chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ear,heart pounding fast in my ear; Fever/Temperature of 105.5; hard time getting up to going to bathroom; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature. Concurrent medical conditions included Cancer. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ALLOPURINOL (ZYLOPRIM) and VITAMIN D NOS for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, Body temperature: 105.5 (High) 105.5.         Patient did state in the past they have Pre-mature Ventricular Contraction (PVC) but this time it was not like that since their blood pressure was normal. Patient also stated they did not decide to contact their HCP since the fever and other symptoms have been subsided. Patient did mention during the end of the call that they will contact their HCP since they have cancer and other underlying conditions.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Pruritus
Clinical narrative: itching; shortness of breath; Allergic reaction to booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itching), DYSPNOEA (shortness of breath) and ALLERGY TO VACCINE (Allergic reaction to booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), DYSPNOEA (shortness of breath) and ALLERGY TO VACCINE (Allergic reaction to booster dose). At the time of the report, PRURITUS (itching) and DYSPNOEA (shortness of breath) outcome was unknown and ALLERGY TO VACCINE (Allergic reaction to booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: weak; she had high fever 103 degree F temperature; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), PYREXIA (she had high fever 103 degree F temperature), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12H21B) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (weak), PYREXIA (she had high fever 103 degree F temperature), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at a dose of 325 mg, 1 tablet. At the time of the report, ASTHENIA (weak), PYREXIA (she had high fever 103 degree F temperature), HEADACHE (headache) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Body temperature: 103 (High) High fever 103 degree F temperature.         Patient reported that after 1st and 2nd dose, she already reported to Medical information that she was sick for 3 days, had high fever, headache and was weak.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm after all 3 shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm after all 3 shots) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm after all 3 shots). At the time of the report, PAIN IN EXTREMITY (soreness in the arm after all 3 shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any concomitant medications. Treatment include over the counter painkiller medications    This case was linked to MOD-2021-409787, MOD-2021-409788 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity
Clinical narrative: soreness in the arm after all 3 shots; weak; sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (soreness in the arm after all 3 shots), ASTHENIA (weak), PAIN (sore) and FATIGUE (tired) outcome was unknown.            Patient was on no concomitant medication.  Treatment for the events included over the counter painkiller medication.   This case was linked to MOD-2021-409784, MOD-2021-409788 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Soreness in the arm after all 3 shots; On and off mild headaches/different areas of head, back, on top/soreness in forehead; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm after all 3 shots) and HEADACHE (On and off mild headaches/different areas of head, back, on top/soreness in forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the arm after all 3 shots) and HEADACHE (On and off mild headaches/different areas of head, back, on top/soreness in forehead). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm after all 3 shots) and HEADACHE (On and off mild headaches/different areas of head, back, on top/soreness in forehead) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information included over the counter painkiller medication.   This case was linked to MOD-2021-409787, MOD-2021-409784 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: not feeling well; fever; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills). At the time of the report, MALAISE (not feeling well), PYREXIA (fever), HEADACHE (headaches) and CHILLS (chills) had not resolved.            Concomitant medication of the patient was not reported.   No treatment information was provided by the reporter.   The patient asked if she could take Tylenol for the pain. The symptoms of the patient were ongoing.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: Leg cramp and it was not all the time, It was on and off; Pain in right leg that radiated; Fatigue; Fever low grade; First dose on 31MAR2021, 2nd shot on 28MAY2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue), PYREXIA (Fever low grade) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue), PYREXIA (Fever low grade) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31MAR2021, 2nd shot on 28MAY2021) had resolved. On 31-May-2021, MUSCLE SPASMS (Leg cramp and it was not all the time, It was on and off), PAIN IN EXTREMITY (Pain in right leg that radiated), FATIGUE (Fatigue) and PYREXIA (Fever low grade) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED 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 EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Sleep disorder, Vaccination site pain
Clinical narrative: needing to sleep; sore left arm at the injection site,; chills; some muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches). At the time of the report, SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-409964 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Feeling hot, Neck pain, Vomiting
Clinical narrative: hot in her left arm/ arm got so hot/ neck is hot; crazy dreams; achiness specially around the neck; Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer (dose 2) on 27-Mar-2021 and pfizer (dose 1). Past adverse reactions to the above products included No adverse reaction with pfizer and pfizer.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times). At the time of the report, FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow-up received contain significant information - New events crazy dreams, achiness specially around the neck and all of a sudden up it went - she has thrown up a couple of times added. Dates of the events updated. The historical vaccine changed.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: they found on 27Jul2021 a cervical adenopathy measuring 1.78cm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (they found on 27Jul2021 a cervical adenopathy measuring 1.78cm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced LYMPHADENOPATHY (they found on 27Jul2021 a cervical adenopathy measuring 1.78cm). At the time of the report, LYMPHADENOPATHY (they found on 27Jul2021 a cervical adenopathy measuring 1.78cm) had not resolved.            No Concomitant product use was reported.  The reporter was calling on behalf of their mother who was the patient stated that after patient received their 2nd dose of the Moderna Covid-19, they found a cervical adenopathy measuring 1.78cm on 27-Jul-2021. The reporter said that the normal size was up to 1cm and was having it for months now.  No treatment information was provided.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose). On 11-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered a Moderna booster dose to an 11 year old patient instead of a Pfizer pediatric dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not experience any known symptoms and not received any treatments.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11-years old sister received both Moderna Vaccines; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11-years old sister received both Moderna Vaccines) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11-years old sister received both Moderna Vaccines). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11-years old sister received both Moderna Vaccines) had resolved.            No concomitant medications were reported No treatment medications were reported.  The 11 year old sister received both Moderna Vaccines in November 2021.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Pale area around the injection site; Inflamed limp node in the right armpit; Pinkish area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety.    On 09-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Pale area around the injection site), LYMPHADENITIS (Inflamed limp node in the right armpit) and VACCINATION SITE ERYTHEMA (Pinkish area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information includes steroid cream prescribed by local pharmacist.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Swelling in left arm in lymph nodes under the armpit; She also had a rash down her back; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in left arm in lymph nodes under the armpit) and RASH (She also had a rash down her back) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling in left arm in lymph nodes under the armpit) and RASH (She also had a rash down her back). At the time of the report, LYMPHADENOPATHY (Swelling in left arm in lymph nodes under the armpit) had resolved and RASH (She also had a rash down her back) outcome was unknown.      Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-409864 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Rash erythematous, Skin warm, Vaccination site rash
Clinical narrative: felt like her arm was tight; It is warm in arm up there; rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm; red rash, like a red mark from below the injection site to the elbow, the front part; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), MUSCLE TIGHTNESS (felt like her arm was tight), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H2114, 029L20A and 031MZEA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm). On an unknown date, the patient experienced MUSCLE TIGHTNESS (felt like her arm was tight). At the time of the report, RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), MUSCLE TIGHTNESS (felt like her arm was tight), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up received contains NNI
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck; Rash under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) and RASH (Rash under the left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) and RASH (Rash under the left arm). At the time of the report, LYMPHADENOPATHY (Swelling in the lymph nodes underneath her arm pit that traveled to her left breast and left side of neck) had not resolved and RASH (Rash under the left arm) was resolving.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-409831 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm for 24 hours after the second Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Spinal operation NOS (Cervical spine area surgery) in April 2021. Concomitant products included METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine). In April 2021, VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine) had resolved.            No treatment medication information was reported.   This case was linked to MOD-2021-409868, MOD-2021-409877 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer and Cancer surgery (Cancer removed from his hand and face) on 09-Dec-2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-409903, MOD-2021-409906 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-409900, MOD-2021-409905 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-409900, MOD-2021-409905 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Break out in hives again; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Break out in hives again) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21H, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, 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 experienced URTICARIA (Break out in hives again). At the time of the report, URTICARIA (Break out in hives again) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient had hives again which was not that significant and did not itched. It was also reported that hives took a little time to disappear.   This case was linked to MOD-2021-409888, MOD-2021-409900 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Break out in hives again; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Break out in hives again) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21H, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, 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 experienced URTICARIA (Break out in hives again). At the time of the report, URTICARIA (Break out in hives again) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient had hives again which was not that significant and did not itched. It was also reported that hives took a little time to disappear.   This case was linked to MOD-2021-409888, MOD-2021-409900 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: heart palpitations; severe headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (heart palpitations) and HEADACHE (severe headaches) 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 PALPITATIONS (heart palpitations) and HEADACHE (severe headaches). At the time of the report, PALPITATIONS (heart palpitations) and HEADACHE (severe headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-409883 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Pain at Injection site; Slight headache; A sore injection arm that had inflamed to the size of a tennis ball.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Slight headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.) and HEADACHE (Slight headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at Injection site). At the time of the report, VACCINATION SITE INFLAMMATION (A sore injection arm that had inflamed to the size of a tennis ball.), VACCINATION SITE PAIN (Pain at Injection site) and HEADACHE (Slight headache) 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster dose given past 30 day use by expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26 (Patient received J&J vaccine dose) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (booster dose given past 30 day use by expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Date the vial was initially stored in the refrigerator: 11 Nov 2021   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Non Significant follow up appended. Contact information was updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Slight fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) positive.         Patient stated that they had hybrid immunity because in November 2020 patient was not feeling well and tested positive for COVID 19.   No concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-409884, MOD-2021-409904 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Vaccination complication
Clinical narrative: severe reaction; was in bed for 3-4 days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) and BEDRIDDEN (was in bed for 3-4 days.) in an 89-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 12-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 COMPLICATION (severe reaction) and BEDRIDDEN (was in bed for 3-4 days.). At the time of the report, VACCINATION COMPLICATION (severe reaction) outcome was unknown and BEDRIDDEN (was in bed for 3-4 days.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has concomitant medications but the reporter did not have the list. No treatment medications were reported.   This case was linked to MOD-2021-409907, MOD-2021-409908 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 expired booster dose was administered past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Date the vial was initially stored in the refrigerator was 10-Nov-2021. As per HCP, the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (tired after booster dose) and myalgia (sore after booster dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included cancer (removed from his hand and face) on Dec 9, 2020. On Dec 9, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 9, 2021, patient experienced fatigue (tired after booster dose) and myalgia (sore after booster dose). At the time of the report, fatigue (tired after booster dose) and myalgia (sore after booster dose) outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-409887, MOD-2021-409903 (patient link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction for this one was a 12 hour span; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction for this one was a 12 hour span) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (reaction for this one was a 12 hour span). In 2021, VACCINATION COMPLICATION (reaction for this one was a 12 hour span) had resolved.            Patient has concomitant medications but her reporter did not have the list. No treatment reported   This case was linked to MOD-2021-409899, MOD-2021-409908 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: felt hot; mine itched terribly/itched for weeks; a red line around the injection site./I can see a red line; Raised; red round welt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA (a red line around the injection site./I can see a red line), VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE PRURITUS (mine itched terribly/itched for weeks), VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING and VACCINATION SITE URTICARIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She is scheduled to get her second dose on 21Dec2021,   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: I got the wrong dose for booster of moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (I got the wrong dose for booster of moderna) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (I got the wrong dose for booster of moderna). At the time of the report, INCORRECT DOSE ADMINISTERED (I got the wrong dose for booster of moderna) 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.