chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injected limb mobility decreased, Injection site discolouration, Injection site erythema
Clinical narrative: All documented with doctor along with pictures and timeline. 9/17 5:15pm Shot taken - initial injection felt a little tingly/itchy sensation within a couple mins of injection (thought it could possibly be the bandaid since it was a rougher bandaid that can sometimes irritate my skin), 9/17 around 8:30pm noticed my arm started a rash at injection site, red bump, still itchiness. Provider believes injection site allergic reaction non-life threatening; 9/17 2:15am continued red rash down my upper arm and darker red circle appeared at injection site, 9/18 12:36pm arm swollen, big red quartersize circle at injection site and small rash underneath stayed same during day along with sore arm, by 9/19 12:12pm Silver dollar size swollen red dot, itchy, sore arm, 9/20-9/21 remained same symptoms as 9/19, on 9/22-9/23 red dot size and swelling started to decrease leaving small quarter size reaction that was decreasing. On 9/24 a week exactly after provider believes covid arm started; 9/24 7:58pm rash came back, skin puffed up making a large silver dollar red mark and skin pain. 9/25 2:15am progressed to a large circle (bottom of a cup size), extremely itchy, very bad swelling with raised bump, hot to touch, 9/25 11:29am same as earlier 9/25 symptoms but swelling started to extend to side of arm, 9/25 12:58pm continued same symptoms but felt increased tension and limited movement in arm due to severe swelling in upper arm at injection site, 9/26 1:33 am continued large coffee cup circle size with swelling spread at injection side  with pain and itchiness, 9/27 12:10 am swelling starts to go down, continued rash but now extreme nerve pain from elbow to wrist feeling like dull nerve pain where it was hard to use fingers like carpel tunnel feeling and extreme pain at elbow, 9/27 7:28pm circle gone down to quarter size - nerve pain continued in arm - headache all day, 9/28-9/29 continued red small circle quarter size, itchy nerve pain started to subside and itchiness as well first days of showing improvement.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site rash
Clinical narrative: All documented with doctor along with pictures and timeline. 9/17 5:15pm Shot taken - initial injection felt a little tingly/itchy sensation within a couple mins of injection (thought it could possibly be the bandaid since it was a rougher bandaid that can sometimes irritate my skin), 9/17 around 8:30pm noticed my arm started a rash at injection site, red bump, still itchiness. Provider believes injection site allergic reaction non-life threatening; 9/17 2:15am continued red rash down my upper arm and darker red circle appeared at injection site, 9/18 12:36pm arm swollen, big red quartersize circle at injection site and small rash underneath stayed same during day along with sore arm, by 9/19 12:12pm Silver dollar size swollen red dot, itchy, sore arm, 9/20-9/21 remained same symptoms as 9/19, on 9/22-9/23 red dot size and swelling started to decrease leaving small quarter size reaction that was decreasing. On 9/24 a week exactly after provider believes covid arm started; 9/24 7:58pm rash came back, skin puffed up making a large silver dollar red mark and skin pain. 9/25 2:15am progressed to a large circle (bottom of a cup size), extremely itchy, very bad swelling with raised bump, hot to touch, 9/25 11:29am same as earlier 9/25 symptoms but swelling started to extend to side of arm, 9/25 12:58pm continued same symptoms but felt increased tension and limited movement in arm due to severe swelling in upper arm at injection site, 9/26 1:33 am continued large coffee cup circle size with swelling spread at injection side  with pain and itchiness, 9/27 12:10 am swelling starts to go down, continued rash but now extreme nerve pain from elbow to wrist feeling like dull nerve pain where it was hard to use fingers like carpel tunnel feeling and extreme pain at elbow, 9/27 7:28pm circle gone down to quarter size - nerve pain continued in arm - headache all day, 9/28-9/29 continued red small circle quarter size, itchy nerve pain started to subside and itchiness as well first days of showing improvement.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Neuralgia, Pain, Pain in extremity, Pain of skin
Clinical narrative: All documented with doctor along with pictures and timeline. 9/17 5:15pm Shot taken - initial injection felt a little tingly/itchy sensation within a couple mins of injection (thought it could possibly be the bandaid since it was a rougher bandaid that can sometimes irritate my skin), 9/17 around 8:30pm noticed my arm started a rash at injection site, red bump, still itchiness. Provider believes injection site allergic reaction non-life threatening; 9/17 2:15am continued red rash down my upper arm and darker red circle appeared at injection site, 9/18 12:36pm arm swollen, big red quartersize circle at injection site and small rash underneath stayed same during day along with sore arm, by 9/19 12:12pm Silver dollar size swollen red dot, itchy, sore arm, 9/20-9/21 remained same symptoms as 9/19, on 9/22-9/23 red dot size and swelling started to decrease leaving small quarter size reaction that was decreasing. On 9/24 a week exactly after provider believes covid arm started; 9/24 7:58pm rash came back, skin puffed up making a large silver dollar red mark and skin pain. 9/25 2:15am progressed to a large circle (bottom of a cup size), extremely itchy, very bad swelling with raised bump, hot to touch, 9/25 11:29am same as earlier 9/25 symptoms but swelling started to extend to side of arm, 9/25 12:58pm continued same symptoms but felt increased tension and limited movement in arm due to severe swelling in upper arm at injection site, 9/26 1:33 am continued large coffee cup circle size with swelling spread at injection side  with pain and itchiness, 9/27 12:10 am swelling starts to go down, continued rash but now extreme nerve pain from elbow to wrist feeling like dull nerve pain where it was hard to use fingers like carpel tunnel feeling and extreme pain at elbow, 9/27 7:28pm circle gone down to quarter size - nerve pain continued in arm - headache all day, 9/28-9/29 continued red small circle quarter size, itchy nerve pain started to subside and itchiness as well first days of showing improvement.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin swelling, Skin warm, Tension
Clinical narrative: All documented with doctor along with pictures and timeline. 9/17 5:15pm Shot taken - initial injection felt a little tingly/itchy sensation within a couple mins of injection (thought it could possibly be the bandaid since it was a rougher bandaid that can sometimes irritate my skin), 9/17 around 8:30pm noticed my arm started a rash at injection site, red bump, still itchiness. Provider believes injection site allergic reaction non-life threatening; 9/17 2:15am continued red rash down my upper arm and darker red circle appeared at injection site, 9/18 12:36pm arm swollen, big red quartersize circle at injection site and small rash underneath stayed same during day along with sore arm, by 9/19 12:12pm Silver dollar size swollen red dot, itchy, sore arm, 9/20-9/21 remained same symptoms as 9/19, on 9/22-9/23 red dot size and swelling started to decrease leaving small quarter size reaction that was decreasing. On 9/24 a week exactly after provider believes covid arm started; 9/24 7:58pm rash came back, skin puffed up making a large silver dollar red mark and skin pain. 9/25 2:15am progressed to a large circle (bottom of a cup size), extremely itchy, very bad swelling with raised bump, hot to touch, 9/25 11:29am same as earlier 9/25 symptoms but swelling started to extend to side of arm, 9/25 12:58pm continued same symptoms but felt increased tension and limited movement in arm due to severe swelling in upper arm at injection site, 9/26 1:33 am continued large coffee cup circle size with swelling spread at injection side  with pain and itchiness, 9/27 12:10 am swelling starts to go down, continued rash but now extreme nerve pain from elbow to wrist feeling like dull nerve pain where it was hard to use fingers like carpel tunnel feeling and extreme pain at elbow, 9/27 7:28pm circle gone down to quarter size - nerve pain continued in arm - headache all day, 9/28-9/29 continued red small circle quarter size, itchy nerve pain started to subside and itchiness as well first days of showing improvement.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: chest tightness; EKG done WNL
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: OK
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Hard, painful lump at injection site larger than the size of a quarter. Lump is still present as of today, over a week and a half later. Redness has lessened.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash pruritic, Skin warm
Clinical narrative: Had a itchy hot rash that spread throughout my entire body for 23 days (lingered longer in some spots but was more manageable). Went to family  doctor, dermatologist, allergist and urgent care. Received a topical steroid and continued to use cold packs to help relieve the pain and itch.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram, Culture urine, Full blood count
Clinical narrative: On July 17 in the middle of the night I woke up with severe pain under my belly, I went to the restroom and I had flood coming out instead of urine. I went to the ER where they did a CT scan, administered antibiotics, took a urine sample. The results came out as a mixed culture. They had given me Keflex which I finished. The symptoms returned within a week after Keflex was finished, this time I contacted my OB/GYN andThey wrote another urine test and gave me Nitrofurantoin. The results were the same as last time and there was no clear sign of a UTI at all. After 2 weeks that the antibiotics were done, My skin started to get severe rashes All over and I also got hives. I went to see my dermatologist and he said that It?s because of my body?s reaction to an infection that I?m getting this. So he?s put me on three anti-histamines.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infection, Rash, Sleep disorder, Urinary incontinence, Urine analysis
Clinical narrative: On July 17 in the middle of the night I woke up with severe pain under my belly, I went to the restroom and I had flood coming out instead of urine. I went to the ER where they did a CT scan, administered antibiotics, took a urine sample. The results came out as a mixed culture. They had given me Keflex which I finished. The symptoms returned within a week after Keflex was finished, this time I contacted my OB/GYN andThey wrote another urine test and gave me Nitrofurantoin. The results were the same as last time and there was no clear sign of a UTI at all. After 2 weeks that the antibiotics were done, My skin started to get severe rashes All over and I also got hives. I went to see my dermatologist and he said that It?s because of my body?s reaction to an infection that I?m getting this. So he?s put me on three anti-histamines.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis abnormal, Urticaria
Clinical narrative: On July 17 in the middle of the night I woke up with severe pain under my belly, I went to the restroom and I had flood coming out instead of urine. I went to the ER where they did a CT scan, administered antibiotics, took a urine sample. The results came out as a mixed culture. They had given me Keflex which I finished. The symptoms returned within a week after Keflex was finished, this time I contacted my OB/GYN andThey wrote another urine test and gave me Nitrofurantoin. The results were the same as last time and there was no clear sign of a UTI at all. After 2 weeks that the antibiotics were done, My skin started to get severe rashes All over and I also got hives. I went to see my dermatologist and he said that It?s because of my body?s reaction to an infection that I?m getting this. So he?s put me on three anti-histamines.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Condition aggravated, Laboratory test, Stridor
Clinical narrative: I experienced anaphylaxis-throat closing, tachycardia, audible wheezing, stridor, feelings of impending doom. I administered my epi-pen and was taken to the emergency room for further observation and treatment. I received IV Solumedrol and Versed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Throat tightness, Wheezing
Clinical narrative: I experienced anaphylaxis-throat closing, tachycardia, audible wheezing, stridor, feelings of impending doom. I administered my epi-pen and was taken to the emergency room for further observation and treatment. I received IV Solumedrol and Versed.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash all over face, neck, chest, and back.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: Hives on my face, skin itching, temperature increase in face neck and ears. Happens mainly in the evening or night time.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Intensive care, Pulmonary oedema
Clinical narrative: After taking the 2nd dose of the vaccine, a few days later, father was taken to the ICU with fluid in his lungs. He had never gone to the ICU with this issue prior to the vaccine. He has since been in the ICU for fluid in his lungs 6 times over a span of 4 months. Again, he had never had to go to ICU before the vaccine was given. It may have caused adverse effects in combination with his other medications.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: patient having left shoulder pain 1 day after vaccine administration that still persists, losing range of motion to shoulder. Now 12 days out from vaccination and still having pain. There is no swelling, redness or lump noted to deltoid.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Non-tobacco user
Clinical narrative: Pt tested + for Covid  1 day after vaccine and a 4 days later was coughing up blood with no hx of pulmonary problems.  Feeling entirely well prior to receiving vaccine.  Non-smoker.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood electrolytes, Condition aggravated, Muscle twitching, Pain
Clinical narrative: After receiving my first shot of the Moderna vaccine, immediately I noticed that my legs felt very heavy. The same night, my calves were extremely sore and my left calf continued to be sore for days after getting the shot. Along with being sore, I felt this pulsating feeling in my calf that was constant throughout the day. This went on for about 10 days until the pulsating feeling traveled to my left thigh. It was very clear that the pulsating feeling was actually my muscle twitching. I could see my thigh muscle twitching very clearly through my skin. This twitching occurred all day, every day until the time of my 2nd shot. Three days after receiving the 2nd dose of the vaccine which I received on September 1st, 2021, the muscle twitching began again but in every muscle in my body this time. The twitching is sporadic and occurs in different muscle groups including my thighs, calves, buttocks, intercostal muscles, back, shoulders, forearm, triceps, chest, hamstrings, eyes, tongue and lips. The muscle twitching occurs at rest, while standing and while sitting. Some days the twitching is more intense and I can see I through my skin, other days they are less intense where I can feel them, however, they are not visible through my skin. There has not been a day where I have not experienced these fasiculations since receiving my first dose of the moderna vaccination.  It has been almost a total of two months of experiencing muscle twitching. I have seen my primary doctor, a neurologist and been to an Emergency room. I believe it is possible that the vaccine triggered a central nervous system response that is causing neuron excitability. My primary care doctor prescribed Diazepam 5mg to aid with the twitches, primarily at night so I am able to sleep, however, I can still feel the twitches mildly even after taking the medication. Certain locations such as my left thigh, and right upper back  seem to be popular locations for the muscle twitches. The twitches often occur the longest and the most often in those muscles. Lastly, sometimes, a dull ache/soreness accompanies the twitching. Usually in my entire arm or legs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Dyspnoea, Echocardiogram, Electrocardiogram, Tachycardia
Clinical narrative: At the second injection became tachicartic and short of breath. This was reported by the facility.  After that had sporadic tachycardia events that have become progressively more frequent. Now occurring several times per day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dizziness, Fatigue, Pruritus
Clinical narrative: missed mentrual cycle; extreme fatigue; slight dizziness ; mild itching the next day and intermittently to date ;
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstruation delayed, Menstruation irregular
Clinical narrative: Changes in mensuration. First month after shot I missed my period. Second month it came but was very light. Third month it was late and ever since then I?ve been getting it on and off randomly (roughly every 2 weeks for a few days)   For reference, my cycle has always been consistent 28 days. My whole life. Never had any changes to it.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Chills, Diarrhoea
Clinical narrative: 27 Sep -1415 Injection L Arm  -2307 Noticeable feeling of being cold in 70° indoor office 28 Sep -0035 stomach pain and rapid onset of diarrhea, onset of chills/shivering -0130 chills/shivers, wearing jacket and wrapped in light blanket in 73° indoor office, shaking intermittently. -0300 Under heavy blanket, cold shivers and heartburn. 1 Dose Liquid Extra strength Gaviscon taken.  -0430 Fever and hot sweats -0600 Fever temperature taken, 103° forehead, 101° temple.  -0630 CPAP in use with Ice cubes in reservoir to chill breathable air easing breathing. 2 X 500mg Tylenol Extra Strength Pain Reliever and Fever Reducer Caplets -1530 Fever breaks and sweating stops, feeling of muscle fatigue and injection size pain.  -1700 Shower water temperature feels normal, body muscle fatigue in all extremities, low pressure migraine and occasional nerve tingling. Possible aggravation of nerve and muscle twitches from not taking medications in two days.  29 September  -0030 Muscle fatigue and low pressure migraines continue. Temperature Forehead 99.2°, Temple and Ear 98.6°. Knee and elbow joint pain making sitting uncomfortable. Forehead pressure. Appetite normal, intermittent feeling of abdominal discomfort and soft stool.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Faeces soft, Feeling cold, Hyperhidrosis, Injection site pain
Clinical narrative: 27 Sep -1415 Injection L Arm  -2307 Noticeable feeling of being cold in 70° indoor office 28 Sep -0035 stomach pain and rapid onset of diarrhea, onset of chills/shivering -0130 chills/shivers, wearing jacket and wrapped in light blanket in 73° indoor office, shaking intermittently. -0300 Under heavy blanket, cold shivers and heartburn. 1 Dose Liquid Extra strength Gaviscon taken.  -0430 Fever and hot sweats -0600 Fever temperature taken, 103° forehead, 101° temple.  -0630 CPAP in use with Ice cubes in reservoir to chill breathable air easing breathing. 2 X 500mg Tylenol Extra Strength Pain Reliever and Fever Reducer Caplets -1530 Fever breaks and sweating stops, feeling of muscle fatigue and injection size pain.  -1700 Shower water temperature feels normal, body muscle fatigue in all extremities, low pressure migraine and occasional nerve tingling. Possible aggravation of nerve and muscle twitches from not taking medications in two days.  29 September  -0030 Muscle fatigue and low pressure migraines continue. Temperature Forehead 99.2°, Temple and Ear 98.6°. Knee and elbow joint pain making sitting uncomfortable. Forehead pressure. Appetite normal, intermittent feeling of abdominal discomfort and soft stool.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Muscle fatigue, Paraesthesia, Positive airway pressure therapy, Pyrexia
Clinical narrative: 27 Sep -1415 Injection L Arm  -2307 Noticeable feeling of being cold in 70° indoor office 28 Sep -0035 stomach pain and rapid onset of diarrhea, onset of chills/shivering -0130 chills/shivers, wearing jacket and wrapped in light blanket in 73° indoor office, shaking intermittently. -0300 Under heavy blanket, cold shivers and heartburn. 1 Dose Liquid Extra strength Gaviscon taken.  -0430 Fever and hot sweats -0600 Fever temperature taken, 103° forehead, 101° temple.  -0630 CPAP in use with Ice cubes in reservoir to chill breathable air easing breathing. 2 X 500mg Tylenol Extra Strength Pain Reliever and Fever Reducer Caplets -1530 Fever breaks and sweating stops, feeling of muscle fatigue and injection size pain.  -1700 Shower water temperature feels normal, body muscle fatigue in all extremities, low pressure migraine and occasional nerve tingling. Possible aggravation of nerve and muscle twitches from not taking medications in two days.  29 September  -0030 Muscle fatigue and low pressure migraines continue. Temperature Forehead 99.2°, Temple and Ear 98.6°. Knee and elbow joint pain making sitting uncomfortable. Forehead pressure. Appetite normal, intermittent feeling of abdominal discomfort and soft stool.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster, Pain, Pyrexia
Clinical narrative: severe pain, fever, now shingles signs and symptoms in mouth, face, nose, eye
Sex: U
Vaccine: COVID19
Symptoms: Skin sensitisation
Clinical narrative: SPOT ON ARM WAS LITTLE SENSITIVE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced spot on arm was little sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spot on arm was little sensitive. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Diarrhoea, Fatigue, Hallucination
Clinical narrative: Flu like symptoms, extreme fatigue, & nausea, diarrhea, chills, fever, hallucinations and confusion
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms, extreme fatigue, & nausea, diarrhea, chills, fever, hallucinations and confusion
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Fever (102) chills headache muscle aches/soreness dizziness
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: A patient received PROQUAD and VARlVAX; This spontaneous report has been received from a physician, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.    On 07-SEP-2021, at the same time, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T029099 and expiration date 23-FEB-2022; and with varicella virus vaccine live (oka/merck)(VARIVAX) lot# T014309 and expiration date 24-APR-2022 (Overdose) (dose, route and anatomical location were not provided for any vaccine) both  for prophylaxis.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Proquad was administered following a supported temperature excursion; This spontaneous report was received from an executive concerning a 12 month old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.      On 28-JUN-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) suffered a supported temperature excursion at a temperature of 8.4 F degrees for 1 hour and 30 minutes (incorrect product storage).  On 23-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T031603, expiration date: 15-MAR-2022, as prophylaxis (strength, dose and route of administration were not reported).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.   Since 25-JUL-2021, there was temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), which was stored from 6 F to 14 F (7.3 F) for 37 minutes. On 11-SEP-2021, the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (at the dose of 0.5 ml, subcutaneous; lot # T016990, expiration date 11-NOV-2021) was administered to the patient as prophylaxis (product storage error).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 76-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about 2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles. At the reporting time, the outcome of the event was unknown.   The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Ill-defined disorder
Clinical narrative: herpes zoster related injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 73-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about 2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: herpes zoster-related injuries (ill-defined disorder). At the reporting time, the outcome of the event was unknown.   The reporter considered the events of herpes zoster-related injuries (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; administration of MMR II and VARlVAX one day apart; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 21-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliters (ml) (lot number T016195 which has been verified to be valid, expiration date reported as 30-MAY-2022, but upon internal validation established as 11-JUN-2022). On 22-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml (lot number U002395 which has been verified to be valid, expiration date reported and validated as 22-JAN-2023) (routes of administration and anatomical sites of injection were not reported) (inappropriate schedule of product administration). Both of the vaccines were administered as prophylaxis. No additional adverse events were reported in the patient.
Sex: F
Vaccine: MMR, TTOX
Symptoms: Illness
Clinical narrative: Caller believes that the MMR vaccine and Tetanus shot made both her and her mother sick and that vaccines cause cancer; This spontaneous report was received from a consumer via Pfizer, referring to her mother, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and tetanus vaccine (manufacturer unknown) (strengths, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis.  On an unknown date, the consumer reported that the shots made her mother sick (illness).  The outcome of illness was not reported. The causal relationship between the event and the suspect therapy was related.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005734: US-009507513-2109USA005991:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no addtional AE; products experienced an excursion had been administered to patient; This spontaneous report was received from a registered nurse (also reported as medical assistant) referring to a 4-year old patient of unknown gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not provided.    Per reporter, varicella virus vaccine live (oka/merck) (VARIVAX) with lot# U015682, U002394, and U010400 experienced an excursion of minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 07-SEP-2021 during transport and minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 20 minutes on 09-SEP-2021 during transport. On 09-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U015682, expiration date 18-MAY-2023, dose: 1 (unit unknown); strength and route were unknown) for prophylaxis (product storage error). Previous temperature excursion of this vaccine was reported as minus 10 degree Celsius to 8 degree Celsius (4 degree Celsius) for 7 hours and 30 minutes. No additional adverse event reported.  This is one of several reports received from same reporter. ; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005632: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005758: US-009507513-2109USA005648: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005639: US-009507513-2109USA005662: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005618: US-009507513-2109USA005881: US-009507513-2109USA005902:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Expired vaccine used; Information has been received from a nurse practitioner via Merck Vaccine Representative regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 21-SEP-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, for prophylaxis, lot number S029455 with expiration date in 19-SEP-2021 (dose, route of administration, strength and anatomical location not reported) (expired vaccine used).  No temperature excursion was reported.  No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Rash
Clinical narrative: Shingles; Still have Nerve damage caused from shingles; Rash by shingles which went internally and caused nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced shingles, nerve damage and rash. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the shingles, nerve damage and rash to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the shingles vaccine and 4 days later got the shingles.  It had been almost a year and patient still had nerve damage caused from the shingles.  The shingles did produce a rash but the rash went internally and caused nerve damage.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Myalgia, Pain
Clinical narrative: Muscle sore; Tired; Painful; Worst case ever of diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In September 2021, several days after receiving Shingles vaccine, the patient experienced diarrhea. On 18th September 2021, the patient experienced tiredness and pain. On an unknown date, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovered/resolved and the outcome of the diarrhea was unknown and the outcome of the tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness, diarrhea, tiredness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient just had shingles shot a few days from the reporting date and had muscle sore for half a day and then they were presented with the worst case ever of diarrhea. The last three days from the reporting date were tired and painful.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Outbreaks of shingles continued after having Shingrix shot; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In August 2017, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 years old. The patient received 1st and 2nd dose with an interval of 2 months. The patient had 3 outbreaks of shingles per year which had continued after having two Shingrix shots.  The reporter asked whether a third dose ( or booster dose) could be given. The reporter agreed to follow-up. For tolerance of the 2nd dose, refer case US2021AMR200657 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200657:Same patient, same reporter, same suspect, different dose (second dose)
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: currently on my third go-around\ suspected Vaccination failure; currently on my third go-around; This one Hurts; itched; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (At age 12) and shingles (at age 62).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles at ages 12 and 62. The patient stated he/she Shingles vaccine was hurts, 1st 2 only itched. The patient stated he/she had two different shingles vaccinations and had shingles (currently on third go-around). The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: vaccine hurts; This case was reported by a consumer via  media and described the occurrence of injection site pain in a 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that the Shingles vaccine hurts. The patient enquired that the vaccine probably did not hurt as bad as shingles. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Throat irritation
Clinical narrative: Scratchy throat; flu like symptoms; Extreme fatigue; Felt badly; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, feeling unwell and throat irritation. On an unknown date, the outcome of the influenza-like symptoms, fatigue and feeling unwell were recovered/resolved and the outcome of the throat irritation was unknown.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, feeling unwell and throat irritation to be related to Shingrix.  Additional details were reported as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The physician reported that she herself had received the first dose of the Shingrix vaccine on Friday night. On 18th September 2021, Saturday morning, woke up with flu like symptoms, extreme fatigue and felt badly for about six days. The patient stated that she did not check herself for other illnesses but less than a week after vaccination had a scratchy throat and felt badly. The reporter did not agree to follow up. This case had been linked with US2021AMR085370, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR085370:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The reporter reported the first one was supposed to work. Then said it did not last. The patient received dose of Shingles vaccine and experienced allergic reaction. After the first of two, the patient could not take the second. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shots and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shots and got shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Didn't work, and vax / Suspected vaccination failure; Didn't work, 3 months of worst case ever; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's son or daughter. The age at vaccination was not reported. The patient had vaccine and 3 months of the worst case ever. The reporter stated it did not work for patient. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the vaccine and still got them / Suspected vaccination failure; still got them; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the vaccine 2 years before day of reporting and still got shingles. The patient stated it was painful lordy but not as bad as he or she thought. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated, it flare up / Suspected vaccination failure; once in a while it flare up; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got vaccinated but once in a while it flare up. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.