chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID symptoms returned; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms returned) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Naproxen and all muscle relaxers (Naproxen and all muscle relaxers). Past adverse reactions to the above products included Allergy with Naproxen and all muscle relaxers. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (COVID symptoms returned). At the time of the report, COVID-19 (COVID symptoms returned) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, SARS-CoV-2 test: positive (Positive) COVID symptoms returned after paxlovid and tested  positive again.         The patient took any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. No treatment medications were reported. Company comment: This spontaneous case concerns a 40-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. There was no information regarding the first dose. On May 6, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. There was no information regarding the first dose. On May 6, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028L20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included High cholesterol (hig cholesterol, controlled with statin) and Drug allergy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to 28-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Concomitant medication information was not provided by the reporter.  On 04-May-2022, it was reported as resurgence of symptoms 6 days after last Paxlovid. Uncontrollable sneezing, runny nose and body aches. Now in 2nd full day of those, no improvement.   Device date was reported as 06-May-2022. Company comment: This spontaneous case concerns a 69-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. Additionally, Drug ineffective was also reported. The initial two doses of mRNA were administered 8 months prior to the administration of third dose Pfizer, the interval between the two doses is 29 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The date of onset of the event was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. Additionally, Drug ineffective was also reported. The initial two doses of mRNA were administered 8 months prior to the administration of third dose Pfizer, the interval between the two doses is 29 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest pain, Heart rate, Lymphadenopathy, Mobility decreased
Clinical narrative: had a sore arm with all shots of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (anti-inflammatory drugs), Food allergy (green pepper), Food allergy (garlic), Milk allergy, Food allergy (raw onions), Spice allergy (spicy food), Arthritis (50 years ago. Recent change in status-worsened), Asthma (20 years ago. Recent change in status- worsened, but not on any medications for it), Neck pain (5 years ago. Recent change in status-worsened) and Heartbeats irregular (20 years ago. Recent change in status-stable). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine). At the time of the report, VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) outcome was unknown.            The patient had never tested or diagnosed with COVID. The patient had not received other vaccines within 1 month prior to Moderna COVID-19  vaccine.  The patient had a sore arm with all shots of the Moderna vaccine. Treatment information was not provided.   This case was linked to MOD-2022-565147, MOD-2022-564313, MOD-2022-565145 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Painful respiration, Vaccination site swelling
Clinical narrative: had a sore arm with all shots of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (anti-inflammatory drugs), Food allergy (green pepper), Food allergy (garlic), Milk allergy, Food allergy (raw onions), Spice allergy (spicy food), Arthritis (50 years ago. Recent change in status-worsened), Asthma (20 years ago. Recent change in status- worsened, but not on any medications for it), Neck pain (5 years ago. Recent change in status-worsened) and Heartbeats irregular (20 years ago. Recent change in status-stable). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine). At the time of the report, VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) outcome was unknown.            The patient had never tested or diagnosed with COVID. The patient had not received other vaccines within 1 month prior to Moderna COVID-19  vaccine.  The patient had a sore arm with all shots of the Moderna vaccine. Treatment information was not provided.   This case was linked to MOD-2022-565147, MOD-2022-564313, MOD-2022-565145 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a sore arm with all shots of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (anti-inflammatory drugs), Food allergy (green pepper), Food allergy (garlic), Milk allergy, Food allergy (raw onions), Spice allergy (spicy food), Arthritis (50 years ago. Recent change in status-worsened), Asthma (20 years ago. Recent change in status- worsened, but not on any medications for it), Neck pain (5 years ago. Recent change in status-worsened) and Heartbeats irregular (20 years ago. Recent change in status-stable). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine). At the time of the report, VACCINATION SITE PAIN (had a sore arm with all shots of the Moderna vaccine) outcome was unknown.            The patient had never tested or diagnosed with COVID. The patient had not received other vaccines within 1 month prior to Moderna COVID-19  vaccine.  The patient had a sore arm with all shots of the Moderna vaccine. Treatment information was not provided.   This case was linked to MOD-2022-565147, MOD-2022-564313, MOD-2022-565145 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022; Vaccine was expired on 05-May-2022 and administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) outcome was unknown. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Total nine people were vaccinated on 06-May-2022 with Moderna vaccine lot number 084J21A and expiration date 05-May-2022. Of those, all were administered boosters doses except one who had their second dose. The vial did not undergo any temperature excursions. The expired vial was moved from the freezer to the fridge on 29-Apr-2022. The vial was stored in the refrigerator for less than a month ago. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received non-significant information narrative updated. On 11-May-2022: Significant Live follow-up appended- Date on which vial was removed from refrigeration updated
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was moved from the freezer to the fridge on 29-Apr-2022; Vaccine expired on 05-May-2022 which got administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 which got administered on 06-May-2022) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions.  Less than a month ago vial was initially stored in the refrigerator (HCP believes it was last Friday).  Concomitant drugs were not reported.  Treatment details were not given.  It was reported that they have vaccinated only nine people with Moderna on 06-May-2022. They originally thought it was 10. Of those, all were boosters except one who had their second dose.  Expired vial was moved from the freezer to the fridge on 29-Apr-2022   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Live Follow received contains non-significant information-Number of patients who received expired vaccine was reconfirmed. On 11-May-2022: Live Follow up received contains significant information: Date of refrigeration was added.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was moved from the frezeer to the fridgeon 29-Apr-2022; Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Expired vial was moved from the frezeer to the fridgeon 29-Apr-2022) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridgeon 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient took expired on 06-May-2022 which expired on 05-May-2022/people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow up received contain non significant information event verbatim has been updated. On 11-May-2022: Follow up received contain significant information, date on which vial was removed from refrigeration has been updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022; Nine people vaccinated with the expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient received the booster dose on 06-May-2022..  The vial did not undergo the temperature excursion. It was reported that they have vaccinated only nine people with Moderna on 06-May-2022.  The expired vial was moved from the freezer to fridge on 29-Apr-2022   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow received contains non-significant information-Number of patients who received expired vaccine was reconfirmed. On 11-May-2022: Follow-up received and date on which the vial moved from the freezer to the fridge was updated and event verbatim for product storage error was updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022; Nine people vaccinated with the expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (The vial expired on 05-May-2022, was moved to fridge on 29-Apr-2022 and was administered on 06-May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose on 06-May-2022. Concomitant medication list was not provided. Nine people were vaccinated on 06-May-2022.The vial was moved from the freezer to the fridge on 29-Apr-2022. The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Followup received with Updated narrative. On 11-May-2022: Followup received with added refrigeration date of the vial in the narrative.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: Rash develop on body; Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy; Red wheal all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 665K21A, 019F21A, 007M2019 and 032L20A) for COVID-19 vaccination.     Patient not tested positive for Covid and never undergone test or diagnosis for Covid.  Patient did not had known medical history. Patient did not receive other vaccine prior to the Moderna Covid-19 Vaccine.  Concurrent medical conditions included Drug allergy (it started 20 years ago) and Allergic to dogs.   On 26-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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body). The patient was treated with PREDNISONE for Rash, at a dose of UNK, qd. At the time of the report, RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body) had not resolved.        No concomitant medication was reported.  It was reported that the patient was not checked by doctor yet. Patient visited a primary care center and was asked to take prednisone daily for the rashes. Patient did not have the information of the primary health clinic.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Myalgia, Myositis, SARS-CoV-2 test
Clinical narrative: Acute myositis; weakness; difficulty standing; pain in muscles upon touch; This spontaneous case was reported by a physician and describes the occurrence of MYOSITIS (Acute myositis), ASTHENIA (weakness), DYSSTASIA (difficulty standing) and MYALGIA (pain in muscles upon touch) in an 87-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products) Patient have multiple orthopedic problems.  The patient's past medical history included COVID-19 (tested positive in Feb 2022) in February 2022. Concurrent medical conditions included Blood pressure high.    On 07-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOSITIS (Acute myositis), ASTHENIA (weakness), DYSSTASIA (difficulty standing) and MYALGIA (pain in muscles upon touch). At the time of the report, MYOSITIS (Acute myositis), ASTHENIA (weakness), DYSSTASIA (difficulty standing) and MYALGIA (pain in muscles upon touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-564775 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm was sore with all the shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (my arm was sore with all the shots) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Patient states had a huge list of allergies. There was no history of myocarditis or pericarditis reported.  Concurrent medical conditions included Arthritis (started 50 years ago, recent change in status was worsened), Asthma (started 20 years ago, recent change in status was worsened but was not on any medications for it), Neck pain (started 5 years ago, recent change in status was worsened), Heartbeats irregular (History of irregular heart beat started 20 years ago, recent change in status was stable.), Drug allergy (anti-inflammatory drugs allergy), Food allergy (green pepper allergy), Food allergy (garlic allergy), Milk allergy (milk products allergy), Food allergy (raw onions allergy) and Food allergy (spicy food allergy). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm was sore with all the shots). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (my arm was sore with all the shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient had experienced similar reaction to the flu shot many years ago.  Patient never had COVID positive test or diagnosis.   This case was linked to MOD-2022-564313, MOD-2022-565146 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm was sore with all the shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm was sore with all the shots) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     Patient did not had other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient had never tested for diagnosed with COVID. Patient had no history of COVID-19 infection and myocarditis/pericarditis. Patient had a huge list of allergies.  Concurrent medical conditions included Drug allergy (anti-inflammatory drugs), Food allergy (green pepper allergy), Food allergy (garlic allergy), Milk protein allergy (milk products allergy), Food allergy (raw onions allergy), Spice allergy (spicy food allergy), Arthritis (50 years ago and still ongoing, recent change in status was worsened.), Asthma (20 years ago and still ongoing, recent change in status was worsened.), Neck pain (5 years ago and still ongoing, recent change in status was worsened.) and Heartbeats irregular (20 years ago and still ongoing, recent change in status was stable.). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, DULOXETINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), ATORVASTATIN, TRAZODONE and LOSARTAN for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm was sore with all the shots). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (my arm was sore with all the shots) outcome was unknown. Patient had a sore arm with all shots of the Moderna vaccine.   This case was linked to MOD-2022-565146, MOD-2022-564313, MOD-2022-565145 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011f21a, 045a21a and 010a21a) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions. Patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), METFORMIN, CHLORTALIDONE (CHLORTHALIDONE), POTASSIUM (POTASIUM M), OMEPRAZOLE, AMITRIPTYLINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LACTULOSE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.). At the time of the report, AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.) had resolved.            Other concomitant medications was reported are tyrod medicine, hormone pill, doco stool softer. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient did not seek medical care and patient did not experienced any similar event in the past. Treatment medications were not reported.   This case was linked to MOD-2022-565150 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Covid-19; 6weeks before she passed.) in February 2022. Concurrent medical conditions included Latex allergy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-565183 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Swelling in the arm; A reaction like a red rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in the arm) and RASH ERYTHEMATOUS (A reaction like a red rash) in a 51-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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in the arm) and RASH ERYTHEMATOUS (A reaction like a red rash). At the time of the report, PERIPHERAL SWELLING (Swelling in the arm) and RASH ERYTHEMATOUS (A reaction like a red rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer (Open ulcer) and Prostate cancer. Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.   This case was linked to MOD-2022-565257, MOD-2022-565270 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: She also felt she couldn't catch her breath; started itching/ itching on arm; her arm started swelling; was red/ red on arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She also felt she couldn't catch her breath), VACCINATION SITE PRURITUS (started itching/ itching on arm), VACCINATION SITE SWELLING (her arm started swelling) and VACCINATION SITE ERYTHEMA (was red/ red on arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048M21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified (she already had heart issues) and COVID-19 in December 2021. Concurrent medical conditions included Latex allergy (Anything with latex), Fruit allergy (Strawberries), Fruit allergy (Pineapples), Drug allergy (Gabapentin), Drug allergy (Olanzapine), Drug allergy (Trazodone), Drug allergy (Taxodone) and Drug allergy (Haldol). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 09-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced VACCINATION SITE PRURITUS (started itching/ itching on arm), VACCINATION SITE SWELLING (her arm started swelling) and VACCINATION SITE ERYTHEMA (was red/ red on arm). On an unknown date, the patient experienced DYSPNOEA (She also felt she couldn't catch her breath). At the time of the report, DYSPNOEA (She also felt she couldn't catch her breath), VACCINATION SITE PRURITUS (started itching/ itching on arm), VACCINATION SITE SWELLING (her arm started swelling) and VACCINATION SITE ERYTHEMA (was red/ red on arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient received Pfizer vaccine as first and second dose. The injection site reactions were still there at the time of reporting. Treatment details included Triple antibiotic.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Ulcer
Clinical narrative: Open ulcer got worst; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Ulcer (Open Ulcer) and Prostate cancer. Concurrent medical conditions included Penicillin allergy (allergic to penicillin). Concomitant products included OMEPRAZOLE for Ulcer.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain). The patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE (SIFROL) ongoing since an unknown date for Ulcer, at a dose of Double twice a day for 10 days. At the time of the report, ULCER (Open ulcer got worst) and PAIN IN EXTREMITY (arm pain) outcome was unknown. After receiving his 2nd Moderna vaccine, his open ulcer got worst and 2nd shot was the worst. No treatment medication was provided.   This case was linked to MOD-2022-565213, MOD-2022-565270 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received her 2nd dose too early/received it 21 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her 2nd dose too early/received it 21 days after the 1st dose) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her 2nd dose too early/received it 21 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her 2nd dose too early/received it 21 days after the 1st dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient received second dose of the Moderna COVID-19 vaccine at 21 days interval, after the first dose. Patient was told by another pharmacist that the second dose was considered invalid due to this and should repeat the dose.  The reporter did not have any further information on the patient as patient did not receive the prior doses of the Moderna vaccine at his facility.   No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever) in a 71-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, Body temperature: 100.4 100.4 yesterday. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Took a Binex rapid test yesterday...negative. On 11-May-2022, Body temperature: 98.6 Now its just 98.6 and 99 Today 99. In May 2022, Body temperature: 101.7 101.7, 100.7 100.7 and 99.5 99.5 normal 2 days.         No concomitant medications was provided by the reporter.   Patient received 2nd booster dose Patient experienced Fever from Friday night for two and half day 101.7, 100.7, 99.5 then normal 2 days, then back up to 100.4 yesterday. on the day of reporting it was 99 and its 98.6 and No other symptoms of anything. No treatment medications was provided by the reporter.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administer a first dose of the Moderna covid19 vaccine to a  15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old) in a 15-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administer a first dose of the Moderna covid19 vaccine to a  15 year old) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: got a Moderna shot and she could not use left arm later on.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (got a Moderna shot and she could not use left arm later on.) 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 an unknown date, the patient experienced HYPOKINESIA (got a Moderna shot and she could not use left arm later on.). At the time of the report, HYPOKINESIA (got a Moderna shot and she could not use left arm later on.) outcome was unknown.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Follow up document attached.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Hives with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke out in hives). At the time of the report, URTICARIA (broke out in hives) outcome was unknown.            No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling hot, Tachycardia
Clinical narrative: After each one became hot; Tachycardic; Lightheaded; Rather weak-feeling starting approx. 10 minutes after the injection; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20a) for COVID-19 vaccination.     No allergies.  Patient never had COVID positive test or diagnosis.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection). In March 2021, FEELING HOT (After each one became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported.  No vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Approximately 10 mins after second dose, patient became hot, tachycardic then lightheaded and rather weak-feeling and lasted for approximately 30 mins. AE did not cause patient to seek medical care and patient did not experience a similar event in the past. No treatment medications were provided. This case was linked to MOD-2022-566610, MOD-2022-566670 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live significant follow up-Reporter details, patients details and dose information were added.