chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.36 for dose administered on 11-Jan-2021. No concomitant medications were reported.  Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
After approximately a month after 2nd dose, have been having memory issues  that have persisted to this day.
Suspected vaccination failure; I had two shingle shots and still got it on my left side of my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had two shingle shots and still got it on my left side of my face). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date:26-JUN-2023 The case was received from the patient interactive digital media. The patient had two Shingle shots and still got it on his/her left side of face. The patient stated that worst thing he/she ever had. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Arm was swollen, hot to the touch, redness. Went to the Dr on 4/6/17 and was diagnosed with Cellulitits. Was given Augmentin.
Slightly elevated temperature Chills Body aches Headache Fatigue Muscle pain deltoid extends to arm (this pain is starting to resolve.)
Pt recvd vax 29MAY92 & MAY92 pt noticed inc bruising; pt stated that had always bruised easily, but not appears to bruise even more easily; No further details were provided;
Usual sore arm at administration site within 1st 2 hr after vaccine. By 1pm 5/17, diffuse myalgia (mild) & mild fatigue. By 5/18 8AM, progressive myalgia/fatigue, photophobia, anorexia, diffuse HA, neck stiffness. Temp 101 w/ emesis by 5/19 3AM. Also loose stool x 3 w/in 24 hr. Persistent prolonged HA, nausea, neck stiffness & photophobia for 56 hr. Myalgias continue 5/24. Pt used acetaminophen, CELEBREX & massage tx to continue sx.
Became febrile, poorly responsive. Taken to the MGH ED. En route while in ambulance, he experienced a convulsion with rhythmic shaking in all limbs lasting several seconds.  He had a second episode requiring midazolam and levetiracetam. On arrival to MGH ED, the patient was afebrile, heart rate 133, blood pressure 173/93, oxygen saturation 99% on a nonrebreather.  He was found to be severely encephalopathic, mute, and not answering questions or following commands.  He was admitted to the neuroICU and intubated for airway protection given his poor mental status. He was started on broad-spectrum antibiotics for empiric treatment of meningoencephalitis, but these were discontinued after his CSF was not concerning for a bacterial infection herpes simplex encephalitis.  Antibiotics were discontinued. He was extubated on hospital day 2.  After extubation he had persistent mixed receptive-expressive aphasia that was slowly improving over time. At discharge from the hospital, he was able to occasionally say a simple sentence, could repeat simple phrases, and could follow simple commands. He was discharged to Rehab
MINOR STUFFY NOSE; COUGH; CHILLS; NAUSEA; FELT LIKE WAS HIT BY TRUCK; BRAIN FOG; SHAKY/JITTERY; ACHY; LETHARGIC; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A01A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced shaky or jittery. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced felt like was hit by truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced minor stuffy nose. On 09-APR-2021, the subject experienced cough.  On 12-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative and Rapid influenza diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like was hit by truck, chills, minor stuffy nose, and cough, had not recovered from nausea, brain fog, shaky/jittery, and lethargic, and the outcome of achy was not reported. This report was non-serious.
Hep A vaccine was drawn up by staff and syringe was labeled. Injection was then administered by a different staff member. When that staff member went to document the injection it was discovered the vaccine was expired by 1 week.
Product storage error; no adverse event; HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.) and NO ADVERSE EVENT (no adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP notes that 49 doses in Nov2022 were expired open multidose vials and discarded.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was reported that the site which had Moderna vaccine in a freezer unit had good readings on the digital data logger until August. In Aug-2022, the battery died and they had no logs from 01-Aug-2022 until 01-Jan-2023. Reporter was asking Moderna about the viability of the vaccines. 1 Box of vaccine with Lot 011B22A with more than 12 red vials were expired. Vaccines were still in the freezer. HCP confirmed that there had been some doses given between 01-Aug-2022 to 01-Jan-2023.  HCP checked notes left and indicated 100 doses were received and 30 doses were currently left discarded due to expiration. HCP noted that 49 doses of open multi dose vials in Nov-2022 were expired and discarded. Possibly 2 patients were given that vaccine, one patient on 01-Aug-2022, gender was unknown and birth year was 1940. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712563 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712563:Adult patient
first dose of Shingrix on 14Feb2020 / not received the second dose yet; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose recieved on 14th February 2020, batch number 3N7F2, expiry date 25th March 2022).   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: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient had received 1st dose of Shingrix at primary reporter's facility. The reporter consented to follow up via email
First dose was given on 07-Mar-2021 and second dose was given on 17-Aug-2021; fever; my heart is skipping/ it stops beating for a second/ tried to palpate the pulse it skips every 10 beats; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (my heart is skipping/ it stops beating for a second/ tried to palpate the pulse it skips every 10 beats), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Mar-2021 and second dose was given on 17-Aug-2021) and PYREXIA (fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 003A21A) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concomitant products included FLUTICASONE for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced HEART RATE ABNORMAL (my heart is skipping/ it stops beating for a second/ tried to palpate the pulse it skips every 10 beats) and PYREXIA (fever). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Mar-2021 and second dose was given on 17-Aug-2021). At the time of the report, HEART RATE ABNORMAL (my heart is skipping/ it stops beating for a second/ tried to palpate the pulse it skips every 10 beats) and PYREXIA (fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Mar-2021 and second dose was given on 17-Aug-2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Heart rate: my heart is skipping/ it stops beating for a secon (abnormal) my heart is skipping/ it stops beating for a second/ tried to palpate the pulse it skips every 10 beats.         Treatment product information was not provided.   This case was linked to MOD-2021-291325 (Patient Link).
Moderate pain in left arm, started after injection time of approximately 3:15pm.  Continued  aching until 3/14/2021 approximately 5pm.
Joint point, nervous system spasms on side of injection, bruising in the arm pit, fever, hot & cold sensations, nausea, headache. Was given the DTAP vaccine, but not sure which one.
Sever muscle aching, intense back pain unrelieved with Advil and Tylenol.  Irritability in trying to sleep.  Also, less severe was deltoid pain L arm.
CHILD'S DATE OF BIRTH WRITTEN INCORRECTLY AND AGE 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN DATABASE WITH CORRECT DATE OF BIRTH. CHILD TOO YOUNG FOR VACCINE IN 7/2021.
Beginning about 02/06/2023, I started having morning nausea. Some days it would continue into the early afternoon. It was continuous for 14 days straight then intermittent after that. Probably happening 4 to 5 days a week since then. There was no vomiting involved. It was significant enough to interfere with my concentration, my activities. I called the doctor in February and they scheduled an upper GI which could not be performed until 04/05/2023. I saw the doctor for the report on 04/12/2023. The report said that I had a small hiatal hernia. They couldn't see any strictures, but that did not mean that there weren't any. They couldn't see. The doctor did give me medication to try: Omeprazole. One thing to mention as well is that I did receive my first shot of Shingrix in between my 5th vaccine and this health event. Unsure if this is related.
This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19 during the first part of August) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (tested positive for COVID-19 during the first part of August). At the time of the report, COVID-19 (tested positive for COVID-19 during the first part of August) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided.
PRURITUS THROUGHOUT THE BODY ALTERNATES IN DIFFERENT AREAS OF THE BODY/ ITCHINESS (BACK OF LEFT ANKLE, BACK OF BOTH ARMS, SIDE OF LEFT LEG ON CALF AREA AND WAIST AREA,LEFT HAND),ITCHY AREAS WITH RED MINOR BUMPS SIZE OF A QUARTER TO HALF-A DOLLAR LIKE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 262 pounds, and height was 69 inches. The patient's past medical history included rheumatic fever in childhood, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area, left hand), itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area,left hand),itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. This report was non-serious.
Swollen lymph nodes under arm and neck. Extensive, itchy hives on legs, scalp and neck.
stated she had always been extremely regular, since having the vaccine she was two weeks early; This is a spontaneous report received from a non-contactable consumer (patient) from Pfizer-Sponsored Program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had her first dose of the covid-19 vaccine this past Saturday and then got her period, she stated she had always been extremely regular, since having the vaccine she was two weeks early. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swelling of the lymph nodes underneath the left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of the lymph nodes underneath the left armpit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph nodes underneath the left armpit). At the time of the report, LYMPHADENOPATHY (swelling of the lymph nodes underneath the left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Very itchy; Skin was pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Skin was pink) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Skin was pink). At the time of the report, VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Skin was pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took the regular medication Tylenol as treatment as she always takes.
Pt noticed facial swelling at 11am, 2.5 hrs after receiving flu vaccine (edema @ forehead, bridge of nose, under eyes).  No swelling of lips/mouth/throat/airway.  VSS stable, not in distress.  Breathing without difficulty.  Pt also reports slight tingling in fingers of R hand.   Benadryl PO administered at 12:05pm. Pt returned to office but advised to go to ED if ssx do not resolve.  At 1:30 no changein swelling for better or worse, arrived home, and took another 25mg  benadryl.  Again advised to go to ED since ssx are not resolving.  Unknown whether she did go to ED or not.
One week after I was vaccinated, my partially breast fed infant daughter died in her sleep on 11/28/2020. The cause of death is not known. I am reporting her death here because of the relative proximity of my vaccination and her death.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TREMOR (shaking), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low grade fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 043L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced TREMOR (shaking), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), TREMOR (shaking), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
The Patient presented with skin peeling from his hands and arms in large patches. It looks very bad (most of his skin is missing from his arms). I advised him to seek emergency medical attention immediately.