chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia
Clinical narrative: nerve pain and everything that had gone away with the surgery,came back roaring; Her legs had multiple cramps; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) and MUSCLE SPASMS (Her legs had multiple cramps) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nerve pain and Spinal operation NOS.    In March 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 NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) and MUSCLE SPASMS (Her legs had multiple cramps). At the time of the report, NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) had not resolved and MUSCLE SPASMS (Her legs had multiple cramps) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient used ice packs on her for the adverse reactions. Patient had not diagnosed with COVID 19, myocarditis or pericarditis.   This case was linked to MOD-2021-409114 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; 2-3 weeks of persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (2-3 weeks of persistent headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (2-3 weeks of persistent headache). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Persistent headache, at an unspecified dose and frequency. In April 2021, HEADACHE (2-3 weeks of persistent headache) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included the patient took ibuprofen 2 or 3 times but it did not help relieve the symptoms.   This case was linked to MOD-2021-409890 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 633H21A, 021C21A and 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for COVID-19) in November 2020 and Feeling unwell in November 2020.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Slight fever) and MYALGIA (Body aches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant information was not provided.  Patient reported to have an hybrid immunity as the patient experienced COVID-19 in Nov 2020 prior to vaccination.  Treatment information was not provided.   This case was linked to MOD-2021-409895, MOD-2021-409904 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Vaccination site pain
Clinical narrative: cold sweats; Sore injection site arm for 2 days; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (cold sweats), VACCINATION SITE PAIN (Sore injection site arm for 2 days) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer on 09-Dec-2020 and Surgery (Had cancer removed from his hand and face on9DEC2020 and may have been tired from that procedure.) on 09-Dec-2020.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HYPERHIDROSIS (cold sweats), VACCINATION SITE PAIN (Sore injection site arm for 2 days) and PYREXIA (fever). On 07-Mar-2021, VACCINATION SITE PAIN (Sore injection site arm for 2 days) had resolved. In March 2021, HYPERHIDROSIS (cold sweats) and PYREXIA (fever) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-409887, MOD-2021-409906 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination complication
Clinical narrative: The first dose hit him the same way the second dose hit others who did not have COVID-19 before; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042K21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (it came back positive) in November 2020 and Feeling unwell (wasn't feeling well) in November 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before). At the time of the report, VACCINATION COMPLICATION (The first dose hit him the same way the second dose hit others who did not have COVID-19 before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that they had hybrid immunity since the patient experienced COVID -19 in  Nov-2020 and then received the vaccine Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-409884, MOD-2021-409895 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Genital herpes, Herpes virus infection, Limb mass, Oral herpes
Clinical narrative: in her right arm there is a ball; herpes in the mouth; Herpes in the back of her ear; herpes in vagina near anus; red spicks in body; itching; rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus) and ERYTHEMA (red spicks in body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shoulder pain. Concomitant products included MELOXICAM for Shoulder pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 500 dosage form and FLUCONAZOLE for Adverse event, at a dose of 150 milligram. At the time of the report, LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash) outcome was unknown.            The patient following the vaccination with the 2nd dose reported that, in October in their right arm there was a ball and experienced herpes in the mouth and in the back of their ear, herpes in their vagina near their anus and red spicks in their body. Reportedly, the patient had rash and itching.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: in her right arm there is a ball; herpes in the mouth; Herpes in the back of her ear; herpes in vagina near anus; red spicks in body; itching; rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus) and ERYTHEMA (red spicks in body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 011a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shoulder pain. Concomitant products included MELOXICAM for Shoulder pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at a dose of 500 dosage form and FLUCONAZOLE for Adverse event, at a dose of 150 milligram. At the time of the report, LIMB MASS (in her right arm there is a ball), ORAL HERPES (herpes in the mouth), HERPES VIRUS INFECTION (Herpes in the back of her ear), GENITAL HERPES (herpes in vagina near anus), ERYTHEMA (red spicks in body), PRURITUS (itching) and RASH (rash) outcome was unknown.            The patient following the vaccination with the 2nd dose reported that, in October in their right arm there was a ball and experienced herpes in the mouth and in the back of their ear, herpes in their vagina near their anus and red spicks in their body. Reportedly, the patient had rash and itching.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Today, a patient received a 3rd dose (0.5mL) of vaccine from a syringe that was pre-drawn on Friday (10Dec2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years old and received Moderna COVID19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine). On 08-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old and received Moderna COVID19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received Moderna COVID-19 booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster) in a 12-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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna COVID-19 booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.). On 10-Dec-2021, ACCIDENTAL UNDERDOSE (Received their 1st dose as 0.25 mL instead of 0.5 mL for their first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not on any concomitant medication.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Migraine, Musculoskeletal stiffness, Tremor
Clinical narrative: ended up in bed/Weak; Shaky; Migraines/ triggering migraines that took weeks to go away; stiffness went up her arm to the back of her head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Migraine (She states she's had migraines since she was 30 years old.). Concurrent medical conditions included Thinking abnormal NOS.    On 09-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 ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (ended up in bed/Weak), TREMOR (Shaky), MIGRAINE (Migraines/ triggering migraines that took weeks to go away) and MUSCULOSKELETAL STIFFNESS (stiffness went up her arm to the back of her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  The patient received her Moderna booster (lot 051F21A) on 10Nov2021 in right arm. The patient received second dose (lot 029K20A) on 06Feb2021 in right arm and Moderna booster (lot 051F21A) on 10Nov2021 in right.  The patient stated she had brain fog, but she doesn't remember whether it started after the first or second dose. She could not think straight. She states the brain fog has improved slowly,but she is not back to what she was before the first dose. She was so debilitated that she was in bed for months. It wasn't until evening that she could get out of bed. The patient states she does not know if anything could be done. She stated she was totally not functional she was still weak. She was scared to take another Moderna shot in the future.   This case was linked to MOD-2021-409950, MOD-2021-410013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up events updated
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: says she cannot get her right foot to move correct but thinks this is due to MS; injection site was like touching a heating pad; Bright pink rash at injection site that was itchy and went 2 inches above elbow; Bright pink rash at injection site; Nauseous for a few hours; Woke up dizzy after turning to side in bed; Bright pink rash at injection site that was itchy and went 2 inches above elbow; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced DIZZINESS (Woke up dizzy after turning to side in bed). On an unknown date, the patient experienced GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow), VACCINATION SITE ERYTHEMA (Bright pink rash at injection site), VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours). At the time of the report, GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) outcome was unknown and VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she cannot move her right foot correctly and she thinks that it might be due to multiple sclerosis.  Concomitant drugs included blood pressure medication.  No treatment was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: says she cannot get her right foot to move correct but thinks this is due to MS; injection site was like touching a heating pad; Bright pink rash at injection site that was itchy and went 2 inches above elbow; Bright pink rash at injection site; Nauseous for a few hours; Woke up dizzy after turning to side in bed; Bright pink rash at injection site that was itchy and went 2 inches above elbow; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced DIZZINESS (Woke up dizzy after turning to side in bed). On an unknown date, the patient experienced GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow), VACCINATION SITE ERYTHEMA (Bright pink rash at injection site), VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours). At the time of the report, GAIT DISTURBANCE (says she cannot get her right foot to move correct but thinks this is due to MS), VACCINATION SITE WARMTH (injection site was like touching a heating pad), DIZZINESS (Woke up dizzy after turning to side in bed), VACCINATION SITE PRURITUS (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and VACCINATION SITE ERYTHEMA (Bright pink rash at injection site) outcome was unknown and VACCINATION SITE RASH (Bright pink rash at injection site that was itchy and went 2 inches above elbow) and NAUSEA (Nauseous for a few hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she cannot move her right foot correctly and she thinks that it might be due to multiple sclerosis.  Concomitant drugs included blood pressure medication.  No treatment was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: I am not feeling well.; chills; fever; pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (I am not feeling well.), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (I am not feeling well.), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, MALAISE (I am not feeling well.), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: severe shooting pains in my chest; severe shooting pains in my chest; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (severe shooting pains in my chest) and CHEST PAIN (severe shooting pains in my chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (severe shooting pains in my chest) and CHEST PAIN (severe shooting pains in my chest). At the time of the report, PAIN (severe shooting pains in my chest) and CHEST PAIN (severe shooting pains in my chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: A lump where I got the shot; It's red all around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site). At the time of the report, VACCINATION SITE MASS (A lump where I got the shot) and VACCINATION SITE ERYTHEMA (It's red all around the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The patient had no problem with the first 2 Moderna shots.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: on that night arm is huge, is very large, is very big, very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 021A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen). At the time of the report, PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-410096, MOD-2021-410095 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Muscle spasms, Pyrexia
Clinical narrative: Can hardly walk when the leg cramps are going on after booster; Leg cramps from knees to toes after booster; Mild Fever after booster; Mild Chills after booster; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can hardly walk when the leg cramps are going on after booster), MUSCLE SPASMS (Leg cramps from knees to toes after booster), PYREXIA (Mild Fever after booster) and CHILLS (Mild Chills after booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Leg cramps (mild leg cramps that flared up every once in a blue moon).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced PYREXIA (Mild Fever after booster) and CHILLS (Mild Chills after booster). On 11-Dec-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk when the leg cramps are going on after booster) and MUSCLE SPASMS (Leg cramps from knees to toes after booster). On 09-Dec-2021, PYREXIA (Mild Fever after booster) and CHILLS (Mild Chills after booster) had resolved. At the time of the report, GAIT DISTURBANCE (Can hardly walk when the leg cramps are going on after booster) and MUSCLE SPASMS (Leg cramps from knees to toes after booster) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-410071 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen for a day or two) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen for a day or two). At the time of the report, PERIPHERAL SWELLING (Arm was swollen for a day or two) had resolved.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-410054, MOD-2021-410095 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Feeling hot, Rash erythematous
Clinical narrative: was hot to the touch for five days; he got dizzy and weak after the shot; he got dizzy and weak after the shot; red rash on the side of arm; the second one was big red / second one was worst than the first and the second one was big red.; got covid arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and FEELING HOT (was hot to the touch for five days) in a 64-year-old male 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 was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (was hot to the touch for five days). In March 2021, the patient experienced ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot). On 18-Mar-2021, FEELING HOT (was hot to the touch for five days) had resolved. At the time of the report, ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot) outcome was unknown.            No treatment medication was provided.   This case was linked to MOD-2021-410051 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: was hot to the touch for five days; he got dizzy and weak after the shot; he got dizzy and weak after the shot; red rash on the side of arm; the second one was big red / second one was worst than the first and the second one was big red.; got covid arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and FEELING HOT (was hot to the touch for five days) in a 64-year-old male 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 was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (was hot to the touch for five days). In March 2021, the patient experienced ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot). On 18-Mar-2021, FEELING HOT (was hot to the touch for five days) had resolved. At the time of the report, ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot) outcome was unknown.            No treatment medication was provided.   This case was linked to MOD-2021-410051 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Menstruation irregular, Milk allergy
Clinical narrative: stomach ache; extreme dehydration; period was shifted; diarrhea; fever; allergy to cow milk; This spontaneous case was reported by a consumer and describes the occurrence of MILK ALLERGY (allergy to cow milk), ABDOMINAL PAIN UPPER (stomach ache), DEHYDRATION (extreme dehydration), MENSTRUATION IRREGULAR (period was shifted) and DIARRHOEA (diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MILK ALLERGY (allergy to cow milk). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), DEHYDRATION (extreme dehydration), MENSTRUATION IRREGULAR (period was shifted), DIARRHOEA (diarrhea) and PYREXIA (fever). At the time of the report, MILK ALLERGY (allergy to cow milk) had not resolved, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown and DEHYDRATION (extreme dehydration) and MENSTRUATION IRREGULAR (period was shifted) had resolved.            No Concomitant medication was reported.    No treatment medications were reported.   Patient had to drink vitamin water to rehydrate.   This case was linked to MOD-2021-410127 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stomach ache; extreme dehydration; period was shifted; diarrhea; fever; allergy to cow milk; This spontaneous case was reported by a consumer and describes the occurrence of MILK ALLERGY (allergy to cow milk), ABDOMINAL PAIN UPPER (stomach ache), DEHYDRATION (extreme dehydration), MENSTRUATION IRREGULAR (period was shifted) and DIARRHOEA (diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MILK ALLERGY (allergy to cow milk). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), DEHYDRATION (extreme dehydration), MENSTRUATION IRREGULAR (period was shifted), DIARRHOEA (diarrhea) and PYREXIA (fever). At the time of the report, MILK ALLERGY (allergy to cow milk) had not resolved, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown and DEHYDRATION (extreme dehydration) and MENSTRUATION IRREGULAR (period was shifted) had resolved.            No Concomitant medication was reported.    No treatment medications were reported.   Patient had to drink vitamin water to rehydrate.   This case was linked to MOD-2021-410127 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) 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 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and PYREXIA (fever) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache) outcome was unknown and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not taking any chronic condition medications/vitamin/supplement. The patient had no pre-existing medical condition.   This case was linked to MOD-2021-410117 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Needle used was actually a shorter subcutaneous needle although it was given IM; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle used was actually a shorter subcutaneous needle although it was given IM) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle used was actually a shorter subcutaneous needle although it was given IM). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle used was actually a shorter subcutaneous needle although it was given IM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis flare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EN8737) at the age of 67 years as dose 1, single and administered in arm right, administration date 20Apr2021 09:00 (Lot number: EN8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing); "HTN" (unspecified if ongoing); "Aortic valve leak (minor)" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN; OMEPRAZOLE. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination and no known allergies. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "Rheumatoid Arthritis flare". Therapeutic measures were taken as a result of rheumatoid arthritis included Prednisone and NSAIDS. Clinical course included Rheumatoid Arthritis flare (first in 6 years; was in remission and on no maintenance meds) appropriate 9 days after first dose, 4 days after second dose. Patient was incapacitated.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Interchange of vaccine products
Clinical narrative: Developed Shingles along left back extending around to left chest wall 2 weeks after receiving pfizer covid booster; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 18:00 (Lot number: FH8030) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ASPIRINE; VITAMIN D [ERGOCALCIFEROL]; TURMERIC [CURCUMA LONGA]. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 029L20A, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 20Jan2021, when the patient was 47 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 011J20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 23Dec2020, when the patient was 47 years old, for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 12Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious) with onset 26Nov2021 15:00, outcome "not recovered", described as "Developed Shingles along left back extending around to left chest wall 2 weeks after receiving pfizer covid booster". The event "developed shingles along left back extending around to left chest wall 2 weeks after receiving pfizer covid booster" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. Ae was treated with Valaciclovir.  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.