chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023; No adverse event; The vaccine was administered on day 37; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 26-Jun-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 (The vaccine was administered on day 37). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023).    Concomitant product use was not provided by the reporter.  Unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Suspect product dosage text was reported as unknown.  The intact carton 0.4 ml did not undergo any temperature excursions. Vials were kept between 2-8 C for the entire time.  It was reported that vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use, provided the expiration date was not exceeded.  Moderna COVID-19 Vaccine, Bivalent should be used 30 days from the date the vaccine was exposed to temperatures above 36°F (2°C). Vials can be used by the end of day on day 30.  Expired vaccine or vaccine past the 30-day beyond use date (BUD) will need to be discarded.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730937 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730937:Same reporter
temporary change in stool pattern (mucousy stool, then diarrhea, then no stool for more than two days)   was temporarily switched to soy formula, then was recommended a glycerin suppository if constipation persisted
PAINFUL HEADACHE; FAINTING/LOSS OF CONSCIOUSNESS; HEART RACING; APPEARED WHITE; FELT WARMTH IN EARS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 22 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, around eight hours later after vaccination, the patient felt a warm in her ears and her heart was racing. She appeared as white as a ghost and the patient fainted with complete loss of consciousness for approximately less than a minute. She had regained consciousness and still had accelerated heart rate until she ate and drank water and then calmed down. On 08-APR-2021, the patient had a very painful headache when she wake up and a low grade fever. She wanted to know if she can take Motrin or Tylenol for her events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling of warmth in ears, fainting, complete loss of consciousness, and heart racing on 07-APR-2021, had not recovered from very painful headache, and low grade fever, and the outcome of appeared white was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416890-JANSSEN COVID-19 VACCINE-Fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication reported. On unknown dates the patients received doses of improperly stored ZOSTAVAX (lot # L011533, expiration date 03-JUL-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse effects was reported. This is one of two cases received from the same reporter. Additional information has been requested.
Dizziness immediately after getting; Headache immediately after getting; Rash up arm and across chest; a rash across the chest and in the vaccinated arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date Aug2021 (Lot number: FC3181, Expiration Date: 31Oct2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Aug2021, outcome "unknown", described as "Dizziness immediately after getting"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache immediately after getting"; RASH (non-serious) with onset Aug2021, outcome "unknown", described as "Rash up arm and across chest"; VACCINATION SITE RASH (non-serious) with onset Aug2021, outcome "unknown", described as "a rash across the chest and in the vaccinated arm".  Follow-up attempts are completed. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101069070 Same reporter/drug, different patient/similar AE
Football shaped rash appeared day after injection 5 inch x 3 inch in size near site of injection after 7 days rash is finally fading.
Hot to the touch; Her right foot the top of the foot in the middle swelled up; Still got a redness in her foot; Warm and slight burning sensation behind her shoulder; A sensation of tightness in her arm pit; Foot started to hurt/ Aching all the way through the arch underneath, like a band on it; Aching in the joint above the deltoid; The rash appeared; It was red and hot to the touch; it became extremely sore; Her shoulder cap was swollen; Her arm was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It was red and hot to the touch), PAIN (it became extremely sore), JOINT SWELLING (Her shoulder cap was swollen), FEELING HOT (Hot to the touch) and PAIN IN EXTREMITY (Foot started to hurt/ Aching all the way through the arch underneath, like a band on it) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Her arm was tender). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It was red and hot to the touch), PAIN (it became extremely sore), JOINT SWELLING (Her shoulder cap was swollen) and VACCINATION SITE RASH (The rash appeared). On 13-Feb-2021, the patient experienced ARTHRALGIA (Aching in the joint above the deltoid). On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Foot started to hurt/ Aching all the way through the arch underneath, like a band on it). On 15-Feb-2021, the patient experienced FEELING HOT (Hot to the touch), PERIPHERAL SWELLING (Her right foot the top of the foot in the middle swelled up), ERYTHEMA (Still got a redness in her foot), BURNING SENSATION (Warm and slight burning sensation behind her shoulder) and AXILLARY PAIN (A sensation of tightness in her arm pit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE WARMTH (It was red and hot to the touch), JOINT SWELLING (Her shoulder cap was swollen), VACCINATION SITE RASH (The rash appeared) and VACCINATION SITE PAIN (Her arm was tender) had resolved. At the time of the report, PAIN (it became extremely sore), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Foot started to hurt/ Aching all the way through the arch underneath, like a band on it), PERIPHERAL SWELLING (Her right foot the top of the foot in the middle swelled up), ERYTHEMA (Still got a redness in her foot), BURNING SENSATION (Warm and slight burning sensation behind her shoulder), AXILLARY PAIN (A sensation of tightness in her arm pit) and ARTHRALGIA (Aching in the joint above the deltoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt reports developed cellulitis to site with fever & chills. Sought treatment with PCP. Notified by pt when returning to work.
3 days after first vaccine, I became suddenly violently ill as though I had food poisoning.  Vomit, very loose stools, cold, clammy for 24 hours
I was diagnosed with COVID, 3 days after receiving the vaccine. Apologies if this does not count as adverse event, but would like to share all of my available info in case it will be helpful.
Chills, fever, nausea, muscle aches, headache, redness/swelling/pain in injection site.  All of these symptoms lasted 3 days from onset.
3 days after my 2nd Moderna shot, I began experiencing ear ringing in my left ear which was literally the sound of like a little bell constantly pinging (not the ear ringing one might associate with what can be heard after attending a loud concert or loud music in a club).  The sound was most noticeable when I was in a very quiet space like a car with no music on, going to sleep at night or just sitting in a quiet space and lasted in total about 3 1/2 weeks.  I did see an Ear, Nose and Throat doctor who tested my hearing which was fine and in tact.  The 4th day after my 2nd Moderna vaccine shot, I experienced flue like symptoms of a mild fever and chills for about 3 days.
I had all three [Pfizer] vaccines and still ended up getting Covid twice; I had all three [Pfizer] vaccines and still ended up getting Covid twice; I had all three [Pfizer] vaccines and still ended up getting Covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I had all three [Pfizer] vaccines and still ended up getting Covid twice". Clinical course: patient age was reported as 52 (unit not provided). Eye rolling feeling about getting another booster. Patient had all three Pfizer vaccines and still ended up getting Covid twice. It is nice to know that omicron is included.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID vaccine #2  given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
Became dizzy when she bent into the freezer and remains with "vertigo".  Unable to walk without a cane or walker.
actually passed out slightly; Really dizzy; can't move and stand by; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration on 27Mar2021 (batch/lot number: ER8730) at 55 years old at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Type II diabetes, Thyroid inactive, and blood pressure management, all from an unknown date. Concomitant therapy included unspecified blood pressure medication. On 27Mar2021, the patient actually passed out slightly (loss of consciousness), got really dizzy (dizziness), and can't move and stand by (movement disorder). It was reported that about 5 minutes after vaccination, patient got really dizzy and actually passed out slightly and was dizzy for about that day; he was dizzy all day, he can't move and stand by. Patient stated that he actually got better but took five days. Patient further stated, "I just determine, because of the reaction, people say, second is worse and I don't know if its allergic reaction or is that normal. If they consider." Outcome of the events was recovering.
Rashes started 11/23/03 aching behind the eye.  Went to see PMD.  Not continuable Benadryl for reaction from flu shot, 3 tab day.
Minumum exposure to a person covid positive before the day he got the vaccine; A spontaneous report was received from a 30-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had minimum exposure to a person covid positive before the day he got the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 12 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot: 011L20A) intramuscularly in left arm for prophylaxis of COVID-19. On the same day of administration, the patient was informed that he was directly exposed to a person COVID positive. He stated that the contact with this person (a few days prior to the vaccination) was minimum and short. He wanted to know "is this will affect somehow". No symptoms reported. No treatment information provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, minimum exposure to a person covid positive before the day he got the vaccine, was unknown.; Sender's Comments: Based on the fact that the event occurred prior to administration of mRNA-1273 the event is assessed as unlikely related to mRNA-1273.
Bad rash; itching; Palpitations; Erythema; Painful rash/severe rash on front torso front to waist/up my spine and on my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bad rash), PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031621A and 044A21A) for COVID-19 vaccination.     Previously administered products included for Antiviral prophylaxis: shingles vaccine (Shingrix / Hives on torso) since 2017. Past adverse reactions to the above products included Hives with shingles vaccine. Concurrent medical conditions included Penicillin allergy (Penicillin/ hives), Drug allergy (Sulfa / hives), Allergy to antibiotic (levaquin /  Numbness of hand and feet) and Drug allergy (Codeine /  nausea).   On 11-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back). On an unknown date, the patient experienced RASH PRURITIC (Bad rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 30-Apr-2021, PRURITUS (itching) outcome was unknown, PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) had resolved. At the time of the report, RASH PRURITIC (Bad rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment  Medication included anti-itch cream and ice packs for the pain.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received from initial reporter: Patient's medical history, new events erythema, palpitations and start date and end date were added
severe shaking, chills, a racing heart, pounding in my head, nausea, and painful body aches
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE; PROZAC; OMEPRAZOLE; KLONOPIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid treatment from 24Dec2022 to 29Dec2022. There was no Known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely.
rash that is similar looking to hives manifest on their face; Initial information received from on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced rash that is similar looking to hives manifest on their face while receiving vaccines INFLUENZA VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported) and a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported), both for prophylactic immunization.   On an unknown date, the patient developed a non-serious event of rash that is similar looking to hives manifest on their face (rash) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and INFLUENZA VACCINE.  Action taken was not applicable for both the suspects.  It was not reported if the patient received a corrective treatment for the event (rash that is similar looking to hives manifest on their face).  At time of reporting, the outcome was Unknown for the event.
The second day I was tired, sickness, had headaches and the third was the same. I had a heart attack after the second dose. I have never had anything like that before. The participant was really frustrated and recorded a heart attack and just kept talking about how the vaccination is not safe. Participant said she is not sure it was heart attack but a coronary nerve disease.
Patient is not showing or exhibiting any sign or symptoms of any adverse reaction. No changes from the patient baseline.
developed Covid 19 after receiving 1st dose of the Pfizer vaccine; developed Covid 19 after receiving 1st dose of the Pfizer vaccine; wasn't feeling well enough; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Mar2021, the patient developed COVID19 after receiving first dose of the vaccine. The patient was informed to receive the second dose of vaccine if she felt better but she was not feeling well enough. The outcome of the events was unknown.  Information regarding lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Development of maculopapular rash present on  medial thighs and abdomen. Nonpruritic and nonpainful. Developed 9 days following vaccine administration.
About 1 hour after receiving TB test and Varicella, mom calls office stating child is short of breath and pulse is elevated.Had just taken Singulair 5mg. Advised to go to ER.
4hrs p/vax pt cyanotic & stiff x 5mins; tx hospitalized for poss rxn
Around 7 PM pt had headache, fever, emesis, malaise, unable to tolerate POS therefore went to the ED. Received IVF in ED, labs drawn and pt was told it was vaccine reaction, next day fever and emesis resolved. By day #2 post shots, 6 rating pos et at baseline. Had ZEFRAN x 1 day on day1 post vaccine. Records requested from hospital.
Breakthrough Case 06/2021  Covid + Pt. states that after receiving the 1st dose of Moderna 03/28/2021, started experiencing symptoms of hives/sores, tongue swelling, shortness of breath, headaches, and rattling in the chest. Still continuing to experience symptoms with treatment with inhalants.
Began vomiting around 3:00am on 12/30/2021, and complained of feeling dizziness. The following morning noted dried blood on his bedsheets/pillow and coagulated blood in the ear canal when swiped with a cotton swab. Dried blood on the external ear as well. Reached out to office with no word back.
Headache, HYPERtension, anxiety, foggy Narrative: pt stated with 2nd pfizer vaccination, she had reaction and went to ER. so she wanted to be monitored closely after the booster dose. pt seemed very anxious. requested to check b/p frequently, sbp ranged from 181-207, dbp 84-100.pt started to c/o HA, fogginess and left arm injection site. denies of SOB or chest pain. called 911 for ER eval