chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint achiness; weakness; Injection site was extremely tender; low grade fever of 100 degrees F; sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced joint achiness, weakness, injection site was extremely tender, low grade fever of 100 degrees f, sweats, chills. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 101 F. It was reported that event took place after use of product. The outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.
pt recvd vax & t107.3 R, encephalopathy, sz, elevated liver enzymes; pt was unresponsive for 3 days w/improve rapidly; mild URI & viral sx x 2 days;
My period started after being on menopause for a year.  It started in April 2021. Both of my breast have been in pain for past month.  This week, I got my period again, except much heavier than last month.  I had an MRI done last week and the lining of the uterus thickening was seen.  In the past, my period was only 3 days but this month, it's been 5 days and I'm still bleeding.
10/18/00 Could not sleep, talkative, hyper, chills and hot to touch. 11:30 temp was 103 was given Tylenol and was restless. Tylenol in the am on 10/19/00. Slept until 1:00 pm. 1/20/00 seems to feel better thinks fever is down. Arm very swollen in deltoid area, red and hard. Call MD. Had congestion next day. No fever. On 10/23/00, most swelling was gone.
Fever low grade x 2 wks after Imm then rash x 4 days following fever - Rash is on face, behind ears, trunk 20 - 5mm papules L thigh
covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was covid positive on 12Jan2021 with outcome of unknown. The patient underwent lab tests included covid-19 virus test: positive on 12Jan2021.  Information about lot/batch number has been requested.
Five hours post vax, pt experienced a red swollen ring around the injection site that was warm to the touch.
The pt developed erythema at injection site with minimal swelling and pruritis. Normal movement of arm and fingers, no pain. Treated with Atarax, cool compresses and Motrin.
Information has been received from a RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. It was reported that there was an outbreak of chickenpox at a school health center including a 3rd grader who experienced a case of wild varicella. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Several episodes of epistaxis, ranging from 30 mins in length to over an hour.  Profuse bleeding, from no known other cause.  Woke patient up from sleep, happened in the shower, etc.  No trauma to the area prior to episode.
according to grandparent, child became hoarse w/decreasing ability to talk;examined @ clinic then referred to hosp to r/o laryngitis;
Right after the vaccination ion Friday,  I felt fatigue. (at the 15 minutes wait time), I left the facility at 130, Took Prednisone 20 mg per my pulmonologist request at 235pm.  I felt the lungs are heavy, by around 545 pm, I started to have  shortness of breath, at 11 pm that evening, wheezing started.  I started  xopenex, and atrovent neb solution and tylenol for the headache (which started around time of wheezing) By Saturday afternoon, the ribcage is very tight, hard for me to breath, can only take short breath.  I continue to take prednisone 20 mg daily per doctor.  On Monday, telemedicine visit with the pulmonologist, he increase to 60 mg, Ribcage tightness relieved about 1 hour and 45 minutes, back to tightness again.  Tuesday morning, I went to Emergency room, admitted as observation.  Discharged on Thursday.  I was given iv solumedrol while under observation in the hospital.  I return home with oral prednisone prescription.   I feel fine on Friday, Saturday, the ribcage started to tighten again, along with shortness of breath.  Doctor contacted on Monday 3/8/21 with continuation of prednisone and taper down by 10 mg a week.  I am still having shortness of breath and ribcage tightness, especially, when walk, stand, talk.  As of now, I am still home and have not return to work.
always being tender at the injection site with getting her vaccinations; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves an unknown age female patient who experienced always being tender at the injection site with getting her vaccinations while receiving vaccine Influenza Vaccine (Flu vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA433828(FLUZONE HD QUAD vaccine).   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch and expiry date requested.  On an unknown onset and latency, the patient developed a non-serious always being tender at the injection site with getting her vaccinations (vaccination site pain).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered on an unknown date for the event.
Lost hearing in one ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hearing loss unilateral (Verbatim: Lost hearing in one ear) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was not reported.   It was unknown if the reporter considered the hearing loss unilateral to be related to Shingles vaccine.     It was unknown if the company considered the hearing loss unilateral to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her friend received Shingles vaccine and experienced lost hearing in one ear. Follow-up would not possible as no contact details were available.
I felt pain as soon as the flu vaccine needle was inserted into my left arm, she inserted the needle too high and too deep. I immediately had range of motion issues and excruciating pain. The pain and ROM issues did not subside so a week later I returned to the work health clinic to report, they told me to see my primary care doctor so I went to urgent care. The urgent care told me I need to see an orthopedist so I returned to the work clinic and they sent me out to be evaluated at clinic. I received 19 sessions of physical therapy that had little results because they did not know how to treat my injury properly. I got an MRI that showed fraying of the infraspinatus tendon and bone marrow edema. I received a stem cell injection that my family paid for out of pocket which had 0 results. I went to another clinic and was referred to Dr. at Orthopedic clinic where I got an MRI Arthrogram that showed a labral tear. I received better physical therapy at orthopedic clinic to regain active motion in my left arm/shoulder 10 sessions total. I then underwent shoulder surgery to fix the labral tear but they determined no Labral Tear but cleaned out scar tissue and added fractures to the humoral head to promote healing. Dr. said this was from the vaccine. I am now recovering and off work for 8 weeks for now and could be more. I have been in pain every day since 11/13/2021 and it has not gotten better.
PATIENT WAS GIVEN BOTH THE FLU SHOT AN PNEUMONIA SHOTS ON 10/15/03.  A FEW HOURS AFTER SHE RECEIVED THEM, SHE WENT HOME AND HER RIGHT ARM BEGAN SWELLING (RIGHT ARM-FLU/LEFT ARM-PNEUMONIA).  SHE CLAIMS THAT IT WAS DOUBLE THE SIZE THAT IT IS NORMALLY.  SHE ALSO STATED THAT SHE FELT WEAK.  LATER ON IN THE AFTERNOON, BETWEEN 4 AND 5 PM, SHE WENT TO EAT DINNER WITH A NEIGHBOR AND BEGAN FEELING VERY ILL.  THEY LEFT THE RESTAURANT AND WHEN SHE GOT HOME, SHE FAINTED.  THE PARAMEDICS WERE CALLED BUT DID NOT FIND ANYTHING ON EXAMINATION. SHE CONTINUED TO FEEL VERY BAD FOR THE NEXT 4 DAYS, AND ON 10/20/03 SHE WENT TO HER PHYSICIAN.  HE ALSO EXAMINED HER AND FOUND NOTHING. I SPOKE WITH HER TODAY, AND SHE STATED THAT SHE STILL DOES NOT FEEL WELL. PATIENT HAS RECEIVED FLU VACCINES IN THE PAST WITH NO PROBLEM.  I ALSO ASKED HER IF THE SHOT HURT WHEN IT WAS ADMINISTERED.  SHE CLAIMS THAT THERE WAS A SLIGHT STINGING SENSATION BUT NO SEVERE PAIN.
Moderna vaccine. Following vaccine I complained of feeling dizzy, lightheaded, "off" for several weeks. So much it impacted my ADIs/training for a marathon. There were days I would run and couldn't focus my eyes and texted friends I was dizzy/didn't feel well. Prior to this I was having pulsile tinnitus - with no other symptoms- just noise in my ear. When dizziness/ light headedneaa came on, I was very concerned and saw my doctor. I had CT, MRI, hearing tests. They could not pinpoint cause of tinnitus (ironically it started when I started running more than 50 miles a week and after my marathon as soon as I stopped running, the tinnitus stopped); all labs normal; CT; however incidental finding on head MRI included small vessel ischemia in . Very unusual for 48 year old. Could be related to vaccines/ similar to Pfizer vaccine - increased risk of stroke? More that happy to share MRI /CT with your team
fever of 100.1 aches, acute dizziness, achy and a rash and lump around injection site
patient received an extra dose of TDAP (BOOSTRIX) and MENQUADFI with no reported adverse event; ended up receiving extra dose of menquadfi and boostrix with no reported AE; Initial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old female patient who experienced patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and ended up receiving extra dose of menquadfi and boostrix with no reported ae while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (Boostrix) for Prophylactic vaccination; and althaea officinalis root, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL).  On 08-Dec-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine lot U7576AB via intramuscular route in unknown administration site for Immunisation.  On 11-Jan-2023 the patient developed a non-serious event of patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event (extra dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine. On 11-Jan-2023 the patient developed a non-serious event of ended up receiving extra dose of menquadfi and boostrix with no reported ae (incorrect dose administered) 1 month 3 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient received an extra dose of TDAP (Boostrix) and Menquadfi with no reported adverse event, ended up receiving extra dose of menquadfi and boostrix with no reported AE).  At time of reporting, the outcome was Unknown for the event patient received an extra dose of tdap (boostrix) and menquadfi with no reported adverse event and was Unknown for the event ended up receiving extra dose of menquadfi and boostrix with no reported ae.   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.
Day after: sore arm, tired and headache  3/7/21: extremely tired, nausea, hot, cold, body aches, swelling and itching at injection site.  Some better by 3/9/21. Just some head aches.  3/11: on a video call i noticed facial drop on right side of face around mouth and slight puffiness.
Hives/welts size of dimes all over legs, arms and lower torso (so far)
3RD DOSE OF SHINGRIX WAS GIVEN; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th January 2021) and Shingrix (received 2nd dose on 26th July 2021).   On 18th February 2022, the patient received the 3rd dose of Shingrix. On 18th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
paralyzed; severe Guillian Barre Syndrome; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who was had severe guillian barre syndrome and paralyzed after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu. Information on batch number and expiry date was requested.  On an unknown date the patient had events of severe guillian barre syndrome (guillain-barre syndrome) and paralyzed (paralysis) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown.  Seriousness criteria: Medically significant for both the events.; Sender's Comments: Sanofi company comment dated 22-Dec-2022: This case involves Adult and unknown gender patient who was had severe guillian barre syndrome and paralyzed after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Excrutiating low right side back pain, 8 hours after 2nd dose.  Lasted 24 hours.
Pt recvd 3 Engerix-B vax on 24APR90, 7JUN90, & 23OCT90 following these titer=3; pt was given a 4th dose of vax 31JAN91 & pt seroconverted p/4th dose;
No additional adverse events reported; Administration of GARDASIL 9 during the excursion; This spontaneous report was received from a health professional concerning a 10-year-old patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 23-OCT-2020, the patient was vaccinated with a dose (during an excursion) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), (dose and frequency was not reported) (lot No. S022599 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 25-FEB-2022), 0.5 milliliter for prophylaxis.    On 23-OCT-2020 the patient experienced product storage error. No additional adverse events reported.  There was no previous temperature excursion. The call was made due to the data logger. The minimum temperature was 1.8°C with a time frame of 7 hours and 25 minutes. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
16FEB96 2PM shaking,goosebumps-APAP repeated;642PM t102 orally,dec appetite,sore arm;17DEC96 emesis,irritable,t103.2 orally;
face is burning/ if her cheeks are on fire; was aching all over/body aches; whole face was itching/her arm was itching; her arm has never stopped hurting/arm is killing in her/sore arm; headache; nausea; extreme fatigue; had a little fever; took benadryl because she thought it was an allergic reaction; This is a spontaneous report received from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1 st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter had her first dose of the vaccine. The patient arm was killing in her, yesterday she had nausea, extreme fatigue, body aches, was aching all over and had a little fever and all of that. The caller took benadryl because she thought it was an allergic reaction and her arm was itching, face was itching and burning, she took a Benadryl, allertec and applied a cold compress to her face, face was on fire, arm pain was an 8/10 so she has been taking Tylenol. Since then, she wanted to know if this was an allergic reaction. The caller felt like it had calmed down since she took the benadryl and allertec. Patient had a headache, her arm had never stopped hurting and sore arm the first two days. The patient thought the benadryl was a trigger to this. She said she took Benadryl, and Alertex to treat the symptoms. She wanted to know if having these side effects 2 weeks after the 1st dose was normal and if these side effects have been reported before. The outcome of events was unknown.    Information about lot/batch number requested.
Sweaty, clammy, decreased BP (80s/50s), decreased HR (40s), loss of consciousness, decreased O2, vasovagal response/possible decorticate seizure. Oxygen administered, transported to emergency department for further evaluation.
Flu like symptoms; Psoriasis; Dose 1 administared on Apr-2021 and dose 2 on Oct-2021; Vision issue; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Psoriasis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VISUAL IMPAIRMENT (Vision issue) and MIGRAINE (Migraine). In October 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis). At the time of the report, VISUAL IMPAIRMENT (Vision issue), MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Psoriasis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021) outcome was unknown.            No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event's of VISION ISSUE, MIGRAINE, FLU LIKE SYMPTOMS and PSORIASIS was not provided for Humira. No treatment drug details was reported.
Information has been received from a physician concerning a male pt who was vaccinated with 2 doses of Hep-B vaccine recombinant, (dates unknown). Concomitant therapy at the time of the 1st dose included, Ceclor. After the 1st dose, the pt experienced serum sickness. Subsequently, the serum sickness subsided. Later, the pt was vaccinated with the 2nd dose of the vaccine and post vax, he experienced serum sickness "again". Also, the reporter indicated that the "pt is experiencing peripheral myopathy, weakness, numbness, joint swelling, muscle tenderness and urticaria. Additional information has been requested.