chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting Friday patient experienced extremely painful area around administration site in the arm. The later she started to experience achy joints described as flu-like symptoms and extreme fatigue. On day 4 she reports about being 80% well with aches being gone but still muscle weakness.
FEELS DEAD; DIZZINESS; CAN'T MOVE ARM; SHAKINESS; CAN BARELY WALK UP THE STAIRS; UNABLE TO DRIVE; ARM PAIN; MUSCLE ACHES FROM HEAD TO TOE; FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021, the subject experienced feels dead. On 30-JUL-2021, the subject experienced dizziness. On 30-JUL-2021, the subject experienced can't move arm. On 30-JUL-2021, the subject experienced shakiness. On 30-JUL-2021, the subject experienced can barely walk up the stairs. On 30-JUL-2021, the subject experienced unable to drive. On 30-JUL-2021, the subject experienced arm pain. On 30-JUL-2021, the subject experienced muscle aches from head to toe. On 30-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels dead, fever, muscle aches from head to toe, shakiness, arm pain, dizziness, can barely walk up the stairs, unable to drive, and can't move arm. This report was non-serious.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Reported swelling and redness at injection site described as a hard lump. Also redness and swelling of axillary area of left arm. Said to be soft when touched. Started 05/12/16. PCP said to give fever/pain reducer as needed and apply warm compress. Take to ER or urgent care if it worsens. Call 911 if any signs of symptoms of anaphylactic reaction occur. 5/18/16 Follow up call - Redness is gone and swelling is almost gone per mother.
12 hours after receiving my 2nd shot. I developed a fever of 102, terrible chills, nausea, headache.  Sometime during the next few hours I got itchy and then got a total body rash similar to hives.
pt devel aching, malaise & an inj site rxn (redness) in OCT96 p/vax;no other info available;this case was reported by MD via company representative;
received the ACTHIB vaccine that was expired with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 years old male patient who received the HIB (PRP/T) VACCINE [ACT-HIB]  that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 07-Dec-2022, the patient received a  dose of 0.5ml of suspect HIB (PRP/T) VACCINE, (frequency: once) (lot: UJ635AAA  ; expiry date: 30-Nov-2022) via unknown route in unknown administration site for immunization. It was reported that the  patient received the Acthib vaccine that was expired with no reported adverse event (expired product administered) (onset date: 07-Dec-2022; latency: same day). Thee reporter will reschedule the patient to come in to get another dose of the vaccine   Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Extreme shortness of breath that begin 36 hours post vaccine #2. Almost 4 weeks out abs I am no better. Have been treated with many medications and nothing has worked.
Pt complained of onset of arthritis in right hand beginning shortly after the second vaccine.  Patient is not sure if they are related but had no issues prior to the vaccine.
blue bruising at the base of right finger; Skin around my lips was red and swollen; skin around my lips was red and swollen; My right pinky finger was white and  numb- quite likely Reynaud's syndrome; my right pinky finger was white and numb; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (blue bruising at the base of right finger), CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's syndrome (had Reynaud's several decades ago.).    On 11-Feb-2021 at 3:50 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb). On 07-Mar-2021 at 4:00 PM, the patient experienced CONTUSION (blue bruising at the base of right finger). At the time of the report, CONTUSION (blue bruising at the base of right finger), CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) with response to the events was not applicable.  No concomitant medications were reportd.  No treatment medications were reported.  On 07-Mar-21, patient noticed that his right pinky finger was white and numb - quite likely Reynaud's syndrome. She had another episode later that day at 4 pm in which the finger was again numb, this time it had blue bruising at the base. Both times it was very hard to warm up the finger. Because it is unusual to have two autoimmune reactions in one day, patient made note of it. The incidence of Reynaud's continued  2-3 times/day over the next week and then subsided. Patient stated that she had Reynaud's, several decades ago but never this many times or this severe.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Updated reporter's information and outcome of all events from unknown to  recovered/resolved.
After 1 and 1/2 days, itching, red + swollen and hard, no fever, 3" long 1 1/12" wide. Took 3 weeks to resolve.
7/26/12 Pt seen NP Dx with cellulitis. Rash on left upper arm - described as erythematous macular, painful, confluent in arrangement. Warm and exquisitely tender to palpation 3" x 3" area. No discharge or bleeding. Told to use hot compress on site, continue ibuprofen, Rx'd KEFLEX qid x 10d. Seen at hospital and given IV antibiotics.
Information has been received from a registered nurse concerning an 8 year old female on 08/22/95 (received at different facility)  and 01/12/01 was vaccinated with MMRII.  On approximately 01/14/01, the patient developed a "rash" and a fever. the patient was diagnosed, The patient's mother informed the nurse that a physician later told her that the rash was not related to the immuniozation. The patient gabe the nurse a note from a physican stating the patient had a lab-confirmed case of measles. The patient had a rash and was generally "not well" feeling. The patient's sister experienced a similar event after vaccination with MMRII (WAES01040482). In follow-up, the nurse reported that on 11/24/01, arubella titer "resulted as immune". Additional information has been requested.
swelling at injection site, droplets of blood at injection site . Placed ice pack on injection site for 20 minutes, pt waited in office 20 mins after the injection was given. Pt had no other reactions at this time. Pt left office at 12:10pm.
patient sat on observation chair, slumped over some, said she felt tired, patient then would not respond to RPh questions, 911 called, patient woke up vomiting
Patient was given the vaccine at 12:26 pm and was advised to wait for observation. While waiting, patient started to complain of some anxiety and lightheadedness.  We advised patient to wait a little longer for further observation. A few minutes later, at 12:36 pm patient said the lightheadness was getting worse and then passed out for a few seconds while waiting sitting in our observation area. The pharmacy technician was in the area to hold up the patient and keep her calm while patients mother requested that EMS/911 be called.  EMS came minutes later and patient was coherent and talking to the technician and her mother. EMS asked patient if she wanted to be taken to the hospital and patient agreed.  Patient called a few hours later to follow up with pharmacy staff and informed us that she was discharged and feeling better.
SHOULDVE BEEN GIVEN THE PEDIATRIC SHOT== NO ADE REPORTED FROM PT MOM
FATIGUE, ACHEY, JOINTS STIFF, HEADACHE, CHILLS, INJECTION SITE RED/RAISED/HOT
(Athletic 40 yr old female endurance athlete, 115lb, no prescription meds or hormonal birth control). Have confirmed HLA-B27 antigen disorder (autoimmune eye issues, not in flare, not on meds). Also have chronic history of low-ish iron/borderline anemia.  MILD case of blood spots / petechiae rash on both lower legs  & forearms 48 hours after both pfizer vaccines, deep muscle aches, one severe nosebleed (nosebleeds are chronic, but had been under control for some months). Feeling of blood pressure surges in large muscles, esp lower legs.  Petechiae resolved in one day and did not worsen. Nosebleed clotted normally in 5min. Consulted with family dr over telehealth & followed up with routine yearly cardio exam. No concerning pulse, headache or chest pain, did not feel need for urgent care.  Normal athletic function recovered in 3 weeks, yearly physical vitals were normal 1.5 month later.
the temperature excursion happened on 11/14/2020. On 11/16/2020, MMR II and VAQTA were administered to one patient before evaluation; This spontaneous report as received from a medical assistant refers to a 1-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant drug, and drug reactions/allergies was not reported.   On 14-NOV-2020, there was temperature excursion happened with hepatitis A vaccine, inactivated (VAQTA) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II). On 16-NOV-2020, the patient was vaccinated with the improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T014835, expiration date 17-JUL-2021; dose and route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (lot # S029454, expiration date 19-SEP-2021; dose and route of administration were not reported) for prophylaxis (product storage error). It was reported that the hepatitis A vaccine, inactivated (VAQTA) was exposed to a temperature of below 2 Celsius degree (1.9 C) for 1 hour 15 minutes and 0 seconds. There was no previous temperature excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Started with really bad headache then trouble breathing . stay at site for almost and hour .Very dizzy could not stand .Blood pressure was elevated. Fever and body aches and nausea for over a week.
heart palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations". 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.  Additional information: One of her husband's golfing buddies had heart palpitations from Covid booster. The event was reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300319508 same reporter and suspect product, similar events, with different patients;
Received flu shot, Fluviron, Lot #765704, 11/17/03. Came in to office 11/18/03 with a pruritic dermatitis-type rash on both arms, both legs, and abdomen. No other complaints. Had never had a problem with previous flu shots. Treating with OTC antipruritic creams and lotions.
Chickenpox (mild case) began on 2/16/00 after being exposure in this vaccinated pt. Had about 30 maculo-papular lesions on trunk, scalp and labia.
Diarrhea; Fatigue; ache; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: GNG204) via an unspecified route of administration in left arm on 18Mar2021 at 14:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, prostate cancer, cholesterol and blood pressure. The patient had allergies to sulfur. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received medications (unknown) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG198) via an unspecified route of administration in left arm on 25Feb2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced diarrhoea, fatigue and ache. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diarrhoea, fatigue and ache was not resolved at the time of this report.   No follow up attempts are needed. No further information is expected.
malaise, fatigue, myalgias, split finger nails, nausea, rhinorrhea
Approximately 25 minutes after my shot my whole body went tingly- from my head to my toes.  I became light headed, dizzy, and my heart was beating rapidly.  I drove myself to an ER because I thought I was having an allergic reaction.  They kept me for a few hours but I did not receive any treatment.  The other symptoms subsided, however I?m   concerned that my left arm is still tingling.
Tinnitus (high-pitched ringing in the ears) starting after vaccination.  Doctor's visual inspection of eardrum indicates everything looks normal.  Wait and see if tinnitus gets better/worse/same.  Recommended to contribute with second vaccination dose.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 09-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (dose and route were not reported, lot # K024035, expiration date 26-NOV-2016) and with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
allerg react of unk sx; pt called MD office from vacation in MI this AM & said thought was having allerg react to the shot had 5 days ago; not seen by MD; 20AUG93 fever 102 1 wk p/vax; rash on arms x 2 days;
Next day post vax, the pt became ill with nausea and vomiting. Pt had fever but did not take temperature, became very lethargic.
Neck swelling, general pain, flu like symptoms, fever, exhaustion, muscle and body aches, swollen glands, headache, injection arm feels like it?s going to fall off
My vision in both eyes went blurry.  I could not read even with my usual reading glasses and a magnifying glass.  I could not see anything more than 5 feet away clearly even though my right eye is 20/20 vision.  My eyes ached.  By the next evening all blurriness had cleared up.  No repeat problem.
Night following shot severe lower back and leg pain, headache, freezing feeling, drastic temperature fluctuations severe thirst, tingling feeling in lega
The patient received a dose from a vial more than 30 days on the fridge; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of the first episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and the second episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced the first episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, last episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial was initially stored in the refrigerator on 20-Apr-2021. The patient did not experienced any adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up information received contains no new information. On 02-Nov-2021: Follow-up information received contains additional details related to the Events. On 05-Nov-2021: Follow-up information received contains no new information.; Sender's Comments: This case concerns a 36-year-old, female patient, with no reported medical history, who experienced Expired product administered. This event occurred on both first and second dose administration of the Moderna COVID 19 vaccine. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In JANUARY 2011, a healthcare provider at a healthcare facility administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In OCTOBER 2016, the patient was treated by a healthcare provider at a healthcare facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 76 years old female patient. The patient's medical history included shingles rash. the patient was vaccinated with ZOSTAVAX in early November 2012. Patient route of administration and lot no. were not provided. No other co-suspects were reported. No concomitant medications were reported. The patient developed an itchy sensation on her back after receiving vaccination with ZOSTAVAX. It started gradually since receiving the vaccine. She explained that the sensation is in a patch of space on her back and is not indicated by any changes in the skin. The patch is located in the same location as a previous shingles rash she'd developed 2 years ago, prior to receiving the vaccine. The patient did not seek medical attention. Treatment included ice and OTC itch creams. The outcome of developed an itchy sensation on her back after receiving ZOSTAVAX is unknown. The relatedness for developed an itchy sensation on her back after receiving ZOSTAVAX is unknown for ZOSTAVAX. Additional information has been requested.
Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.
Client was given Adult dosage of Hep A vaccine on 10/14/2020. Mother reports no adverse side effects on 11/3/2020. Mother does report the clients iron and lead levels were increased at his last PCP appointment. RN contacted clients PCP with no return call at this time. Medication error was found during monthly inventory of vaccines on 11/2/2020.