chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Had Vx, and shingles/suspected vaccination failure; Shingles come out; Stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had Vx, and shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles come out) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received new one shingles vaccine. The patient know that he/she experienced shingles and they come out when he/she was under a lot of stress. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Light-headedness, "adrenaline"-type rush;  warm and tingling sensation on right side of face; pulsing sensation at injection site.  Occurred about ten minutes after injection.  Intensity greatly diminished after about ten minutes, but slight light-headness lasted for about 45 min-  1 hour.
Hives on Chest, complained of throat tightness.    Admin 10mg Benadryl liquid PO B/P 166/86, P-99, Sa02 99% RA.   10 mins additional 12.5 mg. Benadryl liquid PO  B/P 136/70, P-68, Sa02 99% RA.   Pt. symptoms subsided.  Pt. refused EMS being called.
Patient had vaccines administered and left the office  and returned 10-15 minutes later with rash/hives all over his body.   Benadryl was given PO and an Epi Pen was ready for administrating if needed.
Patient was shopping in the aisles and fell we are not sure if she slipped (it was a rainy day) her foot was stuck under aisle shelf, pt was unconscious + breathing (Ambulance came and took her)
Migraines began approx 48 hours after receiving Moderna booster vaccine. Since receiving this booster I have been having migraines 1-2 times weekly. Prior to receiving booster I would get a migraine once every couple years.
Developed symptoms severe debilitating bone pain "down into the marrow" and joint pain and feeling "sick".  Started the evening or the next day (1/6/18) after the shot. Waited a couple of days to go to the ER. When it didn't resolve went to the ER where "ER tests were done such as x-rays, CT, bloodwork for inflammation". States they couldn't figure out what was wrong and suggested she see a rheumatologist. They started he on Steroids. Symptoms resolved after about 3 weeks.  Then she received another dose in June "at my work" and same symptoms occurred starting within 2 hours--ended up in ER sooner and started on Steroids sooner. Symptoms lasted about 1 1/2 weeks this time. She was giving the same vaccine at her work to a patient and developed allergic reaction symptoms while handling it to hands, up arms, into throat and she discovered the vaccine had latex. This is the same vaccine she received. She then found out her second dose also had latex. After the first dose she had no symptoms and it was a latex-free Hep B vaccine. She feels the symptoms were due to the latex in the vaccine.
? injection site pain  ? tiredness ? headache ? muscle pain ? chills ? joint pain ? nausea ? feeling unwell ? swollen lymph nodes (lymphadenopathy)
My Daughter started having pap smears when she was 16 and things were fine until she started getting the shots. After the second dose she had a abnormal pap. Her dr further investigated and ended up burning cells off cervix. The next pap came back CIN 11 Moderate Dysplasia. She ended up having a LEEP done in March 08. She will go back to the dr in August, 08 to have another pap. This is a result of this vaccine. My daughter was fine until these shots and now she may later on have to have further surgery.
Mis-administered Zostavax for Varicella 11/15/06. 11/22/06 Alerted parent- no reaction at this time.11/23/06  Headache and throwing up, fine after that.
death Narrative: Patient with consistent decline over the last year; March 2021- increased confusion related to dementia, falls, hospitalizations wt loss. Enrolled in home hospice on 3/26 family's goal was to keep patient home and comfortable. Patient received J&J vaccine in the home through agency on 4/6/2021, Patient had a fall on 4/7/2021, Patient with rib pain after the fall no other injury noted. Patient passed away on home hospice on 4/11/2021.
14AUG96 rash evolved into pox lesions which spread;pt ataxic & could not ambulate w/o stumbling or falling;end gaze nystagmus & horizontal sustained gaze were noted;lt babinski sign;dx post-viral cerebritis encephalitis w/ataxia;
2 1/2 inch diameter rash at injection site appeared on day 8.   Itchy and painful.  Lasted for about 4-5 days.
On 11/30/98, the pt received the second dose of Hep B IM. On 12/1/98 she began to experience visual disturbances that "fluctuated and became very evident and severe."  The woman reported that she had previously had perfect vision. She also experienced "acne of the boil type." No further information is available.
extreme pain around his hips, hollering out in pain that he cannot move them /he couldn't hardly stand the pain around his lower waist, by his hips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: Jul2020, stop date: Jul2020; "Broken Left Leg/broke his right leg up by where the bone connects to the hip/broken both legs", start date: Jul2020 (unspecified if ongoing), notes: her husband has broken both legs since July and is recovering; "has multiple stents" (unspecified if ongoing); "had open heart surgery" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; XARELTO.  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "extreme pain around his hips, hollering out in pain that he cannot move them /he couldn't hardly stand the pain around his lower waist, by his hips".  Additional information: Caller states that she and her husband received the first pfizer coivd 19 vaccine on Tuesday 2Mar2021. Her husband was okay Tuesday. His physical therapist came that day and he was fine. On Wednesday, he couldn't hardly stand the pain around his lower waist, by his hips. States that he couldn't move his hips due to the pain, and he just hollers when he tries to move them. Caller states that he has fought 2 injuries since Jul2020. He broke his left leg, and then broke his right leg up by where the bone connects to the hip. So, he's been in therapy. States that he was in a rest home for 3 months, and he has been home for 4 months; and has home physical therapy and a home care nurse that comes. At first they thought that the pain may have just been from the physical therapy on Wednesday, but when the in home nurse came on Thursday, she said that therapy wouldn't have done that and she thought it was a side effect of the vaccine. The nurse also said that her dad complained of the same thing after getting the vaccine. Caller asks, have there been any complaints of hip pain before? How long has it lasted? And what can they do? Caller wanted to know what she can do to help the hip pain her husband is having States that he has a lot of medical conditions. He is on the blood thinner Xarelto; he's a diabetic and takes insulin; he has major heart conditions. It was reported that Patient Age was 78.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021259635 same reporter/drug/event, different patient.
3 hrs post vac - mild muscle pain radiating to wrist. By eve (R) arm severe muscle pain entire arm with fluid forming under skin, puffiness, tingling, inability to move arm d/t pain. ALEVE failed to relieve pain. Sxs above for 3 da. After 2nd da sxs were mild. Partial use of arm. Still had numbness, tingling, tender 5th da - back to normal. No pain reliever needed. No bruising pt reported above on 1-18-11.
Severe pain at the injection site however she was also having trouble with weakness in her left lower extremity and some speech problems.  She was slightly confused couldn't work her garage door opener.  According the daughter the patient is extremely sharp and very active for her age.  Speech was very slow and purposeful instead of free fluid and fast like her normal speech pattern is.  Also noted that she was having trouble with her left lower extremity.
Angry itching rash on the side of his stomach; Red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Angry itching rash on the side of his stomach) and ERYTHEMA (Red) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013AZ1A) for COVID-19 vaccination.     The patient's past medical history included Eczema and Liver transplant (The patient is a liver transplant recipient since 12 Oct 2009.) on 12-Oct-2009. Concurrent medical conditions included Blood pressure (High blood pressure was reported.). Concomitant products included LOSARTAN for Blood pressure high, TACROLIMUS, AMLODIPINE, PRAVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and FISH OIL (FISH OIL OMEGA 3) for an unknown indication.    On 04-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (Angry itching rash on the side of his stomach) and ERYTHEMA (Red). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) for Itchy rash, at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Angry itching rash on the side of his stomach) and ERYTHEMA (Red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states that at his routine appointment with his liver doctor, he showed rash to the doctor and the doctor told him that it was normal.
Complained of congestion and difficulty swallowing post-vaccination. Denied itching/coughing. Reported 1 episode of vomiting. Also complained of feeling light headedness. Reported feeling similar reaction from 1st dose of same vaccine and improved with Benadryl (person did not initially report having taken Benadryl and difficulty swallowing from 1st dose of same vaccine; prior to receiving 2nd vaccination, person had denied to clinic staff of having problems with 1st dose). Person also noted to have rash on left forearm. Vital signs stable. Provider gave person 2 tabs of Benadryl at 12:05pm. Person appears well but was transferred to the Emergency Room for further evaluation due to concern for difficulty swallowing.
Fever 103 F; Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 103 F) and MYALGIA (Aching all over) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-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) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PYREXIA (Fever 103 F) and MYALGIA (Aching all over). In 2021, PYREXIA (Fever 103 F) and MYALGIA (Aching all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 103 f (High) 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment information provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Telephone Contact Report was received and the event outcomes were updated.
Became very sick that same night after the vaccine, very dizzy, severe joint pain, nausea, headache, vision felt different, brain fog, chills in bed for 2 days, On day 3 developed tingling in hands and feet, felt in face with muscle weakness in legs and arms. Very fatigued hard to do anything, still feeling this way at day 6 from shot.
Client call 3 hrs post inj of IPV and Yellow Fever, and C/o dizziness and heart rate 100 beats/min. Denies any other symptoms. Nurse advised client to f/u with PCP, lay down with bilat LE above her heart and to increase fluids. Clients symptoms were resolved x 1 hr after resting and increase of fluids. Client followed up with PCP and no visit necessary.
Patient reports the evening of vaccination her arm hurt so bad she could not reach over her head. She states it became sore to the touch, was burning, began to swell down to the elbow, was warm to the touch, and red. She states her husband told her he saw blistering under her arm.
Began having itching, swelling and pain at injection site 1 hour after immunized. Local reaction spread down left arm, swelled, reddened and painful down elbo. Saw MD next day who said was allergic to the vaccine or something in it.
Twelve hours after injection sudden onset of Fever >101. Chills Myalgia Headache  Symptoms persisting for at least 12 hours post onset
patient experienced significant pain, swelling, reddness, and itching at injection site.  Size was 3 inches long x 2 inches wide.  patient also reported at raised bump in the center of the site.
Information has been received from a pharmacist (R.Ph.), concerning a 64 years old male patient. The patient did not present any pertinent medical history or concurrent conditions at the time of the report. On 05-AUG-2016, the patient was vaccinated with ZOSTAVAX lot # L046896, expiration date 25-FEB-2017, 0.65 ml per subcutaneous route. Concomitant therapies were not provided. The pharmacist reported that on 08-AUG-2016, the patient went in to the pharmacy because he had developed a circular, red rash to an inch and a half above the injection site that was itchy, tender and sore. There were no diagnostic laboratory tests performed and there was no treatment given for the events. The outcome of circular red rash, itchy, tender and sore was not recovered at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient hospitalized 9/5/21-9/8/21 for COVID Pneumonia/AMS, Treated with dexamethasone IV and Remdesivir.
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine.  Treatment medications were not provided.  This case was reported for elderly patient 10 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:patient 1
Approx 11 hours after receiving vaccine, severe chills, body aches and nausea began. Lasted in severe category for approximately 2 hours and then continued in mild-moderate state ongoing during fate of 2/12
Pregnant; This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The cesarean delivery occurred on 04-Feb-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Pre-Term Birth w/o Complications. On 18-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Breakthrough case admission after 2 vaccines Moderna 2/28/21 Lot# 025A21A;  Moderna 3/28/21 Lot# 045A21A
5-22-08 Presented with pain redness 7x5cm irreg bordered eryth. hot, tender swollen, axillary lymphadenopathy, cellulitis. KEFLEX x 7d - Right arm deltoid.
Itchy, red painful area with blisters near site of injection.  Started 1/6/2021 and progressively has gotten worse.
I got got the vaccine at 10:47 AM on 2/1/2021. On the morning of the 5th  I was itching. The on the 4th I have a lady who comes out to my house and helps me bath and she put gold bond lotion all over.  I thought it was the lotion so I bathed again and got the lotion off my body. It is has since gotten worse and worse, I have  little red spots on back, shoulders and arm. My shoulder has red bumps on it, looks like a rash and is rough feeling. The itching and spots are still there as of 2/23/2021. I spoke PA at my doctor's office and she called in  a prescription Pepcid AC 20 MG (one a day) and Wal-zyr (generic Zyrtec )  on the 2/19/2021. I have also been putting some Hydrocortisone cream on it as well.
received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 11th October 2022, the patient received the 1st dose of Shingrix. On 11th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168220:same reporter US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169911:same reporter
Shingles outbreak  in mouth involving right side of hard palate and fever peaking at 101. 4 orally on 01/07/21. Began with minor itching and irritation in mouth on 01/06/2021 midmorning. Began treatment with  Valacyclovir 1 gm twice a day to take for 7 days at 1:00 pm.  I am using Orajel topically on the lesions and Boost nutritional supplement drink for food source currently.