chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired dose stored in refrigerator/ administered expired dose to the patient; Patient received expired dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     The previous history of COVID-19 vaccination was unavailable.     In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna vaccine) and PRODUCT STORAGE ERROR (Expired dose stored in refrigerator/ administered expired dose to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received second booster dose.  The date when the vial was initially stored in the refrigerator was the same date that the dose was administered. The vial did not undergo any temperature excursions. The pharmacist thought the expiration date was 2069, like it was printed on the vial but the expiry date was 29-Apr-2022.  Treatment information was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood test, Chills, Joint swelling, Pyrexia
Clinical narrative: Right ankle swollen; Right ankle painful; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), JOINT SWELLING (Right ankle swollen) and ARTHRALGIA (Right ankle painful) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced JOINT SWELLING (Right ankle swollen) and ARTHRALGIA (Right ankle painful). At the time of the report, CHILLS (Chills), PYREXIA (Fever), JOINT SWELLING (Right ankle swollen) and ARTHRALGIA (Right ankle painful) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: showed no inflammation rheumatoid arthritis Showed no inflammation rheumatoid arthritis those markers were fantastic.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       HUMIRA(Solution for injection in pre-filled pen) was given as citrate free for moderate to severe RA.The reporter causality for events with Humira was no reasonable probability. Concomitant drugs were not reported. Treatment information was not provided. On an unknown date blood work was done which showed no inflammation, rheumatoid arthritis those markers were fantastic. It was unknown if patient was enrolled in COVID-19 clinical trial.   This case was linked to MOD-2022-570161, MOD-2022-570179 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (slightly sore right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Patient did not had COVID positive test or diagnosis.  The patient's past medical history included Premature ventricular contractions (One episode lasted two weeks and resolved. Patient had a history of experiencing PVC's. Also it occurred long time ago. No change in condition after vaccination). Previously administered products included for Drug use for unknown indication: Shingles vaccine on 04-Apr-2021 and Klonopin (she withdrew from taking Klonopin two years ago and that caused a lot of withdrawal side effects). Past adverse reactions to the above products included No adverse event with Shingles vaccine; and Withdrawal symptom with Klonopin. Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Pre-diabetic (No change in condition after vaccination) and Allergy to antibiotic (various antibiotics allergy).    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (slightly sore right arm). At the time of the report, VACCINATION SITE PAIN (slightly sore right arm) outcome was unknown.            Concomitant medications were not reported.  It was stated that the patient was not immunocompromised.   Treatment medications were not provided.   This case was linked to MOD-2022-569840, MOD-2022-570092 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Experienced parosmia immediately after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAROSMIA (Experienced parosmia immediately after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Experienced parosmia immediately after receiving the vaccine). At the time of the report, PAROSMIA (Experienced parosmia immediately after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  Patient also mentioned that he was recording the call to send it to media.  No treatment medication was provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022; Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 Vaccine on 07-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson COVID-19 Vaccine.   On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacist did not realize that it expired 29Apr2022, so she administered it to 8 patients. They were all given the second booster of 0.25 ml. These doses came from different vials, but from the same carton with lot number 042J21A. The expired doses were administered on 4May2022, 10May2022, 16May2022, and 17May2022. The pharmacist stated that she thought the expiration date was 2069, like it was printed on the vial.  The vial did not undergo any temperature excursions. Patient received first Moderna booster on 15 NOV 2021 and second Moderna booster on 10 MAY 2022.   No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: higher glucose levels/glucose has gone up 15-30 points.; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic.    On 16-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.). At the time of the report, BLOOD GLUCOSE INCREASED (higher glucose levels/glucose has gone up 15-30 points.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood glucose: high (High) Glucose has gone up 15-30 points. On an unknown date, Blood glucose: 120 (Borderline) 120 (prediabetic).     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Patient received the first Moderna COVID-19 vaccination on Monday.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-570138 (Patient Link).   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain after first dose for one day; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain after first dose for one day) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     Patient did not had any any allergy and never had covid positive test or diagnosis.  Concurrent medical conditions included Diabetes (25 year ago) and Blood pressure high. Concomitant products included INSULIN GLARGINE (TOUJEO) for an unknown indication.  On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (pain after first dose for one day). In March 2021, PAIN (pain after first dose for one day) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No treatment medications was provided by the reporter.   This case was linked to MOD-2022-570141 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was expired on 29Apr2022 and Dates the vial was initially stored in the refrigerator*: the same date that the dose was administered (17-May-2022).; expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vail was expired on 29Apr2022 and Dates the vial was initially stored in the refrigerator*: the same date that the dose was administered (17-May-2022).) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was expired on 29Apr2022 and Dates the vial was initially stored in the refrigerator*: the same date that the dose was administered (17-May-2022).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vail was expired on 29Apr2022 and Dates the vial was initially stored in the refrigerator*: the same date that the dose was administered (17-May-2022).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The primary series of the patient may have been Moderna but there was no documentation available. No concomitant medications were reported. The vial was initially stored in the refrigerator at the same date that the dose was administered. The vial did not undergo any temperature excursions. Treatment Not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.). At the time of the report, BLOOD GLUCOSE INCREASED (Experiencing higher glucose levels,After the vaccination, their glucose has gone up 15-30 points.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Blood glucose: glucose has gone up 15-30 points. Glucose has gone up 15-30 points.Patient's baseline was reported to be always under 100..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm is having a lot of pain/pain is below the vaccine part/above the joint; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 013F21A, 030A21A and 011AZ1A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in October 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (Start Date: 25 years ago) and Blood pressure high. Concomitant products included INSULIN GLARGINE (TOUJEO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; MELOXICAM for Pain, at a dose of 15 milligram once a day and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm is having a lot of pain/pain is below the vaccine part/above the joint) had not resolved.            Patient saw a doctor, who told him to do exercises and put ice.  The patient states he took Motrin the first couple of days, but was told to stop because it could bump his blood pressure up. He was prescribed a pain killer called meloxicam 15 mg to be taken one table once a day. He has been taking it every day. He is also using Voltaren topically. Symptoms are ongoing as same.   This case was linked to MOD-2022-570131 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 17-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022) outcome was unknown.            No concomitant medications were reported. It was reported that the daily dose of HUMIRA(Solution for injection in pre-filled pen) was given as citrate free. On an unknown date patient blood work was done which showed no inflammation, rheumatoid arthritis those markers were fantastic. It was unknown if patient was enrolled in COVID-19 vaccine trial. No treatment medications were provided.   This case was linked to MOD-2022-570161, MOD-2022-570179, MOD-2022-570086 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis on upper arms) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis). Concomitant products included BETAMETHASONE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis on upper arms). At the time of the report, PSORIASIS (Psoriasis on upper arms) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two) in a male 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two) outcome was unknown. No information on concomitant medication was reported. Patient had his primary series and first booster of Moderna. After the 3rd Moderna, he was laid up for a day or two with flu-like symptoms, but they weren't bad. No information on treatment medications was reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Dysgeusia
Clinical narrative: Mild case of Covid after 3 doses of Moderna Covid; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) and COVID-19 (Mild case of Covid after 3 doses of Moderna Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 vaccination.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth). On an unknown date, the patient experienced COVID-19 (Mild case of Covid after 3 doses of Moderna Covid). At the time of the report, DYSGEUSIA (Metallic taste in mouth) had not resolved and COVID-19 (Mild case of Covid after 3 doses of Moderna Covid) outcome was unknown.            No other medications, medical conditions, labs, testing was reported.  On 13 MAY 2022, after taking Paxlovid immediately within 15 minutes of taking it, patient got a metallic taste in his mouth. Also reported that he had been double vaccinated and had one booster. The metallic taste in his mouth started spontaneously after the first dose of Paxlovid and it was still ongoing.  No treatment medications were provided by the reporter. COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old male patient with  medical history of 3 doses of Moderna COVID-19 Vaccine in January, February and August 2021 who experienced the unexpected events   of COVID-19 (AESI) and DYSGEUSIA unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. On May, 13, 2022 the patient started with NIRMATRELVIR, RITONAVIR at an unspecified dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old male patient with  medical history of 3 doses of Moderna COVID-19 Vaccine in January, February and August 2021 who experienced the unexpected events   of COVID-19 (AESI) and DYSGEUSIA unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. On May, 13, 2022 the patient started with NIRMATRELVIR, RITONAVIR at an unspecified dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Symptom recurrence
Clinical narrative: Had a rebound in sympotoms and more severely since the night of 12-May-2022; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. N31m20a and 045A21A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Endometriosis, Chronic pain, Chronic fatigue, Inflammation (Chronic inflammation) and Acute bronchitis (acute/recurring bronchitis). Concurrent medical conditions included Polycystic ovarian syndrome, Fibromyalgia and Drug allergy (Hyocine).   On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 9:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022). At the time of the report, SYMPTOM RECURRENCE (Had a rebound in sympotoms and more severely since the night of 12-May-2022) had not resolved.            The patient was taking any other medications/products(unspecified) within 2 weeks of starting COVID-19 treatment.  Patient had a rebound in symptoms and more severely since the night of 12-May-2022.  Patient's health was improving and the meds helped severe sickness while taking them but the rebound seemed to be worse.  No treatment medication were provided.  Patient had a negative test after finishing the course of the med on 08-May-2022 and a negative test on 09-May-2022. The patient tested positive again on 13-May-2022.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: a lot of dental work done today and "they cut into my gums and stuff''; This spontaneous case was reported by a patient and describes the occurrence of TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff'') in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff''). At the time of the report, TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff'') outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.   It was reported that the patient had to undergo dental work on 18-May-2022 including cutting into gums and stuff. Patient stated that she had an appointment set a day after reporting for her 2nd Moderna booster dose.  No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: YF
Symptoms: Exposure via transplant, Neurological symptom, Organ transplant
Clinical narrative: Neurologic symptoms; exposure via transplant; Initial information was received on 11-May-2022 regarding an unsolicited valid serious case received from a health professional.  This case involves an Adult and unknown gender patient who experienced neurologic symptoms and had exposure via transplant after organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX  (yellow fever vaccine).  Cluster case- 2022SA176292, 2022SA177055, 2022SA177145 and 2022SA177095  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect yellow fever vaccine - solution for injection (lot number, expiration date, dose, frequency, strength not reported) via unknown route in unknown administration site.  On an unknown date the patient developed neurologic symptoms (neurological symptom) and exposure via transplant (unknown latency).   seriousness- medically significant for neurological symptom  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event neurologic symptoms.  At time of reporting, the outcome was Unknown for the events.; Sender's Comments: Sanofi company comment dated 18-May-2022: This case concerns an unknown age adult patient who had Neurologic symptoms and exposure via transplant after the organ transplant was received from an individual who had received a blood transfusion from a third individual who recently (within 1 week) was vaccinated with YF VAX. Available information is limited. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccine start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 102.0 fever, body aches, fatigue, enlarged lymph nodes, These lasted 48 hours, though enlarged lymph nodes continues at time of report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, COVID-19, Chest X-ray normal, Electrocardiogram normal, Laboratory test abnormal
Clinical narrative: Patient received moderna vaccine on 4/12/21 and 5/10/21. COVID positive on 5/9/22. Presented to ER on 5/9/22. Presented as transfer from hospital for covid 19. Labs remarkable for thrombocytopenia. EKG with NSR. CXR unremarkable. Given 1 dose of remdesivir at hospital.  CT chest angio done at hospital with lingular pneumonia, no pe, bronchitis. Repeat CT chest in 2 months to ensure resolution. Patient doing well on room air, states he is feeling much better and wanting to go home. D/c'ed with augmentin and azithromycin. Discharged on 5/10/22
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Patient received moderna vaccine on 4/12/21 and 5/10/21. COVID positive on 5/9/22. Presented to ER on 5/9/22. Presented as transfer from hospital for covid 19. Labs remarkable for thrombocytopenia. EKG with NSR. CXR unremarkable. Given 1 dose of remdesivir at hospital.  CT chest angio done at hospital with lingular pneumonia, no pe, bronchitis. Repeat CT chest in 2 months to ensure resolution. Patient doing well on room air, states he is feeling much better and wanting to go home. D/c'ed with augmentin and azithromycin. Discharged on 5/10/22
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Dyspnoea, Influenza, Influenza A virus test positive
Clinical narrative: Pfizer COVID-19 Vaccine EUA: patient reported with malaise, presyncope, productive cough, dyspnea, and nausea. Found to have AHRF  due to COVID-19 and influenza A. Received steroids, oxygen, and supportive measures. Discharged home medically stable with supplemental oxygen, steroids, and anticoagulation.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Presyncope, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Pfizer COVID-19 Vaccine EUA: patient reported with malaise, presyncope, productive cough, dyspnea, and nausea. Found to have AHRF  due to COVID-19 and influenza A. Received steroids, oxygen, and supportive measures. Discharged home medically stable with supplemental oxygen, steroids, and anticoagulation.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes, Cardiac disorder, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Increased PVC's, resting heart rate 95 - 124.  Severe rash over back and chest.  Very painful, swollen lymph node in underarm of the injection site shoulder.  Heart issue required ER trip in the  evening of 4/17.   No intervention required. Worsening rash required urgent care visit in the evening of 5/18.  Steroid and antihistamine prescribed.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Increased PVC's, resting heart rate 95 - 124.  Severe rash over back and chest.  Very painful, swollen lymph node in underarm of the injection site shoulder.  Heart issue required ER trip in the  evening of 4/17.   No intervention required. Worsening rash required urgent care visit in the evening of 5/18.  Steroid and antihistamine prescribed.
Age: 0.17
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: No known adverse reaction to receiving this vaccine Patient will have evaluation with pediatrician on 5/23 @ 10:30 am to confirm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypoxia, Iron deficiency anaemia, SARS-CoV-2 test positive
Clinical narrative: Patient received J&J vaccine on 4/30/21. Presented to ER on 5/4/22. COVID positive 5/4/22. admitted on May 5th morning with COVID-19.  Patient was originally seen in Urgent Care but due to hypoxia she was sent here.  Patient started couple this with oxygen.  Start on IV dexamethasone.  Patient also found to have iron-deficiency anemia and IV iron was ordered.  Hematology consulted.  Patient will get 5 days of IV Venofer.  Patient currently needs couple L of oxygen.  Discharged on 5/9/22
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Diaphragmatic paralysis, Echocardiogram, Electromyogram, Nerve conduction studies
Clinical narrative: Partial right Diaphramatic Paralysis
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test, X-ray
Clinical narrative: Partial right Diaphramatic Paralysis
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Oropharyngeal pain
Clinical narrative: April 30, 2022 I felt like I was a little congested like I had the start of a sinus infection.  I woke up on April 31, 2022 with more sinus pressure thought I had the start of a sinus infection. I woke up around 1am on May 1, 2022 with low grade fever around 99.0 and a sore throat. Fever continued throughout the day so I decided to take a home test and it was positive. Fever did run 99.0-100.0 on and off, sinus pressure was still there, get winded very easily and the sore throat was worse.  Called my doctor on Tuesday and she prescribed Paxlovid. Wednesday I started medication and noticed a little difference within 6 hours.  Symptoms did gradually get better. Now I do feel very fatigued and have a dry cough.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: April 30, 2022 I felt like I was a little congested like I had the start of a sinus infection.  I woke up on April 31, 2022 with more sinus pressure thought I had the start of a sinus infection. I woke up around 1am on May 1, 2022 with low grade fever around 99.0 and a sore throat. Fever continued throughout the day so I decided to take a home test and it was positive. Fever did run 99.0-100.0 on and off, sinus pressure was still there, get winded very easily and the sore throat was worse.  Called my doctor on Tuesday and she prescribed Paxlovid. Wednesday I started medication and noticed a little difference within 6 hours.  Symptoms did gradually get better. Now I do feel very fatigued and have a dry cough.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Oropharyngeal pain, Paranasal sinus discomfort, Respiratory tract congestion
Clinical narrative: On Monday morning I felt sinus pressure on the left side of my face. The feeling lasted throughout the day. I took a Sudafed when I got home from work. Over night I developed congestion and runny nose. I had to take a COVID-19 test due to the symptoms. I took an at home test which was positive. I worked from home and reached out to my doctors office. He prescribed Paxlovid. Every so often I take a Tylenol to relieve the pressure but most of the symptoms are gone. I have a little bit of a sore throat but that's all. I had no fever and very mild symptoms. I will retest on Tuesday morning after my Paxlovid is done.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On Monday morning I felt sinus pressure on the left side of my face. The feeling lasted throughout the day. I took a Sudafed when I got home from work. Over night I developed congestion and runny nose. I had to take a COVID-19 test due to the symptoms. I took an at home test which was positive. I worked from home and reached out to my doctors office. He prescribed Paxlovid. Every so often I take a Tylenol to relieve the pressure but most of the symptoms are gone. I have a little bit of a sore throat but that's all. I had no fever and very mild symptoms. I will retest on Tuesday morning after my Paxlovid is done.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient received Shingrix vaccine on a Thursday. On Saturday two days later, she noticed she had a rash on her arm (below the site of injection but not at or around the actual site). The rash persisted for a week after vaccination. It was not itchy or painful, but was warm to the touch. She ended up seeing her doctor on 4/28/22. The doctor noticed that she also had a rash on her other arm. She did not think it was an infection and concluded it may have been an allergy to a component of the vaccine but couldn't be sure. She was prescribed a course of Prednisone and the rash cleared up shortly after.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Confusional state, Cyanosis, Dizziness
Clinical narrative: Symptoms: shortness of breath, chest pain, peripheral cyanosis, lightheadedness, dizziness, increased heart rate with very minor activities (conversations, very light walking), mental confusion  Went to urgent care after my wife pointed out that I wasn't speaking coherently to her, which is when I noticed that I was short of breath and had chest pain. Urgent care believed I may have a cardiac issue from receiving the covid booster  Still having the same issues three weeks after the adverse event
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Incoherent
Clinical narrative: Symptoms: shortness of breath, chest pain, peripheral cyanosis, lightheadedness, dizziness, increased heart rate with very minor activities (conversations, very light walking), mental confusion  Went to urgent care after my wife pointed out that I wasn't speaking coherently to her, which is when I noticed that I was short of breath and had chest pain. Urgent care believed I may have a cardiac issue from receiving the covid booster  Still having the same issues three weeks after the adverse event
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Fatigue
Clinical narrative: Pt called to states that he had a event of body jerking in the evening at bedtime.  He did not experienced this with his previous doses. He states that he is okay the next day ,just tired but felt the body jerking was severe.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by state for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Computerised tomogram thorax normal, Dyspnoea, Hypoxia
Clinical narrative: Pfizer COVID-19 Vaccine EUA: presents with shortness of breath for two weeks, hypoxic necessitating supplemental oxygen, found to be COVID-19 positive. Was treated with steroids and remdesivir. Discharged  to home charge medically stable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pfizer COVID-19 Vaccine EUA: presents with shortness of breath for two weeks, hypoxic necessitating supplemental oxygen, found to be COVID-19 positive. Was treated with steroids and remdesivir. Discharged  to home charge medically stable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test normal, Burning sensation, Chest discomfort, Chest pain
Clinical narrative: tachycardia, numbness and tingling, prickles, gripping sensations in chest and diaphragm that occasionally lead to burning icy hot /acid feeling, pain in different areas of front torso, episodic tachycardia, burning/ hot flashes, weight loss associated with this, occasional pain under right ribs when eating, sensitive to temperature fluctuations, especially cold, easily chilled after episodes.  These symptoms have persisted for 7 months since vaccination with periods of wax and wane and fluctuating severity  multiple treatment trials ranging from integrative treatments using nutriceuticals, Medicine formulas, as well as conventional treatments including antihistamine therapies,  15 day course of prednisone
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmatic disorder, Echocardiogram normal, Electrocardiogram normal, Feeling cold, Hot flush
Clinical narrative: tachycardia, numbness and tingling, prickles, gripping sensations in chest and diaphragm that occasionally lead to burning icy hot /acid feeling, pain in different areas of front torso, episodic tachycardia, burning/ hot flashes, weight loss associated with this, occasional pain under right ribs when eating, sensitive to temperature fluctuations, especially cold, easily chilled after episodes.  These symptoms have persisted for 7 months since vaccination with periods of wax and wane and fluctuating severity  multiple treatment trials ranging from integrative treatments using nutriceuticals, Medicine formulas, as well as conventional treatments including antihistamine therapies,  15 day course of prednisone
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal chest pain, Paraesthesia, Tachycardia, Temperature intolerance
Clinical narrative: tachycardia, numbness and tingling, prickles, gripping sensations in chest and diaphragm that occasionally lead to burning icy hot /acid feeling, pain in different areas of front torso, episodic tachycardia, burning/ hot flashes, weight loss associated with this, occasional pain under right ribs when eating, sensitive to temperature fluctuations, especially cold, easily chilled after episodes.  These symptoms have persisted for 7 months since vaccination with periods of wax and wane and fluctuating severity  multiple treatment trials ranging from integrative treatments using nutriceuticals, Medicine formulas, as well as conventional treatments including antihistamine therapies,  15 day course of prednisone