chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; red mark on her shoulder and was burning and itching; the pain and burning felt like a burn; eye was still irritated; like a rash at the injection site; Vaccination site swelling; left aye turned very red; Injection site itching; Cold sweat; Vaccination site pain/ burning at the injection site; nauseas; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching) and PAIN (the pain and burning felt like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20P) 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 ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), ZINC and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (nauseas). On 30-Mar-2021, the patient experienced COLD SWEAT (Cold sweat), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (left aye turned very red). On 05-Apr-2021, the patient experienced PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), EYE IRRITATION (eye was still irritated), VACCINATION SITE RASH (like a rash at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 06-Apr-2021, OCULAR HYPERAEMIA (left aye turned very red) and EYE IRRITATION (eye was still irritated) outcome was unknown. At the time of the report, DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (like a rash at the injection site), NAUSEA (nauseas), VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A, 026L20A and 026L20A) for COVID-19 prophylaxis.     The patient had no known allergies. Patient had no acute and chronic illness at the time of vaccination and up to one month before was reported.  Previously administered products included for Product used for unknown indication: Flu shot (JX223) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  The vial was initially stored in the refrigerator on 27-May-2022 The vial did not undergo any temperature excursions  It was unknown whether the patient had been diagnosed with or tested positive for COVID 19.   This case was linked to MOD-2022-593739 (Patient Link).
pt experience syncope with normal blood pressure, but low pulse and loss of vision for short eperiod of time. EMS reported normal BP, heart check and pulse and oxygen. vision did return and pt felt better after about 20 minutes
31/F w no medical hx came to the clinic. She had Tdap and c/o dizziness and throat tickling so BP was checked. Her SBP went down to 70's and she was placed in Trendelenburg position.  IVF  w NS initiated and kenalog 40mg  given in case doe allergic reaction. She says she start feeling better after kenalog and IVF. BP recovered. EMT came to eval her and let her decide if she wants to ER now or later :  She choose to go ER later once her husband comes here. no LOC  SBP dropped to 81 to 75 :  She c/o dizziness IVF w NS kenalog 40 given :  now she feels better Her SBP improved to 110-120's No desaturation Her chest tightness resolved 911 called, paramedic here to access her VS so far stable DDX allergic Rx Vs vasovagal episode  addendum at 14:55 She is asking for letter to ER :  provided She is going to go ER by her husband's car for close observation/poss admission RTC PRN   PI revised on 10/14/20per pt's request :  She wanted to have more details in PI
2 people developed alopecia after getting the vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on an unspecified date single for covid-19 immunisation. The HCP states on unspecified date of 2021 two people developed alopecia after getting the vaccination. The outcome of the event was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Muscle feels hard @ injection site- (L) deltoid.  Pt complains of muscle soreness @ & around injection site.  Muscle soreness on back of (L) shoulder blades.
Beginning about 11:00 hours after the second shot and lasting about one and a half days: achy muscles, chills, fever, and fatigue.  Since this morning around 5:00 am (and after the other symptoms resolved) I have noticed an itchy, reddish rash along the inside and outside of the arm (some in the should bit mostly in the bicept and tricept area) of the arm where I received the shot. The rash is also warm to the touch.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: Other medical history: OSA; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "morbid obesity" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "PAF" (unspecified if ongoing), notes: Other medical history: PAF,. The patient took concomitant medications. There are no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (17Jul2022) Positive, notes: Positive rapid Covid detected 6 days after completion of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment orally for COVID-19 from 07Jul2022 to 11Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Achenbach Syndrome, a rare, untreatable condition, according to the internet.  My doctor was unfamiliar with the syndrome.   My husband and I had already figured out the name of the condition.  I took that information with me to the doctor on 5/25/21.  Today (5/27/21), I met a former nurse who immediately recognized the syndrome.   She said it was seen rarely.  Seeing my finger gave her goosebumps! Severe pain in fingers as blood vessel pops (sharp burning, stinging, tingling).  Fingers swells and lose mobility, movement is severely limited/restricted.  Usage of the finger aggravates the problem and causes it to last longer. Condition persists in varying degrees for at least 3 days.  This happened to my right index finger 5 times since the onset.  Each time it seems to be worse.  It also happened to my left index fingers but it was less severe and shorter lasting.
1/8  3a after getting the vaccine had a fever of 101.00 treated with Advil, Nausea, weakness, chills. Not going to see a professional or go to urgent care because I have had covid in the past and I know a few people who have experienced this after the shot
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), on 25Mar2021 as dose 2, single (Lot number: ER8730), on 04Oct2021 as dose 3 (booster), single (Lot number: 301358A) and on 21May2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetes" (unspecified if ongoing); "s/p breast ca" (unspecified if ongoing); "s/p endometrial ca" (unspecified if ongoing); "BMI 41/obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro family of abx, reaction(s): "Known Allergies: Cipro family of abx". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2023 at 09:00, outcome "recovered" (28Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2023) Positive, notes: I tested positive for covid on 23Aug2023; (28Aug2023) Negative, notes: Tested negative on Monday28Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested positive for covid on 23Aug2023. Very mild sx. She got Paxlovid the same day and completed the full course. Tested negative on Monday28Aug. Got scratchy throat on Thursday 31Aug. Tested positive for covid, felt like sinus infection/head cold.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product  BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) and BNT162B2  to the reported events Drug ineffective COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300290977 same reporter/patient, different product/AE;
4-year-old patient received expired IPOL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00855797) and transmitted to Sanofi on 12-Nov-2021.  This case involves a four-year-old male patient who vaccinated with third 0.5 mL (once) dose of expired IPV (VERO) [IPOL] (lot R1F973M and expiry date 03-Oct-2021) via intramuscular route at an unknown administration site on 12-Nov-2021 for prophylactic vaccination (expired product administered).  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported "caller states that a patient (male/4years) was given a vaccine that expired on 03OCT2021; caller would like counseling on revaccination step and adverse effects."  At the time of report, no adverse event reported.  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.
Tdap given 07/10. 07/11, right arm sore, headache, 7/12-7/13 "flu" symptoms then low fever 99.6. 7/14, fatigue continued and still achy. 07/15, fatigue/achy improving, but developed raised, warm, red, tender circular rash. 07/16, fever, rash increased, achy returned.
No symptoms reported; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist referring to 15-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 12-JUN-2023, the patient was vaccinated with improperly stored and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W0252273 was established as not valid, expiration date was reported as 02-JUN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used, Improper storage of product in use).  On 02-MAR-2023, the suspect vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes. No symptoms reported (No adverse event). No further adverse event (AE) details. No product quality complaint (PQC).  This is one of multiple reports from the same reporter.
Report itchiness of elbow and knees with flushing to entire body 1 week post vaccination that improved within 30 minutes and completed resolved within an 1 hour.  Second episode 2 week post vaccination  itchiness and flushing started with both feet and entire body that improved within 30 minutes completely resolved within 1 hour. Both episodes there was no treatment symptoms resolved on its on.
Pt recvd 3 doses of Engerix-B & on 3OCT91 titers were checked & the vax was found to exhibit seroconversion but no seroprotection, weakly positive result was observed; pt was considered a non-responder & will be revaxed;
Patient developed a local reaction on arm lasting from 6/15/2021 until 7/9/2021. Patient reported that this continued for longer but I cannot confirm or verify this as I have only seen the patient on 7/9/2021 in person and was unable to adequately assess her arm by video visit on 9/3/2021.
Severe body aches, foggy headed, light headed, headaches, body chills without fever, blurred vision.
Pt reported that within 4 hours of receiving first dose of Moderna vaccine she experienced a red, itchy, raised rash on both of her thighs.  The itching lasted for at least one hour then stopped.  She went to bed and when she woke up at 9am the rash on both thighs was gone.
44 y/o male with a history of Tobacco abuse and Hypercholesterolemia, developed dyspnea and progressed to a cardiac arrest on the morning of 5 Sept 08 towards the end of a several mile run and after performing a wind sprint. Member unsuccessfully given CPR and ACLS (at the scene and EMS/ED) and declared deceased at Emergency Department. Subject 2/5 cardiac risk factors: tobacco use and hyperlipidemia; autopsy results support severe atherosclerotic disease with final cardiac examination for myocarditis pending at this time. Member was seen in ED on 25 Aug 2008 (per wife) for a reported "allergic skin rash". Wife reported the SM had the rash as a result of the Smallpox vaccination he had received earlier.  Symptoms: Dyspnea (shortness of breath), Cardiac Arrest, Rash, pruritic. 1/30/09-records received-sudden death while performing PT. Previously lived in foreign country until 8/4/08. Received small pox vaccine on 7/31/08. Presented to clinice on 8/25/08 with C/O pruritic skin rash, pimples on legs and stomach and C/O itching, treated with Keflex, hydrocortisone cream and Benadryl. On 9/4/08 C/O feeling tired. During PT collapsed, difficulty breathing. No C/O chest pain. Stopped breathing. 4/6/09-Medical examiner report received-Probable cause of death:Ischemic heart disease. Contributing conditions:hypertension. hypercholesterolemia.
3 days post vaccine, patient noticed 4-5cm red band below injection site, which was red and swollen.  This procceded to extend upwards into the injection site, which already also was sore.  Today is the 8th day post vaccine and it is improved but not completely resolved.
Client received Hep A injection 03/10/04 around noon. States last pm between 6:30-7pm noticed blotching back left hand. Then both hands from 1st knuckles up to elbows began hurting and felt very sensitive. Also noted right side callar bone felt very sensitive. This am noticed rash on both thighs-no itching no respiratory symptoms-only symptoms as described. Has been getting immunizations to travel out of country.
April 5, 12:00 p.m. - swelling, redness around injection site 6 inches in diameter  April 6, 8:00 a.m. - rash around injection site, fatigue, muscle aches, joint aches April 8, 9:00 a.m. - headache April 9, 8:00 p.m. - swelling in glands around neck, burning sensation in ears
administered frozen Shingrix; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter US-GLAXOSMITHKLINE-US2022061871:Same reporter US-GLAXOSMITHKLINE-US2022061872:Same reporter US-GLAXOSMITHKLINE-US2022061873:Same reporter US-GLAXOSMITHKLINE-US2022061874:Same reporter US-GLAXOSMITHKLINE-US2022061875:Same reporter
This 35 year old patient reported receipt of influenza vaccinations in 1995 and 1996 (dates unknown). Approximately 1 hour post vaccination she complained of sudden onset of nausea with frontal/sinus dull-sharp throbbing headache that radiated over and around to back of her head over next few hours. She also complained of subjective fevers, vaccine site soreness, redness and swelling and diffuse muscle aches. These symptoms lasted for several hours and would resolve in about 7 hours after resting at home. She was deployed overseas in 1998-1999 and did not receive the flu vaccinations. Her next influenza vaccination was given 08 Dec 2009 IM (lot# and manufacturer unknown) again with symptoms as above. She remembers advising medical of symptoms but did not see trying Benadryl x 1 without any relief. Otherwise no medication was taken. Most symptoms resolved within several hours with site reaction within a few days. Her next influenza vaccine was given 26 Nov 2001 (per HPI note 11/29/01 but not recorded in medical records). She again reported onset of nausea with frontal headache that encircled her head, subjective fever, increasing vaccine site tenderness, swelling that was red with blotchy edges and itched about 1 hour later. Over the next 2 hours she began to vomit. Her arm swelling increased to about "1/2 softball" in size. She required assistance from her husband to remove shirt sleeve over swollen deltoid region stating it was too tight. She advised these headaches were not like her childhood migraines (different location, intensity, symptoms). She denied any photophobia or visual disturbances. She notified medical and was given an appointment 2 days later. She went home, rested with resolution of most symptoms in seven hours. By day 3 (11/29/2001) medical documented left upper arm/deltoid with 4 cm erythematous tender hard patch without paresthesia. Headache, fever, n/v and itching had resolved. She was diagnosed with "adverse reaction to influenza vaccine" and treated with Motrin and Atarax. She advised it took another few (3-5) days for these symptoms to resolve. She has not received the flu vaccine since. She denied any similar reactions with any other vaccinations (typhoid, AVA, SPV, hepatitis A/B, MMR, OPV, Td, etc). She denied any egg allergies and can eat eggs. She denied any gelatin or antibiotic allergies, specifically to polymycin B, gentamycin, or neomycin. She has no skin allergies or chronic medical disorders. Symptoms: Edema at injection site 30-50 min, rash, pruritic, headache, general, fever, tenderness, erythema, muscle pain.
Patient was fine a few minutes after given the Janssen Vaccine, then after that patient started to get dizzy/nauseous/lightheaded/feeling faint. Patient asked if it was okay to use the restroom, in which she vomitted. Tech made sure she ok in the restroom during the vomiting episode. After a bit of time she came back out and felt fine, we got her some water and had her sit for 30 more minutes just to make sure she was ok to drive. She was completely fine afterward and state that she did feel anxious after the shot and has had issue with anxiety before in these types of situations
Urticaria - itching all limbs.  Rx - cyproheptadine 4mg, hydrocort cream 1%, ranitidine 150mg.