chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; temperature and His back was warm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (temperature and His back was warm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (temperature and His back was warm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and Physical therapy (wet cloth) for Pyrexia. On 13-Feb-2021, HEADACHE (headache) and PYREXIA (temperature and His back was warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big). The patient was treated with Physical therapy (cold compress) for Vaccination site erythema. On 31-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site rash
Clinical narrative: Her arm was red and inflamed, similar to allergic reactions she had in the past; It started out as a rash but it turned into a big red area; Her arm was red and inflamed, similar to allergic reactions she had in the past; a bit of a sore arm; was a bit tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Adverse event, at a dose of UNK dosage form and CORTISONE (topical) in February 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE RASH (It started out as a rash but it turned into a big red area), VACCINATION SITE INFLAMMATION (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE ERYTHEMA (Her arm was red and inflamed, similar to allergic reactions she had in the past), VACCINATION SITE PAIN (a bit of a sore arm) and FATIGUE (was a bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient was shocked that it took 8 days for the reaction to develop.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Hot at injection site; Itching at injection site; Rash  at injection site; Painful at injection site; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-Apr-2021 contains non-significant information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: red/sore at the site of the injection; red/sore at the site of the injection; running a fever; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache). At the time of the report, VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache) had not resolved.            Concomitant medication was not reported. Treatment medication was not reported. The symptoms were still ongoing at the time of the call.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy, Oropharyngeal pain, Rash
Clinical narrative: hoarse throat; sore throat; feels like "Junk"; swollen lymph nodes in her throat and neck; little bit of rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not have any difficulty breathing and she felt "junk".
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: hoarse throat; sore throat; feels like "Junk"; swollen lymph nodes in her throat and neck; little bit of rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not have any difficulty breathing and she felt "junk".
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastrointestinal pain, Headache, Myalgia
Clinical narrative: little GI distress; nasal congestion; muscle pain; really bad headache; fatigue; chills; body ache; A spontaneous report  was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad headache, chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Amlodipine, OTC generic Zyrtec, Vitamin D, Baby Aspirin for drug use for unknown indication.  On 31 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection and on 29Jan2021,she received second dose of mRNA and has not had any reactions to it yet.  On 11 Jan 2021, the patient experienced the event(s) really bad headache. chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) really bad headache was considered resolved on 16 Jan 2021.The outcome of event(s) chills was considered resolved on 16 Jan 2021.The outcome of event(s) body ache was considered resolved on 16 Jan 2021.The outcome of event(s) muscle pain was considered resolved on 16 Jan 2021.The outcome of event(s) fatigue was considered resolved on 16 Jan 2021.The outcome of event(s) little gi distress was considered resolved on 16 Jan 2021.The outcome of event(s) nasal congestion was considered resolved on 16 Jan 2021 was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: little GI distress; nasal congestion; muscle pain; really bad headache; fatigue; chills; body ache; A spontaneous report  was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad headache, chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Amlodipine, OTC generic Zyrtec, Vitamin D, Baby Aspirin for drug use for unknown indication.  On 31 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection and on 29Jan2021,she received second dose of mRNA and has not had any reactions to it yet.  On 11 Jan 2021, the patient experienced the event(s) really bad headache. chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) really bad headache was considered resolved on 16 Jan 2021.The outcome of event(s) chills was considered resolved on 16 Jan 2021.The outcome of event(s) body ache was considered resolved on 16 Jan 2021.The outcome of event(s) muscle pain was considered resolved on 16 Jan 2021.The outcome of event(s) fatigue was considered resolved on 16 Jan 2021.The outcome of event(s) little gi distress was considered resolved on 16 Jan 2021.The outcome of event(s) nasal congestion was considered resolved on 16 Jan 2021 was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Little bit of a fever; Weak a little bit; Felt woozy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak a little bit), PYREXIA (Little bit of a fever) and DIZZINESS (Felt woozy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.  The patient's past medical history included Diabetes since an unknown date, Blood pressure since an unknown date and Prostate ablation since an unknown date. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (Weak a little bit), PYREXIA (Little bit of a fever) and DIZZINESS (Felt woozy). On 11-Feb-2021, ASTHENIA (Weak a little bit), PYREXIA (Little bit of a fever) and DIZZINESS (Felt woozy) had resolved.            Treatment information includes patient did not take any treatment for fever.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Scratch
Clinical narrative: itch all over his body; "scratch his skin off"; A spontaneous report was received from a consumer concerning a 47-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itch all over his body, scratch his skin off.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine To treat hypothyroidisim, unknown diabetes medications To treat diabetes for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) itch all over his body. scratch his skin off.  Treatment details included None.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), itch all over his body, scratch his skin off was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Mental status changes
Clinical narrative: confusion; change in mental status; This spontaneous case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (confusion) and MENTAL STATUS CHANGES (change in mental status) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CONFUSIONAL STATE (confusion) and MENTAL STATUS CHANGES (change in mental status). At the time of the report, CONFUSIONAL STATE (confusion) and MENTAL STATUS CHANGES (change in mental status) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal disorder, Myalgia, Pyrexia
Clinical narrative: trouble moving her legs; Chills; Fever; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness). At the time of the report, MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: site of injection is in pain; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (site of injection is in pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: TCR - Patient declined for further follow-up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: gel like substance under bandaid at injection sight; bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding). At the time of the report, VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Illness, Vaccination site pain, Vomiting
Clinical narrative: left arm is sore; got terribly ill; projectile vomiting; My head is, of course, hurting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got terribly ill), VOMITING (projectile vomiting), HEADACHE (My head is, of course, hurting) and VACCINATION SITE PAIN (left arm is sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPRIN) for Headache.    The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPRIN) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced ILLNESS (got terribly ill), VOMITING (projectile vomiting) and HEADACHE (My head is, of course, hurting). On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm is sore). At the time of the report, ILLNESS (got terribly ill), VOMITING (projectile vomiting), HEADACHE (My head is, of course, hurting) and VACCINATION SITE PAIN (left arm is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Malaise
Clinical narrative: TIRED; weak, no energy; very loose bowl movement with a lot of mucus; feels yucky; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky). At the time of the report, FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky) outcome was unknown.            no concomitant medication and treatment information provided
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; A spontaneous report (United States) was received from a non healthcare professional concerning a 25-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and some fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L-20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced chills and some fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills and some fatigue were unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Chills and fatigue are consistent with the known safety profile of the vaccine
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Urticaria, Vaccination site erythema, Vaccination site infection, Vaccination site mass
Clinical narrative: Infected; Little Lump; Warm to touch; Swelling; It has gotten bigger at least 3 inches long and 2inches wide; red reaction in the area I got the injection; Chills; Hives/urticaria generalized; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFECTION (Infected), VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), URTICARIA (Hives/urticaria generalized) and VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy (Yeast (Candida)), Asthma, Hay fever, Anxiety and High cholesterol. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 1997 to an unknown date for Anxiety, SIMVASTATIN (STATIN [SIMVASTATIN]) for High cholesterol.    On 29-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (Hives/urticaria generalized) and CHILLS (Chills). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection). On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (It has gotten bigger at least 3 inches long and 2inches wide). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Infected). On 11-Mar-2021, URTICARIA (Hives/urticaria generalized) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE INFECTION (Infected), VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (It has gotten bigger at least 3 inches long and 2inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided included an unknown antihistamine and antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Added email address, past medical history, patient height, weight, race details, concomitant medications information, and events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Infected; Little Lump; Warm to touch; Swelling; It has gotten bigger at least 3 inches long and 2inches wide; red reaction in the area I got the injection; Chills; Hives/urticaria generalized; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFECTION (Infected), VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), URTICARIA (Hives/urticaria generalized) and VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy (Yeast (Candida)), Asthma, Hay fever, Anxiety and High cholesterol. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 1997 to an unknown date for Anxiety, SIMVASTATIN (STATIN [SIMVASTATIN]) for High cholesterol.    On 29-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (Hives/urticaria generalized) and CHILLS (Chills). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection). On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (It has gotten bigger at least 3 inches long and 2inches wide). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Infected). On 11-Mar-2021, URTICARIA (Hives/urticaria generalized) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE INFECTION (Infected), VACCINATION SITE MASS (Little Lump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE ERYTHEMA (red reaction in the area I got the injection), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (It has gotten bigger at least 3 inches long and 2inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided included an unknown antihistamine and antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Added email address, past medical history, patient height, weight, race details, concomitant medications information, and events.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling) in a  patient of an unknown age and gender 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 URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include prednisone Concomitant product use was unknown by the reporter
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vaccination site pain
Clinical narrative: feel achy,(right arm) injection site; Morning felt very sick; General body malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General body malaise), VACCINATION SITE PAIN (feel achy,(right arm) injection site) and NAUSEA (Morning felt very sick) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (General body malaise) and NAUSEA (Morning felt very sick). On an unknown date, the patient experienced VACCINATION SITE PAIN (feel achy,(right arm) injection site). At the time of the report, MALAISE (General body malaise), VACCINATION SITE PAIN (feel achy,(right arm) injection site) and NAUSEA (Morning felt very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided no treatment information given
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Enzyme level test, Hepatic enzyme increased, Pain in extremity, Sensitive skin
Clinical narrative: Elevated Liver Enzymes 600's; Sensitive Skin (the entire body); Chills (Without Fever); Sore arm; Sore arm; A spontaneous report was received from a consumer concerning a 59-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy all over the body, sore arm, chills (without fever), elevated liver enzymes 600's, sensitive skin (the entire body).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 9 Feb 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events achy all over the body, sore arm , and chills (without fever), sensitive skin (the entire body).   The lab tests included elevated liver enzymes 600's performed on 12 Feb 2021.  Treatment details included Tylenol Extra strength 500 mg every 4 hours.  Action taken with mRNA-1273 in response to the events was not reported.   On 11-Feb-2021 outcome was recovered for achy all over the body, Sore arm, Chills and unknown for Sensitive Skin and Elevated Liver Enzymes.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired/fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 infection in October 2020 and was hospitalized. He received plasma for the treatment of it.) in October 2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (Tired/fatigued). On 23-Jan-2021, FATIGUE (Tired/fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient received plasma back in October in when he was in a hospital for COVID, when he was scheduled for his 2nd dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic, Rash vesicular
Clinical narrative: Red spot around elbow area; Red spot on hands; I got red spots in foot; I got rash; Little red itchy spots all over my body; Red spots all over the groin area like blisters; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Little red itchy spots all over my body), RASH VESICULAR (Red spots all over the groin area like blisters), RASH MACULAR (I got red spots in foot), RASH MACULAR (Red spot around elbow area) and RASH (I got rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included NUTRAFOL for Hair loss, FLUOXETINE HYDROCHLORIDE (PROZAC), VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH PRURITIC (Little red itchy spots all over my body), RASH VESICULAR (Red spots all over the groin area like blisters) and RASH (I got rash). On 07-Feb-2021, the patient experienced RASH MACULAR (I got red spots in foot). On 08-Feb-2021, the patient experienced RASH (Red spot on hands). On 09-Feb-2021, the patient experienced RASH MACULAR (Red spot around elbow area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Little red itchy spots all over my body), RASH VESICULAR (Red spots all over the groin area like blisters), RASH MACULAR (I got red spots in foot), RASH MACULAR (Red spot around elbow area), RASH (I got rash) and RASH (Red spot on hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Prozac (fluoxetine) was started on an unspecified date, three weeks prior to the vaccine administration. Other relevant medication history included Vitamin D  Treatment included  alcohol.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Contact details of the reporter updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea; Headache; Nausea; A spontaneous report from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, headache, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date the patient experienced diarrhea, headache, nausea. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, diarrhea, headache,nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: shaking all over /felt a little shaky; dizziness; heavy breathing; weakness; My heart rate was at 96 all day while laying in bed.; felt a little shaky; had a little upset stomach but no vomiting; chilled; fatigue; temperature up to 101F; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness) and HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease and Liver disorder. Concurrent medical conditions included Asthma and Blood pressure.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue), PYREXIA (temperature up to 101F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, TREMOR (shaking all over /felt a little shaky), RESPIRATORY RATE INCREASED (heavy breathing), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue) and PYREXIA (temperature up to 101F) had resolved. On 07-Feb-2021, DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 101 f (High) temperature up to 101F. On 06-Feb-2021, Heart rate: heart rate 96 (High) Heart rate 96. On 06-Feb-2021, Respiratory rate: high (High) heavy breathing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Nervousness
Clinical narrative: shaking all over /felt a little shaky; dizziness; heavy breathing; weakness; My heart rate was at 96 all day while laying in bed.; felt a little shaky; had a little upset stomach but no vomiting; chilled; fatigue; temperature up to 101F; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness) and HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease and Liver disorder. Concurrent medical conditions included Asthma and Blood pressure.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue), PYREXIA (temperature up to 101F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, TREMOR (shaking all over /felt a little shaky), RESPIRATORY RATE INCREASED (heavy breathing), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue) and PYREXIA (temperature up to 101F) had resolved. On 07-Feb-2021, DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 101 f (High) temperature up to 101F. On 06-Feb-2021, Heart rate: heart rate 96 (High) Heart rate 96. On 06-Feb-2021, Respiratory rate: high (High) heavy breathing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate, Respiratory rate increased, Tremor
Clinical narrative: shaking all over /felt a little shaky; dizziness; heavy breathing; weakness; My heart rate was at 96 all day while laying in bed.; felt a little shaky; had a little upset stomach but no vomiting; chilled; fatigue; temperature up to 101F; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness) and HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac disease and Liver disorder. Concurrent medical conditions included Asthma and Blood pressure.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced TREMOR (shaking all over /felt a little shaky), DIZZINESS (dizziness), RESPIRATORY RATE INCREASED (heavy breathing), ASTHENIA (weakness), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue), PYREXIA (temperature up to 101F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, TREMOR (shaking all over /felt a little shaky), RESPIRATORY RATE INCREASED (heavy breathing), HEART RATE INCREASED (My heart rate was at 96 all day while laying in bed.), NERVOUSNESS (felt a little shaky), ABDOMINAL DISCOMFORT (had a little upset stomach but no vomiting), CHILLS (chilled), FATIGUE (fatigue) and PYREXIA (temperature up to 101F) had resolved. On 07-Feb-2021, DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 101 f (High) temperature up to 101F. On 06-Feb-2021, Heart rate: heart rate 96 (High) Heart rate 96. On 06-Feb-2021, Respiratory rate: high (High) heavy breathing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.