chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the first one and I now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and he/she now had shingles. The patient stated that if you got the 1st vaccine out, you should get the newer one. The patient's physician said that he/she needed to get the newer vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles which were painful; painful; This case was reported by a nurse via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included viral infection. Concurrent medical conditions included disability (caused by unspecified virus).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient (nurse) him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had far too many viruses and was disabled from an unnamed virus that he/she caught from a patient in 1981. The patient received 1st dose of shingles vaccine and stated was only partially effective so he/she still had shingles which were painful. The patient stated that they do not had all of the complications and had no idea as to what the sequel of COVID would be, as he/she do not need another virus. If you ignore history, you would repeat it and if you develop COVID now you do know which complications you would have and have no idea as to which Sequel you would have in the long-distance future. The patient stated that this was why you who are young need the COVID vaccination, we who are old did not had vaccination for chicken pox.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was reported by a physician and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In 2020, the patient received 2nd dose of Shingrix and experienced chills and fever for 2 and a half days. The patient completed the series of vaccine last year. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness
Clinical narrative: flu like symptoms; chills; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and chills to be related to Shingrix.  Additional information was provided as follows: The case was reported by the wife of patient. The age at vaccination was not reported. In 2020, the patient received 1st dose of Shingrix on left arm. The patient experienced chills and flu like symptoms which were resolved in 1 day. The reporter mentioned that, her husband had received both the shots in 2020 but could not provide the specific dates. The reporter consented to follow up. For tolerance of 2nd dose, refer case- US2021AMR008973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008962:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter US-GLAXOSMITHKLINE-US2021AMR008973:same patient, 2nd dose
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Welts on his face and chest; Welts on his face and chest / are sore; This case was reported by a consumer via call center representative and described the occurrence of welts in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles. Concurrent medical conditions included kidney transplant.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced welts and pain. On an unknown date, the outcome of the welts and pain were unknown.   It was unknown if the reporter considered the welts and pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but it could be 60 or 61 years.  The patient received 1st dose of Shingrix in right arm. The patient experienced welts on his face and chest and the welts vary in size, were sore and appear intermittently. He had been to a dermatologist. All information was not available. The reporter consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: swelling at the injection site; redness / at the injection site; bruising at the injection site; nausea; body aches; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 21st November 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills. On an unknown date, the outcome of the injection site swelling, injection site erythema, nausea, general body pain and chills were recovered/resolved and the outcome of the injection site bruising was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced redness and swelling at the injection site.  The patient also reports bruising at the injection site, which had not fully resolved.  The patient also experienced chills, body aches, and nausea.   All events except for the bruising at the injection site have resolved. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: swelling at the injection site; redness / at the injection site; bruising at the injection site; nausea; body aches; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 21st November 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills. On an unknown date, the outcome of the injection site swelling, injection site erythema, nausea, general body pain and chills were recovered/resolved and the outcome of the injection site bruising was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site bruising, nausea, general body pain and chills to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced redness and swelling at the injection site.  The patient also reports bruising at the injection site, which had not fully resolved.  The patient also experienced chills, body aches, and nausea.   All events except for the bruising at the injection site have resolved. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Extra dose administered, Incorrect dose administered, Injection site pain
Clinical narrative: The syringe separated from the needle and leaked out on my skin, it appears as i wasn't clear if i got the full dose; The syringe separated from the needle and leaked out on my skin; The pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got; I had a little tenderness, no pain; A spontaneous report was received from a physician, a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "PT had a little tenderness, no pain," "the syringe separated from the needle and leaked out on my skin," and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I  got."  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Feb 2021, at 13:30, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012MZ0A/012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Feb 2021, during vaccine administration, the syringe separated from the needle and leaked onto the patient's skin. It wasn't clear if the full dose was given. The pharmacist administering the vaccine then tried to give a second dose and the same thing happened both times. The patient was not sure how much he received. No treatment was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events of "the syringe separated from the needle and leaked out on my skin", and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I  got", were considered resolved on 01 Feb 2021. The event outcome of "I had a little tenderness, no pain" was considered unknown.; 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.  Very limited information regarding these event/s has been provided at this time
Sex: U
Vaccine: COVID19
Symptoms: General symptom, Incorrect route of product administration, Injected limb mobility decreased, Tenderness, Vaccination site bruising
Clinical narrative: Systemic symptoms; Bruising after vaccination; Limited range of motion in arm and struggles to lift arm; Tender arm; Vaccine inadvertently injected into the bursa; A spontaneous report was received from a nurse concerning a unknown patient of an unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and vaccine inadvertently injected into the bursa/incorrect route of product administration, experienced tender arm/tenderness, systemic smptoms/general symptom, bruising after vaccination/vaccination site bruising, and limited range of motion and struggles to lift arm/injected limb mobility decreased.  The patient's medical history was not provided. No concomitant medications were reported.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient reported that she received her first vaccine, and it was inadvertently injected into the bursa.   The patient later reported that she experienced a tender arm, systemic symptoms, bruising after vaccination, limited range of motion and struggles to lift the injected arm. She stated she will seek medical attention. No treatment information was provided. Consent given for Safety to follow up.   Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the event, vaccine inadvertently injected into the bursa, was recovered on 06 Jan 2021. The events, tender arm, systemic symptoms, bruising after vaccination, and limited range of motion and struggles to lift the injected arm, were not resolved at the time of this report.; 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, fever, chills, slight diarrhea, fatigue
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site erythema, Insomnia
Clinical narrative: 02/03/2020 16:00pm Pain developed in the left deltoid and arm, site of vaccine. Swelling of site was mild. No rash. Difficulty lifting arm, very painful to touch, difficulty removing clothing and difficulty sleeping due to arm pain.  02/04/2020 02:30am Pain worsened in left arm. Developed mouth ulcers which were unexpected and painful. Rigorous chills. Temp normal, 97.7 F. 02/05/2020 05:00am Extreme fatigue, continued pain in left arm and continued painful mouth ulcers. 02/06/2020 02:30am Woke up and symptoms resolved with the exception of arm pain which remained until 02/08/2020. 02/15/2020 05:00am Mild left arm pain at site returned for duration of the day and then resolved by bedtime. 02/17/2020 04:00am 2 inch x 3 inch non-raised rash/redness appeared left deltoid at vaccine site with no pain. Warm to touch.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mouth ulceration, Oral pain, Rash papular, Vaccination site pain
Clinical narrative: 02/03/2020 16:00pm Pain developed in the left deltoid and arm, site of vaccine. Swelling of site was mild. No rash. Difficulty lifting arm, very painful to touch, difficulty removing clothing and difficulty sleeping due to arm pain.  02/04/2020 02:30am Pain worsened in left arm. Developed mouth ulcers which were unexpected and painful. Rigorous chills. Temp normal, 97.7 F. 02/05/2020 05:00am Extreme fatigue, continued pain in left arm and continued painful mouth ulcers. 02/06/2020 02:30am Woke up and symptoms resolved with the exception of arm pain which remained until 02/08/2020. 02/15/2020 05:00am Mild left arm pain at site returned for duration of the day and then resolved by bedtime. 02/17/2020 04:00am 2 inch x 3 inch non-raised rash/redness appeared left deltoid at vaccine site with no pain. Warm to touch.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 02/03/2020 16:00pm Pain developed in the left deltoid and arm, site of vaccine. Swelling of site was mild. No rash. Difficulty lifting arm, very painful to touch, difficulty removing clothing and difficulty sleeping due to arm pain.  02/04/2020 02:30am Pain worsened in left arm. Developed mouth ulcers which were unexpected and painful. Rigorous chills. Temp normal, 97.7 F. 02/05/2020 05:00am Extreme fatigue, continued pain in left arm and continued painful mouth ulcers. 02/06/2020 02:30am Woke up and symptoms resolved with the exception of arm pain which remained until 02/08/2020. 02/15/2020 05:00am Mild left arm pain at site returned for duration of the day and then resolved by bedtime. 02/17/2020 04:00am 2 inch x 3 inch non-raised rash/redness appeared left deltoid at vaccine site with no pain. Warm to touch.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin swelling
Clinical narrative: Week after shot my arm all the sudden starting itching and super sore again and skin is red n swollen.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haemorrhage, Myalgia, Pain in extremity, Productive cough
Clinical narrative: Started with sinus drainage,  which became constant and intermingled with blood.  Arm was sore,  joint and muscular aches.  Then progressed to persistent productive cough.  No fever during  this time.  These symptoms lasted until 2/15/2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Started with sinus drainage,  which became constant and intermingled with blood.  Arm was sore,  joint and muscular aches.  Then progressed to persistent productive cough.  No fever during  this time.  These symptoms lasted until 2/15/2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dissiness for 5 days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Experienced syncopal episode following vaccine. Epinephrine 0.3mL administered by EMS at site.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Fatigue, Injection site reaction
Clinical narrative: Since 12 Feb to present I have had aching bones and joints alone constant fatigue and general weakness in my left arm.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccination out of manufacturers specifications.  Pt stated 2nd dose was within 4 day grace period when in fact after checking the patient was 7 days early.  Discovery was after injection was given.  Per CDC guidelines series not needed to restart.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: red, round rash at injection site. Itching and mild swelling, no pain
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Nausea, Vomiting
Clinical narrative: severe nausea, chills diarehha, throwing up
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site induration, Injection site pain
Clinical narrative: 101.7 fever, chills, headache, muscle aches, joint aches, pain at injection site with hardness and swelling at site. Started with injection site pain and muscle aches at about 12 hours  (12am), chills by 2am, and progressed  to full detailed symptoms by the time I woke up at 615am (fever,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: 101.7 fever, chills, headache, muscle aches, joint aches, pain at injection site with hardness and swelling at site. Started with injection site pain and muscle aches at about 12 hours  (12am), chills by 2am, and progressed  to full detailed symptoms by the time I woke up at 615am (fever,
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Urticaria
Clinical narrative: Received 1st dose COVID-19 Vaccine at 1705.  Ambulated to restroom and noted hives developed on torso and legs with heaviness in chest; denies difficulty breathing.  Received MD evaluation in ED.  Benadryl 50mg IV and Decadron 10mg IV.  Discharged home in stable condition.  Instructed NOT to receive 2nd COVID-19 Vaccine.  Home with Prednisone and Epi-pen PRN.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days   Upper arm still sore after 12 days. Pain on movement and unable  to sleep on that side, as the arm pain awakens me.   Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Sleep disorder
Clinical narrative: Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days   Upper arm still sore after 12 days. Pain on movement and unable  to sleep on that side, as the arm pain awakens me.   Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Paraesthesia, Skin discolouration
Clinical narrative: Wed Feb 17. Fatique feet seem discolored at times arm seems to feel like mild pins and needles
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Red rash and swelling at injection site. The red rash and swelling with pain to touch lasted until Feb 8. then the arm was still slightly swollen and currently black and blue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: SEVERE muscle pain, burning sensation in chest cavity and espophagus, slight fever (1 degree), fatigue, headache. These were the most severe manifestations I have ever experienced. Since I have previously had anaphylaxis, I am more worried about the reactions.  I was not able yo sleep at all due to the strong pain.  I do feel better this morning, but nowhere near ok.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Throat irritation
Clinical narrative: SEVERE muscle pain, burning sensation in chest cavity and espophagus, slight fever (1 degree), fatigue, headache. These were the most severe manifestations I have ever experienced. Since I have previously had anaphylaxis, I am more worried about the reactions.  I was not able yo sleep at all due to the strong pain.  I do feel better this morning, but nowhere near ok.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: ADR occurred covid vaccination clinic on 1/27/21. Employee received covid 2nd vaccination (Moderna Lot 013L20A, Exp 07/08/21) on 1/27/21. Reaction reported 1/29/21 documented left arm red, swelling warmth at covid vaccine site.  Patient was recommended to be seen by physician following Monday for medical evaluation if symptoms continued.  Per documentation in Athena, 1/29/21 patient received a one time diphenhydramine 50mg injection, with instruction to start ice pack.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death on 1/17/2021. Found at home deceased.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Terrible rash on hands and feet
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Facial pain, Formication, Pain
Clinical narrative: Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth.  Chewing on back molars hurt.  As time went on pain worsened and radiated into my cheek, left eye and left ear.  ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises.  These didn't help, so ~ a week after that, he gave  me antibiotic.  No improvement in symptoms until ~ a week after that.  I saw pcp, as it felt like something was crawling inside my left ear.  Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms.  She suggested prescription-strength Naproxen for 10 days, which I did.  the pain/ache has been mostly gone since completing the Naproxen.  For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Toothache, X-ray normal
Clinical narrative: Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth.  Chewing on back molars hurt.  As time went on pain worsened and radiated into my cheek, left eye and left ear.  ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises.  These didn't help, so ~ a week after that, he gave  me antibiotic.  No improvement in symptoms until ~ a week after that.  I saw pcp, as it felt like something was crawling inside my left ear.  Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms.  She suggested prescription-strength Naproxen for 10 days, which I did.  the pain/ache has been mostly gone since completing the Naproxen.  For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Full blood count, Metabolic function test, Mydriasis
Clinical narrative: After injection, she was instructed to stay for observation.  Upon checking on her, patient stated her heart was racing and she felt weak.  She was instructed to remain for 30 more minutes of observation.  Checked patient post 30 mins. and attempted to have ambulate.  She stated she still felt "woozy".  Conversation was had with another RN.  Pulse was checked and 104.  Pupils were dilated and her speech was delayed.  We felt she should go to ED to be checked and she agreed.  Patient was taken by W/C to ED
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Speech disorder developmental
Clinical narrative: After injection, she was instructed to stay for observation.  Upon checking on her, patient stated her heart was racing and she felt weak.  She was instructed to remain for 30 more minutes of observation.  Checked patient post 30 mins. and attempted to have ambulate.  She stated she still felt "woozy".  Conversation was had with another RN.  Pulse was checked and 104.  Pupils were dilated and her speech was delayed.  We felt she should go to ED to be checked and she agreed.  Patient was taken by W/C to ED
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Post-acute COVID-19 syndrome, Pruritus, Rash, Rash erythematous
Clinical narrative: ?Covid arm? , red rash, warm to touch, itchy, painful
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: ?Covid arm? , red rash, warm to touch, itchy, painful
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain in extremity, Vomiting
Clinical narrative: Migraine-like headache started at around noon, got worse at 2pm, slept from 3-6, still had headache. began feeling nauseous, vomited at 8pm.   Took Tylenol and slept at 11pm, feeling OK with sore arm now.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NOTHING
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Vomiting
Clinical narrative: Severe headache and chills after vaccine up to 24 hours. Severe headache remained up to 55 hours. Stomach upset and vomiting (x1) started at 55 hours and continued through 68 hours (present time). Treated with ibuprofen alternating with tylenol for 50 hours. Meds were taken after eating.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Rash macular
Clinical narrative: Rash in blotches around injection site, showed up 8 days later, slightly itchy, warm to the touch
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Nausea, Ocular hyperaemia
Clinical narrative: Extremely fatigue,  nauseA, headace, right eye blood shot, right side jaw pain, swelling right side face , right side ear pqin
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Swelling face
Clinical narrative: Extremely fatigue,  nauseA, headace, right eye blood shot, right side jaw pain, swelling right side face , right side ear pqin
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: "Brain Fog"; Difficulty Concentrating; Difficulty Focusing; Difficulty Finding Words when Trying to Speak; Waves of Fatigue
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: "Brain fog" from day 2 through day 10 after 2nd vaccine dose; difficulty concentrating, loss of focus, difficulty finding words when speaking, waves of fatigue
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: **I WAS GIVEN A SUB Q INJECTION; NOT AN IM INJECTION.  I NEED SOMEONE TO CONTACT THE SITE TO FIND OUT WHO  THE NURSE WAS SO THIS DOES NOT HAPPEN TO OTHER PEOPLE.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Musculoskeletal chest pain, Pain in extremity, Sleep disorder
Clinical narrative: Deep Pain through your my entire arm, under my arm pit and into my rib on the left side Not sore to the touch  The pain is bad enough to wake me up every two hours
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES(NEVER HAD IT EVER)..THE DOC SAID IT WAS THE WORST CASE HE HAD EVER SEEN
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous, Rash papular
Clinical narrative: Raised red rash bump at injection site
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: Swollen lymph node under Left arm. Other sxs included fever, chills, malaise, nausea x 48 hours.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Oral blood blister, Petechiae, Platelet count decreased
Clinical narrative: Patient developed symptoms on 2/13/2021 with epistaxis.  Then developed blood blisters in mouth and petechiae over lower extremities.  Saw me on 2/16 and labs showed platelet count less than 3000.
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: 47 YEAR OLD MALE THOUGHT HE WAS HAVING AN ALLERGIC REACTION. ONSITE EMS AND PHYSICIAN RESPONDED.  BP 142/80 HR 98  PATIENT REFUSED ADDITIONAL EVALUATION AND CARE. RELEASED AGAINST MEDICAL ADVICE.
Age: 12.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE reported; GARDASIL 9 was administered to a patient after experiencing temperatue excursion; This spontaneous report has been received from other reporter and refers to 12- years-old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug reactions or allergies was not provided.  On 18-JAN-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, intramuscularly in left arm for prophylaxis (lot # 1687291 with expiration date 11-SEP-2022) for prophylaxis. The vaccine was stored at 31.0 degrees Fahrenheit for 1 hour and 15 minutes.(it was also reported that the fridge was out of range to -0.28 for 30 minutes). The vaccine experienced previous temperature excursions of 68 degrees Fahrenheit for 17 hours and 30 minutes. The digital data logger was involved. No additional adverse event 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: 1687291; expirationdate: 11-SEP-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
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: issues with right eye impairing vision and requiring surgery; issues with right eye impairing vision and requiring surgery; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 21-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions at approximately 64 years old. Subsequently, the patient was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) : herpes zoster and issue with right eye impairing vision and requiring surgery. The outcome of the events was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; temperature excursion involving VARlVAX / some of the vaccines were administered; This spontaneous report as received from an office manager refers to a patient of unknown age.and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-FEB-2021, the patient was vaccinated with an improperly stored dose varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # T021826, expiration date 25-JUN-2022 (route of administration was not provided) for prophylaxis. The administered dose of vaccine experienced temperature excursion of -9.52 degrees Celsius for 56 minutes. There was no previous temperature excursion reported. The digital data logger was involved. There was no adverse event reported.  This is ne of several cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA005039: US-009507513-2102USA004607: US-009507513-2102USA005061:
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient was involved in a discussion as to how advisable it was for individuals who have had lung transplants to have the shingrix shots.  The patient incurred muscle pain after the first and no side effect after the second.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252443:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: shingles - like rash / symptoms of pain.; symptoms of pain.; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vesicular rash and pain were unknown.   It was unknown if the reporter considered the vesicular rash and pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient experienced shingles-like rash on hand within 2 days of Shingrix vaccination. Valacyclovir decreases symptoms of pain.  The patient asked if it was possible the vaccine caused the shingles-like rash?
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Aphasia, Asthenia, Chest discomfort, Chills
Clinical narrative: Aggravated very quickly; Everything went blank; She can't talk and when she tries to talk she feels like she has the hiccups where she can barely get the words to talk; when she has a hiccup her whole chest hurts; Hiccup; Numbness; Her whole right side would jerk uncontrollably; Weak; fever; itching; sore arm / burning; chills; A spontaneous report (United States) was received from a consumer who was also a 22-year-old female patient, who received Moderna's COVID-19 vaccine who experienced sore arm/ burning (injection site pain), fever (pyrexia), chills, itching (injection site pruritus), numbness (injection site numbness), weak (asthenia), whole right side would jerk uncontrollably (myoclonus), everything went blank (loss of consciousness), couldn't talk and when she tried to talk she felt like she had the hiccups (aphasia), her whole chest hurt (chest discomfort), and quickly became aggravated (anger).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 06 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly in her right deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced a sore arm, fever, chills, itching and burning.   On 07 Jan 2021, on the site where the patient received the injection, she felt numbness and weak. Her whole right-side body would jerk uncontrollably. The patient went to two emergency rooms where they stated they did not know what was wrong and gave her a steroid injection that temporarily helped calm her down.   On 08 Jan 2021, the patient stared at the door and everything went blank. She could not talk and when she tried to talk, she felt like she had the hiccups. She experienced her whole chest hurting when she had a hiccup.   On 25 Jan 2021 and 26 Jan 2021, the patient saw two neurologists, who did testing. The patient's jerking was random, there were no triggers for it, and she did not know how to control or stop it. These adverse reactions made the patient become aggravated very quickly, which was not like her.   On an unknown date, the patient stated it was the first day in the past month she had been able to talk all day.  Treatment for the events included a steroid shot.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, sore arm/ burning, fever, chills, itching, numbness, weak, whole right side would jerk uncontrollably, everything went blank, couldn't talk and when she tried to talk she felt like she had the hiccups and her whole chest hurt, and quickly became aggravated, was not reported.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Chills, fever, injection site pruritus and injection site pain are consistent with the known safety profile of mRNA-1273.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hiccups, Injection site hypoaesthesia, Injection site pain, Injection site pruritus, Loss of consciousness
Clinical narrative: Aggravated very quickly; Everything went blank; She can't talk and when she tries to talk she feels like she has the hiccups where she can barely get the words to talk; when she has a hiccup her whole chest hurts; Hiccup; Numbness; Her whole right side would jerk uncontrollably; Weak; fever; itching; sore arm / burning; chills; A spontaneous report (United States) was received from a consumer who was also a 22-year-old female patient, who received Moderna's COVID-19 vaccine who experienced sore arm/ burning (injection site pain), fever (pyrexia), chills, itching (injection site pruritus), numbness (injection site numbness), weak (asthenia), whole right side would jerk uncontrollably (myoclonus), everything went blank (loss of consciousness), couldn't talk and when she tried to talk she felt like she had the hiccups (aphasia), her whole chest hurt (chest discomfort), and quickly became aggravated (anger).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 06 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly in her right deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced a sore arm, fever, chills, itching and burning.   On 07 Jan 2021, on the site where the patient received the injection, she felt numbness and weak. Her whole right-side body would jerk uncontrollably. The patient went to two emergency rooms where they stated they did not know what was wrong and gave her a steroid injection that temporarily helped calm her down.   On 08 Jan 2021, the patient stared at the door and everything went blank. She could not talk and when she tried to talk, she felt like she had the hiccups. She experienced her whole chest hurting when she had a hiccup.   On 25 Jan 2021 and 26 Jan 2021, the patient saw two neurologists, who did testing. The patient's jerking was random, there were no triggers for it, and she did not know how to control or stop it. These adverse reactions made the patient become aggravated very quickly, which was not like her.   On an unknown date, the patient stated it was the first day in the past month she had been able to talk all day.  Treatment for the events included a steroid shot.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, sore arm/ burning, fever, chills, itching, numbness, weak, whole right side would jerk uncontrollably, everything went blank, couldn't talk and when she tried to talk she felt like she had the hiccups and her whole chest hurt, and quickly became aggravated, was not reported.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Chills, fever, injection site pruritus and injection site pain are consistent with the known safety profile of mRNA-1273.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Myoclonus, Pyrexia
Clinical narrative: Aggravated very quickly; Everything went blank; She can't talk and when she tries to talk she feels like she has the hiccups where she can barely get the words to talk; when she has a hiccup her whole chest hurts; Hiccup; Numbness; Her whole right side would jerk uncontrollably; Weak; fever; itching; sore arm / burning; chills; A spontaneous report (United States) was received from a consumer who was also a 22-year-old female patient, who received Moderna's COVID-19 vaccine who experienced sore arm/ burning (injection site pain), fever (pyrexia), chills, itching (injection site pruritus), numbness (injection site numbness), weak (asthenia), whole right side would jerk uncontrollably (myoclonus), everything went blank (loss of consciousness), couldn't talk and when she tried to talk she felt like she had the hiccups (aphasia), her whole chest hurt (chest discomfort), and quickly became aggravated (anger).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 06 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly in her right deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced a sore arm, fever, chills, itching and burning.   On 07 Jan 2021, on the site where the patient received the injection, she felt numbness and weak. Her whole right-side body would jerk uncontrollably. The patient went to two emergency rooms where they stated they did not know what was wrong and gave her a steroid injection that temporarily helped calm her down.   On 08 Jan 2021, the patient stared at the door and everything went blank. She could not talk and when she tried to talk, she felt like she had the hiccups. She experienced her whole chest hurting when she had a hiccup.   On 25 Jan 2021 and 26 Jan 2021, the patient saw two neurologists, who did testing. The patient's jerking was random, there were no triggers for it, and she did not know how to control or stop it. These adverse reactions made the patient become aggravated very quickly, which was not like her.   On an unknown date, the patient stated it was the first day in the past month she had been able to talk all day.  Treatment for the events included a steroid shot.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, sore arm/ burning, fever, chills, itching, numbness, weak, whole right side would jerk uncontrollably, everything went blank, couldn't talk and when she tried to talk she felt like she had the hiccups and her whole chest hurt, and quickly became aggravated, was not reported.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded. Chills, fever, injection site pruritus and injection site pain are consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate irregular, Palpitations, Pericardial effusion
Clinical narrative: Fluid in the pericardium; Heart skips a beat; Out of breath; Heart pound when sedentary; A spontaneous report was received from a consumer who was also a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fluid in the pericardium (pericardial efflusion), heart skips a beat (heart rate irregular) when out of breath (dyspnoea), and heart pounds when sedentary (palpitations).  The patient's medical history included irregular heartbeat. Relevant concomitant medications taken within two weeks prior to the events were not provided.   On 05 Jan 2021 at 12: 30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, at 12:30 pm, the patient received their second of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient developed fluid in the pericardium, and her heart skipped a beat when out of breath. It would happen when she was sedentary, and her heart would pound when not walking. She had irregular heartbeat before and was prescribed a concomitant medicine which was a nasal steroid.  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 events, fluid in the pericardium, heart skips a beat when out of breath and heart pound when sedentary, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time in this case of serious unlisted event of pericardial effusion and non-serious unlisted events of heart rate irregular, dyspnea, and palpitations. However, patient's medical history of irregular heartbeat is a confounding factor that may play a contributory role providing an alternative explanation. Further information has been requested.