chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received influenza vaccination at 8:30 a.m. Pt developed a red, raised area the size of a nickel at the injection site by 1:00 p.m.  By the next day, the area was as large as a baseball and warm to touch.  Mother applied Triamcinolone Ace Tonide Ointment 1% to the injection site.  Area is less reddened 48 hours after injection.
Numbness across chest, tongue thick and numb (L) shoulder pain radiation into back-which then progressed up neck.
Lymphadenopathy in left axillary region.  Redness and warm to touch in axillary region as well.
Hard lump the diameter of a golf ball (feels disc shaped) developed at injection site. Pain, heat, redness and moderate itching present. Small rash in a circle approximately the same size of the lump is also present.
Mom reported by phone that right arm started itching the day after receiving INFLUENZA vaccine in that arm. Also c/o minimal swelling. Spoke with dr who advised BENADRYL 25 mg every 6 hours and call for appt. next day if persists.
About 3 minutes after receiving the vaccine, patient started to experience itching at neck area. Visible redness and a few hives present.
missed dose; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number TP5E5, expiry date 15th November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 28th December 2018, 183 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details was provided as follows: The age at vaccination was not applicable for 2nd dose. The patient has missed the 2nd dose till the date of reporting, which led to incomplete course of vaccination.
pressure in her ears; fatigue; queasy stomach; bad headache / persistent ongoing dull headaches/ sore head; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (queasy stomach) and HEADACHE (bad headache / persistent ongoing dull headaches/ sore head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHROID), LEVOTHYROXINE SODIUM (SYNTHROID), RAMIPRIL, SIMVASTATIN, TRAZODONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN [VITAMINS NOS], CALCIUM CITRATE and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (bad headache / persistent ongoing dull headaches/ sore head). On 17-Feb-2021, the patient experienced EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach). At the time of the report, EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach) outcome was unknown and HEADACHE (bad headache / persistent ongoing dull headaches/ sore head) had not 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.   No treatment details were reported.  Other concomitant medication include Benifiber 2 Tablespoonsful daily.   This case was linked to MOD-2021-336432.; Sender's Comments: This case concerns a 80 year-old, female with no relevant medical history, who experienced the unexpected events of ear discomfort, abdominal discomfort, and expected events of fatigue and headache. The event occurred approximately 4-5  days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge is N/A (the outcome of the events were unknown or not resolved)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
This spontaneous report was received from a physician regarding a 31 years old male patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot #, dose, route and expiration date not reported) as part of childhood vaccine. No concomitant medications were reported. On an unspecified dates, the patient experienced 4 episodes of shingles already. The patient had sought medical attention(office visit). No treatment was given. The outcome of shingles was unknown. Additional information is not expected.
Child with significant medical history rec'd Flu,MMR,VZV vaccines. He became ill with presumed gastroenteritis, parents also report respiratory symptoms of congestion and hoarse voice. Child refused oral feeds and became dehydrated resulting in a hospital admission from 10/19-11/4/19 at Medical Ctr.   Hospitalization appears secondary to child's chronic medical issues and viral syndrome, however family concerned d/t timing from vaccination Child developed a rash at the injection of site of his flu vaccine, which remains present 4 weeks later
large red bump on upper left arm.  Developed on 10th day after first dose.  Still have it on day 15.  It's less red and less tender.
felt like had the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 22-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced influenza (Verbatim: felt like had the flu). The outcome of the influenza was not recovered/resolved.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 The case was received from the patient via interactive digital media. The patient got a shot one day before the reporting date and on the day of reporting felt like he or she had flu, but after reading all of the comments the patient was so grateful that he or she never got shingles. The patient stated that 2nd shot was scheduled for 3 months from the 1st shot date (one day before the reporting date). The follow-up could not be possible as no contact details were available.
3/10/21 7pm chills, aches, slight nausea slight headache 3/11/21 all day aches, slight chills, slight fatigue 3/11/21 3pm  aches only all other symptoms gone
Approx 2 hrs p/inject c/o severe nausea & vomiting & h/a-phenergan & tylenol; During night developed neck pain; Following 2 days cont w/stiff & sore neck & sl nausea w/occasional vomiting also soreness & stiffness rt arm;
High fever  103 to 106. Shaking , intense head pain, Tylenol brought fever down briefly .diahrea, nausea,  It's the fever that scares me for others. I used a non contact thermometer to check my temp through out the night. At the time it registered 106 I was unable to call for help.
I had pain and swelling in the left are and severe headache that continued for a month. Shortness of breathe, could not get out of bed, to walk a short distance in the home.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Member states he woke up and noticed some bumps on his face and scalp that were somewhat painful. He states his mouth was ver watery too. He states that since waking, he has felt nauseous. Seen at Hospital - Provider states seeing"small red bump on the left occipital scalp similar appearance to acne, smallwhite head visualized. Tender to palpation, Tender red bump below the lower lip in midline chin, No abscesses. Prescribed Keflex Diagnosed at hospital with Cellulitis. Member came into clinic on 9 May 2014 and states the Keflex worked and everything cleared up.
left eye turnrd in for approx 45 min. 10 days after immunization. leg tremmors on 3 different occasions for approx 4-5 seconds the week following eye incident. dr recomended eeg.  11/29/07 Received vax record which provides additional dose & lot #s.  VAERS database updated w/same.  1/8/08 Reviewed hospital medical records which reveal patient experienced abnormal eye movements & leg tremors 1 episode each in 3-4 weeks time.  Outpatient EEG was abnormal.  Referred to peds neurologist & admitted 10/31-11/1/2007.  No further activity while in hospital.  D/C to home w/neuro f/u & to have EEG repeated. FINAL DX: abnormal EEG.
Initial case was received on 31 March 2010 from a consumer/parent. A 5 year old male patient received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 March 2010. Post vaccination, between 06 March 2010 and 17 March 2010, the patient experienced nausea, vomiting and a seizure. Had no pre-existing medical conditions, no known allergies and no concomitant medications. As of this report he continued to be weak and fearful. The outcome status of the nausea, vomiting and seizure was not reported. The patient had previously received an injection (route and site unknown) of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number unknown) on 06 February 2010 and he experienced unspecified fever, nausea and weakness on 21 February 2010, reported in case number 2010-01913. Documents held by sender: None.
Patient urinated blood clot in urine; Patient urinated blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma. Concomitant products included ACALABRUTINIB (CALQUENCE) for Lymphoma, CYANOCOBALAMIN (VITAMIN B-12), CALCIUM and FOLIC ACID for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) (seriousness criterion medically significant) and HAEMATURIA (Patient urinated blood in urine). On 10-Apr-2021, HAEMORRHAGE URINARY TRACT (Patient urinated blood clot in urine) and HAEMATURIA (Patient urinated blood in urine) had resolved. Not Provided      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.   The patient recovered (clarified as the patient's urine was clear and did not have blood clots) on 10 Apr 2021. Patient self treated by drinking lots and lots of fluids (not further clarified).  Company comment: Based on the current available information and the temporal association between the product use and the start sate of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start sate of the events a causal relationship cannot be excluded.
(2/28/2021)Had a video visit with PC and showed painful joints and swelling, referred to rheumatologist for check up and was put on steroids regimen to stop the pain and swelling for 21-27 days. Was successful and no sustained damage or ongoing issue.
Pneumococcal vaccine left bicep in AM Monday May 23, 2016. In PM May 23, 2016 she developed watery non-bloody diarrhea, occurring several times hourly, and which had a "strange odor". This continued through the night, she had some relief on Tuesday but resumed severe watery diarrhea Wednesday. She presented to my office Thursday AM, May 26, having had a fairly benign morning, with respect to bowel movements. She reported that her right flank was "achy", but denied overt abdominal pain or tenesmus. No vomiting, but she was nauseous, poss sec. to the large volume fluid intake. On day 2, she had a temp of 100.7, but was o/w afebrile. No contacts with similar symptoms.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
wrong  DTAP/DT given for 12 yr age group. pt received DTAP (Infanrax), was advised to be given tdap (boostrix).
This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, M-M- R II (lot # K018990 exp: 15-OCT-2016), (lot # K024038 exp: 26-NOV-2016) (dose, route, therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Initial COVID symptoms on 16Jun2022, so I started PAXLOVID; Initial COVID symptoms on 16Jun2022, so I started PAXLOVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025L20A), on 04Feb2021 as dose 2, single (Lot number: 043L20A) and on 14Aug2021 as dose 3 (booster), single (Lot number: 002F21A) for covid-19 immunisation. The patient's relevant medical history included: "zero negative rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history: zero negative rheumatoid arthritis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Initial COVID symptoms on 16Jun2022, so I started PAXLOVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Outreach Covid Vaccination clinic at Jail. Client was starting Covid Vaccination series. Nurse drew up monovalent vaccine in syringe. Preceded to fill out paperwork for clinic and Covid card. Gathered supplies needed to give vaccination. Noticed client was larger bicep. Turned to small prep tray and grabbed syringe with 1 1/2" needle. Gave vaccine. Instructed client of possible side effects. Client left room with group to return to cell. When I turned back to prep table noticed monovalent syringe placed there, full of vaccine.   In summary: client was to receive monovalent vaccine but received Bivalent vaccine as 1st dose in series.  Notified Jail nurse of what had transpired and who the inmate was. Discussed that follow up with inmate would occur from County Health Department the next day. Explained that inmate would need to receive monovalent vaccine for 2nd dose in 3 weeks.  Follow up phone call to jail on 11/21/2022 to speak with nurse in medical unit covering inmate block of cells. Nurse returned call after speaking with inmate. Stated inmate denied any flu like symptoms yesterday afternoon or through the night or this morning. Said inmate only complaining of tender, sore, swollen shoulder at injection site.  No extra treatment given to inmate.
Shingles vacccine: first and second days, just some swelling. But on the third day I spent time in the sun with ths ite exposed. The site became very red and hard and swollen and hurt and remained so for more than a week.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neggram, reaction(s): "know allergies: Neggram", notes: know allergies: Neggram. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received the Paxlovid from 17Jan2023 to 21Jan2023, for treatment of covid-19. Vaccine lot number unknown as unable to locate or read the details.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Fever 24 hours Sore muscles 12 hours  Headache 12 hours  Neck pain small lump, above left clavicle,  started 1-2 days after. Lump still there on April 26 5 days later
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the son who reported for her mother. The age at the vaccination was not reported. The reporter reported that her mother received SHINGRIX vaccine. The patient was complaining of just about every symptoms. No rash or shortness of breath was reported. The reporter wanted to know how long does the symptoms lasts. The reporter left chat before any other information could be obtained.
nausea; Cold; coldness; This case was reported by a consumer via call center representative and described the occurrence of coldness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2019, the patient received the 2nd dose of Shingrix. On 20th April 2019, less than a day after receiving Shingrix, the patient experienced coldness. On 21st April 2019, the patient experienced nausea and cold. On an unknown date, the outcome of the coldness, nausea and cold were recovered/resolved.   It was unknown if the reporter considered the coldness, nausea and cold to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's husband. The patient received the Shingrix on Saturday in her left arm. The patient experienced coldness that night of vaccination and cold and nausea the next day of vaccination and she couldn't eat breakfast, but all had resolved at this point. This case has been linked with US2019AMR073878, reported by the reporter.
Prior to my first injection, I did not suffer with arthritis.  Within a month, I was unable to do yoga exercises as easily as I had prior to my first injection.,  After my second, it got worse and I had to go to an osteopath and starting getting cortisone injections in my hips due to arthritis and bursitis.  Thinking it was only old age, I continued with my Moderna injections.  My distal joints on my right hand were struck with arthritis for which I will need surgery and the final booster brought on Heberden Nodes in my distal joints.  I now suffer with excruciating pain in my hands, scalp and mouth that when touched, feel like my skin has been peeled off and vinegar poured on it.  I have a neurologist appointment in February to diagnose this issue.  No more boosters for me!!
Received vaccine 10/12/16. Injection site red, warm to touch, painful and itchy. Symptoms started 10/13/16. Redness aprx 4inx2in. Treated with Ibuprofen, KEFLEX BID x 7 days, steroid crm, cool compresses and BENADRYL.
Pt Bad fever and hives all over his body. Following that was terrible diarrhea for months. Complete loss of self-awareness.  12/17/09 MR received for DOS 11/29/05.  Pt seen for well baby visit at 11 mos old. Pt presented to "catch up on shots" and several vaccines administered. Tx: Motrin, Tylenol.
HYSTERIA; CONDITIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 experienced hysteria, and conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hysteria and conditions was not reported. This report was non-serious.
Ocular migraine day 5 Tension headaches day 5-9 Dizzy spells day 6-9 Sinus pressure (but no sinus issues) day 5-9  On day 9 today and symptoms are waning/waxing