chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed 2nd dose in recommended Interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval) 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.   No concomitant and treatment medication information was reported. Pharmacist reported on 12May2021 that patient was coming for 2nd dose of Moderna vaccine after 55 days of interval. She received her 1st dose of Moderna vaccine on 18Mar2021 and no symptoms after administration. No more information was provided.
4 hours exactly after vaccine itchiing swelling right eye lasted 2 1/2 days, could not see from eye - patient used OTC Thera Tears.
On 05/21, child began to have runny nose. She then developed a fever on the 25th and 26th with temperatures ranging from 102.7-103.3. On 05/28/2015 child developed a rash that began on her cheeks and spread to the rest of her body. She also is experiencing extreme fatigue.
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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs" (unspecified if ongoing); "known allergies: Crab" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
dx VTE, observed on local imaging; abd pain Narrative: patient reports PE as diagnosed but local imaging did not appreciate same diagnosis. Abd pain continues despite 42 days removed from vaccine administration and other comorbidities present. Hospitalization prolonged for continued workup of reported symptoms
PATIENT DOSE WAS ADMINISTERED, AND SHE WAS INSTRUCTED TO SIT AND WAIT THE RECOMMENDED 15 MINUTES. AFTER WAITING, THE PATIENT WENT TO PICK UP AN ITEM IN THE STORE, AND SHORTLY RETURNED TO THE PHARMACY COMPLAINING OF A TIGHTNESS IN HER CHEST (ROUGHLY 30-40 MINS AFTER ADMINISTRATION). SHE WAS INSTRUCTED TO SIT DOWN AGAIN FOR ANOTHER 15 TO 20 MINS, AND I CHECKED HER BLOOD PRESSURE TWICE AND NOTICED AN UNUSUALLY ELEVATED NUMBER. SHE CALLED HER DOCTOR TO SCHEDULE AN APPOINTMENT FOR THAT DAY
Nine hours after vaccine received, developed headache, nausea and chills. Took Tylenol for relief. Nausea and chills were gone after 16 hours and headache was resolved after 24 hours.
Headache x 2 days, generalized weakness started on day 2 that lasted for 2 days
Moderna Covid-19 Vaccine EUA 2-3 days following booster, I had a mottled redness spreading down to my elbow. Starting 3 days following booster, I began series of debilitating dizzy/ vertigo spells lasting hours and occurred 2-3 times/ week in the month of January 2022; approximately once /week in February  2022; and once every 2 weeks in March 2022. They seem to be winding down now with frequency and intensity.  The dizzy/vertigo spells were exactly like I use to experience in the early stages of my bilateral Meniere?s Disease diagnosis 2014 but I have not had any episodes in 5 years until I had the Miderna booster shot.
Swollen lymph area, under arm pain as of 8/15/23 for 5 days
Moderna COVID?19 Vaccine EUA Acute chest pain beginning about 49 hours after received injection to arm. Went to ER and was hospitalized for 2 days. Eventual diagnosis: Acute Pericarditis. Required to take 3 months of Colchicine 0.6 mg BID
Developed vesicular lesions under chin and on upper back and on right scapula.  Treated with Acyclovir suspension for 5 days.
2/25 Began with fever 102. 2/26 Developed morbilliform rash, fussiness.
Patient received a second dose of COVID vaccine that was different from her first dose.  She received Moderna for her first dose and Pfizer for her second dose. The manufacturer of the first dose was not known at the time second dose was given.
Pt. called 6-19-09 spoke with RN c/o having reverse reactions to vaccines given 6-16-09. Pt. stated she was told to call back Monday 6-22-09 if she did not feel better. . She stated she was sore and her body ached. Upon speaking with pt. today I encouraged her to get checked by a doctor. Name and phone number obtained, and I called her back but did not get an answer at the time.6/22/09 at 4:35 patient returned call stated she just wanted to know if it was common to feel sore and aches after taking the Tdap and wanted to know if she could use her treadmill to exercise. After talking with patient she stated she felt better because reading the vaccine info sheet she got scared. I told her I would call back in the following days to check on her.
Pt states she had her second Covid Vaccine 3 days ago. She states immediately her right arm started hurting and got a knot in it. It has progressed to know it is drawn up, hurts severely, red, warm, hurts to the back of the scapula, the neck and right jaw and under her arm. She has tried Ice and Heat and OTC meds and it has not helped. OTC Benadryl as directed prn Alternate heat and ice 15 min every 1-2 hours prn OTC Pain patch as directed prn Warm showers prn No heavy lifting Toradol 60mg IM Now If no better or worsen RTC or to Urgent Clinic for eval
1 day after vaccination, sternal chest pain , non radiating 0/10-5/10
Erythema, pruritus & swelling about 8 hrs after vaccine. Improved without tx over 48 hrs.
12/23 body aches - generalized all over, just don't feel well. 12/24 body aches, just don't feel well. 12/25 body aches, just don't feel well, skin on back feels itchy and burning - nothing is reliving it. 12/26 body aches, just don't feel well, skin on back feels itchy and burning - difficulty sleeping/getting comfortable.
Headache, Arthralgia, Fever, Chills, Fatigue, Injection site pain Narrative:   Other Relevant History:
fever to 103 day of vax in PM 1MAR96;taken to ER on 2MAR96 w/arm red & swollen to elbow;fever dec;given APAP & Ibuprofen;5MAR96 temp to 105 & pain in pelvin area & legs, poor appetite, crying;
I got the vaccine around 12:30PM on Saturday and I had gotten it in my right arm and it was sore for the whole day which is normal so I kept moving it and trying to keep it going. Sunday when I woke up I was tired, had a headache, nausea, body aches, and joint pain. I've had COVID twice and it felt like that for the first couple of days of having COVID. Monday I woke up and felt better but I still had soreness in my arm and the nausea and that's about it. Tuesday I still had the nausea and I started noticing some breast pain in my right breast and I had almost like a cyst open up on under side of breast and when I felt that happen, because it bled a bit, I felt a mass on top side of breast and I've had some mild soreness and nausea every day since and the mass is still there. I went to the Doctor yesterday 12/02/2021 and he said I should probably not get the 2nd dose until he knows what it is and he put in an order for a mammogram and I have to wait 6 weeks to hear from the CDC. They also did blood work to check clotting, and I have another appointment 12/06/2021 with my female PCP.
Pt reports having hives to L side of neck and onto face starting on 8/5/22; progressively improved over 4 days; intermittent itching at 8/9/22. Pt denies any exposures to substances which would cause hives
States she had a zoster shot 7/15/13. Starting breaking out in a rash on 7/17/13. Seen in my office 7/19/13 with a rash that resembled zoster.
1120AM pain rt arm w/in 1hr p/getting vax;swelling started during noc;frontal h/a this AM & now;rt upper arm red edematous form shoulder to approx 1 1/2" above elbow;
Client said I feel hot I asked her to put her headdown, she raised back up said she felt okay then slumped forward in small confines of mobile unit, slid off stool to floor, sitting on one of her feet.  Picked her up put her back on stool and she  passed out again, we then put ice back on her forehead and put her on the couch in the mobile unit.  (Vaso vagal reaction)  15 minutes later feeling fine except complaining of her foot  being sore
Initial unsolicited report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016553116) on 07-Feb-2017. This case involves a patient (gender and age were not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) at approximately 11 A.M. on 10-Nov-2016. Patient's medical history and concomitant medications were not reported. On 13-Nov-2016, three days following the vaccination, the patient had developed typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unknown date, following the vaccination, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. As corrective treatment, the patient had received 875 mg/125 mg dose of amoxicillin/clavulanic acid started on 21-Nov-2016. The outcome of all the events was not recovered (reported as events were still going). List of documents held by sender: none.
Patient received primary smallpox vaccine on 1/29/03. On Day 14, he developed a large local reaction with swelling of the upper arm and extending to the elbow.  He was evaluated and dx. with a robust reaction to the vaccine.  The symptoms were self-limiting and resolved in 2-3 days.  Six months later, he noticed a change in the appearance of the vaccine scar.  The scar became raised with a papule lesion about the size of a dime.  In september, he noted a scant amount of serious drainage from the lesion.  He presented to KFB medical center for evaluation on  22 September 2003.  Denies, fever, lymphadenopathy,swelling, redness,streaking or rashes.  PCR for vaccinia, viral and bacterial cultures obtained.  Underwendt skin bisopsy by dermatology.
I broke out in minor hives and rash on various places on my body within a couple days of taking the shot. It cleared up in a few days. May or may not be related to the vaccination. This has happened to me once in the past after getting a flu shot. I get a flu shot every year.
Pt presented to pharmacy sunday 10/26/08 with dermatitis in L deltoid area.  Area approximately 3"x2" raised, red area.
I have experienced mild dizziness off and on after the shot since about a half hour after first dose. But today, 6 days after first dose, at around Noon, I experienced a stronger episode of dizziness which then progressed to a presyncope feeling (like I might pass out). I also felt flushed and jittery after the presyncope subsided. Now, I still feel dizzy, off balance and jittery.
weird muscle cramps /muscle cramps are almost like spasms; pain in the legs; tingling in the hands and feet/vibrating/tingling feeling in her arms and legs; more sleepy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (weird muscle cramps /muscle cramps are almost like spasms), PAIN IN EXTREMITY (pain in the legs), PARAESTHESIA (tingling in the hands and feet/vibrating/tingling feeling in her arms and legs) and SOMNOLENCE (more sleepy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Primary hyperparathyroidism (Definitively diagnosed 2.5 years ago), Insomnia (Since age 11), Seasonal allergy and Irritable bowel syndrome. Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control, CANNABIDIOL (CBD OIL) for Insomnia, CINACALCET HYDROCHLORIDE (SENSIPAR) for Primary hyperparathyroidism, BISMUTH SUBSALICYLATE (PEPTO-BISMOL), ALPHA-D-GALACTOSIDASE (BEANO), CLARITHROMYCIN, OMEPRAZOLE, TINIDAZOLE (OTC-HP) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCLE SPASMS (weird muscle cramps /muscle cramps are almost like spasms), PAIN IN EXTREMITY (pain in the legs), PARAESTHESIA (tingling in the hands and feet/vibrating/tingling feeling in her arms and legs) and SOMNOLENCE (more sleepy). At the time of the report, MUSCLE SPASMS (weird muscle cramps /muscle cramps are almost like spasms), PAIN IN EXTREMITY (pain in the legs), PARAESTHESIA (tingling in the hands and feet/vibrating/tingling feeling in her arms and legs) and SOMNOLENCE (more sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had to start adjusting her Sensipar 30 mg daily dose by skipping doses to help regulate the medications affects. The patient was also wondering if her calcium level was too low.  Treatment information was not provided.
I received a phone call from Mom saying that patient was having stomach upset and feeling weak, lethargic and feverish shortly after she got home from receiving the IM Typhoid vaccine. Her arm site of the injection was not showing signs of cellulitis nor reaction. Also, there were no signs of throat swelling or stridor or wheezing. Mom try to give her some fluids and a popcicle, and patient vomited. I told Mom to give patient Benadryl; and later when I called them about 10PM, patient had fallen asleep.
Patient had considerable pain on left shoulder and could not sleep. He had difficulty with the range of motion as well. He said the injection was given too high in the arm almost at the shoulder level. Patient had to go to urgent care due to pain and was told to apply ice and take Ibuprofen.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that the patients were administered improperly stored doses o PEDVAXHIB (doses, route, lot numbers and expiration dates were not provided) on unspecified dates since 13-DEC-2014. No adverse effects reported. Additional information has been requested.
8 hours after the injection I had chills.  12-14 hours after injection I experienced a headache, muscle and joint pain, a fever of 100, and fatigue for 24 hours.  I treated it with a combination of Advil and Tylenol and today which is the 3rd day I began to feel better but not 100%.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8735), in right arm, on 05May2021 as dose 2, single (Lot number: EW0176), in right arm and on 21Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN [ATORVASTATIN CALCIUM], start date: Jan1997, stop date: 24Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Negative, notes: Took the medication as prescribed for 5 days. Tested negative for the next 2 days; (2022) Positive, notes: Day 3 had a scratchy throat and tested positive by that evening. Resulted in full covid infection (fever, congestion, cough) for the next 7 days; (2022) Negative, notes: I now tested negative 2 weeks and two days after first testing positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that patient received the COVID-19 treatment with Paxlovid from 23Jul2022 to 27Jul2022. It was also reported that patient Took the medication as prescribed for 5 days. Tested negative for the next 2 days. Day 3 had a scratchy throat and tested positive by that evening. Resulted in full covid infection (fever, congestion, cough) for the next 7 days and again tested negative 2 weeks and two days after first testing positive.  No follow-up attempts possible. No further information expected.
Pt had dose 1 Moderna on 5/3 within 24 hours had back pain and urinary incontinence unable to ambulate. Hospitalized overnight.
experienced a reaction with Shingrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced adverse reaction to Shingrix. The pharmacist informed that she reached GlaxoSmithKline and not Glen mark pharmaceuticals. The reporter was asked what did the patient experienced with product however she refused to provide it and mentioned that she would call the manufacturer rather. No additional information was obtained.
Pain in the area of appendix.. it lasted several days and almost caused me to go to a clinic, but I began taking doxycycline 100 mg and after several days the pain went away (2 and then 1 per day)
Headache, body aches, fatigue and felt like crap!  Swelling in arm with redness and heat, hurts!
Reactivation of postherpetic neuralgia that had previously been resolved for more than one year; This is a spontaneous report from a contactable consumer, the patient. A 35-Year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via unspecified route of administration in left arm on 18Mar2021 at 12:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included occipital neuralgia and post herpetic neuralgia. Concomitant medications included escitalopram (LEXAPRO) and topiramate (TOPIMAX), from an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 07:30, the patient experienced reactivation of post herpetic neuralgia that had previously been resolved for more than one year. The patient did not receive any treatment for the event. The clinical outcome of the event disease recurrence was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I brought misery to myself by taking this VZV (shingles) vaccine shot.   An incessant itch comes on in the morning or after work. The itching sites are often on my hands, forearms, lower legs and feet, but can vary and spread.   Sometimes I scratch until it bleeds.  Though in the back of my mind I know I am not supposed to, it is humanly impossible to suppress.  The various steroid topical creams I have used make my skin feel like starched, cracked paper.  Anti-histamines make me feel like a zombie in the daytime.   Prednisone provided temporary relief, but caused severe dizziness and hair loss.  When I stopped taking prednisone because of the side effects, the excruciating itch returned, in different parts of my feet, legs, hands, arms, neck and face.  Recently, lesions on my legs and feet have finally dissipated somewhat, but a rush attack can occur at any moment of the day, for no apparent reason.   Sometimes the itch gets to the point that I want to disconnect the affected part of body.    In the past several weeks I have also experienced shortness of breath.  The complaint list goes on; I wish I could have an antidote for this shingles vaccination and get the past year of my life back.
Headache, chills and vomiting twelve hours after my shot. Eight hours later I broke out in hives.
have Covid; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 19Sep2023, outcome "unknown"; COVID-19 (non-serious) with onset 19Sep2023, outcome "unknown", described as "have Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Reporter Type: Patient/Consumer. Serious: No. On 18Sep patient got the new vaccine. On 19Sep patient tested positive and have Covid including fatigue, etc. Paxlovid is helping. Once patient get better do patient need a another vaccination given the proximity of the shot and testing positive?   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
LUMP ON LEFT LEG; LEG TENDERNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced leg tenderness. On 13-APR-2021, the subject experienced lump on left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump on left leg, and leg tenderness. This report was non-serious.
See notes above. Intense itching both sides of hands, left side of back, thickened tongue, noticeable tightening in throat.   Note:  Never had a reaction to a vaccination shot before except soreness on buttocks - tetanus and a swollen sore arm for my first COVID shot.