chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Obsessive-compulsive symptom, Phobia, Pruritus, Screaming, Selective eating disorder
Clinical narrative: Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory processing disorder, Streptococcus test, Thyroid function test, Ultrasound abdomen, Urine output decreased
Clinical narrative: Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Vitamin D
Clinical narrative: Per office note 1/13/20: Patient has a history of sensory processing disorder.  She was previously followed by occupational therapy but was discharge in January of 2019. Her mother reports her sensory issues have been exacerbated since November of 2019 and worsened significantly in the past week.     Last Wednesday she went to school.  When she got home she had a meltdown.  Every day since that day she has had meltdowns with more severity.  She will throw things, hitting mom, screaming.  Mom used to try to ignore the behavior or walk away--3 hour meltdown Thursday which prompted ER visit. Mom has since tried staying with her instead of ignoring the behavior and the meltdowns don't last as long.  The meltdown ends with her going back to normal behavior.  She does not appear tired and doesn't go to sleep.  At the first ER visit she was given benadryl.  At the second ER visit she was started on risperdone.  Her mother really doesn't want her on regular medication until she has further medical and psychiatric evaluation.    Examples of things that have set her off the past few days: clothes--won't wear regular clothes because of things itching or they have germs.   She has been scrubbing her hands and feet with water to the point they are rough and dry/cracked. She won't go in her room due to fear of germs. She even went to grandmother's house due to fear of germs in her own home (no sick contacts at home). Food issues: has always been picky but has been more restrictive recently.  She will not say why she will no longer eat certain things. She has not had much to eat in the past 5 days.  Urine output has also been less--one day in the past 5 she only had uop x 2 in 24 hours.  Drinking a little better past few days.  After this visit, symptoms progressed such that she had severe phobia of germs.  she would not get dressed, would only sit in certain rooms of the house, and had food refusal.  the patient underwent laboratory evaluation and imaging and was referred to OT and psychiatry
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Gait inability, Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: Had a reaction to Pneumovax23; Consequently, the patient was unable to walk or lift the right foot correctly; she experienced numbness and tingling in her right leg; she experienced numbness and tingling in her right leg; This spontaneous report was received from a 68-year-old female consumer, regarding to herself. The patient's pertinent medical history included a spinal tap. She had no previous drug reactions/allergies and her concomitant medications included rosuvastatin calcium (CRESTOR).  On 07-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection single shot, in the left arm (route of administration was not reported; lot number N010106, expiration date 15-NOV-2018 and upon internal validation stablished as the same) as prophylaxis (also reported as "for pneumococcal disease").  On an unknown date, the patient had a reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication).  On approximately 21-AUG-2017 (reported as "two weeks after receiving the vaccine"; also reported as on "07-AUG-2017": inconsistent information), the patient experienced numbness and tingling in her right leg (hypoaesthesia and paraesthesia). Consequently, she was unable to walk or lift the right foot correctly (gait inability). It was reported that the patient sought medical attention and had treatment given for the adverse events, as she ordered a magnetic resonance imaging (MRI) and physical therapy. She also had several unspecified laboratories performed.  At the time of the report, the patient had not recovered from hypoaesthesia, paraesthesia and gait inability. The outcome of vaccination complication was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and hypoaesthesia, paraesthesia and gait inability was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Electromyogram abnormal, Fall, Gait disturbance, Immunoglobulin therapy
Clinical narrative: Had a reaction to Pneumovax23; Consequently, the patient was unable to walk or lift the right foot correctly; she experienced numbness and tingling in her right leg; she experienced numbness and tingling in her right leg; This spontaneous report was received from a 68-year-old female consumer, regarding to herself. The patient's pertinent medical history included a spinal tap. She had no previous drug reactions/allergies and her concomitant medications included rosuvastatin calcium (CRESTOR).  On 07-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection single shot, in the left arm (route of administration was not reported; lot number N010106, expiration date 15-NOV-2018 and upon internal validation stablished as the same) as prophylaxis (also reported as "for pneumococcal disease").  On an unknown date, the patient had a reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication).  On approximately 21-AUG-2017 (reported as "two weeks after receiving the vaccine"; also reported as on "07-AUG-2017": inconsistent information), the patient experienced numbness and tingling in her right leg (hypoaesthesia and paraesthesia). Consequently, she was unable to walk or lift the right foot correctly (gait inability). It was reported that the patient sought medical attention and had treatment given for the adverse events, as she ordered a magnetic resonance imaging (MRI) and physical therapy. She also had several unspecified laboratories performed.  At the time of the report, the patient had not recovered from hypoaesthesia, paraesthesia and gait inability. The outcome of vaccination complication was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and hypoaesthesia, paraesthesia and gait inability was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Lumbar puncture, Magnetic resonance imaging whole body, Mobility decreased, Muscular weakness, Neuropathy peripheral
Clinical narrative: Had a reaction to Pneumovax23; Consequently, the patient was unable to walk or lift the right foot correctly; she experienced numbness and tingling in her right leg; she experienced numbness and tingling in her right leg; This spontaneous report was received from a 68-year-old female consumer, regarding to herself. The patient's pertinent medical history included a spinal tap. She had no previous drug reactions/allergies and her concomitant medications included rosuvastatin calcium (CRESTOR).  On 07-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection single shot, in the left arm (route of administration was not reported; lot number N010106, expiration date 15-NOV-2018 and upon internal validation stablished as the same) as prophylaxis (also reported as "for pneumococcal disease").  On an unknown date, the patient had a reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication).  On approximately 21-AUG-2017 (reported as "two weeks after receiving the vaccine"; also reported as on "07-AUG-2017": inconsistent information), the patient experienced numbness and tingling in her right leg (hypoaesthesia and paraesthesia). Consequently, she was unable to walk or lift the right foot correctly (gait inability). It was reported that the patient sought medical attention and had treatment given for the adverse events, as she ordered a magnetic resonance imaging (MRI) and physical therapy. She also had several unspecified laboratories performed.  At the time of the report, the patient had not recovered from hypoaesthesia, paraesthesia and gait inability. The outcome of vaccination complication was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and hypoaesthesia, paraesthesia and gait inability was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: Had a reaction to Pneumovax23; Consequently, the patient was unable to walk or lift the right foot correctly; she experienced numbness and tingling in her right leg; she experienced numbness and tingling in her right leg; This spontaneous report was received from a 68-year-old female consumer, regarding to herself. The patient's pertinent medical history included a spinal tap. She had no previous drug reactions/allergies and her concomitant medications included rosuvastatin calcium (CRESTOR).  On 07-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection single shot, in the left arm (route of administration was not reported; lot number N010106, expiration date 15-NOV-2018 and upon internal validation stablished as the same) as prophylaxis (also reported as "for pneumococcal disease").  On an unknown date, the patient had a reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccination complication).  On approximately 21-AUG-2017 (reported as "two weeks after receiving the vaccine"; also reported as on "07-AUG-2017": inconsistent information), the patient experienced numbness and tingling in her right leg (hypoaesthesia and paraesthesia). Consequently, she was unable to walk or lift the right foot correctly (gait inability). It was reported that the patient sought medical attention and had treatment given for the adverse events, as she ordered a magnetic resonance imaging (MRI) and physical therapy. She also had several unspecified laboratories performed.  At the time of the report, the patient had not recovered from hypoaesthesia, paraesthesia and gait inability. The outcome of vaccination complication was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and hypoaesthesia, paraesthesia and gait inability was not reported. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and vaccination complication was related.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site reaction, Rash, Rash papular
Clinical narrative: Patient reports that he developed a rash approximately one week post vaccination that covered his entire stomach up to his chest which wrapped around his sides and covered a portion of his back. Left side of rash was worse than the right. Rash was extremely itchy, raised, and crusty. Patient reported this on 2/24/20 and never saw his physician regarding the issue. Rash has improved. Patient also reports feeling that he still has a sensation that something is "still in his deltoid" wear the vaccine was administered. This sensation he claims is affecting his range of motion. Once again, he did not see his physician regarding this.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Scab
Clinical narrative: Patient reports that he developed a rash approximately one week post vaccination that covered his entire stomach up to his chest which wrapped around his sides and covered a portion of his back. Left side of rash was worse than the right. Rash was extremely itchy, raised, and crusty. Patient reported this on 2/24/20 and never saw his physician regarding the issue. Rash has improved. Patient also reports feeling that he still has a sensation that something is "still in his deltoid" wear the vaccine was administered. This sensation he claims is affecting his range of motion. Once again, he did not see his physician regarding this.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperacusis, Injection site erythema
Clinical narrative: Fatigue, head ache, muscle ache, chills, fever, slight redness on arm at injection site, sensitive to sound.  Treatment Aleve and Tylenol and hot shower.  Second injection on 2/23/2020 same adverse side effects.  Both injections were admin by Clinic.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fatigue, head ache, muscle ache, chills, fever, slight redness on arm at injection site, sensitive to sound.  Treatment Aleve and Tylenol and hot shower.  Second injection on 2/23/2020 same adverse side effects.  Both injections were admin by Clinic.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child has not had any adverse symptoms .   Pneumovac 23 was given in error - patient was to receive PVC 13
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme sore/shoulder arm pain still after 6 weeks
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Influenza like illness, Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: swollen glands in neck, painful and large, sore throat, headache, congestion, flu like symtpoms
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory tract congestion
Clinical narrative: swollen glands in neck, painful and large, sore throat, headache, congestion, flu like symtpoms
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Nausea, Pyrexia
Clinical narrative: Severe joint pain, fever, fatigue, nausea.  In bed for two days. Felt affects for 3 days further. Five days total.  Astonished by severity of reaction. My wife had same level of reaction (filed under separate report)
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Severe joint pain, fever, fatigue.  In bed for two days. Felt affects for 3 more. Five total.  Astonished by severity of reaction.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient called me this morning and reported that a day after she received the shingrix vaccine on 1/30/2020 the location on her left arm where the shot was given had swelled up an was a little itchy with tiny bumps and sore and warm and red to touch, but the swelling and itchiness and warmness and redness went away and subsided.  But she reported after the swelling and itchiness went away 3-5 days, but the tiny bumps still stayed till now but no itching and swelling or redness or warmness.  Told patient to get checked with doctor immediately.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient called me this morning and reported that a day after she received the shingrix vaccine on 1/30/2020 the location on her left arm where the shot was given had swelled up an was a little itchy with tiny bumps and sore and warm and red to touch, but the swelling and itchiness and warmness and redness went away and subsided.  But she reported after the swelling and itchiness went away 3-5 days, but the tiny bumps still stayed till now but no itching and swelling or redness or warmness.  Told patient to get checked with doctor immediately.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Hallucination, Headache, Hyperhidrosis
Clinical narrative: Patient reported to pharmacy on 2/27/20 stating reactions to vaccine administered on 2/6/20 started the next day on 2/7. Started with pain in left thumb, traveling to the right ankle and eventually spreading to all joints in the entire body. Pain was so severe that patient could not move or walk. Patient stated she had a fever in the middle of the night and woke up with sweating, also stated she had hallucinations. Joint pain resolved one week ago. Patient experienced severe headache that lasted until the day she came to pharmacy to report. (2/27)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient reported to pharmacy on 2/27/20 stating reactions to vaccine administered on 2/6/20 started the next day on 2/7. Started with pain in left thumb, traveling to the right ankle and eventually spreading to all joints in the entire body. Pain was so severe that patient could not move or walk. Patient stated she had a fever in the middle of the night and woke up with sweating, also stated she had hallucinations. Joint pain resolved one week ago. Patient experienced severe headache that lasted until the day she came to pharmacy to report. (2/27)
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient called with upper body muscle aches in his arms, neck and fingers and muscle stiffness. No treatment
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Dry skin, Injection site nodule, Mastocytoma, Skin discolouration, Skin induration
Clinical narrative: Mastocytoma on abdomen changed from reddish in color and mostly flat to yellowish in color and raised, rough and harder. Warm rash developed on parts of head, shoulder and abdomen and lasted about an hour. Knot formed at injection site.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Skin swelling, Skin warm
Clinical narrative: Mastocytoma on abdomen changed from reddish in color and mostly flat to yellowish in color and raised, rough and harder. Warm rash developed on parts of head, shoulder and abdomen and lasted about an hour. Knot formed at injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms; Inadvertently administered an expired dose of Proquad; This spontaneous report was received from a nurse via company representative, referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medication were not provided.  On 25-FEB-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, exact dose, schedule, route of administration were not reported; lot# R023500, expiry date: 13-FEB-2020) 1 dosage form; in the right arm for prophylaxis (expired product administered) along with a sterile diluent (strength, dose, frequency, route of administration, lot# and expiry date were not provided). No adverse symptoms reported. There was no associated product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Condition aggravated, Depression, Injection site erythema
Clinical narrative: Rheumatoid arthritis aggravated; Chills; Depression; INTERMITTENT FEELING OF ANXIETY; RED DOT AT THE INJECTION SITE; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis aggravated in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), chills, depression, anxiety and injection site erythema. The subject was treated with adalimumab (Humira). On an unknown date, the outcome of the rheumatoid arthritis aggravated, depression and anxiety were unknown and the outcome of the chills and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, chills, depression, anxiety and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. There was no reported medical history. The patient experienced arthritis symptoms worsened and red dot at the injection site with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility.
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis aggravated; Chills; Depression; INTERMITTENT FEELING OF ANXIETY; RED DOT AT THE INJECTION SITE; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis aggravated in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), chills, depression, anxiety and injection site erythema. The subject was treated with adalimumab (Humira). On an unknown date, the outcome of the rheumatoid arthritis aggravated, depression and anxiety were unknown and the outcome of the chills and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, chills, depression, anxiety and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. There was no reported medical history. The patient experienced arthritis symptoms worsened and red dot at the injection site with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Diagnosed with Bell's Palsy; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th January 2020, 29 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient received a dose of Shingrix in right arm. Till the time of reporting, the patient still had the event but it was 80 percent resolved. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Impaired work ability, Pain in extremity
Clinical narrative: red very sore arm severe headache unable to go to work next day
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Bone pain, Fatigue, Lethargy, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, fever, severe  body aches and pains (felt like bones were being crushed), extreme lethargy and fatigue, ulcers on throat, cheeks, and tongue
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal ulceration, Pyrexia, Skin ulcer, Tongue ulceration
Clinical narrative: Sore throat, fever, severe  body aches and pains (felt like bones were being crushed), extreme lethargy and fatigue, ulcers on throat, cheeks, and tongue
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: pt received pneumo 13 injection in clinic. Had allergic reaction, hives. Given 50mg Benadryl(IM), and 40mg Depo Medrol. Pt advised to stay in clinic for one hour post injections. (Will let her go at 1130). Addendum by provider on February 20, 2020 11:31 CST (Verified) Pt departed clinic @ 1130a. Pt reported feeling okay.
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Prior to administering vaccine. Gardasil 9 vaccine was found in the  Hep A vaccine bin in our private refrigerator after unknowingly noticing that the wrong vaccine was in the wrong bin, drawn and administered.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Extreme pain  at injection side , area very red.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Crying, Dyskinesia
Clinical narrative: Persistent Crying, Involuntary movements of the both arms/hands.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: found unresponsive in crib, unresponsive to resuscitation. deceased. autopsy pending
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: PATIENT SAID SHE HAD SORENESS AND REDNESS AT SITE OF INJECTION, ITCHING AND RASH  LASTS FOR MORE THAN 4 WEEKS
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Blood test, Febrile convulsion, Pyrexia, Seizure, Urine analysis
Clinical narrative: Per mom patient came down with a fever and patient started having convulsions that lasted for about 10 minutes, mother called paramedics as this was happening, they took her to hospital and the providers at the hospital diagnosed the patient with febrile seizures. Providers at the hospital also did blood work and urine work per mom. No xrays were done. Per mom providers at the hospital informed her to make an appointment with PCP and made an apportionment with us today (02/28/2020) and informed her to have PCP possibly make a referral to a neurologist. No further treatment was done; mother did not bring ER papers with her to PCP appointment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: REDNESS,SORENESS, ITCHING AN D RASH  FOR EXTENDED PERIOD OF TIME
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Raised red rash on torso and upper arms front and back.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Chest pain, Electrocardiogram ST-T change, Injection site pain, Neck pain
Clinical narrative: Patient contacted our office  on 2/25/2020 to report left arm pain from receiving Pneumovax 23 vaccine on 2/20/2020.  She wanted to make us aware that she went to the emergency room for the pain.  Emergency room records were obtained.  Patient went to Hospital on 2/24/2020 with c/o achy pain in the left deltoid muscle x 3 days.  The pain was constant and exacerbated with movement, radiating to the left neck and chest. She denied any other symptoms. Patient was given prescriptions for Flexeril 10 mg, Norco 325mg-5mg, and Lidoderm 5% patches.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Spinal osteoarthritis
Clinical narrative: Patient contacted our office  on 2/25/2020 to report left arm pain from receiving Pneumovax 23 vaccine on 2/20/2020.  She wanted to make us aware that she went to the emergency room for the pain.  Emergency room records were obtained.  Patient went to Hospital on 2/24/2020 with c/o achy pain in the left deltoid muscle x 3 days.  The pain was constant and exacerbated with movement, radiating to the left neck and chest. She denied any other symptoms. Patient was given prescriptions for Flexeril 10 mg, Norco 325mg-5mg, and Lidoderm 5% patches.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Pain
Clinical narrative: Body aches, chills, headache, general malaise, sore at injection site
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: unspecified doses of improperly stored vaccines may have been administered to unspecified patients; No additional adverse effects reported; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, 0.5 milliliter, subcutaneously, lot # S027463, expiration date 02-MAR-2021 and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, subcutaneously, lot # S021320, expiration date 09-JUL-2021, both for prophylaxis. The temperature was -3.39 degree Celsius for 24 hours. Previous temperature excursion was -2.5 degree Celsius for 17 hours. Digital data logger was not involved. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). No additional adverse effects were reported.  This is a non-valid case due to lack of patients' identifiers.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 13-FEB-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), one dose (lot number S030208, expiration date 25-MAR-2021) (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. No adverse events were reported. According to the reporter, the temperature excursion was -9 to 8/-4 degrees Celsius for a time frame of 20 minutes, without any previous temperature excursion. Digital data logger was involved.
Age: 50.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: GARDASIL 9 at the age of 50; No adverse effects reported; This spontaneous report was received from the patient's wife concerning his husband, a 50 year old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with the first shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect; patient received a dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On 20-FEB-2020, the patient was vaccinated with one improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) (lot# S025993, expiration date 17-OCT-2020) (exact dose, frequency and route of administration were not reported) for prophylaxis. The administered vaccine were stored in a temperature below 36 Fahrenheit degrees (F) (34F) for 27 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient received a dose of VARIVAX that was improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On 25-FEB-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S024369, expiry date: 08-JUN-2021) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported. The vaccine was exposed to a temperature of -13.8 Celsius for a time frame of 13 minutes. Previous temperature excursion of 3.4 Celsius for 1 hour 30 minutes was reported. The call was due to digital data logger. No product quality complaint (PQC) was associated with this report.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: On 11/15/2019, the patient developed arm pain in the whole arm that had received the PNEUMOVAX injection; a patient received adose of PNEUMOVAX on 11/17/2016 and on 11/14/2019; This spontaneous report as received from a nurse refers to a 65-year-old male patient with diabetes mellitus, hypertension, restless legs syndrome, anaemia, elevated alkaline phosphatase, hyperlipidaemia, obesity, thrombocytopenia, muscle cramps and microalbuminuria. Concomitant therapies included atenolol (TENORMIN), atorvastatin calcium (LIPITOR), glimepiride (AMARYL), hydrochlorothiazide, lisinopril(PRINIVIL), metformin, potassium (unspecified) and pramipexole dihydrochloride (MIRAPEX). The patient had no allergies or drug reactions.  On 17-NOV-2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # M026317, expiration date unknown by reporter but established as 11-JAN-2018, intramuscularly for prophylaxis.  On 14-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S018405, expiration date unknown by reporter but established as 23-MAR-2021, intramuscularly for prophylaxis. The patient had also received influenza virus whole virion 3v vaccine inactivated(FLUZONE (INFLUENZA VIRUS WHOLE VIRION 3V VACCINE INACTIVATED)) on the same day but in the opposite arm than the arm that had received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). On 15-NOV-2019, the patient developed arm pain in the whole arm that had received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). There was no treatment given for the adverse event. No lab diagnostics/studies performed. The patient sought medical attention - he called a nurse.  The outcome of arm pain was reported as not recovered/not resolved.   The causality assessment between the event of arm pain and the suspect therapy was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: developed cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided but it could be 66 or 67 years. The patient received the first dose of Shingrix and developed cancer so did not get the second dose. The follow up consent was granted. This case was a medication error without harm.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Encephalitis, Gait disturbance, Haemorrhage intracranial, Herpes zoster
Clinical narrative: hydrocephalus; cranial bleed; no bladder control; rash on back; shingles on back; pain; confusion; difficulty walking; encephalitis; severe muscle pain (left leg); redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema (serious criteria hospitalization). On 8th November 2019, the patient experienced muscle pain (serious criteria hospitalization). On 12th November 2019, the patient experienced rash (serious criteria hospitalization), shingles (serious criteria hospitalization), pain (serious criteria hospitalization), confusion (serious criteria hospitalization), walking difficulty (serious criteria hospitalization) and encephalitis (serious criteria hospitalization and GSK medically significant). On 15th November 2019, the patient experienced bladder incontinence (serious criteria hospitalization). On 30th November 2019, the patient experienced intracranial hemorrhage (serious criteria hospitalization and GSK medically significant). On 13th January 2020, the patient experienced hydrocephalus (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus were unknown.   It was unknown if the reporter considered the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced injection site erythema, muscle pain in left leg, rash, shingles, pain, confusion, walking difficulty, encephalitis, no bladder control, intracranial hemorrhage and hydrocephalus. The patient went to the emergency room on on 15th November 2019 and was admitted to the hospital the same day. on 5th February 2020 the patient was discharged from the hospital.  Reporter consented to follow up
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hydrocephalus, Injection site erythema, Myalgia, Pain, Rash
Clinical narrative: hydrocephalus; cranial bleed; no bladder control; rash on back; shingles on back; pain; confusion; difficulty walking; encephalitis; severe muscle pain (left leg); redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema (serious criteria hospitalization). On 8th November 2019, the patient experienced muscle pain (serious criteria hospitalization). On 12th November 2019, the patient experienced rash (serious criteria hospitalization), shingles (serious criteria hospitalization), pain (serious criteria hospitalization), confusion (serious criteria hospitalization), walking difficulty (serious criteria hospitalization) and encephalitis (serious criteria hospitalization and GSK medically significant). On 15th November 2019, the patient experienced bladder incontinence (serious criteria hospitalization). On 30th November 2019, the patient experienced intracranial hemorrhage (serious criteria hospitalization and GSK medically significant). On 13th January 2020, the patient experienced hydrocephalus (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus were unknown.   It was unknown if the reporter considered the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced injection site erythema, muscle pain in left leg, rash, shingles, pain, confusion, walking difficulty, encephalitis, no bladder control, intracranial hemorrhage and hydrocephalus. The patient went to the emergency room on on 15th November 2019 and was admitted to the hospital the same day. on 5th February 2020 the patient was discharged from the hospital.  Reporter consented to follow up
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: hydrocephalus; cranial bleed; no bladder control; rash on back; shingles on back; pain; confusion; difficulty walking; encephalitis; severe muscle pain (left leg); redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema (serious criteria hospitalization). On 8th November 2019, the patient experienced muscle pain (serious criteria hospitalization). On 12th November 2019, the patient experienced rash (serious criteria hospitalization), shingles (serious criteria hospitalization), pain (serious criteria hospitalization), confusion (serious criteria hospitalization), walking difficulty (serious criteria hospitalization) and encephalitis (serious criteria hospitalization and GSK medically significant). On 15th November 2019, the patient experienced bladder incontinence (serious criteria hospitalization). On 30th November 2019, the patient experienced intracranial hemorrhage (serious criteria hospitalization and GSK medically significant). On 13th January 2020, the patient experienced hydrocephalus (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus were unknown.   It was unknown if the reporter considered the injection site erythema, muscle pain, rash, shingles, pain, confusion, walking difficulty, encephalitis, bladder incontinence, intracranial hemorrhage and hydrocephalus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experinced injection site erythema, muscle pain in left leg, rash, shingles, pain, confusion, walking difficulty, encephalitis, no bladder control, intracranial hemorrhage and hydrocephalus. The patient went to the emergency room on on 15th November 2019 and was admitted to the hospital the same day. on 5th February 2020 the patient was discharged from the hospital.  Reporter consented to follow up