chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date).    No Concomitant medication was reported. No treatment information was provided. This case contains information for the 2nd of 8 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696087 (E2B Linked Report).Sender's Comments:  MODERNATX, INC.-MOD-2023-696087:Patient 2 out of 8 Patients
Patient got Guillain-Barre syndrome from Flu vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got guillain barre syndrome from the flu vaccine. This case has been linked with US2020AMR232526 and US2020AMR232535, (same reporter and same events).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232526:same reporter US-GLAXOSMITHKLINE-US2020AMR232535:same reporter
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 23-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up contain No newinformation
Syringe leaked during administration; Syringe leaked during administration; Syringe leaked during administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received HAB (Twinrix adult) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced accidental underdose (Verbatim: Syringe leaked during administration), syringe leak (Verbatim: Syringe leaked during administration) and pharmaceutical product complaint (Verbatim: Syringe leaked during administration). The outcome of the accidental underdose and pharmaceutical product complaint were unknown and the outcome of the syringe leak was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 The reporter called to report PQC (product quality complaint) with Twinrix syringes on behalf of healthcare professional (HCP).  The reporter did not have any demographics for the patient.  The syringes leaked while administering to patient.  The patient was affected (Related adverse event - underdose).  The reporter contacted HCP (Medical Assistant) for more information regarding PQC.  The defect was discovered after partial use of the box.  The healthcare professional stated that two doses administered prior did not have any issues. The reporter confirmed that Luer Lok needles were used. All syringes leaked between the Luer Lok device and the syringe barrel. The syringe was not pre-assembled with needle some time before administration - syringes were assembled immediately before administration.20 gauge 1 in needle was used.  The blister and/or carton was not damaged. The luer lok was not damaged.  The needle which was used was not available for return. There was no damage/breakage on the syringe barrel.  The HCP did not have suspect product to return , syringes was disposed of.  The GlaxoSmithKline had to issue a credit for dose of Twinrix to GSK direct account.  The reporter consented to follow up. The syringes leaked while administering to patient and the patient dose was affected, which had led to underdose, syringe leak and pharmaceutical product complaint. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR035219:Same reporter US-GSK-US2023AMR035220:Same reporter
Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was sick for six days total. I had real bad chills and shivers and body aches. A whooping headache that lasted 6 days. Immediately  15 mins later after the shot, I had a runny nose with the worse chills and shivers.
He got his vaccine, woke up the next morning, started getting flu-like symptoms of hot and cold sweats.  After about 2 hours he got a hot sweat, it was like a lightening bolt hit his brain.  Felt like a hammer hit him in the head and room started spinning, which scared him to death.  He tried to get himself together, drank a lot of water and Gatorade.  He has no insurance so did not go to the ER, but did go to go to the ER.  He went home, dealt with the headaches and light headedness.  It did go away.  Then about a week later he got the same symptoms again.  Then every weekend he got this as well and now cannot get rid of it.  He did have similar symptoms with the 2nd vaccine.  The headaches go from the left side to right side down to his temples and to the neck, which is sore to touch, and still continues to have the dizziness and the headaches.  He has had some vertigo in the past, but only 4-5 episodes in total.  Now he cannot get rid of the headaches, and has never had headaches like this.  He went to the doctor, had a brain scan and said there was no findings, told to drink a lot of fluids and to go home.   He is just taking Tylenol for the headaches, and continues with the allergy pills which do not alleviate the headaches.    He was told that his allergy medicine could cause vertigo, which he did not have headaches with the vertigo in the past.    He absolutely positively regrets that he got these vaccines as he is now suffering from it.
A HCP reported a pt received a vaccine 6/23/2000, on 6/26 he developed an injection site reaction characterized by 6cm by 8cm area of warmth, erythema, swelling and tenderness. He was treated in the ER and diagnosed with cellulitis. He recovered
hives & itching @ inj site;projectile vomiting, fever >101, fatigue;
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Tinnitus-Medium
Pain in arm,body aches, fever for 2 days.  Two weeks after I started seeing blurred lights (like astigmatism) pain behind eyes and strange feeling in eyes.  I can still see like before but I am seeking lights as though I am looking at a twinkling star.
Vasovagal syncope, 1 min after HepA/B vaccination. No wheezing or decrease in B/P. Was anxious before shot.
NO ADVERSE EVENT.  IT WAS DISCOVERED AFTER VACCINATION THAT PATIENT REPORTED ON CONSENT FORM THAT HE WAS 18 YEARS OF AGE.  HE IS ACTUALLY 17 YOA.  HE WILL BE 18 IN 2 MONTHS.  I HAVE NOTIFIED HIS MOM
What if I missed my second Shingrix vaccine?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient asked what if he or she missed second Shingrix vaccine. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Rash 3/7/96; chronic ear infections until 8/99, gradually became intolerant of his environment. Dx'd with autism 7/98. Started treatment for GI tract problems in 8/99. I found out about vaccine connection 10/99. 60 day follow-up state still has measurable levels of mercury along with symptoms of mercury poisoning.
Shortly after vaccination patient started to feel warm and very dizzy.  Said her throat felt funny but no issues breathing.  Gave her some water, an ice pack for her neck.  Had her return to consultation room and administered 25 mg IM benadryl.  Pt felt slightly better but did another 25 mg Benadryl liquid (10 ml of 12.5/5 solution) Patient left on her own and parent was called 3 hours later and she was tired but overall doing much better and feeling fine.
arm was very sore; injection site was itchy; injection site was swollen; injection site had red dot line; productive cough; feeling "bubbling up"; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), INJECTION SITE PRURITUS (injection site was itchy), VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE ERYTHEMA (injection site had red dot line) and PRODUCTIVE COUGH (productive cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very sore), INJECTION SITE PRURITUS (injection site was itchy), VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE ERYTHEMA (injection site had red dot line), PRODUCTIVE COUGH (productive cough), DISCOMFORT (feeling "bubbling up") and CHILLS (CHILLS). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was very sore), INJECTION SITE PRURITUS (injection site was itchy), VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE ERYTHEMA (injection site had red dot line), PRODUCTIVE COUGH (productive cough), DISCOMFORT (feeling "bubbling up") and CHILLS (CHILLS) outcome was unknown. Not Provided
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable  health care professional nurse, the patient (patient).   A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration  in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination.  The vaccine was administered in a Nursing Home/Senior Living Facility.  Medical history included asthma and known allergies (details not provided).  Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit.  No treatment was  given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Cellulitis at the injection site. Treated with oral antibiotic. Follow-up scheduled in 3 days.
Patient and Mother came to a covid vaccination event at the clinic where flu vaccines are offered. Patient Mother wanted him to get the Flu Vaccine and signed consent for patient to get the Flu vaccine. Medical staff at the Covid vaccination event requested a staff member upstairs on a separate medical Team come give the patient a Flu vaccine. A Medical Assistant went down with a vaccine identified the patient reviewed the consent form and administered the vaccine. Upon charting the vaccine in patient chart it became evident the patient already received Flu Vaccine on 9/19/22 Fluzone U7684B Sanofi Pasteur
Patient developed severe bruising and redness both at the injection site and in another spot below the injection site.
Mother of patient made an appointment for Moderna COVID vaccine clinic.  16 yr old received Moderna vaccine.  No s/s or adverse reactions at this time.
Heart rate has been anywhere from 105 Heart Rate to 136; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136). At the time of the report, HEART RATE INCREASED (Heart rate has been anywhere from 105 Heart Rate to 136) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 136 (High) Increased from 105 to 136.         Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information request declined.
pt presented to hosp with c/o worsening SOB, fever, aches (x5dys); positive for COVID; takes rituximab infusions for NMS; started on remdesivir, steroids, antibiotics; required emergent intubation; pt experienced ventilator dyssynchrony, increased sedation; pt began to spike fevers; pt's condition worsened; comfort measures; extubated and pt died in the hospital
Noted small "lump" over area of VZV injection since injection 2 yrs ago. Not painful. No symptom. On exam, sl asymmetry over injection site.  Sonogram arm NL. No cyst.
peripheral neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 19-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as after received zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered peripheral neuropathy. As a result of these symptoms, the patient was saw and treated by medical provider and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient symptoms have resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient condition. As a resulted of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of conduct, the patient had suffered and incurred damaged, included medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of peripheral neuropathy was not recovered. The reporter considered peripheral neuropathy to be related to zoster vaccine live (ZOSTAVAX).
L thigh swollen and warm. Noticed 24 hours after immunization and got bigger over 2 days. Received DTAP/HIB Comb/Varicella.
08/01 received DTaP, Comvax, Prevnar, IPV, 08/03 developed rash mostly in armpits and groin, 08/04 to MD office, rash consistent with erythema multiform, otherwise asymptomatic, ( no mucous membrane involvement), 08/05 rash self resolved.
Soreness at the injection site progressed rapidly into extensive swelling, redness, heat at the injection site, and pain.
Patient called us today complaining of red streaks on her bicep 4 days after receiving the vaccination, she said she was going to see her physician today to see if there was anything wrong with her arm.
fever of 102 (degree) Fahrenheit; severe chills; under her armpit and right around her collar bone was very swollen; Headache; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: May2021, NDC and UPC number were unknown), via an unspecified route of administration on 24Feb2021 as dose 1, single (at the age of 70-years-old) for covid-19 immunisation. Medical history included asthma and rapid heartbeat (both from an unknown date and unknown if ongoing). Concomitant medication(s) included propranolol taken for rapid heartbeat, start and stop date were not reported. On 25Feb2021, patient experienced severe chills, headache, fever of 102 (degree) Fahrenheit and swelling of her collar bone and left under armpit. Patient stated that she still had very swollen right by the collar bone and under her armpit and had slight chills, not anything like before. Patient would like to know if her symptoms were normal. Patient was scheduled to receive the second dose of the vaccine on 17Mar2021. Patient stated that she fears that the second dose side effects may be more severe. Patient would like to know if she should receive the second dose of the vaccine. Therapeutic measures were taken as a result of fever of 102 (degree) Fahrenheit, severe chills, under her armpit and right around her collar bone was very swollen, headache and treatment included Tylenol. The outcome of fever of 102 (degree) Fahrenheit was recovered on Feb2021, swelling of her collar bone and left under armpit and severe chills was not recovered and unknown for headache.  No follow-up attempts are possible. No further information is expected.