chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 adult patients received the expired Bivalent booster beyond 30 days; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) 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)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days).    This case included information of patient 2nd out of 11 reported patients. No concomitant medication was provided. Vial size was reported as 2.5 ml. Date the vial was initially stored in the refrigerator was 13-Dec-2023.  It was reported that vaccine vials were a case of 10pcs and 7 vials from the case were used to administer vaccines from 13-jan-2023 to 22-Jan-2023. Vial did not undergo any temperature excursions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case - 1st adult patient
I started to itch  soon after vaccine and I still itch  .I'm not sure about  2nd shot reaction could be worst
shingles; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a month after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in in the middle of July and by the 1st week of August had shingles. The patient 2nd dose was due this month and afraid to get it.  The reporter asked what effect would only 1 dose had and how likely would the 2nd shot cause shingles again. That pain was the worst of the worst.
FLU LIKE SYMPTOMS/BAD COLD TYPE SYMPTOMS/FEVERISH/HEADACHE/SICKNESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient went to the hospital because he felt like he had a bad cold. He was quarantined for 12 days. He was tested (Q-tip up the nose) positive, but he felt he was misdiagnosed. Symptoms of Covid went away 2 days into quarantine. He was at a party in close contact with a number of friends and none of them got Covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 20-DEC-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient experienced flu like symptoms/bad cold type symptoms/feverish/headache/sickness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Felt like a temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms/bad cold type symptoms/feverish/headache/sickness on 19-MAY-2021. This report was non-serious.
No additional adverse event reported; Administered a dose of MMRII in the middle of the arm instead of the outer aspect of the upper arm (deltoid region); This spontaneous report was received from a pharmacist, referring to a 37 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-FEB-2021, the patient vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA)(M-M-R II) 0.5 ml, lot # T006167, expiration date 19-FEB-2022, subcutaneously, for prophylaxis (strength and frequency were not reported). The pharmacist stated that the administration was subcutaneously as directed but in the middle of the arm instead of the outer aspect of the upper arm (deltoid region).No additional adverse events reported.
Since the second dose I was dealing with subtle discomfort with my left arm/shoulder which progressively became worse.  I saw my general practioner early part of 2022 and subsequently saw an orthopedist who diagnosed that I have frozen shoulder.  I am currently seeking physical therapy treatment twice per week.  I have been in treatment since the middle of April 2022.
Tingling and numbness in face at 25 minutes post shot.  Told to take Benadryl. Throat began to swell at 35 minutes post shot. Took Benadryl went to bed. Next morning took more Benadryl at 7am. At 11am face started to tingle. Drove to mom's. She said she could see my bottom lip swelling. Face began to twist and droop. Went to ED. Had MRI.
Vaccines given on June 26, 2017 - left arm with 23 x 13 cm area of erythema site with MENACTRA and HPV9. Right arm with 14 cm by 12 cm area of erythema and tenderness.
Parent called the clinic on 11/13/2019, two days after immunization was given, to report that the site around where the immunization was given was red and swollen.
Patient is not of age to receive KINRIX. KINRIX is 4-6 years of age. Patient tolerated well. GSK contacted and awaiting to hear back.
Vomiting; Headaches; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received BNT162B2(Phizer- BioNTech/EP7534) (lot no: Unknown) solution via injection via an unspecified route of administration for Covid 19 immunisation on 15Mar2021. The patient's medical history included Chronic obstructive pulmonary disease (Copd), depression, anxiety, post-traumatic stress disorder (ptsd)and bipolar 1. The patient's past drug history included Bactrim which had caused drug allergy. The patient was not pregnant at the time of vaccination and has not had symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, the patient experienced Nausea, headaches, vomiting and sore arm. No therapeutic measures were taken for the reported events. The clinical outcome of the events was unknown at the time of reporting. No follow up attempts are needed, information about batch number cannot be obtained.
the vaccine wasn't store at right temperature; chills; running fever; body aches; really bad headache. Next morning was really tired.; Next morning was really tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches) and HEADACHE (really bad headache. Next morning was really tired.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature). At the time of the report, PRODUCT STORAGE ERROR (the vaccine wasn't store at right temperature), CHILLS (chills), PYREXIA (running fever), MYALGIA (body aches), HEADACHE (really bad headache. Next morning was really tired.) and FATIGUE (Next morning was really tired) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.
Information has been received from a pharmacist concerning an adult female who was vaccinated on an unspecified date with the 1st dose of Hep-B and within 4 hours, the pt experienced tightness in her throat and numbness up and down her arm. The pt went to a physician who dx'd the symptoms as viral pharyngitis. Addition information has been requested.
Flu like symptoms; severe brain fog; Covid vaccine related issues; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FEELING ABNORMAL (severe brain fog), IMMUNISATION REACTION (Covid vaccine related issues) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.  Reported that patient experienced severe brain fog as an COVID after effect. She had Flu like symptoms following each vaccine and booster. She could not remember any of the dates but said that she got them as soon as they were available.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case belongs to patient no 7 out of 25 patients.  Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Poste vaccination  resident was observed with respiratory distress within an hour. 911 called . Upon arrival Benadryl and Epinephrine administered . Resident was later intubated. Tranferred  via 911.
Patient experienced generalized body pains and aches, dry mouth, flu-like symptoms, loss of appetite, loss of energy
Palpitations; tachycardia; This is a spontaneous report from a contactable nurse (patient).  A 31-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ej1685), via an unspecified route of administration on the left deltoid on 22Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital.  It was reported that prior to vaccination the patient was diagnosed with COVID-19 (unknown date). The patient's concomitant medications were not reported.  The patient had palpitations and tachycardia on 23Dec2020 (also reported as second day post vaccine) which resulted to doctor or other healthcare professional office/clinic visit. The patient received unspecified beta blocker as treatment. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates between 19-APR-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of VAQTA lot # M033611 with expiration date 02-MAR-2018, lot # M038572 with expiration date 11-MAR-2018, lot # M039202 with expiration date 11-MAR-2018 and lot # N005274 with expiration date 03-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 24 hours. A Digital Data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014464: US-009507513-1705USA014494: US-009507513-1705USA014496: US-009507513-1705USA014497:
pt recvd vax 22OCT94 between 10-12AM; on 23OCT94 approx 6PM pt's arm began to itch @ inject site & rash was noted-now rash is itching & generalized; pt was referred to PMD;
Developed s/s of COVID on 5/7, tested positive for COVID on 5/18
My mother received the second dose of her Pfizer vaccine in the late morning of March 28, 2021.  By that night, her blood pressure had dropped significantly.  She's never had that issue previously.  The below normal blood pressure has daily from the date of the second vaccine to now.
FELT LITTLE NAUSEOUS; This spontaneous report received from a patient via a representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported.  On an unspecified date, the subject experienced felt little nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt little nauseous was not reported. This report was non-serious.
I was feeling SOB at work, but by the end of the day I would have to sit down and catch my breath. I didn't feel like I was getting enough oxygen. I was light headed. Removing my scrub top was enough to make me pass out. My boyfriend called 911 and after monitoring me for 45 min, they determined that it was best to go to ER.  Heart rate was in 160s, Respiration was in the 60s, Carbon Dioxide was 11 and pulse ox was around 7%. They did EKG , CT Scan and they gave you oral Benzo. They told me that I probably got the vaccine too soon after COVID diagnosis, which I had in Dec.
12/6/19 - Presented to Emergency Rm with acute lower extremity weakness 12/7/19 Presented to ER cannot walk. Sent to Hospital 12/30/19 Expired
Information has been received from a certified medical assistant (CMA) referring to a patient (5) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 12-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccine were stored under 34.5 F (min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Rash on his left upper arm after receiving DTAP/IPV vaccine without fever, pain.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443553-00.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy, psoriasis. The patient had no relevant medical history and no known allergies. There were no concomitant medications. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn. In Jun2022, the patient experienced COVID-19. Pfizer BioNTech COVID-19 vaccine (tozinameran) was also considered suspect.  The reporter considered "covid-19" related to BNT162b2.  The reporter's causality for the event (s) of COVID-19 with HUMIRA (Adalimumab) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
High fever 103 deg x 3-4 day starting on the evening vaccines given. Not responsive to Tylenol. Fussy but consolable. Prevnar was not given at 2mo check up and no problems then.
her first shingrix vaccine 2 years ago; redness in her arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female 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 (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities and drug dose administration interval too long. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The case reported by patient. Th patient stated that she got her first shingrix vaccine 2 years ago.  She also reported that soon after receiving the vaccine (unknown arm) she had redness in her arm that lasted for about 2 weeks.  The reporter didn't want to provide anymore demographics and didn't have any further details about the vaccine given. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule. From the narrative it was not clear if the patient received 2nd dose late but as per time to onset reported in source document it seems that the patient received 2nd dose 7 months after 1st dose hence lengthening of vaccination schedule coded as event conservatively.
Dose was administered outside of the recommended time window after first vial puncture. Dose was deemed invalid.
PATIENT RECEIVED A DUPLICATE DOSE OF IPV IN THE SAME VISIT. VACCINES ADMINISTERED DURING VISIT WERE: PEDIARIX, IPV,  PCV 13, HIB, ROTATEQ. PATIENTS MOTHER WAS NOTIFIED BY PROVIDER WHEN ERROR WAS NOTED. AS PER PATIENTS MOTHER, PATIENT HAD A LOW GRADE FEVER THE EVENING HE RECEIVED THE VACCINES. NO OTHER ADVERSE REACTIONS NOTED AS PER PATIENTS MOTHER.