chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Musculoskeletal discomfort, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers; It is affecting patient from shoulder blade to their fingers/can't lay down in my arm; can't sleep; severe pain in the arm/The 'terrible pain' in the arm is still going on; could not rise my arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm), INSOMNIA (can't sleep) and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (First dose (J&J, no lot number) and was reported.) on 17-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Hypercholesterolemia, Hypertension and Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm), INSOMNIA (can't sleep) and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on). The patient was treated with MELOXICAM (MOXICAM [MELOXICAM]) at a dose of 15 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not rise my arm for 3 days), MUSCULOSKELETAL DISCOMFORT (Patient cannot lay down in that shoulder or sleep/It is affecting patient from shoulder blade to their fingers), LIMB DISCOMFORT (It is affecting patient from shoulder blade to their fingers/can't lay down in my arm) and INSOMNIA (can't sleep) outcome was unknown and VACCINATION SITE PAIN (severe pain in the arm/The 'terrible pain' in the arm is still going on) had not resolved.            Concomitant medications includes stomach pill, cholesterol medicine, blood pressure medicine, heart medicine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer (patient's mother), describes the occurrence of vaccination complication (side effects from the Moderna booster ten days after) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (side effects from the Moderna booster ten days after). At the time of the report, vaccination complication (side effects from the Moderna booster ten days after) outcome: unknown. Reporter stated her daughter had side effects from the Moderna booster after ten days. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Her right arm is sore/Her arm continues to hurt even at rest; Her right arm felt heavy; In pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A and 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site). At the time of the report, PAIN IN EXTREMITY (Her right arm is sore/Her arm continues to hurt even at rest), LIMB DISCOMFORT (Her right arm felt heavy) and VACCINATION SITE PAIN (In pain at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         The  concomitant medications on use were not provided.  The patient stated that the pain seemed to go away then comes back. It was gotten worse.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza
Clinical narrative: flu; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and INFLUENZA (flu) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.  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. On 10-Jan-2022, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced INFLUENZA (flu). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID) and INFLUENZA (flu) outcome was unknown.  No medical history information was reported.  Concomitantly, the patient was also taking unknown heart medication.  Reportedly, the patient did not have the administration dates and the lot number of Moderna shots because she did not have the vaccination card with her.  The patient received Tylenol as corrective treatment for the event COVID. Treatment information for the event flu was not reported by the reporter.  Company comment:  This case concerns a 55-year-old female patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided .  No further details were provided. Lack of efficacy not captured due to unspecified time between doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 55-year-old female patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately after the 2nd dose of the mRNA-1273 however, the exact time to onset was not provided .  No further details were provided. Lack of efficacy not captured due to unspecified time between doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: They gave the booster on 27-Oct-2021 instead of the additional dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (They gave the booster on 27-Oct-2021 instead of the additional dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart transplant.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (They gave the booster on 27-Oct-2021 instead of the additional dose). At the time of the report, ACCIDENTAL UNDERDOSE (They gave the booster on 27-Oct-2021 instead of the additional dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow-up received contains Non-significant information.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 22-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was reported he heard while he was at his cardiologist's office a female experienced myocarditis after receiving the Moderna COVID-19 vaccine.  No treatment drugs were reported.  Company comment:This Spontaneous case concerns a 22-years-old male patient with no medical history reported, who experienced the expected serious AESI event of Myocarditis (seriousness criteria medically significant) The event Myocarditis occurrence was unknown with respect to the non-specified dose of mRNA-1273 vaccine received on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 22-years-old male patient with no medical history reported, who experienced the expected serious AESI event of Myocarditis (seriousness criteria medically significant) The event Myocarditis occurrence was unknown with respect to the non-specified dose of mRNA-1273 vaccine received on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: received a booster dose  syringe that was prefilled on Friday 18Feb2022 and that was conserved refrigerated the whole time; Patient received 2 booster doses within 2 months apart; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a booster dose  syringe that was prefilled on Friday 18Feb2022 and that was conserved refrigerated the whole time) and EXTRA DOSE ADMINISTERED (Patient received 2 booster doses within 2 months apart) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 066F21A, 006B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Feb-2022 at 8:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a booster dose  syringe that was prefilled on Friday 18Feb2022 and that was conserved refrigerated the whole time) and EXTRA DOSE ADMINISTERED (Patient received 2 booster doses within 2 months apart). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a booster dose  syringe that was prefilled on Friday 18Feb2022 and that was conserved refrigerated the whole time) and EXTRA DOSE ADMINISTERED (Patient received 2 booster doses within 2 months apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received all the doses of the Moderna Covid-19 vaccine in her Deltoid muscle. The refrigeration date of the Booster Dose provided by the patient was 10-Dec-2021. Patient received first dose(0.50ml) on 08-Mach-2021 Patient received second dose (0.50ml) on 05-April-2021 Patient received booster dose(0.25ml) on 02-Dec-2021 Patient received extra booster dose( 0.25ml) on 22-Feb-2022  Patient Dose administered >12/24 hours post puncture (MEDICAL AFFAIRS) and Dose administered after 30-day Use.  The vial was initially stored in the refrigerator on 10-Dec-2021 The vial was first punctured on 18-Feb-2022 ,Friday 2pm. Patient administered vaccine on  22-Feb-2022, 8:30am. The vial did not undergone with  any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) The vial was always refrigerated   No concomitant medication information provided. No treatment medication information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Heart rate, Heart rate abnormal
Clinical narrative: Feeling horrible/she is laying low, "feels crappy"; Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip; Gets sore spot on the chest and hurts a bit; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 15-Mar-2021. Past adverse reactions to the above products included No adverse reaction with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hyperthyroidism (since many years), Vasculitis (since 7 years but does not take any treatment), Penicillin allergy and Allergic reaction to antibiotics (Sulfa and cipro). Concomitant products included LEVOTHYROXINE for Hyperthyroidism.    On 20-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2022, the patient experienced FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy). At the time of the report, FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2022, Heart rate: 52-106 (abnormal) 52 to 106. On 20-Feb-2022, Oxygen saturation: 95 (normal) oxygen level is good at 95.         The patient had not experienced any symptoms like this before receiving the Moderna COVID-19 vaccine. The patient had no history of COVID-19 infection or myocarditis/pericarditis. The patient thought the cause of adverse events was the booster shot and the clinical outcome was unknown.  No treatment medications was taken at the time of the report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: Feeling horrible/she is laying low, "feels crappy"; Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip; Gets sore spot on the chest and hurts a bit; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 15-Mar-2021. Past adverse reactions to the above products included No adverse reaction with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hyperthyroidism (since many years), Vasculitis (since 7 years but does not take any treatment), Penicillin allergy and Allergic reaction to antibiotics (Sulfa and cipro). Concomitant products included LEVOTHYROXINE for Hyperthyroidism.    On 20-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2022, the patient experienced FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy). At the time of the report, FEELING ABNORMAL (Feeling horrible/she is laying low, "feels crappy"), HEART RATE ABNORMAL (Heart rate keeps going up from 52 to 106/Heart rate went funny again/it is 52 now but went up to 79 during a restroom trip), CHEST PAIN (Gets sore spot on the chest and hurts a bit) and DIZZINESS (Feeling dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2022, Heart rate: 52-106 (abnormal) 52 to 106. On 20-Feb-2022, Oxygen saturation: 95 (normal) oxygen level is good at 95.         The patient had not experienced any symptoms like this before receiving the Moderna COVID-19 vaccine. The patient had no history of COVID-19 infection or myocarditis/pericarditis. The patient thought the cause of adverse events was the booster shot and the clinical outcome was unknown.  No treatment medications was taken at the time of the report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that number of doses per vial was nine doses. The vials did not undergo any temperature excursions. The dates and number of doses which was administered are as follows: on 03-Jan-2022 4 doses was administered, on 04-Jan-2022 2 doses was administered, on 06-Jan-2022 2 doses was administered and on 11-Jan-2022 1 dose was administered. No concomitant and treatment drugs were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: all three sites were he have the injection are swelling; sore/ painful/ all three sites were he have the injection are sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful). At the time of the report, VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful) had not resolved.            No concomitant products were reported.   Patient received the booster dose.  No treatment information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: annoying sweats at night/woke up completely sweaty; light tingle on the shot area; The vaccine is making him feel worse than the illness; swelling in the lymph nodes of his neck/feels like if a grape is in there; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A and 032H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2022, the patient experienced HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm). At the time of the report, HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No Treatment medications were reported. It was reported that patient was absolutely certain that he will not get a booster dose of the Vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: annoying sweats at night/woke up completely sweaty; light tingle on the shot area; The vaccine is making him feel worse than the illness; swelling in the lymph nodes of his neck/feels like if a grape is in there; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084521A and 032H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2022, the patient experienced HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm). At the time of the report, HYPERHIDROSIS (annoying sweats at night/woke up completely sweaty), VACCINATION SITE PARAESTHESIA (light tingle on the shot area), FEELING ABNORMAL (The vaccine is making him feel worse than the illness), LYMPHADENOPATHY (swelling in the lymph nodes of his neck/feels like if a grape is in there) and VACCINATION SITE PAIN (pain in the left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No Treatment medications were reported. It was reported that patient was absolutely certain that he will not get a booster dose of the Vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Confusional state
Clinical narrative: patient is very confused; instead of a full additional dose he only received a half dose(booster dose); This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (patient is very confused) and ACCIDENTAL UNDERDOSE (instead of a full additional dose he only received a half dose(booster dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (instead of a full additional dose he only received a half dose(booster dose)). On an unknown date, the patient experienced CONFUSIONAL STATE (patient is very confused). At the time of the report, CONFUSIONAL STATE (patient is very confused) and ACCIDENTAL UNDERDOSE (instead of a full additional dose he only received a half dose(booster dose)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: 10 to 12 hours after her second Moderna Covid-19 vaccine achiness; 10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever; 10 to 12 hours after her second Moderna Covid-19 vaccine chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills). At the time of the report, PAIN (10 to 12 hours after her second Moderna Covid-19 vaccine achiness), PYREXIA (10 to 12 hours after her second Moderna Covid-19 vaccine low grade fever) and CHILLS (10 to 12 hours after her second Moderna Covid-19 vaccine chills) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Skin discolouration, Swelling
Clinical narrative: towards the back of her arm she saw two little marks/ One was perfectly round and red; towards the back of her arm she saw two little marks/ One was light colored; She did have some swelling; warm to the touch; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 003F21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS (diagnosed at age 40). Concomitant products included LIOTHYRONINE for Thyroid disorder NOS, MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE (COQ-10) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-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 ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch). At the time of the report, ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated everything seems to be on track so far and she had routine bloodwork due in August. Patient called her doctor to know if it was okay to take something for her side effects.  No treatment medication were provided.   This case was linked to MOD-2022-492176 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: administer the vaccine from a vial that stay >24 hours at room temperature; administer the vaccine from a vial that stay >24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033k21-2a and 033h21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Recent change in status such as improvement or worsening really high on diabetes).   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2022 at 2:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine from a vial that stay >24 hours at room temperature) and PRODUCT TEMPERATURE EXCURSION ISSUE (administer the vaccine from a vial that stay >24 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that they left a vial open on 21 Feb 2021 at 1:19PM and on 22 Feb 2022 at 2:10 PM they administered the vaccine from that vial. Initially the vial was stored in the refrigerator on 18 Feb 2022. The vial were moved from freezer to refrigerator on 21 Feb 2022. Total amount of time the vial was exposed to room temperature ranged 25 hours 8 to 25 degree Celsius/46 to 77 Fahrenheit. The vials were returned to the maintained at room temperature.   This case was linked to MOD-2022-492698 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered 24 hours post puncture; Dose administered 24 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with Booster Dose. The vial was initially stored in the refrigerator on 20-Feb-2022 Date and time vial was first punctured was on 21-Feb-2022 at 11:01 AM The vial stored post puncture was at Room Temperature The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range was (8 Degree to 25 Degree celsius that equals 46 Degree Fahrenheit  to 77 Degree Fahrenheit )-24 hours and 29 Minutes.  No concomitant medication details was provided. No treatment medication details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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 EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The health care professional (HCP) wanted to know what the protocol was for this situation and if the doses were viable or not. The nurse had not the whole information for the 606 doses so they would gather everything in a spreadsheet (including patient information). HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. It was reported that the nurse wanted to know if Moderna had the following lot number 041C21A.There was no product complaint associated. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 10 hours after the booster dose the patient had a low grade fever; 10 hours after the booster dose the patient had  achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness). At the time of the report, PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness) outcome was unknown.            No Concomitant medication reported.  The patient reports no Adverse events After first dose. Paitent self  reported as  not Immunocompromised.  Patient received Vaccine  in her right arm shoulder deltoid muscle.  No treatment medication reported.   This case was linked to MOD-2022-491822 (Patient Link).   Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 2 weeks after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the first dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A and 007J212A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given >35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 044D21A and 3002179) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days after 1st dose) outcome was unknown.  Concomitant medications were not reported. Treatment medications were not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  The patient's past medical history included Stent insertion NOS (The patient was doing great after receiving the stent.) on 14-Feb-2020. Concurrent medical conditions included Blood pressure high (The patient was suffering with high blood pressure for his entire life and no changes was reported), Heart disease, unspecified (no changes was reported) and Angina pectoris (The patient reported improvement.).  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   The patient had no allergies (medications, food and other products). The patient had both acute and chronic illnesses at the time of vaccination.  Concomitantly, the patient was taking bunch of medicines (no specific medication was reported).  The patient did not seek medical care for the event. It was unknown if the patient experienced a similar event in the past. The patient reported that he received other vaccines during his lifetime (beside Moderna COVID-19) and never had a problem with any of them.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491816 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administered a dose after the 30 days use-by date in the refrigerator) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022J21A) for COVID-19 immunization. No medical history reported. On Feb 22, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 22, 2022, patient administered expired product (administered a dose after the 30 days use-by date in the refrigerator). At the time of the report, administered expired product (administered a dose after the 30 days use-by date in the refrigerator) outcome: unknown. The vial initially stored in the refrigerator on Jan 20, 2022. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture; dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture) and PRODUCT STORAGE ERROR (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture) and PRODUCT STORAGE ERROR (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture) and PRODUCT STORAGE ERROR (dose administered greater than 24 hours at room temperature/ dose administered after more then 12 hours from first puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A vial was removed from freezer and transferred to refrigerator on 08-Feb-2022. It was then removed from the refrigerator and first punctured on 16-Feb at 0930hours and remained at room temperature thereafter. A dose was administered on 17-Feb at 1400hours.   No concomitant medications were reported.  No treatment information was reported.