chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 1st July 2018, for tolerance see case US2018205810). On 9th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, chills and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, chills and pain were unknown. It was unknown if the reporter considered the injection site pain, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he had his dose of SHINGRIX in left arm and experienced pain at injection site, chills and achiness. The patient reported that he experienced the same adverse events on both injections. The patient planned to follow-up with his physician on an unknown date.
She got her vaccine, she had pain, slight fever. She woke up to go to work and she was not able to due to pain in her arms, not able to lift her arm and pain. She continues to have the pain, has been taking Tylenol which helps a little bit, but still not able to work due to the reaction. She went to an UC on 7/5/22 and had an EKG because the pain was in her left arm and she thought that she may have been having a heart attack, they said her EKG was fine.  She had a very red bruise on my right arm, and it went away. She was prescribed OTC medication but she did not get it as she did not want to take so much medication when she is already taking prescription medication. She has an APT to see her PCP on 9/21/2022. She believes her reaction is to the shingles shot as she did not hit herself or fall or do anything to her arm, just has the pain and not able to fold sheets or do much of anything.
Possible Underdose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number MZ7M5, expiry date 25-OCT-2024) for prophylaxis.   On 05-AUG-2023, the patient received the 1st dose of Shingrix. On 05-AUG-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Possible Underdose administration). The outcome of the incomplete dose administered was unknown.   Additional Information: Receipt date: 07-AUG-2023 A patient received Shingrix first dose and after the injection they saw some drops on his pants, so patient was worried about received Shingrix less than recommended volume however pharmacist did not believed the vaccine was leaked. The reporter consented to follow up.  The patient received Shingrix possibly less than recommended volume, which led to incomplete dose administered.
15 minutes after getting the vaccine the patient stated she was feeling a tingling sensation in her mouth. I told her to wait a few more minutes just in case. Then she stated her mouth was  numb. I gave her a dose of benadryl. A couple of minutes later she fainted and was paled and lethargic. She stated her tongue was numb and swelling. A shot of Epipen was given due to tongue swelling. 9-1-1 was called. Few minutes after Epipen she said her tongue was feeling better, but she was feeling cold. Paramedics checked her vitals and said they were within normal levels (including blood sugar). She had difficulty walking so, they brought her to the hospital. At the hospital she was diagnosed with Syncope.
EXTREME FATIGUE; SEVERE HEADACHES; This spontaneous report received from a health care professional concerned a 75 year old African American male. The patient's height, and weight were not reported. The patient's concurrent conditions included emphysema, prostate BPH (Benign prostatic hyperplasia), and hypercholesterolemia, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: unknown) frequency 1 total,  dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  Health care professional called on behalf of a family member. Approximately two weeks post injections, on 24-MAR-2021, the patient began to experience extreme fatigue and severe headaches. Signs and symptoms were ongoing with continuation of taking pain medications to manage signs and symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme fatigue, and severe headaches. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210451417-covid-19 vaccine ad26.cov2-extreme fatigue, severe headache. This event(s) is labeled per RSI and is therefore considered potentially related.
No adverse reaction reported; her son, inadvertently got a 4th dose of GARDASIL 9; This spontaneous report was received from a consumer who is the patient's mother, referring to a 20-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 24-APR-2020 earlier in the morning, the patient was inadvertently vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, route of administration, and anatomical location was not reported; lot number and expiration date were unknown by the reporter) by a physician, who thought the patient had not received the third dose (extra dose administered). No adverse reaction reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 09-JAN-2015, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 13-MAR-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 11-JUN-2015, the patient was vaccinated with the third dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). No adverse symptoms reported. Additional information has been requested.
Patient noticed some what she thought was normal injection site redness and tenderness but after a week she noticed "it was not healing" and a lump had formed. Today she has a 13mm erythematous and very tender area surrounding a 7mm nodule with rounded edges and a central punctum. Lesion is 15cm from the head of the humerus.
I had the typical flu like symptoms which resolved within 24 hours. On 6/24/2021, I went to see my OBGYN for a raised and inflamed bulge on my left breast. I was sent for a mammogram and ultrasound on 7/1/2021 and a biopsy on 7/7/2021. The biopsy was negative for cancer and I was to follow up with PCP for possible autoimmune causes. On 8/10/2021, I went to see my PCP and did blood work. The blood work show positive for double strand DNA, which is a possible indication of lupus. I have an appt with rheumatology in Dec 2021. I have also developed a lot of joint pain especially at night.
Upper left arm swollen, red and warm at the touch. Tx Cefzil 250 mg/5cc for 2 days.
10/19/98 recvd vax. 10/20/98 pain & redness in rt arm& inc over several days at inj site. 10/22/98 dx w/cellulitis. rx w/ antibiotics.10/27/98  pink area @ site & "not feeling well".11/2/98 arm better.
Flu like symptoms, injection site tenderness, muscle and joint ache, head ache, temperature 99.9, general weakness.  Symptoms began 10 hours following injection and lasted approximately 36 hours, full recovery in 48 hours.  Treatment: ibuprofen and acetaminophen.
Information has been received from a physician concerning an approximately 11 year old female who on an unspecified date was vaccinated in the right arm with the first dose of GARDASIL. The patient was also vaccinated in the left arm with a dose of MENACTRA and DTaP. Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Changes in bowel movements. Abdominal pain, gas, bloating, diarrhea, pale stools, skinny stools, urgency and frequency, blood in stool
Shortly after my first covid vaccine, I developed serious symptoms of overactive bladder, including constant urgency, pressure and pain in the bladder and urethra. I had the two vaccines a month apart and had severe bladder symptoms from a few days after the first vaccine through the fall, in August or September. The symptoms gradually declined to almost normal by November. When i had a flareup of the bladder symptoms again after my first booster (3rd vaccine) in early December 2021, I wondered if it may be related. In this case, the symptoms only However, I am a strong supporter of vaccination and assumed it was a coincidence. As i am over 60 and was going to travel to visit my ailing parents, i obtained a 2nd booster the first of May 2022. The next day, my bladder symptoms returned. Again, not nearly as significant as the first occurrence, but still moderately significant (pressure, pain, urgency, nausea) for several days, gradually declining, although still not returned to normal as of the date of this report.
Day after injection-malaise, low temp, arm soreness extending to elbow from inj. site, body aches for 3 days. All symptoms resolved 4 days post administration.
A report has been received from a Health Professional concerning a 47 year old, Male subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 17-Sep-2013. The patient was administered two full doses of FLUMIST, one in each nostril which started on 17-Sep-2013. The outcome of the event of two full doses of FLUMIST, one in each nostril is unknown. The report was considered to be non-serious.
fully vaccinated at Pfizer, Covid in August 2021; Side Effects are brutal and worse than Omicron symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio; "COPD" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio; "Polio" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "fully vaccinated at Pfizer, Covid in August 2021"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "Side Effects are brutal and worse than Omicron symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive, notes: Positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Customer verbatim was Side Effects are brutal and worse than Omicron symptoms.Covid 19+ Fully vaccinated with Pfizer in Jan2021. Pfizer Booster received Sep2021. Covid+ in Aug2021. Received monoclonal antibodies infusion. Covid+ again Jan2022 prescribed the paxlovid. Held statin while taking paxlovid as advised.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Issues with her organs shutting down; Kidney failure; Inflammation in the stomach; booster; This is a spontaneous report received from contactable patient (Consumer or other non HCP) and Other HCP. Other Case identifier(s): UNT-2021-025221. A 47 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; treprostinil diolamin (ORENITRAM), first regimen oral since 05Jan2018 (Batch/Lot number: unknown), second regimen oral (Batch/Lot number: unknown) till Nov2021 at 1.25 mg, third regimen oral (Batch/Lot number: unknown) at 1.25 mg 3x/day and fourth regimen oral (ongoing) (Batch/Lot number: unknown) at 1.5 mg 3x/day (1.5 mg) for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension", start date: 05Jan2018 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot # unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, Lot # unknown), for COVID-19 Immunization. The following information was reported: MULTIPLE ORGAN DYSFUNCTION SYNDROME (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Issues with her organs shutting down"; RENAL FAILURE (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Kidney failure"; IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; GASTRITIS (non-serious), outcome "unknown", described as "Inflammation in the stomach". The patient was hospitalized for multiple organ dysfunction syndrome, renal failure (start date: 09Nov2021, discharge date: 14Nov2021, hospitalization duration: 5 day(s)). The action taken for treprostinil diolamin was temporary withheld on an unreported date in Nov2021 due to the events of renal failure and multiple organ dysfunction syndrome.  Additional info: The patient was not doing well after receiving her booster of COVID-19 Pfizer vaccine on 04Nov2021 and as a result on 09Nov2021, 3 years 10 months and 5 days after initiating PO Orenitram, the patient was admitted to the hospital due to kidney failure and issues with her organs shutting down. The patient was not able to take PO Orenitram while in the hospital. She had to restart the medication and titrate at a slower rate due to inflammation in the stomach.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Lot number: FK5127) and in Jan2022 as dose 2, single (Lot number: FL0007) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: COVID test type post vaccination=Nasal Swab.  Clinical Information: No other vaccine in four weeks. No COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Patient given vaccine. Grandma left room and headed to front desk. Grandma then came back around to medical assistant area stating patient broke out with hives/rash. Patient appeared to have 2-3 red blotchy spots on his forehead, 1-2 blotchy red areas on chest, and 1 blotchy red area on left arm above elbow. Injection sites were noted to have a red rash around both areas of each thigh so that the red rashy area covered most of the outer thigh area. Patient and grandma shown to closest exam room and one medical assistant stayed with grandma and patient while another went to get the doctor. The patient was examined by the doctor and the doctor ordered 3mL BENADRYL 12.5/5mL. Patient and grandma waited for 20 minutes per the doctors instruction and was in exam room closest to medical assistant station in case of further problems  After 20 min patient was re-examined and red blotchy areas on forehead, chest, and left arm where gone. The red rash on right thigh had lessened some and band aids where still applied in that area. The left thigh still had the same area size of red rash as when grandma first notified us but the area of rash had not gotten any larger. The band aids on the left thigh had been removed by grandma. Was checked with doctor and allowed to go home with instruction to call if any further problems and grandma expressed verbal understanding. Patient to also be referred to allergist.
1005A Pt c/o nausea and weakness after injection. Found in bathroom, taken to lounge. Skin warm, dry slightly pale, no SOB noted - pulse 68, steady. Placed in recumbent position, given sip of H2O. Felt better taken to office, symptoms returned 12-15' later. 911 called. 11/5/10 TC and pt who states ER stated not related to vaccine. Feels good no complaints.
19Jan89 pt recv 1 dose vax. 21Feb98 pt exp chickenpox. Approx 30 lesions w/general redness.
Since the second dose everything has been upper respiratory infections and ear infections every month. She has already had her tonsils, removed before this dose, tubes put in her ears. The Upper Respiratory causes runny nose and breathing issues, not to be hospitalized but low. They cannot issue with what is causing the issues. It seems the common cold is causing her to be seen in the urgent care. She has been tested for everything, Flu, COVID-19, Pneumonia. She is another round of antibiotics and medications for upper respiratory infection and ear infections.
No adverse symptoms reported; the patient was "inadvertently administered an expired dose of VAQTA today, 06/30/2020."; This spontaneous report has been received from a pharmacist referring to a 74 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 30-JUN-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot #: S001832, expiration date: 12-MAY-2020; route and dose details were unknown) for prophylaxis (expired product administered). No adverse symptoms reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
had rapid test that was Covid positive on 05May; headache; congestion and stuffy nose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 27Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05May2021, the patient experienced had rapid test that was covid positive on 05May. On an unspecified date in 2021, the patient experienced headache, congestion and stuffy nose. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller's daughter received 1st Pfizer vaccine on 27Apr. Daughter had negative Covid test the day prior to receiving 1st shot. Daughter had rapid test that was Covid positive on 05May with headache, congestion and stuffy nose. On 26Apr2021, the patient underwent lab test which included covid-19 test: negative and on 05May2021, the patient underwent lab test which included covid-19 test: negative. The patient did not receive any treatment for the events. The clinical outcomes of the had rapid test that was Covid positive on 05May, headache, congestion and stuffy nose were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Injection site started to feel itchy; Small round rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Injection site started to feel itchy) and VACCINATION SITE RASH (Small round rash) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergies to sulfa), Allergy to nuts (Allergies to walnuts) and Asthma.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started to feel itchy) and VACCINATION SITE RASH (Small round rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site started to feel itchy) and VACCINATION SITE RASH (Small round rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include Qvar inhaler.   The patient took Benadryl, but didn't have any relief. They then used a Benadryl cream, which helped with symptoms.
chills; strong muscle pain in the body; cold sweats; 38.2F; fatigue; Started with pain in the vaccinated arm (left) spreading to the left side; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) (at the age of 56-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No covid prior vaccination. Not tested for covid post vaccination. On 17Feb2021, at 12:00 AM, started with pain in the vaccinated arm (left) spreading to the left side. Next day, on 18Feb2021 patient experienced chills (electric matrass pad & 2 blankets), strong muscle pain in the body, cold sweats, 38.2F, fatigue. No treatment was given. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.