chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hoarseness; Congestion; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (Hoarseness) and NASAL CONGESTION (Congestion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (Medical history reported as A-fib). Concurrent medical conditions included Diabetes (Medical history reported as diabetes).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPHONIA (Hoarseness) and NASAL CONGESTION (Congestion). At the time of the report, DYSPHONIA (Hoarseness) and NASAL CONGESTION (Congestion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Much more of a reaction; This spontaneous report was received from a pharmacist concerning a 17 years old female patient. The patient's current condition and medical history were not reported. The concomitant vaccine included COVID-19 vaccine.   On an unknown date, the patient was vaccinated with HPV vaccine (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)) (dose, route and batch/lot# not reported) as prophylaxis. It was reported that the patient had much more of a reaction to the HPV vaccine and besides seeing the doctor they didn't report that either. The outcome of event was not reported.   The causality between the event and suspect vaccine was related.; Sender's Comments:  US-MMM-MGR02XIE:
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash around injection site that is spreading down arm), PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 19-Apr-2021, the patient experienced RASH PRURITIC (itchy rash around injection site that is spreading down arm), PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache). The patient was treated with TRIAMCINOLONE ACETONIDE for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 20-Apr-2021, PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache) had resolved. At the time of the report, RASH PRURITIC (itchy rash around injection site that is spreading down arm) outcome was unknown. This case was linked to MOD-2021-061198.
Right thigh area to medical aspect of where immunization given with obvious redness and swelling. Warm to touch. Lines around redness and within 20 mins, lines had spread & swelling enlarged.  3/15/07 Received medical records from hospital which reveal patient experienced right lower extremity pain, swelling & redness on 1/30/07, day after vax.  Initially seen at outlying ER on 1/30 for eval & d/c to home.  Then on 1/31 had increased swelling, pain & limp & was admitted for IV antibiotics overnight, responded well & was d/c to home on oral antibiotics for 7 more days. FINAL DX: right lower extremity swelling, likely secondary to adverse immunization reaction.
Initial: Red line right posterior thigh. Over time, the line grew longer, deeper red, and wider along with a transient blistering rash. Early July 2021-Initial Dx by PA: Poison Ivy. Cream was prescribed. Rash and line continued to increase. July 15, 2021- Saw primary doctor. Dx: Poison Ivy. Oral steroids  No relief. Red line disappeared but transient blistering rash continued and worsened.  August 5, 2021-Dermatologist was seen. No Dx but not Poison Ivy. Bx done on single blister left elbow. Results: Dermatitis. Rash worsening. Return to primary doctor for rash but bradychardia and hypertension precluded rash assessment. Advised by primary to seek emergency treatment. Admitted to Medical Center emergency room on  August 31, 2021.  Admitted to cardiac floor on August 31, 2021. Released September 3, 2021 with name referred to electrophysiology cardiologist.
STARTED WITH FEVER ON SATURDAY 10/7/2023 RASH STARTED MONDAY 10/9/2023 RASH IS WIDESPREAD-FLAT, RED, SMALL TO B LEGS, B ARMS, TRUNK, BACK, AND FACE
This solicited report was received from a pharmacist and refers to a female patient of an unknown age enrolled in a Patient Support Program. The patient's concurrent conditions and concomitant medications were not reported. The patient had poison ivy prior to getting ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On an unknown date, after ZOSTAVAX administration, the patient experienced rash and also "an outbreak rash on her face". The patient was treated with unspecified steroids. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to a 1 day old non-pregnant female patient with no pertinent medical history, current conditions or drug reactions or allergies. On 19-APR-1995, the patient was vaccinated with the first dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 1, route, anatomical location, batch/lot # and expiration date not reported). On 12-JUN-1995 the patient was vaccinated with the second dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 2, route, anatomical location, batch/lot # and expiration date not reported). On 15-DEC-1995 the patient was vaccinated with the third dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 3, route, anatomical location, batch/lot # and expiration date not reported). There were no concomitant medications. On 16-JUN-2014, titers were ran for the patient and the results came back "nonreactive" (exact values and units not provided). No treatment was given for the adverse event. Outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Contracted alopecia aereata and has been fighting it for over a year. She is bald from vaccine
Shortness of breath  CHF (congestive heart failure) (CMS/HCC)  Renal failure Anemia
Extremely heavy and painful menstruation, lasting 7-10 days compared to previous 4-5 day, mild period. Some bleeding between periods.
Shingles-like rash on the torso; Like a mild case of shingles; Started to itch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2022 (Lot number: FJ6369) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: I had it 17 years ago, but now it's on the opposite side".; "Blood pressure" (ongoing); "COVID", start date: 18Dec2021 (unspecified if ongoing), notes: like a whole month. She reports fatigue leftover from COVID. Family history included: "Borderline diabetes" (unspecified if ongoing), notes: The borderline diabetes has been on her record because it runs in her family. Concomitant medication(s) included: METOPROLOL SUCCINATE taken for blood pressure measurement (ongoing); OLMESARTAN MEDOXOMILO + HIDROCLOROTIAZIDA taken for blood pressure measurement (ongoing).  The following information was reported: RASH (non-serious) with onset 2022, outcome "recovered", described as "Shingles-like rash on the torso"; HERPES ZOSTER (non-serious) with onset 2022, outcome "recovered", described as "Like a mild case of shingles"; PRURITUS (non-serious) with onset 2022, outcome "recovered", described as "Started to itch". Therapeutic measures were taken as a result of rash, herpes zoster, pruritus.  Additional information: As treatment she self administered tea tree oil, washing or keeping the area clean with alcohol. She received the Pfizer COVID-19 vaccine on 23Feb2022 and is due to get the second COVID-19 vaccine on 23Mar2022. Caller states it is a week away. She reports that days after she received the COVID-19 vaccine she developed a rash resembling shingles, like a mild case of shingles, on her right side trunk area. She states the rash is still going on and she still has a small patch of the rash, like it is going away, its healing. She is due to get the COVID-19 vaccine again on 23Mar2022 and she wants to know is it safe to get second dose with this reaction from the first dose. Clarifies a week after Wednesday, 23Feb2022 when she received the COVID-19 vaccine it was not the next day or Friday but like the Thursday of the following week after the shot, when she noticed itching. She states the rash was on her right torso below her right breast down to not even the pubic area. Caller clarified to the navel not the pubic area. She had her first shot she had a rash that resembled shingles on the right side of her torso but milder than shingles, like a mild case that lasted like 2 or 2.5 weeks. Time the Vaccination between 2:30pm and 3:00 pm on 23Feb2022. She reports she has been taking concomitant drugs for years. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None  No follow-up attempts are possible. No further information is expected.
Muscle soreness - started with upper legs, spread to back (lower and upper) and neck. Got progressively worse over several months. Has not abated.
1/28/22 admitted to ER with severe abdominal pain, vomiting. Blood work, abdominal & pelvic ultrasound and CT scan done. Transferred to hospital on 1/29/22 repeat abdominal ultrasound done.  Appendicitis ruled out.  Discharged 1/29/22.  Readmitted to ER on 1/31/22 with increasing pain and constipation.  Repeat abdominal ultrasound done.  discharged.  2/7/22 saw pediatric gastroenterologist and diagnosed with Mesenteric Lymphadenatitis.  Pain, nausea, vomiting at times bloody, constipation persists to date.
Night sweats, body aches, temp 100, severe fatigue. Symptom onset approximately 6 hours after vaccine, resolution within 24 hours
This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
devel rash, torso-neck-face & scalp; 3 days p/vax on 2NOV92 DTP/OPV/HIB/Hep B mom reports pt is cranky but is breast feeding well; exam maculo papular rash confluent ever areas;
PATIENT CALLED ON 7/22/2012 AT 1:00 PM AND ASKED ABOUT A RAISED, RED, HIVE-LIKE AREA AT THE INJECTION SITE OF HER VACCINE.  SHE STATED THAT SHE NOTICED IT BECAUSE IT STARTED ITCHING. PATIENT STATES TAHT IT IS ABOUT THE SIZE OF A QUARTER AND NICKEL SIDE BY SIDE AND THAT IT IS SLIGHTLY SWOLLEN.
Information has been received from a nurse practitioner concerning an 8 week old female with no pertinent medical history or drug allergies who on 20-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# 659917/0017X).  Concomitant vaccinations administered on that same day included a dose of PEDIARIX, a dose of PREVNAR and a dose of ACTHIB.  On that same day the patient experienced seizure-like activity for 1 & 1/2 minutes.  "The patient was sent to the emergency and was admitted to the hospital overnight."  Lab diagnostic studies included a "CAT scan and LP."  Subsequently, the patient recovered.  There was no product quality complaint.  No further information is available.
BlurredVision, Myalgia, Diarrhea, NauseaVomiting, chills, fatigue, anterior scleritis, sweats Narrative: 1/14 - chills, achiness, fatigue for 36 hours. 1/15 - Then had mild diarrhea 1/17 - worsening diarrhea (ha h/o IBS), nausea, abdominal pain and sweating - These resolved as of 1/21. 1/17 eye swelling started in her right eye. She saw an opthalmologist on 1/23 who said she had anterior scleritis which she said might've been an excessive inflammatory response to the vaccine. She also reports blurred vision starting 1/23. 1/25 -Eye swelling still present in her right eye but improved. She's on prednisolone eye drops for it. The blurred vision is starting to improve. She has a f/u appointment with her opthalmologist on 1/28.
Administration Error - According to the patient's immunization record in the  System the patient received his 1st COVID vaccine on 3/27/21 - it was the Moderna vaccine and given by the Health Department; then the 2nd vaccine is documented as being given on 4/17/21 but this time the patient was given Pfizer, also administered by the Health Department.  Patient was given 2 different products/manufacturers of vaccine.  No adverse event known.
received Pentacel and Pediarix / consumer received a double dose of the Dtap-IPV component on the day of the injections / Pentacel and Pediarix contain those components; the consumer is behind on their vaccine schedule; This case was reported by a nurse via other manufacturer and described the occurrence of overdose in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (batch number UJ129AAA, expiry date 11th March 2020) for prophylaxis.   On 22nd October 2019, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL. On 22nd October 2019, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: It was reported that the patient ordered to receive Pediarix and ActHIB but the patient received Pentacel and Pediarix. The nurse reported that, the patient received a double dose of the Dtap-IPV component on the day of the injections due to the Pentacel and Pediarix contain those components, which led to overdose of Dtap-IPV.  The patient was behind on their vaccine schedule, which led to inappropriate schedule of vaccine administered. This suspected adverse reaction report was submitted and classified as a medication error solely.
My son got his 2 month shots at 10:30ish and around 2 hours later he projectile vomited his whole bottle that he ate after his shots were received. Ever since then he has projectile vomited every bottle and it is now 1 pm the next day. And he's refusing a bottle.  Also in his right leg where he got one shot is very red and has a bump the size of a quarter. He has no fever. I'm scared he's going to become dehydrated. His doctor said that him puking isn't from the vaccines but I know they are.
This spontaneous report was received from a licensed vocational nurse concerning an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II lot # K004949, expiration date 04-APR-2016, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
The same day of receiving both vaccinations, the patient started having symptoms of swelling, redness and tenderness and by bedtime the pain was so severe that she could not lay on her left side.  By the second day the pain was so bad that she could not let arm hang freely.  Most of upper arm was very red and warm.  Patient stated the redness was even worse on the third day.  Most of the tenderness subsided after 1 week but patient states that arm still has redness after almost 3 weeks (although definitely has gotten better).
Headache (8/10 on pain scale; interferes with normal daily activities), Light headedness, Nausea, Drowsiness, shortness of breath, significant fatigue (interferes with normal daily activities)
Low grade fever, nausea, fatigue, lightheaded, extremely sore arm at and around injection site, headache, body aches and chills
soreness while lifting weights/a sore arm for a few days; significant tenderness in the vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Sep2021 (Lot number: EW0164) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness while lifting weights/a sore arm for a few days"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "significant tenderness in the vaccination arm".  Additional Context: Caller states he has had a slightly unusual reaction to the Pfizer Covid vaccine, wants to know how to move forward. Caller got first shot on 08Sep2021, states he had a normal reaction afterwards, a sore arm for a few days, states since he considered himself low risk of exposure, he had planned to delayed his second shot, he states he was going to wait about 8 weeks to not have as strong of an immune response. States that around 20Oct2021, about 6 weeks after the first dose of the vaccine, he noticed a significant tenderness in the vaccination arm, clarifies he received the first dose in his left arm, states that more recently after 6.5-7 weeks and had significantly reduced range of motion in that shoulder. Caller is concerned about this delayed reaction.   Follow-up attempts are completed. No further information is expected.
56 years old complaints of nausea 10 minutes after given Moderna  2 nd dose. Given  Zofran by sublingual by EMS. Felt better ater 10 minutes. Cleared by EMS and NP>
Desorientation while working at design work in computer Sudden weight loss -muscle mass Tiredness Extremely often urination Demotivation
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles/ blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-MAY-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (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 not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
no adverse event; dose of PROQUAD expired on 4/11/2022 and was administered today, 4/26/2022; This spontaneous report was received from a nurse and referred to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapy and drug reactions or allergies were not reported. The patient had 2 sisters.  On 26-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (Therapy type: recombinant Human albumin (rHA)), 0.5 milliliter (route of administration was not provided; lot #T034828 has been verified to be a valid lot number, expiration date: 11-APR-2022) for prophylaxis (Expired vaccine used). It was reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) never had a temperature excursion. No additional adverse event reported (No adverse event).