chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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 (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date).    Pharmacist called to report that Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.  He stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry  The vial size was 2.5 mL  The date the vial was initially stored in the refrigerator was 19Jun2023 , 22Jun2023, and 23Jun2023  The vial did not undergo any temperature excursions. This case was for patient 5th out of 5. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Master case (Patient 1)
Hospitalized hypoxemic respiratory failure in the setting of COVID-19 infection. Start Dexamethasone 20 mg x 5 days then 10 mg x 5 days (10/16 start) - Remdesivir 200 mg then 100 mg x 4 (10/16 start)  - Tocilizumab 800 mg x 1 dose (10/16)
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
pt recv vax & approx 1 to 2hr p/vax pt stopped breathing;pt was taken to ER & adm to hosp for 4 days;pt also exp a blast of bloody diarrhea;stool cult presented negative results;
Three hours after receiving vaccine patient began to cough & complain of tightness in throat & chest. She then began to exhibit chills, headache, muscle aches and blood shot eyes. She went to local ER and received BENADRYL and steroids.
comatose; having suicidal thoughts; depressed; confused; tired; weak; fatigued; dizzy; Initial information was received on 10-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional (Patient).  This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, confused, tired, depressed, weak, fatigued and dizzy after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  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 unknown dose of suspect influenza quadrival a-b high dose hv vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient developed comatose (coma), having suicidal thoughts (suicidal ideation) ,confused (confusional state) ,tired (fatigue), depressed (depression), weak (asthenia) ,fatigued (fatigue) and dizzy (dizziness) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Reportedly "Consumer states that: "I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (comatose, confused, tired, depressed, having suicidal thoughts, weak, fatigued, dizzy).  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria : Medically significant for comatose and suicidal thoughts.; Sender's Comments: Sanofi Company Comment dated 13-Oct-2023 : This case involves an unknown age male patient who experienced comatose, having suicidal thoughts, after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient).  This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.
Approximately 5 minutes after dose given patient, 1615, was sweaty, fidgety, pale and removing his mask. Patient reported feeling nauseated.
Already did:  2:30 p.m. until about 6:30 p.m., leg cramps and unusual joint pain in hip and knees.  Subsided.  From about 10 pm to 8 am, localized discomfort at injection site, on upper left arm.
Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   On 25th January 2022, the patient received Engerix B. On 25th January 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported a patient was administered an expired dose of the Engerix-B vaccine,which led to expired vaccine used. The reporter consented to follow up.
About 6 hours after receiving the vaccine, I felt dizzy like I was going to pass out. I was seeing spots before my eye. I had to sit down and put my head down. My doctor took me home and the next day all my symptoms were gone. On December 27, 2022, I woke up with a fever, headache and was extremely tired. I felt rather crappy. 100.9 was the highest fever I had. I tested for COVID-19, and it was positive. My doctor prescribed molnupiravir. My symptoms improved on the 4th day. I have completely recovered from my symptoms. I am still tired, and the fever has been gone for more than a week.
vacc on 5-17.  On evening of 6-10, pt has sudden onset of dysarthia, left arm numbness, loss of right side fine motor skills, severe difficulty swallowing by 6-11, admitted to Hospital ICU on 6-11.  Afebrile.  MRI find "bilateral white matter disease" and CSF shows elevated protein of 70; other prelim tests normal
Patient received a Moderna monovalent Covid booster instead of a bivalent Covid booster.
Menveo  reconstituted with sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date unknown) for prophylaxis.   On 20th September 2022, the patient received Menveo. On 20th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received Menveo vaccine which was reconstituted with a non-GlaxoSmithKline supplied diluent (Sterile diluent), which led to wrong solution used in drug reconstitution.
Syncopal or fainting episode less than a minute after receiving Tdap and influenza shots intramuscularly. Patient slumped slowly in physician's arms & was allowed to lie on floor for 10 minutes with 2 liters of oxygen. Orthostatic vitals normal.
Patient was given the monovalent vaccine vs the bivalent. no known adverse outcome. We were told by regulatory authority to record this as a med error.
Overall weakness and dizziness within minutes of the shot, had to sit down for a while/close eyes, legs tingling, hands shaking, had almost no energy in limbs or to stand, etc extreme sweating/hot then chills later, nausea, muscle pain upper neck/back/shoulders, and some symptoms continued an hour later including diarrhea. Some symptoms were better in 30 minutes or so as I stayed at Walgreens until I felt better, and hours later much better but still mild symptoms.
On the following day I had a fever, unbearable pain in arm which I had expected, but this rash that appeared on my torso worried me.   The rash was a mystery, since I had all the other vaccines and I felt fine after.  The rash was on my chest area and below my breast surrounding my stomach and lasted for two days.  It was not itching just there.  I did not tell my primary care doctor or the hospital  where I received the booster, because I felt ok after the rash was gone.  My apologies for the delay in reporting my side effect.  Thanks!
Narrative: 51yo male with Major depressive disorder, Recurrent episode, with psychotic features & housing stability issues was found deceased in his house, cause of death unknown, date of death 12/11/2021. No medical information in pt's medical chart providing information about pt's death. Pt had received covid vaccines on 2/9/21 & 3/11/21. Likely vaccines not related to this death given the long length of time btwn date vaccines given & date of death.
Covid arm; Little nervousness; Couldn't get out of the bed; Very fatigue; Arm was red and swollen; Arm was red and swollen; Pain in the site of injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was red and swollen), NERVOUSNESS (Little nervousness), ASTHENIA (Couldn't get out of the bed), VACCINATION SITE REACTION (Covid arm) and ERYTHEMA (Arm was red and swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen). On 26-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue). On 29-Apr-2021, the patient experienced NERVOUSNESS (Little nervousness). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). On 26-Apr-2021, PERIPHERAL SWELLING (Arm was red and swollen) and ERYTHEMA (Arm was red and swollen) had resolved. On 28-Apr-2021, ASTHENIA (Couldn't get out of the bed) and FATIGUE (Very fatigue) had resolved. At the time of the report, NERVOUSNESS (Little nervousness), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain in the site of injection) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided
Local reaction, 3 x3 erythema, 1x1 induration, light tenderness, treatment NSAIDS.
Ma informed RN that she had administered by accident double dose of Rota virus vaccine. Pt mom and father were called and informed of situation. Mom was informed that the provider was aware as well as Nurse manager. Mom and father were given ER warnings as stated by Dr. Mom and father were advised to call the clinic if they had any questions or concerns. Father stated that pt is stable and alert at the moment.
Chronic left-sided, non-cardiogenic, intractable chest pain began in July 2021 and has continued to date (05 June 2023)
swelling quadrupole in size; arm SORENESS; arm started to swell, warm and red.; arm redness; warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Autoimmune Disease - Undifferentiated Connective Tissue Disease.), Constipation, Heartburn and Allergy (indoor and outdoor allergies). Concomitant products included LINACLOTIDE (LINZESS) for Constipation, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Heartburn, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) for Joint pain, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Multiple allergies, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness) and VACCINATION SITE WARMTH (warm). On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling quadrupole in size). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm SORENESS), PERIPHERAL SWELLING (arm started to swell, warm and red.), ERYTHEMA (arm redness), VACCINATION SITE WARMTH (warm) and PERIPHERAL SWELLING (swelling quadrupole in size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported
05/10/2021 Received phone call from case father and states daughter is not feeling well and is concerned" if the vaccine is live and causing her not to be feeling well".Father informed vaccine is not live vaccine.Father states she has arm soreness at the site with swelling.Father advised to have daughter use ice packs off and on to help with the soreness and swelling.Father advised to closely monitor for any worsening symptoms and to contact PCP for evaluation..On 05/17/2021 received phone call from father and "daughter is not feeling any better and could the vaccine have given her meningitis" due to arm soreness and swelling and legs aching and soreness in her hips. .Father was advised importance to seek medical care with ER or PCP for evaluation.Father states daughter has been seen by family Chiropractor for the concern.Father states daughter has been very busy with her school schedule and not sure she is doing what she was advised to do.Father was advised to enter into VAERS.On 05/19/2021 spoke with mother of case and she states daughter has been taking magnesium supplements and this was the cause of her discomfort.Mother states daughter was seen again today at the chiropractor for evaluation. Mother advised importance for follow up care with PCP.
Had cold like symptoms and was worried it might be Covid 11/14 and went to the ER at a local hospital to get the test done. Results turned out to be negative from the fast test. Mucinex and Robitussin was suggested. Was advised I would be fine after a few days. Developed into Bronchitis and had Laryngitis. Through Telehealth got a prescription for antibiotics 5 days.
Vaccines given 11/29 @ 10:45, on 11/29 @ 1pm pt was being taken out of car seat by mom, eyes appeared glazed, body seemed tense, a lot of saliva and choking, no color change, no tonic clonic movements, 911 was called. Test were done all within normal limits. CT, and ECG NL.
presents to the hospital due to acute R sided weakness and numbness which developed a few minutes after receiving her 1st Covid-19 vaccine.  Got 1st shot at POD.  Patient not sure if it was the Pfizer or Moderna vaccine.  Patient developed RUE weakness, R face and arm numbness and dysarthria shortly after receiving her vaccination.  Mild hives were also observed along chest in the ED. Patient received Diphenhydramine and tenecteplase
Administered expired Vaccine on 03Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered expired Vaccine on 03Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-438047, MOD-2022-438073 (Patient Link).
11/20/04 1pm pain right shoulder where shot administered swellings and swollen down to elbow. On Monday some swelling down yellow streak down toward arm pit. Red streak under near arm pit. 4-5 inches long "appear under skin blood" PMD states. Treated with ice x 2 days. Heat on third day.
Severe muscle pain on arm, shoulders; Severe muscle pain on arm, shoulders; Severe muscle pain on arm, shoulders; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EWO150), via an unspecified route of administration on 04Apr2021 (at the age of 62-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Apr2021 the patient experienced severe muscle pain on arm, shoulders. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any treatment for the adverse event. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt recv vax on 1/8/99; 1 hr post vax pt exp joint swelling, edema of hands & face, nausea
Pt's mother reported his right arm at the injection sites began swelling and turning red.  On the morning of 8/11/16 he woke up and the swelling had enlarged, patient is lethargic, with a fever of 102. "Feels awful".
tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had a lot of Tachycardia after taking the Moderna COVID-19 vaccines. No treatment information was reported.   Reporter did not allow further contact
Headache, Myalgia, Fatigue Narrative: Missed one day of work after second dose due to flu-like symptoms
After 15 minutes of recieving the vaccine , My heart started racing really fast to the point I felt I was going to passout. I have the heart racing daily multiple times a  day off and on throughout the day.
This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On an unknown date in November 2012, the patient received their first dose of GARDASIL (lot#, expiry not reported) and their second dose in November 2013 and will be receiving their third dose of GARDASIL (lot#, expiry not reported) today on 24-MAR-2014. No adverse effects reported. Additional information has been requested.
allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medication were reported.