chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from pharmacist on 15-OCT-2018, concerns a 62-year-old, adult, female patient. On 12-Sep-2018, the patient was administered FLUAD (TIV) [route of administration, anatomical location, dose, batch number and expiry date: not reported]. On an unspecified date in Sep-2018, one week after vaccination, the patient had a red rash on thighs, armpits and groin. On an unspecified date in Sep-2018 (reported as two weeks after), the patient had recovered from the event. The reporter assessed the case as non-serious. Follow-up received from the pharmacist on 16-Nov-2018: Start date of the suspect vaccine was changed from 12-Sep-2012 to 12-Sep-2018. The outcome of the event red rash was changed from not reported to recovered. Narrative was amended accordingly.
Mom reported 104 fever that lasted 3 days & also rash all over body that was there for these 3 days. (Mom says brother had this same reaction after his 1st MMR).
Initial misuse report received from a healthcare professional on 27 September 2013 and on 21 March 2014 . A 17 old (gender unknown) was given FLUZONE ID on an unknown date. The patient received incorrect product. No adverse event was reported. The list of documents held by sender: None.
Pt recvd 1 & 2 doses of vax uneventful; 4 days post 3rd dose of vax pt exp lightheadedness, bad h/a, SOB, paresthesias on one side; Required hospitalization (ICU); MD suggested poss assoc of event w/vax;
Both vaccines given in Left arm due to double mastectomy. Left arm swelled within 2 hours of vaccine completion. Patient noticed rash on the front of stomach 24 hours after vaccines given. Rash itches but no visible blisters. Blood sugars dropped to approximately 60mg/dL. Rash still present 10/20/2018. Patient has used hydrocortisone cream and rash has improved but still present.
Moderate stomach aching lasting 2 days, moderate diaherra lasting 12 hours. Sore right tricep, swelling, redness, heat 4 inch circumference lasting 3 days, 4th day was much better.
Extreme pain in left shoulder; upper back pain on left side; left arm pain; numbness and tingling in fingers of left hand; numbness and tingling in fingers of left hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 12Oct2023, outcome "not recovered", described as "Extreme pain in left shoulder"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2023, outcome "not recovered", described as "left arm pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 12Oct2023, outcome "not recovered" and all described as "numbness and tingling in fingers of left hand"; BACK PAIN (non-serious) with onset 12Oct2023, outcome "not recovered", described as "upper back pain on left side". The events "extreme pain in left shoulder", "upper back pain on left side", "left arm pain" and "numbness and tingling in fingers of left hand" required physician office visit. Therapeutic measures were taken as a result of arthralgia, back pain, pain in extremity, hypoaesthesia, paraesthesia. Additional information: Treatment for adverse events was diclofenac.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around September of 2021. I had Eczema 50 years ago. It came back a little after the first two vaccinations, but I did not think anything of it. A couple of weeks after my 3rd vaccination, the eczema came back a lot worse. I would put cortisone cream on it and it would come and go. In November, I saw the doctor. The doctor gave me Hydroxyzine, tacrolimus and a cortisone shot. The hydroxyzine did not help, but the tacrolimus did help, but did not go away. It took a while, but the shot seems to help some. It went away, then came back again. I also got a blood clot the first of December. I went to the ER. They did a sonogram and said it was in the greater saphenous vein. It went to foot to ankle to calf.  Since then, I have had 4 sonograms and it has not gone away. Now I am on aspirin, and we are waiting to see. It may not go away. The blood clot could be from a cortisone shot I had earlier for the eczema.
Ramsay Hunt syndrome 3 days after second vaccine shot; This is a spontaneous report from a contactable consumer(patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12May2021 (at age 25-years-old) (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient experienced Ramsay Hunt syndrome 3 days after second vaccine shot on 15May2021. Treatment was received for the event that resulted to doctor/ healthcare professional clinic visit and emergency room/urgent care. Outcome was not recovered. Patient was not diagnosed with COVID prior to vaccination.
This spontaneous report was received from a physician referring to a 68 year old female patient without drug reactions or allergies. The patient's medical history included high blood pressure and breast cancer. On 29-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot number, expiration date, dose, route and anatomical location were not reported. Concomitant therapies included Atenolol and Amlodipine. On 31-OCT-2015, the patient broke out in a rash in right arm and had one rash like spot on left arm, she noted that her rash was painful and she was not able to sleep (insomnia). On 03-NOV-2015, the patient went to the physician's office and she was diagnosed with Shingles from receipt of the vaccine. As treatment, the physician wrote a prescription for 1 gram of VALTREX twice daily for five days. At the time of the report, the outcome of Shingles and insomnia was reported as not recovered/not resolved. There was not a product quality complaint involved. Additional information has been requested.
Pt. experienced dizziness post first pfizer vaccination. Pt. found on ground conscious and responsive. EMS called. Vital signs stable. Pt. given juice, cleared by EMS.
very sore left arm; swollen arm; achy; tired; my lymph nodes became swollen/swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04524A, 003C214 and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands). At the time of the report, PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands) outcome was unknown.            Reporter reported that she received her pneumonia shot on same day as her COVID-19 booster dose. (01-DEC-2021)   No treatment drug information was provided.   This case was linked to MOD-2021-428245 (Patient Link).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Sender's Comments: US-009507513-1708USA013517: US-009507513-1708USA013519: US-009507513-1708USA013516: US-009507513-1708USA013518.
Rash on face, back, trunk and legs.  No fever.  Eating and drinking fine. Not crying, seems to be playing normal.
pt recv vax went to work 2PM & felt as though throat was swelling this sensation lasted 45min 5PM devel a fine rash from elbow to hands some on thighs & chest;itching;
@1215 Pt complained of R arm numbness post vaccination. +CMS to R arm. Instructed pt to keep moving R arm and to ice vaccination area. Instructed to message PMD today about her symptoms, follow up with PMD if pain lasts for more than 3 days, and ED precautions. Pt verbalized understanding. Dr aware.
Chills , swollen glands in neck, can?t turn head to one side without pain, runny nose green, fatigue, heavy eyes
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-FEB-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Give intradermal vaccine influenza vaccine to 66 yr old licensed for 18-64 yrs.
was not immune after receiving the 3 dose series; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In 1998, the patient received the 3rd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination was not reported. The patient received 3 doses of Engerix B in 1998 and was found not immune at the time of reporting. The patient was recommended for re-starting the Engerix B series. Consent to follow up was granted.
This spontaneous report was received from an approximately 63 year old female nurse practitioner, reporting on herself. No information on patient's medical history and concurrent conditions was reported. On unspecified date in November 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Concomitant therapy was not reported. Approximately in 2014, 10-12 days after vaccination, the patient experienced right trigeminal mandibular pain that was lasting for 4 weeks. Dental cause was ruled out. The persistent pain relieved after ibuprofen was administered. The outcome of pain in jaw was reported as recovered/resolved, on an unknown date. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. The event of right trigeminal mandibular pain required medical/surgical intervention to prevent one of the serious criteria as the patient went to dentist and was considered to be medically significant by the reporter. Additional information has been requested.
Tech administer vaccine (1st dose). After approximately 5 minutes, the patient stated she felt light headed, dizzy and had trouble breathing. Checked her blood pressure (Check #1 156/127 Check #2 148/93) Admnistered Benadryl with patient consent. She stated her face felt numb and she continued to decline. Pharmacist called 911 and technician prepped EpiPen explained to patient and administered at 4:59 pm. Patient was turned over to the paramedics and transported.
On 12-22-2020, approx. 2 days after vaccine, I noticed several non-tender lumps under my chin/adjacent to left jaw line ~ small gum drop size lumps seemed to congeal together over next 9 days into a single half-dollar dollar sized lump - not completely round.
Pt had tightness in throat, pale, wheezing and collapsed in clinic lobby. Mom took him right to ER. He had anaphylaxis to vaccines. Received Epinephrine IM, BENADRYL IV, SOLUMEDROL IV and PEPCID IV. Continued SOLUMEDROL q 4 hours x 24 hours.   7/7/09 Hospital records received DOS 6/0/09 to 6/3/09. Assessment: Anaphylactic shock post varicella and hepatitis B vaccines. Patient presents with shortness of breath, trouble breathing, throat swelling, weakness, nausea - 10 minutes after getting vaccines. Rapid breathing, anxious.  7/9/09 ICD-9 codes received: 9994. 74689, V5866, V5861
Rt arm with fluctuant erythematous mass - I/d --> (-) culture Clindamycin & ROCEPHIN.
Dizziness; vertigo; Nonintractable headache, unspecified chronicity pattern:  ear fullness   Sought diagnosis/treatment from Ear, Nose and Throat physician (12/1/21)- prescribed Motrin 200 mg -- 2 tablets three times with food a day for next two to three days. If symptoms are not improved, needs to have neurology evaluation   Symptoms have not improved, have appointment with Neurologist physician (first available) 02/01/22
I ended up getting enlarged lymph nodes going up through my neck. The swelling in my neck has gone down but the rest has not. We have not performed any biopsies or any tests other than an ultra sound and checking my CBC which is continuing to stay normal at this point.
INTENSE PAIN IN THE HAND OF THE LEFT ARM, IMMOBILITY OF THE HAND AND FINGERS. EMERGENCY ADMISSION
Patient became pale and stated that they felt dizzy and nauseous approximately 1 minute after injection. Stated their face felt warm. Patient was instructed to recline with feet elevated until dizziness subsided. This took about 7-8 minutes.
Patient vaccinated on the left arm SQ, might have bruising in a day. Unknown as of now. No signs of adverse event after vaccination.
There is redness warmth and induration from her left mild deltoid area o almost the elbow. Kinrix and Varicella were given on L deltoid. Benadryl and Ibuprofen given in clinic. Rash showed some improvement with Benadryl and Ibuprofen.
Pt got hives all over his body just after he left out clinic. Pt brought photos of the hives to the second clinic (we didn't give him his second dose)
Patient started experiencing symptoms about 6 hours post vaccine administration including chills headache fever muscle aches and fatigue that lasted a full 24 hours before resolving.
Had vaccinations, Dtap, IPV, Comvax, Prevnar, Rotateq on Wed 9/6/06. Parent noticed what appeared to be blood in stool Thurs 9/7/06. On 9/9/6 + hemocult in office. Baby exclusively BF Dr to monitor condition at this time. Mom to monitor conditions at this time. Mom to monitor dairy intake, IE milk allergy baby.
The pt experienced multiple joint and muscle pain of severe intensity that has been somewhat migratory, often bilateral accompanied by joint laxity and muscle weakness resulting in severe compromise of all ADL activities and functional mobility. Treated by rheumatologist  with dilofenal and sylfasalazine
Psoriasis aggravated; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Psoriasis aggravated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis aggravated.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated). At the time of the report, PSORIASIS (Psoriasis aggravated) had not resolved.        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.   The concomitant medications were not reported.   Reporter did not allow further contact
The pt was brought into the ER in full cardio respiratory arrest. Autopsy states cause of death as hypernatremia.
14 days later, a few bumps appeared near the injection site; Physician said it was probably chicken pox; This spontaneous report was received from Representative and refers to an 12-13 months old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-FEB-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml (strength, lot #, expiry date, route of administration, and indication were not provided).  On 09-MAR-2023 (also reported as 14 days after admision of VARIVAX), a few bumps appeared near the injection site. Physician said that it was probably chicken pox. No reported further spread of bumps. At the time of reporting, the outcome of the events Vaccination site mass and Varicella post vaccine was not known. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding Vaccination site mass and Varicella podt vaccine.  The causal relationship between Vaccination site mass and Vaccination site mass and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Additional information has been requested.
PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case
No other information provided; Caller reports dose of expired VAQTA administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 02-AUG-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA)vial,  dose: 1 milliliter, lot # T033517, expiration date: 11-JUL-2021,  for prophylaxis (route of administration was not reported). No other information provided. No product quality complaint or additional adverse events were reported.
pt recv vax 10FEB97 & 27FEB97 pt devel classic chickenpox;
patient said she was nervous about getting the shot & needles. I told her to relax and she would be fine. After getting shot she fell over, started sweating & shaking. I called 911. She wanted to lay down. Paramedics took her BP and it was low but she started to feel ok. She refused going to hospital. A friend came and drove her back to work
when pharmacist administer vaccine to the patient arm,  most of the dose leaked out due to the faulty syringe so per CDC COVID 19 vaccine administration errors and deviations protocol another authorized dose was administered to the patient immediately. Also patient reported dry mouth feeling after the vaccination
psoriatic arthritis flare up; pain in rib cage; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4317437-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "pain in rib cage". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of psoriatic arthritis flare up and pain in bib cage was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) :The reporter's causality for the event(s) of psoriatic arthritis flare up and pain in bib cage was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events psoriatic arthropathy and musculoskeletal chest pain cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.