chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quite ill; Acute allergic reaction; Severe moderna rash on both arms/Across her upper chest/Across her upper chest; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Quite ill), HYPERSENSITIVITY (Acute allergic reaction) and RASH (Severe moderna rash on both arms/Across her upper chest/Across her upper chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy and Penicillin allergy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Quite ill), HYPERSENSITIVITY (Acute allergic reaction) and RASH (Severe moderna rash on both arms/Across her upper chest/Across her upper chest). The patient was treated with OMALIZUMAB (XOLAIR) for Eczema, at an unspecified dose and frequency and DUPILUMAB for Eczema, at an unspecified dose and frequency. At the time of the report, ILLNESS (Quite ill), HYPERSENSITIVITY (Acute allergic reaction) and RASH (Severe moderna rash on both arms/Across her upper chest/Across her upper chest) outcome was unknown.        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.  Patient's treatment medication went on for 6weeks. It has lessened but still having breakthrough in the form of small red patches. Consumer is taking Benadryl 3-4 times a day and Allegra once a day. She is on hold for Pneumonia, and shingles vaccine due to bad reaction.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
About half vaccine leaked from syringe/came out onto skin. Dose was going to be invalid. Withdrew needle and did not administer remaining vaccine in syringe. Delivered a valid dose of vaccine at that time. Two pokes occurred with needing to administer another vaccine.
Arm at site of immunization edema, erythema, warmth area 16X11.5 cm, no pain, no pruritus.
Pt. became dizzy/lightheaded, instant headache after injection given. A few minutes later she reported her head and ears were "muffled". Pt. had bilateral feet elevated (supine on exam table)/cold rag given to pt./ice water (per her request, after 15 minutes from injection). Pt. was in exam room 30 minutes after injection for R.N. to observe. Pt.'s stated she was no longer dizzy and her head "was feeling better. Pt. reports today that is fine.
Patient is a 75 y.o.female with PMH HTN, DM2, obesity, former tobacco abuse (15 pack yr hx) who presents to ED on 7/8/2021 for worsening SOB and "not feeling right". Patient states that she was sitting watching TV when she became severely short of breath. She reports her granddaughter was dx with covid-19 ~3-4 weeks ago, her main symptom was loss of sense of taste and smell. She had been around her granddaughter and starting 7/7/21 she began to feel SOB, she did not notice wheezing but her family did. She says she could not get comfortable with her breathing so came to the ED. No fevers, no chills, no chest pain. Also, she had a recent cough that she attributed to sinus issues and post nasal drip- this improved with Flonase. She has completed pfizer vaccine series for covid. CXR in the ED with clear lungs, rapid covid test positive, patient placed on 2L NC and admitted. Consulted on 7/9/2021 for covid, ?remdesivir. Patient reports she feels her breathing is better now that she has oxygen on. No prior lung hx of COPD, asthma, VTE or OSA. She denies recent travel, no surgery, no immobility. She denies LE swelling or any heart issues. She is a former smoker, quit in 1995 (before that smoked 1 pack per day x 15 years). She does not follow with a pulmonologist, no OP inhalers, no PFT's
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
FLU LIKE SYMPTOMS (HEADACHE, TIREDNESS, FATIGUE); This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced flu like symptoms (headache, tiredness, fatigue). Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms (headache, tiredness, fatigue) on 01-JUN-2021. This report was non-serious. This case, involving the same patient is linked to 20210612409.
My arm swelled from my elbow up my arm to my neck and into my back, it was hot, and red and painful. That lasted 8 days. But my lymph nodes have been swollen and painful since I received my second covid shot and that has never gone away. It is causing pain and tenderness, head aches, irritation, and exhaustion.
Redness, itching, small red bumps on legs, fever. Worsening quickly.
left side of his mouth was "numb"; painful to touch; Bells Palsy effecting left side of face; bad "outer ear" ache, painful to touch; This case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2022, the patient received the 1st dose of Shingrix. On 18th May 2022, 8 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain and tenderness. On 26th May 2022, the patient experienced numbness oral. On an unknown date, the outcome of the bell's palsy, ear pain, numbness oral and tenderness were unknown.   The reporter considered the bell's palsy, ear pain, numbness oral and tenderness to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-May-2022 Reporter's comments: The patient received Shingrix on 10th May late in the day. The reporter wanted to check the chart again to verify the date being that week and not the following week. On 18th May 2022, the patient complained of a bad outer ear ache. Like all around the left ear lobe. Not tender but painful to even touch. On 26th May 2022, late evening,16 days after receiving Shingrix, he noticed the left side of his mouth was numb. Like he had been to the dentist he said. Early morning on 27th May 2022, symptoms of Bell's Palsy affected the left side of the face. The reporter googled and saw something about if the breve around the ear becomes inflamed then there had been some correlation between the Shingrix vaccine and Bell's palsy.
Headache; Muscle pain; Right arm pain from the injection site; Difficulty to move and stretch the arm; Swelling from the injection site; A spontaneous report was received from a consumer concerning a 52-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, pain, swelling to the arm, muscle pain and difficulty to move and stretch the arm.   The patient's medical history was not provided. Concomitant product use was not provided.   On 30-dec-2020, The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly in the right arm  for prophylaxis of COVID-19 infection.    On 30-dec-2020, the patient experienced headache, pain, and swelling to the arm.   Action taken with the second dose of mRNA-1273 in response to the events is not applicable.  The outcome of the events headache,injection site pain and swelling to the arm, pain from injection site to the elbow,  muscle pain and difficulty to move and stretch the arm were considered resolving.; Reporter'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.
Received PREVNAR 13 inj., 0.5 ML on above date. Arm hurt a little after receiving shot which I could understand. However, as time went on it got worse to a point I can't lift my right arm or carry anything. It appears there might be a lump in the arm and it feels hot at times. Went to the doctor and he prescribed ibuprofen with exercise to possibly work it out but unable to exercise much because of the pain. Said to check back in 3 weeks but didn't really seem sure about what the problem was. Could possibly be an infection. This limits my ability to not only do housework but also many outside activities.
Around injection site  red , raised , hot to touch about 6 in long & 4 inches wide
Pt. received vaccine at 4pm.  Mom noted pt. to be nauseous at midnight, with emesis at 430am.
got really sick; Initial information received on 21-Jan-2022  and live follow-up received on same day (processed together) regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 75 years old female patient who experienced got really sick while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] delivered via dupilumab prefilled syringe.  The patient's past medical history included Anaemia, unspecified, anorexia nervosa, unspecified, anxiety disorder, unspecified, difficulty in walking, not elsewhere classified, essential (primary) hypertension, gastro-esophageal reflux disease without esophagitis, Major depressive disorder, single episode, unspecified, Sleep disorder, unspecified, nonrheumatic mitral (valve) insufficiency, Unspecified protein-calorie malnutrition and dvrtclos of intest (intestine), parunsp, w/o perf or abscess w/o bleed (Diverticulosis of intestine, part unspecified, without perforation or abscess without bleeding) The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing unspecified atrial fibrillation and atopic dermatitis, unspecified. Patient had no known drug allergy.  Concomitant medications included LORATADINE (CLARITINE).  On 26-Jan-2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW (every other week) subcutaneously (strength: 300mg/2ml, lot - IL346A and expiry date: 31-May-2024) for atopic Dermatitis, unspecified delivered via dupilumab prefilled syringe.  On 20-Jan-2022, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, lot number and expiry date were unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On 20-JAN-2022 the patient developed a non-serious event "got really sick"(illness)11 months 25 days following the first dose intake of DUPILUMAB.  On 20-JAN-2022 the patient developed a non-serious event "got really sick" (illness) following the administration of INFLUENZA VACCINE  It was reported"pt (patient) had flu shot and got really sick last night. she said after some time had passed today she feels better. to her shot yesterday and she got very night. and after a Few hour or so she okay. She passed pt due dupixent shot tomorrow. She wasnt sure if she should take medication. advised her that if she didn't fell may consider holding off on dose."   Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got really sick).  At time of reporting, the outcome was Recovered / Resolved in January 2022 for the event got really sick.
Allergic reaction, sensation of throat closing requiring benadryl; Allergic reaction, sensation of throat closing requiring benadryl; This is a spontaneous report from a non-contactable physician. A 47-year-old female patient (non-pregnant) received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of bnt162b2 for COVID-19 immunisation. The patient experienced allergic reaction, sensation of throat closing requiring diphenhydramine hydrochloride (BENADRYL). Event resulted in emergency room/department or urgent care. Therapeutic measures were taken included diphenhydramine hydrochloride and famotidine (PEPCID). Outcome of the event was resolved.  No follow up attempts are possible. Information about Lot/ Batch could not be obtained.
Two, Three front teeth, My upper lip and then, My whole nose went numb after, I got the shot yesterday.; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21Aug2021 as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in Aug2021 patient experienced two, three front teeth, my upper lip and then, my whole nose went numb after, consumer got the shot yesterday. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  FUP (PRD/SRD 02Sep2021): Follow-up activities closed. Batch/lot number not available.
Site was red, slightly swollen and warm to the touch where Varicella was given. Benadryl given. MD advised to continue use of heat pack and will follow up in the AM to check whether symptoms have improved.
Monday around 11:30pm started experiencing headaches, fever, muscle cramps, and body aches. Next morning the headache and body aches persisted through the day. Only taken 1 benadryl, 4 loratadine. Wednesday night taking a shower started feeling some discomfort on the left side of my neck. Today 4/15/2021 still bothers. Feel like a swollen muscle or ganglion.
Post vax, pt stated "I feel dizzy" "I see dark spots" then he fainted for about 2 seconds, mother was at the side, we both held him and laid pt to the floor, legs were positioned up. MD was called. Pt responded and opened eyes and stated "I see yellow spots". MD arrived and vital signs were checked; BP 110/80, R 18. Pt was given orange juice and skin was white and sweating, warm and cold at the same time. Pt stayed for observation and left under stable condition with mother. Pt stated "I feel better" and skin color was back to brown and pinkish. No distress noted.
No additional AEs reported; expired V AQT A was administered; This spontaneous report was received from a medical assistant and refers to a 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 10-JUN-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T008698 was verified to be valid with expiration date 04-JUN-2021) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported). No additional adverse events were reported. The outcome of expired vaccine used was unknown.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2109USA005216:
Fatigue, headache, body aches all started around 8:45 the night of my vaccination. All but headache were gone by 9 am the following morning. All were manageable with ibuprofen
Both arms with red areas right arm 2 1/4 in diameter left arm 2 1/2 inch diameter. Slightly edematous and painful to touch. Advised to give Benadryl and apply cool compresses QID. To call back in am if no better.
Day of Injection had slight soreness at injection sight.  Then about 7 days later a red baseball size area appeared around injection sight .The red area is warm and itches, no pain.  I have been applying cortisone-10 lightly as needed.   Seems to help.
This spontaneous report was received from a pharmacist, and refers to a 18 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 10-AUG-2018, the patient was vaccinated with a properly stored but expired VARIVAX, lot number M030183, subcutaneously for prophylaxis (expiration date was reported as 15-JUN-2018). The patient developed a welt at the injection site on an unspecified date in August 2018. She did not seek medical attention, no laboratories were performed to her. She did not receive any treatment for the event. At the time of the report, the patient was recovering from the welt at the injection site. The pharmacist did not assess the causal relationship between the event and vaccination with VARIVAX. Lot number M030183 is an invalid lot number for varicella virus vaccine live (oka/merck).
Wife came into pharmacy and said his arm "knotted up" she described it as a edema like area than ran from his shoulder and down his arm.
Rash all over back, chest, stomac, and upper leg; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old patient with unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration on the left arm on 16Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included dental implantation (Mar10 and 11th). The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Vitamins unspecified (MANUFCTURER UNKNOWN), amoxycillin (MANUFACTURER UNKNOWN), tylenol, codeine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 09:00 (2 days after receiving vaccine) the patient experienced rash all over. The patient stated that broke out in rash all over back, chest, stomach, and upper leg. The patient was prescribed with hydroxyzin hcl 25mg for the event. The event resulted to doctor visit. The clinical outcome of the event rash all over was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Nerve pain day 2&3 Arthritic pain day 3&4 Sick sick sick day 4-6 oxygen level 75 percent Headache day 10
Patient reports a rash and redness to her chest, entire back, and abdomen. The rash and redness stopped at waistline and did not extended to her upper extremities bilaterally. Per patient the rash and redness subsided on Sunday 30 Jun 2019. Patient also voices she is experiencing dizziness and lightheadedness.
very tired; sore arm; abdominal cramping; diarrhea; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (sore arm), ABDOMINAL PAIN (abdominal cramping), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 was reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LIMB DISCOMFORT (sore arm), ABDOMINAL PAIN (abdominal cramping), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). On 06-Feb-2021, the patient experienced FATIGUE (very tired). At the time of the report, LIMB DISCOMFORT (sore arm), ABDOMINAL PAIN (abdominal cramping), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-095359 (Patient Link).
RESIDES IN ASSISTED LIVING FACILITY. NURSING INFORMED PHARMACY THAT RESIDENT REPORTED FEELING DIZZY AND HAD NAUSEA UPON AWAKENING DAY AFTER VACCINE WAS ADMINISTERED AND THAT HE "WALKED INTO WALL".
fever; joint pain throughout body; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were recovered/resolved.   It was unknown if the reporter considered the fever and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and had a horrible reaction to it that lasted almost a year. Starting with fevers to joint pains throughout his/her body. The patient researched and did find some cases that were worse than patient. The patient gather he/she was rather lucky. The patient brother had shingles and lasted for a few months until he healed.  The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR199708 and US2021AMR199709 reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199708:Same reporter US-GLAXOSMITHKLINE-US2021AMR199709:Same reporter
extrememly severe flu symptoms- severe body pain to touch, body aches, severe headache, stomach pain, unable to get out of bed for 24 hours-seemed extreme for a vaccine side effect so am reporting for data collecting purposes.
Throughout the night and into the next morning, my heart has been racing and I?ve been having some palpitations. I haven?t had a fever so it?s not related to that.