chrisvoncsefalvay/vaers-outcomes huggingface dataset:
psoriasis; autoimmune disorders; She is losing her hair, the hair on the back of her wrist and arms are lost.; red rash all over face, head, ears, neck; back in hell; Broke out scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (back in hell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune arthritis.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced DISABILITY (back in hell) (seriousness criteria disability and medically significant), SKIN DISORDER (Broke out scalp) and RASH (red rash all over face, head, ears, neck). On an unknown date, the patient experienced PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders) and ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash on face, at a dose of UNK dosage form and ULOBETASOL PROPIONATE (LEXETTE) for Scalp rash, at a dose of UNK dosage form. At the time of the report, DISABILITY (back in hell), SKIN DISORDER (Broke out scalp), PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders), ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.) and RASH (red rash all over face, head, ears, neck) outcome was unknown.            Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-194580 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow-up added on 02-JUN-2021, Contact information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
At the time of the visit (6/21/17) Mom reported patient's left upper thigh looked more swollen and slightly bruised. Mom thought it may have looked that way before her 6 month vaccinations. No significant redness, bruising, sores, blisters noted with the exception of a firm area on her upper leg after one vaccine that resolved on its own. Mom could not recall which leg. No apparent pain, itching or distress by patient. No increase in fussiness or change in behavior. No recent fever, known trauma to area or sores on skin noted. Area was not hot to touch. Infant bearing weight well and using legs equally. Examination by physician noted left lateral midthigh localized area of decreased subcutaneous fat. Skin with faintly visible violacious vascular markings around the area. No palpable subcutaneous lesion. Non-tender area. Patient referred to dermatologist. His report, 8/18/17, states patient has lipoatrophy of the left thigh. He suspects that it is related to immunization, although it would be uncommon. Could be related to immunization and trauma. It is more common when it is given in fat (not muscle) especially in the buttocks; and may be more common in a child with more normal adipose. There is no specific treatment. Time may improve the appearance. Digital images were taken to monitor progress to insure no other process is going on. Follow up in 6-8 weeks time.
Body wide inflammation, muscular pain, heaviness, rash on lower back, squeezing chest pain, pain between shoulder blades, headaches, painful neck glands, fatigue, eye inflammation, and joint pain.
Itching, redness, swelling, bruising at the injection site.   Rash on the stomach, back, thighs, and hips, nausea, diarrhea, headache
Fever 102.3, Tylenol 1 gram every 8 hours x 2 days.  Reduced fever to 99.8. Headache, joint pain, muscle cramps, body aches.
1 of 8 pts (4-6 yr old range) seen /win the past wk /w severe local rxns, Pt had 3 X 3 inch area of redness, tenderness & warmth, also had low fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling freezing cold as they administer vaccine follow by sweaty hands and fingertips tingling. After I felt dizzy, my blood pressure increase, heart rate increase, light headache, my hands continue to sweat and fingertips cold and tingling. I felt a strange sensation on my chest (not pain but if I had ate and something got stuck on my throat and mid chest). Extreme anxiety, I wanted to run and get fresh air. A strange rash on my upper arms they looked like scratches.
Patient had developed rash band around arm (about 6 inches below where vaccine injection site was). Rash band was approximately 3 in wide. Patient reported rash appeared 24 hrs after vaccine administered. Also reported general headache and a brief period of shaking.
After covid vaccination I started having extremely heavy period to the point I could not leave the house.  I have never had blood clots before and started having tons of blood clots in my periods with heavy pain.   My periods have always been light for the past 29 years and never experienced any issues like this.
Initial report received from a consumer's parent on 09 November 2010. A 15 month-old female child received on 20 October 2010 a left thigh injection (route not reported) of PENTACEL, lot number not reported. The patient had no illness at the time of vaccination. The patient had received 2 or 3 prior doses. Her medical history and concomitant medications were not reported. The patient's parent reported that on the evening after the injection, the patient started limping. She continued to limp for 4 or 5 days. No other reactions were noted and the patient had no other problems. The patient was reported as "okay now" and no further limping was noted. The outcome was reported as recovered. Documents held by sender: None.
found by husband with AMS on 3/4/21, not responding to questions or following commands. taken to the ER- fever 101.2, HR elevated, decreased BP
Information has been received from a physician, concerning a 15 year old female patient with "some baseline hypotonia," who on 02-JUL-2007 was vaccinated with the third dose of Gardasil (route, site and lot # not reported).  Concomitant vaccine therapy at the visit included a dose of MENACTRA.  In October 2007, "the patient experienced an adverse reaction," described as Guillain Barre syndrome (GBS)-type symptoms.  She was hospitalized in an intensive care unit for 3 weeks though no diagnosis was made during that time.  The patient was then transferred to an inpatient rehabilitation center for "about 3 months."  The reporting physician stated the patient just became her patient within the past week and a half.  She stated that the patient had not yet fully recovered, and was currently undergoing outpatient rehabilitation.  Additional information has been requested. 04/07/08-records received for DOS 10/27-11/6/07- DX DC: Weakness, elevated ANA. Presented with 1-2 months of neurological symptoms which began as diffuse mild back pain for 2 months, aching, then 2-3 weeks ago experienced heaviness of limbs, particularly her upper arms and upper legs, non-painful tingling but no numbness. Muslces feel achy all over. Diffuse headache. Mild nausea. Neck pain and siffness times 1 week. General feeling of fatigue and malaise. Weakness progressing from proximal to distal extremities. Unable to walk independently. Short of breath with mild exertion. Lightheaded when standing up. Diplopia. Poor appetite. Constipated for 1 week.  Thought to have a significant psychiatric component to current presentation. Tensilon test no improvement in strength.
Narrative: Fasting labs done 3/11/21. LFT's in 3000s and BR over 18-sent patient to ER for evaluation. Patient was admitted 3/12-3/14/21 for painless jaundice/abdominal pain and hematuria. Dr. of GI was consulted. CT/MRI of abdomen normal; no signs of tumor, mass or stone. LFTs trended down and patient was discharged to f/u with Dr. in the office re: possible liver biopsy. Hepatitis A, B, C all negative. Patient did f/u with Dr. on 3/16/21-Seeing again May 3rd and may consider liver ultrasound and liver biopsy. Hand written note from Dr.- Repeat CBC and Hepatitis panel 3/16/21 with genetic testing for hemachromotosis. Labs drawn in hospital and not back yet ANA and AMA. These labs suggest acute process resolving: Hep. B's old and cured. EBV is old (IGG) not IGM. Thus far cause not clear; we are working it up. May end up with liver biopsy if labs do not improve. Collection DT Specimen Test Name Result Units Ref Range 03/11/2021 08:48 PLASMA PROTEIN,TOTAL 6.7 g/dL 6.3 - 8.2 03/11/2021 08:48 PLASMA ALBUMIN 3.5 g/dL 3.5 - 5.2 03/11/2021 08:48 PLASMA SGOT(AST) 3204 H U/L 5 - 34 03/11/2021 08:48 PLASMA SGPT(ALT) 3627 H U/L 10 - 55 03/11/2021 08:48 PLASMA ALKALINE PHOSPHAT 333 H U/L 38 - 126 03/11/2021 08:48 PLASMA TOT. BILIRUBIN 18.2 H mg/dL 0.2 - 1.3 03/11/2021 08:48 PLASMA DIR. BILIRUBIN 12.9 H mg/dL 0.1 - 0.4 Note patient received first dose of COVID19 vaccine Moderna on 3/3/21 ONE WEEK after exhibited extreme elevations of liver enzymes. With NO previous history. Still unknown cause. PA has major concerns of this patient having a second vaccine and does not recommend at this time.
Pt presented to vaccination site appx. 2 hours after receiving FLU MIST.  Pt presented with mild redness to face and upper torso, Airway was patent, pt speaking in full sentences.  Pt c/o "scratchy throat". Pt given Benadryl 25mg PO, EMS called.  EMS arrived and transferred pt for evaluation to nearest Emergency department, Pt was discharged from ED after evaluation.
Moderna COVID-19 Vaccine EUA symptoms for approximately 18 hours: Chills and fever of 100.1 degrees F Headache like a vise grip causing brain fog (lack of concentration) Lack of appetite
Mother states pt had temp Q 103.8 headache - went up to 104.4 highest. Gave Motrin temp did go down 6/15 AM. Mom called our office with 830 AM to report incident and the pt vomited several times. Dr spoke with mom and told her to bring him in if not better - 1145 did F/U call - Gave Cl liquids - Temp down - mom came to office with pt 1pm. Much improved Dr states allergic reaction to Pertussis - Mom aware - chart flagged for allergy.
no additional AE details were available; inadvertent concomitant administration of VARIVAX and PROQUAD to a patient; This spontaneous report has been received from a medical assistant referring to a 1-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 28-MAY-2021, the patient was inadvertent concomitantly vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # T025944, expiration date: 30-JUL-2022; strength and route were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) (0.5 mL, lot # T029099, expiration date: 23-FEB-2022; strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The reporter was requesting any information on what to look for with the patient. No additional adverse event details were available.
Patient developed severe pain in the arm where vaccine was administered. Difficulty moving arm. Pt was advised to go to an urgent care for evaluation and treatment of pain. Pt given vicodin with minimal relief of symptoms. 5 days later still reporting arm pain.
Some discomfort after flu injection but, pain continued to worsen, to the point it is very painful to lift the arm, at all, now.
Sore/swollen arm, chills, joint pain, headache, muscle ache, sweating profusely  Treated with Tylenol and alkaselzer plus.
This case is related with case # 2013SA115640. Ini6tial medication error report received from a physician on 05 November 2013. The 03 year old unknown gender patient received FLUZONE 0.25 ml (lot # was unknown) at unknown site on 04-Nov-2013. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Muscle marked by swollen and tender with movement, early fever and distal extremity erythematous rash. Rash was confluent and blanchable in all 4 extremities. Rash and fever subsided but pain and swelling in muscle have persisted for several days. No cellulitis noted on exam. No other SX prior to today with some tingling in his arm.
This spontaneous case reported by a consumer, describes the occurrence of injection site pain (pain in the injection site) and musculoskeletal stiffness (kind of stiffness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No reported medical history. On Jan 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced injection site pain (pain in the injection site) and musculoskeletal stiffness (kind of stiffness). At the time of the report, injection site pain (pain in the injection site) and musculoskeletal stiffness (kind of stiffness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Significant headache. Began approximately 11:30am the following day... progressed for 48 hours, on L side of head only. So severe thought potential stroke/aneurism at one point. Headache lasted approximately one week, finally resolving Saturday morning.
The pt developed a local reaction, 30 hours post vax with Infanrix, with erythema and swelling with pain at the knee area (injection at thigh). It's size is 2 1/2" X 3".
Local mild reaction, 2 inch circular area red, indurated, no drainage, no fever KEFLEX 125mg/5ml Susp.
COVID in February 2021 / hospitalize for maybe 2 months; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 19th October 2021) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. In February 2021, between 3 and 5 months after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization). 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 details were provided as follows: The patient received 1st dose of Shingrix and had COVID and being hospitalize for 2 months. The reporter was unsure of dates of hospitalization and site of Shingrix administration. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR167468.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167468:Same reporter.
Information has been received from a licensed practical nurse concerning an approximately 8 year old patient who on 06-NOV-2000 was vaccinated with a dose of VARIVAX (Merck). On approximately 15-NOV-2007, the patient experienced about 25 to 30 lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
10/15- body aches, diarhhea, fever (sweats, fever blister on lip) 10/16 symptoms continued and felt a little better. without diarrhea this morning(10/17/2008).  Still  aches and nausea.
Donor donated on 02/04/2018 and had her injection after her donation. Donor sat for 15 minutes after with no reaction noted. Donor came in today, 02/08/2018 to donate plasma and reported a reaction. When this medical staff associate looked at the donor's arm, she had a nickel sized lump. Donor reported that it started swelling the night of 02/04/2018. Donor also reported some mild itching, but it was not itching today. After donating today, 02/08/2018, the lump was approximately a 50 cent size or larger and showing some redness. Donor advised to use moist heat to the area as often as possible. If that did not help, then to use ice.
Patient with pustular lesions on erythematous base beginning on lower legs and spreading below knee as well as few lesion on back and chest 3 weeks status post smallpox vaccination on 6 AUG 2009. Patient with pruritus and pain in feet but without fever, h/a, myalgia.
Short term memory loss, Severe fatigue, Chills, Mild HA, Depression - lasted 5 hours and was gone.
23 weeks pregnant, due 8/1/2021.  My arm was very sore starting a few hours after the injection. I was also very tired the day after the injection.
Large local reaction to left upper arm with redness and swelling. Reaction vs cellulitis diagnosis.  Placed on antibiotic for 10 days.
Pregnant patient (15 weeks) ws given second dose of HPV vaccine instead of Hep B vaccine.
At 10 hours in,  I had body aches, fatigue, chills, elevated heart rate, a very bad headache, joint aches (only in area I currently having, or have had, issues with... my back (not current), my knees, and my ischial bursitis area (current)), and my teeth hurt!   At 18 hours in, I awoke to a splitting headache, nausea,  slight fever.  I later had diarrhea. I felt crummy  all day. It took about 30 hours in to feel back-to-normal.  I took both Advil and Tylenol to alleviate my symptoms, and stayed in bed most of the day, with light covers, so as not to elevate the fever.
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions for about 30 hours, severe headache, entire body shutdown arms legs incapable of functioning normally, soreness, aching, dizziness, shortness of breath, chest pains when inhaling.
This spontaneous case reported by a consumer, describes the occurrence of illness (sick) and headaches in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick) and headaches. At the time of the report, illness (sick) and headaches outcome: unknown. No concomitant medication or treatment information provided. Patient stated the organization giving the doses told him everybody has been sick and has side effects after the second injection (headaches, etc.).
I had swelling of left ankle beginning early to mid-March; I monitored this; it got worse, and I was sent for a doppler sonogram on April 21, 2021.  A DVT was identified, and I was put on Xarelto for 4 weeks; the clot is gone.  It was determined that the DVT was unprovoked, and there is no explanation for why it occurred.
Would it be harmful if a patient received an extra Menveo vaccination?; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received extra dose of Menveo vaccine. Health care professional enquired that would it be harmful if patient received extra Menveo vaccination. No other information was provided.
Patient reports waking up the morning after receiving the vaccine drenched in sweat (had to change clothes and sheets), migraine type headache, sore throat, and ringing in his ears. Patient denied being around any loud noises in the past week.
pt recv vax;reddened rt arm, inject site red;another red spot on arm below inject site;rash rt side & behind lt knee; APAP given;
Patient came in for second primary shot at same clinic, when she had recieved her first shot the wrong DOB had been entered. Not sure if scribes and vaccinator did not ask for child's birthday or how old she was but she was given a second primary when she was too young. Local County RN contacted patient mother to explain situation and provide legal documentation showing birthday, mother said she would email but didnt. After that RN could not contact mother any further for documentation.
pt exp swelling of lt arm & noted egg shaped lump in axilla area 2 days following vax; pt also c/o soreness in arm & shoulder area; no redness noted seen by MD who placed on ATB skin infect;
PATIENT HAD HEAVY CHEST WHILE LYING DOWN, BUT FELT BETTER IF AT UPRIGHT POSITION.  HE ALSO EXPERIENCED SHORTNESS OF BREATH, AND FELT HE HAD PALPITATION.  HE DIDN'T HAVE ANY BLOOD PRESSURE MONITOR AT HOME.
She felt like he was developing cold sores in her body; She is very itchy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (She felt like he was developing cold sores in her body), PRURITUS (She is very itchy) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (Chills). On 31-Jan-2021, the patient experienced ORAL HERPES (She felt like he was developing cold sores in her body) and PRURITUS (She is very itchy). On 28-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, ORAL HERPES (She felt like he was developing cold sores in her body) and PRURITUS (She is very itchy) outcome was unknown.            Concomitant and Treatment medications were not provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Employee stated hours after injection, area became red, swollen, itchy, and discomfort.  Ice applied.  Employee stated symptoms persisted for 3 days before resolved.
Pt called on 9/30/13 - she received vaccine on 9/23/13. She has felt fine until today when she experienced redness and swelling in upper arm - no fever or fatigue reported.
Hives like rash across the body including back of head, neck, abdomen, chest, arms, and groin. Urgent care provided an oral steroid prescription.