chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy bothersome rash/hives; itchy bothersome rash/hives; little red bumps all over his back, legs, arm, and chest.; This case was reported by a consumer and described the occurrence of itchy rash in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dry skin (every winter gets dry skin from taking hot showers) and pruritus (had some itching on his back before he got the shingles shot, but no rash).   On 17th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced itchy rash, hives and erythropapular rash. The patient was treated with prednisone. On an unknown date, the outcome of the itchy rash and erythropapular rash were not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the itchy rash, hives and erythropapular rash to be related to Shingrix.  Additional information was provided as follows: The patient received of Shingrix and developed an itchy bothersome rash and hives, little red bumps all over his back, legs, arm, and chest. The rash was not on his neck or head. The patient visited his regular doctor and was prescribed Prednisone 5 mg one tablet per day for 7 days. The patient mentioned that, this prescription did not do much. Around 7th December 2020, the patient visited a dermatologist and was prescribed with Prednisone 10 mg which eliminated the rash after 3 weeks. About 4 days after discontinuing the tablets, the rash reappeared. The patient had called the dermatologist and asked for more prednisone and was told that another prescription for prednisone had been phoned in for him. The patient was planning on picking up the prescription on the day of reporting. The reporter went online to see what the possible side effects were of Shingrix and that he didn't get any of them except rash or hives. The reporter stated that every winter he gets dry skin from taking hot showers and he stated that he did have some itching on his back before he got the shingles shot, but no rash. The reporter did not consent to follow up.
Patient did not have adverse event. Reporting a VAERS due to administering vaccine when FDA/CDC released on August 31, 2022 that we were supposed to stop administering monovalent Moderna boosters. Vaccine was administered in the morning prior to the news release in the afternoon. The pharmacy was unaware of the news release during time of administration.
IGM POSITIVE, IGG NEGATIVE; This spontaneous report received from a patient via a company representative via social media (Facebook) concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed with additional information received from Central complaint vigilance on 29-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown).5 ml,1 total, start therapy date were not reported for prophylactic vaccination. 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, four months later the patient had IgM positive, IgG negative. Laboratory data (dates unspecified) included: IgG (NR: not provided) Negative, and IgM (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of IgM positive, IgG negative was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210761815  This report was associated with product quality complaint: 90000187621; Sender's Comments: V0: 20210760356-COVID-19 VACCINE AD26.COV2.S- IgM positive, IgG negative. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Soreness in the arm; Itchiness; With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the arm) and PRURITUS (Itchiness). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (With a red band around their arm 3-4 inches wide starting at the injection site wrapping around the bicep, feels more like sunburn instead of a rash) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment information was specified.
After 36 hours I started running a temperature that went up to 104. Went back to hospital emergency care . Received antibiotics.
had the flu symptoms within 20 minutes of getting the shot; IInitial information regarding an unsolicited valid non-serious case received from a consumer (patient) via  Digital Media through social media  on   02-Dec-2020.  This case involves a adult male patient who had the flu symptoms within 20 minutes of getting the shot (influenza) , while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date within 20 minutes starting the suspect vaccine therapy, the patient had the flu symptoms of getting the shot (influenza) and the patient had flu off and on for 18 months (outcome resolved)  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on batch number for this case .
Found a lump in my breast and under arm.  At the time of mammogram and ultrasound I was asked about the timing of my Covid shot.  I was not aware it causes swelling of the lymph nodes.  I have had the two vaccinations and two boosters.
Neck and Spine Problem; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spinal canal stenosis (Narrowing of Spinal Canal about 3 years ago).    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.  The reporter stated that Patient had to receive epidural injection on 16JUN2021 in the Neck and Spine.    Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received and event outcome was updated from unknown to recovered.
Swelling, warmth and redness that has increased since injection. I applied cool compresses, took Ibuprofen and Tylenol. No itching at site and mild pain with palpation only. Has low grade temp and general achiness.
left arm pain and hives fever, diarrhea, myalgias, abdominal pain
47 days past the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (47 days past the first dose of vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (47 days past the first dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (47 days past the first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.   It was noted that the patient did not have any symptoms following the vaccination. She did not receive any treatment.
pt recvd vax 23JUN92 & w/in 10 mins of inject exp 1 or 2 hives in axilla & itching localized to axilla;
Approx 5 days after pt received vaccine he developed macular papular circular area near the injection site. When seen in office on 10/21/13 the area center had returned to normal skin but had 2.5 cm x 4.5 cm boarder to it. No vesicles, drainage of new skin lesions noted. Pt was afebrile.
30 year old male found resting in cot. clinic staff found patient on ground. patient states he has known responses to injections. felt faint and assisted self to ground. syncopal. unknown duration, no trauma. hypotensive/bradycardic. 12 lead performed. non-stemi. secondary/neurological exam normal. base contact made for a association.
Approximately 24 hours, post vax, pt experienced swelling and inflammation involving 3/4's of deltoid area extending down right arm.
an itchy rash appeared on day seven.  It is not a big deal, but I looked it up and the article encouraged me to report it.  Will probably get some benedryl cream later today to treat
Pt received Moderna Covid Vaccine outside of recommended age range. Pt is 17 years old at time of vaccination. No documented symptoms within the 15 minute evaluation time post vaccination.
Elevated ALT for about 2 months; Elevated AST for about 2 months; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), first dose via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, body mass index from an unknown date and unknown if ongoing BMI>30 / <35. Concomitant medications included vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks included Vitamin D3, Carvedilol, Losartan. The patient experienced elevated ALT for about 2 months, elevated AST for about 2 months since an unspecified date in Apr2021. It was reported that, "Elevated ALT and AST for about 2 months. Previous results were always within normal range. As an example, on 24Apr2021 AST was 745 and ALT was 1,578. Earlier results were higher, with results returning to normal (20/26) by 14Apr2021". Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests and procedures which included alanine aminotransferase: elevated on an unspecified date, alanine aminotransferase: 26 (units unspecified) on 14Apr2021, alanine aminotransferase: 1,578 (units unspecified) on 24Apr2021, aspartate aminotransferase: elevated on an unspecified date, aspartate aminotransferase: 20 (units unspecified) on 14Apr2021, aspartate aminotransferase: 745 (units unspecified) on 24Apr2021, body mass index: >30 / <35 on an unspecified date, Sars-Cov-2 test: negative on an unspecified date in Aug2021 Nasal Swab. On 08May2021 the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) in left arm, as dose 1, single for COVID-19 immunisation. The patient was tested for COVID-19 since the vaccination. The outcome of the events was reported as resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Patient cannot eat or drink water; body aches; nausea / sick to stomach; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2, Primary Series), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and Primary Series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 28-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach). At the time of the report, FEEDING DISORDER (Patient cannot eat or drink water), MYALGIA (body aches) and NAUSEA (nausea / sick to stomach) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received her first Moderna Covid-19 booster dose as the bivalent dose.  It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient reported that she then needed to end the interview as she wanted to call a Pharmacy associated with her Pharmacy.   Treatment medication was not provided by the reporter.
have been given patients  vaccines that have been expire; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (have been given patients  vaccines that have been expire) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (have been given patients  vaccines that have been expire). At the time of the report, EXPIRED PRODUCT ADMINISTERED (have been given patients  vaccines that have been expire) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.
Severe allergic reaction to the shingles vaccine. My arm was swollen, red and hot. I was treated with several medications and the symptoms subsided but as of today have returned. I have a call in to my doctor. 11/10/09 Medical records received for date 10/13/09 to 10/15/09. OV pt received shingles vax 10/13. OV 10/15 c/o swelling, pain at site of injection left arm, fever. Assessment: left posterior arm with erythema and induration. Noted recent bx left wrist, with some cellulitis noted. 10/16 pt. stated sx worse, sent to ER. 10/19 call to MD from pt. stated went to ER was tx and dc. Sx. Cont to worsen. 10/20 pt states problem resolved.   12/09/09 ED notes for DOS 10/16/09.  DX: cellulitis, localized allergic reaction, insect bite. Pt presented for evaluation of a possible reaction to a vaccine. Pt received a vaccine injection and 2 days later developed L arm injection site redness and itchy. Tx: Benadryl, Zyrtec and Keflex, Solumedrol.  System review: negative. Pt's arm in sling.
On 6-4-08, patient reported 1 1/2#, very red, and itching reaction at injection site of ZOSTAVAX sub-q injection.  No other symptoms have developed other than at injection site.  "Feels warm" and a "little itchy."  Not spreading however, as of 6-5-08, has not dissipated.  Probably a local reaction only.  Recommended oral Benadryl to relieve itchiness and redness.
Incoming TC from patient, reporting possible COVID-19 side effects / adverse reaction:  Patient called in reporting difficulty breathing, rapid heartbeat, chest tightness, dizziness when walking ""had to hold onto my dad's shoulder while walking so I don't faint, I feel anxious like something is going to happen.""  Reports received 2nd dose Pfizer 5/07 felt "okay" afterwards. Starting 1 week ago 5/18 started to rapid heartbeat, anxious, even at rest. States HR is 78 O2 sat 98%. Was seen at a clinic 1 week ago, EKG performed WNL.  Advised to call 911, or seek emergency care. Pt stated he will have his dad drive him toER.
Shot given at 17:45 - onset of itching and hives 18:05 lasted approx. 2 days w/ low grade temp. Nausea and diarrhea. Took Benadryl headache, APAP w/ Caffeine.
"pt recv vax & pt devel an inj site rxn characterized by redness, induration & warmth;pt was seen by MD & tx w/ATB;"
Red splotchy area with several bumps on right thigh, BENADRYL for itching.
1min post vaccination pt reported feeling dizzy, and had a witnessed syncopal event and associated fall. Pt slid out of his chair and hit his right knee on the ground. Pt fell forward and his face hit the ground. LOC for a "few seconds". Pt was shaking and diaphoretic, drenched in sweat.  Pt recalls waking up to hear voices. Pt was transported via wheelchair to private observation area, vitals were taken after event when pt was lying down. Vitals @13:26 BP 88/47, HR 44, RR 20, SpO2 96% -- > @13:30 102/60, 46,99% -- > @13:35 118/68, 53, 16, 100% -- > @13:50 114/74, 61, 16, 100% Pt reports lower HR at baseline, previous runner, now bikes 10 miles/d.  Exam: A+O x 4, immediately arousable, shallow abrasion to base of tongue due to biting or teeth digging into tongue when face hit the floor. .5cm superficial abrasion to the bridge of nose- tender. No ecchymosis, no bleeding from nose, some bleeding from the bridge of the nose. Tender, redness, bump palpable lateral R to mideline forehead. Right anterior knee red, tender to palpation with mild swelling. Neuro exam: CN 2-12 intact, UE and LE motor intact. Neck- full ROM without pain or tenderness, sensation intact. Pt speaking normally.  CV: Regular rhythm, rate 60  Lungs: CTAB Pt given juice, crackers, and water. Recommended APAP, ice to the bridge of his nose, and f/u with pt's PCP w/in 48hrs.  Pt observed for 30mins after the onset of the syncopal event.  No aditional abnormal symptoms noted. Educated pt on signs/sx warranting emergent and urgent evaluation and to seek care if these occur. Pt verbalized understanding.   Pt stable and released from the vaccination site.  PMH significant for anxiety, major depressive disorder, hyperlipidemia/hypercholesterolemia, Vitamin Deficiency, Kidney Stones, Dysmetabolic Syndrome X.  Pt is a smoker. No Known medications or allergies.
Patient received ZOSTAVAX on August 31, 2013. Began to notice tingling sensation on ankles within 24 hrs after receiving vaccine. progressed to burning, and then blisters began to develop on back of leg behind the nee. Went to ER 48 hours later, and given a viral antidote. (Acyclovir)
patient was given monovalent Pfizer 6mo-<5yr for the 3rd dose instead of Pfizer bivalent 6mo-<5yr.  No treament needed no reaction parents notified of monovalent given instead of bivalent
Nervousness, headache, sleeplessness first night.  Morning and following 2 days: fatigue, nausea, dizziness.
Sore arm; headache; temperature; body aches; tired; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, general body pain, tiredness and diarrhea. On an unknown date, the outcome of the pain in arm, headache, fever, general body pain, tiredness and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, headache, fever, general body pain, tiredness and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter had his Shingrix vaccine one day before reporting. On the day of reporting the patient had the side effects sore arm, headache, temperature, body aches, tired, mild diarrhea. The reporter asked how long would these side effects last.
Information has been received from a nurse practitioner concerning a 15 year old female with asthma and mitral valve prolapse and no known drug reactions/allergies who on 01-JUL-2008 was vaccinated intramuscularly with the 0.5 ml first dose of GARDASIL vaccine (yeast) (LOT # 660389/1968U). Concomitant therapy included FLONASE, albuterol and montelukast sodium (MSD). Several hours after the vaccination, the patient developed itching on her chest and chest pain. Several hours after onset, the patient recovered from itching on her chest and chest pain. The symptoms resolved without any treatment. On 30-JUL-2008, the nurse practitioner reported that the patient saw a cardiologist and the physician felt that it was just a muscular pain. Additional information has been requested.
Pfizer 5y-11y (orange cap vial) was not diluted before vaccination. Pt received 0.2 mL of undiluted vaccine. No adverse reactions observed after administration.
Pt experienced hives, vertigo, tinnitus. Sent to ER-pt received orders to take BENADRYL 25 mg po tid for 5 days, and prednisone 60 mg po daily for 4 days. Instructed to go back to ER if symptoms get worse.
For first dose, unusually sore arm for approximately 24 hours but resolved.   For second dose, no side effects at all.
Woke up aprox 3 am feeling feverish, chills, headache, over all felt sick. Felt like what I remember feeling when I had the flu. It?s been years since I?ve gotten the flu. Rested, and took ibuprofen   Felt better and more like myself around 10 am. Short lived, thankfully.  Feel fine now.
Left arm nerve type pains similar to a sunburn pain. Now getting red spots with small bumps.
Pt given Fluad that is not recommened or indicated for her age group. No adverse reactions noted.