chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 71 year old male patient received an expired dose of Menactra, no AE; 71 year old male patient received an dose of Menactra, no AE; Initial information received on 03-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71 year old male patient who was vaccinated with an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered and Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 03-Feb-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date: 26-Jan-2021) (frequency once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration (latency on same day).  It was also reported that description pharmacy operations manager said that they had a vial of MENACTRA that expired on 26-Jan-2021. She says that they accidentally administered the vaccine to a patient today. Caller would like to find out if the vaccine would need to be re-administered to the patient. Additional Description of event adverse events a pharmacy operations manager reporting on behalf of a consumer that received an expired dose of Menactra, on 03-Feb-2021.   Reporter relationship: (HCP) health care professional, Product used: used still using product: no  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Slight pain at injection site for a couple days.  Then at day 7, itchy round rash developed at injection site.  Raised red area about 3 inches across, feels warm, and itches.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: soreness on the arm where I got the shot,  body aches & tiredness
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, hardness, and warmth in the area of the vaccination (upper left arm)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Pain, Pyrexia
Clinical narrative: 31 weeks + 3 pregnant. estimated due date 4/12/21. Low grade fever of 100 degrees F, body aches, chills, headache. Lasted until 2/12/21 at 8:00am.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Eye swelling, Laboratory test, Rash
Clinical narrative: Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Rash to sore rash to upper chest , and bloating and diarrhea, swollen eyes where vision was like looking through a glass of water.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Stiff arm( 5 days after injection) Then red rash on arm (2.5 inch diameter) (7 days after injection) Then swollen lymph nodes in armpit of injection arm (2 weeks after injection) Then (3 weeks after vaccine) - full body rash/hives, itchy
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Large hot, red rash about 2 inches under injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Covid Arm - 8 days after injection I woke up with a oval shaped red area around the injection site.  It was very puffed up, a bit hard, sore and itchy.  I had no previous side effects except a slight sore arm for a day or two after the injection.  Since I was a bit concerned, I looked up the effect online and found that this is a less common reaction, but does exist.  I plan to keep an eye on it and call my doctor if it hasn't resolved in a couple of days
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Covid Arm - 8 days after injection I woke up with a oval shaped red area around the injection site.  It was very puffed up, a bit hard, sore and itchy.  I had no previous side effects except a slight sore arm for a day or two after the injection.  Since I was a bit concerned, I looked up the effect online and found that this is a less common reaction, but does exist.  I plan to keep an eye on it and call my doctor if it hasn't resolved in a couple of days
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling
Clinical narrative: 1/30/21 at 1pm developed lower lip swelling, progressed down chin to L cheek, no shortness of breath or chest pain Following day extremely tired  Started on prednisone x 5 days with Pepcid.  Symptoms totally resolved after 2 days
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Lip swelling, Metabolic function test
Clinical narrative: 1/30/21 at 1pm developed lower lip swelling, progressed down chin to L cheek, no shortness of breath or chest pain Following day extremely tired  Started on prednisone x 5 days with Pepcid.  Symptoms totally resolved after 2 days
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Tremor
Clinical narrative: Shaking chills, nausea, dizziness, fatigue
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cooling therapy, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I went from couch watching a movie to my husband helping me walk to the bedroom.  My body was locked i could barely move. I went  into a cold hypothermia chill, I could get warm. ( teeth chattering) My husband said I burning up hot on my body . I didn't think to take my temperature.  I was so scared. I've never had the flu ,or anything like this before  in my entire life. I called into work the next day , because  my job is physical.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia
Clinical narrative: 2nd COVID-19 vaccination on 02-11-2021.  NO symptoms with 1st vaccination.  I woke up to a fever of 99.8 on 02-12-2021, which gradually escalated to 102 within 2 hours.  It remained at 102 for most of day. Finally came down to 101.1 by around 6:00PM.  My normal body temperature is low- around 97.6.  I also had an odd sensation at the back of my throat- cannot really describe it- sometimes hurt to swallow- but not consistently.  Only felt that symptom the day of 02-12-2021.  The next morning, my temperature was 99.2.  Eventually returning to normal around 3:00 PM that afternoon. I did not take any OTC medications during the course of recovery.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Vomiting
Clinical narrative: chills sweats, throwing up headaches body aches
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Rash pruritic
Clinical narrative: Red itchy bumps all over my body; starting on lower extremities, and moving to arms and neck.  Large (over quarter size) very swollen lump under skin appeared on right shin- it is firm to touch.   Other details: I did not consume any foods out of my ordinary diet. I did have 1 gin and tonic the night before (first alcohol since getting the vaccine)  I have not been bitten by any bugs to my knowledge, and have not spent any significant time outside.   Benadryl cream on bumps soothsayer for a short time, but itchiness remains. The more I scratch the more they appear.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Started with itching on back and arms on Wednesday 2-10-21.  By Friday evening I had a rash all over my back and hives on my back and right arm.  Some hive are also apparent on my left hand and wrist.  I contacted my doctor Sunday 2-14-21 as the rash and itching were not being controlled by benadryl and hydroctorisone cream.  My doctor gave me Prednisone to take 60mg daily for 5 days.  I am now on day 2 of therapy and the rash on my back has gone down some, the rash on my right wrist and hand are still severe.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: By 10 pm on the evening of the shot, I had a very red and bumpy rash about 2 inches in diameter and 1 inch in height between by breasts. I have never had a rash there before nor have I ever had anything that looks like this.  By around 2 am, I had soreness in my neck and radiating down the entire left side of  my body.   A crinkle in the sheet hurt and I needed to attempt to smooth it out but it was difficult and painful to move. By 4 am the soreness was much diminished. Around 7 am fever, body aches, and headache started. I attempted to sleep it off but the symptoms got so severe around 12 noon that I took Advil. I continued to sleep through the day. I had no appetite and felt nauseous.  Around 2pm I felt well enough to eat something.  By 6 pm I felt mostly normal with only a slight headache. Through the 2nd day I continued to have the rash and it did not change but did become slightly itchy.  Tiredness continued but I was able to make it through most of the 2nd day without irritation or exhaustion. I did go to bed earlier than normal on the 2nd day. Third day rash is the same but itchiness is intensified.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: By 10 pm on the evening of the shot, I had a very red and bumpy rash about 2 inches in diameter and 1 inch in height between by breasts. I have never had a rash there before nor have I ever had anything that looks like this.  By around 2 am, I had soreness in my neck and radiating down the entire left side of  my body.   A crinkle in the sheet hurt and I needed to attempt to smooth it out but it was difficult and painful to move. By 4 am the soreness was much diminished. Around 7 am fever, body aches, and headache started. I attempted to sleep it off but the symptoms got so severe around 12 noon that I took Advil. I continued to sleep through the day. I had no appetite and felt nauseous.  Around 2pm I felt well enough to eat something.  By 6 pm I felt mostly normal with only a slight headache. Through the 2nd day I continued to have the rash and it did not change but did become slightly itchy.  Tiredness continued but I was able to make it through most of the 2nd day without irritation or exhaustion. I did go to bed earlier than normal on the 2nd day. Third day rash is the same but itchiness is intensified.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hip arthroplasty, Pyrexia
Clinical narrative: 100.8°F fever began 12 hours after receiving dose and persisted for 18 hours.  Fatigue; hip pain throughout these hours.  Mild headache began 24 hours after dose, but lasted only a few hours.  Fever did not subside with 1000mg of acetaminophen taken every 4-5 hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Headache, Nausea, Pain
Clinical narrative: 1st Vaccine 1/14/21; 2nd Dose Vaccine 2/2/21; developed nausea, elevated temp, chills, body aches, and severe headache 2/3/21.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Immediate swelling/raised and red area with some itching. Day 9 increased itching/irritation, hot to the touch and still swollen and red raised area.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Immediate swelling/raised and red area with some itching. Day 9 increased itching/irritation, hot to the touch and still swollen and red raised area.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Immediate post-injection reaction, Myalgia, Pain in extremity
Clinical narrative: Pain in arm, full body muscle and joint aches, fever several dats later, immediate rash now spreading across body,severe chills
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Pain in arm, full body muscle and joint aches, fever several dats later, immediate rash now spreading across body,severe chills
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Intermittent pain in arm several inches away from injection site which has continued for 10 days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Malaise
Clinical narrative: Swelling and red rash on arm at site of injection which is still present, body ache and headache, general malaise the day following the injection resolving within 24 hours
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Swelling and red rash on arm at site of injection which is still present, body ache and headache, general malaise the day following the injection resolving within 24 hours
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Cannot not set up an appointment
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash macular
Clinical narrative: Allergic reaction six days after receiving vaccine...red blotch at vaccine site, itchy...this is second day and still the same. Have photo if needed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red swelling  and itching around injection site that didn't appear until a week after the 1st dose of the vaccine.  Swollen spot is about the size of the palm of my hand.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Lymph node pain, Rash erythematous, Rash papular
Clinical narrative: After 8 days post vaccine, a red raised rash appeared at injection site.  Rash was circular and 5 inches in diameter.  There was pain in elbow area (lymph nodes?) as well.   No other symptoms. There was no rash or redness after the vaccine, only appeared 8 days later.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Painful, reddened big toe on left foot within 24 hours of injection. Pain and redness disappeared after 24 hours. Itchy, reddened rash at injection site on left arm which is still present as of 2/15/21.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain
Clinical narrative: Initially, focal pain in left shoulder, subscapular. In susequent days more diffuse in location and more intense. Distribution shoulders and upper back, greater on left. Exacerbated by motion and pressure. Relieved by acetominophen.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt. reported itching on back and bilateral arms. Pt. did not complain of shortness of breath, GI upset, difficulty breathing; redness to bilateral upper arms and scapular region. Pt. stated she does have an allergy to penicillin but does not carry emergency medication for treatment. Pt. declined EpiPen and shared with pt and husband, the driver, that it was protocol to call EMS at this time due to reaction. Pt and husband upset and concerned about cost of EMS ride. Driver (husband) stated he would take pt to ED if emergency care was needed. Called 911 to have EMS dispatched and while on line with dispatcher, husband stated he was leaving and proceeded to exit the vaccination site.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: began to feel foggy headed which came and went on day 2. On day 3 the foggy head also came with nausea. Persisted off and on all day. When I went to bed around 11:30 pm that day I began to feel like I was inside a closed up box. This persisted and disappeared around 3 am on the 4th morning and hasn't returned
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: no additional AE; the patient received a 4th dose of GARDASIL 9; the first dose was administered 25-FEB-2016, 2nd dose administered on 05-JUN-2018; This spontaneous report was received from a registered nurse 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 25-FEB-2016, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 05-JUN-2018 and 11-DEC-2018, the second and the third dose of the vaccine (exact doses, route of administration, anatomical location, lot # and expiration date were not reported) were administered to the patient, respectively (inappropriate schedule of vaccine administered). On 09-FEB-2021, the patient received the fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T026954, expiration date 13-APR-2022 (exact dose, route of administration and anatomical location were not provided) (extra dose administered). No adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; 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
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of ROT ATEQ was administered to a patient on 2/9/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-FEB-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot#S012679, expiration date reported as 17-JAN-2021, but upon internal review established as 07-JAN-2021 (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was a second dose of the series. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered not recovered/not resolved (reported as would continue suffer ongoing injuries). The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Morphoea
Clinical narrative: morphea; Information has been received from a lawyer, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 54 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 03-JUN-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: morphea. The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related conditions; shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. The patients concurrent conditions and historical conditions were not reported. On or about 11-AUG-2016,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zosterrelated conditions.As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The evenst were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Death, Herpes zoster, Pain, Vaccination failure
Clinical narrative: died from heart problems; suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of heart disorder in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles when he was 8 years.).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the heart disorder was fatal and the outcome of the vaccination failure, shingles and pain were unknown. The reported cause of death was heart disorder.   It was unknown if the reporter considered the heart disorder, vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient received shingrix in his early 80s and he ended up  with shingles. The patient had bad pain until he  died from  heart problems.; Reported Cause(s) of Death: Heart disorder
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Cognitive disorder, Dysarthria, Dyspnoea
Clinical narrative: Rash around injection site; Could not think straight / described as decreased cognitive ability; Night sweats; Labored breathing; slurred speech; difficulty sleeping; Llegs felt very heavy / hard to move; joint pain; Pain at the injection site; Malaise; Fatigue; Llegs felt very heavy / hard to move; Pain above the rib cage; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, malaise, fatigue, heaviness in leg, chest pain, joint pain and mobility decreased. On 16th December 2020, the patient experienced cognitive disturbance, night sweat, labored breathing, slurred speech and difficulty sleeping. On 17th December 2020, the patient experienced injection site rash. On 15th December 2020, the outcome of the injection site pain was recovering/resolving. On an unknown date, the outcome of the malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site pain, malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at physician's office and immediately felt pain at the injection site.  Two hours later, the patient experienced malaise and fatigue and reported that his legs felt very heavy and hard to move.  The patient experienced pain above the rib cage.  The patient could not think straight, described as decreased cognitive ability. The patient had joint pain and slurred speech. The patient experienced night sweats and difficulty sleeping and experienced labored breathing.   2 days later, the patient had rash appeared around the injection site.  The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site rash, Insomnia, Limb discomfort
Clinical narrative: Rash around injection site; Could not think straight / described as decreased cognitive ability; Night sweats; Labored breathing; slurred speech; difficulty sleeping; Llegs felt very heavy / hard to move; joint pain; Pain at the injection site; Malaise; Fatigue; Llegs felt very heavy / hard to move; Pain above the rib cage; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, malaise, fatigue, heaviness in leg, chest pain, joint pain and mobility decreased. On 16th December 2020, the patient experienced cognitive disturbance, night sweat, labored breathing, slurred speech and difficulty sleeping. On 17th December 2020, the patient experienced injection site rash. On 15th December 2020, the outcome of the injection site pain was recovering/resolving. On an unknown date, the outcome of the malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site pain, malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at physician's office and immediately felt pain at the injection site.  Two hours later, the patient experienced malaise and fatigue and reported that his legs felt very heavy and hard to move.  The patient experienced pain above the rib cage.  The patient could not think straight, described as decreased cognitive ability. The patient had joint pain and slurred speech. The patient experienced night sweats and difficulty sleeping and experienced labored breathing.   2 days later, the patient had rash appeared around the injection site.  The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Mental impairment, Mobility decreased, Musculoskeletal chest pain, Night sweats
Clinical narrative: Rash around injection site; Could not think straight / described as decreased cognitive ability; Night sweats; Labored breathing; slurred speech; difficulty sleeping; Llegs felt very heavy / hard to move; joint pain; Pain at the injection site; Malaise; Fatigue; Llegs felt very heavy / hard to move; Pain above the rib cage; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, malaise, fatigue, heaviness in leg, chest pain, joint pain and mobility decreased. On 16th December 2020, the patient experienced cognitive disturbance, night sweat, labored breathing, slurred speech and difficulty sleeping. On 17th December 2020, the patient experienced injection site rash. On 15th December 2020, the outcome of the injection site pain was recovering/resolving. On an unknown date, the outcome of the malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping were unknown.   It was unknown if the reporter considered the injection site pain, malaise, fatigue, heaviness in leg, chest pain, cognitive disturbance, night sweat, labored breathing, injection site rash, joint pain, slurred speech, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at physician's office and immediately felt pain at the injection site.  Two hours later, the patient experienced malaise and fatigue and reported that his legs felt very heavy and hard to move.  The patient experienced pain above the rib cage.  The patient could not think straight, described as decreased cognitive ability. The patient had joint pain and slurred speech. The patient experienced night sweats and difficulty sleeping and experienced labored breathing.   2 days later, the patient had rash appeared around the injection site.  The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, 2am the patient passed away. Administrator marked as natural causes. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was fatal. The patient died on 30 Dec 2020. The cause of death was reported as unknown.  The reporter did not provide an assessment for the event, passed away.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, after vaccine administration, the patient experienced a severe allergic event. The event was angioedema which required multiple epinephrine injections.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, angioedema, was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of angioedema. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: patient had allergies; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case from physician.  This case involves patient (unknown demographics) who had allergic reaction (Hypersensitivity), after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (Hypersensitivity) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the event.  There will be no information on the batch number to be requested for this case.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: Right foot toe(next to big toe) turned bluish like a bruised toe. Showed Doctor she said that if it turned cold(which it hasn't) go to an emergency room. As of today 2/15/2021 it is still looking the same
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching started on my neck around 4pm.  Then noticed after undressing that I had a rash with hives on my neck, torso, back, and upper thighs.  Took benadryl 25mg x 1 dose and went to bed.  Around 6am the next day the rash was completely gone.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Patient reported tingling of her right hand right after she got her vaccine.  Patient stated that the same happened when she got the first dose.  At 94:43 am she stated she is feeling better and tingling is going away.  She wants to go home.  At 9:47 am patient stated she is going home, she is feeling ok now.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, slight swelling and itchy at vaccine site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain
Clinical narrative: Severe back and abdominal pain, leading to emergency department visit
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fever 102, Nausea, and fatigue
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever 101 diharrea Sever Fatigue very week
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Hypotension, Malaise
Clinical narrative: Pt experienced lightheadedness, hypotension to 70's /30's, and coughing episode ~10-15 min after receiving dose of Pfizer vaccine. Pt appropriately waited in immediate waiting room and began to feel unwell. Patient taken to ED via EMS.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Urticaria
Clinical narrative: 8 days later, I experienced swelling at the injection site and I broke out in hives. The hives were mostly on my arms, but some were on my neck, face and stomach.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever, headache.  This started at 6pm Feb 5, 2021 and continued until Feb 7, 2021 at 1am.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Chills, Dizziness, Drug interaction
Clinical narrative: 3-5 min following second dose of daily/regular lamotrigine, blood pressure fell (to the level of being lightheaded almost passing out), rapid heart rate and tightness in chest and decreased ability to fully inflate lungs when attempting to take a deep breath.  Symptoms began almost immediately following ingestion of lamotrigine and lasted approximately 5-7 min. Other symptoms include-fever (100.4), extreme body chills, swelling in left knee, extreme fatigue, painful muscles at site of injection. Symptoms began approximately 12 hours following injection. High fever and extreme body chills lasted approximately 3 hours, low grade fever and fatigue lasted ~24 hours after injection, swelling in left knee lasted ~ 4-5 days following injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypopnoea, Injection site pain, Joint swelling
Clinical narrative: 3-5 min following second dose of daily/regular lamotrigine, blood pressure fell (to the level of being lightheaded almost passing out), rapid heart rate and tightness in chest and decreased ability to fully inflate lungs when attempting to take a deep breath.  Symptoms began almost immediately following ingestion of lamotrigine and lasted approximately 5-7 min. Other symptoms include-fever (100.4), extreme body chills, swelling in left knee, extreme fatigue, painful muscles at site of injection. Symptoms began approximately 12 hours following injection. High fever and extreme body chills lasted approximately 3 hours, low grade fever and fatigue lasted ~24 hours after injection, swelling in left knee lasted ~ 4-5 days following injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 3-5 min following second dose of daily/regular lamotrigine, blood pressure fell (to the level of being lightheaded almost passing out), rapid heart rate and tightness in chest and decreased ability to fully inflate lungs when attempting to take a deep breath.  Symptoms began almost immediately following ingestion of lamotrigine and lasted approximately 5-7 min. Other symptoms include-fever (100.4), extreme body chills, swelling in left knee, extreme fatigue, painful muscles at site of injection. Symptoms began approximately 12 hours following injection. High fever and extreme body chills lasted approximately 3 hours, low grade fever and fatigue lasted ~24 hours after injection, swelling in left knee lasted ~ 4-5 days following injection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: About thirty hours after receiving  first dose I started feeling waves of nausea, 2 days later it has improved but not completely gone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash pruritic
Clinical narrative: Within 3 days large red rashy type patch around injection site much larger than original bandaid. Within 9 days mild itchy rash on neck and across back and a number of raised red bumps all over back-but back bumps not itchy.  Rashes passed within a day. Rsised bumps still present to some extent.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After administering first covid dose, pt. began developing hives across chest and collar bone area. Patient declined shortness of breath, itching, GI upset, difficulty swallowing. Epi-Pen and 9-1-1 offered, patient declined. At this time, pt. stated about 15 years ago developed an idiopathic allergic reaction to an unknown allergen requiring epinephrine administration. The patient stated she does not carry an EpiPen nor does she have one at home. Patient declined 9-1-1 and EpiPen and stated she wanted to remain in observation area for a few more minutes. Patient remained in car in observation area for approximately 20 minutes longer and then choose to return home. At time of departure, patient did not have shortness of breath, GI upset, difficulty swallowing, itching and exited from drive thru site on her own.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Oral herpes, Pyrexia
Clinical narrative: Approximately 24 hours post injection-fever-102.4, and fatigue.  Fever persisted for 24 hours then resolved.  Fatigue persisted for 48 hours then resolved.  Possible side effect-72 hours post injection-queasy stomach, malaise-Duration-approx. 6 hours all resolved.  Also, cold sores erupted on lower lip for no reason.  Being treated with Abreva.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chills, Pneumonia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Moderna COVID?19 Vaccine EUA  Patient received her first dose of Moderna on 2/10/2021. On 2/11/2021 she developed chills and fever of 104. She was sent to Hospital. Was admitted and chest Xray showed patchy spots suspicious of pneumonia. She remained inpatient for two days with antibiotic treatment. Was discharged home on 2/13/2021 with oral antibiotic and follow up appointment with pulmonary.  PCR and rapid COVID testing while inpatient was nagative for COVID-19
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying
Clinical narrative: Unable to keep liquids and food  down for over 11 days. Had to receive IV fluids and nutrients.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Polymenorrhoea
Clinical narrative: Started my period five (5) days early - have a very regular cycle Swollen lymph nodes under left arm - arm vaccine was given in
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram carotid abnormal, Brain stem infarction, Cerebral infarction, Computerised tomogram head, Dysarthria
Clinical narrative: A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Magnetic resonance imaging brain abnormal, Muscular weakness
Clinical narrative: A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash, Swelling
Clinical narrative: Rash, swelling, itching, some lethargy and slight headache, Tylenol, Rash and itching diminishing, other symptoms gone
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Malaise, Pyrexia
Clinical narrative: Chills, fever of about 100 degrees , fatigue, malaise.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get warm
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get warm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystectomy, Gallbladder disorder, Nausea
Clinical narrative: Extreme nausea, which triggered gallbladder attack. Resulting in hospitalization for emergency gallbladder removal.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain
Clinical narrative: Body aches, cough - unclear if adverse reaction to vaccine or just symptom onset with some time proximity to vaccine administration
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Vomiting
Clinical narrative: Headaches and Migraines and vomiting,  Maxalt  10 mg Tylenol
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeding disorder, Gait inability
Clinical narrative: Severe chills, unable to walk, unable to sleep, severe leg aches, severe backaches, unable to eat, symptoms lasted 32 hours. Fatigue continues. Husband had absolutely no symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Severe chills, unable to walk, unable to sleep, severe leg aches, severe backaches, unable to eat, symptoms lasted 32 hours. Fatigue continues. Husband had absolutely no symptoms.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Oesophageal spasm, Pruritus, Wheezing
Clinical narrative: Anaphylactic Reaction: itching, redness of skin, wheezing, esophageal spasms and constriction requiring 911, ER and anaphylactic protocols
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip pain, Lip swelling, Pain, Pyrexia
Clinical narrative: Serve lip swelling and lip pain; Fever of 104; Chills; Aches; 3 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: Pain and soreness at injection site.  Lightheaded for few hours following injection.  Mild Fatigue several hours after injection.  Occasional itching at injection site a few days after injection.