chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a nurse, describes the occurrence of administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 071F21A) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On Oct 25, 2021, patient experienced administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster). On Oct 25, 2021, administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated 5 patients received a 0.5mL dose instead of a 0.25mL dose for the booster shot. This case linked to MOD-2021-363591, MOD-2021-363330 (patient link).
Pt. requested Shingles vaccine at time of visit and wrote on history form that she had never received it. When Dr. went to document exam notes she saw Immunization Record showing Shingles had been given in 2015. Pt. developed rash on trunk 10 days after vaccine. Rash symmetrical but limited to trunk. Itches, no blisters, no pain, no burning, No fever, no redness or rash at vaccine site.
ED HPI Comments (7/12/17): This is a 4-year-old female presenting to the emergency Department today with complaints of redness and swelling at the site of her immunizations. The patient's mother states that she had her well-child check visit with her pediatrician yesterday and had immunizations in her bilateral thighs. The mother notes that the immunization sites were bruised following the visit and then throughout the evening into the morning became erythematous and edematous. The mother notes the patient seems to be walking without any difficulty and does not have any other symptoms to include fever, cough, congestion, headache, nausea and vomiting or irritability. The patient's mother states she is eating and drinking as normal and using the bathroom as normal. At this time nothing seems to make the patient's symptoms any better or worse. ED Assessment/Plan: The patient once again presented with areas of infection following immunizations. On exam the patient had bilateral leg cellulitis post-routine vaccination. There is no abscess or systemic issues present. The patient was afebrile, nontoxic, well-appearing in no acute distress. The patient?s mother was informed that we will prescribe her Keflex twice daily for 10 days and to follow-up in the next 1-2 days with her pediatrician for a wound recheck. GH History of Present Illness (7/17/17): The symptoms began 5 days ago.  Had shots 7 days ago.  Dtap-IPV in right leg and MMRV in left leg. The next day noted some redness.  Looked more bruised and swollen in the right leg 2 days after. Went to ER. Documented 2X3 cm of redness and diagnosed with cellulitis of bilateral legs and given cephalexin. Looking better overall. Still a good bruise on left leg. GH Assessment/Plan: Local reaction to tetanus vaccine, subsequent encounter (T50.A95D). Combination shot including Dtap and IPV in right leg. Unclear if infection present as local reaction can be warm, red and swollen. Local reaction to immunization with measles-mumps-rubella (MMR) vaccine, subsequent encounter (T50.B95D)  Combination shot with MMR and VZV given in left leg, bruising still present and normal expected reaction. Unclear if infection was present last week, but normal at this time. Cellulitis, unspecified cellulitis site (L03.90).  On cephalexin for concern for bilateral cellulitis which is unusual given the local reaction to vaccines can be large.  Plan to use cool compresses and Benadryl if local reactions are a concern in the future.  Complete cephalexin as prescribed by previous provider.
quarter size bruise at the injection site; ecchymosis; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site bruising in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site bruising (Verbatim: quarter size bruise at the injection site) and ecchymosis (Verbatim: ecchymosis).  The outcome of the injection site bruising was not reported and the outcome of the ecchymosis was unknown.   It was unknown if the reporter considered the injection site bruising and ecchymosis to be related to Arexvy.     It was unknown if the company considered the injection site bruising and ecchymosis to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-OCT-2023 The reporter reported the event to a field representative. Field representative did not have complete information. The agent directly called to reporter and reporter stated that after giving a patient an Arexvy vaccine, she developed a quarter size bruise at the injection site. The reporter consented to follow up.
Patient presented to pharmacy on 07/30 stating that on 7/26 she had developed lesions on the legs, groin and stomach area. Possibly, the patient has more than fifty lesions between the knees and chest, with the highest concentration around the groin area. Pharmacist witnessed less than 10 lesion on right leg. Lesions are round, small (less than a dime in size), very itchy and not very raised. At different times, Patient applied Sarna Lotion and hair spray to try to improve symptoms. Patient also tried taking one Benadryl. Pharmacist suggested taking more Benadryl. On 7/30, upon examination by the pharmacist, injection site was one inch in diameter, red slightly raised, and not itchy. Patient denied exposure to any environmental triggers.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        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 were reported.  No treatment medication were provided.   This case was linked to MOD-2021-092150 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received on 25-MAY-2021 included No newinformation.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB, lot number and expiration date and dosage not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Developed redness initially and small pustules the night after the vaccine was given, then progressed to blisters with continuing redness, pain and swelling.
sudden blindness-optic neuritis; same event happened last yr p/flu vax; 16SEp93 sc of sudden blindness/optic neuritis on 6OCT92; resolved p/steroid rx;
Pt stated she had a mild stomach to eggs as a child. After 5 minutes, came back to say she felt a tightening in her throat. Chlorpheniramine tab given. Pt with parents. Instructed to watch for increased signs and symptoms of difficulty breathing and go to ER if worsening; T/C pt at home.
First day of shot had muscle spasms and a week later started having sharp pains that radiated to her chest. Went to ER because the pains and spasms got real bad. Gave her a muscle relaxer and it helped a little bit. Pain still come here and there
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT PASSED OUT/FAINTED BUT DIDNT LOSE FULL CONSCIOUSNESS, WAS ABLE TO STATE HER NAME AT FIRST RECALL
Upon receiving the Moderna vaccination , I immediately (within a minute)  experienced an all over body tingling (it was an uncomfortable electric tingling running through my skin).  I felt my chest tighten also.  I felt hot and a little nauseous. The symptoms lasted 10 - 12 minutes. I have not experienced an adverse reaction to previous vaccines, ie shingles, flu....
Pain at injection site; Headache; Vomiting; Chills; Dizziness; Nausea; Tiredness; Body ache; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and DIZZINESS (Dizziness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and C25J2CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Tiredness), MYALGIA (Body ache) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Tiredness), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.        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 reported. Treatment included Tylenol and Nyquil
Information has been received from a pharmacist concerning a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot # H011333, expiration date: 06-SEP-2013) on 19-SEP-2012. On 19-SEP-2012, the patient developed a red, raised area about the size of her palm around the injection site following the vaccination with zoster vaccine liv. The pharmacist mentioned that the patient stated "the area feels tight". No treatment was given. At the time of the report the patient had not recovered. Additional information has been requested.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.            No concomitant medication was given by reporter. No treatment medication was given by reporter.  Patient had side effects after the Moderna booster shot. It was nothing that needs to go to hospital, nothing dangerous and was just a COVID arm. The patient did not have side effects after the first and second dose.
Patient was accidently given a 3rd dose of the meningococcal Vaccine - Menactra.
rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rash injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (rash injection site). At the time of the report, VACCINATION SITE ERYTHEMA (rash injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After the shot, my periods have been out of wack.; I'm on day four, and it's just spotting; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy in 2006 and 2012 and removal of tubes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patients period had been normal for the past 20 years except for when she was pregnant in 2006 and 2012. On 28May2021, after the shot, her periods had been out of wack. The patient was on her third period since her second dose, and her period was acting just like the last two, so she knew something was wrong. Usually, her second day of menstruation was her heaviest and had always been like that. The patient was on day four, and it was just spotting. Her last two periods were the same. She would spot for about four days, and then her period would arrive for just three days. Her regular periods were intense for the second to fourth day then would end on day five or six. The patient was reporting this because something was up with her cycle. She wouldn't get pregnant because she had removed her tubes, so it was not a pregnancy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events after the shot, periods had been out of wack, was on day four, and it was just spotting, last two periods were the same, she would spot for about four days, and then her period would arrive for just three days was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Guillain-Barre syndrome; change in mental status; This spontaneous report as received from a consumer refers to an unspecified female patient of unknown age.  the patient's concurrent conditions, medical history and concomitant therapies were unknown.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, lot and dosage information were unknown) for prophylaxis.  On an unknown date the patient developed Guillain-Barre síndrome  and change in mental status.   The outcome of Guillain--Barre syndrome and mental status changes was unknown.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was also unknown.  The reporter stated that there should be more research performed in the  population for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).    Upon internal review Guillain--Barre syndrome was considered to be a medically significant event.   This is one of three cases from the same reporter (2007USA000339 and 2007USA000340). The patient's sisters experienced the same adverse events after vaccination.; Sender's Comments:  US-009507513-2007USA000339: US-009507513-2007USA000340:
Severe left shoulder pain CT scan with Evaluation limited, superior subluxation of the humeral head         abutting the acromion, likely related to complete full-thickness         tear of the supraspinatus tendon with severe muscular atrophy.          Possible partial thickness tear of the infraspinatus tendon mild         atrophy of the muscle.                   Long head of biceps tendon not well seen in the bicipital groove         likely subluxed or torn.                   Severe degenerative changes noted affecting the a.c. and         glenohumeral joint joint effusion noted.
Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of it along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 23rd patient out of 25 patients.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
Sever rash on the left side of torso: after the first shot I noticed it after about two weeks, a 2x2 inch spot with little "bubles" like in "second degree burn". It was a little itchy. After the second shot (the one I report) it became larger and painful. And several other spots appeared (all on the left side of torso). I am trying to use 1% corticosteroid cream and over the counter anti-histamine. I am not sure if it helps because it looks like it is getting worse after four days after the vaccine.
the patient had no symptoms or adverse events following administration; nurse who reports administration of vaccines following temperature excursion.; This spontaneous report has been received from a nurse referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) at a dose of  0.5 milliliter once, lot number T032918 was determined to be valid for vial formulation for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date: 12-NOV-2022 (vaccination scheme, and route of administration were not provided), and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally at a dose of  2ml once, lot number U038864, expiration date: 22-APR-2023  (vaccination scheme was not provided), as prophylaxis following a temperature excursion of minus 0.8 degrees Celsius (C) for 1 hour 10 minutes (product storage error), there was stated that no previous temperature excursion occurred. The patient had no symptoms or adverse events following administration of the vaccine.  This is one of several cases from the same reporter.
Moderna COVID-19 Vaccine EUA Congestion, wheezing, slight difficulty breathing starting about 1pm on 3/26/2021.  Symptoms lartgely controlled with my albuterol rescue inhaler.  Symptoms stopped around 2am on 3/27/2021.
Ball (inflamation) behin my arm.. a lot pain and inflamation its notorios; Ball (inflamation) behin my arm.. a lot pain and inflamation its notorios/he had ball behind his arm and still there; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: ER8736) via unspecified route of administration in left arm as dose2, single on 02May2021 03:00 for COVID-19 immunization (at the age of 43-years-old). The most recent COVID-19 vaccine was administered in the pharmacy. Medical history was not reported. The patient's concomitant medications were not reported. There were no known allergies. The patient historical vaccine included first dose of BNT162B2; Lot/batch no: EW0161) via unspecified route of administration in left arm, as dose 1, single on 11Apr2021 03:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that, after 2 days 2nd dose (04May2021) he had ball behind his arm and still there. On 13May2021 patient experienced ball (inflamation) behin my arm. A lot pain and inflamation its notorios. Events resulted in physician office visit. Treatment received included steroids and Naproxen. The clinical outcome for the events was not recovered.
Headache, Myalgia, Fever, arm pain, fever 100.6, body aches, h/a, shoulder pain  Narrative:
51 y/o male seen in Infectious Disease Clinic on 30Jan2015 with hx of RA and on methotrexate. Received Zostavax on 09 Jan 2015 and developed pretty classic, mild disseminated VZV rash 6-10 days later. On 30 Jan 2015 patient seen in IM clinic first, then derm (masked), followed by Infectious Disease Clinic and was isolated at that time in a negative pressure room in ID Clinic. Patient had 50 lesions total. The rash is non-pruritic and not painful. Over the past 12-15 days he has continued to develop new lesions. He denies having any other symptoms including fevers, chills, cough, shortness of breath and headache. Per MD if VZV grows in culture may try to send for strain typing to determine whether this was Oka-strain or WT varicella. Treated with Valtrex dosed 1gm PO TID for 10-days to expedite resolution of infection.