chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Gait disturbance, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: He also doesn´t feel stable on his feet; he stumbles; he feels like he has been hit; moderate pain in the arm; it did bleed a little; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it did bleed a little, moderate pain in the arm, he feels like he has been hit, he also doesn´t feel stable on his feet and he stumbles.   The patient's medical history was not provided by the reporter. Concomitant medications reported included blood pressure medication, rosuvastatin and fenofibrate drugs used for unknown indication.   On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient experienced it did bleed a little. On 31 Jan 2021, the patient experienced moderate pain in the arm. On 01 Feb 2021, the patient experienced he feels like he has been hit. On an unspecified date, the patient experienced he also doesn´t feel stable on his feet and he stumbles.  Lab details were not provided.  Treatment for the events included aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, it did bleed a little was considered as resolved.  The outcome of events moderate pain in the arm, he feels like he has been hit, he also doesn´t feel stable on his feet and he stumbles, were considered unknown.; 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 (vaccination site pain, feeling abnormal and injection site hemorrhage) a causal relationship cannot be excluded. However, very limited information regarding these events- balance difficulty, and gait disturbance has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: developed a rash of 4 inches by 6 inches; it was hot but not anymore. just for 2 or 3 days; itching; redness and sore; Redness and sore; A spontaneous report was received from a Consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site redness and sore, itching and developed a rash of 4 inches by 6 inches which was hot.  The patient's medical history was not provided. Concomitant medications reported were Simbastetin 10mg, Losartan, Baby aspirin, Vitamin C, Vitamin D, Multi vitamin, Calcium.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced redness and sore .   On 22 Jan 2021, the patient experienced itching .   On an unknown date, the patient developed a rash of 4 inches by 6 inches. It was hot but not anymore. just for 2 or 3 days.  Treatment details included Benadryl cream to keep it from itching.  Action taken with mRNA-1273 in response to the events was unknown.   On 25 Jan 2021 the outcome of feeling hot was resolved. The outcome of other events were considered to be unknown. ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Feeling dizzy; Feeling anxious; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious). At the time of the report, DIZZINESS (Feeling dizzy) and ANXIETY (Feeling anxious) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Nausea, Pain, Vaccination site reaction
Clinical narrative: She was in bed for a better part of the week; she drank tea and heard it swish in her stomach; Pain on my left side of my body; projectile vomiting 6 or 7 times until I emptied out the stomach; a horrible reaction to it; feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible) and ASTHENIA (She was in bed for a better part of the week) in a 70-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 19-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it) and FEELING ABNORMAL (feeling horrible). On an unknown date, the patient experienced ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach). At the time of the report, PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible), ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach) 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.   Patient has used heating pad for body pain. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information was received. Reporter's email was added. It contains non significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting projectile
Clinical narrative: She was in bed for a better part of the week; she drank tea and heard it swish in her stomach; Pain on my left side of my body; projectile vomiting 6 or 7 times until I emptied out the stomach; a horrible reaction to it; feeling horrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible) and ASTHENIA (She was in bed for a better part of the week) in a 70-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 19-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it) and FEELING ABNORMAL (feeling horrible). On an unknown date, the patient experienced ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach). At the time of the report, PAIN (Pain on my left side of my body), VOMITING PROJECTILE (projectile vomiting 6 or 7 times until I emptied out the stomach), VACCINATION SITE REACTION (a horrible reaction to it), FEELING ABNORMAL (feeling horrible), ASTHENIA (She was in bed for a better part of the week) and NAUSEA (she drank tea and heard it swish in her stomach) 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.   Patient has used heating pad for body pain. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information was received. Reporter's email was added. It contains non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: off and on diarrhea; nausea; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (off and on diarrhea) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-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 DIARRHOEA (off and on diarrhea) and NAUSEA (nausea). At the time of the report, DIARRHOEA (off and on diarrhea) was resolving and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication and treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse reactions) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-Jun-2021 contains no new information; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-047837 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit sore in the upper arm; A Spontaneous report was received from Consumer concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little bit sore in the upper arm.  The patient's medical history was not reported. The concomitant medication reported included ACE inhibitor lisinopril (not taking regularly).  On 26-Jan-2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A, Expiration date: 06-Jul-2021) on the right arm for prophylaxis of COVID-19 infection.   On an unknown date, after administration of vaccine, the patient experienced a little bit sore in the upper arm. Treatment information not provided.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome event a little bit sore in the upper arm was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 77-year-old male who experienced a non-serious unexpected event of Pain in extremity.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: started the next morning with a tensional head ache; A spontaneous report was received from a Consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  the headache starting next morning with a tensional head ache.  The patient's medical history was not provided. Concomitant medications reported were Doxycycline 20 mg, Oxydutynin 5 mg for  for unknown indication.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Jan 2021 morning, the patient experienced tensional head ache. The patient also reported that she woke up every morning with the same ache but on that day it was like a tension head ache and it felt it all day. The patient reported that she never had a head ache in the entire life.  Treatment details included Tylenol, Advil (Ibuprofen)  The seriousness criteria of event headache was other as per source document.  Action taken with mRNA-1273 in response to the events was not reported.   On 01 Feb 2021, the outcome of the event tensional headache was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of headache, a causal relationship cannot be excluded
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: my temperature was about 100.8, and at 2 pm it was 101.4; My arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (My arm was pretty sore) and PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (My arm was pretty sore). On 29-Jan-2021, the patient experienced PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 30-Jan-2021, PYREXIA (my temperature was about 100.8, and at 2 pm it was 101.4) had resolved. At the time of the report, INJECTION SITE PAIN (My arm was pretty sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 101.4 f at 2pm and 100.8 f (High) at 11am in the morning.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender'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. Further information has been requested
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Some tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness). The patient was treated with METHOTREXATE for Rheumatoid arthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Some tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on blood thinner and also taking methotrexate for AR but he clarified with HCP and deferred the treatment in order to taken vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: Bruise; Rash; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) and RASH (Rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Bruise) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, cream. At the time of the report, CONTUSION (Bruise) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Sneezing
Clinical narrative: COLD; she is sneezing a lot; SHE HAS A SORE THROAT; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD), SNEEZING (she is sneezing a lot) and OROPHARYNGEAL PAIN (SHE HAS A SORE THROAT) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN, PANTOPRAZOLE and METFORMIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NASOPHARYNGITIS (COLD), SNEEZING (she is sneezing a lot) and OROPHARYNGEAL PAIN (SHE HAS A SORE THROAT). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NASOPHARYNGITIS (COLD), SNEEZING (she is sneezing a lot) and OROPHARYNGEAL PAIN (SHE HAS A SORE THROAT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: injection site it is red and swollen; injection site it is red and swollen; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, INJECTION SITE ERYTHEMA (injection site it is red and swollen), INJECTION SITE SWELLING (injection site it is red and swollen) and LYMPHADENOPATHY (Lymph nodes swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: Arm began itching; A Larger red spot around the injection site; inflamed around the injection site; Red spot around the injection site; Mild fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE PRURITUS (Arm began itching), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills). On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arm began itching) and VACCINATION SITE ERYTHEMA (A Larger red spot around the injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 26-Jan-2021, VACCINATION SITE INFLAMMATION (inflamed around the injection site), VACCINATION SITE ERYTHEMA (Red spot around the injection site), PYREXIA (Mild fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm began itching) and VACCINATION SITE ERYTHEMA (A Larger red spot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: NNI; Sender'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: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm is completely abnormally swollen; it is hot; hard to the touch; had some swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is completely abnormally swollen), VACCINATION SITE WARMTH (it is hot), VACCINATION SITE INDURATION (hard to the touch) and VACCINATION SITE SWELLING (had some swelling) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (had some swelling). On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is completely abnormally swollen), VACCINATION SITE WARMTH (it is hot) and VACCINATION SITE INDURATION (hard to the touch). At the time of the report, PERIPHERAL SWELLING (arm is completely abnormally swollen), VACCINATION SITE WARMTH (it is hot), VACCINATION SITE INDURATION (hard to the touch) and VACCINATION SITE SWELLING (had some swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: This case concerns a female of unknown age who experienced NS unexpected events of peripheral swelling, vaccination site warmth and NS expected events of vaccination site swelling, vaccination site induration.  Event onset occurred the same days as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; It feels a little bit harder in the area; A little patchy; so it looks like there might be swelling there; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (It feels a little bit harder in the area), VACCINATION SITE PRURITUS (A little patchy), VACCINATION SITE SWELLING (so it looks like there might be swelling there) and VACCINATION SITE ERYTHEMA (Redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 (Warm to the touch), VACCINATION SITE INDURATION (It feels a little bit harder in the area), VACCINATION SITE PRURITUS (A little patchy), VACCINATION SITE SWELLING (so it looks like there might be swelling there) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (It feels a little bit harder in the area), VACCINATION SITE PRURITUS (A little patchy), VACCINATION SITE SWELLING (so it looks like there might be swelling there) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient stated that her doctor told her it was ok to try acetaminophen and ceterizine for today 01Feb2021 for treatment of symptoms following vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: itchiness all over; red dots on her face; break out with hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (break out with hives), PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-Jan-2021, the patient experienced URTICARIA (break out with hives). On 02-Feb-2021, the patient experienced PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face). At the time of the report, URTICARIA (break out with hives) had not resolved and PRURITUS (itchiness all over) and RASH MACULAR (red dots on her face) 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Influenza virus test
Clinical narrative: cough; High fever; had trouble getting out of bed; Chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (had trouble getting out of bed), COUGH (cough), CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 25-Jan-2021, the patient experienced MOVEMENT DISORDER (had trouble getting out of bed). On 26-Jan-2021, the patient experienced COUGH (cough) and PYREXIA (High fever). On 25-Jan-2021, MOVEMENT DISORDER (had trouble getting out of bed) had resolved. On 01-Feb-2021, COUGH (cough) had resolved. At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 104.6 (abnormal) high fever of 104.6. On an unknown date, Influenza virus test: (Negative) Negative. On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported that the patient went to visit his HCP who did a rapid Covid-19 test that came back negative .He was sent to the Emergency Room there they did a complete work-up and 3 more Covid-19 tests.They concluded he may have had a virus but were not sure and he had a negative test for influenza.They sent him home and would not answer whether he should receive second vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Pyrexia, SARS-CoV-2 test
Clinical narrative: cough; High fever; had trouble getting out of bed; Chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (had trouble getting out of bed), COUGH (cough), CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 25-Jan-2021, the patient experienced MOVEMENT DISORDER (had trouble getting out of bed). On 26-Jan-2021, the patient experienced COUGH (cough) and PYREXIA (High fever). On 25-Jan-2021, MOVEMENT DISORDER (had trouble getting out of bed) had resolved. On 01-Feb-2021, COUGH (cough) had resolved. At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 104.6 (abnormal) high fever of 104.6. On an unknown date, Influenza virus test: (Negative) Negative. On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  It was reported that the patient went to visit his HCP who did a rapid Covid-19 test that came back negative .He was sent to the Emergency Room there they did a complete work-up and 3 more Covid-19 tests.They concluded he may have had a virus but were not sure and he had a negative test for influenza.They sent him home and would not answer whether he should receive second vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Histamine level, Illness, Mechanical urticaria, Pain in extremity
Clinical narrative: itching sensation to my whole body; tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body; still sick/could not physically sign forms; felt a burning sensation; pins and needles sensation; Dermatographic urticaria; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographic urticaria), PAIN IN EXTREMITY (Sore arm), PRURITUS (itching sensation to my whole body), URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body) and ILLNESS (still sick/could not physically sign forms) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 MECHANICAL URTICARIA (Dermatographic urticaria), PAIN IN EXTREMITY (Sore arm), PRURITUS (itching sensation to my whole body), URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body), ILLNESS (still sick/could not physically sign forms), BURNING SENSATION (felt a burning sensation) and PARAESTHESIA (pins and needles sensation). At the time of the report, MECHANICAL URTICARIA (Dermatographic urticaria), PRURITUS (itching sensation to my whole body), BURNING SENSATION (felt a burning sensation) and PARAESTHESIA (pins and needles sensation) outcome was unknown, PAIN IN EXTREMITY (Sore arm) had resolved and URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body) and ILLNESS (still sick/could not physically sign forms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Histamine level: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Second dose was received on 15 Feb 2021 at 09:00.  Treatment information included Antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: ADR form was attached on 15-JUN-2021, second dose details were added. On 12-Jul-2021: Follow-up received on 12-JUL-2021 contains no new information. On 12-Jul-2021: Follow up received on 12-jul-2021 contains Added New event still sick.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: itching sensation to my whole body; tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body; still sick/could not physically sign forms; felt a burning sensation; pins and needles sensation; Dermatographic urticaria; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographic urticaria), PAIN IN EXTREMITY (Sore arm), PRURITUS (itching sensation to my whole body), URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body) and ILLNESS (still sick/could not physically sign forms) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-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 MECHANICAL URTICARIA (Dermatographic urticaria), PAIN IN EXTREMITY (Sore arm), PRURITUS (itching sensation to my whole body), URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body), ILLNESS (still sick/could not physically sign forms), BURNING SENSATION (felt a burning sensation) and PARAESTHESIA (pins and needles sensation). At the time of the report, MECHANICAL URTICARIA (Dermatographic urticaria), PRURITUS (itching sensation to my whole body), BURNING SENSATION (felt a burning sensation) and PARAESTHESIA (pins and needles sensation) outcome was unknown, PAIN IN EXTREMITY (Sore arm) had resolved and URTICARIA (tried to wear gloves to work and I broke out in welts (temporary)/ random hives on my body) and ILLNESS (still sick/could not physically sign forms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Histamine level: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Second dose was received on 15 Feb 2021 at 09:00.  Treatment information included Antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: ADR form was attached on 15-JUN-2021, second dose details were added. On 12-Jul-2021: Follow-up received on 12-JUL-2021 contains no new information. On 12-Jul-2021: Follow up received on 12-jul-2021 contains Added New event still sick.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain that never goes away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain that never goes away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     The patient's past medical history included Foot fracture (patient as a history of a fractured foot on Christmas,).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm pain that never goes away). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain that never goes away) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment included also heat and ice to help with the pain.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded. On 31-Mar-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vision problems and seeing objects moving; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision problems and seeing objects moving) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration.    On 27-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 VISUAL IMPAIRMENT (Vision problems and seeing objects moving). At the time of the report, VISUAL IMPAIRMENT (Vision problems and seeing objects moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated he saw water on the floor in kitchen moving and a statue in one of his rooms moving upwards or doubling up.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching at the injection site; burning sensation at the injection site; redness at injectrion site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (burning sensation at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (burning sensation at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION SITE PAIN (burning sensation at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at injectrion site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Cortisone with aloe.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Sever rash at injection site almost 8 days later; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Sever rash at injection site almost 8 days later) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Sever rash at injection site almost 8 days later). At the time of the report, VACCINATION SITE RASH (Sever rash at injection site almost 8 days later) outcome was unknown. Not Provided      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 information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: numbness an tingly feeling in both her hands, arms, legs and feet; numbness an tingly feeling in both her hands, arms, legs and feet; Left side of body had most pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Myalgia, Numbness of extremities and Tingling of extremity, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet), PARAESTHESIA (numbness an tingly feeling in both her hands, arms, legs and feet) and MYALGIA (Left side of body had most pain) had not resolved.            Concomitant medications included birth control pills.