chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Thursday...3:05pm...metallic taste, sore/hot arm/beginning to swell... Tylenol taken Friday...5pm...severe chills, severe body aches, high fever, exhaustion, thirst until 2:30 am...Motrin taken at around 7pm...Dayquil taken around 1am Saturday 2:30 am chills subside, body aches continue, fever continues, exhaustion continues, thirst continues until 10am Saturday 10am fever subsides and sweating/clamminess begins, body aches subside. Tired Arm is still swollen at this time, burning and itching. Rash appears. Saturday 4pm no longer sweating, slight head ache Monday I still have a rash on the injection point and soreness and slight swelling. Still tired.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Skin warm, Thirst
Clinical narrative: Thursday...3:05pm...metallic taste, sore/hot arm/beginning to swell... Tylenol taken Friday...5pm...severe chills, severe body aches, high fever, exhaustion, thirst until 2:30 am...Motrin taken at around 7pm...Dayquil taken around 1am Saturday 2:30 am chills subside, body aches continue, fever continues, exhaustion continues, thirst continues until 10am Saturday 10am fever subsides and sweating/clamminess begins, body aches subside. Tired Arm is still swollen at this time, burning and itching. Rash appears. Saturday 4pm no longer sweating, slight head ache Monday I still have a rash on the injection point and soreness and slight swelling. Still tired.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: patient bp was recorded as 85/75mmhg at the time patient felt light headednes. rechecked again after 15 minutes and pt felt better and bp recorded-120/79mmhg
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Rash, Rash pruritic
Clinical narrative: Started with a fever - that began about 6 hrs after the injection.  That lasted a little more than 24 hours, then went away.  Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning.  Also, slight swelling of my lips
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: I noticed some hives on my arms, face, and chest area at around 3 or 4pm, and next day it was still present but a little red. It?s better but still here.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: I developed red,warm, hard spot about 2? long and 1? wide at the injection site that appeared over a week later. It was sore and tender after the shot but seemed to go away and now it is back.   I haven?t gone to the doctor about it, I just thought maybe it should be reported. I will continue to watch it.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: After giving the vaccination, patient developed immediate reaction at injection site: warmth, swelling at the site. He did bleed a little and after putting on the bandaid, I went to grab an ice pack and I started applying the icepack to the site. Checked on patient every 5 minutes. Even did a follow up call to him an hour later and he told me he was doing okay. No more warmth in the area, some pain but the swelling had gone down substantially. I suggested to continue to monitor, apply icepack
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pruritus, Rash erythematous
Clinical narrative: Covid arm rash. Large area of red and itchy skin on arm of vaccine site. Also itchy red area on chin and around mouth. Started one week after receiving the vaccine. Also had swollen lymph glands in several places. Some joint pain for a few days
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol  acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Injection site pain, Insomnia, Pain
Clinical narrative: Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol  acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol  acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Covid Arm ? itchy red rash in arm, swelling, appeared 8 days after first shot.  Two days later it is still itchy and has spread further down and inside the arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain
Clinical narrative: Patient had back pain and lower abdominal pain about 24 hours after receiving vaccine.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chills, Confusional state, Decreased appetite
Clinical narrative: Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and  loss of appetite, chills, on  02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Lethargy, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and  loss of appetite, chills, on  02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: 100 degree fever, headaches and intermittent nausea
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 8 days after injection, itching and red lump at site of inject ion- right arm
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mental impairment, Pain, Sleep disorder
Clinical narrative: Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc.  Thinking became foggy - everything became difficult to do.  I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021.  All symptoms had lessened by 30%-50% during the day on 2/26/2021.  By 2/27/2021, I felt pretty much like me again.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pyrexia, Thirst
Clinical narrative: Slight nausea about 4 hours after dose Fever with chills about 8 hours after dose. Very thirsty. Lasted 12 hours General unwell feeling from about 12 to 36 hours after dose
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspepsia, Erythema, Fatigue, Heart rate increased
Clinical narrative: 03/07/21 - after 4 days with no irritation at injection site, arm became red, swollen, hot, amd itchy.  Also experienced high heart rate, amd heartburn. No fever.  03/02/21 - initial side effects severe fatigue, severe joint pain throughout entire body, minor nausea,
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 03/07/21 - after 4 days with no irritation at injection site, arm became red, swollen, hot, amd itchy.  Also experienced high heart rate, amd heartburn. No fever.  03/02/21 - initial side effects severe fatigue, severe joint pain throughout entire body, minor nausea,
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Migraine, Pain
Clinical narrative: I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was "fighting" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was "fighting" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: Approximately 18 hours after the vaccination (the next day when I awoke) I experienced a very sore arm with tenderness at the injection site, plus headache, body aches and chills. This subsided later that day, after approximately 10 hours. The arm at the injection site is slightly tender after 42 hours.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: -pounding headache lasting 8 days  -swelling of the face, eyes, neck, and lymph-nodes in neck for 9+ days (ongoing)  -Swelling of the armpit and pain in the lymph-node under the armpit for 5 days
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: -pounding headache lasting 8 days  -swelling of the face, eyes, neck, and lymph-nodes in neck for 9+ days (ongoing)  -Swelling of the armpit and pain in the lymph-node under the armpit for 5 days
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Delayed reaction to Moderna Covid-19 vaccine.  Rash itching, hot sensation on left arm where the 1st dose was administered.  This started happening 1 week after the injection.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Hyperhidrosis
Clinical narrative: Difficulty breathing High level anxiety  Chills then sweats
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive after 14 days from receiving second covid vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Thirst
Clinical narrative: High fever, chills, sweating , thirst.  Lasted 3 hours and subsided after taking tylenol
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Migraine
Clinical narrative: I don't get headaches -- day after mild headache --  2 days after 8-10 ocular migraines and a good headache.   3 days after things started to clear.     Chronic ache in injection right arm for over a day ..  Started several hours after injection.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aminopyrine breathing test, Chest discomfort, Dizziness, Dyspnoea, Erythema
Clinical narrative: On  the day of the shot, by Noon I could feel the vaccine moving into my throat and my  face. My throat and left cheek started to swell and turn slightly red.  I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment.  At the hospital, they gave me steriods, benadryl and Pepcid in an IV.  After allowing this to work, they sent me home with a  steriod prescription for 60Mg for the next 5 days.  They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine.  Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned.  I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on  Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days.   They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body.  It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees.  In the morning, it is usually in my face and then it moves around during the day.  I can feel this fluid moving around in my body because the redness brings swelling/fluid.  This last saturday 3/6/2021 was horrible, it was in my right ear and right foot.  It was very painful and made me very dizzy. I struggled to walk.  Then on Sunday morning, I felt fine all day.  Today Monday, it feels like it is in my right foot again, but I feel like It is  getting better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Malaise, Pharyngeal swelling, Skin warm, Swelling
Clinical narrative: On  the day of the shot, by Noon I could feel the vaccine moving into my throat and my  face. My throat and left cheek started to swell and turn slightly red.  I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment.  At the hospital, they gave me steriods, benadryl and Pepcid in an IV.  After allowing this to work, they sent me home with a  steriod prescription for 60Mg for the next 5 days.  They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine.  Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned.  I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on  Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days.   They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body.  It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees.  In the morning, it is usually in my face and then it moves around during the day.  I can feel this fluid moving around in my body because the redness brings swelling/fluid.  This last saturday 3/6/2021 was horrible, it was in my right ear and right foot.  It was very painful and made me very dizzy. I struggled to walk.  Then on Sunday morning, I felt fine all day.  Today Monday, it feels like it is in my right foot again, but I feel like It is  getting better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: On  the day of the shot, by Noon I could feel the vaccine moving into my throat and my  face. My throat and left cheek started to swell and turn slightly red.  I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment.  At the hospital, they gave me steriods, benadryl and Pepcid in an IV.  After allowing this to work, they sent me home with a  steriod prescription for 60Mg for the next 5 days.  They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine.  Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned.  I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on  Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days.   They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body.  It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees.  In the morning, it is usually in my face and then it moves around during the day.  I can feel this fluid moving around in my body because the redness brings swelling/fluid.  This last saturday 3/6/2021 was horrible, it was in my right ear and right foot.  It was very painful and made me very dizzy. I struggled to walk.  Then on Sunday morning, I felt fine all day.  Today Monday, it feels like it is in my right foot again, but I feel like It is  getting better.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 101fever Chills Severe headache  Vomiting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Chills, Cold Sweat, Nausea, Headache, Body Aches, Body/Skin burning, Thirst
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Skin burning sensation, Thirst
Clinical narrative: Chills, Cold Sweat, Nausea, Headache, Body Aches, Body/Skin burning, Thirst
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pruritus, Rash
Clinical narrative: Severe rash started on the back of my knees. Stomach, underarm, legs lower back and top of feet. Unbearable itch.  Caused me to lose time off work and visits to 5 different dr?s with no solution.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Motor dysfunction, Muscular weakness
Clinical narrative: A few days after vaccine I started having pain, burning in my right wrist, shoulder, and elbow. Now having severe burning and pain in both wrists, elbows, and shoulders. Difficulty picking up items, grasping, pushing up. Have never had these symptoms. Now about 5 weeks since vaccine and still remains. Have not seeked medical attention.  Wanted information in data base in case it is common.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site raised after 8 days, itchy, red. Redness and itching spread to larger area of arm 9 days after injection.
Age: 1.25
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, 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 15-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 22-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines 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 (original cases # 2102USA004059 and 2102USA003923). 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-009507513-2102USA004059:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 22-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232: US-009507513-2102USA007557: US-009507513-2102USA007556: US-009507513-2102USA003923:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant Human albumin (rHA) (M-M-R II) vaccines experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.   On 19-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, dose number and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event was reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDV AX HIB administered after temperature excursion.; This spontaneous report was received from a physician (also reported as an other) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.        On 26-FEB-2021, the patient was administered haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route were not provided; lot# was T026959 and expiration date was 11-MAR-2023) 0.5 ml involved in a temperature excursion for prophylaxis (product storage error).   The administered dose experienced a temperature excursion at 19.7 degree Celsius for 1 hour. There was no previous temperature excursion. The temperature excursion was detected by a data logger.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia.  The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg.    On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer.  On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved.   The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021.  The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Skin discolouration, Tremor
Clinical narrative: Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia.  The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg.    On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer.  On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved.   The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021.  The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Nose is stuffy; Trembling; Metallic taste in mouth; Hands and fingers turned a rust orange color; severe body ache; Headache; body chills; fever of 102F; Fatigue; Received first shot of Pfizer vaccine and scond shot of Moderna's; A regulatory authority report was received from a healthcare provider concerning a 19-year-old, male patient who received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, metallic taste in mouth/dysgeusia, fatigue and severe body ache/myalgia.  The patient's medical history included allergies to codeine and anxiety. Products known to have been used by the patient, within two weeks prior to the event, included Fluoxetine 40mg, Lamotrigine 100mg, Amlodipine 10mg and Lunesta 3mg.    On 01 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received a dose of the mRNA-1273 (Batch number: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient went to pharmacy and was offered his second dose of the vaccine, at the time of administration, the patient stated he was unaware that the vaccine given to him was from Moderna. His first vaccine was from Pfizer.  On 02 Feb 2021, the patient stated he felt very sick, he had a headache, nose was stuffy, body chills, severe body aches, a fever of 102 degree Fahrenheit, and noted rust colored spots on his hands. The patient stated these symptoms lasted two days after the vaccine was administered. The patient also stated he had a metallic taste in his mouth that worsened when he drank water or other beverages. At the time of this report, the metallic taste in mouth had not resolved. The patient visited Urgent Care and was instructed to take a baby acetylsalicylic acid once a day.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, metallic taste in mouth/dysgeusia, was considered not resolved.   The outcome of event, received first shot of Pfizer vaccine and second shot of Moderna's/wrong product administered, were considered resolved on 01 Feb 2021.  The outcome of events, headache, nose is stuffy/nasal congestion, chills, trembling/tremor, fever of 102F/pyrexia, hands and fingers turned a rust orange color/skin discoloration, fatigue and severe body ache/myalgia, were considered recovered on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: hurt arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/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 had both shots and his/her arm hurts with second shot. The reporter mentioned that, had to get both shots or not effective, 90 percent chance it works, but to be expected, putting foreign vaccine in body which attacks it, 12 hours of symptoms but it was in there and worth the price of not insured. The follow-up would not possible, as no contact details were available. This case had been linked with US2021AMR020541, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR020541:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Asthenia, Herpes zoster, Rash, Scar
Clinical narrative: Took a full year for the rash scaring to disappear; Took a full year for the rash scaring to disappear; I was down for a month; This case was reported by a consumer via interactive digital media and described the occurrence of scar in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date, non-GSK) and Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scar, rash and weakness. On an unknown date, the outcome of the scar was recovered/resolved and the outcome of the rash and weakness were unknown.   It was unknown if the reporter considered the scar, rash and weakness to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported The patient stated that, shingles were excruciating and the doctor suggested it would worse without the shot. The patient received original shingles vaccine. The patient now received 2 doses of Shingrix and experienced side effects. The patient was down for a month and it took a full year for the rash scaring to disappear. The patient had no long lasting effects. No other information was available
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: fainted; became sweaty; This case was reported by a consumer via media and described the occurrence of fainting 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, several hours after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and sweating. On an unknown date, the outcome of the fainting and sweating were unknown.   It was unknown if the reporter considered the fainting and sweating to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and few hours later became sweaty and fainted. The patient wanted to know that would the 2nd dose produce the same reaction, as he/she had been scheduled to get 2nd dose 19th March 2021 and also how long could he/she wait before getting the 2nd vaccine as COVID vaccines were here now.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in injected (left) arm; This case was reported by a consumer and described the occurrence of pain in extremity in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional details were provided as follows: The patient's daughter reported the case. The patient received Shingrix in left arm about 2 weeks ago of the reporting date, at doctor's office and had pain in injected left arm. Till the time of reporting, the pain was still persisted. The lot unknown to the reporter. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: still has pain; This case was reported by a consumer and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had pain. The reporter requested medical advice for pain relief. The medical disclaimer was provided and HCP consultation was recommended. The customer disconnected abruptly because wanted medical advice. No additional information was collected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash
Clinical narrative: Missed dose; All over body rash; A spontaneous report was received from a physician concerning a 41-year old, female patient who received Moderna ' s COVID-19 vaccine (mRNA-1273) and experienced an all over body rash and missed second dose.   The patient's medical history was not provided. Concomitant medications were not provided/unknown.   On 04-JAN-2021, approximately 24 hours before the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number 026220A) intramuscularly for prophylaxis of COVID-19 infection  ,  On 05 Jan 2021, the patient experienced an all over- body rash. The patient reported being out of the country and missing her second dose.   Treatment for the event included cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not unknown.   The outcome of the event, all over body rash, was considered recovering and resolving.  The outcome of the event, missed dose, was considered recovered/resolved on an unknown date.; 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 of rash, a causal relationship cannot be excluded.  The causality for the event of missed dose is assessed as not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Needle issue
Clinical narrative: The patient received more than 0.5 ml dose; Needle issue; A spontaneous report was received from pharmacist concerning a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient received more than 0.5 ml dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient received dose spilled out of the needle and down the patient's arm. The immunizer then drew up another dose and gave that to the patient and the patient received more than 0.5 ml dose. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of the event the patient received more than 0.5 ml dose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose and syringe issue for mRNA-1273, lot # unknown, with no associated AEs.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient got the first dose at the age of 16; A spontaneous report was received from a pharmacist concerning a 16-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got the first dose at the age of 16.   The patient's medical history was not provided. Concomitant product use was not provided by the pharmacist.  On 06 Feb 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient got the first dose at the age of 16 (Inappropriate age at vaccine administration). The patient was fine and no symptoms at all. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event patient got the first dose at the age of 16 was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration  for mRNA-1273, lot # 010M20Awith no associated AEs.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Vaccine ran down arm; Vaccine ran down arm; A spontaneous report was received from a consumer concerning a 76-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the vaccine ran down his arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 012M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, during administration some of the vaccine ran down the arm of patient.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, during administration some of the vaccine ran down the arm was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure via skin contact issue for mRNA-1273 (lot # 012M20A)  with no associated AEs reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: Vaccine leaked out of patient's arm; A spontaneous report was received from a pharmacist concerning an unknown age patient who received Moderna's COVID-19 vaccine (mRNA-1273), some of vaccine leaked out of the patient's arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown), unknown route for prophylaxis of COVID-19 infection. It was reported that some of vaccine leaked out of the patient's arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event some of vaccine leaked out of the patient's arm considered resolved.; Reporter's Comments: This report refers to a case of vaccination site discharge for mRNA-1273 vaccine, batch number unknown, with no associated AEs.