chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; Arm started to ache; tongue felt weird; tongue was stinging; achiness; tiredness; Whole body started to ache; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (Arm started to ache), PARAESTHESIA ORAL (tongue felt weird), GLOSSODYNIA (tongue was stinging) and MYALGIA (achiness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (Arm started to ache), PARAESTHESIA ORAL (tongue felt weird), GLOSSODYNIA (tongue was stinging), MYALGIA (achiness), FATIGUE (tiredness), VACCINATION SITE PAIN (Whole body started to ache) and HEADACHE (Bad headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (Arm started to ache), PARAESTHESIA ORAL (tongue felt weird), GLOSSODYNIA (tongue was stinging), MYALGIA (achiness), FATIGUE (tiredness), VACCINATION SITE PAIN (Whole body started to ache) and HEADACHE (Bad headache) outcome was unknown.            Multivitamin, Antihistamine, Vitamin D and Calcium used as a Concomitant medication. Treatment medication were not reported/unknown.
pt recvd vax; pt woke up from nap & was irritable & warm; pt had a sz; t 101; to hosp; pt tx w/ apap; sz was tonic clonic & lasted 2 min according to grandma;
Large local Rx to shots. Admitted to hospital for observation given only Benadryl per mom. Per attending Doc Allergic Rx.  10/26/07 Reviewed hospital medical records which reveal patient admitted 10/6-10/7/2007 for observation.  Experienced vomiting, swelling, warmth, itching  & redness of left arm vax site.  Left arm swollen from forearm to above the elbow w/full ROM.  D/C to home FINAL DX: inflammatory reaction secondary to vaccination.
Got vaccinated 4/22/15. Friday 4/24 developed lump, redness warmth in area of shot. No fever no other symptoms. 4/28/15-still red and warm to touch.
Pt recvd 3 doses of Engerix-B vax & was found to be a non-seroconverter;
Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath.  Never had previous issues with any vaccines or injections, and never previously had vasovagal response.  Since injection, I was constipated for 3 days and suffering extreme muscular/skeletal pain and headaches.
Severe low abdominal pain; weak, blacked out, sat down. Seen in ER. Rx painkillers.
I received my first Moderna Covid vaccine Saturday afternoon. About 24 hours later I went into a-fib, having previously been in sinus rhythm since my last cardiac ablation on Oct 30, 2020.  No meds were missed. The next morning, however, I woke up in sinus rhythm and feel normal.
Initial unsolicited report received from nurse on 11-Sep-2018. This case involves a [24 months old] male patient who was vaccinated with once 0.5 ml dose of PENTACEL Batch number, expiration date, route and site of administration was not reported) on an unknown date without ACT HIB. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique (PENTACEL diluent portion given without ACT HIB). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The first symptom was fever ranging from 99.9 to 99.1 (still there last night). I noticed that I still had the temperature when I went to my doctor on Tuesday, and they took my temperature, and it was 99.3. It sits at 99.1 since then but have not taken my temperature today. I have a swollen lymph node on left underarm (arm pit). Lymph node started on Sunday on the 24th and that is still occurring. No treatment. I still can feel the swelling under my left armpit. Note: I received the flu vaccine September 23, 03:30PM   - injection in my left arm - at - I don't remember the brand name of the vaccine.
Suspected Vaccination Failure; herpes zoster; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received both Shingrix doses last year from the date of reporting. After receiving Shingrix, the patient had herpes zoster again at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Cough. Headache. Body aches. Fatigue. Nausea. Congestion.
Fever - 102.2 degrees F x 24 hrs with local reactions measuring 8.5 cm x 12 cm of redness without induration at the time the patient was seen.
Pale area around the injection site; Inflamed limp node in the right armpit; Pinkish area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.    On 09-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information includes steroid cream prescribed by local pharmacist.
Erythema and significant swelling at LLE one day after DTaP given. Bid Benadryl, Tylenol, cool compress and Duricef.
Upper gastric pain; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "Upper gastric pain"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Awoke from nap crying, then moaning, stridor, limp, greenish color, not responsive, lasting about 30 minutes. In Emergency room noted to be wheezing. Resolved with albuterol, Benadryl, prednisolone.
Right thigh 2 1/4 x 2" in red, raised area, warm to touch, hard circular area.
I got the shot for shingles and got them anyway/ Suspected vaccination failure; I got the shot for shingles and got them anyway; Had some blasters and they were very pain full; Had some blasters and they were very pain full; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient got the shot for shingles and got them anyway and had some blisters and they were very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
This solicited report was received from a physician referring to an 89 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2008, the patient was vaccinated with his first dose of ZOSTAVAX, one time injection (route of administration, lot # and expiry date were not reported). On an unknown date in July 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
temp to 102, flu-like sz w/achiness, weakness, n/v;onset approx 8hr p/vax;
Patient felt chest pain after the vaccination. Onsite EMS was called BP 112/77 HR 68 97% O2. Patient set for half hour and was asked to goto the ER but she declined and said Dr. will see her soon at the same clinic we are at.
RUNNY NOSE; Runny nose, sneeze, sore throat; SNEEZE; Runny nose, sneeze, sore throat; SORE THROAT; Runny nose, sneeze, sore throat; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: ASKU    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced runny nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced sneeze (preferred term: Sneezing). On an unknown date, the patient experienced sore throat (preferred term: Oropharyngeal pain).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     At the time of reporting, the event of runny nose, sneeze and sore throat was improving.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): runny nose, sore throat and sneeze.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Patient called pharmacy around 5 pm on 10/15/2020 reporting he was experiencing shakiness, achiness, and headache. Patient did not have a fever.
Nausea; felt dizzy; A lot of aches and pains; Felt weak; Arm was extremely sore; Blurred vision; Fever; Chills; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore) and VISION BLURRED (Blurred vision) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Throwing up). On 03-Mar-2021, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, VOMITING (Throwing up) outcome was unknown. At the time of the report, DIZZINESS (felt dizzy), PAIN (A lot of aches and pains), ASTHENIA (Felt weak), LIMB DISCOMFORT (Arm was extremely sore), VISION BLURRED (Blurred vision), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        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.   No concomitant medication details was reported. No treatment medication details was reported.
Symptoms were noticed after school the day after vaccine administration; left arm was red from the shoulder to the elbow, the area was warm to the touch, and reported pain with pressure.
About 7 days after injection, left deltoid muscle became swollen, hot and tense to touch.  Initially after injection has local tenderness and small swelling but seems to resolve after 2-3 days. Was feeding tired the first two days.  Then on Saturday a week after injection, felt a slight itchiness on left deltoid area and then as the day progressed, the swelling became more prominent. Still confine to the deltoid area.
Myo/pericarditis which started on 08/31. Pt presented to Hospital on 08/31. Treated with colchicine and ibuprofen. Pain improved and troponin trended down. Pt was discharged on 09/02.
EUA Moderna Vaccine administration error report - Moderna vaccine administered to patient under 18 years of age.  Second vaccine dose administered on 3/31/21 with Moderna lot 021B21A.  Age under 18 years recognized by vaccine providers after second dose administered.   No adverse event reported by recipient.
3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL)) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J1A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (dose 2) and Pfizer Covid-19 vaccine (dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine and Pfizer Covid-19 vaccine.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. The patient had received First booster dose of Moderna vaccine on 23-Dec-2021. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-572158, MOD-2022-572185 (Patient Link).
I had the first COVID vaccine on 1/30/21. The shot itself was painful, and afterward the site of the shot was painful and I could not move my arm without pain. The pain was intense to the point that I could not sleep well that night. Could not lie on my left side because of the pain caused by pressure on the arm. The pain gradually went away within 48 hours of the shot. Today, 2/10/21, 11 days after the shot, the area around the injection site, over 2 inches in diameter, is still red and inflamed. There is no pain.
received the first dose on January 14 and due to a cardiovascular condition her Physician recommended to wait until her cardiovascular condition was monitored; cardiovascular condition; received the first dose on January 14 and due to a cardiovascular condition her Physician recommended to wait until her cardiovascular condition was monitored; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient wanted information about dose 2 of BNT162B2 because she received the first dose on 14Jan2021 and due to a cardiovascular condition her physician recommended to wait until her cardiovascular condition was monitored. The outcomes of received first dose on 14Jan2021 and cardiovascular condition were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash under the right breast and along the right side/ affected area is/ painful/  pain has lessened significantly; affected area  /had a burning sensation/ the burning sensation under the skin has subsided; affected area is discolored,/discoloration is now minimal; rash under the right breast and along the right side/ affected area is / itchy/ rash is still very itchy; affected area is /warm to the touch; affected area is discolored, warm to the touch, painful; first/ in November of 2020/ 2nd dose in February of 2021/ an episode of Shingles/ suspected Vaccination failure; experiencing an episode of Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episodes lasting between 2 and 3 weeks).   In February 2021, the patient received the 2nd dose of Shingrix. In November 2020, the patient received the 1st dose of Shingrix. In May 2021, less than 4 months after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, skin discoloration, pruritus, skin warm and pain were not recovered/not resolved and the outcome of the burning sensation skin was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, burning sensation skin, skin discoloration, pruritus, skin warm and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported that she have been experiencing an episode of Shingles for approximately 4 weeks. The patient reported symptoms include rash under the right breast and along the right side, affected area was discolored, warm to the touch, painful, itchy, and had a burning sensation under the skin. The patient reported discoloration was minimal at the time of reporting, the burning sensation under the skin had subsided, and the pain had lessened significantly. The rash was still very itchy. The patient stated this was the longest episode of Shingles she had experienced. This case was considered as suspected vaccination failure as laboratory test confirmation of shingles was unknown at the time of reporting. The reporter consented to follow up.
No adverse event; 1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jun-2023 at 9:30 AM, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Jun-2023 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna bivalent that was administered beyond 12 hrs or longer at room temperature (exact duration unknown to HCP)).    Concomitant medication not reported. The dose was initially placed at room temperature at 11:47 AM on 31MAY2023 and initially punctured at 2:30 PM on 31MAY2023. No reported symptoms. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2023: Live Follow-up received contains updated patient initials, date of birth of patient, administration date, dose no, route of administration, batch no and narrative.