chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) in a 39-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy from July 2015 to 01-Apr-2016. Previously administered products included for an unreported indication: TDAP on 18-Mar-2021. Concomitant products included SERTRALINE from 25-Jan-2021 to an unknown date, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), MAGNESIUM OXIDE and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PEPTIDES NOS at an unspecified dose and frequency. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used Benadryl and Peptide as treatment medications. Patient had one previous pregnancy with pregnancy end date 01 Apr 2016.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient information is added; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Hot at the injection site; Hardness at the injection site; Itchy at the injection site; Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination; Patient stated that 2 days after the vaccination, she had dime size redness at the injection site; Patient stated that 2 days after the vaccination, she had mild flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms), VACCINATION SITE INDURATION (Hardness at the injection site), INJECTION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms) and VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination). 22-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), INFLUENZA LIKE ILLNESS (Patient stated that 2 days after the vaccination, she had mild flu like symptoms), VACCINATION SITE INDURATION (Hardness at the injection site), INJECTION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Patient stated that 2 days after the vaccination, she had dime size redness at the injection site) and VACCINATION SITE ERYTHEMA (Redness increased to a size of 2 silver dollar size coin 2 weeks after the vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided.  No Treatment information  provided  Patient stated that she had dime size redness which increased to a size of 2 silver dollar size coin 2 weeks after the vaccination.   This case was linked to MOD-2021-256850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: updated outcome of the events and 2nd dose and its events information
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: wasn't able to sleep; after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), BENAZEPRIL, FOLIC ACID, METFORMIN and PRAVASTATIN for an unknown indication.    On 14-Feb-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 INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs). At the time of the report, INSOMNIA (wasn't able to sleep) and PRURITUS (after 6 days, I was scratching my arm/ itching a lot in both arms and legs below the knees/ still itching in the legs) 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.   Treatment included Tylenol and Hydrocortisone
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Injection site pain, Pyrexia
Clinical narrative: Burning sensation on both arms; Headache; Heart beat went faster; Burning sensation when they put the needle in; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning sensation on both arms), HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever) and CHILLS (Chills) in a 79-year-old male 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.     The patient's past medical history included COVID-19 (was pretty sick and took 2 weeks to recover) from 01-Dec-2020 to December 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever) and CHILLS (Chills). On 24-Jan-2021, the patient experienced SKIN BURNING SENSATION (Burning sensation on both arms) and HEADACHE (Headache). On 26-Jan-2021, SKIN BURNING SENSATION (Burning sensation on both arms), HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Burning sensation on both arms; Headache; Heart beat went faster; Burning sensation when they put the needle in; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning sensation on both arms), HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever) and CHILLS (Chills) in a 79-year-old male 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.     The patient's past medical history included COVID-19 (was pretty sick and took 2 weeks to recover) from 01-Dec-2020 to December 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever) and CHILLS (Chills). On 24-Jan-2021, the patient experienced SKIN BURNING SENSATION (Burning sensation on both arms) and HEADACHE (Headache). On 26-Jan-2021, SKIN BURNING SENSATION (Burning sensation on both arms), HEART RATE INCREASED (Heart beat went faster), INJECTION SITE PAIN (Burning sensation when they put the needle in), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after first dose of vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    On 28-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 COVID-19 (Tested positive for COVID after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after first dose of vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    On 28-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 COVID-19 (Tested positive for COVID after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hallucination, visual, Hypersomnia, Illness
Clinical narrative: Saw strange visions; diarrhea; slept a lot; Fatigued; Felt sick; A spontaneous report  was received from a Consumer and other HCP  concerning a  79Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like Felt sick, Fatigued, Diarrhea, Slept a lot, Saw strange visions.   The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 16th Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly  for prophylaxis of COVID-19 infection.   On date 16th  Feb 2021, The patient experienced the event like Felt sick, Fatigued, Diarrhea, Slept a lot, Saw strange visions. She stated that she's feeling better now.  Laboratory details not provided.    No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events are 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    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 VACCINATION SITE PAIN (sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood pressure pills.  No Treatment information for the event was provided. Patient reported that Patient has scheduled a steroid injection for his shoulder on 25Feb2021.   This case was linked to MOD21-035602 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    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 VACCINATION SITE PAIN (sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood pressure pills.  No Treatment information for the event was provided. Patient reported that Patient has scheduled a steroid injection for his shoulder on 25Feb2021.   This case was linked to MOD21-035602 (E2B Linked Report).; Sender's Comments:  MOD21-035602:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 71-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 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 VACCINATION SITE PAIN (Sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (Sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD21-035563 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 71-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 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 VACCINATION SITE PAIN (Sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (Sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD21-035563 (E2B Linked Report).; Sender's Comments:  MOD21-035563:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Dizziness, Gait disturbance
Clinical narrative: body is getting weaker and weaker; Shakiness; Dizziness; having difficulty getting into their car because they have to lift their leg up with their arm; joint pain; fever of 99.5; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm) and ARTHRALGIA (joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (fever of 99.5). On an unknown date, the patient experienced ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm), ARTHRALGIA (joint pain) and PYREXIA (fever of 99.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 99.5 (Borderline) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: body is getting weaker and weaker; Shakiness; Dizziness; having difficulty getting into their car because they have to lift their leg up with their arm; joint pain; fever of 99.5; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm) and ARTHRALGIA (joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (fever of 99.5). On an unknown date, the patient experienced ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (body is getting weaker and weaker), TREMOR (Shakiness), DIZZINESS (Dizziness), GAIT DISTURBANCE (having difficulty getting into their car because they have to lift their leg up with their arm), ARTHRALGIA (joint pain) and PYREXIA (fever of 99.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 99.5 (Borderline) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Trouble sleeping; Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm). On 18-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping). On 19-Jan-2021, INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, 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 start dates of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HERPES ZOSTER (shingles).   On 21-Jan-2021, HERPES ZOSTER (shingles) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Hypoaesthesia, Paraesthesia oral
Clinical narrative: a lot of tingling in lips; Felt like she had gotten a dental block and was just coming out of it; numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (a lot of tingling in lips), DENTAL DISCOMFORT (Felt like she had gotten a dental block and was just coming out of it) and HYPOAESTHESIA (numbness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Lip augmentation (in march 2020). Concomitant products included Estrogen Patch, Toprolol XL, ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB (CELEBREX) and MONTELUKAST for an unknown indication.    On 22-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 PARAESTHESIA ORAL (a lot of tingling in lips), DENTAL DISCOMFORT (Felt like she had gotten a dental block and was just coming out of it) and HYPOAESTHESIA (numbness). At the time of the report, PARAESTHESIA ORAL (a lot of tingling in lips) and DENTAL DISCOMFORT (Felt like she had gotten a dental block and was just coming out of it) outcome was unknown and HYPOAESTHESIA (numbness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included NONE   Reporter did not allow further contact; 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: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: was very nervous about taking the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (was very nervous about taking the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included ESTRADIOL (ESTROGEN), METOPROLOL SUCCINATE (TOPROL XL), ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB (CELEBREX) and MONTELUKAST for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (was very nervous about taking the vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ANXIETY (was very nervous about taking the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got dose 1 and 2, still don not know if vaccine worked for him. Patient stated that he would not recommend to any patient to took the vaccine or not.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-230245 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Vaccination site erythema
Clinical narrative: reaction from the vaccine; Red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (reaction from the vaccine) and VACCINATION SITE ERYTHEMA (Red circle on arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 INJECTION SITE REACTION (reaction from the vaccine) and VACCINATION SITE ERYTHEMA (Red circle on arm). At the time of the report, INJECTION SITE REACTION (reaction from the vaccine) and VACCINATION SITE ERYTHEMA (Red circle on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05-july-2021 event and event outcome were updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Decreased appetite, Ear pain, Headache
Clinical narrative: No Medical History information was reported.    On 08-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 MOVEMENT IMPAIRMENT (couldn't lift her arm in the air), NECK PAIN (sore neck), EAR PAIN (ear ache), DECREASED APPETITE (loss of appetite), BODY TEMPERATURE INCREASED (temperature 101F), MYALGIA (body ache), CHILLS (shivering) and HEADACHE (headache). The patient was treated with UBROGEPANT (UBRELVY) for Headache, at a dose of 50 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her arm in the air), NECK PAIN (sore neck), EAR PAIN (ear ache), DECREASED APPETITE (loss of appetite), BODY TEMPERATURE INCREASED (temperature 101F), MYALGIA (body ache), CHILLS (shivering) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The patient reported  48 hours after her shot she could not lift her arm  in the air. On Tuesday night she reported headache and  took 50 mg of Ubrogepant (Ubrelvy) for treatment. The patient reported 18 days after her vaccine she woke up with a sore neck, headache, temperature of 101F, loss of appetite, ear ache, body ache and was shivering. The patient took a rapid COVID-19 test and it came back negative. 32 hours later she reported feeling totally fine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: No Medical History information was reported.    On 08-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 MOVEMENT IMPAIRMENT (couldn't lift her arm in the air), NECK PAIN (sore neck), EAR PAIN (ear ache), DECREASED APPETITE (loss of appetite), BODY TEMPERATURE INCREASED (temperature 101F), MYALGIA (body ache), CHILLS (shivering) and HEADACHE (headache). The patient was treated with UBROGEPANT (UBRELVY) for Headache, at a dose of 50 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her arm in the air), NECK PAIN (sore neck), EAR PAIN (ear ache), DECREASED APPETITE (loss of appetite), BODY TEMPERATURE INCREASED (temperature 101F), MYALGIA (body ache), CHILLS (shivering) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The patient reported  48 hours after her shot she could not lift her arm  in the air. On Tuesday night she reported headache and  took 50 mg of Ubrogepant (Ubrelvy) for treatment. The patient reported 18 days after her vaccine she woke up with a sore neck, headache, temperature of 101F, loss of appetite, ear ache, body ache and was shivering. The patient took a rapid COVID-19 test and it came back negative. 32 hours later she reported feeling totally fine.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Left arm soreness; Chills; Headache; Bodyache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) in a 46-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 an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, PAIN IN EXTREMITY (Left arm soreness), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: back pain; neck pain; Shoulder pain, Hip pain, joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain). At the time of the report, BACK PAIN (back pain), NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain, Hip pain, joint pain) outcome was unknown.            Concomitant medications were not reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-230245, MOD-2021-230245 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Head discomfort, Headache, Myalgia
Clinical narrative: Mild Cough; Achy Body; Sneezing; Head Congestion; Low Grade Fever; Sore Arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and VACCINATION SITE PAIN (Sore Arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 17-Jan-2021, the patient experienced COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and PYREXIA (Low Grade Fever). On 10-Jan-2021, VACCINATION SITE PAIN (Sore Arm), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving. On 20-Jan-2021, COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and PYREXIA (Low Grade Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Sneezing, Vaccination site pain
Clinical narrative: Mild Cough; Achy Body; Sneezing; Head Congestion; Low Grade Fever; Sore Arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and VACCINATION SITE PAIN (Sore Arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 17-Jan-2021, the patient experienced COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and PYREXIA (Low Grade Fever). On 10-Jan-2021, VACCINATION SITE PAIN (Sore Arm), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving. On 20-Jan-2021, COUGH (Mild Cough), MYALGIA (Achy Body), SNEEZING (Sneezing), HEAD DISCOMFORT (Head Congestion) and PYREXIA (Low Grade Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Slight sore arm initially; last 3 days arm sore and swollen and sorer; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4496160) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer). At the time of the report, PAIN IN EXTREMITY (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provid   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU was added on 16-APR-2021 and it contains NNI
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced SOMNOLENCE (sleepy). At the time of the report, SOMNOLENCE (sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain in extremity, Skin burning sensation
Clinical narrative: Tennis ball bump under the arm.; Arm soreness; Feel burned at the arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm). At the time of the report, AXILLARY MASS (Tennis ball bump under the arm.), PAIN IN EXTREMITY (Arm soreness) and SKIN BURNING SENSATION (Feel burned at the arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  No treatment information specified.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body Aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second 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) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). 27-Jan-2021, the patient experienced MYALGIA (Body Aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body Aches) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 test) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19. On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE and negative (Negative) NEGATIVE.     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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated the lab test COVID-19 , tested positive on Jan 15, two weeks later he tested positive again and a few days after that he tested negative
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Hotness in right arm; Itchiness on right arm; Burning in right arm; Swelling in the right armpit; Swelling in right arm; Rash on right arm; Soreness in the right armpit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm) and AXILLARY PAIN (Soreness in the right armpit) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-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 SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm), AXILLARY PAIN (Soreness in the right armpit) and VACCINATION SITE LYMPHADENOPATHY (Swelling in the right armpit). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm) and VACCINATION SITE PAIN (Burning in right arm). At the time of the report, VACCINATION SITE WARMTH (Hotness in right arm), VACCINATION SITE PRURITUS (Itchiness on right arm), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE RASH (Rash on right arm), AXILLARY PAIN (Soreness in the right armpit), VACCINATION SITE PAIN (Burning in right arm) and VACCINATION SITE LYMPHADENOPATHY (Swelling in the right armpit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications included fluocinonide 0.05% cream, tylenol and Claritin.