingers and toes. He went to a nearby Urgent Care. Labs were drawn on 5/29/2021. When patient returned to that clinic for follow-up on 6/16/2021, he was given his results of glucose level of 300 and hemoglobin A1c of 12.0%. He was started on metformin 500mg twice a day. He was also started on empagliflozin 10mg daily and dose was tapered up to 25mg daily two weeks later. Patient had repeat labs done at our facility on 6/30/2021: glucose 94, A1c 10.2%. Patient purchased a diabetes monitor. His glucose levels from 6/30 to 7/13/2021 showed his average daily glucose was now only 89 and patient had 10 episodes of low glucose (<70). His highest glucose level was 147 and he did not have any levels above 180. Patient was taken of empagliflozin, kept only on metformin, and will be followed up in 2 weeks. Prior to vaccination, patient had no hospitalizations, illnesses, or any steroid treatments. He is a very healthy, patient with a BMI of 26 who works out 6 days per week.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned 3 patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patients experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006371, 20211006668, 20211006798 and 20211009632.
The DTaP shot was given in the right leg on Friday.  By Sunday it was swollen twice the size as the left leg and extremely red and hot.  He was unable to walk on it.  Taken to clinic and they treated him with some steriods.  Leg is still swollen today but not red.
pink spot IS; Dizzy; Headache; "hot inside"; "cold outside"; "big red spot" IS; Itch "like hell" IS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ("big red spot" IS), VACCINATION SITE PRURITUS (Itch "like hell" IS), FEELING HOT ("hot inside"), FEELING COLD ("cold outside") and DIZZINESS (Dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (NO HISTORICAL CONDITION REPORTED.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN ("big red spot" IS) and VACCINATION SITE PRURITUS (Itch "like hell" IS). On 25-Feb-2021, the patient experienced FEELING HOT ("hot inside") and FEELING COLD ("cold outside"). On 28-Feb-2021, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (pink spot IS). At the time of the report, VACCINATION SITE PAIN ("big red spot" IS), VACCINATION SITE PRURITUS (Itch "like hell" IS), FEELING HOT ("hot inside"), FEELING COLD ("cold outside"), DIZZINESS (Dizzy), HEADACHE (Headache) and VACCINATION SITE DISCOLOURATION (pink spot IS) outcome was unknown.
she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "For the first two she felt a little tired", "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine"; Bnt162b2 (DOSE 3, SINGLE), for Covid-19 immunization, reaction(s): "she usually have body and muscle ache after getting the vaccine", "she usually have body and muscle ache after getting the vaccine". The following information was reported: PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "she usually have body and muscle ache after getting the vaccine / For the boosters she had body aches".  Additional information: Caller mentioned that she usually have body and muscle ache after getting the vaccine. For the boosters she had body aches. NDC number of COVID-19 vaccine was not provided. Other Products was not provided. She doesn't have high blood pressure or heart issues or anything.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
mild delayed inflammatory response; lumps in lips; A spontaneous report was received from other health care professional, via letter,  concerning an unknown age female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced delayed inflammatory response (inflammation) and lumps on lips (lip swelling).  The patient's medical history was not provided. History of application of lip filler (1 milliliter of Restylane kysse) to upper and lower lips on 08-Dec-2020. No relevant concomitant medications were reported.     On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, 6 days post  vaccination, per HCP the patient had mild delayed inflammatory response and lumps in lips. Treatment included Medrol pack and antihistamine for the reported events.  No laboratory data was provided.  Action taken with mRNA-1273 in response to the event delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not provided.  The outcome of the delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not recovered/not resolved.  No concomitant medications were reported. No treatment related information has been reported.
Felt itchy - skin rash developed night of 10/19/2009 - still dealing with rash and itchiness 10/21/2009.
Patient was in the clinic for her 4 y/o Well Child Check. Patient was supposed to receive ProQuad  and Quadracel. Instead of receiving Quadracel the patient was administered Gardasil. Staff member realized her mistake and informed manager and provider immediately. PCP looked at the vaccine side effects and documented information to provide to patient's parent. Staff, provider and manager called patient's mother and informed her of the situation.
Received Pfizer vaccine on 1/15/21 and 2/5/21. On 4/21/2021 developed loss of taste/smell, rhinorrhea, headache, sore throat, nausea/vomiting and fatigue. Tested positive for COVID.
After  first vaccine which was done on a Monday I became sick on Friday, by Sunday I was at the walk-in clinic getting tested for Covid.  Results were negative, but I was put on antibiotic for bilateral ear infections.  My symptoms were congestion, headache, ear pain, cough.  After my second vaccine I had terrible body aches, headache and fatigue.  After receiving the vaccines I have had a strange new pain in the muscles of my neck and upper back/ shoulder area.  It comes and goes, but is unlike any pain I have ever had, and be a quick severe pain that takes my breathe away.
Swelling, inflamed (hot), redness (5" diameter), hard lump at injection site. After about a week from injection, blisters appeared on leg (shin), forehead, groin, and has progressed to mouth and tongue. Also, stinging sensation around lips. The blisters come and go.  This has continued until April 3, 2013. Will they ever stop? I am using OTC Benadryl tablets and cream.
c/o p/vax 9NOV98 rt arm swelling w/pus @ site-black dot in center;arm tender & swollen @ site;had fever & temp all sx started approx 1-2 days p/vax;
Narrative:  He reports experiencing nausea and mild myalgia/headache s/p the first vaccination, which started around 4-6 hours after vaccination and resolved by the next day. Myalgia/HA were a/w OTC acetaminophen. He denied other common adverse effects including vomiting and abdominal cramping and did not try or apply other therapies.
Vaccine given on 26Jan12, day of deployment.  Seen by medical provider in deployed location on 24Feb12 where he reported having a rash on his right arm and flank that began 6 days after receiving the Anthrax vaccine and believed it was brought on by the vaccine. Given po prednisone for tx that cleared the acute rash.
104 degree fever, sore throat, bad cough, headache, leg muscle soreness.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 04-MAY-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a physician's medical office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a walk-in-clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Brain fog, inability to concentrate, left arm pain, left face tingling left arm paralysis, tia, blood clots, bilateral artery stenosis, vascular, cognitive issues
The site of injection stayed sore and red. The muscle below began to get hot and swelled to the size of a baseball within 2 days of the injection. The area remained hot and swollen for about a week. The area was the middle of the bicep,  about 6 inches below the injection site.
From the description by the patient: "I got really sick", pain from head to toe (3 days), congestion (nasal, continuing for 8 days), chills (2 days), cough (I still have it), pain all over my body and very strong in the legs, headache (5 days), alot of tiredness (I still have it), and pain in my neck (4 days).
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 54 years and 11 months old. The requested vaccination was reported as Pfizer-BioNtech COVID-19 (12 plus) vaccine. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that patient did not had any adverse reactions and there was no reactions after the administration of vaccines. No treatment medication were provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master case number
Itching and hives-like splotches  on left and right sides of arm, below injection site.
In 2004 the subject suffered significant depression with suicidal ideation. He admitted himself to a mental health facility for 4 days of treatment. In 2005 he began to experience anorexia with significant weight loss. He had a discharge from his penis, a bacterial infection of his prostate, an infection of his right saliva gland and a series of other infections. He improved in the fall of 2005 but became ill again in the winter of 2006 with anorexia and several more infections. He was referred to a endocrinologist an in Feb 2006 had a scan of his pituitary that was normal. In Apr 2006 he lost ten pounds in one week. He saw his physician and had a cortisone infusion stimulation test (results unk). In Apr 2006 the subject had chest pain, left arm pain and jaw pain. He was admitted to a hospital for 3 days for evaluation. Cardiac enzymes and angiogram results were normal. In Apr2006 the subject began to have hot and cold feelings and sweating. His endocrinologist told him that he had adrenal insufficiency. In May 2006 the subject had various blood tests (results unk). The subject has an appt scheduled at the clinic in June. The subject also reports that his testicles are shrinking and the he is weak. 60 day Follow-up Information 24-OCT-2006: No further information on this report. In the event that additional relevant medical information is received, a follow-up report will be submitted.
Had 4 yo booster 4/3/07 DTaP, MMR, Ipol 4/5/07 red welt warm to touch 4/6 seen in our office dx with local vaccine reaction Rec Benadryl and cool compress
Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that vial of COVID-19 vaccine was punctured on 01 Oct 2021 at 12 Noon. A dose of the vaccine was administered to a patient at 12:25 on 02 Oct 2021. It was reported that the vial was initially stored in the refrigerator on 27 Sep 2021.Date and time vial was first punctured at 12:00 on 01 Oct 2021.Date of administration of vaccine 12:25 on 20 Oct 2021. The vial was stored post puncture under refrigeration. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) about 2 minutes.  No concomitant medications were reported.  No treatment medications were reported.