chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) 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 (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727945:Same reporter
Patient presented 10/17/08 to c/o "fainting" on 10/10/08 pm - 2 days following GARDASIL 10/08/08.  On 10/09/08 patient had URI type.  Symptoms of runny nose - o/w well.  On 10/10/08 patient was in bathroom, standing and starting to feel faint; she saw "stars" and fell to the floor.  Negative LOC.  Appeared "lost" for few minutes.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient had an abnormal pap after receiving GARDASIL vaccine (yeast). The patient was seen in the physician's office. No other information was available. Additional information has been requested.
Trumenba was given to a patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms; Trumenba was given to a patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms; This is a spontaneous report from a contactable healthcare professional on behalf of a physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 10Jun2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The meningococcal group b rlp2086 (TRUMENBA) was given to patient yesterday and the patient called today with a fever of 102 degrees and flu-like symptoms. The outcome of the events was unknown.  The following information on the batch number has been requested.
arm pain at the injection site; Caller is looking for pain relief on her muscles; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: Unknown, She had the other Pfizer COVID vaccines up to this point), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm pain at the injection site"; MYALGIA (non-serious), outcome "unknown", described as "Caller is looking for pain relief on her muscles". Additional information: Patient experienced arm pain at the injection site. Caller is looking for pain relief on her muscles. She has a homeopathic medication named arnica montana and wants to know if it is okay to use around the injection site. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Case number PHEH2015US026977 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 35-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that the she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
got the shot and have had them Three times in different variations./ suspected vaccination failure; had them Three times in different variations.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles three times in different variations. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
patient had the flu; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who had the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination and had the flu. Medical history, medical treatment, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Continuous pain in arm (muscle). Patient reported to a doctor and got referred to a specialist. Seeing specialist on 01.02.2020. Will follow up with us.
Headache, fever, chills, body aches, joint pain, sweating, fatigue, vivid dreams
Had seen PCP on Jan 5, for two weeks of persistent L-sided throat/neck/jaw pain, referred for neck ultrasound. Neck ultrasound was scheduled for Jan 10, which showed two benign lymph nodes to the L neck (at sites of most prominent neck pain), but also reported an enlarged heterogeneous thyroid concerning for autoimmune thyroid disease. Had thyroid related labs drawn on Jan 13, which showed an elevated free T4, and low TSH, negative thyroid peroxidase antibodies. No clinically apparent symptoms of hyperthyroidism. Referred to see endocrinology, appointment scheduled for Mar 4, waiting to be seen.   - Regarding outcome - L sided neck pain slowly improved on its own by the next week, still waiting to be seen by endocrinology for next steps.
Client returned 7 days after immunization with large bruise on right upper arm, extending from deltoid (bottom edge) to elbow, approx 5" in width. States progressed from redness/swelling under injection sight to progressively larger bruise. Complained of moderate pain at site, tingling sensation in right hand, weakness in both arms, declines fever. Client saw healthcare provider on 1/21/09, TX given (per client) 1 week physical therapy and pain medication.
coma; collapsed; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 14 years old female patient who was in coma and collapsed while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient was in coma (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening. The patient was hospitalized for this event.  On an unknown date the patient collapsed (circulatory collapse) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported" 14-year-old collapsed on pitch, is fighting for her life in an artificial coma."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed, coma).  At time of reporting, the outcome was Unknown for all.; Sender's Comments: Sanofi Company Comment dated 02-Feb-2022. This case involves a 14 years old female patient who was in coma and collapsed while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed. Further information regarding time to onset, cause of collapse, medical history, past drugs, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case
Rash over trunk and arms. Fever of 104. Today 101.5  01/24/2003
MUSCLE PAIN; PAIN IN LOWER LEGS; HEADACHE; BACK PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination.  The batch number is not reported and has been requested . No concomitant medications were reported. On 19-MAR-2021, the subject experienced muscle pain. On 19-MAR-2021, the subject experienced pain in lower legs. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, pain in lower legs, headache and back pain was not reported. This report was non-serious.
pt recv vax; 24 hr later, devel diffuse erythema in neck which migrated to the proximal & lower extremities, & vasculitis;
Nausea fever of 102.1, hot flashes, headache,  ear pains, diareah, body cramping
skin redness at the thigh injection site; induration at the thigh injection site; Initial information received on 08-Oct-2019 and additional information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA281611 and 2019SA281612 same reporter.  This case involves a 7 years old female patient who experienced skin redness at the thigh injection site (vaccination site erythema) and induration at the thigh injection site (vaccination site induration), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered.  On 02-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Frequency = 8th) lot UJ223AA, Expiration Date: 30-Jun-2020 via intramuscular route in the right thigh.  On an unknown date, the patient developed a non-serious skin redness at the thigh injection site (vaccination site erythema) and induration at the thigh injection site (vaccination site induration) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  (Other relevant tests included no lab data.)  Final diagnosis was induration at the thigh injection site and skin redness at the thigh injection site.   The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and used Ice.  The outcome of the event was Unknown.  Documents held by sender: none.
Vaccination site bleeding really bad after 1st dose,bleeding through band-aid and through shirt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding really bad after 1st dose,bleeding through band-aid and through shirt) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LEVOTHYROXINE and GABAPENTIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding really bad after 1st dose,bleeding through band-aid and through shirt). At the time of the report, VACCINATION SITE HAEMORRHAGE (Vaccination site bleeding really bad after 1st dose,bleeding through band-aid and through shirt) outcome was unknown. Not Provided      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 treatment medications were reported.
After my second covid injection I had issues with breathing and my walking. The people that I walk with, would comment breathing is abnormal. It was really deep and noise. My breathing has not returned to normal. My doctor sent me to a cardiologist and pulmonologist and nothing has came up. I still cant walk like before, due to my muscles aching, and that wouldn't happen before.
T104, stomachache, sore throat;saw MD;c/o fever, stomachache, sore throat saw MD;rapid strep negative;then blisters in oral cavity & on lip;saw MD dx oral herpes to use glyoxide rinse;
PATIENT REPORTED FATIGUE , HEADACHE, SICK FEELING BUT NO FEVER FOLLOWING VACCINE FROM 11/19/21 TO 12/13/21.
During night after vaccine developed pain at injection site; the next day significant fatigue, joint pain, headache, chills; day 4 rash abdomen (tender, bright erythema, sl raised). Over next several days increased dermatomal pain -> rash=shingles.
Thick, scaly, itchy rash appeared 2 wks after 1st dose from base of spine upward to just below bra area , also exyending outward from spine  about 6" each side of waist& also along shin of left leg. Appears to be fading away presently after more than 3 mon. Also experienced  a fine, prickly type rash across buttocks that lasted abt 3 wks as well as brief intervals of intense itching in nostrils & ear canals that subside then recur.
bad runny noses; sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but unknown manufacturer), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 28Sep2022, outcome "unknown", described as "bad runny noses"; SNEEZING (non-serious) with onset 28Sep2022, outcome "unknown".  Additional information: It was reported He and his wife both got the shot a little less than two days ago within 24 hours with him worse than his wife, they had a bad runny nose and sneezing and he happens to be the worst and today is no better or maybe slightly better than yesterday. Has no fever or anything like that but it is constant blowing the nose and sneezing and is wondering if that is one of the symptoms to be expected and how long it will last; did not experience this when they got the original shots and had little to no side effects from those and this was the result of the shot. The patient said that he and his wife received the new Pfizer covid-19 booster shot two days ago and both of them developed a terrible runny nose and sneezing. Caller wanted to know if these symptoms were caused by the booster shot and how long its supposed to last.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197796 Same reporter/vaccine/event, different patients;
Swelling and redness around site of vaccine, left thigh measuring 2x2 area of induration.
Tested positive for COVID-19 on 4/13/2022; Tested positive for COVID-19 on 4/13/2022; sore throat; cough; congestion; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6206), on 03Apr2021 as dose 2, single (Lot number: EP7533) and on 30Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE, COVID-19 all with onset 13Apr2022, outcome "unknown" and all described as "Tested positive for COVID-19 on 4/13/2022"; NASAL CONGESTION (non-serious) with onset 13Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 13Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 13Apr2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 13Apr2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive.  Clinical courses: No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Immediate large welts and hives on arm then appeared on the entire body; confusion reported (and observed by me when she called me that afternoon on the phone) later, throat began to swell and constrict.  She has Biphasic delayed protracted anaphylaxis as a result of multi drug allergy syndrome and her symptoms were consistent with that in this case as she has had this kind of on going response to other anaphylaxis events in the past.  She had severe joint pain for more than 2 weeks and has ongoing recurrent hives on the injection site that have not completely subsided yet.  She developed additional allergic responses and ultimately ended up in the ER after this and was seen by local allergist who advised DO NOT take next shot/vaccination.
Injection given 10/6/20- right deltoid- joint pain all over- had an enlarged lymph node on right side of neck but is larger today, 10/7/2020.
Covid 19 break-through infection 8/6/2021, received REGEN-COV due to risk factors next day.
Red bumps all over body started approx. 8hrs after injection. Counseled to take Benadryl.
congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.