chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose;  All over muscle, body, joint, pain, stiffness, and swelling.  After 2nd dose; pain, stiffness, and swelling increased in severity.  Difficulty walking, grasping, and holding things.  After short or long periods of inactivity, pain and stiffness increases and I have an inability to completely close my hands (make a fist), and I'm constantly dropping things and can't pick up semi-heavy or heavy items.  Significant swelling at the joints especially the finger joints.  I did not have any of these all over body joint & inflammation issues until after I received the vaccine. I was tested for RA on 7/1/21 ( CCP Ab IGG (Cyclic Citrulinated Peptide)), I was told results are normal. Symptoms continue to date...
Hives - occur at night x2 nights, went away in morning patient took BENADRYL.
Child started having major sleep issues including insomnia and severe night terror Child started having Gastric Issue and chronic stomach pain Child started withdrawing  Child started turning away foods previously loved Child started having behavioral problems Child started hitting and biting
First noticed symptoms evening of vaccine - raised red patch of skin at injection site - burning and irritating to touch. About 3 inches in diameter. Area grew to this size over a 2 day period then she presented to pharmacy. Has not tried any treatments.
unilateral sensorineural hearing loss with unrestricted hearing on contralateral side; herpes zoster; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 64 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 14-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side. On an unspecified date, the patient was treated by a nurse practitioner for herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side.  The outcome of herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side was unknown.    The reporter considered herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the event unilateral sensorineural hearing loss with unrestricted hearing on contralateral side was determined to be medically significant.  Additional information has been requested.
On 12/24 Noticed a rash from head to toe. 12/25 nauseous, fever 101 degrees oral. Vomit x 1, rash present swelling around eyes, red eyes, sore throat. 12/26 nauseous, rash. 12/27 nauseous, rash - started BENADRYL 25 mg 1 tab BID. 12/28 BENADRYL 25 mg 1 tab BID - rash slowly resolving 12/29. Rash lessening. Reported to employee health.
Myalgia, Arthralgia, Diarrhea, FATIGUE Narrative:
Day 0 - Vaccine 4/30/12. Day 1 - Sore (L) arm at injection site 5/1. Day 2 - 5/2/12 under left arm swollen & painful. Day 3 - 5/3/12 - still swollen/painful - took ADVIL & applied heat.
Muscle ache; Bones ache; Headache; Fatigue; Nausea; Pain in lymph node of my left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 25mcg for unknown indication. It was unknown whether the patient had any known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00  (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:30, the patient experienced muscle ache, bones ache, headache, fatigue, nausea and pain in lymph node of left arm pit that has lasted after the other symptoms have gone. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle ache, bone pain, headache, fatigue, nausea and lymph node pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Non-English speaking pt received vaccination of Moderna , No symptoms post event, pt assessed and watched by paramedics x 45 minutes. Medical director notified with plan of daily follow up visit 3 days.
Inappropriate age/a 61-year-old patient received a dose of Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On 17-APR-2023, the patient received the 1st dose of Bexsero. On 17-APR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age/a 61-year-old patient received a dose of Bexsero). The outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 19-MAY-2023 The pharmacist reported that the 61 year old patient received a dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Subject lactating at time of vaccination on Aug 3. Baby, 7mos/M, had fever 38'C Aug 8-Aug 10. Baby recovered from fever. Infant was vaccinated with H. Influenza Jul 24 and had fever overnight.
Fever/Cough/Body Aches.  Covid +, Pneumonia and Sepsis
Pt. d/c 3/3/14 had PNEUMOVAX on day of discharge. Returned to hospital the following day with very swollen RUE and lethargy. She was given one dose vancomycin. Admitted and treated with several doses of TORADOL for pain. Started on several days of Amoxicillin which will finish as outpatient. Patient was afebrile, clinically improved and stable at d/c.
Pt seen 3 days after injection.  Had area of erythema of 7 1/2 X 12 cm on biceps left arm, site used for PNEUMOVAX.
Felt terrible / Felt raunchy; Did not get back to normal; Sleep Restless; feeling very bloated; Bit nauseous; Vomitting; Slightly elevated fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated) and NAUSEA (Bit nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Irritable bowel syndrome, Osteoporosis and Drug allergy (Cipro). Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Asthma, ATORVASTATIN for Cholesterol, OPIUM TINCTURE for Irritable bowel syndrome.   On 10-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever). At the time of the report, FEELING ABNORMAL (Felt terrible / Felt raunchy), MALAISE (Did not get back to normal), POOR QUALITY SLEEP (Sleep Restless), ABDOMINAL DISTENSION (feeling very bloated), NAUSEA (Bit nauseous), VOMITING (Vomitting) and PYREXIA (Slightly elevated fever) had resolved.            Concomitant medication Vitamin D  was reported.  Treatment drug information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up received update patient history, updated suspect drug dosage regimen, added concomitant drugs and new event added restless sleep and updated medical history and outcome of events
10APR96 pt fainted 3AM;numbness in hands & feet-progressed up legs on 13APR96 & had loss of balance & weakness in legs & hands;high BP (did not have high BP prior to vax);exp numbness & tingling of hands & feet;
This spontaneous report as received from a healthcare worker who placed a nurse on the line refers to a patient of unknown age. On 27-FEB-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H011780 expiration date 16-FEB-2014) (dose, frequency and route) unknown. No adverse effect reported. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 3DEC90, 4FEB91 & 24JUN91 & 4SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B; pt recvd a booster dose of Engerix-B 12SEP91; 10DEC91 lab tests indicated pt converted;
Given Japanese encephalitis vaccine #1 in clinic on 2-21-08 at 2:55 pm. Developed low-grade fever, chills, myalgias, nausea, and headache afterwards but no rash or hives.  Self-limited; lasted 1-2 days.  Given Japanese encephalitis vaccine #2 in clinic on 2-28-08 at 12:45 pm.  The next day she developed fever, chills, and rash at the injection site, which spread to her arms, legs, and trunk, but not palms or soles.  No oral lesions, swelling, hives, or shortness of breath.  This lasted 3-4 days with gradual improvement.  Rash is starting to fade, and fever has come down; however, low grade fever persists as of 3-3-08.  Should be noted that she started Bactrim DS 2 tabs bid for abdominal MRSA on 2-28-08.  However, she is still taking the drug, and the rash is starting to fade.
During charting of above administered vaccines, noted patient had received 4 year well vaccines two days prior on 10/24 (mom had marked "no" to vaccines in prior 4 weeks on screening form, and printed vaccine records available at time of visit did not list vaccines from 10/24. Vaccines received in duplicate: Fluzone, Lot UJ879AB, given in Left thigh on 10/24/22 MMRV, Lot W020548, given in Right thigh on 10/24/22 Kinrix, Lot 2kl4k, given in Left thigh on 10/24/22
Before the vaccine I had small amounts of hair loss due to my thyroid.  They were about dime and quarter size hair loss. Simple case of alopecia.  After the vaccine, I lost the entire back hair totally by May 15th.  And then by July 4th, I lost all of my hair.  I thought the vaccine could have caused my autoimmune to go into overdrive.  So a problem that was already active, became hyper active to attack my entire hair follicles.  I took the COVID19 vaccine in April 5, 2021 and the second does was on May 3, 2021.
Information has been received from a pharmacist and a physician concerning a 33 year old female consumer who on 21-MAR-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). The patient was to received varicella virus vaccine live (Oka/Merck) (MSD), but zoster vaccine live (Oka/Merck) was dispensed by the pharmacist and administered by the physician. No product confusion identified, the incorrect product was selected in error and the error was never caught. No problems or symptoms reported. Medical attention was sought in the physician's office. The physician called the pharmacist. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the pharmacist indicated this was a case of human error, that the pharmacist just grabbed the wrong one. She indicated it had nothing to do with the product, the label, the storage or anything else. It was just a mistake. She said the label was placed on it with the patient's name for dispensing, it went thru the pharmacist, the doctor, the patient, and wasn't caught. Additional information is not expected.
Mother reported by phone:  Reaction began 12-16 hours after immunization, entire left thigh with swelling and redness, lasted <24 hours, tx'd with ibuprofen.  Mom read in VIS that she should report adverse events, so she did.  Pt was not seen in the office.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004181, MCM-004187, MCM-004186, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Dull pain to injection site developed 6 days later with muscle spasms in neck radiating into rt shoulder. Seen at Urgent Care on 07/24: off work 1 week, started on Flexeril and Ibuprofen. Returned to Urgent Care 07/28: muscle spasms continue and lymph node swelling below rt ear developed. Continues to have muscle spasms on rt neck and shoulder. Alternating cold and hot packs to sites.
I had the booster at 10:30am about 11:30am I started itching on my legs then all over. I took 2 Benadryl pills but the itching continued. I took 2 Tylenol because my head started bothering me. The itching got worse and my throat was also feeling scratchy so around 4pm I took 2 more Benadryl pills. My skin was red and some whelps. So, I called advise nurse and was told go to Urgent Care for evaluation. The itching was all over my body 12/1/2021 feel better but still some itching and discomfort
pt recv vax & devel pain & stiffness lasting two to three days post inj;
day 1 severe hot and cold flashes  bad headache and severe arm pain today  could not stand up sat down felt Like I was going to pass out sat on floor  bad cold sweats  feeling  nauseous bad  diarrhea
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient experienced rash over large area of body several days after receiving booster. She did not experience any adverse events after her first 2 doses. Oral prednisone helped releive some symptoms but the rash came back, her doctor thinks it is booster related.
Low grade fever 99F or 100F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever 99F or 100F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Low grade fever 99F or 100F). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade fever 99F or 100F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Pyrexia: 99f or 100f (High) Patient had low grade fever 99F or 100F.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Patient is a 20 y.o. male with no significant past medical history presenting with acute burning retrosternal chest pain and diaphoresis, found to have diffuse concave STE with PR depressions and reciprocal changes in AVR, along with significant troponin elevation (peaked at 8K), c/f STEMI, LHC therefore pursued on 5/13 which revealed clean coronaries. TTE also with pEF and no WMA. Of note, pt recently received 2nd dose of Moderna COVID-19 Vaccine, myopericarditis therefore considered, CRP elevated at 45, subsequently started on high dose ASA + colchicine therapy. CMR also pursued and was noted to be unremarkable. Pt without return of presenting chest pain.
Red rash for six days, then black  and blue at site of injection, then red rash again..  NUsea for ten days, and intestinal issues
a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263367 and 2019SA263394 (same reporter).  This case involves a 20 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the right deltoid on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
On 2/10/00, the pt called to ask if there was any sulfa in the Flu vaccine. The pt received the vaccine on 01/19/00 within less than 24 hours, the pt developed sore throat. The symptoms worsened on the second day, sought medical intervention, pt was placed on antibiotics. Symptoms worse in 48 hours.  Pt saw a throat specialist and was diagnosed with allergies. Client has jut completed a course of Bactim prior to flu shot. Stayed on Bactrim again this week and developed hives. Sulfa allergy is suspected.
moderate high fever 103-104 3 days p//vax;also w/vomiting;
This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation. Other diagnoses E87.6 - Hypokalemia R09.02 - Hypoxia R74.01 - Elevated transaminase level J18.9 - Multifocal pneumonia U07.1 - COVID-19
pain in right arm down to elbow and across back of right collarbone.  Pain is tolerable during the day but if I sit on the couch or try to lie down to go to bed, the pain intensifies greatly. Get occasional tingling in right fingers.
Intrauterine fetal death discovered at 24 weeks and 3 days gestation. Infant girl delivered on March 24, 2022.  This is patient's second pregnancy. First pregnancy  was successful.
increased blood pressure, increased stress levels, increased heart rate, fatigue, body aches, severe lower back pain, worsening eye sight - now need bi-focals; severe cramping due to assigned blood pressure medications; lymph node swelling under left armpit; swollen/bleeding/peeling lips and gums
Information has been received from a licensed practical nurse (LPN) concerning a 23 year old female with papilloma viral infection (diagnosed in 2006), peanut oil allergy, egg allergy and allergy to nuts and a history of Papanicolaou smear abnormal, loop electrosurgical excision procedure for the treatment of dysplasia (2007) who on 08-DEC-2006 was vaccinated with her first dose GARDASIL (653978/0955F), 0.5 ml, IM, left deltoid. Concomitant therapy included YASMIN, which was discontinued on approximately 12-FEB-2007. On 13-FEB-2007, the patient received her second dose GARDASIL (lot #654702/0011U), 0.5ml, IM, left deltoid. On that same date, the patient was placed on therapy with YAZ. On 22-JUN-2007, the patient received her third dose of GARDASIL (lot #657868/0523U), 0.5ml, IM, left deltoid. Therapy with YAZ was discontinued (date and reason not reported). On 24-AUG-2007, the LPN reported that the patient was pregnant Last menstrual period reported as 28-JUN-2007, estimated delivery date is 03-APR-2008. Follow up information has been received from a nurse who reported that on an unspecified date the patient had a vaginal preterm delivery at 35 weeks gestation due to a partial placental abruption with pre-term labor. She delivered a healthy, normal male, weighing 6 pounds 4 ounces with good cord blood ph values at delivery. No additional information is expected.
soreness at site of injection - lasted 10 days itchiness at site of injection - lasted  13 days lump a few inches away from injection site - lasted 14 days  9 days after injection, noticed that both thighs were retaining large amount of fluid (like a water balloon). Larger veins were visible at the surface, pronounced, raised in a ridge about the size of my finger...at least 6-8 veins across each thigh.  There were literally waves of swollen flesh. Very unusual, in fact, the way they looked was very scary. There was no pain or aching at the time. I elevated legs, iced them, took a diuretic for the next 3 days and they eventually deflated. Following few days had aching from waist down. Nothing since.
left sided radial fracture, left sided superior and inferior pelvic rami and left sacral ala fracture. Orthopedic surgery was consulted and reduced and splinted her wrist. Repeat XRs were stable. They recommended non-operative management of her fractures for now. During her hospitalization, she had issues with orthostatic hypotension. Internal medicine was consulted and adjusted her antihypertensive medications. This resulted in improvement to her hypotension with standing and she was able to work with therapies. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a female pharmacist who was vaccinated IM with a second dose of Gardasil. The pharmacist reported that she did not feel the second injection. The patient's outcome was unknown. Additional information has been requested.