chrisvoncsefalvay/vaers-outcomes huggingface dataset:
error resulting in administration of expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment-This spontaneous case concerns a patient with no relevant medical history who experienced the unexpected event of expired product administered. Rechallenge was not applicable since due to nature of the event, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report  No concomitant medication were reported.  No treatment information was reported.     This case was linked to MOD-2021-395523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up received contains significant information Added: updated patient details.; Sender's Comments: This spontaneous case concerns a patient with no relevant medical history who experienced the unexpected event of expired product administered. Rechallenge was not applicable since due to nature of the event, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report
RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 18 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 in total administered, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s booster dose (suspension for injection, route of admin not reported, batch number: 1822809 OR 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered (dose number in series: 2) on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-NOV-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient received half dose for their booster dose and off label use (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202193, 20211201450, 20211201286, 20211204104, 20211201179 and 20211201443.
Hurting all over ,chills & fever , horrible pain  Couldn't move. For 2 days  3rd day hurting but could get out of bed  4th day asleep 18 hours
None at this time. Administration happened within the current hour. PROQUAD given at the same time as VARIVAX, separate sites. PROQUAD should have been MMR vaccine only.
This spontaneous report was received from a physician via company representatives and from a support services director concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 22-APR-2014, the patient was vaccinated with an improperly stored GARDASIL "PFS 6x1.5mg/0.5ml w/oSftySyr" lot # J009098, expiration date 04-DEC-2015 (route and dose were not provided). This vaccine had a temperature excursion of 2652 hours. The highest temperature recorded was 59.9 degrees Fahrenheit (15.5 degrees Celsius). The vaccine status was reported an "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
High blood pressure of 173/89; Rash on right arm that itched; A little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure of 173/89), RASH PRURITIC (Rash on right arm that itched) and FATIGUE (A little fatigued) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure of 173/89), RASH PRURITIC (Rash on right arm that itched) and FATIGUE (A little fatigued). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High blood pressure of 173/89), RASH PRURITIC (Rash on right arm that itched) and FATIGUE (A little fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt recv vax on 1/28/99; 3 hr post vax pt exp general body aches & swollen glands in neck
Information has been received from a physician concerning an 7 month old male with no pertinent medical history or allergies who was vaccinated with a dose of Rotateq. There was no concomitant medication. At the end of July 2007 the patient experienced intussusception. The patient was seen by the physician and was hospitalized. Lab diagnostic studies performed included a complete blood count which was normal and an abdominal ultrasound which revealed significant free fluid in abdomen. The patient was formally diagnosed with via ultrasound through a tertiary care center. An air enema was utilized twice to treat the patient. Subsequently, the patient recovered from intussusception. There was no product quality complaint. The event was also considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.  10/08/2007 Vax record received. Child did not receive Rotateq per office RN. TC to prior PCP's office whose record was sent along with vax record. Rotateq was not given in that office either.  11/8/2007 Records received from initial hospital for DOS 7/15-16/07 for DX: Acute Gastritis with Dehydration, Rhinitis and 7/20-21/2007  D/C DX: Vomiting, persistant.  Free fluid in abdomen. MR received from transfer facility for DOS 7/21-23/2007 for DX: Ileocolic Intussusception.  Infant had a 1 week hx of fussiness and vomiting after feeds with intermittant low grade fevers.  Twice admitted to local facility for dehydration.  Free fluid in abdomen reported and infant transfered to this facility. PE (+) for tenderness to palpation of the abdomen with guarding.  Otherwise WNL. Air contrast enemas X2  with sucessful reduction of the IS. Pt D/Cd after tolerating po feeds and making BM.   Vax record received. Child did not receive Rotateq per office RN. TC to prior PCP's office whose record was sent along with vax record. Rotateq was not given in that office either. Per CDC: "For VAERS 291937: please update VAERS data so that rotavirus vaccine is not listed in box 13 of VAERS report". Child did NOT receive Rotateq. Case closed.
Initially on 14 Apr 07. Patient had pain at the site; Left upper arm and numbness and tingling that proceeded down her arm and into her hand and fingers that lasted for a few minutes. Today 15 April 2007 patient has a headache rated on "8" on a scale of 1-10 that has been persisted since 0900 this AM and is increase in severity. Patient has been tearful since 1200.
After approximately 8 minutes after receiving 6 vaccinations, pt. c/o feeling faint.  Pt. became unresponsive and began jerking movement of her head and arms along with eyes rolling back in head.  This lasted approximately 2-3 minutes.  Pt was lifted out of chair and placed on floor with head and feet raised.  BP 120/70 P-60.  EMT arrived.  Pt. alert and oriented x 3.  Skin was warm and clammy but now was warm and dry.  Pt denied urinating or having any dizziness or complaints.  Pt. left oh her own accord, ambulatory and 5 any complaints.
extreme dizziness; Vertigo; This is a spontaneous report received from a contactable reporter (Consumer - patient's sibling) from medical information team.  A 68 year-old female patient received bnt162b2 (BNT162B2) (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: DIZZINESS (non-serious), outcome "unknown", described as "extreme dizziness"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo". Therapeutic measures were taken as a result of dizziness.  Additional information: Reporter states, she was on hold for so long yesterday, just trying to get an answer. She kept being told she was next in line for over an hour and a half. She finally hung up and was very, very frustrated. Spoke to caller from the fact sheet for patients and caregivers. Referred the reporter and provided the CDC phone number and website. Reporter states she spoke a weeks ago and filed a safety report and has not received any follow up. Reporter received her 1st Pfizer vaccine dose on 13Mar2021 and was due for her 2nd dose on 03Apr2021. Her HCP recommended she had not took the 2nd dose due to her significant side effects. Since her 1st dose she had extreme dizziness and vertigo, which continues today. She also mentioned her "sister had the same problem after her first Pfizer vaccine. The reporter states she had some relief from the dizziness by taking meclizine. Spoke to the reporter from the attached document. Spoke to the reporter from the attached document. Referred to Inquiry Management (Off-Label or No Info) (v14.0) Referred to section- "no information found" regarding medical question. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 8/24/98, at a 2 month check-up, pt received 4 vaccines. That evening, noticed twitching in left hand and left foot. On 9/18/98, pt had twitching in left foot and then on 10/01/98, she had a full seizure. Her nose, lips and tongue were quivering; her pupils were dilated, she was gasping for air and was unresponsive. Her father called 911. She had come out of the seizure by the time EMS arrived. On 10/2/98, she began to twitch again, lasting 4 minutes. Her doctor told us to admit her to the hospital on the same day. They started IV of Phenobarbital and kept her until Sunday. She was prescribed Phenobarbital. We took a family trip on 10/23/98 and she had a big seizure, this time she turned blue and it lasted 4 minutes. We were told to up her Phenobarbital lever to 30ml. On 10/28/98, at her 4 month check-up, she received her 2nd set of shots. That night she ran a fever, we took her in to ER again. They gave her Tylenol. They said she had a urinary tract infection. From this day on, her health started to get worse. Seizures started getting stronger and more often. We asked the doctor about her skin rash, he didn't think much of it. He increased her Phenobarbital lever to 45ml. Every time she had a seizure and they would give her a shot of Ativan. Every time we took her to ER, she started getting diarrhea and rashes very bad on her buttocks. The doctor was very puzzled and he wasn't sure what was causing her problems. He started treating her with Iron, Vitamin B, Phenobarbital, all at the same time. Her health seemed to be deteriorating. She would wake up, have a seizure and fall asleep again. She wasn't eating very much nor drinking much because she was so tired from the seizures and the medication. The doctor had her at a level of 100ml a day for some time. We told him that we didn't think the medications were helping in any way. Her skin was getting rashes and her diarrhea had become very devastating to her skin and hair began to fall out. I had a nurse tell me that she thought my daughter was having an allergic reaction to the medication. I told this to the doctor but he didn't believe this was the case. I called a pharmacy to ask if Phenobarbital has a skin rash associated with an allergic reaction, he said yes it does. The doctor put her on Dilantin, Tegretol, Topamax. None of these medications worked. The doctor's opinion about her prognosis was "I think she is deteriorating" and "all we can do is make her comfortable as possible". I felt the doctor had given up. I elected to inform him that I wanted her taken off all her medications because I told him that nothing he has given her has ever helped her situation. She seemed like she was a zombie most of the time because of high levels of medications she was on. We had to have a monitor at home and oxygen for her because her seizures were getting so close together and lasting more than 5 minutes.
Patient inadvertently administered 1st dose of Moderna covid 19 vaccine to person under 18 years of age. Patient administered 2nd dose of Moderna covid 19 vaccine on 3/3/2021 with approval of Chief and Medical Director.
Daughter received #1 vaccination at the Pharmacy.  Moderna Went to different Pharmacy and the vaccinator gave her Pfizer.
c/o dizziness-lightheaded-unsteady gait;slurred speech;
fully vaccinated (Pfizer, 1/11/21, 2/1/21); onset of symptoms 8/1/21
PATIENT REPORTED TO FEELING DIZZY WITHIN A MINUTE OF RECEIVING VACCINE. PATIENT APPEARED PALE AND PRESENTED WITH COLD AND CLAMMY HANDS. COLD PACK AND AMMONIA INHALANT WAS PROVIDED TO PREVENT FAINTING.  PATIENT BEGAN VOMITTING SHORTLY AFTER. PATIENT WAS ADVISED TO REMAIN SEATED UNTIL FEELING BETTER. AFTER ABOUT 15 MINUTES, PATIENT AND MOTHER WERE SEEN WALKING AROUND SHOPPING
Pt at clinic for initial Covid Pfizer vaccine, pt. denies allergies , she did state she had her flu vaccine last week and had no problem with it . Pfizer information reviewed, patient stated she had no further questions. Vaccine given at 1605 in right arm , within mins patient stated that she felt a tightness in her throat and that it felt like she had lump in it that wasn?t going away,  Patient was holding her throat and said if feels like the pressure is now in my chest also, she also complained of dizziness like she felt she was ?going to pass out? and felt nauseous like she was ?going to vomit?, Extra staff called to bring epi kit in case needed, RN arrived and assessed patient again, pt again stated she felt she had a tightness in her throat and pressure in her chest, Adult dose epipen given in R thigh at 1607, vital signs were obtained and were stable, patient felt improvement in her symptoms and no longer had the tightness in her throat, 7 minutes later she felt the tightness in her throat and pressure down in the chest return as well as shortness of breath, a second dose of adult dose epipen was administered in the right thigh. Oxygen was delivered via nonrebreather. She was transferred into a chair with her feet elevated. EMS had arrived within 15 minutes after start of the event. Patient?s symptoms had again improved however patient did state she still felt nauseous. Vital signs were stable and patient was alert and oriented throughout event. Patient was then transferred to local hospital via EMS.
9-21-2020 8:45 a.m. received a Influenza  vaccine at my Clinic CNP/ nurse administered it and gave me the Influenza. My chart says .5ml(6mo fluzone/Flulaval/Fluarix, 3yr + Afluria) . I inquired and the company is Santa Fe. I have only had one flu shot in the past and that was last year. This the same company for both last years and this years vaccine.  At approximatley 12:30 p.m. I noticed that my left arm to my finger tips felt numb and tingling. At approximatley 1:30 p.m. I called the Clinic to report the symptoms, as I did not see that list of symptoms of the handout and awaited a call back.  I called the clinic back again at about 2:00 p.m. and by then the numbness and tingling was now in my left shoulder, neck and face. I was advised to go the ER. I arrived at the ER at the Hospital at approximatley 2:45 p.m. I was there until 6:00 p.m. As of 9-22-2020  I am still experiencing numb and tingling in my left arm down to my forearm and also in my left cheekbone area.
had a rash since Christmas; itch; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received vaccine 4 years before the time of reporting).   In October 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 3 months after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were unknown.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were received as follows: The patient had a rash that was itch and red after vaccination. The patient asked whether it was shingles. The patient asked whether the others had the same reaction after vaccination. The patient had put off seeing physician because of the flue going around and was trying to avoid crowds at the time. The GSK representative suggested to the patient be administered in the time range between now and March.
ON 04/18/04 PT RECEIVED FOUR (4) VACCINES:  MMR, VARIVAX, DTAP AND IPOL. PARENTS CALLED ADVICE LINE @1218 ON 04/20/08 REGARDING SWELLING OF (L) UPPER ARM AT VACCINATION SITES.  PT TAKEN FOR APT AN HR LATER. EXAMINING MD DR NOTED (L) ARM TO BE ERYTHROMATOUS; ARM NON-TENDER, NO INDURATION. PT TREATED W/BENADRYL AND PREDNISONE WHICH TOOK FOR LESS THAN 24HRS (DIDN'T LIKE TASTE).
p/vax pt exp wheezing, erythema multiforme & swelling of the lips & face;pt reportedly was seen by MD 7/13/99; hepatitis, jaundice;hosp;
The day after receiving shot, patient had pain in pneumovax 23 shot given arm, and had extreme difficulty moving arm, especially laterally upward motion.  Patient needed help in doing simple motions such as raising arm enough to place purse over shoulder.  This continued to hinder her, gradually getting better, over the next three days, until it was back to normal around day 4 (with around 3 total days where full motion/pain free) of arm was felt.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 11-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency and route unspecified) (lot number: K020187 with expiry date 27-JAN-2016) which had been exposed to a supported temperature excursion. Concomitant medications were not reported. No adverse experience has been reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
NO ADVERSE EVENT. Patient received Covid Moderna vaccine 40 days after Monoclonal antibody infusion.
Phone triage: arm red, swollen, warm recommended TYLENOL, cortisone cream.
edema; some swelling in her feet that was very mild; This spontaneous case was reported by a health care professional and describes the occurrence of OEDEMA (edema) and PERIPHERAL SWELLING (some swelling in her feet that was very mild) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Chronic kidney disease stage 3, Autoimmune disorder NOS, Chronic interstitial cystitis NOS, Essential tremor, Pelvic floor dysfunction and Arthritis. Concomitant products included HYDROXYZINE, TOLTERODINE, URO MP, MELOXICAM and CYCLOBENZAPRINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OEDEMA (edema) and PERIPHERAL SWELLING (some swelling in her feet that was very mild). At the time of the report, OEDEMA (edema) and PERIPHERAL SWELLING (some swelling in her feet that was very mild) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In addition to the above concomitant medications, the patient also uses a vaginal suppository which includes a combination of valium, ketamine, lidocaine and gabapentin per source document.   No treatment was specified after the first dose of the vaccine and the onset of the aforementioned adverse events. The patient was prescribed treatment after the second dose of the vaccine and onset of additional subsequent adverse events. Treatment included hydrochlorothiazide and propranolol.   This case was linked to MOD-2021-062259 (Patient Link).
Severe night time nose bleed 2 weeks after first Pfizer COVID vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 08Feb2021 09:45 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation. Medical history included diabetic, high blood pressure, obese (other medical history). Patient Known allergies were none. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included lisinopril (LISINOPRIL) 5 mg; metformin (METFORMIN) 500; pantoprazole (PANTOPRAZOLE) 40 mg (Other medications in two weeks). On 23Feb2021 01:00 the patient experienced severe night time nose bleed 2 weeks after first pfizer covid vaccination. Adverse event led to Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for the adverse event. Outcome of the event was unknown.   Information about Lot/batch number has been requested.  Follow-up (06Apr2021): Follow-up attempts are completed. No further information is expected.