chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Headache, Hypoaesthesia, Hypoaesthesia oral, Nausea
Clinical narrative: heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness of the lips; numbness of the throat; dry mouth; super thirsty; elevated blood pressure of 175/56; couldn't talk; shaking; terrible pain in chest and mid area; gassiness; headache; Nausea; A spontaneous report was received from a Consumer concerning a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events like bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  The patient's medical history provided included Lupus and Sjogren's. No relevant concomitant medications were reported.     On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, The patient experienced the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  Laboratory details were not provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, nausea, right arm went numb, resolved on 12 Feb 2021.  The outcome of the event headaches was resolved on 13 Feb 2021.  At the time of the report the events of chest pain and gassiness were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of  Lupus and Sjogren's can be contributing factor. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal hypoaesthesia, Tachycardia, Thirst, Tremor
Clinical narrative: heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness of the lips; numbness of the throat; dry mouth; super thirsty; elevated blood pressure of 175/56; couldn't talk; shaking; terrible pain in chest and mid area; gassiness; headache; Nausea; A spontaneous report was received from a Consumer concerning a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events like bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  The patient's medical history provided included Lupus and Sjogren's. No relevant concomitant medications were reported.     On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, The patient experienced the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  Laboratory details were not provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, nausea, right arm went numb, resolved on 12 Feb 2021.  The outcome of the event headaches was resolved on 13 Feb 2021.  At the time of the report the events of chest pain and gassiness were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of  Lupus and Sjogren's can be contributing factor. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received less than the recommended dose; A spontaneous report, was received from a nurse, a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date in Jan 2021, one day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  The nurse stated that they administered a vaccine and the patient received less than the recommended dose on an unknown date in Jan 2021. The nurse doesn't have any further information regarding the patient at this moment.   Treatment is not applicable  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, unknown lot number  with no associated AEs.  Causality for this medication error is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: PE; DVT; A spontaneous report was received from a pharmacist concerning patient (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a pulmonary embolism (PE) and deep vein thrombosis (DVT).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a PE and DVT. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, PE and DVT, were not reported.; Reporter's Comments: Very limited information regarding the reported evens have been provided at this time.  No additional  information is expected as consent to follow up was denied.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age) with no associated adverse events.  The patient's medical history was not provided. No concomitant medications was reported.  On 17-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 016M20A) via unknown route for prophylaxis of COVID-19 infection.  Treatment information was not applicable.  Action taken with mRNA-1273 was not provided..  The outcome of the event, vaccine was administered to a 16 year old, was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age 16 year old for mRNA-1273 (Lot number: 016M20A) with no associated AEs reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Doses administered less than one month apart; A spontaneous report was received from a consumer concerning a 66-year-old female patient who received two doses of Moderna's COVID-19 vaccine (mRNA-1273) less than one month apart.  The patient's medical history was not provided. No concomitant medications were provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021. On 10 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) in the for prophylaxis of COVID-19 infection.  On 10 Feb 2021, second dose administered less than one month apart from first dose. On 19 Feb 2021, the patient donated blood one week after receiving both doses of the vaccine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event doses administered less than one month apart was considered recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, batch # unknown,  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Felt some of the dose going down arm; Felt some of the dose going down arm; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient moved during the vaccination consequently some of the dose went down her arm.   The patient's medical history was not provided. No concomitant product use was reported.  On 19 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 16M20A) intramuscularly for prophylaxis of COVID-19 infection. It was reported that the patient moved during the vaccination consequently some of the dose went down her arm.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event felt some of the dose going down arm, was considered as recovered on 19 Feb 2021.  .; Reporter's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # 16M20A with no associated AEs. Causality for the medication error is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose to a patient who is under 18 years of age by a couple months; A spontaneous report was received from a pharmacist concerning a patient under 18-year-old, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown), unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, patient who is under 18 years of age by a couple months received Moderna's COVID-19 vaccine (mRNA-1273) was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration for mRNA-1273, batch number - unknown, with associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain
Clinical narrative: received the vaccine too high on her shoulder; Experienced a lot of pain; A spontaneous report ( was received from a physician concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received the vaccine too high on her shoulder (incorrect route of product administration) and a lot of pain.  The patient's medical history was not provided by the reporter. Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   It was reported that the patient, who was a healthcare worker, received her vaccination too high on her shoulder.  Additionally, she experienced a lot of pain.  Treatment for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, received the vaccine too high on her shoulder, was considered recovered/resolved.  The outcome of the event, a lot of pain, was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected event of Incorrect route of product administration for mRNA-1273 (lot # unknown) with associated unexpected adverse event of pain.  Adverse event outcome unknown. 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: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose earlier than the recommended dosing window; A spontaneous report was received from a registered nurse for a 35-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and receieved the second dose earlier than the recommended dosing window.    The patient's medical history was not provided. No concomitant product use was reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021, approximately 19 days apart, patient received second of the two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient received second dose a little early.  No AEs were reported and no treatment medications were reported.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, received dose earlier than recommended dosing window, was considered recovered/resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A  with no associated AEs.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was very ill for two weeks after the flu shot, never had another and never got the flu, It has been like 40 years; Initial information was receive on 07-Oct-2020 regarding an unsolicited valid non-serious case from the consumer/non-health care professional.  This case involved an unknown age female patient who was very ill for two weeks after the flu shot, never had another and never got the flu, it has been like 40 years (illness), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was very ill for two weeks after the flu shot, never had another and never got the flu, it has been like 40 years (illness), (latency: unknown) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown at the time of reporting.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Pharyngeal swelling, Swollen tongue, Vertigo
Clinical narrative: Right after shot swelling on tongue and throat.  Reason for hospital visit abdomen pain steadily increasing all labs were negative so if had to be a reaction to injection in addition to a lot of vertigo and nausea
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Headache
Clinical narrative: After receiving her vaccine client stated that she has headache and dry throat.  Vital signs obtained by EMS BP 163/83, HR 79, O2 sat 96% Client states she feels better.  Client discharged home by EMS.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Headache
Clinical narrative: headache, fatigue, high blood sugars
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: After receiving her vaccine client complained of pressure in her chest.  Vital signs obtained by EMS. BP 162/106, HR 82, O2 Sat 99%. Client states she feels better.  Client discharged home by EMS.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: general moderate joint pain, chills, moderate headache, fatigue  mostly gone by the morning of 3/5/2021
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Redness, pain, swelling, rash, itching
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The injection site is sore and swollen 1 week after the injection. It was sore 1 day after, subsided, and returned suddenly 1 week later
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Pain, Pruritus
Clinical narrative: Large red blotch. Hot, itchy.. looks like a giant hive Also was tired and achey with headache.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Large red blotch. Hot, itchy.. looks like a giant hive Also was tired and achey with headache.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: Swelling under left eye
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Fever (Tmax 101.2° F), nausea, and lethargy began at 0200 the morning following 2nd dose of COVID-19 vaccine, with symptoms lasting 24 hours. Before I experienced these side effects after both the 1st and 2nd doses of the COVID-19 vaccine, I had never experienced even expected side effects after a vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: redness of injection arm
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Enlarged nymph node under left armpit Swollen left arm with pain along the inner left arm
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Feeling hot, Nausea
Clinical narrative: Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FAINTING- NO LOSS OF CONSCIOUSNESS-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE, PATIENT STATED SHE WAS LIGHT HEADED. THEN PROGRESSED TO NAUSEA AND PLACED HEAD BETWEEN LEGS SAYING SHE FELT HOT. ICE PACKS WERE PLACED ON PATIENTS NECK. SHE SAID SHE NEEDED TO LAY DOWN AND TRIED TO TAKE HER TO MINUTE CLINIC BUT SHE WAS PLACED ON FLOOR BECAUSE SHE WAS UNSTABLE WALKING. SHE LOST CONTROL OF HER BOWELS AND HAD DIARRHEA ON HERSELF AND THE FLOOR. 911 WAS CALLED AND VITALS WERE TAKEN AND SHE WAS STABLE. SHE REFUSED TO GO TO ER BECAUSE SHE SAID SHE WAS BETTER.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: FAINTING- NO LOSS OF CONSCIOUSNESS-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: IMMEDIATELY AFTER VACCINE, PATIENT STATED SHE WAS LIGHT HEADED. THEN PROGRESSED TO NAUSEA AND PLACED HEAD BETWEEN LEGS SAYING SHE FELT HOT. ICE PACKS WERE PLACED ON PATIENTS NECK. SHE SAID SHE NEEDED TO LAY DOWN AND TRIED TO TAKE HER TO MINUTE CLINIC BUT SHE WAS PLACED ON FLOOR BECAUSE SHE WAS UNSTABLE WALKING. SHE LOST CONTROL OF HER BOWELS AND HAD DIARRHEA ON HERSELF AND THE FLOOR. 911 WAS CALLED AND VITALS WERE TAKEN AND SHE WAS STABLE. SHE REFUSED TO GO TO ER BECAUSE SHE SAID SHE WAS BETTER.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Pruritus, Rash, Vision blurred
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt complained of blurred vision and anxiety 15 min after injection.  After another 10 min, pt complained breathing was becoming difficult. She refused oral Benadryl.  I called 911.  Paramedics gave her IM Bendaryl. Pt refused to go to ER as symptoms had improved.  She waited an additional 20 minutes in pharmacy before going home.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt complained of blurred vision and anxiety 15 min after injection.  After another 10 min, pt complained breathing was becoming difficult. She refused oral Benadryl.  I called 911.  Paramedics gave her IM Bendaryl. Pt refused to go to ER as symptoms had improved.  She waited an additional 20 minutes in pharmacy before going home.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Additional Details: PATIENT HAD UPPER SKIN REACTION (REDNESS OF BOTH ARMS BUT LEFT ARM WAS MORE, ITCHIING AND LATER USED THE RESTROOM. SHE REPORTED OK IN UNDER 30 MINUTES AND LEFT THE FACILITY. i CALLED AFTER WORKING HOURS AT 8 P.M TO FOLLOW UP AND NO ONE PICKED UP THE PHONE, I LEFT A MESSAGE
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremities)-Mild. Systemic: Allergic: Itch Generalized-Mild. Systemic: Chest Tightness/Heaviness/Pain-Medium. Systemic: Tingling (specify: facial area, extremities)-Medium.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, Painful, Swollen at injection site 2 inch circumference.  Fatigue. 650 mg Tylenol every 6 hours for 24 hours.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes normal, Blood test normal, Electrocardiogram normal, Headache, Influenza like illness
Clinical narrative: Tachycardia around 5am the next day. Woke up to tachycardia following sleep and checked pulse and it was over 140. Emergency room advised over the phone to come in.  Prior to that, flu like symptoms all day following vaccine; headache, muscle pain, body aches ? unable to ease symptoms through liquids and flu medication.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sinus tachycardia, Tachycardia
Clinical narrative: Tachycardia around 5am the next day. Woke up to tachycardia following sleep and checked pulse and it was over 140. Emergency room advised over the phone to come in.  Prior to that, flu like symptoms all day following vaccine; headache, muscle pain, body aches ? unable to ease symptoms through liquids and flu medication.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 4.42
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Pain
Clinical narrative: Within one hour of vaccine, pain at sight of injection.  Within three hours of receiving vaccine, body aches, joint aches.  Within 8 hours of vaccine, headache.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt was walking out and collapsed on the floor, pt regained consciousness after couple seconds, pt is alert and responsive, and he thinks he just got up too fast, pharmacy gave pt water and he was okay after sitting and resting
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Chills, some fatigue and body aches.  Left arm sore, red, and hot to touch
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Chills, some fatigue and body aches.  Left arm sore, red, and hot to touch
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Malaise
Clinical narrative: Radiating pain at the injection site. Intermittent dizziness and chills. Malaise, joint pain, body aches, sleepiness..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Radiating pain at the injection site. Intermittent dizziness and chills. Malaise, joint pain, body aches, sleepiness..
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Headache and Bad upper arm/shoulder pain the first night and second day.  Severe upper arm/shoulder pain - so bad that it kept me up at night and I couldn't lay on my left side.  Along with the shoulder pain the second night the headache continued on and off (took aspirin to try to help) the second day and through the night and a low grade fever 99.5-100. developed through the second night.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Headache and Bad upper arm/shoulder pain the first night and second day.  Severe upper arm/shoulder pain - so bad that it kept me up at night and I couldn't lay on my left side.  Along with the shoulder pain the second night the headache continued on and off (took aspirin to try to help) the second day and through the night and a low grade fever 99.5-100. developed through the second night.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Paraesthesia
Clinical narrative: Tingling in the arm and high blood pressure of 170/86.  Paramedics assessed pt. once symptoms subsided pt. was released to leave.  Tent 14.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Skin warm
Clinical narrative: raised red rash covering the bicep, warm to touch, itchy
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate decreased, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: I had no reaction to the first shot , except sore arm for one day.  After the 2nd shot, the next day I developed a high fever (103) and chills.  I called urgent care that evening to see how to bring the fever down.  They told me that was my body building antibodies.  The fever "broke" later that night.  I never have gotten rid of the chills.  I did not see a doctor for this reaction. During this time, not exactly sure of the dates, the cardiologist started me on a new medicine - Verapamil.   I thought the chills might be from the medicine.  She reduced the dosage due to low heart rate, and I'm still taking the medicine.   I now have a rash on my side and on my left thigh, which is blotchy, red, and itchy.  I do not know if these reactions are from the medicine or from the vaccine, but I suspect it is the Moderna vaccine.  The chills are mostly centered in my legs.  They are not letting up.  I have not seen my doctor about the rash yet.  I have had the rash for a couple of weeks, trying to get rid of it myself.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I had no reaction to the first shot , except sore arm for one day.  After the 2nd shot, the next day I developed a high fever (103) and chills.  I called urgent care that evening to see how to bring the fever down.  They told me that was my body building antibodies.  The fever "broke" later that night.  I never have gotten rid of the chills.  I did not see a doctor for this reaction. During this time, not exactly sure of the dates, the cardiologist started me on a new medicine - Verapamil.   I thought the chills might be from the medicine.  She reduced the dosage due to low heart rate, and I'm still taking the medicine.   I now have a rash on my side and on my left thigh, which is blotchy, red, and itchy.  I do not know if these reactions are from the medicine or from the vaccine, but I suspect it is the Moderna vaccine.  The chills are mostly centered in my legs.  They are not letting up.  I have not seen my doctor about the rash yet.  I have had the rash for a couple of weeks, trying to get rid of it myself.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: chills, low grade fever 100. just not feeling wee. Started around 1 am.  Its 8 am now.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Contusion, Pain in extremity
Clinical narrative: Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vaccine and persisted until 3/4/2021. Pain improved on 3/4/2021 but not resolved. Left upper arm/shoulder pain w/full ROM.  Reported no side effects after 1st COVID-19 vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Modern a COVID-19 vaccine EUA arm swelled and rash at injection site 2 weeks after injection
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient reported 1st dose gave her jaw tingling on her way home after her 15 minute obs.  She states on arriving home it had dissappeared.  Today we agreed with charge nurse we would keep her additional 15 minutes.  As   first dose at the 15 min mark she reported tingling in jaw at 20 minutes she reported the tip of her tongue was tingling.  She states some times when eating hard candies she has the same sensation with her tongue.  At 10:14 she states vaccine side effects have resolved bp 156/86 HR 80 OX 100 %  We agreed she would stay 15 minutes   longer.  We discussed any oral itching of throat itching any airway sensations she will seek medical attention.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Lymphadenopathy, Pain, Renal pain
Clinical narrative: Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post shot painful lymph node pain under left arm and side of breast
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: Reported from patient over the phone after the incident:  tingling lips with swelling. Scratchy throat and  cough. Treated with oral Benadryl with relief of symptoms duration Approx  1 1/2-2hours
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swelling in lymph nodes on left side of body. Armpit area. Painful.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Reported fever of 100.6-101, fatigue,headache, muscle ache. Resolved with rest.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Palpitations
Clinical narrative: Heart palpitations, extreme joint pain, extreme headache, nausea for 72 hours. Over the counter medicine of any kind did not aid in symptom relief.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: High fever  Body aches  Headache  Neck pain Sore throat
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Epilepsy, Magnetic resonance imaging
Clinical narrative: I had epileptic seizures 6 days later and they haven't stopped. Never had seizures in my life
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Glossodynia, Oropharyngeal pain, Swollen tongue, Tongue erythema
Clinical narrative: swollen, red, painful tongue with sores lasting for 18 hours followed by sore throat and ear pressure
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: swollen, red, painful tongue with sores lasting for 18 hours followed by sore throat and ear pressure
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Extreme muscle and joint pain
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and smell
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pyrexia, Stomatitis
Clinical narrative: Blisters in my mouth. Extreme tiredness. Headache. Soar throat. Slight fever.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: General malaise, acetaminophen was given every 6 to 8 hours
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Body Aches, Fever as high as 101.6. Fever started the following day (02-26-2021) at 930am and lasted approximately 12 hours. Was down to 99.0 around 8:30pm
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Somnolence
Clinical narrative: Extreme thirst,Fatigue, sleepy, mild muscle pain,joint pain, chills during night
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Extreme thirst,Fatigue, sleepy, mild muscle pain,joint pain, chills during night
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Headache, Nausea
Clinical narrative: Headache, chills, nausea, dry mouth
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Sleep disorder
Clinical narrative: Woke up to swelling, itchiness and redness around injection site.  No fever.  Took Zyrtec and applied cortisone cream to arm.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA005233: US-009507513-2102USA005234: US-009507513-2102USA005235: US-009507513-2102USA005236: US-009507513-2102USA005237: US-009507513-2102USA005238: US-009507513-2102USA005239: US-009507513-2102USA005240: US-009507513-2102USA005241: US-009507513-2102USA005242: US-009507513-2102USA005243: US-009507513-2102USA005244: US-009507513-2102USA005245: US-009507513-2102USA005246: US-009507513-2102USA005247: US-009507513-2102USA005248: US-009507513-2102USA005249: US-009507513-2102USA005250: US-009507513-2102USA005251: US-009507513-2102USA005252: US-009507513-2102USA005253: US-009507513-2102USA005254: US-009507513-2102USA005255: US-009507513-2102USA005256: US-009507513-2102USA005257: US-009507513-2102USA005258: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: vaccines were administered to patients; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T013540, expiration date 17-OCT-2021, 0.5 milliliter 1 dose, subcutaneous (SQ) route (formulation and anatomical location were not reported) for prophylaxis. The reporter did not have cumulative and complete temperature excursion information. It was unknown if a data logger was involved to capture the temperature excursion.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2102USA004608:01865322 US-009507513-2102USA004759:01865321
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error, Product quality issue
Clinical narrative: the healthcare provider used a diluent that did not come with vaccine and administered vaccine to customer; the customer was not provided the diluent for vaccine; no additional adverse events reported; This spontaneous report was received from a male patient of unknown age, who was referring to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date, the patient purchased measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical location, lot # and expiration date were not provided) but was not provided the diluent for the vaccine (product quality complaint). On an unknown date, the healthcare provider used a diluent that did not come with the vaccine to reconstitute the dose and administered it to the patient (wrong diluent used). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: itching around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not selected as per vaccination indication. The patient received his/her Shingrix injection and had severe itching around the injection site.  The reporter asked if it was okay to apply cortisone to the area?
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: 3 incredibly itchy fluid filled blisters / on my pinky on my right hand / on my thumb on my left hand / 2 on my chest; 3 incredibly itchy fluid filled blisters; fever; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 2nd dose of Shingrix. On 12th January 2021, less than a day after receiving Shingrix, the patient experienced fever. On 15th January 2021, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister, fever and pruritus were unknown.   It was unknown if the reporter considered the blister, fever and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had my 2nd Shingrix vaccination on 12 January 2021. The patient developed 3 incredibly itchy fluid filled blisters one on my pinky on right hand, one on thumb on left hand, and on chest. The night of the Shingrix vaccination the patient had a fever. The patient wanted to know why 3 fluid filled blisters after the 2nd Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Swelling
Clinical narrative: body aches; fatigue; very swollen underneath my armpit; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced general body pain, fatigue and local swelling. On an unknown date, the outcome of the general body pain, fatigue and local swelling were unknown.   It was unknown if the reporter considered the general body pain, fatigue and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had 2nd Shingrix vaccine 2 days ago and experienced body aches and fatigue. At the time of reporting it was very swollen underneath armpit.  The patient asked if this was normal?
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial dose on September 15th, 2020 / and contracted shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient do not have a history of contracting chicken pox. The patient took the initial dose of the Shingrix Vaccine from healthcare provider and contracted shingles. The patient was prescribed Valtrex to address the symptoms. The patient's doctor told to contact GlaxoSmithKline to determine if the patient should take the second dose or not.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Fatigue, Headache, Paraesthesia, Pruritus
Clinical narrative: Initial dose on September 15th, 2020 / and contracted shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient do not have a history of contracting chicken pox. The patient took the initial dose of the Shingrix Vaccine from healthcare provider and contracted shingles. The patient was prescribed Valtrex to address the symptoms. The patient's doctor told to contact GlaxoSmithKline to determine if the patient should take the second dose or not.
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Asthenia, Chills
Clinical narrative: chills; weakness; he has loss his taste; he has loss his / smell; This case was reported by a consumer and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, weakness, taste loss and loss of smell. On an unknown date, the outcome of the chills, weakness, taste loss and loss of smell were unknown.   It was unknown if the reporter considered the chills, weakness, taste loss and loss of smell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient was reporter's husband.  The patient experienced chills, weakness. At the time of reporting the patient lost his taste and smell. The reporter asked that if experienced side effect by the patient was common side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain, Pyrexia
Clinical narrative: Fever of 100.9; Having extreme body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced extreme body aches and fever was 100.9. The reporter asked if was it ok. The follow-up would not possible, as no contact details were available.