chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Influenza like illness, Pain, Pyrexia
Clinical narrative: Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions; Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day; Sore arm; Felt slightly tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions), INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported by reporter.  It was reported after taking Ibuprofen or Tylenol (pain reducer) patient slept through night and felt fine after waking up next morning.   This case was linked to MOD-2022-607286, MOD-2022-607284 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Immunisation reaction, Influenza like illness
Clinical narrative: Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions; Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day; Sore arm; Felt slightly tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions), INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported by reporter.  It was reported after taking Ibuprofen or Tylenol (pain reducer) patient slept through night and felt fine after waking up next morning.   This case was linked to MOD-2022-607286, MOD-2022-607284 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions; Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day; Sore arm; Felt slightly tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions), INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported by reporter.  It was reported after taking Ibuprofen or Tylenol (pain reducer) patient slept through night and felt fine after waking up next morning.   This case was linked to MOD-2022-607286, MOD-2022-607284 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Influenza like illness, Pain in extremity
Clinical narrative: Reacted pretty strongly to all Moderna doses I got; Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms; got really achy; 8 hours after the second dose I spiked a fever of 100F; chills; joints were painful; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got), INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), CHILLS (chills) and ARTHRALGIA (joints were painful). 10-Apr-2021, the patient experienced PYREXIA (8 hours after the second dose I spiked a fever of 100F). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F), CHILLS (chills) and ARTHRALGIA (joints were painful) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100°F.         No concomitant medications were reported.   This case was linked to MOD-2022-607280, MOD-2022-607286 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Influenza like illness, Pain, Pyrexia
Clinical narrative: Reacted pretty strongly to all Moderna doses I got; Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms; got really achy; 8 hours after the second dose I spiked a fever of 100F; chills; joints were painful; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got), INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), CHILLS (chills) and ARTHRALGIA (joints were painful). 10-Apr-2021, the patient experienced PYREXIA (8 hours after the second dose I spiked a fever of 100F). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F), CHILLS (chills) and ARTHRALGIA (joints were painful) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100°F.         No concomitant medications were reported.   This case was linked to MOD-2022-607280, MOD-2022-607286 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Immunisation reaction, Influenza like illness
Clinical narrative: Reacted pretty strongly to all Moderna doses I got; Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms; got really achy; 8 hours after the second dose I spiked a fever of 100F; chills; joints were painful; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got), INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), CHILLS (chills) and ARTHRALGIA (joints were painful). 10-Apr-2021, the patient experienced PYREXIA (8 hours after the second dose I spiked a fever of 100F). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F), CHILLS (chills) and ARTHRALGIA (joints were painful) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100°F.         No concomitant medications were reported.   This case was linked to MOD-2022-607280, MOD-2022-607286 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Reacted pretty strongly to all Moderna doses I got; Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms; got really achy; 8 hours after the second dose I spiked a fever of 100F; chills; joints were painful; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got), INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), CHILLS (chills) and ARTHRALGIA (joints were painful). 10-Apr-2021, the patient experienced PYREXIA (8 hours after the second dose I spiked a fever of 100F). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 2 days/flu like symptoms for just about a day/flu like symptoms), PAIN (got really achy), PYREXIA (8 hours after the second dose I spiked a fever of 100F), CHILLS (chills) and ARTHRALGIA (joints were painful) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses I got) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 100°F.         No concomitant medications were reported.   This case was linked to MOD-2022-607280, MOD-2022-607286 (Patient Link).
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial) in an 11-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 059M21A) for COVID-19 immunization. No medical history reported. On Jul 12, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 12, 2022, patient had incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial). At the time of the report, incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial); This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric patients might have received adult Moderna COVID-19 vaccine (Red Cap Vial)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to INC.-MOD-2022-607276 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2022-607276:MOD-2022-607283(9 year old patient)same reporter
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received the first dose of the vaccine as a booster (Half dose); This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)). At the time of the report, UNDERDOSE (Patient received the first dose of the vaccine as a booster (Half dose)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. A patient received the first dose of the vaccine as a booster (Half dose). The second dose was a full dose. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Chest discomfort, Chest pain, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (still feels a pressure on her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 010M20A and 013L20A) for COVID-19 prophylaxis. The patient's past medical history included Suspected COVID-19 (Not sure but may have had in February or March of 2020. Treatment received: antibiotics) in 2020. Concurrent medical conditions included Blood pressure high. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-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 CHEST PAIN (chest pain) and CHEST DISCOMFORT (still feels a pressure on her chest). The patient was treated with ROSUVASTATIN for High cholesterol, at a dose of 5 milligram once a day. At the time of the report, CHEST PAIN (chest pain) outcome was unknown and CHEST DISCOMFORT (still feels a pressure on her chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2022, Magnetic resonance imaging: could not find a cause. On an unknown date, Blood cholesterol: had high cholesterol. Concomitant product use was not provided by the reporter. The patient experienced chest pain within the last few weeks of this report. She went to see her cardiologist 2 weeks ago, was told she had high cholesterol and was put on Rosuvastatin 5mg daily. She went to the ER due to the chest pains a day before the date of this report, they did an MRI and they could not find a cause. She still felt a pressure on her chest. This case was linked to MOD-2022-607259 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: severe adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (severe adverse reaction). At the time of the report, IMMUNISATION REACTION (severe adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.             No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long hauler COVID/ I am suffering from LHC and it is crippling; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long hauler COVID/ I am suffering from LHC and it is crippling) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05; Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05; This spontaneous case was reported by a non-health professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) and UNDERDOSE (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) and UNDERDOSE (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) and UNDERDOSE (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) outcome was unknown.            No concomitant medication was reported by reporter.  Patient got booster dose.  No treatment medication was reported by reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: First dose 15-Apr-2021 and second dose on 05-Jul-2021; Since May 2021 I have had no lumps under my right arm. Since August 2021 I have had no lumps under my left arm.; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Since May 2021 I have had no lumps under my right arm. Since August 2021 I have had no lumps under my left arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 15-Apr-2021 and second dose on 05-Jul-2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hidradenitis suppurativa (Patient had it from29 years, under both arms (armpits) and groin.).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Since May 2021 I have had no lumps under my right arm. Since August 2021 I have had no lumps under my left arm.). On 05-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 15-Apr-2021 and second dose on 05-Jul-2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Since May 2021 I have had no lumps under my right arm. Since August 2021 I have had no lumps under my left arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 15-Apr-2021 and second dose on 05-Jul-2021) outcome was unknown.            Patient reported taking Antibiotics 4 times a day as patient still was suffering with the lumps in groin.  The patient had reported have been suffering with Hidradenitis Suppurativa for 29 years. Its under both arms (armpits) and groin. Patient reported  since May-2021, patient had no lumps under right arm and since Aug-2021 patient had no lumps under left arm. Patient was still suffering with the lumps in groin. Patient had the sweat glands removed from groin already.  Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Dysphagia, Gait inability
Clinical narrative: I had another episode of weakness; slurred speech; unable to drink; couldn't walk; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk). At the time of the report, ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk) outcome was unknown.            No concomitant medication was reported. Patient reported that prior to this episode it had been at least 6 months since the last episode. No treatment information was reported.   This case was linked to MOD-2021-101864, MOD-2021-101869 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tolosa-Hunt syndrome
Clinical narrative: Tolosa-Hunt syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE: Tolosa-Hunt syndrome presenting after COVID-19 vaccination. Cureus;13(7):e16791     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,  after starting mRNA-1273 (Spikevax), the patient experienced TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) (seriousness criterion medically significant). At the time of the report, TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TOLOSA-HUNT SYNDROME (Tolosa-Hunt syndrome) to be related.    Concomitant and treatment medications were not reported.  Patient had Tolosa-Hunt syndrome (THS), a granulomatous inflammatory process of the cavernous sinus, occurring in a patient one week after getting COVID-19 vaccination. Reported that this rare diagnosis of exclusion must be considered in patients presenting with painful ophthalmoplegia.  Company Comment: This is a literature-non-study case concerning  a  45-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Tolosa-Hunt Syndrome. The event occurred on an unknown day after the unspecified dose of mRNA-1273  Vaccine which was administered on an unknown date. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a literature-non-study case concerning  a  45-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Tolosa-Hunt Syndrome. The event occurred on an unknown day after the unspecified dose of mRNA-1273  Vaccine which was administered on an unknown date. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: diarrhea; tired; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) and FATIGUE (tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A, 048C21A, 047B21A and 046A21A) for COVID-19 vaccination.     The patient had no allergies. The patient did not have COVID positive test or diagnosis.  Concurrent medical conditions included Skin disorder NOS (history of skin, many years before the 1st dose of Moderna vaccine) and Blood pressure abnormal (history of blood pressure many years before the 1st dose of Moderna vaccine). Concomitant products included HYDROCHLOROTHIAZIDE and ATENOLOL for Blood pressure abnormal, METHOTREXATE for Skin disorder NOS.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and FATIGUE (tired). At the time of the report, DIARRHOEA (diarrhea) and FATIGUE (tired) outcome was unknown.            The patient reported that 3 days later, after receiving the 2nd booster she had diarrhea and was tired. The patient also reported that she did not have any other side effects.   The patient reported that she had a mammogram scheduled on 15-Aug-2022.   The patient did not receive any treatment for the events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The side effects that both my husband and I experienced lasted about 2 days.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had medical challenges.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.). At the time of the report, IMMUNISATION REACTION (The side effects that both my husband and I experienced lasted about 2 days.) had resolved.            No concomitant medications were reported.  The patient was a senior and stated that they received 3 doses of Moderna COVID-19 vaccine so far, 2 primary and 1 booster dose. The patient's third and last Moderna shot was in Oct-2021, 9 months ago. The patient and their husband experienced the side effects which lasted about 2 days and they got over it. It was also reported that patient was still working.  No treatment information was provided by the reporter.   This case was linked to -MOD-2022-607724 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Live Follow-up received contains non significant information: Reporter phone number was added.; Sender's Comments:  -MOD-2022-607724:Crosslinked (Husband case) (Same Reporter)
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Immunisation reaction
Clinical narrative: Patient had side effects after moderna covid-19 vaccination; Patient stated that the 3rd shot was the same as the 2nd shot.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Patient had side effects after moderna covid-19 vaccination) and ACCIDENTAL OVERDOSE (Patient stated that the 3rd shot was the same as the 2nd shot.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced IMMUNISATION REACTION (Patient had side effects after moderna covid-19 vaccination) and ACCIDENTAL OVERDOSE (Patient stated that the 3rd shot was the same as the 2nd shot.). In 2021, IMMUNISATION REACTION (Patient had side effects after moderna covid-19 vaccination) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (Patient stated that the 3rd shot was the same as the 2nd shot.) outcome was unknown.            Patient age was reported as 70 plus or senior.  Reporter stated that the last shot was administered about 9 months ago.  No concomitant medications were reported.  It was stated that patient travel a lot.  No treatment medications were reported.   This case was linked to MOD-2022-607723 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Follow up received contains significant information updated reporter's phone number and narrative was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Apr-2021 and Pfizer on 09-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known allergies. Acute illness and Chronic illnesses at the time of vaccination and up to one month before was reported as unknown.  Concomitant medications details were not reported by the reporter.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as none.  It was reported that patient had received three doses of Moderna and two doses of Pfizer one day after and wants a booster dose. The patient had received first dose of the Moderna on the 18-Mar-2021, the second dose on the 20-Apr-2021. And then a first Pfizer dose on the 21-Apr-2021, a second Pfizer dose on the 09-Jun-2021, and a first booster dose of Moderna on the 07-Sep-2021.  Treatment details were not reported by the reporter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 1:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 1:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was administered with First Booster. Date the vial was initially stored in the refrigerator was reported as unknown. The vial was stored post puncture at Room temperature in the Pyxis machine. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-607743 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am; patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 9:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that patient was administered with second Booster.  It was unknown when vial was initially stored in the refrigerator. The vial was first punctured at 30-Jun-2022 at 10 AM and the vaccine was administered on 01-Jul-2022 at 9.50 AM.  The vial was stored post puncture in room temperature in the Pyxis machine.  The vial did not undergo any temperature excursion.  For roughly 24 hours vial was exposed to room temperature range.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of vaccine after 35 days of first dose; This spontaneous case was reported by a physician assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 007C21A) for COVID-19 prophylaxis.     It was reported that the patient did not have any allergies to medication, food and other products.Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Patient did not experienced a similar event in the past.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of vaccine after 35 days of first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   This case was linked to MOD-2022-607744 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 80-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no pre-existing condition. Concomitant product use was not provided by the reporter. It was reported that expired vaccine was administered to the patient as first booster day after it's expiration. Treatment information was not provided.