chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381:     Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261  US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261.
Patient received vaccine on 10/24/14. On Saturday 10/25/14, she woke up with severe pain at the injection site. There was no pain at the injection site at the time of administration or later that day. Today, on 10/29 she still has pain in the arm. Patient was taking TYLENOL for pain. Applying heat to area.
Recent COVID + diagnosis/Covid exposure; Recent COVID + diagnosis/Covid exposure; This is a spontaneous report from two contactable nurses via a Pfizer sales representative.  This author reported similar events for 4 patients. This is 1st of 4 reports.  A patient of unspecified age and gender receive 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had been vaccinated with a 1st dose and had to defer to 02Feb2021 due to recent COVID + diagnosis/COVID exposure. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021035087 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035086 the same reporter, product and adverse events in different patients;US-PFIZER INC-2021035085 the same reporter, product and adverse events in different patients
4/17/2021- 1st dose Moderna  (lot 047B21A IMRA)- no adverse reactions/events. 5/6/2021- I had a hysterectomy-no complications and fully recovered. 5/17/2021- I went to get my 2nd dose of Moderna, which my doctor did approve. That evening, I spiked a fever and chills. The following day, I had pain in my right arm and it felt warm to the touch. I had fever and was throwing. I decided to go to the ER. They did blood work and my WBC were high so I was admitted. I was in the hospital for 3-4 days and was given IV antibiotics. They found I had an infection in my abdomen where they did the hysterectomy. I was discharged with oral antibiotics Cipro, Flagyl, Zofran, Ketorolac, Tylenol, and Ibuprofen.
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
pt recvd vax;mom states pt became febrile during noc;t of 105;apap given x3 since vax;irritable; v; has some d;to MD then hosp;
"Covid arm" rash with moderate pain started roughly 36 hours after injection.  Rash is below injection site, not surrounding it.  grew to 5" x 3.5" within 72 hours.  Started treating with hydrocortisone cream at 68 hours.  Now 3 days from injection.
TOOK 3 UNREFRIGERATED DOSES OF VIVOTIF; A spontaneous case report was received from a caregiver on 29-May-2019 for two consumers.  Based on the information obtained from a caregiver, two individual case safety reports PVX201905-000436 (PVX2019-1366; first daughter) and PVX201905-000437 (PVX2019-1367, second daughter) were created and cross-linked in the database.  This case describes a female consumer who "took 3 unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif at 73 degree Fahrenheit and then, took three unrefrigerated doses. She took the first dose of Vivotif on 25-May-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000436:
Herpes zoster diagnosis in two-dose varicella vaccine recipient. Diagnosed by Dermatology. MR#02404814. It started with 1 bump on her right hand in between her fingers, then turned into a cluster, then spread up her right arm and onto her chest. Some on leg and one on foot. No pain or itchiness, but numbness in hand. Treated with antiviral (unknown name). No underlying medical conditions. Lasted less than 4 weeks.
First dose on 28 Jul 2021, no second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet). On 13-Sep-2021, PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet) had resolved.            No concomitant medications were reported.  Treatment information was not provided.
Information has been received from a consumer concerning a 9 year old male with allergies to carbamazepine and trileppal, attention deficit / hyperactivity disorder, and bipolar disorder who on 07/03/1996 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  The reporter indicated that on 02/25/2005 the patient experienced a rash on his left leg.  One physician stated that the rash appeared to be shingles.  It was noted that the experience occurred after a bicycle incident that caused trauma to his left leg.  The patient was noted to be experiencing:  sever, stabbing, burning pain in his left leg; patchy rashes inside of the left thigh, behind the knee and running down the leg; bruising of the left leg; and swollen lymph nodes.  Unspecified medical attention was sought.  There were no laboratory diagnostic studies performed.  The outcome was reported as not recovered.  There was no product quality complaint.  Information received on 03/02/2005 contained the following adverse experience:  trauma to his left leg.  Additional information has been requested.
She took the Covid test last 22Mar, and got the positive result today which is 24Mar; She took the Covid test last 22Mar, and got the positive result today which is 24Mar; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got the first shot of the vaccine last 08Mar2021. She took the Covid test last 22Mar2021, and got the positive result today which was 24Mar2021. Her 2nd dose schedule would be on 29Mar2021, and the facility advised her for rescheduling. The outcome of events was unknown.    Information about lot/batch number has been requested.
Expired vaccine administered to patient; No additional adverse events reported; This spontaneous report as received from a physician refers to a patient of unknown age ro gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 17-DEC-2021 the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (dose details not provided) with lot # S035355 and expiration date of 05-NOV-2021, for prophylaxis (expired product administered. The dose was properly stored up through the time of the administration. No adverse event was reported.
1st in Jul2019, never followed for 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on right deltoid in July 2019). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not applicable for this report. The patient was never followed up for her second dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient stated she would speak to her health care professional before deciding on if she should take the second dose.  The reporter consented to follow-up.
Patient reported on 6/15/18 "pain through the arm, shoulder and that side of chest, It feels like it did when I had the Shingles on the other side. Also a hard lump in the armpit of arm that he got the vaccine in." Follow up call 7/9/18 still some aching on that side but lump is gone and feeling improved. Still a "little achy on that side".
Bruising all over body/coagulopathy beginning 2 days after Pfizer vaccine
Complained of itching and burning hands on both palm areas, and on the top of her head.  The hands were red and warm to touch, but no rash or swelling noted.  No hives noted on patient body at all. She denied SOB or difficulty swallowing and not swelling was noted in mouth, throat, or face.  The patient did complain on nausea after EMS arrived on scene.
Patient presents with multiple complaints. He complains of all of his symptoms started after his Moderna vaccine in 1/2021. He complains of fatigue, and in particular muscle fatigue, muscle wasting, urinary frequency, urinary urgency (but denies dysuria), myalgias involving his legs, leg weakness, unsteady gait, frequent falls, nausea without vomiting, dyspnea walking across the room. He is wheezing a lot this morning, it started after the Moderna vaccine.He had a recent heart cath that did not show any significant blockage. He had a recent MRI of his head that was normal. He reports his wife had covid 19 in the latter part of 11/2020. He never developed symptoms. He was not tested after she became ill. He admits to significant reaction his first covid 19 vaccine in 1/2021. All symptoms resolved except for his complaints as listed above.            He is a very active 81-year-old. He states he was winning weightlifting contests. He would do 3 sets 50 pushups, bench press 150 pounds and do pulled downs with 160 pounds daily. He now experiences dyspnea and muscle fatigue walking across the room.
Post vax, the pt developed red rash which started on legs and spread to face. Red rash had white centers.
DEATH; This spontaneous report received from a health care professional concerned multiple patients of an unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients' received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.    It was reported that the patients from died of unknown cause of death after taking the johnson and johnson, moderna and pfizer vaccine jabs. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211122133 -covid-19 vaccine ad26.cov2.s- death. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
18AUG92 mom report lt leg w/golf ball size, reddened, swelling @ inject site; no other s/s; advised to watch for oth s/s; 19AUG92 leg site size swelling 4 1/2" x 2 1/2"; 19AUG92 MD states pt is allergic reaction DTP; pt to have DT in future
Dark spots, red rash, right arm pained from 5 to 6 weeks, dark spots legs, arms, stomach and body itch, fungus right finger, infection right ear, right eye complication..  Medication for itch, infection and spots
On Tylenol 500 mg every 6 hours from Tuesday to Friday; On Ibuprofen 600 mg every 6 hours from Tuesday to Friday fever from Tuesday to Thursday; headaches, joint pain and pain on injection site from Tuesday to present; fatigue from Tuesday to present; tachycardia/ shortness of breath on exertion Thursday and Friday
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 24 years and 5 months. No concomitant drug information was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine number 1 NDC code was reported as 80777027399. No treatment drug information was provided.
14JAN92 pt recvd booster dose of Engerix-B vax 830AM & @ 1230PM lt side of mouth felt numb; lips were swollen & lt side of face was puffy; 130PM rt side of face was tingling & devel h/a; pt taken to ER;  pt felt poss bells palsy;
Moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; moderate to severe headache and body aches, specifically in my left arm and in my lower back; Dose number: 3; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in the left arm, administration date 30Nov2021 at 09:00 (Lot number: FJ8762) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot Number: ER8730, Anatomical site: Left Arm, Route of administration: unspecified), administration date: 30Mar2021 at 09:00, when the patient was 40 years old, for COVID-19 immunisation and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot Number: EW0162, Anatomical site: left Arm, Route of administration: unspecified), administration date: 20Apr2021 at 09:00, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 09:00, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious), PAIN (non-serious), PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 30Nov2021 at 16:00, outcome "recovered" (an unknown date in 2021), and all described as "moderate to severe headache and body aches, specifically in the left arm and in the lower back". Therapeutic measures were not taken as a result of headache, pain, pain in extremity and back pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Vaccine was give at 10:35 . At 1040  patient c/o feeling  warm at injection site, tired , dizzy and anxious. At 10:50 am Vital signs included  160/100, 126, 19, at 99%RA.  Pt. Was helped to lay down in a supine position with legs eleveted.  At 10:56 vitals were 140/90, 83, 20, 99%RA. Cold ice pack was applied at the back of his neck. At 11:15 am symptoms subsided with BP of 130 /85.
Vaccine was diluted with sterile water instead of Normal saline solution. Pt reports no adverse effects post-vaccination.
Delayed reaction:  red, swollen, itching arm near injection site.  Started about day 9 concluded about day 13.  Home treatment with cortisone.
first dose 65 days ago; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago) in an 87-year-old male patient who received mRNA-1273 (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL HCL for Blood pressure, LOVASTATIN for Cholesterol, OMEPRAZOLE for GERD, PREDNISONE and MIRTAZAPINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 65 days ago) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment details provided.
This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
This is a spontaneous case, initially received from pharmacist on 19-Nov-2018, concerning a 47-year-old, adult male patient. The patient had no medical history and concomitant medications. On 19-Nov-2018, the pharmacist administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019) to the patient. Reporter stated that, before administering the vaccine he expelled the air bubble from the prefilled syringe and thought that at that moment a very small amount of the vaccine's fluid may have run down the syringe (a small drop), then he administered the vaccine to the patient. It was reported that, when pharmacist covered the vaccine with the tip cap to prevent stings with the needle, he felt something in the eye and thought that a small amount of vaccine might have splashed into his eye/or eyelashes. The event happened between 9-10 AM, then he washed the eye with water and was fine with no effects. Later, around 1 PM-1:30 PM, pharmacist felt some eye irritation and washed with water again. Pharmacist stated that, he had no redness. The outcome of the event eye irritation was not reported. The reporter assessed the case as non-serious.
Lt thigh has inoculation reaction with about 10 cm red base with multiple (6) vesicles with clear fluid. Varivax given at site 2 days prior.
Received injection Tuesday at 10 am.  4 hours after injections started feeling very lethargic.  Fell asleep 5 hours after injection and slept for 3 hours mid-afternoon, which is unusual.  12 hours after injection began feeling achy and took Tylenol, then developed 101 fever around midnight (14 hours after injection.)    Stayed in bed with fever, fatigue, and aches most of the day after the injection.  Fever broke around 4 p.m., about 31 hours after injection.   Woke up Thursday feeling fine.