chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Moderna Covid-19 vaccine administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Additional information received on 03 Sep 2021 contains no new information.
Patient came in today 8/11/18 to report that her left lower abdomen starting hurting and is "uncomfortable". Per patient this began "a couple of days after the injection. Patient showed me the tender area, there does not appear to be a rash or bruising.
Patient reported to pharmacy aproximately 4 months after 2nd dose with complaints of sore shoulder occuring since administration.
Vaccine was administered to a 17 year old female. Moderna has EUA for 18 years and older.
Patient had itchy on arm the same night she received the injection. It bothered her all through the night. The next morning her arm was swollen, hot, and red. Patient went to on-site clinic next day where they gave her an injection of antibiotics. Patient starting oral antibiotics today. Swelling and heat has gone down. All info was obtained from patient herself with a follow up phone call
thinks the vaccine was given SubQ instead of intramuscularly; some fluid leaked out down her arm after injection; some fluid leaked out down her arm after injection; This spontaneous case was reported by a physical therapist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks the vaccine was given SubQ instead of intramuscularly), ACCIDENTAL UNDERDOSE (some fluid leaked out down her arm after injection) and DEVICE CONNECTION ISSUE (some fluid leaked out down her arm after injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks the vaccine was given SubQ instead of intramuscularly), ACCIDENTAL UNDERDOSE (some fluid leaked out down her arm after injection) and DEVICE CONNECTION ISSUE (some fluid leaked out down her arm after injection). On 12-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (thinks the vaccine was given SubQ instead of intramuscularly), ACCIDENTAL UNDERDOSE (some fluid leaked out down her arm after injection) and DEVICE CONNECTION ISSUE (some fluid leaked out down her arm after injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had not taken any treatment steps for the second dose events.
mild nausea, aches & pains; On 7JUN had funny h/a;
approx 24hr p/vax pt became tired appearing; several hr later devel tonic posturing w/rt arm near ear & frog leg positioning of legs;(no gen tonic clonic sz activity noted);no fever;episode lasted several min;
p/vax had t101.5-102 then 24 hrs p/vax had febrile sz & taken to ER w/nl exams; had sl inc WBC on CBC but no further treatment given then observation; playful p/sz resolved;
Hives on arms and face, swelling of face developed evening of 10/21/11, no difficulty breathing, but did complain of difficulty with talking due to face feeling swollen. Encouraged to call MD. Reported to health dept. 10/24/11.
she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022; she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 21Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022, outcome "unknown" and all described as "she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive.  Clinical course: The patient was asking that how long does she had to wait after the infection before getting her booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT EXPERIENCED INFLAMATION AND PAIN UNDER THE ARM ON INJECTION SITE ARM. PATIENT WAS SEEN BY DR OFFICE AND WAS GIVEN IBUPROFEN 800MG  EVERY 8 HOURS AS NEEDED ON 12/06/2021.
Patient received Adacel in left arm and Havrix in right arm on 1/18/08. Patient had had mild URI prior to visit.  Temp at time of injections was 98.6 Fahrenheit.  He developed pain and fever the following day, along with mild chest pain. The pain increased on the second day, necessitating an ER visit.  Patient was diagnosed with viral pericarditis on basis of EKG with ST elevations across pericardium.  ECHO was normal. He was treated with Advil and rest.  He was seen by Cardiology on Jan 24.   EKG was now normal.  The impression was that the pericarditis was secondary to the antecendant viral illness and not the two injections.
pt mom brought pt in w/prescription from MD to receive all needed vaccines; pt recvd only MMR; started screaming when vax administered & then quieted down & stared  blankly for 5 seconds; pts sister said was having seizure;
Red pruritic spots at injection site on right thigh red patchy spots on chin chest back very itchy. Have sent pt for a varicella titer.
Breakthrough Case  Patient received a booster vaccine. Different vaccine from original series Moderna Lot #01221A on 10/25/2021 at Pharmacy.
Start Date/Time: [Pfizer] 27-JAN-2021 05:00 PM/Start Date/Time: [Pfizer] 10-FEB-2021 01:30 PM; my resting heart rate escalated to 140 BPM; my vision got blurry; feel sore today; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on 10Feb2021 13:30 (at the age of 30-year-old) as dose 2, single for covid-19 immunisation. Medical history included substance use from an unknown date and unknown if ongoing smoked weed it made my lungs feel strange. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Left on 27Jan2021 05:00 PM (at the age of 30-year-old) as dose 1, single for covid-19 immunisation and experienced lungs feel strange. Patient concomitant medications were not specified. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021, the patient experienced start date/time: pfizer 27-jan-2021 05:00 pm/start date/time: pfizer 10-feb-2021 01:30 pm. On the second dose patient had an edible instead and just little smoke (weed). For some reason his resting heart rate escalated to 140 BPM and his vision got blurry about six hours from the second dose maybe an hour or two after eating the edible. It stayed above 100 for at least 2 hours until he fell asleep. Patient put his hands above head and breathed deeply trying to calm himself down. Patient felt like he was running a marathon while laying in bed. Patient had a small edible and he was very used to eating weed. Patient stated that he was worried if someone is ingesting marijuana or smoking weed on their second dose that it could hurt their heart if they have a pre existing heart condition. Patient feel sore today and his pulse was stable. The patient underwent lab tests and procedures which included heart rate: 140 bpm on 10Feb2021 escalated to 140 BPM. The reporter assessed the events as non serious. No treatment was taken as a result of heart rate increased, blurry vision, pain. The outcome of the events heart rate increased, blurry vision, pain were recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt recvd series of 3 hep B vax  & titer indicated pt nonresponder.Pt recvd booster 31OCT90.
patient had negative titers for Hepatitis B; patient had negative titers for Rubeolla; patient had negative titers for Chicken pox; This spontaneous report was received from a medical assistant referring to a 21 years old non-pregnant female patient. Information about concurrent condition, concomitant medications, drug reactions/allergies or medical history was unknown. On unknown dates in 1997, the patient received two separate doses of unspecified hepatitis B vaccine (manufacturer, dosage detail, route, lot number and expiration date unknown) for prophylaxis, and on an unknown date in 1998, the patient received another dose of unspecified Hepatitis B vaccine (manufacturer, dosage detail, route, lot number and expiration date unknown). On an unknown date in 1998, the patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live(M-M-R II) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On an unknown date in 2001, the patient received varicella virus vaccine live (oka/merck)(VARIVAX) (lot number and expiration date unknown) for prophylaxis reconstituted with  sterile diluent (manufacture unknown). On an unknown date in 2002, the patient received another dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live(M-M-R II) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On an unknown date in 2007, the patient received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage detail, route, lot number and expiration date unknown) for prophylaxis reconstituted with sterile diluent (manufacture unknown). On 17-JUL-2019, the patient performed a blood test and had MMR, chicken pox and hepatitis B titers drawn, the results showed negative titers for "rubeolla", chicken pox and hepatitis B. The patient sought medical attention from physician. No treatment was given for the events. The outcome of the events was not received at the time of this report. The causality between the events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck)(VARIVAX), the unspecified hepatitis B vaccine were not provided.
positive COVID-19 test; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection, Lot Number: EN6206), administered in Arm Left on 10Mar2021 11:15 am as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fluconazole taken for an unspecified indication, start and stop date were not reported. The patient tested positive for covid-19 on 14Mar2021. The patient underwent lab tests and procedures which included Nasal swab, rapid and PCR were positive on 14-mar-2021.Patient did not have covid-19 prior vaccination. Patient did not received treatment adverse event and didn't have known allergies. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021288981 same drug/event, different patient.
This is a spontaneous case, initially received from other non-health professional on 15-Feb-2018, concerning a 39-year-old adult female pregnant patient. The patient had no medical history. The patient's concomitant medication included prenatal vitamin for an unknown indication. The patient had no maternal or paternal medical history (hereditary disease) relevant to pregnancy. The patient had 2 previous pregnancies. The patient had no still birth, miscarriage, birth defect or congenital anomaly occurred in previous pregnancy. The patient did not use any contraceptive method. The patient had not received any medications prior to pregnancy and no medication taken by the fetus's father prior to conception. The patient's LMP (last menstrual period) date was 28-Dec-2017. It was reported that, there was no evidence of defect or adverse finding from a prenatal test. On 14-Feb-2018, the pregnant patient at gestation age of 7 weeks (first trimester) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) (explicitly coded vaccine exposure during pregnancy). It was stated that, the patient did not experience any adverse effect after the vaccination. The patient's EDD (estimated date of delivery) was 04-Oct-2018. The reporter assessed the event as non-serious.
She started to experience loss of strength below her elbow only on her right arm; She says it might be a brachial neuritis; On her left arm she has a radiating pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain). At the time of the report, ASTHENIA (She started to experience loss of strength below her elbow only on her right arm), RADICULITIS BRACHIAL (She says it might be a brachial neuritis) and PAIN (On her left arm she has a radiating pain) outcome was unknown.            Relevant concomitant medications were not provided. Approximately in May patient started to experience the events. Treatment medication was not provided.   This case was linked to MOD-2021-292108 (Patient Link).
Rash at injection site 7 days after first moderna shot along with swollen lymph nodes and soreness.
A report has been received from a physician via Merck concerning a patient of unknown gender, who had been receiving FLUMIST (intranasal), dose unknown. Concomitant medications included varicella virus vaccine, live. FLUMIST started on an unknown date. The physician reported that VARIVAX was administered to the patient within less than 4 weeks from FLUMIST spray. The outcome of VARIVAX was administered within less than 4 weeks from FLUMIST spray was unknown. The reporter's description of the event(s) was as follows: Please see the attached document. The report was considered to be non-serious.
Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 21st October 2019, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient completed a Shingrix 2 dose series in the past. Two days before the time of reporting, the patient was diagnosed with shingles 2 days. The patient received Valtrex last night. The patient's further details and product information not available. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Raised splotchy red rash all over body which started about 2.5 weeks after MMR injection given. No difficulty breathing or other sx.
Information was received on 25-APR-2017 from a nurse who gave the phone to the physician. The physician reported that on 25-APR-2017 an improperly stored ROTATEQ was administered to an unspecified patient.  Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. The action taken was not applicable and the outcome was not reported. The physician did not rate the causal relationship. Name of vaccine involved: ROTATEQ (lot # M038207, expiration date 02-MAY-2018) Temperature: 31.1 degrees Fahrenheit Time Frame: 30 hours Was it administered: yes Previous temperature excursion: no Was call because of a "data logger"? yes No further information was provided. Additional information has been requested.
"Moderna COVID-19 Vaccine" Pain at injection site, hardness, swelling, hot to the touch
Myoclonus in right arm  following Covid Booster.   I had a Tetanaua booster in my left arm earlier in. The week and made my vaccination site well aware of this.   Initially no problems but over a week later developed twitching in my arm inferior to Covid booster injection site.  ( My 1st 2 Covid vacs were Pfizer and were close to a year prior to this Booster).  I also had Covid in very late Dec/early Jan.    I still have myoclonus in my arm although it has gotten much better as of Mid April 2022.  I saw my pcp for this issue.  The twitching was intermittent and very localized. It could be seen and palpated by her and her trainee as well as my spouse. It moderately interfered with ADLs.
Pt noted increased pain with in hours after injection, pain increased over 24 hrs then redness noted at ZOSTAVAX site, pt used ice, TYLENOL which help some. Pt then came to clinic presented with 13cm x 23cm redness with 5cm x 3cm center of raised blister center - area warm to touch - (L) arm where ZOSTAVAX was given - (R) arm also with redness & swelling at site of PPV/Flu 13cm x 19cm.
Information has been received from a physician concerning a 22 month old female with a milk allergy resulting in diarrhea and no exposure or history of chickenpox who on 4/26/00 was vaccinated in the left leg IM with a dose of varicella virus vaccine live. Subsequently, on 3/3/01, the pt developed a vesiculo-pustular rash on the right side of forehead and right eyelid with swelling and redness around it and right conjunctivitis. The pt also developed herpes zoster described as pre-septal cellulitis on the right eyelid, right forehead and right eye conjunctivitis. She had symptoms of decreased alertness and a temperature of 102.7F. A specimen taken from the pt's right eye was obtained on 3/5/01. The results from the frozen isolate specimen of the child's right eye vesicular lesion was VZV positive and was identified as the OKA/Vaccine strain. Follow-up information has been received from a physician who reported the child has been dx'd with Job-Buckley Syndrome (hyperimmunoglobulinemia E). It was noted that the child's IgE level was in the 1200 range. It was also noted that the pt has eczema and frequent "draining ears". The physician reported that the child was seen with this periorbital cellulitis and it appeared that lesions of herpes zoster also existed. The cellulitis culture grew Hflu, pneumonia, strep and staph and the culture of the child's eye grew the VZV that was identified as the OKA/Vaccine strain. The child was treated in the hospital with antibiotics and acyclovir. The child recovered and the lesions healed, however, there is some residual scarring.
Henoch-Schonlien purpura/nasty rash, severe joint paint and itchy/burning skin; vasculitis; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: Lot Number: EW0164), via an unspecified route of administration, administered in the left arm on 22Apr2021 at 17:00 as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (VIENVA); ibuprofen, phenylephrine hydrochloride (manufacturer unknown); montelukast (manufacturer unknown) and loratadine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19. The patient previously received the first dose of BNT162B2 on 01Apr2021 at 16:00 (lot number: er8733) on the left arm for COVID-19 immunization. On 24Apr2021 the patient experienced Henoch-Schonlien purpura (vasculitis). The patient had a nasty rash, severe joint pains and itchy/burning skin. The patient visited the emergency room/department or urgent care due to the events. The patient was prescribed steroids as treatment for the event. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Itchiness at the injection site developed after ~ 2 days, still persistent at day 10.  Minor swelling of  lymph nodes near the arm pit at ~ 5 days, reduced at day 10 but not completely gone.
one pt inadvertently recvd 2 doses of DTP; observed in clinic 30 minutes p/dose; no problems; sent home; following day pt had a fever of 101 R; seen in office 4 days later; recovered w/no residual sequelae;
pt recv vax; died next day; COD unk; autopsy pending; MFR has been notified of adverse event;