chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pollakiuria, Pyrexia
Clinical narrative: 2/3/21 Started with headache. Then overnight fever and chills. Dizzy, body ache, frequent urination. Next morning 2/4/21, fever, headache, upset stomach, body aches, fatigue. I had to quit work and go to bed.  2/5/21 fever has passed. Still have headache and some body aches.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Erythema
Clinical narrative: Moderna COVID-19 Vaccine EUA  At approximately 9:00pm on the day of my second dose I experienced some dizziness. At approximately 12:30 at night, I woke up due to the pain I was feeling all over my body (in particular in my joints and lower back). I also have a severe headache. At approximately 2:30am I experienced nausea and some vomiting followed by chills without fever. The headache, body aches, and extreme exhaustion continued until approximately 9pm the day after the shot. Two days later, almost all symptoms were gone (I still felt tired). I had a small red spot at the injection site that lasted 2 days but the injection site pain was way worse for the first shot than the second one.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA  At approximately 9:00pm on the day of my second dose I experienced some dizziness. At approximately 12:30 at night, I woke up due to the pain I was feeling all over my body (in particular in my joints and lower back). I also have a severe headache. At approximately 2:30am I experienced nausea and some vomiting followed by chills without fever. The headache, body aches, and extreme exhaustion continued until approximately 9pm the day after the shot. Two days later, almost all symptoms were gone (I still felt tired). I had a small red spot at the injection site that lasted 2 days but the injection site pain was way worse for the first shot than the second one.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder, Vomiting
Clinical narrative: Moderna COVID-19 Vaccine EUA  At approximately 9:00pm on the day of my second dose I experienced some dizziness. At approximately 12:30 at night, I woke up due to the pain I was feeling all over my body (in particular in my joints and lower back). I also have a severe headache. At approximately 2:30am I experienced nausea and some vomiting followed by chills without fever. The headache, body aches, and extreme exhaustion continued until approximately 9pm the day after the shot. Two days later, almost all symptoms were gone (I still felt tired). I had a small red spot at the injection site that lasted 2 days but the injection site pain was way worse for the first shot than the second one.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Currently 11.5 weeks pregnant, due August 21st. The night of the first dose I began to get cramps/muscle pain in both legs from the hip down. Next day the pain moved to only the left leg. Going on day two and still have consistent pain in the left leg.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Tenderness, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: January 27, 2021--No immediate reactions other than very slight tenderness and a dime-size bruise from vaccine.  February 3-present--vaccination site is swollen, hot, and itching
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone, Body temperature increased, Constipation, Cough, Dehydration
Clinical narrative: Bad headache, Fatigue, with muscle aches.  Sore Throat, coughing with shortness of breath (seems to get better with movement, slight temperature 99.8 but using old ear thermometer, nausea, some trouble with eating but can taste foods fine.  I had a hysterectomy 3 months ago that had several fibroids, cysts and polys and Type 3 endometriosis.  This is still causing constipation and my physician said I was slightly dehydrated at lab testing taken January 28.    Was checking for pre-menopause symptoms which were inconclusive but did indicate I am still ovulating.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eating disorder, Fatigue, Headache, Myalgia
Clinical narrative: Bad headache, Fatigue, with muscle aches.  Sore Throat, coughing with shortness of breath (seems to get better with movement, slight temperature 99.8 but using old ear thermometer, nausea, some trouble with eating but can taste foods fine.  I had a hysterectomy 3 months ago that had several fibroids, cysts and polys and Type 3 endometriosis.  This is still causing constipation and my physician said I was slightly dehydrated at lab testing taken January 28.    Was checking for pre-menopause symptoms which were inconclusive but did indicate I am still ovulating.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Bad headache, Fatigue, with muscle aches.  Sore Throat, coughing with shortness of breath (seems to get better with movement, slight temperature 99.8 but using old ear thermometer, nausea, some trouble with eating but can taste foods fine.  I had a hysterectomy 3 months ago that had several fibroids, cysts and polys and Type 3 endometriosis.  This is still causing constipation and my physician said I was slightly dehydrated at lab testing taken January 28.    Was checking for pre-menopause symptoms which were inconclusive but did indicate I am still ovulating.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Started yesterday and mu arm was itching and i had a red circle . this morning  the circle is now about the size of .50 piece called dr and was told to take Benadryl
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Started yesterday and mu arm was itching and i had a red circle . this morning  the circle is now about the size of .50 piece called dr and was told to take Benadryl
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and sense of smell for less than 24 hours
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular, Sleep disorder
Clinical narrative: On February 03, 2021 my arm started itching.  On February 04, 2021 my arm continued to itch with the appearance of three distinct circular areas of bumps (dime sized circles).  On February 05, 2021 I was awakened from my sleep due to my arm itching.  The previous distinct dime sized circles had merged into one large red papule (oval shaped 3 inches long by 2 inches wide).  I contacted Dermatology clinic for an appointment.  In the meantime I applied Hydrocortizone ointment to the area and took a benadryl tablet orally for the itching.  My doctors appointment is scheduled for 02/05/2021 at 10:30 AM.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Swollen tongue, Throat tightness
Clinical narrative: Time of symptoms: 5 minutes after vaccine; lasted 45 minutes Symptoms: Throat tightening, tongue swelling, and severe nausea Treatment: Benadryl and observation until symptoms subsided Outcomes: full recovery; not advised to take second Moderna dose
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: body aches, headache, low grade fever, soreness in site of vaccine, tired, weak
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches, headache, low grade fever, soreness in site of vaccine, tired, weak
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Red, swollen, itchy, and hot at site of vaccination.. Still red and hot 12 hours later, but not as red and swollen.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site reaction, Nausea, Pyrexia
Clinical narrative: Headache, Fever highest recorded at 101.7 F,  severe chills, nausea. Started at 8:30p on 2/3 and continued until 6p 2/4. Used 650 mg acetaminophen q8h and 400mg Ibuprofen q6h, hot compress for headache, and increased fluid intake. Developed red splotches on skin near injection site on 2/5
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Headache, Fever highest recorded at 101.7 F,  severe chills, nausea. Started at 8:30p on 2/3 and continued until 6p 2/4. Used 650 mg acetaminophen q8h and 400mg Ibuprofen q6h, hot compress for headache, and increased fluid intake. Developed red splotches on skin near injection site on 2/5
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: lymph node swelling in axilla in arm of injection site started with 6 hours after vaccination.  Fatigue, fever as high as 101 , chills, nausea started approx. 12 hours thereafter.  Ibuprofen was used to treat systemic symptoms.  Systemic symptoms resolved after 12 hours.  Lymph node swelling resolved after 7 days.  Patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Fatigue, Headache
Clinical narrative: Severe muscle and joint pain, headache, nausea, stomach cramps, fatigue/weakness, fever
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Severe muscle and joint pain, headache, nausea, stomach cramps, fatigue/weakness, fever
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: nausea, low grade fever, body aches, headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever of 101.9, chills, fatigue, weakness, loss of appetite
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Vomiting
Clinical narrative: TEMP 101.6, VOMITING, HEADACHE, CHILLS/MUSCLE ACHES
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Rash
Clinical narrative: Large lump on arm where injection occurred, body rash.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: Narrative: Per ER MD: "2nd dose of covid vaccine today then went home. His family found him unresponsive and started CPR and he woke up."
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Severe right shoulder pain. Still unable to raise arm fully.  Unable to raise arm above 45 degree angle.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Hypertension, Hypoaesthesia, Neck pain, Ocular hyperaemia
Clinical narrative: facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches, headaches, and fever through the night (12 hours). Sore arm and exhaustion (36hours).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, short of breath, tired, achy. Took Tylenol and slept. First day was worse than the second. Feeling better today. Temp didn?t go above 99.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatinine increased, Blood glucose increased, Fatigue
Clinical narrative: Narrative: Vaccine received 1/20/21. Pt reports feeling tired starting the following day (expected), however, blood sugars went up over 400. Went to ER for evaluation and treatment. Found to have elevated CR and markedly elevated liver enzymes (AST/ALT over 1000) which slowly improved after hospitalization, IVF, and insulin. 1/28/21 labs showed CR back to normal. ALT down to 555 AST 304. Blood sugars 200s.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Laboratory test abnormal
Clinical narrative: Narrative: Vaccine received 1/20/21. Pt reports feeling tired starting the following day (expected), however, blood sugars went up over 400. Went to ER for evaluation and treatment. Found to have elevated CR and markedly elevated liver enzymes (AST/ALT over 1000) which slowly improved after hospitalization, IVF, and insulin. 1/28/21 labs showed CR back to normal. ALT down to 555 AST 304. Blood sugars 200s.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Magnetic resonance imaging, Retching
Clinical narrative: 3rd day became very dizzy, dry heaves.  Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nasopharyngitis, Nausea, Retching
Clinical narrative: 3rd day became very dizzy, dry heaves.  Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Sinus disorder
Clinical narrative: 3rd day became very dizzy, dry heaves.  Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Arthralgia, Asthenia, Blood bicarbonate normal, Blood gases
Clinical narrative: Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pH normal, Chest X-ray abnormal, Chronic left ventricular failure, Condition aggravated, Dyspnoea
Clinical narrative: Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction abnormal, Ejection fraction decreased, Fatigue, Headache
Clinical narrative: Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Left ventricular hypertrophy, PCO2 normal, PO2 decreased, Pleural effusion, Pulmonary oedema
Clinical narrative: Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Hyperhidrosis, Pyrexia
Clinical narrative: Sweats and hot flashes, chills, low grade fever, exhaustion.  They started Thursday early in the AM. They will go away for a certain period of time but then they return.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache
Clinical narrative: Achy  joints, headache, lack of energy
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Wife reported patient expired on 2/3/2021
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Heart rate increased
Clinical narrative: Chills beginning at 8pm and continuing until 3pm, lower pack pain, fatigue, rapid heart rate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Moderna Covid 19 Vaccine EUA. I have 3 inch circle rash at injection site.  It  itches.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild pain in upper right arm approximately 24 hours after injection that lasted about 2 days
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Pain in extremity
Clinical narrative: Mild headache that evening, arm slightly sore during the night and the next day.  Frontal headache and muscle aches the next day on 1/22/21.  Some fatigue and nasal congestion that next day as well.  Some fatigue and headache on 1/23/21.  Took Tylenol once on 1/22 and 1/23.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Mild headache that evening, arm slightly sore during the night and the next day.  Frontal headache and muscle aches the next day on 1/22/21.  Some fatigue and nasal congestion that next day as well.  Some fatigue and headache on 1/23/21.  Took Tylenol once on 1/22 and 1/23.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Dyspepsia, Vomiting
Clinical narrative: Sour stomach and vomiting. Inability to hold down food or tums. The vomiting occurred twice the day after the 1st vaccine and then as time progressed my stomach discomfort decreased. The stomach pain went away after day 3.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Red welt about 3 inches in diameter at injection site, warm and itches
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Started having chills and feeling feverish around 10am.  By lunchtime, I was feeling nauseous as well.  Spent afternoon and evening with chills, feeling fatigued and nauseous.  Nausea went away by bed time but still fatigued and chilled.  Never did spike a fever.  The next morning when I got up, I felt fine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury
Clinical narrative: Soreness in both knees and right elbow.   (I  struck right elbow a couple of days earlier but it only hurt for a couple of minutes .  The day after the shot it became sore.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Fever of 104.3 degrees; chills; dizziness; exhaustion; headache.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate irregular, Rash
Clinical narrative: Rash, increased irregular heartbeat, feeling off-have not contacted anyone yet
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Presyncope
Clinical narrative: got very dizzy and almost fainted; Near fainting; This spontaneous report was received from an office manager referring to a 11-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.    On 08-JAN-2021 (reported as today, also reported as 08-JAN-2020), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter once, intramuscularly for prophylaxis (strength, lot number and expiration date were not reported).        On 08-JAN-2021 (also reported as 08-JAN-2020), the patient got very dizzy and almost fainted (dizziness and presyncope). The patient had never lost consciousness. They waved an ammonia tab under the patient's nose to prevent the patient from fainting. The reporter stated that it was a very short episode, and the patient went home without any further intervention. The outcome of both events were reported as resolved on the same date.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and both events was not reported.
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: no additional AE; a nurse reconsituted VARIVAX with monactra instead of the sterile diluent and she administered it to a patient; a nurse reconsituted VARIVAX with monactra instead of the sterile diluent and she administered it to a patient; This spontaneous report was received from a nurse and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JAN-2021, the patient was vaccinated with an improperly reconstituted dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (exact dose, anatomical location, lot # and expiration date were not provided) for prophylaxis (product preparation error). A nurse reconstituted the vaccine with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (reported as monactra) instead of the sterile diluent (wrong product administrated). There was no adverse event (AE) reported.
Sex: U
Vaccine: VARZOS
Symptoms: Facial discomfort, Haemoptysis, Myalgia, Pneumonia, Productive cough
Clinical narrative: Cough, sputum production, with sometimes streaks of blood, rhinorrhea, facial pressure and myalgias; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 04-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered cough, sputum production, with sometimes streaks of blood, rhinorrhea, facial pressure and myalgias. The patient was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of pneumonia was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Pneumonia was considered a disabling event by the reporter.  Upon internal review, pneumonia was considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Cough, sputum production, with sometimes streaks of blood, rhinorrhea, facial pressure and myalgias; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 04-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as shortly after receiving the vaccine), the patient suffered cough, sputum production, with sometimes streaks of blood, rhinorrhea, facial pressure and myalgias. The patient was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of pneumonia was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Pneumonia was considered a disabling event by the reporter.  Upon internal review, pneumonia was considered a medically significant event.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Impaired work ability, Myalgia
Clinical narrative: muscle/body aches/chills, feeling feverish, nausea, headache, lightheaded. Ibuprofen and acetaminophen alternating every 2-3 hours helped reduce severity of symptoms. Had to leave work due to symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: muscle/body aches/chills, feeling feverish, nausea, headache, lightheaded. Ibuprofen and acetaminophen alternating every 2-3 hours helped reduce severity of symptoms. Had to leave work due to symptoms.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: swollen and sore armpit / Left armpit, axillary area - swelling and tenderness started; swollen and sore armpit / Left armpit, axillary area - swelling and tenderness started; Left armpit, axillary area - swelling and tenderness started; injection site soreness; headache; muscle aches; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and headache. On 5th December 2020, the patient experienced swelling arm, axillary pain, muscle pain and tenderness. On an unknown date, the outcome of the injection site pain, swelling arm, axillary pain and tenderness were recovering/resolving and the outcome of the headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, swelling arm, axillary pain, headache, muscle pain and tenderness to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and experienced headache, muscle aches, injection site soreness and left armpit, axillary area swelling and tenderness also swollen and sore armpit. On 8th December 2020, headache and muscle aches were recovered No other information was provided. The reporter consented to follow up.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: swollen and sore armpit / Left armpit, axillary area - swelling and tenderness started; swollen and sore armpit / Left armpit, axillary area - swelling and tenderness started; Left armpit, axillary area - swelling and tenderness started; injection site soreness; headache; muscle aches; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received Shingrix (intramuscular). On 4th December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and headache. On 5th December 2020, the patient experienced swelling arm, axillary pain, muscle pain and tenderness. On an unknown date, the outcome of the injection site pain, swelling arm, axillary pain and tenderness were recovering/resolving and the outcome of the headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, swelling arm, axillary pain, headache, muscle pain and tenderness to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and experienced headache, muscle aches, injection site soreness and left armpit, axillary area swelling and tenderness also swollen and sore armpit. On 8th December 2020, headache and muscle aches were recovered No other information was provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: swollen armpit after Shingrix; This case was reported by a consumer and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient received Shingrix and experienced swollen armpit. No other information was provided. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Lip blister, Oral herpes
Clinical narrative: I have 2 fever blisters on my lips; This case was reported by a consumer and described the occurrence of fever blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was recovered/resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were reported as follows: The patient stated that had bad reaction to 2nd dose of Shingrix shot, ok till the time of report. The patient had 2 fever blisters on lips and the patient was wondering was that was related to shot. No other information was provided. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever blisters; This case was reported by a consumer and described the occurrence of fever blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient asked could fever blisters be side effect of Shingrix shot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: I WAS VERY COLD AND SHIVERING AROUND 10:00 PM , FEVER (101) AROUND 01:15 AM  TOOK TYLENOL AROUND 01:30AM
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Very dizzy; Weak; Nausea; Little apetite; Tired; Shivers; Racing heartbeat; First dose on 10/30/20 / Second dose on 12/5/20; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing. On an unknown date, the outcome of the drug dose administration interval too short was unknown and the outcome of the dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing were recovering/resolving.   It was unknown if the reporter considered the drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing to be related to Shingrix.  Additional details were reported as follows: The patient had 2nd dose of Shingrix too soon, which led to shortening of vaccination schedule. The patient had worse reaction, very dizzy, weak, nausea, little appetite, tired, shivers the night the patient got the shot and racing heartbeat. The patient was better but not great. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Nausea, Palpitations
Clinical narrative: Very dizzy; Weak; Nausea; Little apetite; Tired; Shivers; Racing heartbeat; First dose on 10/30/20 / Second dose on 12/5/20; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing. On an unknown date, the outcome of the drug dose administration interval too short was unknown and the outcome of the dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing were recovering/resolving.   It was unknown if the reporter considered the drug dose administration interval too short, dizziness, weakness, nausea, appetite impaired, tiredness, shivers and heart racing to be related to Shingrix.  Additional details were reported as follows: The patient had 2nd dose of Shingrix too soon, which led to shortening of vaccination schedule. The patient had worse reaction, very dizzy, weak, nausea, little appetite, tired, shivers the night the patient got the shot and racing heartbeat. The patient was better but not great. The information regarding consent to follow up was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer and described the occurrence of rash in a 89-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced a rash after the first dose of Shingrix, but did not believe it was related to the vaccine at the time. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2020243348.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243348:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Body aches; Tired; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingles vaccine. In December 2020, less than a week after receiving Shingles vaccine, the patient experienced general body pain and tiredness. On an unknown date, the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced body aches and Tiredness after second shot of Shingles vaccine. The patient wanted to know how long do the side effects last .
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypokinesia, Movement disorder
Clinical narrative: affected the movement of muscles in neck, back, shoulder and all the left side of her body; awful; This case was reported by a consumer via other manufacturer and described the occurrence of movements reduced in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced movements reduced and feels awful. On an unknown date, the outcome of the movements reduced and feels awful were recovered/resolved.   It was unknown if the reporter considered the movements reduced and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received the Shingrix vaccine and had an awful adverse reaction.  It affected the movement of muscles in neck, back, shoulder and all the left side of her body and while it lasted some weeks. The patient did not want to go through that experience again so wanted to wanted to know the full list of ingredients of the Covid vaccine. The consent to contact HCP was requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: fever as high as 100.5, chills, body aches, fatigue, nausea
Sex: U
Vaccine: VARZOS
Symptoms: Candida infection
Clinical narrative: if thrush is also a side-effect from / since I've had both shots; This case was reported by a consumer and described the occurrence of thrush in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced thrush. On an unknown date, the outcome of the thrush was recovered/resolved.   It was unknown if the reporter considered the thrush to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced thrush. The patient said I was wondering if thrush is also a side effect from Shingrix. The reporter did not consent to follow up. This case has been linked with US2020AMR245377, reported by same reporter and same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Candida infection, Vaccine positive rechallenge
Clinical narrative: if thrush is also a side-effect from / since I've had both shots; This case was reported by a consumer and described the occurrence of thrush in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of candida infection (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced thrush. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the thrush was unknown.   It was unknown if the reporter considered the thrush to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced thrush. The patient said I was wondering if thrush is also a side effect from Shingrix. The reporter did not consent to follow up. This case has been linked with US2020AMR245365, reported by same reporter and same patient.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Flushing, Gait disturbance
Clinical narrative: C/O 'off balance' as walking out of waiting area he felt off balance and was leaning to the right side, face was flushed and gait unsteady  Vital signs were monitored every 10 minutes for half hour, given benadryl by mouth @ 6:15 PM Left to go home with wife who was able to drive him home. Instructed to F/U with PCP  to have second dose on 3/4/21
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Limb immobilisation, Mobility decreased, Pain
Clinical narrative: Excruciating pain; Immobilized shoulder arm; Administered in my shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, injected limb mobility decreased and product administered at inappropriate site. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the pain, injected limb mobility decreased and product administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain and injected limb mobility decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received Shingrix vaccine mis administered in his/her shoulder causing excruciating pain and immobilized shoulder arm, which led to product administered at inappropriate site. The patient went to orthopedic doctor and got a cortisone shot that was helping. The patient wanted to know as how to know if this shot was protecting his/her.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Experienced joint pain / described as severe / resolved within two months; This case was reported by a Nurse via call center representative and described the occurrence of arthralgia in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2015-2016 season) for prophylaxis.   The patient's past medical history included psoriatic arthritis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2015-2016 season. On an unknown date, several weeks after receiving Influenza vaccine Quadrivalent 2015-2016 season, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was recovered/resolved.   It was unknown if the reporter considered the arthralgia to be related to Influenza vaccine Quadrivalent 2015-2016 season.  Additional details were provided as follows: Age at vaccination was not reported. The health care professional, who was also the patient, reported that she received an adjuvanted flu vaccine made in 2015. The  patient experienced joint pain a couple weeks after receiving vaccine. Joint pain was described as severe. Joint pain resolved within two months, no resolution date provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020242244:Same reporter
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: extreme fatigue, body aches, severe headache, sore arm at injection site, fever
Sex: M
Vaccine: VARZOS
Symptoms: Crying, Glossodynia, Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster
Clinical narrative: Suspected vaccination failure; got it over side face, in mouth jaw ear eye was really bad; shingles in ear; got it over side face/in mouth jaw was really bad; pain; he cryed; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant), shingles, pain and crying. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient got shingles over side face, in mouth, jaw, ear and eye. The reporter stated it was really bad. The reporter had to take care of patient. The reporter stated it was awful see the patient, pain effected tongue and the patient cried. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, details regarding actual time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got it over side face, in mouth jaw ear eye was really bad; shingles in ear; got it over side face/in mouth jaw was really bad; pain; he cryed; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant), shingles, pain and crying. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster oticus, shingles, pain and crying to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient got shingles over side face, in mouth, jaw, ear and eye. The reporter stated it was really bad. The reporter had to take care of patient. The reporter stated it was awful see the patient, pain effected tongue and the patient cried. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, details regarding actual time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.