chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Rash pruritic, Rash vesicular, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Less than 50 lesions; Diagnosed with Varicella; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Macular, papular, vesicular, itchy generalized rash; Vaccine administered to a 1 year patient; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2016US088664).  This spontaneous report was received from an other health professional and refers to a 1-year-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, lot number L025205, expiration date was not reported, but upon internal verification was established as 07-JUL-2017 (injection site and route of administration were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) 1 dosage form (therapy type, injection site, route of administration, lot # and expiration date were not provided), pneumococcal vaccine, polyvalent (manufacturer unknown) 1 dosage form (injection site, route of administration, lot # and expiration date were not provided), hepatitis a vaccine (manufacturer unknown) 1 dosage form (injection site, route of administration, lot # and expiration date were not provided) and influenza virus vacc seasonal inn, 1 dosage form (injection site, route of administration, lot # and expiration date were not provided) all for immunisation. On 01-APR-2016, he experienced macular, papular, vesicular, itchy generalized rash. On 04-APR-2016, varicella virus test and polymerase chain reaction (PCR) were performed with positive results and the patient was diagnosed with varicella. On an unknown date, he developed less than 50 lesions. The outcome of rash pruritic, varicella post vaccine, skin lesion, rash papular, generalised rash, rash macular and rash vesicular was reported as recovered/resolved on unknown dates.   The relatedness between the events and varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), pneumococcal vaccine, polyvalent (manufacturer unknown) and hepatitis a vaccine (manufacturer unknown) was not reported. The relatedness between the events and influenza virus vacc seasonal inn was reported as suspected.  The reporter considered the events of rash pruritic, varicella post vaccine, skin lesion, rash papular, generalised rash, rash macular, rash vesicular and inappropriate age at vaccine administration to be medically significant.; Sender's Comments:  633515:
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; Information has been downloaded from RA (US-GLAXOSMITHKLINE-US2019AMR147356).  This spontaneous report has been received from a physician, referring to an 81 years old male patient. The patient's concurrent condition included eosinophilic asthma, chickenpox (experienced years ago), hypertension and hyperlipidemia. The patient's history condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (route unknown) for prophylaxis. In January 2019, the patient started therapy with mepolizumab (NUCALA) (route and frequency were unknown) for eosinophilic asthma. In January 2019 and May 2019, the patient was vaccinated with zoster rge vaccine (mammalian) (SHINGRIX) solution for injection (intramuscularly) for prophylaxis, respectively. The dose, strength, lot number and expiration date for all suspect products were unknown.   On 01-JUL-2019, the patient experienced suspected vaccination failure and shingles. The action taken with mepolizumab (NUCALA) was reported as dose not change. The outcome of suspected vaccination failure was reported as unknown. The outcome of shingles was reported as recovered on 18-AUG-2019. The causality assessment between zoster vaccine live (ZOSTAVAX) and both events was not reported. The causality assessments between other suspect products and both events were reported as probable.  The reporter considered both events to be serious for the following reason: medically significant.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Feeling hot, Herpes zoster, Musculoskeletal pain, Myalgia
Clinical narrative: Suspected vaccination failure; Warm shooting pains which spread up his back to the should blades; Nerve pain; Shingles; Muscle pain; welts on neck; Information has been downloaded from RA (US-GLAXOSMITHKLINE-US2019164647).  This spontaneous report was received from a consumer referring to a 65-year old male patient. The patient experienced chickenpox as a child and then again around age of 32 years. Concurrent condition and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 11-APR-2018, the patient was vaccinated with zoster rge vaccine (mammalian)(SHINGRIX) (dose related details were unknown) and on 23-AUG-2019, the patient received another dose of zoster rge vaccine (mammalian) (SHINGRIX) (dose related details were unknown) for prophylaxis.  In August 2019, the patient experienced welts on neck. On unknown dates, the patient experienced suspected vaccination failure, warm shooting pains which spread up his back to the should blades (pain), nerve pain, shingles and muscle pain. The outcome of suspected vaccination failure, nerve pain, welts on neck and muscle pain was unknown. The outcome of warm shooting pains which spread up his back to the should blades and shingles was reported as recovered. The causality between all events and suspect vaccines was unknown.  All events were determined to be medically significant by the agency.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain, Urticaria, Vaccination failure
Clinical narrative: Suspected vaccination failure; Warm shooting pains which spread up his back to the should blades; Nerve pain; Shingles; Muscle pain; welts on neck; Information has been downloaded from RA (US-GLAXOSMITHKLINE-US2019164647).  This spontaneous report was received from a consumer referring to a 65-year old male patient. The patient experienced chickenpox as a child and then again around age of 32 years. Concurrent condition and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 11-APR-2018, the patient was vaccinated with zoster rge vaccine (mammalian)(SHINGRIX) (dose related details were unknown) and on 23-AUG-2019, the patient received another dose of zoster rge vaccine (mammalian) (SHINGRIX) (dose related details were unknown) for prophylaxis.  In August 2019, the patient experienced welts on neck. On unknown dates, the patient experienced suspected vaccination failure, warm shooting pains which spread up his back to the should blades (pain), nerve pain, shingles and muscle pain. The outcome of suspected vaccination failure, nerve pain, welts on neck and muscle pain was unknown. The outcome of warm shooting pains which spread up his back to the should blades and shingles was reported as recovered. The causality between all events and suspect vaccines was unknown.  All events were determined to be medically significant by the agency.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Cold sweat, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: Patient was sitting on the high medical table with a cloth face mask around her chin she had pulled down to breath. Doctor walked into the exam room and told us to pull our masks up around our noses and we did. Patient was given first two vaccines in her right arm. Then she was given another injection  in her left arm. All doctors and nurses then left the room and it was Patientt and myself, her mother. Patient then looked dizzy and moved to a lower chair by me. She then groaned loudly, eyes rolled back in her head and she started falling over towards the floor. I then reached over and caught her by her arms, holding her up as to not hit her head on the hard floor. Both of my hands were holding her up and I was yelling for help. Doctor comes in with nurses, they take her and prop her up. I am asking for them to call 911, and to take off her face mask so she could breath. I then told them to open the door to the hot room. Patient's eyes were half opened and whole eye was black due to pupils being dilated. Her face, lips completely white. She looked 'zombie' like. Very scary. She was jerking her body. Doctor sat with her, but kept saying they were waiting. I continued asking them to call 911 and get her to an emergency room. Patient slowly became more aware. I asked them to get her some water. I asked why she looked so bad and that her eyes were still dilated. It took around 10 minutes former to come back to life.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Fall, Moaning
Clinical narrative: Patient was sitting on the high medical table with a cloth face mask around her chin she had pulled down to breath. Doctor walked into the exam room and told us to pull our masks up around our noses and we did. Patient was given first two vaccines in her right arm. Then she was given another injection  in her left arm. All doctors and nurses then left the room and it was Patientt and myself, her mother. Patient then looked dizzy and moved to a lower chair by me. She then groaned loudly, eyes rolled back in her head and she started falling over towards the floor. I then reached over and caught her by her arms, holding her up as to not hit her head on the hard floor. Both of my hands were holding her up and I was yelling for help. Doctor comes in with nurses, they take her and prop her up. I am asking for them to call 911, and to take off her face mask so she could breath. I then told them to open the door to the hot room. Patient's eyes were half opened and whole eye was black due to pupils being dilated. Her face, lips completely white. She looked 'zombie' like. Very scary. She was jerking her body. Doctor sat with her, but kept saying they were waiting. I continued asking them to call 911 and get her to an emergency room. Patient slowly became more aware. I asked them to get her some water. I asked why she looked so bad and that her eyes were still dilated. It took around 10 minutes former to come back to life.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mydriasis, Pallor
Clinical narrative: Patient was sitting on the high medical table with a cloth face mask around her chin she had pulled down to breath. Doctor walked into the exam room and told us to pull our masks up around our noses and we did. Patient was given first two vaccines in her right arm. Then she was given another injection  in her left arm. All doctors and nurses then left the room and it was Patientt and myself, her mother. Patient then looked dizzy and moved to a lower chair by me. She then groaned loudly, eyes rolled back in her head and she started falling over towards the floor. I then reached over and caught her by her arms, holding her up as to not hit her head on the hard floor. Both of my hands were holding her up and I was yelling for help. Doctor comes in with nurses, they take her and prop her up. I am asking for them to call 911, and to take off her face mask so she could breath. I then told them to open the door to the hot room. Patient's eyes were half opened and whole eye was black due to pupils being dilated. Her face, lips completely white. She looked 'zombie' like. Very scary. She was jerking her body. Doctor sat with her, but kept saying they were waiting. I continued asking them to call 911 and get her to an emergency room. Patient slowly became more aware. I asked them to get her some water. I asked why she looked so bad and that her eyes were still dilated. It took around 10 minutes former to come back to life.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, body aches, chills
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; The unspecified patient experienced "fever" and "rash" that "could be chickenpox".; This spontaneous report was received from a nurse, referring to a child patient between 1 and 2-year-old of an unknown gender. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were unknown by the reporter.  On an unspecified date, the child was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dose administered subcutaneously, as "routine vaccination" (lot number S027459 which has been verified to be valid, expiration date reported and validated as 02-MAR-2021) (vaccination scheme and anatomical site of injection were not reported).  On an unspecified date (also reported as "within 1-10 days of administration"), the patient experienced fever (pyrexia) and rash. According to the nurse, it could be chickenpox (varicella). The patient sought medical attention, however, no treatment was given for the events and the patient did not have any laboratory diagnostics or studies performed.   The outcome of the events pyrexia, rash and varicella was reported as recovered. The causal relationship between the aforementioned events and therapy with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) was not reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001873: US-009507513-2007USA001874: US-009507513-2007USA001872:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 26-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical location, route of administration were not reported; from lot number S030208, expiration date: 25-MAR-2021 or from lot number S031704, expiration date: 06-APR-2021) as prophylaxis (product storage error). Also, the use of a sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown by the reporter) was reported. No adverse symptoms reported.  The vaccines experienced a temperature excursion between 6 degrees Fahrenheit (F) to 14F (9.9F) for 1 hour and 12 minutes, as recorded by data logger. There was no previous temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at the physician's office, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been downloaded from Agency (US-BEH-2012033474).  This spontaneous report was received from a healthcare professional concerning to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, previous drugs reactions and allergies were not reported.   On an unknown date, the patient was vaccinated with zoster vaccine live  (ZOSTAVAX), with a dose of 0.65 milliliter (ml), for immunization (strength, formulation, dose schedule, route of administration, anatomical site of injection and expiration date were not reported; lot number was unknown) and influenza virus vaccine (unspecified) (FLU VACCINE) (strength, formulation, dose, route of administration, anatomical site of injection and expiration date were not reported; lot number was unknown).   On an unknown date, the patient experienced herpes zoster.  The outcome of herpes zoster was reported as not resolved.        The causality assessment between all the suspect vaccines and the event of herpes zoster was not provided.   The event of herpes zoster was considered to be medically significant.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Shingles [rash]; [Shingles] rash; Itchiness; Information has been downloaded from Agency (US-BEH-2014047537).  This spontaneous report was received from a health care professional and refers to a 64 year old male patient. The patient's medical history included herpes zoster on an unspecified date in 1984 (reported as "1984-1985"). Concomitant therapies included rosuvastatin calcium (CRESTOR) and lisinopril. Information about the patient's concurrent conditions and drug reactions or allergies was not provided.  On 08-NOV-2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (batch # reported as "00006-4963"), in the left arm (via reported as "SYR"), for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided). On the same date, the patient was also vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (AFLURIA) (batch # reported as "33332-0014-01"), in the right arm (via reported as "SYR"), for prophylaxis (strength, dose, frequency, lot number and expiration date were not provided).   On 09-NOV-2014, the patient experienced herpes shingles (zoster), pruritus and itchy sensation of extremities (rash). At the time of reporting, the outcome of herpes zoster, pruritus and rash was reported as not resolved.  The causal relationship among zoster vaccine live (ZOSTAVAX), influenza virus split virion 3v vaccine inactivated (AFLURIA) and the reported events was not provided.  The reporter considered the events as serious, medically significant.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Impetigo, Injection site erythema, Injection site inflammation, Pustule, Rash
Clinical narrative: Half dollar sized red inflamed area at inj. site; Various pox spots on left hand, forearm, and bicep; Half dollar sized red inflamed area at inj. site; Impetigo/rash area under nose, right nostril.; Impetigo/rash area under nose, right nostril.; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030612).  This spontaneous report was received from a other health professional referring to a 61 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.      On 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # M027117, expiration date not reported, but upon internal validation established as 26-JUL-2017) for immunisation. On the same date, the patient was also vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN) 1 dosage form, intramuscularly (lot # 1619521, expiration date was not reported) for immunisation.  On 26-OCT-2016, the patient experienced half dollar sized red inflamed area at injection site, various pox spots on left hand, forearm, and bicep and impetigo/rash area under nose, right nostril. The outcome of the events unknown. The causality between the events and both suspect vaccines was not provided.   The reporter considered all events to be serious for the following reason: medically significant.
Sex: F
Vaccine: MEN
Symptoms: Haemorrhagic disorder
Clinical narrative: serious bleeding disorder; This case was reported by a consumer via interactive digital media and described the occurrence of hemorrhagic disorder in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, couple of weeks after receiving Meningococcal B vaccine, the patient experienced hemorrhagic disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the hemorrhagic disorder was unknown.   It was unknown if the reporter considered the hemorrhagic disorder to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. my daughter developed a serious chronic bleeding disorder, within just a few weeks after her meningitis shot.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Joint noise, Loss of personal independence in daily activities
Clinical narrative: My daughter felt right at the time of administration that something was wrong.  She said she felt the medication going down her arm.  Immediate soreness in left arm where as for a week she could barley lift her left arm.  Pain did not go away with Tylenol or Ibuprofen.  After about a week the pain lessened but was still there.  Pain not constant but more positional and worse at night.  She had decreased range of motion and still does two weeks later, whereas she has trouble washing her hair and putting on deodorant.  If she tries to pull herself up onto something the arm just gives out.  The left arm also has a lot of cracking and popping noises when she moves her arm.  Pain will shoot down the arm at times.   She was examined at Hospital on 7/8/2020 .  Ultrasound scheduled for 7/9/2020.  We were told she may orthopedic consult and physical therapy.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Muscular weakness, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: My daughter felt right at the time of administration that something was wrong.  She said she felt the medication going down her arm.  Immediate soreness in left arm where as for a week she could barley lift her left arm.  Pain did not go away with Tylenol or Ibuprofen.  After about a week the pain lessened but was still there.  Pain not constant but more positional and worse at night.  She had decreased range of motion and still does two weeks later, whereas she has trouble washing her hair and putting on deodorant.  If she tries to pull herself up onto something the arm just gives out.  The left arm also has a lot of cracking and popping noises when she moves her arm.  Pain will shoot down the arm at times.   She was examined at Hospital on 7/8/2020 .  Ultrasound scheduled for 7/9/2020.  We were told she may orthopedic consult and physical therapy.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever (100.4) Extreme Fatigue Muscle Aches (whole body) Joint pain (whole body) Weakness
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itched at site immediately. Itching,redness,,swelling and heat still after three days. (Area of about a 3 inch circle )
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient due for Meningitis vaccine.  Trumenba vaccine was administered in error.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting and diarrhea about 24 hours after vaccine
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Vomiting, headache and body aches.  Patient was seen by telehealth on 7/3/20.  Zofran was called in.   Patient was back to normal on 7/4/2020 according to Dad
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMRV and Varicella were given at the same time in error.   MMR and Varicella should have been given.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: There was no place for me to list the date of my second shingrex vaccine which was 7/7/2020.  For both doses, I experienced similar reactions.  For the first one I had pain at the injection site for 3 days, I awoke the morning after the vaccine and nearly fainted from lightheadedness, I felt extreme fatigue for a few days, and I had swollen and painful lymph nodes under the armpit of the side I received the injection for three days.  For the second dose, I again still have pain at the injection site two days later, extreme fatigue, and painful lymph nodes under the armpit of the side I received the injection as well as pain that extends down the inside of my arm towards my elbow.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Similar reaction on previous exposure to drug
Clinical narrative: There was no place for me to list the date of my second shingrex vaccine which was 7/7/2020.  For both doses, I experienced similar reactions.  For the first one I had pain at the injection site for 3 days, I awoke the morning after the vaccine and nearly fainted from lightheadedness, I felt extreme fatigue for a few days, and I had swollen and painful lymph nodes under the armpit of the side I received the injection for three days.  For the second dose, I again still have pain at the injection site two days later, extreme fatigue, and painful lymph nodes under the armpit of the side I received the injection as well as pain that extends down the inside of my arm towards my elbow.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Myalgia, Skin warm
Clinical narrative: Pain in muscle, redness down arm to elbow, achiness around elbow, warm to the touch
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SWELLING, REDNESS AND WARMTH
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Condition aggravated, Sickle cell anaemia with crisis
Clinical narrative: Sickle Cell Crisis within 48 hours
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 dose shot  vaccine administered.  The site of injection is swollen and red.  I had body chills and pain on the arm  plus fatigue and didn?t  feel  well  over all .  Today I don?t have chills but still pain on site and is still swollen plus fatigued on today  second  day.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pain in extremity
Clinical narrative: 2 dose shot  vaccine administered.  The site of injection is swollen and red.  I had body chills and pain on the arm  plus fatigue and didn?t  feel  well  over all .  Today I don?t have chills but still pain on site and is still swollen plus fatigued on today  second  day.
Age: 37.0
Sex: M
Vaccine: ANTH, JEV1, TYP, UNK
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Morning of 7JUL20, appx 0900, received injections in both left and right shoulder (see block 17).  Routine redness and tenderness associated from injections was present. Left shoulder was more tender than right shoulder throughout 7JUL20 (as expected with Anthrax).   Evening of 7JUL. left shoulder displayed swelling at injection site, redness, and warmth to touch.  Expected pain from injection did not self resolve.  Mooring of 8JUL20, left shoulder injection site displayed increase of swelling, redness, warmth and tenderness, but not to the point to cause concern. Afternoon and evening of 8JUL20, recorded temperature of 99.8, used Tylenol (2x 200mg) to address body aches and pain. Evening of 8JUL20, injection sight swelling, redness, and warmth continued to increase (area now encompassed most of the shoulder and some of the bicep). Evening of 8JUL20, tenderness transitioned to pain, causing some difficulty in routine arm use and sleeping. Morning of 9JUL20, area of swelling, redness and warmth grew  by estimated 20%, now encompassing 1/2 of the bicep and all of the shoulder.  Itching and burning sensation with pain/tenderness of the skin was present beginning morning of 9JUL.   Fever was not detected on morning of 9JUL20 as Tylenol was taken for pain before temperature was taken. Consulted doctor on the morning of 9JUL for suspected cellulitis associated with the injections on the left shoulder.
Age: 37.0
Sex: M
Vaccine: ANTH, JEV1, TYP, UNK
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Pain
Clinical narrative: Morning of 7JUL20, appx 0900, received injections in both left and right shoulder (see block 17).  Routine redness and tenderness associated from injections was present. Left shoulder was more tender than right shoulder throughout 7JUL20 (as expected with Anthrax).   Evening of 7JUL. left shoulder displayed swelling at injection site, redness, and warmth to touch.  Expected pain from injection did not self resolve.  Mooring of 8JUL20, left shoulder injection site displayed increase of swelling, redness, warmth and tenderness, but not to the point to cause concern. Afternoon and evening of 8JUL20, recorded temperature of 99.8, used Tylenol (2x 200mg) to address body aches and pain. Evening of 8JUL20, injection sight swelling, redness, and warmth continued to increase (area now encompassed most of the shoulder and some of the bicep). Evening of 8JUL20, tenderness transitioned to pain, causing some difficulty in routine arm use and sleeping. Morning of 9JUL20, area of swelling, redness and warmth grew  by estimated 20%, now encompassing 1/2 of the bicep and all of the shoulder.  Itching and burning sensation with pain/tenderness of the skin was present beginning morning of 9JUL.   Fever was not detected on morning of 9JUL20 as Tylenol was taken for pain before temperature was taken. Consulted doctor on the morning of 9JUL for suspected cellulitis associated with the injections on the left shoulder.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported), as prescribed and/or administered by a pharmacist at a pharmacy, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by healthcare provider, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was unknown. The reported considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine, Swelling
Clinical narrative: Allergic to pneumonia inj: swelling; This spontaneous report was received from a physician via Pfizer and refers to a patient of anonymized age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown): swelling. The outcome of the event was not reported.  The reporter considered drug hypersensitivity to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was administered a dose of MMR II via the intramuscular route rather than the recommended subcutaneous route; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-JUL-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) lot # S015093, expiration date 15-MAY-2021 (strength, dose and frequency were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent lot # S038697, expiration date 10-AUG-2022 (reported as 10-MAY-2022) and administrated via the intramuscular route rather than the recommended subcutaneous route.  No adverse symptoms were reported. The outcome of the events was unknown.
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: [Broke out in an active shingles] rash from underarm to nipple; Broke out in an active shingles [rash from underarm to nipple]; Information has been downloaded from Agency (US-BEH-2017077065).  Information has been received from a consumer referring to a 60 years old male patient. The patient's medical history, concurrent condition and concomitant medication were not provided.  On 13-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (subcutaneous; strength, dose, lot # and expiration date were unknown) for unknown indication. On the same day, the patient also vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) (0.5 ml, intramuscular; strength, lot # and expiration date were unknown) and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (intramuscular; strength, dose, lot # and expiration date were unknown) for unknown indication.      On 22-OCT-2016, the patient experienced broke out in an active shingles [rash from underarm to nipple]. On an unknown date, the patient experienced [broke out in an active shingles] rash from underarm to nipple. The outcome of both events was unknown. The causality between both events and all the suspect therapies was not reported.      The agency considered both events to be medically significant.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise, Social problem
Clinical narrative: the 6 month mark for second dose was back in March 2020 / due to COVID.; made her sick for 2 days; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced sickness and social problem. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The reporter inquired about guidance on second dose of Shingrix. Patient  received the first dose of Shingrix in September 2019 and the 6 month mark for second dose was back in March 2020.  Walgreens initially told patient she had a year for second dose due to COVID and another pharmacy said it was 6 months. She called in to get clarity.  She mentioned the Shingrix first dose made her sick for 2 days and she had the flu shot at the same time and she never gets sick from her flu shot. The patient stated that she planned to receive her 2nd dose of Shingrix in a couple of days but she did not specified the date. She also stated that she heard from the pharmacy that it was not a problem when the 2nd dose was applied, but she did not rely on the pharmacy, so she will be reaching her main doctor to clarify. The reporter consented to follow up. The case US2020115710 was found to duplicate of case US2020AMR116179. The case US2020115710 would be deleted and all the future corresponding information will be added in the present case  (US2020AMR116179) which stands as case of record for this subject.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115710:same paient
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Shingles outbreak; shingles rash; Large blisters; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles 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, 3 days after receiving Shingrix, the patient experienced shingles, rash and blister. On an unknown date, the outcome of the shingles, rash and blister were unknown.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix.  Additional details were provided asa follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, the patient had shingles rash on lower ankle and large several blisters. 3 days after vaccination with 2nd dose of Shingrix, had outbreak.
Age: 1.0
Sex: M
Vaccine: MEN
Symptoms: Intensive care, Meningitis, Vaccination failure
Clinical narrative: suspected vaccination failure; meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   The patient's past medical history included meningitis (Family History) (patient's uncle died due to meningitis).   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown.   It was unknown if the reporter considered the vaccination failure and meningitis to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The reporter's brother died of this same meningitis when he was young and there was no vaccine. The patient received vaccine and had meningitis. The patient was in the ICU.
Sex: F
Vaccine: TDAP
Symptoms: Death
Clinical narrative: died; This case was reported by a consumer via interactive digital media and described the occurrence of death in a 5-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to DTPa vaccine.  Additional case details were reported as follows: The reporter was patient's grandparent. The age at vaccination was not reported. The patient died from a DTP vaccine. Further information would not be available.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: MEN
Symptoms: Adverse drug reaction, Loss of personal independence in daily activities
Clinical narrative: horrible reaction; she may not be able to live in a dorm; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse drug reaction and activities of daily living impaired. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the adverse drug reaction and activities of daily living impaired were unknown.   It was unknown if the reporter considered the adverse drug reaction and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported.. The reporter stated that, after vaccination the patient had horrible reaction and might not able to lived in a dorm. and because of the reaction could be worse, the patient could not have 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Headache; Nausea; swelling at Injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female 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 headache, nausea, injection site swelling and injection site erythema. On an unknown date, the outcome of the headache, nausea, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the headache, nausea, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced some swelling and a large, size not specified, redness at the injection site and experienced nausea and headache, which had resolved. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020118902.
Sex: F
Vaccine: MEN
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: Lymph nodes were swollen; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a 15-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   The patient's past medical history included detoxification (detox from mercury).   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 7 shots and experienced lymph node swollen for 6 years. The reporter stated that, the patient's body was detox from mercury sent to her body. The reporter reported that, the patient had very bad reaction to vaccines all poison in it.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pyrexia, Somnolence
Clinical narrative: upset stomach; low grade fever; tired; sleep for several hours; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingels vaccine (received 1st dose on an unknown date).   On 1st July 2020, the patient received the 2nd dose of Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced upset stomach, low grade fever, tiredness and sleepiness. On an unknown date, the outcome of the upset stomach, low grade fever, tiredness and sleepiness were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, low grade fever, tiredness and sleepiness to be related to Shingles vaccine.  Additional details were provided as follow: The reporter was patient's mother. The patient received 2nd shingle shot yesterday. She had a low grade fever and had a very upset stomach. She was very tired and had sleep for several hours. The reporter wanted to know how long do the side effects last with a second shingle shot.