chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.) 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 WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border. Patients between 6m-5y of age. Were instead supposed to have received 0.25mL dosage of the dark blue cap and label with gray border presentation.).    No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023. Patients between 6m-5y of age were involved.  No reported symptoms. No treatment medication was provided. This case contains information for the 6th out of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
Narrative: 70 yo M with a history of chronic neutrophilic leukemia(currently not on treatment), HTN, DM, BPH, hepatic cirrhosis secondary to Hep C genotype 1b s/p Tx and relapse, HepA, CKD3, septic arthritis. Patient was admitted to the hospital on 6/17/21 for abdominal pain, ascites, and nausea. Patient was transferred to hospice care on and passed away on 7/1/21. Patient received covid vaccinations on 2/23/21 and 4/16/21. Cause of death listed in patient chart is bacterial peritonitis and is unrelated to covid vaccinations.
01/04/2022: Event occurred after 2nd vaccine. Presented emergency department complaining of a hematuria as well as a rectal bleeding patient has been having increased amount of urinary retention no urinating as much bloated and abdominal discomfort.  Patient stated that he has mainly diffuse malaise he was diagnosed with COVID-19 5 days ago
Got Pfizer COVID vaccine in 8/2021, since has been having numbness, tingling in both hands and both feet.  Right foot has been going numb. Has never had issues before.
6/10/209, 1130 hrs. Clinic evaluation by NP re: "palpable node, left clavicle region within 1 week of receiving vaccination. No other signs or symptoms inflammation, redness noted at injection site on left deltoid. Pt reports pain when raising left arm and shoulder, tender when palpating nodes. No report of fever, body aches or change in appetite. Small, palpable node left supraclavicular region approx. 1.5cm possible reaction to vaccine. Referral to primary care physician for further evaluation. Return to clinic in 1 week for follow-up.
This spontaneous report as received from a female patient who is a physician refers to herself. On an unknown date the physician was vaccinated with ZOSTAVAX (lot # reported as K000455, Exp date: 30-OCT-2014), 0.65 ml, subcutaneous. The physician firstly reported 4 out of 10 patients were vaccinated with same lot of ZOSTAVAX and developed severe reactions (MARRS# 1404USA012020). Multiple injection site reactions which included: angry red swelling at the injection site which cascaded down the arm to the elbow. Redness and swelling circumference around the injected arm. Blisters at the site, which physician confirms was not shingles. Physician stated the last 4 weeks was the most adverse effects she had seen with the ZOSTAVAX vaccine. Physician stated she had seen this change since the last batch label change from 3 piece label to one label. Physician stated she also was vaccinated with the ZOSTAVAX in her left arm, and had the same type of reaction. ZOSTAVAX Lot Check Request K000455 Exp 30-OCT-2014. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Sep2021 15:15 (Lot number: FE3592) at the age of 47 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; ZINC. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer,, Lot number=EW0158,, Lot unknown=False,, Administration date=10Apr2021,, Administration time=03:00 PM,, Dose number=1,, Vaccine location=Right arm), administration date: 10Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: LYMPHADENITIS (non-serious) with onset 13Sep2021 03:00, outcome "not recovered", described as "Swollen armpit"; AXILLARY PAIN (non-serious) with onset 13Sep2021 03:00, outcome "not recovered", described as "Swollen armpit with pain"; LYMPHADENOPATHY (non-serious) with onset 13Sep2021 03:00, outcome "not recovered", described as "Swollen lymph node"; LYMPH NODE PAIN (non-serious) with onset 13Sep2021 03:00, outcome "not recovered", described as "Swollen lymph node with pain near collar bone"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Sep2021 03:00, outcome "not recovered", described as "First dose: 10Apr2021/Second dose: 11Sep2021". Therapeutic measures were not taken as a result of lymphadenitis, axillary pain, lymphadenopathy, lymph node pain, inappropriate schedule of product administration. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Pharmacy or Drug Store. Follow-up attempts are completed. No further information is expected.
Got shots and still had shingles/ suspected vaccination failure; Shingles; 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.   Previously administered products included Zostavax.   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: Got shots and still had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two vaccines the old vaccines and the new one shingles vaccine and still experienced shingles twice and they are bad. 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.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with incorrect storage doses of VARIVAX lot # M027886 and expiration date: 03-JUN-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot # M010689 and expiration date: 11-MAR-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that incorrect product storage had a time frame of 10 hours at 9° F; and the call was given because of a data logger. Previous temperature excursion had not occurred. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005003.
Warm, red, itchy, bumps and sort of hard at injection site. It appeared the night of the injection. I told patient to apply ice to area. I contacted the physician and left him a message about the rxn. Redness has now calmed down to just around injection site after 4 days.
Presyncope directly after injection. SIRVA directly after injection and prolonged.  Fatigue, Chills, Muscle Aches in chest and back set in 4/30/21 at 12:00 pm.
Meningococcal (MCV4) vaccine was administered to 63 year old patient for overseas travel.  After patient left clinic, error was recognized and reported.
Sore Arm, cold chills, night sweats, extreme tiredness, joint pain, sore throat I took Tylenol and went to bed
Extreme fatigue 3 days since the shot. Haven't been able to open left side of my mouth all the way.
Aproximately 1 week after injection, patients states he developed severe joint pain in back hips feet elbows.  No fever.  Sought medical attention from primary doctor.
Itching and swelling started on left arm at the injection site about 8 days after the 1st Moderna vaccine. It is now 13 days later, and I woke up to a red circular rash at the injection site. Still itching and the area is raised and firm.
Starting 05/19/2022, I suddenly felt noticeably warmer and started getting congested and had a cough. No GI symptoms or difficulty breathing. No loss of smell or taste. The fever lasted 2-3 days. The congestion and cough has persisted the entire time. I tested positive on 05/22/2022 and was doing home supportive care. I did the telehealth visit on 05/26/2022 to ensure the proper guidelines I needed to follow due to living with roommates and being around others. I did not qualify for other medicinal treatments but was prescribed codeine to help with the cough. Over the past week, the nasal congestion and the cough have slowly improved.
Red patch on arm with a knot under the skin. Has been that way for a few days.
This solicited report was received from a patient's family member and refers to a female patient of unknown age, enrolled in a market research. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided. In approximately 2007 (reported as about 9 years ago), the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient felt lousy from the shot. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as there was no consent to follow-up.
rash at injection site; rash on forehead; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead). At the time of the report, VACCINATION SITE RASH (rash at injection site) and RASH (rash on forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications provided  Treatment medication was not provided.
07July95 pt recv 1 dose vax. 19Feb98 pt exp "numerous chickenpox lesions" . Additional info indicated pt had "full blown chickenpox" w/no fever. 6 days later, pt recovered
The vaccine refrigerator went out which compromised the MMR vaccines at time of administration. No adverse effects were reported. We plan to revaccinate patient.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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 EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients.  It was unknown if the patient received any other vaccines prior to receiving COVID vaccines.  Treatment details were not reported by the reporter.  This case was considered for 17th adult patient out of 40 adult patients who were received expired bivalent dose of moderna.
Pt received 2nd dose less than 2 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th March 2021, the patient received the 2nd dose of Shingrix. On 25th March 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 16th February 2021, batch number 4FN5F, expiry date 4th October 2022. Pharmacist reported that patient received 2nd dose less than 2 months, which led to shortening of vaccination schedule. The question was asked, did the patient need to be revaccinated? The reporter consent to follow up.
approx 2-5 min p/DTP/OPV/MMR pt fell forward from standing pos hitting her nose; unresponsive, but aroused w/ammonia w/in seconds; combative initially BP 160/80 then 118/84 2 mins later; blotchy rash noted on arms & trunk w/mild epistaxis;
"Within hours", fever, aches, and pains and cough. Significantly increased need to urinate. Ring of redness around the arm starting from injection sites. Treated by Tylenol, fluids, and bed rest, over 4 days.
Wheezing; Cough; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number: EL1283, expiry date: not reported), via an unspecified route of administration, on 21Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the vaccine on 21Jan2021 and had a lot of typical side effects that were listed (further not clarified) but the patient also developed wheezing and a cough on an unspecified date in Jan2021. Outcome of the events was unknown.
Rheumatoid arthritis flare up; body parts swelled up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4423017-00.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered with sequelae", described as "Rheumatoid arthritis flare up"; GENERALISED OEDEMA (non-serious), outcome "unknown", described as "body parts swelled up".  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "body parts swelled up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events rheumatoid arthritis flare up" and "body parts swelled up". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Large welt & raised knot where injection given, red & hot to touch. Painful. Per patient, started morning of injection. Size: baseball size.
Muscle soreness and headache starting 12 hours post-vaccine. Lasted approximately 12 hours post-onset of clinical signs, with fever of 101.4 on morning of 3/17/2021
Patient reported severe radiating pain throughout her entire arm after receiving PNEUMOVAX 23 (within 3 hours), was in such extreme pain that she could not move out of bed (lasted for approximately 12 hours).
11/27/2022 Symptoms - fatigue, headache, stuffy nose, body aches, low grade fever and cold sweats. I contacted my Physician and was prescribed Paxlovid. I finished the 5-day course. On 12/01/2022 my symptoms returned for another 3 days. I took OTC medications for body aches and fever and antihistamines for nasal congestion.
9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the date the vial was initially stored in the refrigerator on 11 Nov 2021  The vial was first punctured at 10 am on 18 Nov 2021   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up information received included patient Initials, gender, age was updated. Suspect product booster dose 0.25 ml and anatomical location was added. Updated contact information.
I started with a fever, chills and just general flu like symptoms that started the day of my 2nd vaccination(3/25/21) all which I knew I may experience. These started around 9pm on Thursday evening, and subsided by 6pm on Friday 3/26/21. On Saturday 3/27/21 I started to feel pain in my lower back. It wasn?t pain in the muscles it was itching of the skin that turned into a piercing pain that covered my lower back. I contacted my primary care and she said it sounded like shingles and asked if I had a rash. I did not. She started me on Gabapentin 300mg 1 capsule by mouth 3x a day as needed for pain. The symptoms lasted until approximately the evening of Tuesday 3/30/21. No rash ever appeared but the burning/itching/piercing pain is what stayed with me for those 3 days.
pt recvd vax & 2 days later devel a fine, pinpoint rash over upper torso & back of neck; 1MAR93 had local react of induration 3cm in diameter;pt exp erythema @ inject site & itching; pt devel scattered papular rashes & pustules 1mm in size;
Pt recvd 2 doses of Engerix-B in SEP91 & OCT91 & 2JAN92 had bald patches on head biopsied; preliminary dx systemic lupus erythematosus;
Muscle pain, lethargy, weakness progressing to fever above 100 degrees F after 3 days - patient went to ER tested negative for flu.
Pt got vaccines on 4/7. Developed intussusception on 4/9. VIS says that diarrhea is supposed to start 7 days after vaccine. Her diarrhea started 2 days later.