chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I waited too long in between the first and second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in January 2020).   In April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comment: This case was reported by patient via interactive digital media. The patient received second dose of Shingles vaccine two weeks ago before the day of reporting. The patient asked for whether he/she required third dose because he/she waited too long in between first and second dose of Shingles vaccine.  The patient was not comfortable for giving his/her personal information. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I'm feel like I got hit by a bus; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Apr-2022 Reporter's comment: The case was received by the patient via interactive digital media. The patient got his/her second vaccine a day before of reporting date and darn he/she was feeling like got hit by a bus. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: 1st in Oct2019, due to Covid never got 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: This case is received from Shingrix. This case was reported by the patient. Due to Covid, the patient never got second shot of Shingrix in 2020.The patient asked what should be done now.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 29 days after 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number G955C, expiry date 20th June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 15th April 2022, the patient received the 2nd dose of Shingrix. On 15th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The patient received Shingrix after 29 days after the 1st dose. The healthcare professional was aware that this was earlier than the recommended interval schedule. The healthcare professional confirmed that this patient was not immunocompromised. The consent to follow up was given. The healthcare professional provided fax number.  Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening of interval between vaccine doses.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Accidentally administering only the diluent portion; Accidentally administering only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA639A, expiry date 31st May 2023) for prophylaxis.   On 19th April 2022, the patient received Menveo. On 19th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments:  The healthcare professional did not have any of patient's demographic.   Pharmacist reported that the nurse accidentally administered only the diluent portion of Menveo, did not reconstitute the vaccine. The consent to follow up was given. Additional Supportive Information: The patient received Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Contusion, Dyspnoea, Headache
Clinical narrative: SHORTNESS OF BREATH; BLURRED VISION; CHEST PAIN; LEG SWELLING; PERSISTENT ABDOMINAL PAIN; EASY BRUISING OR TINY BLOOD SPOTS UNDER THE SKIN BEYOND THE SITE OF THE INJECTION; SEVERE OR PERSISTENT HEADACHES; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, the patient experienced shortness of breath, blurred vision, chest pain, leg swelling, persistent abdominal pain, easy bruising or tiny blood spots under the skin beyond the site of the injection, and severe or persistent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, leg swelling, persistent abdominal pain, severe or persistent headaches, easy bruising or tiny blood spots under the skin beyond the site of the injection, shortness of breath, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vision blurred
Clinical narrative: SHORTNESS OF BREATH; BLURRED VISION; CHEST PAIN; LEG SWELLING; PERSISTENT ABDOMINAL PAIN; EASY BRUISING OR TINY BLOOD SPOTS UNDER THE SKIN BEYOND THE SITE OF THE INJECTION; SEVERE OR PERSISTENT HEADACHES; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, the patient experienced shortness of breath, blurred vision, chest pain, leg swelling, persistent abdominal pain, easy bruising or tiny blood spots under the skin beyond the site of the injection, and severe or persistent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, leg swelling, persistent abdominal pain, severe or persistent headaches, easy bruising or tiny blood spots under the skin beyond the site of the injection, shortness of breath, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 024M20A, 007B21A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            Concomitant medication information was not provided by the reporter.               Patient received the second booster in her left arm shoulder deltoid muscle.              Treatment information was not provided by the reporter.   This case was linked to MOD-2022-546520, MOD-2022-546519, MOD-2022-546515 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Daughter had minimal common side effects after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose). At the time of the report, VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-546533, MOD-2022-546543 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  The vaccine vial was initially stored in the refrigerator on 23-Mar-2022 and was administered on 20-Apr-2022. The vial did not undergo any temperature excursions. The vaccine was given to 3 Males and 3 Females. Patient's age was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got sicker with my 3rd dose of Modernae; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sicker with my 3rd dose of Modernae) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got sicker with my 3rd dose of Modernae). At the time of the report, ILLNESS (I got sicker with my 3rd dose of Modernae) outcome was unknown.            No concomitant information was reported. No treatment information was reported. The year of birth of patient was 1949.   This case was linked to MOD-2022-546565 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient don't had drug allergies. Patient don't had Acute and Chronic illness. Patient don't have daily medications. Patient didn't had COVID-19 within last month.     On 01-Apr-2022 at 10:46 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 10:46 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Date the vial was initially stored in the refrigerator: 25-FEB-2022 Vial didn't undergo any temperature excursions. Patient not experienced any side effects yet. No Treatment information was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden
Clinical narrative: barely get out of bed; super weak/It only lasted about 12 hours or so, but it was extreme.; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (barely get out of bed) and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Atrial fibrillation.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (barely get out of bed) and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.). At the time of the report, BEDRIDDEN (barely get out of bed) outcome was unknown and ASTHENIA (super weak/It only lasted about 12 hours or so, but it was extreme.) had resolved.            No concomitant medications were reported. No treatment information was provided. The patient had a severe reaction on the last one. The doctor told him it might be best not to take the booster.   This case was linked to MOD-2022-546734 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a vaccine past the 30 day storage on the refrigerator; Patient vaccinated with vial that expired on 25-MAR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with vial that expired on 25-MAR-2022) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient don't have allergies. Patient didn't had COVID-19 within last month.  Concurrent medical conditions included Diabetes, Hyperlipidemia, Hypertension and Cardiac murmur. Concomitant products included METFORMIN, LISINOPRIL, GLIPIZIDE, LOVASTATIN, AMLODIPINE, MELOXICAM, SITAGLIPTIN PHOSPHATE (JANUVIA), ASPIRIN [ACETYLSALICYLIC ACID] and LORATADINE for an unknown indication.    On 13-Apr-2022 at 3:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 3:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with vial that expired on 25-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with vial that expired on 25-MAR-2022) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 25-FEB-2022 Vial didn't undergo any temperature excursions. Patient not experienced any side effects yet. No Treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine stored in the refrigerator past 30 days; Vaccinated with the Moderna Vaccine after the expiration of 3/25/22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient did not have any acute or chronic illness and did not test positive for COVID within last month. It was reported that patient had no known drug allergies).  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 01-Apr-2022 at 9:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that HCP confirmed that the patients were not experiencing any side effects yet.  Date the vial was initially stored in the refrigerator was 25-Feb-2022 and the vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-545267 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine past the 30 day storage on the refrigerator; vaccinated with the Moderna Vaccine after the expiration/received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration/received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No known allergies were reported.  Concurrent medical conditions included Hypertension. Concomitant products included LOVASTATIN, LEVETIRACETAM and OFLOXACIN for an unknown indication.    On 06-Apr-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration/received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration/received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total number of doses/vials was 36. On 25 Feb 2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Health Care professional wanted to know how to proceed with 36 patients that received a vaccine past the 30 day storage on the refrigerator. She also wanted to confirm if she needed to report this event as an adverse event, because she was not sure on some storage information on the vaccine and needed further clarification. Treatment medications were not reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered vaccine after 30-day Use By Date; Patient was administered vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known drug allergies. The patient had no chronic/acute illness and it was unknown if the patient tested positive/negative for COVID-19 within last month.     On 20-Apr-2022 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:11 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The number of doses/vials was 36. The vial was initially stored in the refrigerator on 25-Feb-2022 The vials did not undergo any temperature excursion. The frequency was reported as times per. The patient had not received any daily medications. The healthcare professional (HCP) wanted to know how to proceed with 36 patients that received a vaccine past the 30 day storage on the refrigerator. HCP confirmed that the patients were not experiencing any side effects yet.   No treatment medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine stored in the refrigerator past 30 days; Vaccinated with the Moderna Vaccine after the expiration of 3/25/22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included NORETHISTERONE (CAMILA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), GLIPIZIDE, METFORMIN and TERBINAFINE for an unknown indication.    On 20-Apr-2022 at 8:43 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported  The vial was initially stored in the refrigerator on 25-Feb-2022 The vial did not undergo any temperature excursions. Patient did not test positive for COVID within last month. It was reported that patient had no known drug allergies (NKDA). It was reported that HCP confirmed that the patients were not experienced any side effects yet.   This case was linked to MOD-2022-545267 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Sciatica
Clinical narrative: Developed sciatica first time in my life has been steady since booster
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Muscle twitching, Swelling
Clinical narrative: Swelling under arm into breast tissue, quivering sensation to lower lip that feels like some type of  nerve problem
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Client presented at the vaccination site on 12.15.21. Client reported she received first dose Moderna COVID vaccine on 11/16/21. She reported with first dose Moderna COVID vaccine, the next day she had a very painful muscle ache on her left arm 10/10 on a pain scale of 10 on 11/17/21 then it was a 4/10 or 5/10 daily on a pain scale of 10, where she received her injection which lasted for three weeks. She denied rash or redness on the injection site. Client reported she took Ibuprofen 400 mg twice only on 11/17/21 but didn?t take Ibuprofen after 11/17/21. Client denied any chronic illnesses or any known allergies. She stated she didn?t follow-up with her PCP. She reported the injection side muscle ache of the left arm got better last week because she didn?t use her left arm that much. She reported no other symptoms. Client is requesting to get her second dose Moderna COVID vaccine on the same left arm because she stated she needs to use her right arm in case she gets the same painful muscle ache again on her left arm. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the second dose of Moderna COVID vaccine. Per the doctor, approval to proceed with the second dose of Moderna COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the second dose of Moderna COVID vaccine, LOT#: 069H21A on 01/08/22 at 1741 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1811 unassisted and with a steady gait.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Blindness unilateral, Visual impairment
Clinical narrative: Systemic: temporary loss of vision in the right eye-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Feeling abnormal, Lethargy, Pain
Clinical narrative: Started feeling lethargic a couple of hours after the vaccine on Friday. By Friday evening, I was aching and running a low-grade fever. On Saturday, I was still lethargic and running a low-grade fever. I felt like I was probably 20 years older than I am, with knees, back and other joints hurting really bad. Started feeling better by Sunday evening. Today (Monday), I am feeling about 100%.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Started feeling lethargic a couple of hours after the vaccine on Friday. By Friday evening, I was aching and running a low-grade fever. On Saturday, I was still lethargic and running a low-grade fever. I felt like I was probably 20 years older than I am, with knees, back and other joints hurting really bad. Started feeling better by Sunday evening. Today (Monday), I am feeling about 100%.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash macular, Vomiting
Clinical narrative: Systemic: non-allergic rash, see details-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient vomiting about ~30 minutes after receiving vaccine and arrived at store showing rash (non-raised, light red spots on left hand) ~7 hours post administration (no other sx's), referred to urgent care immediately
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Crying, Dysstasia, Heart rate increased
Clinical narrative: 04/ 05/ 2022 1 month after vaccine I began having  tight of muscles in left leg numb Ness  from left butt  cheek all the way down to my acillies tendon numb on bottom of foot then knotty  muscle tissue  and tightly  tendon  un able to sit on toilet or stand on shower until I just could not stop crying Un able still to straighten leg it's still numb hurts my pelvic  to coughing  or sneezing burning sensations constant pain my heart has rapid beats laid my daughter had to wait on me hand and foot  I know what ciatica is and this is not ciatica this is very much different I have to keep the left foot under let butt cheek an lay on left side to not feel pain wakes me up constantly  feels like it's going to tighten a in 1 big not  could not move off the couch except to pee and  have to return to work I use to be able to stand for hours now minutes  before Charlie horse began to tight up  from but to foot feel shake y
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Mobility decreased, Muscle tightness, Nervousness
Clinical narrative: 04/ 05/ 2022 1 month after vaccine I began having  tight of muscles in left leg numb Ness  from left butt  cheek all the way down to my acillies tendon numb on bottom of foot then knotty  muscle tissue  and tightly  tendon  un able to sit on toilet or stand on shower until I just could not stop crying Un able still to straighten leg it's still numb hurts my pelvic  to coughing  or sneezing burning sensations constant pain my heart has rapid beats laid my daughter had to wait on me hand and foot  I know what ciatica is and this is not ciatica this is very much different I have to keep the left foot under let butt cheek an lay on left side to not feel pain wakes me up constantly  feels like it's going to tighten a in 1 big not  could not move off the couch except to pee and  have to return to work I use to be able to stand for hours now minutes  before Charlie horse began to tight up  from but to foot feel shake y
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pelvic pain, Sitting disability, Sleep disorder, Sneezing
Clinical narrative: 04/ 05/ 2022 1 month after vaccine I began having  tight of muscles in left leg numb Ness  from left butt  cheek all the way down to my acillies tendon numb on bottom of foot then knotty  muscle tissue  and tightly  tendon  un able to sit on toilet or stand on shower until I just could not stop crying Un able still to straighten leg it's still numb hurts my pelvic  to coughing  or sneezing burning sensations constant pain my heart has rapid beats laid my daughter had to wait on me hand and foot  I know what ciatica is and this is not ciatica this is very much different I have to keep the left foot under let butt cheek an lay on left side to not feel pain wakes me up constantly  feels like it's going to tighten a in 1 big not  could not move off the couch except to pee and  have to return to work I use to be able to stand for hours now minutes  before Charlie horse began to tight up  from but to foot feel shake y
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Computerised tomogram head normal, Dizziness, Paraesthesia
Clinical narrative: Burning tingling sensation on all extremities accompanied by severe dizziness. Dizziness subsided 3/10 but continues though not as severe. The tingling sensation persists on  lower extremities.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: November 24th, 2021- I went into Cardiac Arrest. I do not have a personal history of heart problems. The doctors at Hospital Center diagnosed me with Myocarditis . I have not been sick and doctors have not been able to explain why I had an inflammation of the heart or for how long.  This has never happened to me before. The only correlation is the two Covid vaccines received 2021.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Cardioversion, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: On day 1, Resting Heart Rate went from normal of 60 BPM to 95 to 105 BPM.  Rate stayed at this level 24/7 for next seven days until Cardioversion on day 7.   Note: on day 3, after some yard work, rate went to 195 BPM for about 15 minutes.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test
Clinical narrative: On day 1, Resting Heart Rate went from normal of 60 BPM to 95 to 105 BPM.  Rate stayed at this level 24/7 for next seven days until Cardioversion on day 7.   Note: on day 3, after some yard work, rate went to 195 BPM for about 15 minutes.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Body temperature increased
Clinical narrative: ATRIAL FIB, INCREASED TEMP LASTED 4 TO 6 DAYS THEN WENT AWAY
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT GIVEN EXPIRED VACCINE NO REACTION PRESENT AT TIME OF INJECTION
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site followed by rash under the elbow, both arms and spreading up the arms; taking antihistamine, anti-itch cream
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heavy menstrual bleeding, Menstruation irregular, Mental impairment
Clinical narrative: It cause my menstrual cycle to come back on after only 10 days of ending my last cycle.   I notified my doctor immediately thinking that it was just going to be spotting and it ended up being a whole entire heavy menstrual cycle that lasted around 7 to 8 days. I am very regular and never miss a beat with my menstrual cycle so I know that this was a result of receiving the booster shot 2 days prior. My concern was that I was losing a lot of blood again in such a short amount of time and it did somewhat effect my daily energy and mental acuity.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a patient under the age of 3. Contacted patient no reaction.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Joint stiffness, Joint swelling
Clinical narrative: Inflammatory arthritis with joint stiffness and swelling since January 2022, with evidence of inflammatory arthritis on recent exam, worsening over the past 3 months.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse outcome, realized vaccine expired 4/16/22 and was given on 4/18/22, verified with Moderna that dose was valid and did not need repeating.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Palpitations, POTS, complete loss of ability to live a normal life due to severe fatigue. Symptoms worsened after booster in January. My health has been destroyed.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cough, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: I started getting symptoms of fever, muscle aches, headaches, congestion, cough, and exhaustion. Rapid test was negative but my husband got a positive test. I went and got a PCR test the next day that was positive. My symptoms lasted for approximately 4 days. I did a telehealth visit and got a prescription for an inhaler to help with cough.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I started getting symptoms of fever, muscle aches, headaches, congestion, cough, and exhaustion. Rapid test was negative but my husband got a positive test. I went and got a PCR test the next day that was positive. My symptoms lasted for approximately 4 days. I did a telehealth visit and got a prescription for an inhaler to help with cough.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Electrocardiogram, Heart rate increased
Clinical narrative: Approximately 2 weeks after I got my 1st booster (3rd shot) I experienced the following symptoms: Fast heart rate. I consulted my doctor and was advised to take Eliquis and it helped with my condition. The fast heart rate lasted for about 8 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site discomfort, Muscle twitching, Pain
Clinical narrative: I had a big discoloration in my left arm at the site of the 2nd Pfizer vaccination. Every so often I have a little pain or twitch. It was purplish at the site. Left shoulder still has a funny sensation. The doctor said it was a bruise.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cautery to nose, Epistaxis, Vein rupture
Clinical narrative: I got home from my 2nd dose and about 2 hours later, I just started with a terrible nose bleed and the thing about it is that I'd never had a nose bleed in my entire life. I felt it was strange so I called my PCP who said to keep an eye. It stopped for a day and a half. Then it started couple days later while I was driving so I put a towel on it. It was fine for 2 days. Then 2 days later while out and it started pouring out again. I went to the ER who said that I had a ruptured blood vessel in my left nostril and they cartelized the vessel in my nose. My point is that it makes no sense that I had this nose bleed and happened on the same day of my vaccine. Since I went to the ER I've not had another nose bleed and have had 2 more vaccines after that.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac disorder, Dizziness, Fatigue, Pyrexia
Clinical narrative: I became very dizzy after my second dose. I was so dizzy I asked restaurant to stop preparing my food and just put something already prepared in a box for me because I was so dizzy and concerned about getting home. I had extreme pain in my spine and all of my joints. I had a fever that lasted for about 10 days. I had ringing in my ears, exhaustion and heart complications. The exhaustion and heart complications went on for months.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Tinnitus
Clinical narrative: I became very dizzy after my second dose. I was so dizzy I asked restaurant to stop preparing my food and just put something already prepared in a box for me because I was so dizzy and concerned about getting home. I had extreme pain in my spine and all of my joints. I had a fever that lasted for about 10 days. I had ringing in my ears, exhaustion and heart complications. The exhaustion and heart complications went on for months.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Patient describes red, with a little swelling, itchy, rash like .  Patient will take benadryl and contact his doctor
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 12/08/21 presents to EC ED for "Cough, dyspnea, fever". PMHx of "MVP, asthma, IBS, htn"
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID Vaccine breakthrough case. Vaccinated 5/4/21 EW0179, 5/25/21 EW0183. amd boosted on 2/10/22 FK9729.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Loud ringing onset in left ear about 2 hours after booster shot.    I have longstanding tinnitus in my left ear but this shot seems to have brought it out of a dormant state and now have loud ringing.   Would never have got this Moderna booster shot if I knew this would occur.   I had two J&J shots in 2021 and had no such problems.     There needs to be a warning about this potential side effect.  Tinnitus in no joke to the suffer.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Liver function test increased, Ultrasound liver
Clinical narrative: I was not having any symptoms except for back ache and the doctor did blood work and discovered the elevated liver function level.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: severe vomiting and diarrhea that continued for an hour and a half
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling of eyelid
Clinical narrative: In Jan, my eyelids started to swell up an spread to my entire eye when I was at home. It happened at work and I went to the doctor. They gave me eyedrops.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fear, Neuropathy peripheral, Paraesthesia
Clinical narrative: She got her vaccine, did fine, a few days later she started getting a burning sensation in her left lower leg.  All of a sudden the burning was going up and down.  She had never experienced anything like that before.  She went online and started researching the vaccine, and saw that it could be an effect from the vaccine getting into the nervous system.   After that it went into her left foot, and then traveled to her right foot which was then a continuous tingling sensation.  She was concerned because she read that it could turn into something serious.  She went to the hospital and they looked her over and said that they did not see any problem, and to come back if it got worse.  The next day it got worse, and went back to the hospital and they told her that there was nothing that they could do.  This lasted for a few weeks to a month.  She did talk to her NP about it, they did not know at that time what was happening, it was unusual coincidental.  She then talked to a friend at the gym, and had the same reaction she had, so did not feel it was a coincidence.  She then went to her chiropractor who said that he had three clients that also developed neuropathy after the vaccine.  She is a healthy woman and has never had any indications of this before and that also she talked to enough people with the same reaction.  She would feel a little tingling off and on, noticeable.  It would then be on and off, and now it is started to get much worse, sometimes keeps her up at night.  She feels like it is going from her heart to her feet, like everything in her body is tingling at times.  The most extreme part of the tingling is in her feet.  It was not as much a concern in the past, and now it is becoming unmanageable and is getting scared as she is an active person and travels world wide and does not want anything to deter her lifestyle.    She shared some of her story on the PRIVATE website.    She did get the 2nd vaccine on 3/15/21 which she did not notice any effects from other than the same from the first.  Her NP verified that she should not get the booster as she has had both of them and has such a reaction as she does react to things more than others.  She eats organic food, and is a very healthy person.    In the last 3 days her symptoms have gotten worse and will probably see a specialist for her problems.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: 04/14/2021 Vaccination; 4-6 Weeks after, I started to experience all over body hives. My hands had the hives the worst, started on my left hand, swelling. Outbreak on my L knee. I went to the dermatologist and allergist first; He prescribed me some Allegra from his office. I told him I was allergic to dye. Then I had to go on the steroids to clean that out. I was on the Allegra 4x a day, 3x a day, 2x a day for a total of 14 days. It did clear up the hives; 24 hour Allegra.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Influenza A virus test negative, Lethargy
Clinical narrative: Chills, sweats, weakness, lethargic, low grade fever.  Ibuprofen and Tylenol.  Symptoms continue after 4 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Chills, sweats, weakness, lethargic, low grade fever.  Ibuprofen and Tylenol.  Symptoms continue after 4 days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood culture positive, Blood pressure increased, Cardiac monitoring, Cardiac stress test
Clinical narrative: I had rapid heartbeat about a couple of weeks after receiving my first dose and increased blood pressure. I had insomnia and anxiety that kept me up some nights. I called my doctor who performed an EKG which showed an irregular x-ray; my doctor referred me to a cardiologist who performed an EKG, blood cultures, stress test, and echocardiogram. They all came back with irregular results so they increased the dosage of my blood pressure medication and placed me on a heart monitor for a week and half. They performed another echocardiogram and stress test for a follow-up exam about 2 months later, and the results came back well.