chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Medium
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Injection site pruritus, Nausea
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Severe dizziness started morning of March 29 Nausea & vomiting  Brain fog Headache  Fatigue Mild chest pain  All these lasted until April 6th
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe dizziness started morning of March 29 Nausea & vomiting  Brain fog Headache  Fatigue Mild chest pain  All these lasted until April 6th
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swelling
Clinical narrative: Itchy red patch developed one week AFTER initial vaccine dose with mild swelling.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal pain upper, Crying, Discomfort, Frequent bowel movements, Haematochezia
Clinical narrative: Blood in stool for 5 days after vaccinations. Increased bowel movements. Stomach pain, crying, inability to sleep more than 1-2 hours without waking uncomfortable for 5 days/nights.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Sleep disorder
Clinical narrative: Blood in stool for 5 days after vaccinations. Increased bowel movements. Stomach pain, crying, inability to sleep more than 1-2 hours without waking uncomfortable for 5 days/nights.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Medium
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Shakiness-Medium
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood test normal, Confusional state, Disorientation, Disturbance in attention
Clinical narrative: I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation.  It was a level of disorientation I have never experienced before in my lifetime.  I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray".  I was having difficulty producing words, a prolonged stutter, you might say.  I was shaking.  The local paramedics came and I was taken to the local ER.  Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA.  An MRI on 04/07/2021 at 5pm produced a negative result.  So i can only attribute my reaction to the vaccine.  It was very significant, and i thought it made sense to report it.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphemia, Gait disturbance, Magnetic resonance imaging head normal, Speech disorder, Syncope
Clinical narrative: I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation.  It was a level of disorientation I have never experienced before in my lifetime.  I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray".  I was having difficulty producing words, a prolonged stutter, you might say.  I was shaking.  The local paramedics came and I was taken to the local ER.  Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA.  An MRI on 04/07/2021 at 5pm produced a negative result.  So i can only attribute my reaction to the vaccine.  It was very significant, and i thought it made sense to report it.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation.  It was a level of disorientation I have never experienced before in my lifetime.  I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray".  I was having difficulty producing words, a prolonged stutter, you might say.  I was shaking.  The local paramedics came and I was taken to the local ER.  Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA.  An MRI on 04/07/2021 at 5pm produced a negative result.  So i can only attribute my reaction to the vaccine.  It was very significant, and i thought it made sense to report it.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Red circle at injection site, warm to touch
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fatigue, headache, aches and pain, low grade fever (99.8)
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient received first dose on 4/1/21. Patient came in on 4/6/21 to report rash/itching throughout his body. Patient first began experiencing symptoms 4/2/21. Symptoms have worsened over time, with rash spreading throughout body. Patient reports no known drug allergies, no new environmental contacts, foods, laundry products, etc. Patient advised to start OTC diphenhydramine and consult with PCP to report potential new allergy and determine risk/benefit of 2nd dose of vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Severe Itching mostly on trunk of my body, rash,  Have been using Cortizone Cream, have had 2 shots of Steroid a week apart, using over the counter cream for itching( not working very well.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Lethargy
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: lymph nodes inflammation Pain at the side of the shot Throughout the rest of my body: Tiredness. Headache. Muscle pain. Chills. Fever.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: lymph nodes inflammation Pain at the side of the shot Throughout the rest of my body: Tiredness. Headache. Muscle pain. Chills. Fever.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: 79 y/o female complain of headache and "empty feeling in stomach."  Vital signs checked by onsite EMS.  B/P 140/82, P 70.  Client monitored for 35 minutes.  Reported symptoms "better".  Encouraged to follow up with ER or PCP if needed.  Verbalized understanding.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Redness, swelling, pain, sensitive to touch around injection site in area about size of an egg.  Also had pain under arm and felt pulling and some pain when raising arm up in air.    Symptoms began about 10 hours from receiving shot and lasted several days.  At one week, swelling and pain gone but some mild redness remains.  Treated pain with Tylenol.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became light headed and pale approximately 5 minutes after injection. Did not pass out. Patient sitting and given water. 10 minutes later patient feeling better and left 30 minutes after injection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient experienced redness surrounding the site of injection, it spread to her shoulder and the rest of her upper arm. Patient reported swelling , pruritis and warmth to the touch. Patient did not report any other adverse symptoms, patient treated with NSAIDs and Benadryl.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient fained and regained consciousness very quickly. patient refused 911. Nurse and pharmacist checked on patient periodically. pt was under monitoring for 30 minutes and reported feeling well after drinking orange juice and some crackers.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Delayed swollen arm 8 days after injection
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, severe body aches, severe arm pain at injection site
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Genital herpes, Headache, Vaccination site pain
Clinical narrative: Soreness in arm; Headache; Chills; Painful genital herpes outbreak; Difficulty walking, uncomfortable, stayed in pajamas all weekend; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (painful genital herpes outbreak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Genital herpes (Patient states she has a history of genital herpes outbreaks.) on 26-Feb-2021.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GENITAL HERPES (painful genital herpes outbreak) (seriousness criterion medically significant) and GAIT DISTURBANCE (difficulty walking, uncomfortable, stayed in pajamas all weekend). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), HEADACHE (headache) and CHILLS (chills). The patient was treated with PROGESTERONE (PROGESTERONE ABBOTT) for Genital herpes, at an unspecified dose and frequency. At the time of the report, GENITAL HERPES (painful genital herpes outbreak), GAIT DISTURBANCE (difficulty walking, uncomfortable, stayed in pajamas all weekend), PAIN IN EXTREMITY (soreness in arm), HEADACHE (headache) and CHILLS (chills) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Exophthalmos, Headache
Clinical narrative: Got her eye bulging; Woke up with bells palsy in lips, nose, eye on the left side; Headache; A spontaneous report was received from a consumer concerning a 73 year old female patient, who experienced eye bulging (exophthalmos), bells palsy in lips, nose, eye on the left side (facial paralysis), and headache.  The patient's medical history was not provided by the reporter. Concomitant medications were also not reported.  On 16 Feb 2021 at 13:30, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021 at 16:00, after receiving mRNA-1273, the patient experienced eye bulging and a headache (intermittent). The headache lasted 3 days until she took a Tylenol.  The patient reported that she woke up with bells palsy in lips, nose, eye on the left side.  The treatment details for the event of headache included Tylenol (paracetamol).   Action taken with mRNA-1273 in response to the events was unknown.   The outcome for  the events of eye bulging (exophthalmos) and  bells palsy in lips, nose, eye on the left side (facial paralysis) was considered as unknown. The event of headache recovered on 18 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Extrasystoles, Inappropriate schedule of product administration, Palpitations
Clinical narrative: Second dose scheduled after 36 days from the first dose; Heart flutters; Episodes of heart racing; Heart miss a beat; A spontaneous report was received from a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced episodes of heart racing/palpitations, heart miss a beat/extrasystoles, heart flutters/cardiac flutter and second dose scheduled after 36 days from the first dose/Inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant product use was not provided.  On 16 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021, approximately 4 days after vaccination, the patient experienced episodes of heart racing, heart miss a beat, and heart flutters. Also, second dose scheduled after 36 days from the first dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, episodes of heart racing, heart miss a beat, heart flutters, were unknown. Action taken with mRNA-1273 in response to the event, second dose scheduled after 36 days from the first dose, was not applicable.  The outcomes of the events, episodes of heart racing, heart miss a beat, heart flutters, were considered to be unknown. The outcome of the event, second dose scheduled after 36 days from the first dose, was considered to be resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot# 012L20A). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Influenza like illness, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Pneumonia; Low blood Pressure; Flu-like symptoms; Fever; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and HYPOTENSION (Low blood Pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization), HYPOTENSION (Low blood Pressure) (seriousness criterion hospitalization), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and VOMITING (Threw up). At the time of the report, PNEUMONIA (Pneumonia), HYPOTENSION (Low blood Pressure), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness, Therapy cessation, Visual impairment
Clinical narrative: Will not be getting the second dose; She felt like someone stab her in the heart; Dizzy, Light Headed; Could not see, looks fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (She felt like someone stab her in the heart) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder and Heart rate increased (She has a history of rapid heart beat.). Previously administered products included for Flu vaccination: flu (She had an allergic reaction to the flu vaccine in October 2020.) in October 2020. Past adverse reactions to the above products included Allergic reaction with flu. Concurrent medical conditions included Multiple allergies (stated "she is allergic to everything").    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ANGINA PECTORIS (She felt like someone stab her in the heart) (seriousness criterion medically significant), DIZZINESS (Dizzy, Light Headed) and VISUAL IMPAIRMENT (Could not see, looks fuzzy). On an unknown date, the patient experienced TREATMENT NONCOMPLIANCE (Will not be getting the second dose). At the time of the report, ANGINA PECTORIS (She felt like someone stab her in the heart), DIZZINESS (Dizzy, Light Headed), VISUAL IMPAIRMENT (Could not see, looks fuzzy) and TREATMENT NONCOMPLIANCE (Will not be getting the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Therapy cessation for mRNA-1273 (Batch no. 013M20A) by the patient's healthcare provider. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Illness, Pyrexia, Tremor
Clinical narrative: Tremors throughout his body; Weak after the fever; sicker than the first; Dizziness; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Tremors throughout his body) and ASTHENIA (Weak after the fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included METOPROLOL and ATENOLOL for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced TREMOR (Tremors throughout his body) (seriousness criterion medically significant), ASTHENIA (Weak after the fever) (seriousness criterion medically significant), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever). At the time of the report, TREMOR (Tremors throughout his body), ASTHENIA (Weak after the fever), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment provided included Tylenol.  This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-059569 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: unilateral loss of hearing; white noise; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (unilateral loss of hearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (unilateral loss of hearing) (seriousness criterion medically significant) and TINNITUS (white noise). At the time of the report, DEAFNESS UNILATERAL (unilateral loss of hearing) and TINNITUS (white noise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Condition aggravated, Pain in extremity, Pyrexia
Clinical narrative: continued to fall after the second shot; sore arm; chills; fever; hair fall completely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (hair fall completely) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ALOPECIA (hair fall completely) (seriousness criterion medically significant). On 15-Mar-2021, the patient experienced CONDITION AGGRAVATED (continued to fall after the second shot), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever). At the time of the report, ALOPECIA (hair fall completely), CONDITION AGGRAVATED (continued to fall after the second shot), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Having treatment on her head twice a day.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further follow-up information is expected.   This case was linked to MOD-2021-059575 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further follow-up information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: "On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient  was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication.   On 07-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved.            Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Chills
Clinical narrative: (197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chills); Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ((197/101) high blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ANASTROZOLE and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED ((197/101) high blood pressure) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), DIZZINESS (Extreme dizziness) and CHILLS (Could not get warm (chills)). On 26-Mar-2021, BLOOD PRESSURE INCREASED ((197/101) high blood pressure) and DIZZINESS (Extreme dizziness) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), PAIN IN EXTREMITY (Sore arm) and CHILLS (Could not get warm (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 196 (High) high. On 25-Mar-2021, Blood pressure measurement: 197/101 (High) High. On 26-Mar-2021, Blood glucose: 190 (High) high. On 26-Mar-2021, Blood pressure measurement: (normal) normal.         No treatment was provided.; Sender's Comments: This case concerns an 83-year-old female with a serious unexpected event of increased blood pressure, and nonserious unexpected dizziness, pain in extremity, glucose increased and expected chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: (197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chills); Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ((197/101) high blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ANASTROZOLE and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED ((197/101) high blood pressure) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), DIZZINESS (Extreme dizziness) and CHILLS (Could not get warm (chills)). On 26-Mar-2021, BLOOD PRESSURE INCREASED ((197/101) high blood pressure) and DIZZINESS (Extreme dizziness) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), PAIN IN EXTREMITY (Sore arm) and CHILLS (Could not get warm (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 196 (High) high. On 25-Mar-2021, Blood pressure measurement: 197/101 (High) High. On 26-Mar-2021, Blood glucose: 190 (High) high. On 26-Mar-2021, Blood pressure measurement: (normal) normal.         No treatment was provided.; Sender's Comments: This case concerns an 83-year-old female with a serious unexpected event of increased blood pressure, and nonserious unexpected dizziness, pain in extremity, glucose increased and expected chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Impaired work ability
Clinical narrative: developed a heart condition; missed work; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (developed a heart condition) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (developed a heart condition) (seriousness criterion life threatening) and IMPAIRED WORK ABILITY (missed work). At the time of the report, CARDIAC DISORDER (developed a heart condition) and IMPAIRED WORK ABILITY (missed work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported  Treatment medication not reported.   Reporter did not allow further contact; Sender's Comments: This case concerns a 57-year-old male with a serious unexpected event of cardiac disorder, and nonserious unexpected Impaired work ability. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Hypoglycaemia, Muscle spasms
Clinical narrative: Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemic crash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and VACCINATION SITE PAIN (Arm soreness). On 21-Mar-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic crash) (seriousness criterion hospitalization), MUSCLE SPASMS (Feet cramping), HYPERHIDROSIS (Sweating) and FEELING COLD (Feeling cold). The patient was hospitalized on 21-Mar-2021 due to HYPOGLYCAEMIA. At the time of the report, HYPOGLYCAEMIA (Hypoglycemic crash), MUSCLE SPASMS (Feet cramping), FEELING ABNORMAL (Brain fog), HYPERHIDROSIS (Sweating), FEELING COLD (Feeling cold) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hypoglycemic crash; Feet cramping; Sweating; Feeling cold; Arm soreness; Brain fog; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Hypoglycemic crash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and VACCINATION SITE PAIN (Arm soreness). On 21-Mar-2021, the patient experienced HYPOGLYCAEMIA (Hypoglycemic crash) (seriousness criterion hospitalization), MUSCLE SPASMS (Feet cramping), HYPERHIDROSIS (Sweating) and FEELING COLD (Feeling cold). The patient was hospitalized on 21-Mar-2021 due to HYPOGLYCAEMIA. At the time of the report, HYPOGLYCAEMIA (Hypoglycemic crash), MUSCLE SPASMS (Feet cramping), FEELING ABNORMAL (Brain fog), HYPERHIDROSIS (Sweating), FEELING COLD (Feeling cold) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Energy increased, Erythema, Feeling abnormal, Flushing
Clinical narrative: Face has stayed slightly red/broken out/more sensitive; Face has stayed slightly red/broken out/more sensitive; Next morning felt supercharged; Face has stayed slightly red/broken out/more sensitive; Headache; Nausea; Heart rate increased (fluttering); Face flushed bright red; Room spinning; Heart rate increased; Feeling odd; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart rate increased (fluttering)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient is not sure, but thinks actually had COVID earlier in the outbreak.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart rate increased (fluttering)) (seriousness criterion medically significant), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged) and RASH (Face has stayed slightly red/broken out/more sensitive). At the time of the report, CARDIAC FLUTTER (Heart rate increased (fluttering)), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged), RASH (Face has stayed slightly red/broken out/more sensitive), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 5-year-old female with serious unexpected events of cardiac flutter, and nonserious unexpected heart rate increased, vertigo, rash, sensitive skin, erythema, flushing, feeling abnormal, energy increased, and expected headache and nausea.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Rash, Sensitive skin
Clinical narrative: Face has stayed slightly red/broken out/more sensitive; Face has stayed slightly red/broken out/more sensitive; Next morning felt supercharged; Face has stayed slightly red/broken out/more sensitive; Headache; Nausea; Heart rate increased (fluttering); Face flushed bright red; Room spinning; Heart rate increased; Feeling odd; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart rate increased (fluttering)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient is not sure, but thinks actually had COVID earlier in the outbreak.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart rate increased (fluttering)) (seriousness criterion medically significant), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged) and RASH (Face has stayed slightly red/broken out/more sensitive). At the time of the report, CARDIAC FLUTTER (Heart rate increased (fluttering)), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged), RASH (Face has stayed slightly red/broken out/more sensitive), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 5-year-old female with serious unexpected events of cardiac flutter, and nonserious unexpected heart rate increased, vertigo, rash, sensitive skin, erythema, flushing, feeling abnormal, energy increased, and expected headache and nausea.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Face has stayed slightly red/broken out/more sensitive; Face has stayed slightly red/broken out/more sensitive; Next morning felt supercharged; Face has stayed slightly red/broken out/more sensitive; Headache; Nausea; Heart rate increased (fluttering); Face flushed bright red; Room spinning; Heart rate increased; Feeling odd; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart rate increased (fluttering)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient is not sure, but thinks actually had COVID earlier in the outbreak.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart rate increased (fluttering)) (seriousness criterion medically significant), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged) and RASH (Face has stayed slightly red/broken out/more sensitive). At the time of the report, CARDIAC FLUTTER (Heart rate increased (fluttering)), FLUSHING (Face flushed bright red), VERTIGO (Room spinning), HEART RATE INCREASED (Heart rate increased), FEELING ABNORMAL (Feeling odd), ERYTHEMA (Face has stayed slightly red/broken out/more sensitive), SENSITIVE SKIN (Face has stayed slightly red/broken out/more sensitive), ENERGY INCREASED (Next morning felt supercharged), RASH (Face has stayed slightly red/broken out/more sensitive), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a 5-year-old female with serious unexpected events of cardiac flutter, and nonserious unexpected heart rate increased, vertigo, rash, sensitive skin, erythema, flushing, feeling abnormal, energy increased, and expected headache and nausea.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Lost vision on her right eye; Numbness in Right side of Face; Numbness in  lip/Numbness in tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLINDNESS (Lost vision on her right eye) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32M209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL (TENORMIN) for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced BLINDNESS (Lost vision on her right eye) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in Right side of Face) and HYPOAESTHESIA ORAL (Numbness in  lip/Numbness in tongue). On 12-Mar-2021, BLINDNESS (Lost vision on her right eye) had resolved. At the time of the report, HYPOAESTHESIA (Numbness in Right side of Face) outcome was unknown and HYPOAESTHESIA ORAL (Numbness in  lip/Numbness in tongue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.