chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 034F21A, 012A21A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Leg amputation.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching). At the time of the report, RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had been to the clinic where they gave him a couple different things to try but nothing was working. It started to clear up but then came right back. He had gone onto a website and seen some other people reported the same thing. This rash was initially down his chest and stomach. Now it had extended down his right leg, foot, buttocks, chest, and stomach. It was everywhere but his face. He had been using a topical medication prescribed to him and a lotion he got from Walmart. Applied this medication morning and night. This relieved the itching momentarily, but as soon as it's dry it continued itching.   No treatment medications were reported.
4/2/07 Child received shot around 3pm. By 730pm mom states child fever around 101 (although she did not know exact temp). States left thigh red and swollen and child crying and unconsolable for past 1 hr. Sent ED at hospital. Told give Tylenol x 24 hrs and observe. In ER temp 99.
4/11/2021 3:00am Dizzy when got up from bed 8:01am - dizzy and nauseous had to crawl, fainted - hit head, injection site very sor Slept rest of day  low blood pressure - 102/67 4/12/2021 -  High blood pressure, dizzy and nauseous 4/13/2021 High blood pressure - went to ER - 177/111 - ER doctor was not aware that J&J was being paused and  told me results had nothing to do with vaccine.  4/15 - Followup phone call with different Dr to review symptons encouraged me to submit symptons
Complete disruption of my menstrual cycle.  I have never had a problem with my cycle prior to May 2021.  After the second dose, my cycle was extremely heavy and continued that way, with only a few short days in between periods of bleeding, until mid July.  Blood test showed I developed acute anemia as a result.  No other abnormalities were identified.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (For tolerance to 1st dose please refer case US2019001666). In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue. The patient was treated with Ginger. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema and pruritus were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the shoulder pain, shivering, headache, dizziness and fatigue were not recovered/not resolved and the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however, it could be 62 or 63 years. The patient received SHINGRIX vaccine in left arm, approximately 8 days ago before the date of reporting. Next day the patient started vomiting. The patient has been eating ginger to help and has now recovered. The patient experienced swollen arm which was better than before but it was still swollen. The patient was still experiencing shivering, headache, dizziness, shoulder pain, redness, itching, and fatigue. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required.
Patient received Moderna and 17 y.o.  No adverse side effects reported.  Moderna Rep informed clinic that the patient may get 2nd dose under off-label use for 16-17 y.o.
patient received moderna vaccine and reported to 15 min observation. patient noted to be slumped in chair, roused patient who sat up and vomited x3.   Denies shortness of breath, no wheezing or respiratory distress. patient tearful. 125/92 96.  EMS called Patient given O2  via  mask. Arrived, patient reported feeling better. Patient and mother declined EMS transport and left vaccination clinic.
Pt arrived with shortness of breath. Has a PMH of COPD, chronic respiratory failure, and chronic diastolic heart failure. Pt was admitted for pneumonia and COVID positivity.
Seven patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  Office manager stated that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment medications are provided.
9 days after the shot a red, itchy rash developed at the injection site. It looks like a hive about 6 inches long and 3 inches wide.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-DEC-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had two separate temperature excursions: 72 hours (Highest recorded temperature was 9 F (9 Celsius) and 48 hours (Lowest recorded temperature was 1 F ( 1 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a licensed vocational nurse concerning a 28 year old female with no pertinent medical history who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot #656051/0244U).  Concomitant therapy included ACCUTANE and DEPO-PROVERA.  On 28-MAY-2007 the patient complained of pain at the injection site, limited mobility and severe weakness in the entire arm for six weeks after injection.  On approximately 03-JUL-2007 the complaints had resolved.  On 27-JUL-2007 the patient was vaccinated with a second dose of Gardasil.  On approximately 27-JUL-2007 eight hours after vaccination the patient had pain at the injection site.  The skin was clear, and there were no complaints of limited mobility at that time.  The patient's outcome was unknown.  On 21-SEP-2007 the patient planned on receiving a third dose of Gardasil.  At the time of the report the patient's outcome related to the third dose of Gardasil was unknown.  Additional information has been requested.
Body aches, increased pain and swelling around vaccine site.  Swelling involved entire lateral aspect of upper arm.
Developed severe myalgias with profound tremors.  Severe lower back pain in the area of the kidneys.  Minimal temperature elevation.  Frontal headache.  All symptoms lasted approximately 16 hours.  Arm pain persisted for 4 days.
Received 3rd Moderna vaccine on 11/04/2021 and did well with the vaccine.  Developed new onset pruritus and acute urticaria on November 13, 2021.  Hives extended to most body surfaces.  There were no other symptoms except for dermatologic symptoms.   initial treatment was per report with H1 and H2 blockers but required course of prednisone.  Acute urticaria resolved by 2 weeks.  She has had persisting dermatographia since that time treated with Allegra and hydroxyzine.    All symptoms have resolved except for dermatographia.
I began menstruating in the evening of Tuesday January 5th, 2021 (on schedule). However by the morning of January 6th, my flow had increased in a way I had never experienced before.  And until midday on January 9th, I was going through 1 ?super? tampon every 2-3 hours. My menstruation flow resembled blood, and was not as clotted as my regular flow. On January 9th, the bleeding slowed and normalized.  I contacted my doctor?s office and was directed to take 1000mg of acetaminophen twice daily, and call back if my flow had not slowed down by Monday because I would have to come in.   I followed the recommendations for one day (on January 8th)  and took a total of 2000mg of acetaminophen.
per pts mom pt crying every time moves legs; upper thigh rt leg reddened & swollen; APAP & ice packs on & off recommended; if worsens to call for office visit;
1 week after 1 year vaccinations patient developed erythematous papules and "water blisters" at site of Varicella vaccine. Over 1 week increase size and with few scattered on abdomen and one patch on left chest.
Patient described about 2 hr post immunization became flushed and vomited. Vomitted 4 more time in that 12 hr period. One episode of diarrhea and complained of chills and flushing within 24 hr the symptoms had subsided and at 30 hr post patient felt fine and was doing well. No treatment done.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 2, single (Lot number: FF8839) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
Fever peaking at 103 degrees, persistent for 3 days. Body aches. Headache. Purple hands and feet. Exhaustion. Treated with alternating ibuprofen and acetaminophen.
Had flushing of his cheeks, chills, diaphoresis, vomited once.  Gave 50mg of diphenhydramine in the office.
Recurrence of AFib which did not respond to ?Pill in a pocket? chemical cardioversion
SMALL PIMPLE ON FACE; RESTED ABNORMALLY; This spontaneous report received from a patient of an unspecified age and sex (reporting on self). 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 not reported) dose was not reported, administered on APR-2021 on an unspecified site for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pimple on face. On APR-2021, the patient experienced rested abnormally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rested abnormally, and the outcome of pimple on face was not reported. This report was non-serious.
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 03/30, Pfizer, dose #2 12/27 COVID swab, result: detected 12/29 COVID swab, result: detected 12/30 pt admit to Medicine cc: "worsening covid symptoms x 1 day" dx: Episode of Hypoxia, COVID-19 Pneumonia, Superimposed Presumed Bacterial (organism unknown) Community Acquired Bilateral Pneumonia LOS: 3 days 12/30 pt cc: cough, fatigue, dyspnea, exposure: unknown 12/30 FIBRINOGEN: 977 12/30 DDIMER: 0.77 12/30 CRP: 25.774 12/30 CTA PE: No pulmonary embolus. Bilateral multifocal pneumonia, right lung worse than left, Follow up demonstrate resolution after treatment in 6 months. 12/30 CXR impression: Suspicious for bilateral pneumonia. 12/31 FERRITIN: 494.3 12/31 FIBRINOGEN: 941 12/31 DDIMER: 0.68 12/31 ESR: 28 12/31 SARS-COV-2 IgG (ABBOTT): 0.01 12/31 PROCALCITONIN: 3.56 1/1 FIBRINOGEN: 722 1/1 DDIMER: 0.61 1/1 procalcitonin: 2.60 1/1 ESR: 38 1/5 clinically resolved
First week of January I started feeling off. I was having headaches. I took my blood pressure which was really high. I logged my blood pressure and saw my doctor about a week later. He ordered an EKG and started me on losartan. The EKG was normal. Presently my blood pressure has improved but is not back to normal.
Patient missed her second dose in recommended timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose in recommended timeframe) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 (Patient missed her second dose in recommended timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose in recommended timeframe) 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.   No concomitant medication reported   No treatment medication reported
One week after my vaccination I was diagnosed with Covid-19 and I was treated with prednisone. I had a COVID-19 test  and it was positive. I had respiratory symptoms like wheezing shortness of breath, cough, muscle aches, and headaches. A week and 1/2 after the vaccination I went to the ER because I had respiratory symptoms and I passed out in the ER. I was diagnosed with pneumonia.
pt recv vax 1AUG96 PM & leg became red & swollen w/ c/o pain by next AM;also began having nausea & vomiting;large knot & hot to touch;taken to ER 2AUG96 leg kept getting redder & more swollen;lt leg red w/streak of red running down leg;
This spontaneous report was received from a pharmacist referring a 69 year old female patient. Concurrent condition and medical history were not reported. On 17-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # L003218 and expiration date on 30-APR-2015 in the arm (unspecified location) (strength, dose#, dose and route of administration were not reported). It was also reported that the patient was concomitantly vaccinated with PREVNAR 13 on the opposite arm on the same day as when she received the ZOSTAVAX. Others concomitant therapies included generic alendronate sodium and levothyroxine sodium (manufacturer unknown). On 17-JUL-2015, afterwards ZOSTAVAX vaccination the patient experienced a localized red rash at the injection site. The patient sought for medical attention but, no treatment was given or laboratory diagnostics studies were performed. At the time of the report, the outcome of the event was unknown. The relatedness of the adverse event and suspect therapy was not provided. Additional information has been requested.
Swelling and erythema to arm from 2" above elbow extending to upper arm, shoulder, and anterior axilla. Painful. Pt reported itching, red rash about 8 hrs. after injection. Prednisone burst x 1 wk. (20mg BID x 7 days).
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORMULA,
Pt. received her second Pfizer dose at 3pm. By 11:30pm she had significant swelling on both of her eyes, mouth, and the start of red splotchy skin on arms and legs. We took her to ER. They gave her 50mg of hydroxizine and sent us home. 5min after leaving the ER at 12:30am on 4/23 she felt a golf ball sized lump in her throat and was having difficulty breathing. We brought her back to the ER.  At this time they gave her an ekg, and at around 1:30am gave her an epi pin and an oral steroid. Within 5min of the oral steroid and epi pin she no longer had difficulty in breathing and the lump in her throat was gone as was the res splotches. By 5am the swelling in her face had reduced drastically to 90% normal in her left eye and 70% normal in her right eye and 70% normal in her lip. She was released from the ER at 5:45am and went home to sleep. At 11:30am on 4/23 her swelling in her face remains the same and she is complaining of a headache. She was given 50mg more of hydroxizine.
ALLERGY SYMPTOMS; She is sore; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  No treatment medication reported.     On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore). At the time of the report, ALLERGY TO VACCINE (ALLERGY SYMPTOMS) and MYALGIA (She is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by reporter.  No concomitant medication reported.  No treatment medication reported   Reporter did not allow further contact
Incorrect amount of 0.8mL NS dilution used in place of 1.8mL. Was given 0.3mL of reconstituted vaccine.  Observed 15 minutes and no reaction.
Friday pneumonia vaccine in clinic- 5 days ago Had some fatigue and a sore arm on the first couple days. 3 later started vomiting- looks acidy and watery. Vomited multiple times yesterday and today. Has been able to drink water. No diarrhea. Has been urinating 3-4 times a day still.  Taking ibuprofen which has been helpful, as well as her scheduled hydrocodone- acetaminophen 5 times daily. H Has also been taking excedrin. Was prescribed zofran to help with sumptoms
Achy arm on arm of injection.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Achy arm on arm of injection.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VIT D [VITAMIN D NOS] and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.   On 08-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 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Achy arm on arm of injection.). The patient was treated with IBUPROFEN for Pain in arm, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Achy arm on arm of injection.) outcome was unknown. Not Provided          Concomitant medications included High Blood Pressure Medications, Antihyperlipidemic, Multivitamin. Action taken with mRNA-1273 in response to the events was not applicable.
pt devel a few scattered papular urticarial lesions on face & upper extremities 5-6 hrs p/vax; no resp sx; treated w/DPH;
a 22 month old patient was injected with Quadracel in error, no AE; Initial information was received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (office staff).  This case is linked to case 2020SA182014 (same reporter)  This case involves a 22 month old female patient who was injected in error with 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5688AA, expiry 26-Nov-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 06-Jul-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE  for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age.  No adverse events were 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 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.
Patient is fully vaccinated and boosted 11/9/2021.  Tested COVID + 1/5/2022. Patient was admitted with change in mental status and vomiting. According to the family she has been getting confused over several weeks and got worse over the last few days.  She also developed bouts of vomiting in the last 3 days.   She was admitted with altered mental status and metabolic encephalopathy.  CT of the abdomen showed retroperitoneal lymphadenopathy.  She was seen by infectious disease and received monoclonal antibodies. HG 8.3.  Her mentation improved and back to baseline at the time of discharge.