chrisvoncsefalvay/vaers-outcomes huggingface dataset:
event: none at time and a few minutes after administration; Pharmacist is reporting that a patient received MMR II vaccine via intramuscular route instead of subcutaneous route; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 08-SEP-2021 (reported as today), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter, once (lot# T022311 has been verified to be a valid lot number and expiration date was 30-JUN-2022) via intramuscular (IM) route instead of subcutaneous (SQ) route for prophylaxis (Incorrect route of product administration).         This report was considered as non-valid due to the lack of patient's identifiers.  Follow up information has been received from the pharmacist on 21-OCT-2021. This case was changed from non-valid to valid, as the patient's identifiers were provided: a 39 years old female patient with details demographic information. The patient had not any illness at the time of vaccination. The patient was accidently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine via IM route instead of SQ (the therapy type of the vaccine has been requested). The anatomical location was reported as right deltoid. The pharmacist was talking to the patient about the vaccine and must had gotten distracted. The reporter notified the patient while she was in store; and the patient waited until the reporter got off the phone with the manufacturer. It was reported there was no adverse event at time of and a few minutes after administration of the vaccine. It was unknown if the patient received any treatment. The reporter tried to contact the patient multiple times and left voicemail with no response.
He felt a little pain in his neck and his legs felt heavy.; He felt a little pain in his neck and his legs felt heavy.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date in May2021 (at the age of 68-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included nephrolithiasis (caller reported that in 28 years he has missed 2 days of work with kidney stones). The patient's concomitant medications were not reported. He do not drink or smoke, and walks 3-4 miles daily 5-7 days per week. On an unspecified date in May2021, the patient experienced he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy. Patient reported that he received the first dose of the Covid-19 vaccine about a month ago and about 2 weeks ago on Wednesday, he got the second dose. Caller reported that he received the first dose of the Covid-19 vaccine about 3 weeks before the second dose. The clinical outcome of the he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy were unknown.  Information on lot/batch number was available. Additional information has been requested.
Join pain bilateral with inflammation and effusion; Join pain bilateral with inflammation and effusion; Join pain bilateral with inflammation and effusion; This is a spontaneous report from a contactable physician (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Arm Left on 28Dec2020 09:00 (at the age of 52-years-old) (Batch/Lot Number: EH9899) as single dose for COVID-19 immunisation. Medical history included covid-19, the patient was diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since 29Dec2020, the patient experienced join pain bilateral with inflammation and effusion. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The adverse event was treated with NSAIDS. The reporter assessed the event as non serious. The patient underwent lab tests and procedures which included Covid test post vaccination (as reported) (Rapid test, Nasal Swab): Negative on 13Dec2020. Since the vaccination, the patient had been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
CHIEF COMPLAINT:   Went to walkin with extreme RLE pain since midnight. R foot mottled, cold to touch, unable to find pulse with doppler at triage. Pt CAO x4. O2 saturation 84% on room air.        REVIEW OF SYSTEMS:     Review of Systems. All other systems reviewed and negative.
Pt became very weak and limp. She needed head support for several days. Her eyes became glassy and she would not interact with people for several days. She stopped cooing for several weeks.
Beginning 4 hours after administration of 2nd dose: headache, malaise, fatigue By 10 hours after dose: worsening headache, low grade fever, body pain By 24 hours after dose: above symptoms continued, but now had bone pain By 48 hours after 2nd dose was "back to normal"
Mother of patient was asking for Moderna  vaccine.  When checking in patient, the technician was not aware of the age minimum of 18 for Moderna vaccine.  Unfortunately the pharmacist assumed that they were older than 18 and didn't acknowledge they were not eligible to Moderna.  Pharmacist spoke with mother and told her to watch for signs of soreness and any reactions to be reported to pharmacy. We would then contact the CDC. Patient has been stable and no reactions after giving the shot.
after patient receive the vaccination with in about 5 minutes she started itching all down her left arm where the injection was given. Administered 25 mg of Benadryl I.M, about 10 minutes after Benadryl was given her itching started to decrease. No shortness or breath, no air way constriction noted.
heart flutter, rapid heartbeat, pounding heartbeat - started within a few days to a week after the second shot
Hives; cough; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via intramuscular route of administration, administered in left arm on 05Mar2021 at 13:30 hours as 1st dose, single (at the age of 45-years-old) for covid-19 immunisation. Medical history included achalasia, asthma, allergy to latex and allergy to penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included patient received within 2 weeks of vaccination included celecoxib (CELEXA); esomeprazole magnesium (NEXIUM) and pramipexole dihydrochloride (MIRAPEX), all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and gabapentin and experienced allergy to erythromycin and allergy to gabapentin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. On 05Mar2021, at 13:30 hours, patient experienced hives, cough, chest pain and shortness of breath. Patient had emergency room/department or urgent care for the events, Patient received epinephrine, Benadryl, steroids and pepcid, as treatment for all the events. The reporter considered the events as non-serious. Patient was not tested for COVID-19 since the vaccination. Events resulted in emergency room/department or urgent care. The outcome of all the events was recovered in Mar2021.  Information on the lot/batch number has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of urticaria, cough, chest pain, dyspneoa and suspect drug BNT162B2 cannot be excluded  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.
Seven days after injection I developed a rash on my left arm at the injection site which became swollen and about 3 inches in diameter it lasted for seven days is fading away now seven days later.
Decreased intake. Slept for hours after injection. When family tried to wake patient, he was limp, pale, refused to eat. Taken to ED and monitored until early AM 4-23-13.
Expired vaccine administered to patient. (Expired 1/21/17, given 1/24/17).
Pt recv vax on 10/28/98; on 10/30/98 pt exp fine papular rash on arms spreading to chest & back
Information has been received from a registered nurse concerning a female patient who on 27-APR-2007 was vaccinated with a dose of Zostavax. It was reported that "a couple days after vaccination", the patient experienced a rash similar to chicken pox lesions. The patient did not experience a fever, hives or difficulty in breathing. The nurse reported that patient was not seen by a physician and it was not confirmed whether the rash was chicken pox lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
NOT CLASSIC LESIONS, BUT HAS RECIEVED 2 VARIRAX AND THE DISTRIBUTION AND ITCHINESS ARE C/W CHICKENPOX.
Just 2 hours after my second vaccination on 5/18/21, my right knee began to swell up to the size of a softball with fluid build up surrounding my knee for no reason. I followed protocols and relied on crutches to get around. Swelling did not seem to subside so I went to the Outpatient services at Health - Hospital on 5/19/21 for advice and a hopeful solution. I met with Client and she did not have any answers, but ordered Xrays and bloodwork. Xrays were done that same day, but I had to come back for bloodwork on 5/20/21. Both tests came back "normal". Two days later on 5/22/21 as my knee was still swollen, I went to Hospital and had some fluid drained from my right knee to help alleviate the pressure in hopes of having some pain relieved and motion regained. They gave me a steroid injection to help alleviate the pain too. So far I've regained most motion of my right knee but I still experience some pain and difficulty with walking and everyday tasks.
Moderna C19 Vaccine EUA Mar 5:  3:15 AM arm started hurting. 8:30AM chills, body ache. 11:40 temp 98.6. arm stopped hurting. 12:05 temp 99.5. slight headache. 12:25 temp 99.9. 1PM  temp 101. 5PM  temp 99.8.   Mar 6:  12:30 PM feeling better. no fever, chills, body ache Mar 9 very difficult bowl movement.  Mar 10/11 stomach problems diarrhea
red, flushing rash on neck, arms and chest; This spontaneous report was received from a registered nurse referring to a 28 year old female patient.  The patient had no pertinent medical history or drug reactions/allergies.  Concomitant therapies included birth control pills.  On 09-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1687291, expiring on 11-SEP-2022, dose 1, intramuscularly, for HPV prophylaxis.    On the same day, several hours after vaccine, the patient developed a red, flushing rash on neck, arms, and chest (rash erythematous).  The patient did not seek medical attention.  No treatment was given for the event.  There were no laboratory tests performed.   The patient recovered from rash erythematous on 10-MAR-2021.   The reporter did not assess the causal relationship between therapy with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Elevated pulse. Tightness in throat, wheezing, shortness of breath. Low blood pressure.  Benadryl OTC 1 pill. Vitals taken within normal limits after visit. no treatment initiated.
The pt described sensation of B/L finger swelling and shaking. No erythema, edema or bruising noted at injection site. Symptoms abated.
began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination.  Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) 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)) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 116th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
49 expired doses administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (49 expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (49 expired doses administered). On 17-Oct-2021, EXPIRED PRODUCT ADMINISTERED (49 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  The nurse states that one of their providers continued to use the Moderna COVID-19 Vaccine after  one month beyond-use-date. They wanted to see if they need to re-vaccinate their patients. Forty-nine doses were administered. The lot number was 048F21A. The provider received the vaccine on 17-Sep-2021, so they determined that the expiration date was 17-Oct-2021. They kept administering Moderna COVID19 Vaccine since 17-Oct-2021 through 02-Nov-2021. The patient information is not available.
Injection site soreness and redness. Swollen lump appeared on left armpit on 11/30 and still there.  Headache from 11/30-12/01.
Case number PHEH2014US003787 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 23 DEC 2013. No adverse event occurred to the  patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Vertigo fir 8 weeks After approximately 5 weeks after #2; both ankles swollen; Light headed & dizzy all the time.; 14Apr2021 dose number=1/28Apr2021, dose number=2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in Arm Left on 28Apr2021 14:00 (at the age of 62-year-old) as, single dose for covid-19 immunisation. The patient medical history was reported as none. The patient didnot have any allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 administered in left arm on 14Apr2021 01:00PM for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 the patient experienced vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen light headed & dizzy all the time. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. No treatment received for the events vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen, light headed & dizzy. The events were considered as non-serious by the reporter. The outcome of the events vertigo fir 8 weeks after approximately 5 weeks after #2, both ankles swollen, light headed & dizzy all the time were not resolved and unknown for other event.  Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning her 12 month old granddaughter with no known allergies who in approximately December 2005, was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Concomitant vaccination included a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine and a dose of pneumococcal 4 Lb 9V 14 1BC 19F 23F conj vaccine CCRM197) (Prevnar). Twelve days post-vaccination, sometime before 25-Dec-2005, the patient developed a chickenpox like rash on the face. Thirteen days post-vaccination, the patient developed a measle like rash. On the fourteenth, the patient was covered head to toe with a measles-like rash. The rash lasted for two weeks. The patient also experienced swelling of the face, nose and lips and was "medicated." Unspecified medical attention was sought and the patient was medicated for the swelling. Subsequently, the patient fully recovered. The patient had a family history of reactions to vaccines including her uncle who had an anaphylactic reaction to an unspecified vaccine and the reporter who has had "trouble" with unspecified vaccines. However, the patient's tow older sisters have had no problems with vaccinations. It was also noted that the patient's mother was four month's pregnant. A product quality complaint was not involved. The chicken-pox like rash, measles-like rash, and swelling of the face, nose and lips were determined to be other important medical events by the reporter (OMIC). Additional information has been requested.
tremendous joint pain in shoulders, hips & knees...had shoulder x ray, took Prednisone & hydrocodone and went to physical therapy
Severe vomiting all night. Fever, flu like symptoms, bed ridden for four days. then sinus congestion sinus headache for week. took about 10 days to fully recover
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On an unspecified date the patient was vaccinated with improperly stored vaccine of ZOSTAVAX (lot # M018593 and expiry date 28-JUN-2017) (dosing regimen and frequency were not reported). No concomitant medications were reported. On 28-JUN-2016, the vaccine was exposed to temperature excursion of 24.5 Fahrenheit for 7 hours. No adverse effects were reported. No product quality complain (PQC) was filed. Additional information has been requested.
pt recv vax 1APR96 7 26NOV96 & pt began breaking out w/chickenpox;
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender were administered doses of VAQTA (Lot# unspecified) dose, route, frequency and location unspecified that was stored outside the recommended temperature range as noted in the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.