chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
About 2 hours after receiving vaccine started with tingling in feet/mouth, joint pain, headache, itch all over and in bed for about 5 days. Heart palpitations started about 12 hours after receiving vaccine. 1 week after started red, raised bumps where vaccine give and back of arm. 5/6 md wrote for Medrol dose pak for patient.
administer only the liquid portion of PENTACEL and not the Hib portion with no adverse event; administer only the liquid portion of PENTACEL and not the Hib portion with no adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 5 months old female patient who was administered only the liquid portion of pentacel and not the hib portion with no adverse event of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine and pneumococcal vaccine both for Immunisation.  On 02-Sep-2022, the patient received suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml (strength, form, lot number, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On 02-Sep-2022 the patient was administered only the liquid portion of pentacel and not the hib portion with no adverse event (single component of a two-component product administered, product preparation error, latency: same day) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) 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.
Sore left underarm/breast lasting several days. Chills and high fever for 2 days. Headache, Neck stiffness and soreness for 4 days (currently ongoing for me). Nausea for 1 day.
Patient experienced swelling and redness of arm that continued to worsen days after vaccination, with swelling down to the elbow. Patient also reports itching on the arm of the vaccine.
5-6hr p/vax pt exp itching, hives, whelps on trunk & buttocks, thighs;eyes, ears, & head swollen;DPH taken @ time;slept all the next day;
A spontaneous report was received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT started on 08-Apr-2014. The patient had been given expired FLUMIST QUADRIVALENT administered/inadvertent administration of expired FLUMIST QUADRIVALENT which started on 08-Apr-2014. The outcome of the event of expired FLUMIST QUADRIVALENT/inadvertent administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
server arm pain in both Armes both hips pain cold chest. Cough chills.  Pain in arms and hips subsidie the next day about 11:00 am . but cold like system still. Here. Taking over the counter med.Running nose.
Acute onset of shaking and chills.  Headache and lightheaded ness started about 6hrs after injection.  Chills and shaking also occurred about 6hrs after injection.  Loss of appetite and nausea with significant headache occurred for about 16hrs after initial onset.  Arm pain present at injection site.  Within 48hrs, symptoms largely resolved.
Rash within 24 hrs. of vaccine administration to face, legs, arms. Denies fever or SOB.
Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; Started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 09Jan2021 (at the age of 27 years old) (Lot Number: EL1283) as 2nd dose, single for COVID-19 immunization. Medical history included Wolf-parkinson-white. No known allergies. No known drug allergy. Concomitant medications included levonorgestrel (MIRENA); melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 ((at the age of 27 years old) in left arm for COVID-19 immunization. The patient experienced started having frequent episodes of symptomatic non-sustained Vtach, bigeminy, trigeminy, had an increased PVC burden (hospitalization) on 13Jan2021. Duration of hospitalization was 1 day. Treatment received for the events included Metoprolol. The adverse events resulted in Emergency room/department or urgent care & Doctor or other healthcare professional office/clinic visit. This is a serious report with seriousness criteria: Caused/prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, Nasal Swab on 13Jan2021, 03Mar2021, 10May2021, all with results of negative. The outcome of the events was recovering.; Sender's Comments: The causal association cannot be excluded between the reported events andBNT162b2 use. 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 AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Patient was pale, lethargic and sweating from forehead.   Patient was fine after for 45 minutes of observation.
has a pretty good size bruise at injection site; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EM9809) as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated her dad received the Covid-19 vaccine on 07Feb2021.She had the Lot number. They were unable to provide the expiry date. She would like to know what that was. Her father also received a pretty good size bruise where it was given. Still had the bruise. Is that not uncommon. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
filling "like water in the left ear"; "washing sounds" in the left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination.     No medical history was not provided by the reporter.  Concomitant products included LOSARTAN, NIFEDIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 3:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear). At the time of the report, EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear) outcome was unknown. Not Provided          Treatment information was not provided by the reporter.
Patient developed Bell's Palsy 2-3 weeks after receiving the 2nd vaccine. Patient reported symptoms that worsened on 4/17/2021.  Patient was currently at work and could not feel her legs. She was able to walk but could not sense her legs. She presented to the ED on 4/17/2021 with bilateral leg numbness and left facial droop. After ED observation she had resolution of left facial droop and left leg weakness. Patient did leave against medical advice but stated she would follow up with her doctor.
Patient reported feeling dizzy and passed out at home when she was alone. She was able to call a friend when she woke up. The friend came to pick her up and drove her to the patients primary care physician. The physician found all labs and vitals to be normal and told the patient to return home and rest.
DEATH; This spontaneous report received from a parent via a company representative via social media concerned a 30 year old male, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was died. The patient died from unknown cause of death. It was unknown if the autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210644799-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Main and most painful is pain in jaw bones, left & right, pain at & close around dental implant post in lower jaw center-right.  Treatment at this time (2/3/21) is (self prescribed,over the counter) 1 Acetaminophen 500 mg pill at bed time.  Joint pain left thumb, especially when making a fist. Neck pain more or less continuous , slight but more or less continuous headache.
Soreness and Rash adjacent to injection site with light itching, redness and some heat to the touch - about one inch in circumference. Applied zinc oxide (self determined) at night and morning after shower. Size of rash area somewhat reduced as result. Still sore to touch.
I felt extremely dizzy, nauseous and had body aches especially in legs. I had chills but no fever. Mouth extremely dry. Slight headache but not as severe as first dose where I had a miserable migraine for an entire day. Arm extremely sore with large bump at site of vaccine.
Hearing my heartbeat in my right  ear practically daily.  Sometimes louder than at other  times.  One day so loud & constant,  it was difficult  to sleep.!
I had extreme neck pain. I attributed it to ergonomics from looking at a computer screen too much. However, when I went to my doctor for an annual check up in April 2022, blood test and ultra sound tests revealed I am suffering from hyperthyroidism. Additionally, the pain in my neck is Subacute Thyroiditis.  Additionally, I have lost my sense of taste as a side effect of the medication I'm presently taking: Methimazole 10MG
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING TO SITE Narrative:
Patient began complaining of nausea and sweaty palms 5 minutes after vaccination.  She remained in the clinic for about 25 to 30 minutes when she stated that the nausea had resolved.  She returned to her place of work. About an hour later our Occupational nurse received a call from the patients place of work stating that she was having extreme vomiting, no other symptoms at that time.  She was instructed to report to the Emergency room
a/student reached class, c/o tingling down both arms; later & info next day c/o back pain; no swelling or redness @ sites of vax;
No rash, right anterior thigh 5 cm x 5 cm red warm firm induration - she is scratching at reaction but no limp when walking. Induration was marked with pen.
She immediately experienced a syncopal episode, lasted less than a minute. (ammonia capsule popped open and under nose), VS low-normal. After syncopal episode, she developed sensation of palpitation, which also improved. EKG performed, showed NSR, PVC noted. She denied any CP or SOB. She was cleared for discharged home, advised to monitor symptoms. Instructed to go to ED should she develop any worsening of palpitations, or develop CP/SOB, advised to f/u as scheduled with PCP.
Patient received vaccine 11am on 9-29-07. On 9-30-07 around 630pm injection site became red, swollen, itchy and burning - symptoms subsided on their own then returned evening of 10-1-07. Patient called pharmacy. She was told to try Benadryl and to report reaction to her doctor. She may possibly be allergic to the to the preservative.
PROLONGED HEADACHE, SYMPTOMS FIRST TWO PFIZER COVID VACCINES. WORSE AND MORE AFTER THE SECOND.
Patient had a pulmonary embolism and infarct to his right lung, pleural effusions bilaterally and right heart strain from the clot.
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional (HCP) did not provide lot number, expiration date, or any other information. The shivering was lasted for 6 hours. The healthcare professional called to find out if patient should still receive the 2nd dose.
I started out feeling feverish and chills, but no fever. Body aches and joint pain. Pins and needles in hands and legs and feet and itching.  In my left leg the joint pain and pins and needles has not gone away. June 19th it got so bad I could no longer walk on that leg and went to ER. they ran test and sent me home on crutches. My primary care doctor prescribed tramadol for pain. The doctor think maybe it's an inflammation response to vaccine.
PATIENT WENT IN TO EMPLOYER ONSITE CLINIC AND SAW PROVIDER WITH COMPLAINTS OF FEVER (103 DEGREES F, BODY ACHES, HEADACHE, AND NAUSEA.
This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer regarding a male patient who developed autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Hib-Titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevnar. Concomitant medications were not reported. A father reported that his son was diagnosed with autism after receiving numerous injections. He commented that he did not feel that his son's autism is related to the injection. The child also received Prevnar. Dates of vaccination were not provided. Outcome is unknown. No additional information was available at the time of this report.
Mother advised of vaccine error; f/u in 1 mo. Any issues please F/U. Mother verbalized understanding. Will be monitoring .
Pt reported itching and slight rash.  NO SOB, no Swelling.  Pt was given 25mg PO Benadryl @14:00.  Pt was advised to take 2nd 25mg dose at home if itchiness continues and see medical attention if condition worsens or develop SOB.  Pt stable and released from the vaccination site.
Brain damage; speech impaired; Can't tie a shoe, can't drive, can't cook; horrible reaction to a vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of brain damage in a 25-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced brain damage (serious criteria GSK medically significant), speech impairment nos, loss of personal independence in daily activities and adverse drug reaction. On an unknown date, the outcome of the brain damage, speech impairment nos, loss of personal independence in daily activities and adverse drug reaction were unknown.   The reporter considered the brain damage to be related to Meningococcal B vaccine. It was unknown if the reporter considered the speech impairment nos, loss of personal independence in daily activities and adverse drug reaction to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The reporter reported that, the patient had a horrible reaction to a vaccine at 7 months old. At the time of reporting, the patient was 25 years old and was could not tie a shoe, could not drive and cook, and speech impaired. The reporter stated that, the patient had brain damage from  vaccine. The reporter reported that, Mercury, Formaldehyde and many other toxins should not be allowed to be injected into our bodies. The reporter stated that, the patient's normal life was robbed.
Information has been received from a nurse practitioner concerning a 14 year old female patient with penicillin allergy and environmental allergy who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported). Suspect therapy included that the patient was vaccinated with a dose of VARIVAX (Merck) (Lot#, dose number and expiration not reported), on the same day. Concomitant therapy included multivitamins (unspecified), ZYRTEC, montelukast sodium (MSD), evening primrose oil, MENACTRA and Tdap. The nurse reported that on 10-AUG-2010 the patient was vaccinated with GARDASIL and developed a viral infection the next day. The viral infection was described as fever, dizziness, sore throat and weakness in both arms. The fever was resolved by 13-AUG-2010 and the rest of the symptoms were resolved by 18-AUG-2010. The patient also received MENACTRA and Tdap on the same date (10-AUG-2010), unspecified sites. The laboratories CBC, CMP, TSH, throat culture with UA were performed (results were not provided). No treatment was given for this adverse event. The patient sought unspecified medical attention. At the time of reporting the patient had recovered. Additional information has been requested.
possible temperature excursion; Patient received an expired vaccine; received an expired vaccine past 30 days in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion), EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) 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 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 PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion), EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported. This adverse events information was for patient 2.
Had shot approx. between 8-9 a.m. Sometime during the day my shoulder started to ache like it usually does with other shots. Certainly around 3 pm it seemed achier than usual. At 6 p.m. it was really sore and my shoulder was stiff and it hurt when I moved my arm. The soreness and stiffness seemed to be going up the left side of my neck. Had trouble going to sleep at night because my shoulder was throbbing. About 11 p.m. I felt a little chill. About 1 a.m. (3/24/2018) my shoulder stopped throbbing. About 4 a.m. I woke up a little sweaty; shoulder still a little stiff and achy but a lot better. 3/24 & 3/25 It felt more like "normal" post-vaccination soreness. Some "point" tenderness on touching at anterior acromioclavicular joint. 3/29/18: No more pain or tenderness.
On 04/13/11 was outside and c/o chills and Headache. Took shower at 8:30 PM and temp. at 9:30 PM had 103 degree fever and went to bed. At 5:30 AM on 04/14/11 temp. 101 derees and took 2 Aleve tablets. Cont to c/o headache, fatigue and weakness throughout the day. Seen by MD on 04/15/11. MD stated exam showed no signs of an infection or other illness not related to vaccine. Recommended Pt increase amounts of Naprosyn. On 04/16/11 c/o swelling at upper half of body accompanied by pain. Severe pain at sternum and upper back between shoulder blades. 04/17/11 pain began to subside but continued to have some fatigue until this AM of 04/18/11.
Pt recvd 1st dose of Hep B vax on 23MAR92 & on 17APR92 devel generalized malaise, low grade fever, arthralgia & low back aches;
The evening of the TDAP vaccine, I experienced flu like symptoms and severe lower back and joint pain. I was unable to work for 2 days after the vaccination. Some of the symptoms subsided however the joint and back pain persisted. Late October, early November I was unable to move my arms when I woke up due to excriating pain in both shoulders, wrists and fingers. The swelling and pain was worse on the right side (the vaccination was administerd in the right deltoid). I went to a rheumatologist who noted that I have muscle wasting in my right shoulder. My right shoulder is now lower than my left. I am being worked up for rheumatoid arthritis. The rheumatologist is suspicious that this may have been caused by the vaccination. I am currently on high dose steroids and NSAIDS. I suffer from bilateral joint pain hands, feet, shoulders and wrists. In addition I have noticed since the vaccination that I experience muscle spasms on the right side of my back and shoulder. I am still under the care of a rheumatologist.
Developed cold chills, T=102.8F, arm tender.  Took liquid Iburofen.