chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: She has red welts same size of an egg, and they hurt; same arm of the injection is hot and he feels like it burns; same arm of the injection is a little swollen; redness on same arm of the injection; same arm of the injection  itch but she don't want to scratch the zone.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06SF21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concurrent medical conditions included Diabetes, Thyroid disorder, Hypertension, Arrhythmia, Cholesterol, Gastritis, Urinary infection and Cardiovascular disorder. Concomitant products included PROPRANOLOL for Arrhythmia, MONASCUS PURPUREUS (RED RICE YEAST) for Cardiovascular disorder, OMEGA-3 FATTY ACIDS and EZETIMIBE (ZETIA) for Cholesterol, METFORMIN for Diabetes, OMEPRAZOLE for Gastritis, LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid disorder, CHLORTALIDONE (HIPREX [CHLORTALIDONE]) for Urinary infection.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.). At the time of the report, URTICARIA (She has red welts same size of an egg, and they hurt), VACCINATION SITE WARMTH (same arm of the injection is hot and he feels like it burns), VACCINATION SITE SWELLING (same arm of the injection is a little swollen), VACCINATION SITE ERYTHEMA (redness on same arm of the injection) and VACCINATION SITE PRURITUS (same arm of the injection  itch but she don't want to scratch the zone.) outcome was unknown.            Treatment medication included: Prosenogel   This case was linked to MOD-2021-349728 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Pharmacist administered 0.25mL (Booster dose, full dose is 0.5mL) of Moderna Covid-19 vaccine, when patient was to receive 0.3mL of Pfizer Covid-19 vaccine for second dose of original Covid-19 vaccine series. Patient was notified and administered second 0.25mL dose of Moderna Covid-19 vaccine to provide a full dose and to complete the original vaccine series. CDC guidance does not recommend mixing mRNA vaccines for original series, but if inadvertently administered recommends no further intervention and patient is considered fully vaccinated for the original series.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: fever, aches, cold chills, overheating, headache
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling cold, Hypersensitivity, Panic attack, Shock
Clinical narrative: Had an allergic reaction closing of throat , chills , very cold , co;or changing , panic attack , and more I was in state of shock
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Skin discolouration, Throat tightness
Clinical narrative: Had an allergic reaction closing of throat , chills , very cold , co;or changing , panic attack , and more I was in state of shock
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient states that her local site injection reaction of a sore arm is still lingering (11/27/21). Proper landmarks of immunization administration were performed and patient had zero complications upon administration of the vaccine. There is no ecchymosis, red streaking, welt or swelling of the extremity. Denies systemic effects.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Vomiting-Mild, Additional Details: Patient left with family after throwing up. Called patient's caregiver several times to follow up but noone picked up. Patient's caregiver had information about vaccine's side effects after taking to pharmacy before they left. Patient will go to ER if there is severe reaction
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient is still experiencing extreme joint pain, fever, head congestion, lethargy. Patients arm that was injected has a big red welt and is swollen. Said arm feels heavy and hard to lift up..
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lethargy, Pain, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient is still experiencing extreme joint pain, fever, head congestion, lethargy. Patients arm that was injected has a big red welt and is swollen. Said arm feels heavy and hard to lift up..
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Urticaria
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient is still experiencing extreme joint pain, fever, head congestion, lethargy. Patients arm that was injected has a big red welt and is swollen. Said arm feels heavy and hard to lift up..
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Laboratory test normal, Limb discomfort
Clinical narrative: 1 week after getting 2nd COVID vaccine, developed chest pain, and left arm heaviness.  Reports intermittent sharp chest pain and chest heaviness for 1 week prior to going to Emergency room.  Patient states he still developed intermittent chest pain, that has not resolved.    Reports left arm heaviness for 3 days and left lymph node swelling.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 1 week after getting 2nd COVID vaccine, developed chest pain, and left arm heaviness.  Reports intermittent sharp chest pain and chest heaviness for 1 week prior to going to Emergency room.  Patient states he still developed intermittent chest pain, that has not resolved.    Reports left arm heaviness for 3 days and left lymph node swelling.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient received vaccine and fell in store after becoming dizzy. hit head on fixture. EMS called.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Muscle rigidity, Peripheral swelling
Clinical narrative: Patient's arm swelled; warm; kind of red.; firm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, ASCORBIC ACID, ASPIRIN [ACETYLSALICYLIC ACID], BILBERRY [VACCINIUM MYRTILLUS], ENALAPRIL, GABAPENTIN, GINKGO BILOBA (GINGKO BILOBA), GLUCOSAMINE, HYDROCHLOROTHIAZIDE, SALMON OIL, METOPROLOL, SIMVASTATIN and LIPO FLAVONOID PLUS for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm). At the time of the report, PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) outcome was unknown.            No treatment medication was reported. Patient had Moderna for the 1st and 2nd dose and did not have any reaction.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Limb discomfort, Limb injury, Neck pain
Clinical narrative: mobility strange/control of my arm weird; lump on my arm/ some kind of muscular tumor; left arm with muscle fiber, right arm is skinner; difficult to sleep; injection site strange; pain on the shoulder and now on my neck; skin feel weird; had a leg injury; now pain up and down of my arm; make my arm spatter; pain on the shoulder and now on my neck; injection site painful for a while; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep) and VACCINATION COMPLICATION (injection site strange) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Leg injury, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while) outcome was unknown.            No concomitant medication information provided by the reporter.  Treatment medication included muscle relaxers.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Skin discomfort, Vaccination complication, Vaccination site mass
Clinical narrative: mobility strange/control of my arm weird; lump on my arm/ some kind of muscular tumor; left arm with muscle fiber, right arm is skinner; difficult to sleep; injection site strange; pain on the shoulder and now on my neck; skin feel weird; had a leg injury; now pain up and down of my arm; make my arm spatter; pain on the shoulder and now on my neck; injection site painful for a while; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep) and VACCINATION COMPLICATION (injection site strange) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Leg injury, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while) outcome was unknown.            No concomitant medication information provided by the reporter.  Treatment medication included muscle relaxers.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: mobility strange/control of my arm weird; lump on my arm/ some kind of muscular tumor; left arm with muscle fiber, right arm is skinner; difficult to sleep; injection site strange; pain on the shoulder and now on my neck; skin feel weird; had a leg injury; now pain up and down of my arm; make my arm spatter; pain on the shoulder and now on my neck; injection site painful for a while; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep) and VACCINATION COMPLICATION (injection site strange) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Leg injury, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while) outcome was unknown.            No concomitant medication information provided by the reporter.  Treatment medication included muscle relaxers.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Monoparesis, Peripheral swelling, Pruritus
Clinical narrative: Area of the upper right arm, swell up and itchy; Upper arm is swell and itchy; Right arm is bigger; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03DM20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger). At the time of the report, PERIPHERAL SWELLING (Area of the upper right arm, swell up and itchy), PRURITUS (Upper arm is swell and itchy) and MONOPARESIS (Right arm is bigger) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: patients received vaccine after temperature excursions; product storage error; Expired product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Sleep disorder
Clinical narrative: Chills; Sore arm; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced chills, pain in arm and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the chills, pain in arm and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had reaction to 2 nd shot of Shingles that night had chills, sore arm & headache.  It lasted into the following day. For the chills, the patient sat next to fireplace with a glass of wine. For sore arm and the patient just didn't sleep on that side.  Two Tylenol's for headache.
Age: 11.0
Sex: M
Vaccine: COVID19, MNQ
Symptoms: Incorrect dose administered, Overdose, Product preparation error
Clinical narrative: dose of Menveo, later received lyophilized menveo with Pfizer diluent; received lyophilized menveo with Pfizer diluent; received lyophilized menveo with Pfizer diluent; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   Co-suspect products included tozinameran (Covid 19 Vaccine Pfizer) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On an unknown date, the patient received Menveo and Covid 19 Vaccine Pfizer at an unknown dose and frequency. On an unknown date, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced overdose, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The action taken with Covid 19 Vaccine Pfizer was unknown. On an unknown date, the outcome of the overdose, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient received 1 dose of Menveo correctly and 1hr. later received the lyophilized menveo with Pfizer Covid 19 diluent when they were supposed to get the Covid Pfizer due to, which led to overdose , inappropriate dose of vaccine administration and wrong solution used in drug reconstitution. No reactions reported. The reporter consented to follow up. This is 1 of the 12 linked cases, reported by the same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypoacusis, Musculoskeletal stiffness, Tinnitus
Clinical narrative: STARTED TO SPACE OUT; STARTED TO SWEAT; HEARING BEGAN TO FADE WAS REPLACED WITH A LOW RINGING; LOSS OF PERIPHERAL VISION; INJECTION ARM STIFFNESS; HEARING REPLACED WITH LOW RINGING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced started to space out, started to sweat, hearing began to fade was replaced with a low ringing, loss of peripheral vision, injection arm stiffness, and hearing replaced with low ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from started to space out, started to sweat, hearing began to fade was replaced with a low ringing, loss of peripheral vision, and hearing replaced with low ringing, and the outcome of injection arm stiffness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Visual field defect
Clinical narrative: STARTED TO SPACE OUT; STARTED TO SWEAT; HEARING BEGAN TO FADE WAS REPLACED WITH A LOW RINGING; LOSS OF PERIPHERAL VISION; INJECTION ARM STIFFNESS; HEARING REPLACED WITH LOW RINGING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced started to space out, started to sweat, hearing began to fade was replaced with a low ringing, loss of peripheral vision, injection arm stiffness, and hearing replaced with low ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from started to space out, started to sweat, hearing began to fade was replaced with a low ringing, loss of peripheral vision, and hearing replaced with low ringing, and the outcome of injection arm stiffness was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Transient Amnesia; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Transient Amnesia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 027A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   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 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AMNESIA (Transient Amnesia). At the time of the report, AMNESIA (Transient Amnesia) was resolving.            No Concomitant product use was reported. No treatment information was provided. The patient stated they had an event after receiving the booster dose. On 13-Nov-2021, from 12:30 to 2 PM the patient had an episode of transient amnesia and stated it was severe at first gradually getting better.  The patient went to their HCP and the patient was diagnosed with transient amnesia. The patient also reported that they were a healthy individual who takes no medications Had some blood work done, and the results were pending. Reportedly, the patient was scheduled for additional exams soon.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, Product storage error
Clinical narrative: outside the recommended 12 hour vial puncture range; vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    Concurrent medical conditions included Drug allergy (Flonase), Food allergy, Drug allergy (hydrocholrothiazide) and Drug allergy (phenylephrine).   On 19-Nov-2021 at 7:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) (Intramuscular) at an unspecified dose. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) to be not related.    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Included case classification, patient demographics, medical history (Allergy) added, suspect drug start date, dose numbers and start time for booster dose added, Co-suspect drug information and events start dates were added.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Jan 28 2021 and second dose on Feb 21 2021) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20a and 029l20a) for COVID-19 vaccination.     Concomitant products included PREDNISONE, METOPROLOL, TAMSULOSIN and CALCIUM for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Jan 28 2021 and second dose on Feb 21 2021). On 21-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Jan 28 2021 and second dose on Feb 21 2021) had resolved.            The patient received booster dose on 17-Nov-2021 (lot number 018f21a).  No treatment information was reported.   This case was linked to MOD-2021-392007 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up document contains no new information
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Left arm is swelled up; Left arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red). At the time of the report, VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red) had not resolved.            No concomitant medications were provided. No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: felt like maybe she had a mild case of the flu for half a day or two; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two). At the time of the report, INFLUENZA (felt like maybe she had a mild case of the flu for half a day or two) had resolved.            No Concomitant medication was reported.     No treatment medications were reported   This case was linked to MOD-2021-392965, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up contains Significant information: Updated contact information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: In additional information included suspect administration date were updated. On 19-Nov-2021: Follow-up information included about patients details. On 19-Nov-2021: Significant FU appended (Second reporter Information is updated).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore arm). At the time of the report, INJECTION SITE PAIN (Sore arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient has had a sore arm after all the doses of the vaccine.   This case was linked to MOD-2021-393534, MOD-2021-393537 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours). On 21-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Interchange of vaccine products, Pain, Pyrexia
Clinical narrative: Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose; Aches; High temperature; Terrible headache; first 2 doses were a different one; This spontaneous case was reported by another health care professional and describes the occurrence of FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches), PYREXIA (High temperature), HEADACHE (Terrible headache) and INTERCHANGE OF VACCINE PRODUCTS (first 2 doses were a different one) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches), PYREXIA (High temperature), HEADACHE (Terrible headache) and INTERCHANGE OF VACCINE PRODUCTS (first 2 doses were a different one). On 20-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (first 2 doses were a different one) had resolved. At the time of the report, FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches), PYREXIA (High temperature) and HEADACHE (Terrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-395583 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Multiple Patients received expired dose of the Moderna vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: having pain under the skull the base of the skull; having pain under the neck; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (having pain under the skull the base of the skull) and NECK PAIN (having pain under the neck) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced HEAD DISCOMFORT (having pain under the skull the base of the skull) and NECK PAIN (having pain under the neck). At the time of the report, HEAD DISCOMFORT (having pain under the skull the base of the skull) and NECK PAIN (having pain under the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Cholesterol Medicine for an unknown indication.  No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain; lightheaded; Fatigue; Headache; I had fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F2117, 028A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 101 (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The symptoms are ongoing but have mostly resolved.    This case was linked to MOD-2021-395827 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm pain; lightheaded; Fatigue; Headache; I had fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F2117, 028A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), DIZZINESS (lightheaded), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (I had fever of 101F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 101 (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The symptoms are ongoing but have mostly resolved.    This case was linked to MOD-2021-395827 (Patient Link).