chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021 at 11:44 AM, 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 07-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) had resolved.        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.   This case was linked to MOD21-118547, MOD21-118561, MOD21-118564, MOD21-118565, MOD21-118567, MOD21-118570 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-Significant FU received on 27-jul-2021
Two days after my second Moderna vaccine, I experienced "COVID arm." I had firm, blotchy rashes over my upper arm and over the extension of my upper arm muscles, which felt like a bruise. I did not experience itching, trouble breathing or rashes elsewhere on my body. The rash lasted less than 24 hours and was gone by the third day after the vaccine.
my arm was really sore; temperature it was up for 100 point something; I did not feel good; Ache; muscle hurt; it (arm) is just swelled up a little bit; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: FF2593) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing). Concomitant medication(s) included: TYLENOL; LISPRO INSULIN taken for diabetes mellitus; HUMALOG taken for diabetes mellitus; TRESIBA taken for diabetes mellitus; VICTOZA taken for diabetes mellitus. Vaccination history included: Bnt162b2 (First dose, LOT# EN6205), administration date: 25Feb2021, when the patient was 70 years old, for COVID-19 immunisation; Bnt162b2 (Second dose, LOT# EN6205), administration date: 18Mar2021, when the patient was 70 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Oct2021, outcome "unknown", described as "my arm was really sore"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Oct2021, outcome "unknown", described as "temperature it was up for 100 point something"; MALAISE (non-serious) with onset 23Oct2021, outcome "unknown", described as "I did not feel good"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Ache"; MYALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "muscle hurt"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "it (arm) is just swelled up a little bit"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: body temperature: increased. Therapeutic measures were not taken as a result of pain in extremity, body temperature increased, malaise, pain, myalgia, peripheral swelling, pyrexia.   Additional information: Patient stated that he got booster yesterday on the COVID shot. This morning he did not feel good, yesterday he forgot it but this morning he got up and his arm was really sore. He checked temperature it was up for 100 point something and it started to go down but he just wanted to know it was right to take Tylenol for fever and stuff. Patient stated that his first two shot and he did not have any reaction at all. The patient further stated he just feels really bad (not clear). His ache and muscle hurt and the patient went to the hospital right now.   No follow-up attempts are possible. No further information is expected.
pt recvd vax; pt devel loss of color, stiff neck, swollen parotid glands, rash at face, neck & moving downward; swollen neck gland around back of head; pt given AB x ear infect;
Sick to my stomic; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomic) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomic). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6200), in left arm, as dose 2, single (Lot number: EN6207), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Positive, notes: positive home test; (31Aug2022) Negative, notes: Tested negative on 31Aug and 01Sep; (01Sep2022) Negative, notes: Tested negative on 31Aug and 01Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient didn't receive other medication in 2 weeks. Patient received treatment for COVID 19 from 01Sep2022 to 05Sep2022.
Patient reported redness and itching of the injection site. Also, noticed hives on lower legs and arms. Prior to injection patient stated being allergic to LATEX. Fluvirin was given as it's approved for patient's with latex allergies.
Patient experienced post-vaccination syncope within two minutes of receiving vaccine. Patient was sitting and got lightheaded and sweaty and fell out of chair. Patient denied any pain but was assisted to wheel chair and brought to medical observation tent where he was given juice and monitored for 15 minutes. Patient BP was checked twice (110/60 and then 102/64) with a heart rate of 86 BPM. Patient declined EMS eval and was sent home
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 65-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Started to see bright colors mixed together and outline of things/people, legs started hurting and could not support himself. He sat down and teacher held him up. Was very pale. Went to school nurse and had sucker and two cups of water. Started to feel better after about 15 minutes except for a headache which lasted about 30 minutes.
Pt. complains of right arm pain, radiating to neck and shoulder, right sided trunk.
Patient did not display any adverse symptoms. The patient did however receive a previous dose of Johnson and Johnson COVID vaccine in May 2021
(From the medical record)  Patient received flu vaccine.  In less than 5 minutes she started to cough and have perioral cyanosis.  The nurse was in the room giving sibling vaccines and called me into the room immediately.  She was placed on the bed, cool towel placed on forehead.  Pulse ox placed, SaO2 was in 80's, oxygen given by face mask.  An erythematous rash was noted on her face and chest.  Benadryl 25 mg was given orally.  Her oxygen saturation came up in the 90's, color returned.  No LOC.  Epi was at bedside, but not needed.  Her head was slightly elevated, she was able to take sips of apple juice, the rash faded.  The oxygen was withdrawn and sats remained in high 90's.  She complained of a stomachache.  No emesis.  She was observed for 20 minutes after the oxygen was removed.  No wheezing or difficult breathing.  Able to swallow easily.  No rash.
Pt called on 8/19/18 stating she is having watery eyes, can't stand light, can't open her eyes. She stated that these symptoms started on 8/18/18. Pt has been advised to go to ER. Pt also stated that she had Fever, chills, headache, dizziness on 8/15/18 which lasted for 3 days and then resolved. Pt also stated that she could not raise her arm for 2 days. After Pt stated that the eye issues started on 8/18/18 after she got a cold. Pt also stated that maybe she got cream in her eyes. Pt has been advised to go to ER right away. Pt stated that she doesn't want to go and is waiting for the doctor covering her MD to call her back. This is the 2nd shot in series. First time Pt didn't have any SE.
pt recvd vax 24MAR93 & on the same day devel h/a, sore throat, lt sided earache, swollen glands & nausea; No further details were provided;
100 degree fever, increased blood pressure 153/70, bright red face reaction for 2 hours after the shot, two days of headache, uncontrollable chills and shaking, nausea and sore throat, aching all over my body, unable to think clearly, extreme thirst, drainage from nose to throat that wasn't a problem prior to shot
Every single joint in my body hurts so bad all night last night, it woke me up about every half an hour and 15 minutes.
very itchy; upper part of arm was quite red; a little red spot the shape of egg; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (a little red spot the shape of egg), PRURITUS (very itchy) and ERYTHEMA (upper part of arm was quite red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (carcinoid cancer). Previously administered products included for an unreported indication: CANCER VACCINES and B12 1000 SR. Concomitant products included LANREOTIDE, METOPROLOL SUCCINATE (TOPROL), LEVOTHYROXINE SODIUM (SYNTHROID), HCI, RIVAROXABAN (XARELTO), FLECAINIDE and CETIRIZINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH MACULAR (a little red spot the shape of egg). On 01-Feb-2021, the patient experienced PRURITUS (very itchy) and ERYTHEMA (upper part of arm was quite red). The patient was treated with CORTISONE ACETATE at an unspecified dose and frequency. On 26-Jan-2021, RASH MACULAR (a little red spot the shape of egg) had resolved. At the time of the report, PRURITUS (very itchy) and ERYTHEMA (upper part of arm was quite red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient reported experiencing "fatigue" after receiving Pnemovax 23 vaccination; This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEMOVAX23) (strength, dose, schedule, lot# and expiry date was not reported) via route reported as injection for pneumonia vaccination. On an unknown date, the patient experienced fatigue after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEMOVAX23). The patient did not undergo any lab diagnostics or studies and did not seek medical attention. There was no associated product quality complaint. Outcome of the event was reported as not recovered. Causality assessment between the suspect therapy and reported event was not provided.
Breakthrough case admission after 5 vaccines Moderna 1/14/21 Lot# 025J20A and 011L20A,  Moderna 2/11/21 Lot# 025J20A;  Moderna 11/20/21 Lot# 013F21A;  Moderna 6/8/22 Lot# 059A22A
Event occurred 30 minutes after visit. Patient was no responsive, limp breathing okay and no color change. 30 mins after was "normal and responsive". No medical advice or care sought.
Pt recvd a series of 3 Engerix-B vax in MAR, APR, OCT90 respectively for prevention of Hep B infect; titers drawn in AUG91 are negative; Booster doses will be given;
Malaise, fever (101.6 F), mild chill, drowsiness, tiredness/fatigue, easy fatigability, muscle aches on both shoulder/upper arms/ upper and middle back/chest, small joint pains on right wrist and some MTP, PIP and DIP in both hands but are now slowly resolving, mild sore throat, mild metallic taste in the mouth,  No headache, no dizziness, no vision changes, no loss of smell, no loss of taste, no nausea and vomiting, no loss of appetite, no diarrhea,  no weakness,
Severe pain in certain muscles and joints.  At the outset, pain was experienced on both sides of the body in elbows, shoulders, ribs, and legs (between knees and hips).  Lasted for approximately 6 hours in right leg, between knee and hip (both joints and muscles).
Narrative:  Breakthrough COVID infection which increased the risk for pulmonary embolism which caused the patient to be hospitalized
Left arm (posterior aspect) approx 2 inch by 2 inch raised red area. Patient describes area as itching and tight. Center of this area is blanched and has a red area in center.
This case was reported by lawyer and described the occurrence of drooping in right side off face in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, muscle pain and weakness, drooping in right side of face, numbness, severe headaches, tingling, visual disturbances, memory loss, cogni9tive problems, neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Non-Hospitalized Breakthrough,  receiving inpatient therapy at the hospital at time of positive test, he remains without SOB, chest pain, nausea, diarrhea, getting his therapies in his room until his 10 days of quarantine have been completed, he remains positive and upbeat, and denied any new complaints today other than continued congestion.
Headache, stomach ache, slight nausea. Some fatigue. Started late evening 3/23, lasted til late afternoon 3/24. No treatment.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, LIQUID PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent (STERILE DILUENT). On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, LIQUID PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, LIQUID PEDVAXHIB and VAQTA.; Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544:
9-5 symptoms of all over rash. Starting the night of the vaccine. The rash continues unabated even after 5 days.
Patient complained of pain, redness at right deltoid site. Then itching as evening came. She applied ice pack. Pain, redness and itching resolved.
pressure like chest pain, no change with exertion or posture starting on 4/11/2021, resolved morning of 4/12/2021, also preceded by expected flu like symptoms on 4/10/2021 with vaccine administered on 4/9/2021
patient was inadvertently given a dose of expired Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUN-2023, the patient received Havrix. On 12-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was inadvertently given a dose of expired Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Jun-2023 The registered nurse did not had patient details or lot number to provide. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
shingles; ill-defined disorder; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 01-JUN-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions and was administered by a pharmacist.  On an unspecified date, subsequent to the patient vaccination, the patient presented shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). As a direct and proximate result, the patient had been treated by a health care provider. Additionally, the patient had and would be continued suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant and related expenses as result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment medication and supplies. As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions.   The reporter considered the event shingles (herpes zoster) and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Headache, Myalgia, chills, weakness, fatigue, injection site pain Narrative:
This case was reported by a nurse and described the occurrence of an injection site reaction in a 15 month old female who received Infanrix. On 3/8/05, the pt received the 4th dose of Infanrix, in the right thigh (lot AC14A009BA). On the same day, the pt also received the 1st dose of MMRII, the 1st dose of Prevnar, at unspecified sites of administration. At an unspecified time following the 4th dose of Infanrix. On 3/8/05, the pt experienced an injection site reaction at the site of the Infanrix administration characterized as swollen, hard, red, warm and painful. The outcome of the injection site reaction was not reported.
high fever,; aches; Muscle pain; No energy for over five days; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 02Mar2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma, and COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D) and biotin (MANUFACTURER UNKNOWN); all were taken from an unknown date for unspecified indication and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not received any other vaccine with in four weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Mar2021 at 00:15, the patient experienced high fever, aches/muscle pain, no energy for over five  days. Therapeutic measures were not taken as a result of the events. Since the vaccination the patient was not tested for COVID-19. The clinical outcome of the event high fever, aches/muscle pain, no energy for over five days was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Syncopal episode approx 7 mins after vaccine administration.  Pt reported feeling weak and flushed before syncopal episode and attempted to drink water to alleviate symptoms.  PT placed in trendelenburg immediately after episode.  Upon regaining consciousness, pt reported continued weakness.  Upon assessment in observation unit pt oriented x4 with initial BP of 86/48, HR of 56, SP02 98%, RR 18, lungs CTA.  PT observed for approx 1.5 hours and was discharged asymptomatic with negative orthostatics.  D/c vitals BP:104/71 , HR:88, SP02:96%, RR:16
Arms very firm, red, and hot to touch. One arm?s firmness spread about three inches in length and five or six inches of redness. Other ask was only about an inch of firmness and inch and a half of redness.
Very high fever lasting 24 hours.  Unable to sleep without Tylenol and cold compress.  Incapacitating fever - she missed 1 day of school. Then after 24 hours of raging fever, it stopped, and she was fine, able to go to school a few hours later!