chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administrated beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 35 years 3 months.  No concomitant drug reported.  It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment information was provided by the reporter.
This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The medical history and drug allergy/reactions were reported as none. The reporter stated that the patient received 3 doses of RECOMBINANT (manufacturer unknown) which were administered on 24-FEB-1993, 05-APR-1993 and 22-OCT-1993 respectively. The lot number and the expiry date were not provided. The concomitant medications were reported as none. On an unknown date, when the titers were done showed negative antibody titers. The outcome of negative antibody titers was unknown. The patient had sought medical attention by calling the physicians office. There was no PQC involved. Additional information has been requested.
Arm pain; Off label; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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., Manufacturer unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 3, Manufacturer unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 4, Manufacturer unknown.), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 26Sep2022, outcome "unknown", described as "Off label"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm pain". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: The patient did not have covid prior to vaccination and patient had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE; a dose of MMRII administered only 20 days after receiving "varicellla"; This spontaneous report was received from a nurse, regarding a 5-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 17-MAY-2016, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (strength, dose, scheme, route of administration, anatomical site of vaccination, lot number or expiration date were not provided); 20 days later, on 06-JUN-2016, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at a dose of 0.5 milliliter (ml) (scheme, route of administration, anatomical site of vaccination, lot number or expiration date were not provided) both vaccines administered as prophylaxis (inappropriate schedule of product administration). On 10-SEP-2020, the patient was vaccinated again with varicella virus vaccine live (manufacturer unknown) (strength, dose, scheme, lot number or expiration date were not reported) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml  (scheme, rout of administration, anatomical site of vaccination, lot number or expiration date were not reported) as prophylaxis. The physician was advised to repeat the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose at least 28 days after the most recently administered dose. No adverse event was reported.
Syncope over twelve hours post vaccination, severe dizziness, lightheadedness, vomiting, diarrhea, fever, chills, body aches
3/10/21 am - developed low grade fever, dizzy, neck, shoulder, arm area soreness, fatigue
Redness noted @ inject site day of vax."Lump noted next day"(inject site).Slight T on eve of day /p inject& following day.Exam 22X3mm induration in SQ fat upper lateral thigh.Rather chubby(?3/8"fat).Induration tender /w overlying ecchymosis
Moderna vaccine 2.   Fever, body pains, Severe headache.   Muscle twitching.
Patient felt stinging in injection area which progressed to pain in left arm. Patient also began to feel faint and dizzy. Vision became blurred momentarily. Nurse from facility's urgent care came to take vitals. Vitals were normal. Gave patient water and allowed her to sit and let the reaction wear off. Patient waiting about 20 minutes before becoming mobile again. No further treatment was given and patient felt okay to go home, but still was too anxious to walk back to car on her own. Husband wheeled her out.
Redness, throat swelling, tongue tingling, itching all over, heart palpitations. Gave me hydroxyzine, sent me home. Every time it wore off, my throat would start swelling again so I took more continued for 4 days then stopped but heart palpitations are still. Happening now
Just a sore arm; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced "just a sore arm" on an unspecified date. The patient outcome of the event was unknown.    This follow-up is being submitted to notify that the batch number is not available despite follow-up attempts made.  Follow-up attempt have been completed and no further information is expected.
A few days after the vaccine I developed hives mostly in my head and the upper part of my leg/thigh area. Wed I went see my PCP and was administer a steroid shot which took care of it within the next day or so.
PT MONITORED FOR 1ST 15MINS POST-VACCINATION - PT C/O DIZZINESS AND LIGHT-HEADEDNESS, PROVIDED WATER, PT REPORTED SHE HAD EATEN LUNCH PRIOR VACCINATION. PT RECOMMENDED TO STAY AT VACCINE SITE, PAST 30MINS FROM RECEIVING THE VACCINE, PT BECAME PALE, CLAMMY, AND ALMOST FAINTED, PT WAS STILL AWAKE AND ORIENTED.  VITAL SIGNS WERE STABLE. RAPID RESPONSE CALLED, PT TRANSPORTED VIA GURNEY TO HOSPITAL'S ER FOR FURTHER WORKUP. PT WAS LATER DISCHARGED FROM ED, NO COMPLICATIONS. PT WAS STABLE.
Localized redness and swelling. Maximum size 3 inches by 4 inches. No fevers. Peaked on day 3 after vaccination, improving by day 4.
Red patch on arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional case details were provided as follows: On Monday (before the reporting date), the patient received Shingrix. The patient got a large red patch on arm after vaccination. The patient asked, whether 2nd dose should be received or not.
Asthma; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Two inch wide rash stripe down middle of face; Rash stripe down middle of face, flushing/Facial flushing- a red stripe down middle of face; Mild itching/Itching spreading to chest, arms, and palms/Body pruritus; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: en6206), via an unspecified route on 09Mar2021 at 15:30 (at the age of 39-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Ehlers-Danlos Hypermobile Type, Mast Cell Activation Syndrome, Asthma, COVID-19 from an unknown date and unknown if ongoing and Known allergies to Aspirin, Albuterol, Yellow dye, Sulfites, sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. On 09Mar2021 at 15:35, the patient experienced two inch wide rash stripe down middle of face, flushing and mild itching that started 5 minutes after injection, at 15:45 red warm spot and pain at injection site. Patient took OTC Benadryl and Ibuprofen 400 mg and it resolved in 2 hours. But then repeated worse the next day around 5pm, rash in same place down middle of face with itching spreading to chest, arms, and palms/ Body pruritus and on 10Mar2021 at 17:00 started having asthma symptoms. Took Epipen and Benadryl. Those symptoms fully resolved again within two hours. Still had red warm spot and pain at injection site 3 days later. Treated self with Ibuprofen and Benadryl immediately after injection to calm effects. After taking the above, reaction subsided within 30 minutes. The outcome of the events was Two inch wide rash stripe down middle of face was unknown, rash stripe down middle of face, flushing/facial flushing- a red stripe down middle of face, Mild itching/Itching spreading to chest, arms, and palms/body pruritus was resolved on unspecified date of 2021, asthma was resolved on 10Mar2021, Red warm spot and pain at injection site was not recovered.  No follow-up attempts are possible. No further information is expected.
Waited 15 minutes afterwards with no problems, however,  about a half hour later (once I was almost home) I had puffed toes, a lower back ached, significantly numb lips and numbness around jaws and cheek area.  No problems with breathing.   Just thought I'd ride it out.  However, within 48 hours I had a strong streaky rash with itching across the front of my neck, and itching on both jaws with small bumps appearing.   Tried to manage it on my own and was soon after needing to travel.  I took an antihistamine daily and used Cortaid topically until returning in hopes it would subside.  When I returned I began to try to get a medical appt via telehealth and sent them images of rashes and the issues.  I finally got an appt. with doctor and by May 19 I began using prednisone protocol, along with antihistamine, flonase and otc pepcid due to some ingredient in that the doctor said would help.   Must return to doc in 2 weeks to see how symptoms are doing.  Please note that the vaccine dose 2 also increased my tinnitus sounds.  Please include this in some study.  I'm not hesitant to get the booster down the road!      contact if you need more info.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ovarian cancer in remission" (unspecified if ongoing), notes: Ovarian cancer in remission; "follicular Lymphoma" (unspecified if ongoing); "known allergies : Fish" (unspecified if ongoing), notes: Known allergies : Fish. Concomitant medication(s) included: ALIGN, start date: 01Dec2021; MELATONIN, start date: 01Dec2020; NYQUIL, start date: 14Jul2022. Past drug history included: Erythromycin, reaction(s): "Known allergies : erythromycin", notes: Known allergies : erythromycin; Bactrim, reaction(s): "Known allergies : Bactrim", notes: Known allergies : Bactrim; Pyridine, reaction(s): "Known allergies:pyridine", notes: Known allergies : Pyridine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: product COVID 19 Treatment (Brand: Paxlovid) was given from 13Jul2022 to 17Jul2022 for indication treatment of COVID-19. Adverse event: rebound of symptoms. Dry cough, fatigue, sore throat (Adverse event start date: 20Jul2022, Not recovered, If treatment ae: No).  No follow-up attempts are possible. No further information is expected.
Patient had a large, red, circular spot on her upper arm. She said this happened right after the second Moderna shot. The first shot she had no problem. She said at one point it was warm to the touch. She said it got bigger since the shot. I advised her to go to the doctor and the doctor diagnosed it as cellulitis. She was prescribed and dispensed (at our pharmacy), Bactrim DS, 1 tablet by mouth twice a day for 10 days, #20.
Recurrence of Atrial fibrillation; Recurrence of Atrial fibrillation; This is a spontaneous report from a contactable physician (patient himself).  A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 25Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD (gastrooesophageal reflux disease), and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient had prior ablations for Afib. The patient had no allergies to medications, food, or other products. On 04Jan2021, 18:00, the patient took the first dose of BNT162B2 (lot number and expiry date unknown) via an unspecified route of administration on the right arm at a single dose for COVID-19 immunization. Concomitant medications included dofetilide, diltiazem, loratadine, rosuvastatin calcium (CRESTOR), and omeprazole (OMEPRA); the patient received these medications within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 28Jan2021 02:00, the patient experienced recurrence of atrial fibrillation after 6 months, the last episode was within a month after an ablation. No treatment was received in response tot eh event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The reported recurrence of atrial fibrillation was more likely due to natural recurrence of underlying atrial fibrillation, and unlikely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Intense pain in left arm 3 days after COVID J&J vaccine. Pain is not at injection site, but below and stops at elbow.
Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Flu like symptoms; Fever; Chills; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 62-year-old male patient received bnt162b2, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: drug ineffective, COVID-19, influenza like illness, pyrexia and asthenia, all with onset 2021, all with outcome unknown.  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient given an expired dose of Moderna. Dose expired 9 pm on 8/17/21, and was given on 8/18/21 around 2 PM
Narrative:  88yo male died at home. Pt's wife called into primary care clinic to inform. Wife did not give information to pt's death. Relevant PMH: Long-term current use of insulin (SCT 71AF- Atrial Fibrillation (SCT 49436004) Ischemic heart disease (SCT 414545008) Loss of sensation (SCT 44077006) Callus (SCT 201040000) Ingrowing nail (SCT 400097005) Peripheral vascular disease (SCT 4000470Adjustment Disorder Unspecified (ICD-9- CM 309.9) Health Maintenance (ICD-9-CM V65.9) CAD (ICD-9-CM 414.9) Benign hypertension (SCT 10725009) Type 2 diabetes mellitus without complication (SCT 313436004) Hyperlipidemia (SCT 55822004) GERD (ICD-9-CM 530.81) Barrett's Esophagus (ICD-9-CM 530.85) Diabetes mellitus (SCT 73211009) Chronic obstructive lung disease (SCT 13Other and unspecified Sleep Apnea (ICD-9-CM 780.57) Hypertrophy (Benign) of Prostate with UrHistoplasmosis (ICD-9-CM 115.90) DJD (ICD-9-CM 715.90) Low back pain (SCT 279039007) Restless Legs (ICD-9-CM 333.94) Colon Polyp (ICD-9-CM 211.3) Rhabdomyolysis (ICD-9-CM 728.88) Tobacco user (ICD-9-CM 305.1) Aneurysm, Aorta, Abdominal (ICD-9-CM 441 Pt had received covid vaccines on 1/16/2021 & on 2/13/2021. Likely pt's death was not related to covid vaccines given pt's advanced age and long time frame between vaccines and date of death.
Initial report received on 04 May 2009 from a health care professional. This patient, who is a 54-year-old male is one of a cluster of five patients who developed cellulitis after administration of DTAP and/or PNEUMOVAX on unspecified dates. The reference case for the cluster of five patient is reported in case 2009-02035. This case refers to the 54-year-old male patient, who developed fever and chills one day after receiving an injection of DTAP (trade name, manufacturer name, lot number, route and site of administration not reported) on 13 August 2008. His one arm was red and swollen from the injection site to the elbow. It was indicated that the patient developed cellulitis. No additional information was provided. The reporter for this case is the same as for case 2008-03081 and 2009-0235 (cluster reference case). Documents held by sender: None.
SIRs, Post Exertion Malaise (PEM-, continuous), Kidney Failure, Dyspnea on exertion, profound extremety weakness, wheezing, Cpk levels fluctuating, headaches, COVID-19, scarring of liver found 10/2022.
Diffuse polyarthropathy starting the day after vaccination and continuing for 7+ days. Currently treating with abx for concern of possible cellulitis, and prednisone 60mg for polyarthropathy. Currently admitted.
pain moved down towards right eye; double vision right eye; bad headache over upper temporal on the right side; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain moved down towards right eye), DIPLOPIA (double vision right eye) and HEADACHE (bad headache over upper temporal on the right side) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (bad headache over upper temporal on the right side). On 01-Apr-2021, the patient experienced EYE PAIN (pain moved down towards right eye) and DIPLOPIA (double vision right eye). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE PAIN (pain moved down towards right eye), DIPLOPIA (double vision right eye) and HEADACHE (bad headache over upper temporal on the right side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication for diabetic and blood pressure were unspecified.
After going for a regular check-up, my doctor noticed that I was experiencing PVC's. They noticed it during an EKG. I was sent to a cardiologist, where they performed the same test and saw it as well. I had a stress test and sonogram completed, which came back normal. I also wore a Holter monitor for 24 hours, but I am still waiting for the results on that.
5 days after shot, vomiting 1 time with no other symptoms 7 days after shot, fever of 100.0, body and joint aches for 12 hours 10 days after shot, body rash of tiny red dots across full body except face, no other symptoms
mom states pt sitting in lap then quit breathing, eyes rolled back, became stiff; taken to hosp; pt had no fever mom said;