chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: still sore; fever; nausea; achy all over; joint pain; Really bad reaction; felt horrible/She felt bad; Migraine 10/10; hot/still warm; hard/ It was initially hard as a rock; Her arm became red/ It is still red/still has a 4x5 inch mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm) and VACCINATION SITE INDURATION (hard/ It was initially hard as a rock) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First shot, LOT- Ej1685, Intramuscular.) on 21-Dec-2020, Pfizer Vaccine (Second shot and LOT- EL1283) on 07-Jan-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine and Pfizer Vaccine.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain). On 30-Dec-2021, the patient experienced VACCINATION SITE PAIN (still sore). On 29-Dec-2021, VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark) and VACCINATION SITE PAIN (still sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) She got a COVID test and it was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's weight was reported as  175 and units were not reported. No concomitant information was reported. Patient Tried to put heat and lots of steroid cream for events. Patient had stated that she still has a 4x5 inch mark in the left deltoid and initially it was hard as rock.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She stated that after the second shot she had enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node). At the time of the report, LYMPHADENOPATHY (She stated that after the second shot she had enlarged lymph node) had not resolved.            No concomitant medications were provided.  No treatment medications were provided.    This case was linked to MOD-2021-435489 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Platelet count, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A214) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction). At the time of the report, EPISTAXIS (bloody nose/casing blood for a couple weeks) and VACCINATION COMPLICATION (really bad reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) her grandmother has low platelets from before..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.   She never went back to get her 2nd dose of the vaccine. She went to a couple ENT doctors, who could not figure out the issue. She received the vaccine in her left arm, the symptoms lasted about a month, and are done.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Mechanical urticaria, Myalgia, Nausea
Clinical narrative: severe itching; burning with hives; dermatographia; Hives, the hives appeared and disappeared periodically; Nausea; vomiting; severe body aches; severe fatigue; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm), PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia) and URTICARIA (Hives, the hives appeared and disappeared periodically) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 012M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 06-Nov-2021, the patient experienced NAUSEA (Nausea), VOMITING (vomiting), MYALGIA (severe body aches) and FATIGUE (severe fatigue). On 15-Nov-2021, the patient experienced PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia) and URTICARIA (Hives, the hives appeared and disappeared periodically). At the time of the report, PAIN IN EXTREMITY (I had a sore arm), PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia), URTICARIA (Hives, the hives appeared and disappeared periodically), NAUSEA (Nausea), VOMITING (vomiting), MYALGIA (severe body aches) and FATIGUE (severe fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-435165, MOD-2021-435187 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria, Vomiting
Clinical narrative: severe itching; burning with hives; dermatographia; Hives, the hives appeared and disappeared periodically; Nausea; vomiting; severe body aches; severe fatigue; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm), PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia) and URTICARIA (Hives, the hives appeared and disappeared periodically) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 012M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 06-Nov-2021, the patient experienced NAUSEA (Nausea), VOMITING (vomiting), MYALGIA (severe body aches) and FATIGUE (severe fatigue). On 15-Nov-2021, the patient experienced PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia) and URTICARIA (Hives, the hives appeared and disappeared periodically). At the time of the report, PAIN IN EXTREMITY (I had a sore arm), PRURITUS (severe itching), BURNING SENSATION (burning with hives), MECHANICAL URTICARIA (dermatographia), URTICARIA (Hives, the hives appeared and disappeared periodically), NAUSEA (Nausea), VOMITING (vomiting), MYALGIA (severe body aches) and FATIGUE (severe fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-435165, MOD-2021-435187 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with vial left in room temperature for over 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was first punctured on 29-Dec-2021 10:15 AM and was administered to this patient on 30-Dec-2021 11:05 AM. The vial was kept in room temperature after first puncture.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Tremor
Clinical narrative: body ached; head is pounding; whole body was shacking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (whole body was shacking uncontrollably), MYALGIA (body ached) and HEADACHE (head is pounding) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced TREMOR (whole body was shacking uncontrollably). On 30-Dec-2021, the patient experienced MYALGIA (body ached) and HEADACHE (head is pounding). At the time of the report, TREMOR (whole body was shacking uncontrollably) outcome was unknown and MYALGIA (body ached) and HEADACHE (head is pounding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 013M20A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-434942 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-434942:Female patient (Vaccination site pain) Same reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: reported a sore arm (2nd dose); side effects (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (reported a sore arm (2nd dose)) and VACCINATION COMPLICATION (side effects (2nd dose)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Lisinopril). Concomitant products included CALCITRIOL (ROCALTROL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (reported a sore arm (2nd dose)) and VACCINATION COMPLICATION (side effects (2nd dose)). At the time of the report, PAIN IN EXTREMITY (reported a sore arm (2nd dose)) and VACCINATION COMPLICATION (side effects (2nd dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications reported   This case was linked to MOD-2021-435277 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) 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 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has not been diagnosed or tested for COVID-19. Booster given 12 hrs  after puncture of via,specifically 4 days later.  No concomitant medication  were reported. No Treatment information was provided.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This morning the rash showed up on the back of arms and forehead.; Rash comes back on & off in different body parts after booster.Rash on both legs after booster.Rash is milder but still has them after booster.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash comes back on & off in different body parts after booster.Rash on both legs after booster.Rash is milder but still has them after booster.) and RASH (This morning the rash showed up on the back of arms and forehead.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced RASH (Rash comes back on & off in different body parts after booster.Rash on both legs after booster.Rash is milder but still has them after booster.). On 30-Dec-2021, the patient experienced RASH (This morning the rash showed up on the back of arms and forehead.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash comes back on & off in different body parts after booster.Rash on both legs after booster.Rash is milder but still has them after booster.) was resolving and RASH (This morning the rash showed up on the back of arms and forehead.) outcome was unknown.            No concomitant medication reported. It was reported that patient spoke to the doctor on the phone and the doctor instructed him to take Antihistamine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001321A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-435282 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 13-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: more than 42 days for administration of second dose; Trouble bending; pain in the lower back; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Trouble bending), BACK PAIN (pain in the lower back) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H1B and 004D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021. Concomitant products included ATORVASTATIN for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In December 2021, the patient experienced MOBILITY DECREASED (Trouble bending) and BACK PAIN (pain in the lower back). On 04-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved. At the time of the report, MOBILITY DECREASED (Trouble bending) had not resolved and BACK PAIN (pain in the lower back) was resolving.            Patient reported anti-inflammatory medicine as treatment medication   This case was linked to MOD-2021-435447, MOD-2021-435447 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder Pain) 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 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ARTHRALGIA (Shoulder Pain). At the time of the report, ARTHRALGIA (Shoulder Pain) outcome was unknown.            No concomitant and treatment medication details were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chest discomfort, Dysphagia, Dyspnoea, Head discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick), PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up) and CHEST DISCOMFORT (felt a heaviness in my chest) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (got very sick), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything). On 08-Apr-2021, the patient experienced PAIN (heaviness in my body), CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing). On 11-Apr-2021, CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing) had resolved. In April 2021, PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything) had resolved. At the time of the report, ILLNESS (got very sick) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  At 4AM on the third day I was fine, was reported.   This case was linked to MOD-2021-435257 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Paralytic disability, Physical disability
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick), PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up) and CHEST DISCOMFORT (felt a heaviness in my chest) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (got very sick), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything). On 08-Apr-2021, the patient experienced PAIN (heaviness in my body), CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing). On 11-Apr-2021, CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing) had resolved. In April 2021, PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything) had resolved. At the time of the report, ILLNESS (got very sick) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  At 4AM on the third day I was fine, was reported.   This case was linked to MOD-2021-435257 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: For the 10 days following the booster dose the itching escalated; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (For the 10 days following the booster dose the itching escalated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 019B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (For the 10 days following the booster dose the itching escalated). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and Bed rest for Pruritus. At the time of the report, PRURITUS (For the 10 days following the booster dose the itching escalated) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For the 10 days following the vaccine the booster dose the itching escalated. She had seen multiple doctors and dermatologists who had treated it with antihistamines including Zyrtec & Benadryl, and a steroid ointment, & they had said that it was not related to the vaccine. She was on a low histamine diet which helped calm it down.  No concomitant medications were reported.   This case was linked to MOD-2021-435255 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Limb discomfort
Clinical narrative: Had no control over her legs; It felt like she was almost going to fall; She was also feeling very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had no control over her legs), FALL (It felt like she was almost going to fall) and DIZZINESS (She was also feeling very dizzy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine in January 2021 and Pfizer vaccine in February 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced LIMB DISCOMFORT (Had no control over her legs), FALL (It felt like she was almost going to fall) and DIZZINESS (She was also feeling very dizzy). At the time of the report, LIMB DISCOMFORT (Had no control over her legs), FALL (It felt like she was almost going to fall) and DIZZINESS (She was also feeling very dizzy) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: may have received 0.25 ml for second dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (may have received 0.25 ml for second dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (may have received 0.25 ml for second dose). On 30-Dec-2021, ACCIDENTAL UNDERDOSE (may have received 0.25 ml for second dose) had resolved.            No concomitant product information was provided. No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer NOS. Concurrent medical conditions included Fish allergy, Shellfish allergy and Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVASC), ATENOLOL, CALCIUM, IRON and GABAPENTIN for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 antibody test
Clinical narrative: Booster given 12 hours past vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours past vial puncture) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.   This case was linked to MOD-2021-416295 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Diarrhoea
Clinical narrative: blood pressure shot up; Diarrhea issue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure shot up) and DIARRHOEA (Diarrhea issue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure shot up.         No concomitant information was reported. Patient saw her doctor who gave her a medicine to bring her blood pressure down to normal.   This case was linked to MODERNATX, INC.-MOD-2021-434942 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-434942:Female patient (Hypertension, Diarrhoea) Same reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination complication, Vaccination site swelling
Clinical narrative: report a reaction/She gets bad reactions when her skin gets punctured like vaccines or bug bites.; redness is growing; getting itchier; swells at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a reaction/She gets bad reactions when her skin gets punctured like vaccines or bug bites.), ERYTHEMA (redness is growing), PRURITUS (getting itchier) and VACCINATION SITE SWELLING (swells at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (Redness and Itchiness) on 25-Feb-2021 and Pfizer COVID-19 vaccine (Redness and Itchiness LOT no.: EP6955) on 18-Mar-2021. Past adverse reactions to the above products included Redness with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis, CALCIUM, ALPRAZOLAM (XANAX) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report a reaction/She gets bad reactions when her skin gets punctured like vaccines or bug bites.), ERYTHEMA (redness is growing), PRURITUS (getting itchier) and VACCINATION SITE SWELLING (swells at the injection site). At the time of the report, VACCINATION COMPLICATION (report a reaction/She gets bad reactions when her skin gets punctured like vaccines or bug bites.), ERYTHEMA (redness is growing), PRURITUS (getting itchier) and VACCINATION SITE SWELLING (swells at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: Period problems; Period problems; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period problems) and MENSTRUATION DELAYED (Period problems) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-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 MENSTRUATION IRREGULAR (Period problems) and MENSTRUATION DELAYED (Period problems). At the time of the report, MENSTRUATION IRREGULAR (Period problems) and MENSTRUATION DELAYED (Period problems) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient's LMP was 06-Jun-2021 and got period on 26-Sep-2021.  No concomitant medication was taken by patient regularly. No treatment medication was reported by reporter.   This case was linked to MOD-2021-429683 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lip swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Chills after booster; The enlarged lymph node came back again; After the booster she had  Headache; After the booster she had a Low grade fever; Today, 30DEC2021 she started having swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Today, 30DEC2021 she started having swollen lips), CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced LIP SWELLING (Today, 30DEC2021 she started having swollen lips). On an unknown date, the patient experienced CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Headache, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Today, 30DEC2021 she started having swollen lips), CHILLS (Chills after booster), LYMPHADENOPATHY (The enlarged lymph node came back again), HEADACHE (After the booster she had  Headache) and PYREXIA (After the booster she had a Low grade fever) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2021-435175 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine). At the time of the report, MIGRAINE (Severe migraine) outcome was unknown.            No treatment medication was reported.  OTC drugs taken were Tylenol and Somatropin.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: she should have gotten a full dose as her 3rd dose because she is immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (she should have gotten a full dose as her 3rd dose because she is immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Reporter states that a patient got her 1st two doses of the Moderna Covid-19 Vaccine, then a booster dose 6 months later.  Then saw her doctor who told her she should have gotten a full dose as her 3rd dose because she is immunocompromised.   Caller states that they do not have any additional information at this time.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: use aspirin or acetaminophen after the Moderna booster dose; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose). At the time of the report, NO ADVERSE EVENT (use aspirin or acetaminophen after the Moderna booster dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: not feeling right; soreness on her arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness). At the time of the report, MALAISE (not feeling right), PAIN IN EXTREMITY (soreness on her arm) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter. .  Patient stated that after vaccination she experienced for 4-5 days not feeling right, soreness on her arm and tiredness   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass
Clinical narrative: Arm has got a big knot in it; Low grade fever/Fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Arm has got a big knot in it) and PYREXIA (Low grade fever/Fever of 99 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Arm has got a big knot in it) and PYREXIA (Low grade fever/Fever of 99 degrees). At the time of the report, VACCINATION SITE MASS (Arm has got a big knot in it) and PYREXIA (Low grade fever/Fever of 99 degrees) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.