chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: Brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant). At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed) was resolving.            Patient had two shots of the Moderna COVID-19 vaccine and they were going to go for the booster dose,  had brain bleed after the moderna shots, reporter does not have the dates and the patient goes to his doctor on the 30Nov2021.  Patient was getting over brain bleed and has been cleared for the seizure medication.  Concomitant product use was not provided by the reporter.   Treatment medication included seizure medication.  Company comment: This is a spontaneous case concerning a 90-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Cerebral haemorrhage. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. It was reported that patient experienced brain bleed after the Moderna shots, he's just getting over and has been cleared for the seizure medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 90-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of Cerebral haemorrhage. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. It was reported that patient experienced brain bleed after the Moderna shots, he's just getting over and has been cleared for the seizure medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood pressure measurement, Heart rate, Hot flush, Inflammation
Clinical narrative: Muscle weakness and twitching; Muscle weakness and twitching; Tingling in hands feet; Significant inflammation (arm is falling asleep at night) in back; Hot flashes, By the end of the month hot flashes every night; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 042B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUCONAZOLE, VALACICLOVIR HYDROCHLORIDE (VALTREX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HOT FLUSH (Hot flashes, By the end of the month hot flashes every night). In September 2021, the patient experienced PARAESTHESIA (Tingling in hands feet) and INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back). In October 2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching). The patient was treated with BUSPIRONE for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and DICLOFENAC for Adverse event, at a dose of 1 dosage form. At the time of the report, HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antinuclear antibody: positive (Positive) ANA test came back positive.. In September 2021, Blood pressure measurement: 147/90 - 150/100 (High) Blood pressure started going up as well to the 147/90 150/100 range. In September 2021, Heart rate: 120 (High) Heart rate spiking to 120.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken buspirone as treatment drug HCPs, thought it was anxiety.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Paraesthesia
Clinical narrative: Muscle weakness and twitching; Muscle weakness and twitching; Tingling in hands feet; Significant inflammation (arm is falling asleep at night) in back; Hot flashes, By the end of the month hot flashes every night; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 042B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUCONAZOLE, VALACICLOVIR HYDROCHLORIDE (VALTREX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HOT FLUSH (Hot flashes, By the end of the month hot flashes every night). In September 2021, the patient experienced PARAESTHESIA (Tingling in hands feet) and INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back). In October 2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching). The patient was treated with BUSPIRONE for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and DICLOFENAC for Adverse event, at a dose of 1 dosage form. At the time of the report, HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antinuclear antibody: positive (Positive) ANA test came back positive.. In September 2021, Blood pressure measurement: 147/90 - 150/100 (High) Blood pressure started going up as well to the 147/90 150/100 range. In September 2021, Heart rate: 120 (High) Heart rate spiking to 120.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken buspirone as treatment drug HCPs, thought it was anxiety.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Off label use
Clinical narrative: Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered; Bell's Palsy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy symptoms) and OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy symptoms). On an unknown date, the patient experienced OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered). At the time of the report, BELL'S PALSY (Bell's Palsy symptoms) and OFF LABEL USE (Patient hasn't been able to receive the second dose because she was recommended not to until she was fully recovered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  10-Jun-2021, Patient started to develop bell's Palsy symptoms.  11-Jun-2021, She went to the doctor who confirmed the diagnosis.   It was reported that patient has not been able to receive the second dose because she was recommended not to until she was fully recovered. Patient still has some numbness and a little weakness, not 100 percent recovered  No treatment medication were provided.  Company comment: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of Bell's palsy. Off label use (LLT: Off label dosing frequency) was considered as an additional event. The event occurred approximately 17 days after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the non serious unexpected an agency of Bell's palsy. Off label use (LLT: Off label dosing frequency) was considered as an additional event. The event occurred approximately 17 days after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient is 15 and was given the first dose of the Moderna Covid19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A patient is 15 and was given the first dose of the Moderna Covid19 Vaccine.) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A patient is 15 and was given the first dose of the Moderna Covid19 Vaccine.). On 21-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A patient is 15 and was given the first dose of the Moderna Covid19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Illness, Myalgia, Vaccination site pain
Clinical narrative: feels cold; all body hurts; had pain where shot was given; felt weak / very weak; ill; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feels cold), ILLNESS (ill), ASTHENIA (felt weak / very weak), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 77C21A and 012B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-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 November 2021, the patient experienced ILLNESS (ill). On 17-Nov-2021, the patient experienced ASTHENIA (felt weak / very weak). On 18-Nov-2021, the patient experienced FEELING COLD (feels cold), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feels cold), ILLNESS (ill), ASTHENIA (felt weak / very weak), MYALGIA (all body hurts) and VACCINATION SITE PAIN (had pain where shot was given) had not resolved.            Concomitant drugs were not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Speech disorder, Swollen tongue
Clinical narrative: Now throat feels kind of enlarged; It is hard to talk; Started feeling that something was wrong with tongue/It was larger on one side than the other; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other), PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341-214) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other). On 18-Nov-2021, the patient experienced PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk). At the time of the report, SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other) was resolving and PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk) outcome was unknown.            Relevant concomitant medications were not reported. Treatment information was not provided.  Company comments include This case concerns a 83-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected events swollen tongue,  pharyngeal swelling, and speech disorder. The events occurred  two days after third dose of mRNA 1273 vaccine. The patient felt her tongue was larger on one side, and throat was enlarged so patient had difficulty speaking. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 83-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected events swollen tongue,  pharyngeal swelling, and speech disorder. The events occurred  two days after third dose of mRNA 1273 vaccine. The patient felt her tongue was larger on one side, and throat was enlarged so patient had difficulty speaking. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm after first moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028421A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm after first moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitants and Treatment medications were reported.   This case was linked to MOD-2021-390789 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder injury (In Mar-2021 had surgery to remove it) from January 2021 to March 2021. Concurrent medical conditions included Asthma (Severe asthma), Acid reflux (esophageal), Anxiety and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, PANTOPRAZOLE for Acid reflux (esophageal), APIXABAN (ELIQUIS) for Anticoagulant therapy, BUSPIRONE for Anxiety, LEVOTHYROXINE, ESTRADIOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALBUTEROL [SALBUTAMOL] and BUDESONIDE for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            Concomitant medication included cholesterol medication. The patient was taking heat as a treatment.   This case was linked to MOD-2021-390768, MOD-2021-390776 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: very ill at the moment; throwing up to the point of not being able to keep water in; having joint aches; injection site is red; injection site is red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill at the moment), VOMITING (throwing up to the point of not being able to keep water in), ARTHRALGIA (having joint aches), INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is red and swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021 at 7:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ILLNESS (very ill at the moment), VOMITING (throwing up to the point of not being able to keep water in), ARTHRALGIA (having joint aches), INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is red and swollen). At the time of the report, ILLNESS (very ill at the moment), VOMITING (throwing up to the point of not being able to keep water in), ARTHRALGIA (having joint aches), INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination complication
Clinical narrative: loosey; flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (loosey) and INFLUENZA (flu symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (loosey) and INFLUENZA (flu symptoms). At the time of the report, VACCINATION COMPLICATION (loosey) and INFLUENZA (flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment were reported   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up received Updated No New Information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm after second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028421A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm after second Moderna Covid-19 vaccine) outcome was unknown.            No concomitant medications were provided by the reporter  No treatment information were provided by the reporter   This case was linked to MOD-2021-390773 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: body aches; headaches; light fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills). At the time of the report, MYALGIA (body aches), HEADACHE (headaches), PYREXIA (light fever) and CHILLS (chills) had not resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: got sick and went to the ER; given the booster shot too soon/6-8weeks after 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (got sick and went to the ER) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick and went to the ER) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose). At the time of the report, ILLNESS (got sick and went to the ER) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the booster shot too soon/6-8weeks after 2nd dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided. Patient was he was given a booster shot 6-8 weeks after he was administered the 2nd vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Moderna dose at day 20; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that we need to know how to proceed because her occupational health doctor wants her to get a 3rd dose immediately. The patient was not experiencing any adverse reactions.   No treatment medications were reported. This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious event of inappropriate schedule of product administration. The event inappropriate schedule of product administration occurred the same day with the second dose of mRNA-1273 vaccine administration, the patient received her second dose with dosage interval of 20 days from the first dose of vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious event of inappropriate schedule of product administration. The event inappropriate schedule of product administration occurred the same day with the second dose of mRNA-1273 vaccine administration, the patient received her second dose with dosage interval of 20 days from the first dose of vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Swelling in lymph nodes under both arms, right arm lymph node is larger; Right arm pain every 30 seconds; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 002A21A and 030A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at a dose of 1 dosage form and IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Swelling in lymph nodes under both arms, right arm lymph node is larger) and VACCINATION SITE PAIN (Right arm pain every 30 seconds) outcome was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: vaccine she received has expired for 72 hours on her receipt; 0.5mL was administered for all 3 doses including the booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included LIFITEGRAST (XIIDRA) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine she received has expired for 72 hours on her receipt) and ACCIDENTAL OVERDOSE (0.5mL was administered for all 3 doses including the booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Birk on her chest; Body aches; Headache; Lowgrade temperature/fever; Chills; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache), PYREXIA (Lowgrade temperature/fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 18-Jan-2021 and Pfizer vaccine (Lot number EL1284) on 08-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 17-Nov-2021, the patient experienced CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache), PYREXIA (Lowgrade temperature/fever) and CHILLS (Chills). On 16-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown and PYREXIA (Lowgrade temperature/fever) had not resolved.            No medical history was provided by the reporter.  Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Birk on her chest; Body aches; Headache; Lowgrade temperature/fever; Chills; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache), PYREXIA (Lowgrade temperature/fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 18-Jan-2021 and Pfizer vaccine (Lot number EL1284) on 08-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 17-Nov-2021, the patient experienced CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache), PYREXIA (Lowgrade temperature/fever) and CHILLS (Chills). On 16-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, CHEST DISCOMFORT (Birk on her chest), PAIN (Body aches), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown and PYREXIA (Lowgrade temperature/fever) had not resolved.            No medical history was provided by the reporter.  Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: some patients who received Moderna vaccine post the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (some patients who received Moderna vaccine post the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (some patients who received Moderna vaccine post the expiration date). In November 2021, EXPIRED PRODUCT ADMINISTERED (some patients who received Moderna vaccine post the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Reporter stated that the vaccine was pulled from the freezer on 15-Nov-2021 and moved to the refrigerator and administered on 15-Nov-2021 and 16-Nov-2021.  Company Comment : This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 expired vials of 10 dose each were used to give booster dose to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 expired vials of 10 dose each were used to give booster dose to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Pharyngeal swelling, Swelling face, Vaccination site pain
Clinical narrative: Swelling in the face; Swelling throat; Body aches; Allergic reaction; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling in the face), PHARYNGEAL SWELLING (Swelling throat), PAIN (Body aches), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE PAIN (Right arm sore) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011d21a, 037a21b and 025c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced SWELLING FACE (Swelling in the face), PHARYNGEAL SWELLING (Swelling throat), PAIN (Body aches), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE PAIN (Right arm sore). At the time of the report, SWELLING FACE (Swelling in the face), PHARYNGEAL SWELLING (Swelling throat), PAIN (Body aches), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE PAIN (Right arm sore) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient got the booster of the Moderna COVID-19 vaccine on 17-Nov-2021 and on 18-Nov-2021, the patient was having an allergic reaction, swelling in the face and throat, right arm sore and body aches.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: Stomach did not feel well after 2nd dose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever). In 2021, ABDOMINAL DISCOMFORT (Stomach did not feel well after 2nd dose) and PYREXIA (Fever) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported after the 2nd dose, they had a fever, and their stomach did not feel well.   This case was linked to MOD-2021-390846 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: body aches; headache; higher fever,Fever reached 103.5 degrees Farenheight; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (body aches), HEADACHE (headache) and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache) and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight). At the time of the report, MYALGIA (body aches) and HEADACHE (headache) outcome was unknown and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) 103.5 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-390825 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pyrexia, Vaccination site pain
Clinical narrative: Site of injection start to hurt; Fever; Slight discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Slight discomfort), VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Slight discomfort). On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever). At the time of the report, DISCOMFORT (Slight discomfort), VACCINATION SITE PAIN (Site of injection start to hurt) and PYREXIA (Fever) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided. Patient wants to know if it's ok to take aspirin for the fever or ibuprofen for the pain.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.  The patient was doing fine and was not worried about it.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient). On 17-Nov-2021, PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that underwent a temperature excursion in freezer administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided  Moderna Covid-19 vaccine in Freezer underwent temperature Excursion.The Freezer reached 53 degrees Farenheight. and was administered to patient.