chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Cataract nuclear, Macular oedema, Metamorphopsia, Optic neuritis
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 11-APR-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2016 (reported as shortly after receiving ZOSTAVAX), the patient suffered macular edema left eye (OS), neuroretinitis OS, distortion of vision both eyes (OU), and nuclear sclerosis OU. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were considered not resolved. Causality assessment was related. Upon internal review, macular edema OS and neuroretinitis OS were considered to be medically significant events. The lawyer considered macular edema OS, neuroretinitis OS, distortion of vision OU, and nuclear sclerosis OU to be disabling. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-FEB-2019, the patient was vaccinated with M-M-R II lot # N014482 (albumin status: RHa), expiration date 10-MAY-2019 and VARIVAX lot# N026072, expiration date 20-SEP-2019; both vaccines via intramuscular route for prophylaxis. In addition, both vaccines were reconstitute with sterile diluent. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, general body pain and injection site pain. On an unknown date, the outcome of the headache, general body pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. Recently the patient received a dose of SHINGRIX but the exact date was not known. The headache and body aches lasted for a day and the sore arm was for a few days. The reporter did not consent to follow-up. This case has been linked with US2019034291, reported by same reporter for the patient's sister.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: I got the shingles shot on Wednesday 2/27  and started severe itching all over on Sunday 3/3.  It was awful and a Sunday (no doctor hours)  so  I started taking 1 then 2 tablets of Allergy pills. and that finally helped get rid of the itching.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, UNK, VARCEL
Symptoms: Crying, Haemangioma, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Right arm was swollen by injection site. Hemangioma on right shoulder became swollen. 3 days later rash broke out all over body. Fever and crying after vaccines also.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, UNK, VARCEL
Symptoms: Rash generalised
Clinical narrative: Right arm was swollen by injection site. Hemangioma on right shoulder became swollen. 3 days later rash broke out all over body. Fever and crying after vaccines also.
Age: 23.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site streaking
Clinical narrative: Called clinic today with 3 days of swelling, tenderness and redness at injection site on left deltoid. Patient asked to come in and be seen, treated for localized cellulitis/possible reaction. Noted raised erythematous area with streaking and induration the size of a quarter at site of injection. Patient beleives it is where Tdap was given but she cannot be sure. No fevers or s/s of systemic illness.
Age: 23.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Injection site swelling
Clinical narrative: Called clinic today with 3 days of swelling, tenderness and redness at injection site on left deltoid. Patient asked to come in and be seen, treated for localized cellulitis/possible reaction. Noted raised erythematous area with streaking and induration the size of a quarter at site of injection. Patient beleives it is where Tdap was given but she cannot be sure. No fevers or s/s of systemic illness.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Lethargy
Clinical narrative: 105 temperature, Lethargy.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Malaise, Oxygen saturation decreased, Pyrexia, Regressive behaviour
Clinical narrative: Febrile seizure occurred on 12/28/2016. Bed shaking for 5 minutes. Fever of over 105.5 when ambulance arrived. Took over 20 minutes for her eyes to be able to focus on me. Oxygen initially low. Taken to ER. Started regressing in February 2017, with screaming, visual stimming in March as well as smearing feces. Started getting sick a lot. Seemed to do a little better by August of 2017. Another vaccine given in November 2017, which is reported separately for reaction to flu vaccine.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Screaming, Tremor, Vision blurred
Clinical narrative: Febrile seizure occurred on 12/28/2016. Bed shaking for 5 minutes. Fever of over 105.5 when ambulance arrived. Took over 20 minutes for her eyes to be able to focus on me. Oxygen initially low. Taken to ER. Started regressing in February 2017, with screaming, visual stimming in March as well as smearing feces. Started getting sick a lot. Seemed to do a little better by August of 2017. Another vaccine given in November 2017, which is reported separately for reaction to flu vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site erythema, Pain in extremity
Clinical narrative: She reports that her arm was sore the night of receiving the second dose of SHINGRIX, but was resolved by day #2. However, in morning of day #2, patient had diarrhea and chills that lasted 1.5 days.  She states that she also had a redness that went spread from the injection site down her arm about 5 inches and then went across perpendicular, she said it resolved within 3 days. Patient denies any current side effects, states that it has all resolved at this time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Nausea, Pain, Pyrexia
Clinical narrative: Low grade fever, tiredness, nausea, achy body, mild flu symptoms.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Aggression, Anaphylactic reaction, Aphasia, Autism spectrum disorder
Clinical narrative: I am a pharmacist who did not initially connect the dots to the vaccine as a parent. Within 2 days of the vaccine, my daughter was throwing herself, screaming on the floor several times a day. She started having 20-30 meltdowns by lunchtime. I have videos of her playing with her brother and play pretending 2 days prior to the vaccine, and within 48 hours after the vaccine, she could not tell me what she wanted for breakfast. Pt very quickly regressed into severe autism. She lost almost all speech after being called a baby genius by her pediatrician at age 2 (saying she was one of the smartest children she ever met). Pt knew her phonics at 24 months, and counted objects to 15 at 25 months. In May of 2018, her IQ was tested to be at 59, and she started a speech school. My husband and I have paid out nearly 100,000 dollars to recover her, which is the same amount I have in retirement. She has been in 5 therapies weekly, and we have devoted our lives to helping her to live the best life she can. I the summer of 2017, pt visited the ER for vomiting episodes and her GI specialist said her findings were consistent with Irritable Bowel Disease. She had cyclic vomiting, an anyphylactic dairy allergy, and her GI doctor said her findings were consistent with Celiac at 4 years old. She lost all eye contact this year, and had several other seizures, and would get sick for 3 weeks at a time, with a cold that should not have been severe. Several febrile seizures followed. In the summer of 2018, Autism Center diagnosed pt with severe autism.  Her brother has also had vaccine reactions. Pt's developmental pediatrician believes that her findings are consistent with secondary mitchondrial dysfunction.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Coeliac disease, Cow's milk intolerance, Cyclic vomiting syndrome, Decreased eye contact, Electroencephalogram abnormal
Clinical narrative: I am a pharmacist who did not initially connect the dots to the vaccine as a parent. Within 2 days of the vaccine, my daughter was throwing herself, screaming on the floor several times a day. She started having 20-30 meltdowns by lunchtime. I have videos of her playing with her brother and play pretending 2 days prior to the vaccine, and within 48 hours after the vaccine, she could not tell me what she wanted for breakfast. Pt very quickly regressed into severe autism. She lost almost all speech after being called a baby genius by her pediatrician at age 2 (saying she was one of the smartest children she ever met). Pt knew her phonics at 24 months, and counted objects to 15 at 25 months. In May of 2018, her IQ was tested to be at 59, and she started a speech school. My husband and I have paid out nearly 100,000 dollars to recover her, which is the same amount I have in retirement. She has been in 5 therapies weekly, and we have devoted our lives to helping her to live the best life she can. I the summer of 2017, pt visited the ER for vomiting episodes and her GI specialist said her findings were consistent with Irritable Bowel Disease. She had cyclic vomiting, an anyphylactic dairy allergy, and her GI doctor said her findings were consistent with Celiac at 4 years old. She lost all eye contact this year, and had several other seizures, and would get sick for 3 weeks at a time, with a cold that should not have been severe. Several febrile seizures followed. In the summer of 2018, Autism Center diagnosed pt with severe autism.  Her brother has also had vaccine reactions. Pt's developmental pediatrician believes that her findings are consistent with secondary mitchondrial dysfunction.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Intelligence test abnormal, Malaise, Mitochondrial cytopathy, Nasopharyngitis
Clinical narrative: I am a pharmacist who did not initially connect the dots to the vaccine as a parent. Within 2 days of the vaccine, my daughter was throwing herself, screaming on the floor several times a day. She started having 20-30 meltdowns by lunchtime. I have videos of her playing with her brother and play pretending 2 days prior to the vaccine, and within 48 hours after the vaccine, she could not tell me what she wanted for breakfast. Pt very quickly regressed into severe autism. She lost almost all speech after being called a baby genius by her pediatrician at age 2 (saying she was one of the smartest children she ever met). Pt knew her phonics at 24 months, and counted objects to 15 at 25 months. In May of 2018, her IQ was tested to be at 59, and she started a speech school. My husband and I have paid out nearly 100,000 dollars to recover her, which is the same amount I have in retirement. She has been in 5 therapies weekly, and we have devoted our lives to helping her to live the best life she can. I the summer of 2017, pt visited the ER for vomiting episodes and her GI specialist said her findings were consistent with Irritable Bowel Disease. She had cyclic vomiting, an anyphylactic dairy allergy, and her GI doctor said her findings were consistent with Celiac at 4 years old. She lost all eye contact this year, and had several other seizures, and would get sick for 3 weeks at a time, with a cold that should not have been severe. Several febrile seizures followed. In the summer of 2018, Autism Center diagnosed pt with severe autism.  Her brother has also had vaccine reactions. Pt's developmental pediatrician believes that her findings are consistent with secondary mitchondrial dysfunction.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Regressive behaviour, Screaming, Seizure
Clinical narrative: I am a pharmacist who did not initially connect the dots to the vaccine as a parent. Within 2 days of the vaccine, my daughter was throwing herself, screaming on the floor several times a day. She started having 20-30 meltdowns by lunchtime. I have videos of her playing with her brother and play pretending 2 days prior to the vaccine, and within 48 hours after the vaccine, she could not tell me what she wanted for breakfast. Pt very quickly regressed into severe autism. She lost almost all speech after being called a baby genius by her pediatrician at age 2 (saying she was one of the smartest children she ever met). Pt knew her phonics at 24 months, and counted objects to 15 at 25 months. In May of 2018, her IQ was tested to be at 59, and she started a speech school. My husband and I have paid out nearly 100,000 dollars to recover her, which is the same amount I have in retirement. She has been in 5 therapies weekly, and we have devoted our lives to helping her to live the best life she can. I the summer of 2017, pt visited the ER for vomiting episodes and her GI specialist said her findings were consistent with Irritable Bowel Disease. She had cyclic vomiting, an anyphylactic dairy allergy, and her GI doctor said her findings were consistent with Celiac at 4 years old. She lost all eye contact this year, and had several other seizures, and would get sick for 3 weeks at a time, with a cold that should not have been severe. Several febrile seizures followed. In the summer of 2018, Autism Center diagnosed pt with severe autism.  Her brother has also had vaccine reactions. Pt's developmental pediatrician believes that her findings are consistent with secondary mitchondrial dysfunction.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythematous round warm area on left upper arm- marked area with permanent marker and advised pt to take Benadryl and put ice on the area and if it increased in size to call the clinic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Malaise
Clinical narrative: Pt claims that reaction started almost immediately as pain, soreness at injection site; malaise;  Pt still have what he described as pain in shoulder, clavicle and joints on left side; pt stated range of motion is not limited, no restrictions.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cyst, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Call regarding swelling post vaccination. Patient is known to me and sent a text on 3/3/19 stating the following: "So this huge cyst popped up yesterday right at the injection point of my shot (received MMR vaccine 1/30/19). It hurts really bad today. Like anytime it gets bumped or rubbed I feel like crying. Is this usual? Any advice?" I texted back: "A harder bump isn't uncommon a week or two later. But I've never heard of symptoms that late. 5% of people can get a rash a week or two after but it's not painful. Can u send a picture of the whole back of your arm?" First photos she texted were not clear and I responded: "I can't see a cyst in any of the pictures. Is it just red? Is it raised at all? I'll ask about it when I see the doctor next. Any fever?" She sent a better photo the next day (3/4/19) and she replied, "It is hard and hot now. The hard part is about 1 x 2 inches and then swollen and red around it." I forwarded the photo of her arm to my supervisor to view and review with a doctor at the health department. I then left her a phone msg and also texted her back to go to urgent care (is currently traveling) to r/o cellulitis and see if she needed an ABO.  Will also initiate VAERS report and YCCHS incident report. RN
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Arm pain and dizziness starting day of vaccination. Dizziness has continued since time of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Chills, aches, possible fever, fatigue, mild nausea.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh where injection was given was red, swollen, hot/hard to touch and size of quarter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Dizziness, Fatigue
Clinical narrative: Woke up in the middle of the night with aching leg muscles and stomach discomfort. Had pain at injection site from the beginning. 7 days later I had shivering which rotated with fever, also had fatigue, headache, stomach bloating, dizziness, and had 3 spots on my face - these all continued through day 12.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Middle insomnia, Myalgia, Pyrexia
Clinical narrative: Woke up in the middle of the night with aching leg muscles and stomach discomfort. Had pain at injection site from the beginning. 7 days later I had shivering which rotated with fever, also had fatigue, headache, stomach bloating, dizziness, and had 3 spots on my face - these all continued through day 12.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Woke up in the middle of the night with aching leg muscles and stomach discomfort. Had pain at injection site from the beginning. 7 days later I had shivering which rotated with fever, also had fatigue, headache, stomach bloating, dizziness, and had 3 spots on my face - these all continued through day 12.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site mass
Clinical narrative: Small lump formed at injection site and never went away. Patient asked doctor in January and was told to monitor it. Patient came into pharmacy on 3/6/19 and told the pharmacist about the lump.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: Afebrile in morning and no signs of sickness. 6 hours after vaccine, patient had fever of 101.9F, cough, nasal congestion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Labyrinthitis, Nausea, Vertigo positional
Clinical narrative: The next morning I woke up with severe BPPV (benign paroxysmal positional vertigo) involving mostly my right ear, but somewhat my left. I also had most likely an inner ear infection as well, which I did not have symptoms of the previous night. I was developed increasingly worse nausea Sunday, March 3 through Monday noon March 4th. It was eased with the PT treatment for the BPPV as described below and with DRAMAMINE.
Age: 1.0
Sex: M
Vaccine: HEPA, MENB, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: This was not an adverse reaction. BEXSERO vaccination was given instead of PREVNAR 13. Mom advised to watch for fever, local reaction. If occurs call office.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Pt. has local reaction with large area of erythema on injection site. Start more than 12 hours after. Seen on day 6. No evidence of abcess, erosion or cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Local reaction, Vaccination site erythema, Vaccination site induration
Clinical narrative: Local reaction from vaccine at the vaccination sites (both deltoids) with erythema and induration of 2-3 inches.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Urticaria
Clinical narrative: After the 1st shot, I began having occasional hives pop up and go away. On February 13, 2019, my lips became severely swollen. I had the 2nd SHINGRIX shot on February 20, 2020. and within 24 hours began severe hives on various parts of my body. They begin to ease up after a couple of days, but I still am having hives, swollen areas, and invisible itching. My top lip became swollen on February 28, 2019, and went away after about 24 hours. Then, again my top lip became swollen on March 5, 2019. I've been to an allergist and have a follow up scheduled on March 12, 2019.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Lip swelling, Pruritus, Swelling, Urticaria
Clinical narrative: After the 1st shot, I began having occasional hives pop up and go away. On February 13, 2019, my lips became severely swollen. I had the 2nd SHINGRIX shot on February 20, 2020. and within 24 hours began severe hives on various parts of my body. They begin to ease up after a couple of days, but I still am having hives, swollen areas, and invisible itching. My top lip became swollen on February 28, 2019, and went away after about 24 hours. Then, again my top lip became swollen on March 5, 2019. I've been to an allergist and have a follow up scheduled on March 12, 2019.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 83-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The batch number and expiry date were unknown. This case was considered, as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 83-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The batch number and expiry date were unknown. This case was considered, as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown.
Age: 67.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Nausea, extreme fatigue, headache, dizziness.
Age: 67.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Nausea, extreme fatigue, headache, dizziness.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Alopecia areata, Asthma, Autoimmune disorder, Bronchitis, Dyspnoea
Clinical narrative: Heavy breathing & wheezing a day after. Turned into bronchitis and later pneumonia. Diagnosed with asthma.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Immune thrombocytopenic purpura, Lung infection, Pneumonia, Wheezing
Clinical narrative: Heavy breathing & wheezing a day after. Turned into bronchitis and later pneumonia. Diagnosed with asthma.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, RV5
Symptoms: Rash
Clinical narrative: Body rash on the core (both chest and back).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Tremor
Clinical narrative: Uncontrollable shaking and overall freezing cold feeling. It started when I got into bed and lasted around 1-1/2 hours. Took Advil, put warm blankets on, and the shaking subsided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 05-FEB-2019, the patient was vaccinated with M-M-R II (lot # N001531, expiration date: 13-JAN-2019, subcutaneous; dose and frequency unknown) for prophylaxis (expired product administered). No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 4 years old patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On 14-FEB-2019, during the same office visit, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (thimerosal-free) (route: intramuscular, lot # : R00674, expiration date : 09-NOV-2020; strength: 5/0.5 mcrg/ml) and a dose of PEDIARIX (lot #, expiration date, dose, strength, route, and frequency were not reported) for prophylaxis (accidental overdose). No adverse effects were reported in the patient.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. On 22-JUL-2016, the patient received the first dose of GARDASIL 9 (dose detail, strength, lot #, and expiration date were not reported) via intramuscular for prophylaxis. On 13-AUG-2018, the patient received the second dose of GARDASIL 9 (dose detail, strength, lot #, and expiration date were not reported) via intramuscular for prophylaxis. The patient did not get the third dose yet. No adverse effect was reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Myocarditis
Clinical narrative: This spontaneous report was received from a consumer referring to a male patient of unknown age (reported as "mid-30s"). The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 15-FEB-2019 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, frequency, lot # and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (strength, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On an unknown date in February 2019 the patient experienced an injection site reaction, however there was some confusion as to which injection was received in which arm, so it is unknown which vaccine caused the reaction. Within days he developed myopericarditis, which was originally diagnosed as a heart attack in the emergency room (ER).  The outcome of the events was reported as recovered. Causality was unknown. Upon internal review, myopericarditis was determined to be medically significant.
Age: 74.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician via a company representative referring to a 74 year old female patient. The patient's history condition included she was a stem cell patient. The patient's concomitant medication and drug reactions/allergies were not reported. On 26-FEB-2019, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. Physician reported the patient did not experience any adverse effects from receiving dose of GARDASIL 9.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Facial paralysis, Herpes zoster meningoencephalitis, Tremor
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer and the representative of the estate concerning a deceased male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. On an unknown date, after receiving the ZOSTAVAX, the patient developed tremors, Bell's palsy, and varicella encephalitis. On 08-APR-2017, the patient succumbed to his injuries and passed away. As a result, the patient suffered sustained severe and fatal personal injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, and loss of enjoyment of life. As a direct result of ZOSTAVAX, the patient incurred medical expenses, and other economic harm. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to ZOSTAVAX. As a result patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered fatal. It was unknown if autopsy was done. Upon internal review, Bell's palsy, and varicella encephalitis were determined medically significant. Tremors, Bell's palsy and varicella encephalitis were considered disabling. Additional information has been requested.; Reported Cause(s) of Death: Bell's palsy; tremors; varicella encephalitis.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided. On 13-FEB-2019, the patient was administered 1 dose of RECOMBIVAX HB (lot # R006746 with expiration date 09-NOV-2020; strength, dose detail and route was not provided) and 1 dose of PEDIARIX (unknown manufacturer) (Inappropriate dose of vaccine administered) for prophylaxis. No adverse effects. The causality of the events was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 28-FEB-2019 (reported as yesterday), the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) one month early in a two dose regiment for prophylaxis. No adverse effects were reported. No product quality complaint was filed.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Neuropathy peripheral, Urine analysis normal
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a currently 21-year-old female patient. The patient had no known drug allergies and no information was provided regarding her concurrent conditions, medical history and concomitant medications. On unknown dates the patient was vaccinated with the first and the second doses of GARDASIL (doses, route, lot# and expiry dates not reported). On 28-JUN-2013 the patient was vaccinated with the third dose of GARDASIL lot # reported as "H02002", expiry date 08-AUG-2015, intramuscularly. On an unknown date the patient experienced neuropathy. On 28-JUN-2013 urine and hemoglobin tests were performed and both showed normal results. The outcome of neuropathy was unknown. The causality assessment was not provided. Upon internal review neuropathy was considered to be medically significant adverse event. Lot number H02002 is an invalid lot number for GARDASIL.
Sex: F
Vaccine: HPVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This spontaneous report was received from a consumer refers to a female patient of unknown age. Patient's concurrent condition included allergy to TDaP and poliovirus vaccine inactivated. Information regarding patient's medical history and concomitant medication was not reported. On an unknown date, she received one or two doses of GARDASIL 9, or GARDASIL and that may have not been shaken before administration of the dose. No adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-NOV-2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an adult patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 28-FEB-2019, the patient was inadvertently vaccinated with expired VAQTA injection 50/1.0 U/ml, lot # N028743 (expiry date: 23-NOV-2018) intramuscularly (dosage details were not reported) for prophylaxis (expired product administered). The patient did not experience any adverse effects. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician via Pfizer regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, lot#, expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to vaccine. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse practitioner, concerning a 14 years old patient of unknown gender. Patient's historical condition, current condition, concomitant medication, previously drug reactions and allergies were not reported. On 04-MAR-2019, the patient was administered with a dose of PROQUAD subcutaneous injection for prophylaxis (anatomical location, lot number and expiration date were not reported) (product use in unapproved population). No adverse effects were reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1903USA002615:
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Information has been received from a nurse practitioner, concerning a 16 years old patient of unknown gender. Patient's historical condition, current condition, concomitant medication, previously drug reactions and allergies were not reported. On 04-MAR-2019, the patient was administered with a dose of PROQUAD subcutaneous injection for prophylaxis (anatomical location, lot number and expiration date were not reported) (product use in unapproved population). No adverse effects were reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1903USA002536:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received 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 injection site pain, fever, weakness, general body pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, fever, weakness, general body pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, weakness, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 or 61 years. The patient experienced severe injection site pain, high fever, weakness, body aches, and general flu-like symptoms for 4 days post vaccination. The patient needed 2nd dose but she would hate to have to repeat this process in a few years. The patient stated that there was no one to follow up with.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of anaphylaxis in a patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included chemotherapy. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician wanted to give Solu-Medrol (Pfizer) to the patient, however the patient had anaphylaxis to concentrated yeast. They had a reaction to chemotherapy and the Hepatitis B vaccine (names unknown).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Many patients have complained of significant arm pain after receiving SHINGRIX. No additional details was provided. No information was provided. This case has been linked to the case US2019034286, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX (batch number 32ZG4, expiry date 31st July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site inflammation and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site inflammation and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site inflammation and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in left arm. The patient experienced redness, swelling, and inflammation in a circular area at the injection site. She also experienced a low grade fever. The reporter did not consent to follow-up. The reporter was in a hurry and was unable to provide additional information.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip pruritus, Lip swelling, Pruritus, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 57-year-old male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th November 2018, 9 days after receiving SHINGRIX, the patient experienced swelling, pruritus, lip swelling and lip pruritus. On an unknown date, the outcome of the swelling, pruritus, lip swelling and lip pruritus were not recovered/not resolved. It was unknown if the reporter considered the swelling, pruritus, lip swelling and lip pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and itching at various sites on his body (including the lips) which were ongoing till the time of reporting. The symptoms began approximately one week prior to 22nd November 2018.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX (batch number A4D72, expiry date 23rd May 2021) for prophylaxis. On 16th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and myalgia upper extremities. On an unknown date, the outcome of the pain in arm and myalgia upper extremities were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the left arm. The patient experienced a sore arm with muscle pain after the injection. The pharmacist consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 19th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythema, skin warm and pain. The patient was treated with Ice Pack (No Medication). On an unknown date, the outcome of the erythema and pain were recovering/resolving and the outcome of the skin warm was recovered/resolved. It was unknown if the reporter considered the erythema, skin warm and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the right deltoid. The pharmacist stated that they gave a SHINGRIX vaccine to the patient and down below the injection there was a red warm area, like it hurt her. They did put an ice pack on it, which took away the heat feeling. The reporter clarified that it was an inch or two from the injection site and it started to develop the next day. The reporter then called the patient a couple days after and she said it was getting a lot better. It was not a rash or infection. The patient declined to provide date of birth. Information as provided by caller.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Movement disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of movement disorder in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced movement disorder. On an unknown date, the outcome of the movement disorder was unknown. It was unknown if the reporter considered the movement disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had trouble lifting their arm after receiving SHINGRIX. No additional details was provided. This case has been linked to the case US2019GSK040430, reported by same reporter.