chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on MAR-2021. This report was non-serious.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-AUG-2015 the patient received an expired dose of M-M-R II (lot # J008728 with expiration date of 26-JUL-2015; strength, dosage, frequency and route unspecified). No adverse effect was reported. Additional information has been requested.
Began to feel flu like symptoms - fever, chills, joint and muscle aches, and the injection site hurt. On 11/07/2013 the injection site began to feel hot, the injection site turned brite red, about a 3.5" diameter area, and itched.
This retrospective pregnancy case was reported in a literature article and described the occurrence of polydactyly in a infant. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with polydactyly. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of polydactyly was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the polydactyly may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of polydactyly in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccine (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed polydactyly. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported The authors did not comment on the relationship between polydactyly and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of 12 valid cases in the same literature article.
everyday getting weaker and weaker; legs cannot support weight for the first time in his life; can't get out of bed; Fever with a temperature range of  99.9-100.8 F intermittently; pain, hurting; headache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently) and MYALGIA (pain, hurting) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Aug-2021, Body temperature: 99.9-100.8 f (High) 99.9-100.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Unknown amount of vaccine ran down the back of his arm; A spontaneous report was received from a consumer concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had an unknown amount of vaccine drip down his arm.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter   On an unknown date, the patient received their first of two planned doses of mRNA-1273.   On 01 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Feb 2021, during administration, some of the vaccine dripped down the back of the patient's arm and onto his pants. The amount of vaccine administered was unknown. Treatment information was not provided/unknown.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event vaccine dripped down arm was considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 030L20A  with no associated AEs.
Consistent twitching in left eye - Starting immediately after2nd  injection. Pressure in chest & tingling in both arms started about 5-6 days after 2nd injection.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/19/2021 with Pfizer EW0162 IM right deltoid.
Rash ~ 5-7 days after receiving 1 year shots. Patient is a 12 month old male who presents today with his mom for a 5-7 day history of rash. According to mom the rash started with pink cheeks and then spread to his trunk. It is now spreading to his arms and legs. He has been very irritable and has been snoring, which he has not down in the past. She feels that maybe he is drooling little more than usual and appetite had been poor He does have some rhinorrhea as well. Diaper area is also affected with rash. He had his 12 month vaccines 12 days ago which included an MMR.
Pt seen in emergency room on 4/4 for abdominal pain and vomiting that began the evening of receiving her covid vaccine.  Pt found to be in fulminant liver failure and ultimately transferred to a tertiary level care center at hospital.
Injection site reaction, swelling, erythema, myalgia, fever/chills.
I became drowsy within a few minutes of receiving the first dose of the Moderna vaccine. Since receiving the first dose, I have experienced chronic fatigue. After getting 7-8 hours of sleep a night, I wake up feeling fine, and then I am physically tired within 2-3 hours of normal activity.
2 days after vaccine around 3pm i felt heart palpitations. went for a walk to see if it would subside. as i was walking my left leg buckled a bit, within a few seconds of that happening my entire body went limp. the person i was walking with grabbed me, i could not stand. i looked up and i could not see, it did not go black, all i can see were wavy lines. that lasted about 10 min until i came to . since that day i feel the nausea coming up and my head pushing down, as if it is in a vice. i feel tired and disoriented (loopy) It has been difficult to funtion. It is now almost 1 week since 2nd dose and I still have the same symtoms.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD therapy type (albumin status): rHA, lot # L031602, expiry date 18-FEB-2017, lot # M004892, expiry date 25-JUL-2017 (strength, dose and route of administration were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
HYPERtension tingling lips Narrative:  presented back to vaccine clinic 25 minutes after administration with c/o tingling lips. B/P 144/96, HR 78, O2 99% at 10:13, Benadryl 25 mg PO at 10:15. BP 140/87 at 10:20. Lips no longer tingling at 10:35. 10:39 BP 118/77, HR 76, O2 99%. No further monitoring needed.
No additional adverse event; inadvertently administered a dose of RECOMBIVAX instead of ENGERIX-B; This spontaneous report as received from a medical assistant (also reported as nurse) refers to a 23- year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 28-MAY-2020, the patient was inadvertently vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal-free injection, lot # R028529, expiry date 09-JUN-2021 (dose, route of administration and vaccination site were not specified) instead of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B). No additional adverse event was reported. Product quality complaint (PQC) was not involved.
Medication error: Monovalent Covid-19 vaccine given instead of Bivalent covid-vaccine. Pharmacy has identifed root causes of the error and is putting mitigation strategies into place including barcode scanning to minimize chances of error re-occuring. A total of 3 patients have been impacted by this error.
Sore arm; Headache; Joints kind of hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting). The patient was treated with DOXYCYCLINE on 23-Nov-2021 for Adverse event, at a dose of 100 milligram twice a day; OMEPRAZOLE on 23-Nov-2021 for Adverse event, at a dose of 40 milligram twice a day and METRONIDAZOLE on 23-Nov-2021 for Adverse event, at a dose of 500 milligram three times a day. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and ARTHRALGIA (Joints kind of hurting) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was taking unspecified concomitant medications for other health conditions.   This case was linked to MOD-2021-396953 (Patient Link).
C/o bumps on chin and cheeks that started on 12/10/09. Now states she can feel them more. Denies itching, fever, HA, chest pains, GI upset or muscle/joint pain. No problem after AVA 1, or HEP 1. Denies change in diet/soaps/ lotions. No h/o allergies. PMH: no chr medical probs. Digital pictures received and reviews by the agencies Dermatology.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Patient reports to pharmacy that he is diagnosed with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy). Diagnosing neurologist said FLUVIRIN caused the condition.
excessive, unconsolable crying-day p/inj for 3hr, then off & on x 5-7days after
I had a rash on injection site appear 9 days after vaccine. It was warm, itchy, painful to the touch and a red streak about 2 inches long.
The pt received Influenza 0.5ml, IM, LA at approx. 12:45. At 14:31, he was found DOA in his car at a local plaza. The fire dept report states that the pt was found slumped behind the wheel of his car. Pt was found to be pulseless/apneic and clutching a NTG bottle in his left hand. The pt was cold, mottled with pooling in the face and arms. Estimated down time 1/2 to 1 hours, according shopkeeper (maybe longer) who noticed car in space for extended time. No trauma noted. Pupils fixed/dilated, pooling in face secondary to position. Pt leaning over steering wheel; neck, arms stiff. Rigor secondary to pt pooling line in hands/forearms, extended down time. Cold, pale/mottled, dry; obvious morbidity. COD as per death certificate -- cardiorepiratory arrest
No Adverse Event; Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients).    No concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Vaccine details updated. On 28-Feb-2023: follow up received contains no new information. On 28-Feb-2023: Patient demographics and vaccine details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1 of 15
Two days after boater vaccination in right arm I lost my hearing in my right ear. Ear has been ringing non stop and lost my hearing. Have been to 2 different Specalist and still haven?t been able to regain hearing and stop ringing.
Allergic reaction borderline anaphylaxis shock 50 ml BENADRYL, oxygen support treated. Redness throughout body head to foot including hives swollen lips/hands, itching everywhere, breathing compromise, uncontrollable diarrhea, & nausea.
On March 17 2014 I received a Tdap vaccine as part of a routine exam. I have had tetanus shots before with no problems. On April 7 2014 I noticed numbness in my feet and trouble moving my toes, stabbing back pains. Within a week I was 90% paralyzed from the waist down. Unable to urinate, walk, no sensation in legs. It felt like my abdomen was wrapped tightly with duct tape. My legs would involuntarily fly all over the place. The facility sent me to hospital for MRI. The results indicated multiple demyelinating plaques suspicious for Multiple Sclerosis. The paralysis began to spread up my trunk and I was taken by ambulance to hospital emergency. I was admitted, a Lumbar puncture was done and the tests revealed no infectious causes. I was diagnosed with Transverse Myelitis. The Neurologist and the infectious disease doctor there. They put a PICC line in and gave me SOLU MEDROL for 6 days and discharged me to the infirmary. I had a wheelchair but gradually learned to walk with a walker, I was incontinent. I was on a prednisone taper for months and have improved. I still have problems with urination, walking, leg strength, pain. I had a follow up MRI done 6 months later which revealed the lesions on my spinal cord have improved but there are still multiple areas of altered signal. I will gladly release my medical records to you if it will help. I was tested for everything and it was all negative. In talking with the Physician's Assistant here it is believed the Tdap vaccine caused all my problems. I am enclosing a newspaper article that sounded very similar to my case except I never had enterovirus D68. I wondered if there might be a link between Tdap vaccine and these cases involving children with myelitis like I suffered. I have always been in good health other than this. Basically after receiving Tdap within 3 weeks I had Transverse Myelitis and was disabled and in the hospital. This is all documented through.
No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no ad). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no ad) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no ad) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
New multi dose vial was opened and diluted with .2ml NS.  The recommended diluent volume is 2.2mL.  The dose of .2mL was then drawn up and administered to the patient by LPN.
There was no reaction. The patient was 17 at the time the vaccine was administered. The Moderna vaccine is only approved for 18 and up.
12/2/09 1:30pm T.C. received by nurse from pt's daughter that pt c/o dizziness and her eyes are "purple" on eyelids. Pt gets flu shot every year without reaction. Daughter denies SOB or difficulty breathing or any other symptoms. At 2:15pm pt came to PHC with daughter and seen by nurse. No purple eyelids noted and dizziness, oriented x3, skin color fine.
24 hrs after shots had episode of vomiting and developed seizure. Hospitalized and started on Phenobarb.  3/9/09 Received hospital medical records of 1/13-1/14/2009. FINAL DX: no d/c summary available,  Neuro consult states new onset seizures. Records revea patient experienced vomiting, lethargy, pale, shaking.  Transported to ER when continued w/vomiting, lethargy & shaking.  Tx w/IVF, LP & IV antibiotics.  Transferred to higher level of care.  Continued to be lethargic in hospital.  Parent had fever & malaise few days prior to pt admit.  Neuro consult done.  Tx w/Pb.  Improved in AM w/hydration & d/c to home on continued Pb w/neuro outpatient f/u.
rheumatoid arthritis has been flaring; fatigue; congestion; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis has been flaring"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; COUGH (non-serious), outcome "unknown", described as "cough". Clinical course: Patient reported Xeljanz held when she received COVID vaccinations, did not reported adverse effects during holds. she was sick with other things after vaccinations and Xeljanz was held, did not provide names of illnesses, dates, or adverse effects during holds. Xeljanz was held 1 week before and 2 weeks after booster shot on 12Dec2021. reports about 3 weeks after re-starting Xeljanz, she was diagnosed with COVID infection with antiviral treatment, no hospitalization. Xeljanz on hold since the week of 24Jan2022. stated she has long COVID affecting her lungs and md advised her to wait for lungs to heal before re-starting Xeljanz. during hold her rheumatoid arthritis has been flared with fatigue, congestion, cough, her prednisone and lupus medication is also on hold. MD aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.
Large red center, indurated surrounding, the injection site, occurred within a few hours of injections (right arm).