chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No symptomatic AEs / no additional AE details; administered an extra dose of PROQUAD after completing the series.; This spontaneous report was received from a healthcare professional and refers to an 11-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-JUN-2022, the patient was vaccinated with an extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiration date and route of administration were not provided) for prophylaxis, together with sterile diluent (STERILE DILUENT) (lot #, expiration date and route of administration were not provided) (Extra dose administered). No adverse events were reported (No adverse event).
FELT BAD; HANGOVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt bad, and hangover. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt bad and hangover was not reported. This report was non-serious.
My period did not come the month following the 1st dose (May). I've always had regular periods since my teens. The only thing different from April to May was me taking the COVID vaccine.
Client became pale after 4th vaccination. Client wanted to lay against wall in office. Placed client on floor in side lying position. Client remained conscious. Client stated "I felt as if I were going to pass out and could not hear well out of ears". Client's facial color very pale. Blood pressure 116/83 pulse 81, SPO2 97 percent on room air. Client remained conscious. After laying on floor, color returned to face and client began to feel better. Monitored client for 15 plus minutes. Vitals 140/92 pulse 93. Client has history of hypertension. Client stated feeling normal prior to leaving clinic.
Headache, body pain, chilly sensation, pain at the injection site since 9pm 1/27/2021.
This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) in a  patient of an unknown age and gender 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red), VACCINATION SITE SWELLING (arm is still very swollen), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NIGHT SWEATS (night sweats), MYALGIA (body aches), CHILLS (chills) and FATIGUE (fatigue) was resolving and VACCINATION SITE WARMTH (arm is still very warm to the touch), VACCINATION SITE PAIN (arm is still very sore), VACCINATION SITE ERYTHEMA (arm is still very red) and VACCINATION SITE SWELLING (arm is still very swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported.
1. Developed urticaria. Anytime my skin heats up -- working out, taking a shower, mowing the lawn -- I break out into a rash that covers my arms, neck, and patches on my stomach/chest. Never had any allergies or reactions to anything in my life.
On Saturday, 10/23/22 I felt like laryngitis. On Sunday, 10/24/22, I had a raw sore throat, bad laryngitis, heaviness on my chest, bad congestion and coughing, chills, bad headache, my sinuses were bad.  I felt like they were going to explode. I was very tired. No fever. I could not stay awake for the like of me.   On Monday 10/24/2022, I took a COVID-19 home test and it was positive. I did a tele visit with the doctor. The doctor prescribed the Paxlovid. On 10/25 and today I started to feel a little bit better. I still have a sore throat, but not as raw. On 10/25/22, I started having a metallic taste in my mouth. I have not eaten in 4 days. I lost my appetite totally. My nose is so stuffed.
Pt was given Bivalent Pfizer 6mo - 4yr vaccine instead of the monovalent Pfizer 6mo - 4yr.
Patient had flu like symptoms and rash (approx 2 inch circle) around the injection site for 2 days following the vaccination
G62.9 NEUROPATHY 4/26/2023 OCCULT BLOOD IN STOOL
On day 4 after vaccine developed worsening muscle soreness throughout the upper back as well as acute onset R leg tingling, numbness not c/w radiculopathy. Also not c/w GBS. Suspect all related to muscular symptoms.
I got the shot at 4 PM at 11:34 PM I was experiencing fever chills body aches and pains and I cannot lift my arm it hurts
one dose of PROQUAD was administered. Temperature 12.2F; This spontaneous report was received from a medical assistant concerning a currently 4 year old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included sterile diluent.  On 05-MAY-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously (dose, dose number, and location of administration were not reported) (lot # S021234, expiration date 05-JAN-2021), administered for immunization for measles, mumps, rubella and varicella.   The vaccine was exposed to a temperature of 12.2 degrees Fahrenheit (F) for a time frame of 26 minutes as recorded by a digital data logger. There were no previous temperature excursions.
patient was administered expired quadracel around a month after expiration date with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reportedlly patient was administered expired quadracel around a month after expiration date with no reported adverse event. (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV) (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA  and expiry date: 26-Aug-2022) (form, strength, dose, frequency: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient was administered expired quadracel around a month after expiration date with no reported adverse event(expired product administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  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.
moderna vaccine       developed Parsonage Turner  L arm,  same as vaccine      moderate deltoids weakness and very mild biceps weakness
I got vaccinated 5 days before and my arm get irritated with heat; face getting numb; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-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 LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb). At the time of the report, LIMB DISCOMFORT (I got vaccinated 5 days before and my arm get irritated with heat) and HYPOAESTHESIA (face getting numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
This case was reported by a healthcare professional and described the occurrence of injection site lump in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline; unknown; left arm) given on 22 September 2011 at 13:00. On 21 October 2011 at 12:30 the subject received 2nd dose of CERVARIX (.5 ml, unknown route, left arm). On an unspecified date in October 2011, less than one month after vaccination with CERVARIX, the subject experienced injection site lump. At the time of reporting the event was unresolved. Follow up information received from the healthcare professional on 13 January 2012. The healthcare professional contacted the subject in mid November 2011 and the subject reported to the healthcare professional the she was doing "well" and had just a little tenderness in her arm. At the time of the follow up report, the events were resolved.
Itching on the area of injection; Red spot about the size of a nickle; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching on the area of injection/ vaccination site pruritus, red spot about the size of a nickle/ vaccination site erythema.  The patient's medical history included hypertension. Concomitant medications reported were Apixaban, Ticagrelor, blood pressure medicine.  On 22 Feb 2021, nine days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events itching on the area of injection, red spot about the size of a nickle.  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching on the area of injection, red spot about the size of a nickle was unknown.
onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.
as I mentioned, he had a fever and aches one day prior to the first vaccine.  following the vaccine the fever spiked as high as 103 and fatigue continued.  four days later a rash developed on his back, and a dry cough developed.  He also is experiencing and continues to experience some numbness/tingling in his legs and arms.  Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs.  However, a fourth covid test was given and it was negative like the previous three tests.
diagnosed with covid; This is a spontaneous report from contactable consumer (patient reported herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 21Jan2021 in series via injection at single dose to her left arm for COVID prevention. The patient's medical history and concomitant medications were not reported. Caller stated she received the first dose of the Pfizer Covid 19 vaccine on 21Jan2021 and has been diagnosed with Covid. Caller stated her second dose on 11Feb2021 and wanted to know if she could get the second dose. Caller hung up on the agent before the offer to be transferred to unit could be made. Caller stated she was very disappointed in the information that Pfizer could give about getting the vaccine after a diagnosis of Covid. AE noted. It was reported that on 01Feb2021, just came down with a mild case of COVID. Caller reported that the lot number was not written on her vaccine card. Caller stated she was due for her second dose on 11Feb2021, and she is wondering if she still needs to get the second dose of the product. Caller reported that her primary care physician was not aware of her current situation but provided consent for follow up anyway. Caller was tested for COVID on Monday 01Feb2021, and it was a 48hour test. Caller got results that morning that were positive for COVID. Caller had no other vaccines on the same day as the COVID vaccine. Caller stated that her husband had COVID, and she decided to get tested. Caller confirmed that her husband had not yet had the COVID vaccine, he had not had it because he had been sick. On 01Feb2021, COVID-19 48hour test showed positive. Outcome of the event was unknown. No more information available. No PQC Present.  Information on Lot/Batch number has been requested.
Patient stated to nurse she doesn't feel good and her throat is feeling different and itchy. Patient stated she has a history of allergies with anaphylactic reaction.  Vitals obtained with BP 148/100 Hr62 rr16 SP02 98% no respiratory distress noted. Dr. ordered X 1 Benadryl PO. Nurse remained with patient and checked vitals every 5 minutes.  5 minutes post medication pt. denies any itching. Patient left with family and denies she will drive.
Patient received first dose on 3/24 and got second dose today 4/8 ( 1 week early). No adverse effect during observation.
03/10/11 TC from patient, received vaccines 3/9/11 12 noon. At 3PM developed a headache and Temp 99.8 took ADVIL with some relief. Today she still has a headache, jaw aches, Temp. 101.3, and feels tired. Advised to monitor symptoms and consult with PMD.
light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
Generalized itching and hives which started the night after she was vaccinated. Currently treating with PO antihistamine. no angioedema or anaphylaxis
Generalized muscle aches, soreness at vaccine site (right arm), low grade fever of 99.3F,
RED, RAISED,NON VESICULAR,  PRURITIC RASH ON LEGS,
Patient received vaccine and then went to sit in designated chair for the 15 minute wait.  As he was walking to the chair he stated that he felt faint, hot, sweaty, weak and shaking.  Upon arriving to the patient, the patient was hot to touch and had beads of sweat to forehead.  Patient was sitting crossed legged on the floor with head down.  Asked patient if he wanted 911 called and patient adamantly declined.  Patient was alert and oriented.  Pharmacy gave patient  a water bottle.  Had patient lie back with feet up.  After a few minutes patient started to feel better.  Had patient stand  up and sat patient in the chair in waiting room.  After going into the exam room for a few minutes to get ready for next patient, I went back into waiting room and patient was sitting on the floor again with legs crossed and head down.  Had patient come back to exam room and lie down on exam table with feet up.  After approx. 10 more minutes, patient was standing up in hallway and stated that he was feeling better and would walk around the store.  Patient left the store without checking back in.  Called patient to follow up at end of shift and patient did not answer.  Left a message letting the patient know we were checking on him.
rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medial history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash). On 08-Jan-2021, RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Daughter began to experience night terrors.  She sits up in bed screaming and crying and can not be awakened.  She also has been experiencing severe nightmares.  This went from occurring every few months to occurring nightly since the night after her 5 year old vaccinations.
A non-serious spontaneous report of expired FLUMIST was given was received from a health professional concerning a female child. Neither medical history nor concomitant medication was reported for this patient. The product expired on 12-Dec-2010. On 16-Dec-2010, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 03-Mar-2011 and incorporated into case: no late occurring adverse events.
REDNESS AT LEFT DELTOID WHERE KINRIX WAS ADMINSTERED. PT HAS HAD FEVER FOR 3 DAYS WITH FEVER BEING MANAGED BY TYELENOL.
About two weeks after my shot I developed continuous ringing in both ears. I thought maybe I had wax in my ears and used an over the counter product which did not help. I then developed swollen glands in my neck and behind my left ear. . I made an appointment to see my PCP doctor to remove any ear wax and check out my glands.
Indy is a 12 mo M previously healthy recently received his 12 mo vaccinations including varicella on 7/9/2021, subsequently developed discrete vesicles and papules between 07/21/2021 and 07/28/2021, which progressed and scabbed. He presented to the family medicine clinic on 08/03/2021. He had associated subjective fever and rhinorrhea. No other sick contacts. On exam, he is well appearing with crusted rhinorrhea, noted to have scattered erythematous based papules and vesicles in various stages of healing. No oral lesions. A few lesions on his back appear to have honey crusting. 2 new vesicles were deroofed and swabbed for VZV. The varicella-Zoster virus PCR from swab returned positive on 08/23/21.
I had nasal congestion, felt feverish, chills, body aches, headache, I thought my ear was going to start hurting or get infected, but it did not. All of this starting on March 21, 2023, the next day I choose to use a home COVID-19 test that came back positive. I called and had a telehealth visit with my doctor's office. I was prescribed the Paxlovid medication that I started taking on March 24, 2023. I am feeling better and have recovered.
Area of indention measuring 3.5cm, area was red with a rash, two days. No treatment needed.
Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication used by the patient were not reported. The treatment medication were not reported.
Mom brought patient to office today reporting rash - 1 week after vaccine, scabbed lesions X 8 < 0.5 mm to right post ribcage in thoracic to lumbar level one inflamed vesicle to right upper medial arm - 1 mm no pruritus but fever and fussy, painful to touch over lesions. Treated with Zovirax 400 TID for 14 days.
Pt woke with injection site red swollen and tender to touch, has pain radiating up into left shoulder joint. no fever or systemic signs.
Extreme Headache front left behind eye. Some numbness in extremities. Nausea on 11/08/15. Headaches continue through date of report, 11/16/15. Not constant but severe.
arm has been itchy for the last 3 days; but today, it's driving her crazy; Big hard disc; It's driving me crazy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy), FEELING ABNORMAL (It's driving me crazy) and SKIN INDURATION (Big hard disc) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (It's driving me crazy). On an unknown date, the patient experienced PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy) and SKIN INDURATION (Big hard disc). At the time of the report, PRURITUS (arm has been itchy for the last 3 days; but today, it's driving her crazy), FEELING ABNORMAL (It's driving me crazy) and SKIN INDURATION (Big hard disc) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.