chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Musculoskeletal chest pain, SARS-CoV-2 test positive, Syncope
Clinical narrative: Vaccine administered on 2/11/21. Presented to emergency department on 2/18/21 following an episode of syncope and collapse at home. Patient reports becoming dizzy and diaphoretic at home and passed out in bathroom. Presented with left-side rib pain and headache attributed to hitting door and ground during fall. Was checked for COVID19 prior to transferring to observation unit and was found to be positive. Patient was discharged home in stable condition from observation on 2/19/21.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over my body.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Haemodialysis, Hyperkalaemia, Joint range of motion decreased
Clinical narrative: 1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Mental status changes, Pneumonia, Renal failure
Clinical narrative: 1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: I have a round lesion that is raised and warm and about  3 inches in diameter at the injection site. EXTREMELY itchy!
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: FALL ON  2/18/2021
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count abnormal, Haemoglobin decreased, Unevaluable event
Clinical narrative: CBC blood count reading--all counts low, including very low hemoglobin (9.3)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Severe fever blisters covering my entire mouth and tongue.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Mobility decreased, Nausea, Vertigo
Clinical narrative: Upon getting up next day felt like I was having vertigo It became full blown on the 19th (two days later). Was unable to get out of bed that day. But got medicine to help with dizzy ness and nausea.  No fever. Just headache and dizziness
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Atrial fibrillation, Blood uric acid increased, C-reactive protein decreased
Clinical narrative: Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on  2/24/2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Pain
Clinical narrative: Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on  2/24/2021
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: 5 d after vacc (1/11/21) tender grape size lump at inj site.  8 d after vacc HA, fatigue, feverishness 9 d after vacc (1/15/21) large red tender area at inj site.  lump resolved.  sore L shoulder, clavicle and LUE
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 5 d after vacc (1/11/21) tender grape size lump at inj site.  8 d after vacc HA, fatigue, feverishness 9 d after vacc (1/15/21) large red tender area at inj site.  lump resolved.  sore L shoulder, clavicle and LUE
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Epistaxis, Fatigue, Haemoptysis
Clinical narrative: Day after vaccine she felt tired, today she woke up coughed up  blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Day after vaccine she felt tired, today she woke up coughed up  blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fatigue. Bizarre dreams
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea
Clinical narrative: Covid Arm ( itching/red/swollen) after one week. Headache for three days and nausea after shot. Fatigue. Bizarre dreams
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Food aversion, Headache, Injection site pain
Clinical narrative: chills, nausea, fever, fatigue, food aversion, headache, muscle ache, Injection site pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: chills, nausea, fever, fatigue, food aversion, headache, muscle ache, Injection site pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: large, red, warm band of swelling about 1 inch below injection site.  very painful. firm to the touch.  measures approx 5 inches in length and 2 inches wide
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Neck pain, Urinary tract infection
Clinical narrative: Received 2nd dose of Moderna on 1/26/21.  Went to the hospital and admitted 2/21/21-2/22/21 for UTI, weakness, and neck pain.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: My left arm was a little sore for a couple of days but not bad.  Then I noticed  an itchy feeling on the muscle below where I had the shot.  This was for a couple of days, Today  (six days after the vaccine) I have a little rash there.  Left arm, muscle.  I put calamine lotiin on it today.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 8 am felt arm around injection site a bit sore and found redness around injection site.  A bit sore and itchy.  No treatment.  It went away by the next day.. I have photograph.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Head ache, nausea
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Lethargy
Clinical narrative: FALL AM OF 2/18/2021 T 99.5 WITH LETHARGY
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was mistakenly given Moderna vaccine and was under the age of 18.  At the time of his monitoring pt had no adverse effect of the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Deep itch at vaccine site.  Used alcohol wipe and small knot in arm. The itch is a annoying bug bit sensation almost 24 hours now
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain
Clinical narrative: Low grade constant 24:7 head ache on right side if forehead. Began within 24 hours of vaccine. Going on  21 days. Difficult to sleep with pain. If I?m active It masks the pain and I do not  notice it as much. But when I stop an activity iand just sitting or lying down , the pain is must prevalent.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to age inappropriate patient.  Pt tolerated vaccine without any complications
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Sx of fatigue, fever, SOB, and nausea since then that have remained the same. Says she may not have a fever anymore, but has not checked her temperature. COVID test (-) on 2/16/21. Sent to Medical facility for follow up today 2/16
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Palpitations
Clinical narrative: 64 YEAR OLD FEMALE HAS A HISTORY OF A-FIB. ABOUT 15 MINUTES AFTER RECEIVINE VACCINE, SHE FELT HER HEART RACE. ON SITE EMS RESPONDED. THIS WAS HER FIRST VACCINE, EVER. HER INITIAL HR WAS IN THE 140'S IT IMPROVED TO 82 OVER TIME. OTHER FINAL VITALS BELOW. EMS RAN SEVERAL EKG'S. THEY APPEARED NORMAL. IT WAS RECOMMENDED TO GO TO THE ER, BUT SHE REFUSED.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: statrted day after the vaccine I had Whelping and itching on my neck and my back  . i took Benadryl
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Joint stiffness, Myalgia, Pyrexia
Clinical narrative: The night after the injection I had a fever, chills, muscle aches and pains, joint stiffness, headache, and uncontrollable shivering.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid-19 on 2/11/2021. Admitted into hospital. Stayed for 7 days.  Released on oxygen
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: severe headache, general flu-like symptoms started 4 hours after vaccine and lasted 36 hours
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amniotic fluid index decreased, Foetal exposure during pregnancy, Foetal growth restriction, Ultrasound scan
Clinical narrative: Prior to the vaccine my pregnancy was progressing along normally with both normal AFI and fetal size. My first dose was given 12/28/20 at 30 weeks 3 days lot #026L20A, my second dose lot # 013L20A was given 1/25/21 at 34w3d. After receiving the vaccine my fetus began to measure small for dates. An ultrasound showed the fetus has dropped in to the low 20% percentile for weight. Then my AFI decreased also. On all recent scans the AFI has been 6, prior to the vaccines all scans indicated more amniotic fluid.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient stated she got a severe headache after vaccination. Onsite EMS was called and vitals taken BP 190/94 HR 72  99% O2 room air. Patient went home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Moderna COVID?19 Vaccine EUA.   Red, sore, warm and itching skin around injection point. It is roundish, with a diameter of about 4 inches
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Administered dose 1 Moderna 026L20A 1/22/2021 Administered dose 2 Pfizer EL1284 2/23/2021, instead of Moderna dose 2..  Patient sat on Pfizer side instead of Moderna side.   Observed for 30 minutes. Closely monitored with no adverse side effects reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dry throat, Dyspnoea, Fatigue
Clinical narrative: Tiredness, out of breath after a few normal activities.  Five days later cold/sinus symptoms started with a sore throat, severe dryness of throat, nose, then congestion, runny nose, chills, NEVER a fever. A week later still tire, a little congestion, cough, some white liquid flem.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal dryness, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, Sinus congestion
Clinical narrative: Tiredness, out of breath after a few normal activities.  Five days later cold/sinus symptoms started with a sore throat, severe dryness of throat, nose, then congestion, runny nose, chills, NEVER a fever. A week later still tire, a little congestion, cough, some white liquid flem.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort
Clinical narrative: Patient experienced chest tightness and anxiety 5 minutes after vaccination. Onsite EMS was called vitals are HR 89  BP 160/79  99% O2 room air. Patient went home.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; proquad was improperly stored and then administered; This spontaneous report was received from a physician refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 12-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T023920, expiration date was reported and also validated as 09-JAN-2022 (dose was unknown; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The data logger registered, that the vaccine was stored at the temperature of 30 Fahrenheit degree (F) for 11 hours and 45 minutes. There was no previous temperature excursion detected. No additional adverse event (AE) was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: painful outbreak of skin rash; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 24-JUN-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) being administered, the pt developed a painful outbreak of skin rash. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presenting prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of zoster vaccine live (ZOSTAVAX) that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event was not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of rash to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Aches all over; Aches / especially in the back; Aches / legs; Fatigue; Slight fever; Headache; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th December 2020 14:00, the patient received the 2nd dose of Shingles vaccine. In December 2020, less than a day after receiving Shingles vaccine, the patient experienced general body pain, back pain, leg pain, fatigue, fever and headache. The patient was treated with naproxen. On an unknown date, the outcome of the general body pain, back pain, leg pain, fatigue and fever were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the general body pain, back pain, leg pain, fatigue, fever and headache to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. On the day of reporting, the patient  woke up with aches all over especially in the back and legs, fatigue, headache and slight fever (100.3 degree celsius) was coming down. The patient stated, the temperature was back to normal and ache and fatigue was gone. The patient took Naproxen and had some relief. The patient was asking how to differentiate the symptoms as he/she was concerned that the side effects mimic Covid 19 symptoms. The consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Aches all over; Aches / especially in the back; Aches / legs; Fatigue; Slight fever; Headache; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th December 2020 14:00, the patient received the 2nd dose of Shingles vaccine. In December 2020, less than a day after receiving Shingles vaccine, the patient experienced general body pain, back pain, leg pain, fatigue, fever and headache. The patient was treated with naproxen. On an unknown date, the outcome of the general body pain, back pain, leg pain, fatigue and fever were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the general body pain, back pain, leg pain, fatigue, fever and headache to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. On the day of reporting, the patient  woke up with aches all over especially in the back and legs, fatigue, headache and slight fever (100.3 degree celsius) was coming down. The patient stated, the temperature was back to normal and ache and fatigue was gone. The patient took Naproxen and had some relief. The patient was asking how to differentiate the symptoms as he/she was concerned that the side effects mimic Covid 19 symptoms. The consent to follow up was requested.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster, Pruritus, Wound haemorrhage
Clinical narrative: Shingles; Chest,back legs,hands, itch; Bleeding from scratching all The time; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles, pruritus and wound bleeding. On an unknown date, the outcome of the shingles, pruritus and wound bleeding were unknown.   It was unknown if the reporter considered the shingles, pruritus and wound bleeding to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  The patient got Flu shot and two days later developed shingles. The patient's chest, back, legs and hands itch and there was bleeding from scratching all the time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Joint stiffness, Joint swelling, Laboratory test, Sensation of foreign body
Clinical narrative: Left knee swelled up; Burning of throat; Lump in the throat; Stiffness in left knee; felt miserable; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of joint swelling (patient received inflenza vaccine quadrivalent 2020-2021 season for tolerance, refer case US2021AMR013009).   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable. On an unknown date, the outcome of the swelling of knees and stiff knees were not recovered/not resolved and the outcome of the burning in throat and lump feeling in throat were recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and felt miserable afterwards.  The patient stated that within a day or two her left knee swelled up, developed a lump in her throat, and there was also burning in the throat.  The patient described the lump as the size of a large grape that was located right in the middle where the Adam's apple would be and that it was no longer there, but it did take a long time for it to go away.  The patient was still had stiffness in the left knee that says was better, but not back to normal.  The patient never had any reactions like this before and was otherwise healthy.  The patient did visit her health care professional where they did an ultrasound and was also sent to an endocrinologist but a diagnosis was never made. The reporter did not consent to follow up. Not all information was available and did not give permission to follow up with their HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013009:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation, Ultrasound scan
Clinical narrative: Left knee swelled up; Burning of throat; Lump in the throat; Stiffness in left knee; felt miserable; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE with an associated reaction of joint swelling (patient received inflenza vaccine quadrivalent 2020-2021 season for tolerance, refer case US2021AMR013009).   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable. On an unknown date, the outcome of the swelling of knees and stiff knees were not recovered/not resolved and the outcome of the burning in throat and lump feeling in throat were recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and felt miserable afterwards.  The patient stated that within a day or two her left knee swelled up, developed a lump in her throat, and there was also burning in the throat.  The patient described the lump as the size of a large grape that was located right in the middle where the Adam's apple would be and that it was no longer there, but it did take a long time for it to go away.  The patient was still had stiffness in the left knee that says was better, but not back to normal.  The patient never had any reactions like this before and was otherwise healthy.  The patient did visit her health care professional where they did an ultrasound and was also sent to an endocrinologist but a diagnosis was never made. The reporter did not consent to follow up. Not all information was available and did not give permission to follow up with their HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013009:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: soreness and stiffness radiated up to the neck and shoulders; soreness and stiffness radiated up to the neck and shoulders; soreness and stiffness radiated up to the neck and shoulders; soreness and stiffness radiated up to the neck and shoulders; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain, muscle stiffness, neck pain and shoulder soreness. On an unknown date, the outcome of the pain, muscle stiffness, neck pain and shoulder soreness were recovered/resolved.   It was unknown if the reporter considered the pain, muscle stiffness, neck pain and shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 56 or 57 years. The patient received 1st dose in the upper left arm. The patient experienced muscle stiffness and soreness for 5 days after receiving the 1st dose of the Shingrix vaccine.  The patient also stated that the soreness and stiffness radiated up to the neck and shoulders. The reporter did not gave permission to follow-up with her health care professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Ophthalmic herpes zoster, Paraesthesia, Rash erythematous, Skin irritation
Clinical narrative: suspected Vaccination failure; Eye irritation that was diagnosed as shingles in the eye; Eye irritation; Irritation underneath the right armpit; Right armpit with little red dots / from her back to the breast; Bad sensation upon touch and a reaction (like it has a life of its own); This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 11 and 12 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), eye irritation, skin irritation, red rash and tenderness. The patient was treated with topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of the Shingrix vaccine back in last March and the 2nd dose last June.  The patient stated that in the beginning of this month she had an eye irritation that was diagnosed as shingles in the eye by her doctor. The patient reported that there were no pimples or pustules on the face. She was prescribed an antibiotic ointment and an antiviral that cleared it up.  A week later, she had another irritation underneath the right armpit with little red dots that stretched from her back to the breast. The patient was given the same antiviral to take. The patient stated that the irritation did not show anything on the body, except there was a bad sensation upon touch and a reaction (like it has a life of its own). The reporter did not consent to follow-up. Not all information was available. This case was reported as suspected vaccination failure since the details regarding laboratory confirmation was not given.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Vaccination failure
Clinical narrative: suspected Vaccination failure; Eye irritation that was diagnosed as shingles in the eye; Eye irritation; Irritation underneath the right armpit; Right armpit with little red dots / from her back to the breast; Bad sensation upon touch and a reaction (like it has a life of its own); This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 11 and 12 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), eye irritation, skin irritation, red rash and tenderness. The patient was treated with topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of the Shingrix vaccine back in last March and the 2nd dose last June.  The patient stated that in the beginning of this month she had an eye irritation that was diagnosed as shingles in the eye by her doctor. The patient reported that there were no pimples or pustules on the face. She was prescribed an antibiotic ointment and an antiviral that cleared it up.  A week later, she had another irritation underneath the right armpit with little red dots that stretched from her back to the breast. The patient was given the same antiviral to take. The patient stated that the irritation did not show anything on the body, except there was a bad sensation upon touch and a reaction (like it has a life of its own). The reporter did not consent to follow-up. Not all information was available. This case was reported as suspected vaccination failure since the details regarding laboratory confirmation was not given.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hypersomnia, Pain, Pyrexia
Clinical narrative: Tested positive for COVID-19; More aches and pains; Tiredness; Sleeping more; Low-grade fever; A spontaneous report was received from a consumer concerning her husband, a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low-grade fever/MedDRA PT: Fever, Tested positive for COVID-19/MedDRA PT: COVID-19, more aches and pains/MedDRA PT: Pain, tiredness and sleeping more/MedDRA PT: hypersomnia.   The patient's medical history was not provided. Concomitant medication information was not provided.   On 14 Jan 2021, the patient developed a low-grade fever.  On 16 Jan 2021, the patient tested positive for COVID 19.   On 19 Jan 2021, the patient received the first dose of two planned doses of mRNA-1273 in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, patient developed "more aches and pains, tiredness and sleeping more. The patient was seen at Urgent Care. Treatment included Vitamin C, Vitamin D, azithromycin, zinc and "mucus relief".   He was hospitalized for 12 days.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of low-grade fever, tested positive for COVID-19, more aches and pains, tiredness and sleeping more was considered unknown.; Reporter's Comments: This case concerns a 69-year-old male was hospitalized for a serious unexpected event of COVID-19, as well as NS unexpected events of hypersomnia and pain, and NS expected events of fever and fatigue. The event of COVID-19 occurred 12 days after the first dose of mRNA-1273.  Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; More aches and pains; Tiredness; Sleeping more; Low-grade fever; A spontaneous report was received from a consumer concerning her husband, a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low-grade fever/MedDRA PT: Fever, Tested positive for COVID-19/MedDRA PT: COVID-19, more aches and pains/MedDRA PT: Pain, tiredness and sleeping more/MedDRA PT: hypersomnia.   The patient's medical history was not provided. Concomitant medication information was not provided.   On 14 Jan 2021, the patient developed a low-grade fever.  On 16 Jan 2021, the patient tested positive for COVID 19.   On 19 Jan 2021, the patient received the first dose of two planned doses of mRNA-1273 in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, patient developed "more aches and pains, tiredness and sleeping more. The patient was seen at Urgent Care. Treatment included Vitamin C, Vitamin D, azithromycin, zinc and "mucus relief".   He was hospitalized for 12 days.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of low-grade fever, tested positive for COVID-19, more aches and pains, tiredness and sleeping more was considered unknown.; Reporter's Comments: This case concerns a 69-year-old male was hospitalized for a serious unexpected event of COVID-19, as well as NS unexpected events of hypersomnia and pain, and NS expected events of fever and fatigue. The event of COVID-19 occurred 12 days after the first dose of mRNA-1273.  Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: vaccine overdosage administered to 4 patients; A spontaneous report was received on 09 FEB 2021 from a healthcare professional concerning an unknown age, unknown gender patients who received Moderna's COVID-19 vaccine, higher dose than 0.5 ml.  The patients medical history was not provided. No relevant concomitant medications were reported.  On unknown date, four patients received their one of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  The healthcare professional reported that four patients were given a higher dose than 0.5 ml of Moderna's COVID-19 vaccine at their office. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccine over dosage administered to 4 patients, was considered recovered/resolved.; Reporter's Comments: This report refers to 4 cases of accidental vaccine overdose, administered for mRNA-1273, lot # unknown with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; A spontaneous report was received from a consumer concerning a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and cellulitis.  The patient's medical history was included lymphedema in her legs. Concomitant product use was not provided.  On 19 Jan 2021, prior to the onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient was hospitalized on 01 Feb 2021 for cellulitis. Treatment for the events included intravenous antibiotics, which the patient reported were antibacterial medications. The patient was switched to oral antibiotics but remained hospitalized.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: area was hot to touch; really red area below where she got her injection; 2&1/2" high and 4" wide; little soreness afterwards; she suspects that the injection was given subcutaneous instead of intramuscular; A spontaneous report was received from a consumer regarding herself, a 65-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and suspects the injection was given subcutaneous instead of intramuscular/inappropriate route of vaccination, area was hot to touch/vaccination site warmth, little soreness afterwards, really red area below where she got her injection/vaccination site erythema, and site 2&1/2 inches high and 4 inches wide/vaccination site swelling.  The patient's medical history was not provided. Products known to have been used by the patient were not included.  On 25 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021, the patient reported that she experienced a little soreness afterward and felt as if the dose was given subcutaneously instead of intramuscularly.  On 05 Feb 2021, approximately 11 days after the patient received the vaccine, she reports that she had warmth, swelling and a raised circle at the injection site.   Treatment information was not provided.   Consent to follow up was obtained.  Action taken with mRNA-1273 was not provided.  The outcome of the events, suspects the injection was given subcutaneous instead of intramuscular, area was hot to touch, little soreness afterwards, really red area below where she got her injection, site 2&1/2 inches high and 4 inches wide, was unknown.; Reporter's Comments: This case concerns a 65-year-old female who had a NS unexpected event of Incorrect route of product administration with associated adverse events of NS unexpected vaccination site warmth and NS expected vaccination site pain, vaccination site erythema, vaccination site swelling. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the Moderna second dose 15 minutes after 6 hour throw away time; A spontaneous report was received from a nurse concerning a 24-year-old male patient, who was administered Moderna's second dose fifteen minutes after six hours throw away time.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second planned doses of mRNA-1273 (Batch number: 09L20A) on 09 Feb 2021 for the prophylaxis of COVID-19 infection.  On 09 Feb 2021 the patient received the second dose of vaccine,however the dose suffered an excursion and remained out of the refrigeration 15 minutes after the 6 hour throw away time after being punctured. The nurse states it was only 15 min after the 6 hour time frame.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, administered Moderna's second dose fifteen minutes after six hours throw away time, was considered resolved.; Reporter's Comments: This report refers to a 24-year-old male who had an NS unexpected event of Expired product administered for mRNA-1273, lot # 09L20A with no associated adverse events. The event occurred the same day as the second dose of mRNA-1273. Reporter stated dose was affected by an excursion out of refrigeration more than 6 hours after being punctured, given 15 minutes after the 6 hours. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: felt some drops going down; felt some drops going down; A spontaneous report was received from a consumer concerning a 74-year-old male patient who stated he received the Moderna COVID-19 vaccine and as the needle was being withdrawn, he felt some drops going down his arm/underdose.   The patient's medical history was not provided.    Products known to have been used by the patient included statin, morniflumate, blood pressure medicine, and clonazepam.   On 07 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  The consumer received first dose of the Moderna COVID-19 vaccine on 07Feb2021. He received the shot on his left (non-dominant) arm. As the needle was being withdrawn, he felt some drops going down his arm. He is not sure whether he received the full dose or not.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event was not reported.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin contact for mRNA-1273 (Lot number: unknown) with no associated AEs.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Wasn't able to get second dose; A spontaneous report was received from a consumer concerning her mother who is 88 year old female, who received her first dose of Moderna Covid -19 vaccine and couldn't take the 2nd dose as scheduled.  The consumer's medical history was not provided except she had a pelvic fracture. Her relevant concomitant medications were not provided. No information on allergies.   On 15-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. She couldn't take her 2nd dose due to hospitalization. She is being hospitalized for a pelvic break prior to her first dose of vaccine and been admitted in rehab facility since then. She is unable to receive her 2nd dose as scheduled.  Action taken with 2nd dose of Moderna Covid-19 vaccine was unknown.  The outcome of the event inappropriate schedule of vaccination is unknown at the time of report.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle leaked (Not sure if any of the dose got in to the patient's muscle); Needle leaked (Not sure if any of the dose got in to the patient's muscle); A spontaneous report was received from a healthcare professional concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following:  needle leaked (device connection issue), not sure if any of the dose got into the patient's muscle (vaccine underdose)  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, while administering the vaccine to the patient, the nurse noted that the needle was not attached properly.  The vaccine leaked and the reporter was not sure if the patient received any of the dose.    Action taken with mRNA-1273 in response to the event was unknown.  The event, needle leaked and not sure if any of the dose got into the patient's muscle, was considered resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose, Vaccination site pain
Clinical narrative: barely soreness; all the liquid from the needle ran down arm; all the liquid from the needle ran down arm; A spontaneous report was received from a consumer concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and liquid from the needle ran down her arm and experienced barely soreness.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin 10 mg, amlodipine 2.5 mg, acidophilus, vit D, aspirin, and coQ10.    On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated that she had her 1st dose of the Moderna Covid-19 vaccine 26 Jan 2021 and felt all the liquid drip down her arm. She was sure if she got anything from the "1st" dose. She felt the needle go in, barely experienced soreness for that day. Treatment information was not provided.    Action taken with the drug in response to the events is unknown.  The outcome of the event barely soreness was resolved on 26 Jan 2021. The event vaccine underdose and device connection issue was considered resolved on 26 Jan 2021.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of soreness, a causal relationship cannot be excluded. The causality of events of vaccine underdose and device connection is not applicable.