chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab
Clinical narrative: 16 April about 1330 received SHINGRIX. 19th of April my scalp became very tender. So much so, that I called my Doctor to get it checked out. My Doctor didn't have clinic so I saw another Doctor. No rash was present at this time, but he gave me a Rx for Prednisone, (he called it Occipital neuralgia). I took the series of pills for 6 days and was going to call the Doctor because I felt a painful rash on my scalp and nothing eased the pain. I took a pill for pain I had (4 years ago). I helped by made me a little lightheaded, I twisted my ankle and my husband took me to the ER. They looked at my head and diagnosed shingles. They gave me an RX for ten day and said to see my family Dr. when I was finished with them. He looked at my scalp and said to take 800mg MOTRIN three times a day. Not much he could say. I had crusted sores across my head and I still can't lay my head down on the right side. Today is May 26th and I still have at least 3 clusters of scabs. I found "TERRASIL" on line and use it on the rash at least three times a day. (It's for Shingles skincare). It does ease the pain and itching. No allergies except TEGRETOL, which I took about 10 years ago. I had a routine check up with my family doctor on the 12th of April. That's when he gave me the script for SHINGRIX which I got around to getting the following Monday. No illness prior to the shot. At hospital medication ordered; Acyclovir 800 mg and a RX for the next 10 days, then follow up with family Doctor. This paper with all the other documents says it all. The scabs have gone however, the scalp pain continues. Vaccination given by the Pharmacist, I don't know anything about the actual injection except it was given in my Rt arm. Which is also the side of my head that was affected with the pain and rash.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry mouth, Fatigue, Injection site erythema, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a adult female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included allergic reaction to analgesics. On 1st May 2018, the patient received SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The patient was not feel sick at the date of reporting. The patient did not have any health conditions such as: heart disease, diabetes or asthma. The patient did not have allergies to latex, medications, food or vaccines (Examples: eggs, bovine protein, gelatin, gentamicin, polymyxin, neomycin, phenol, yeast or thimerosal). The patient was allergic to Acetylsalicylic acid. The patient did not have a reaction after receiving an immunization, including fainting or feeling dizzy. The patient did not ever had a seizure disorder for which the patient was on seizure medication(s), a brain disorder, Guillain-Barre Syndrome. The age at vaccination was not reported. The patient received SHINGRIX in the left arm, which caused a cellulitis.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a adult female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included allergic reaction to analgesics. On 1st May 2018, the patient received SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The patient was not feel sick at the date of reporting. The patient did not have any health conditions such as: heart disease, diabetes or asthma. The patient did not have allergies to latex, medications, food or vaccines (Examples: eggs, bovine protein, gelatin, gentamicin, polymyxin, neomycin, phenol, yeast or thimerosal). The patient was allergic to Acetylsalicylic acid. The patient did not have a reaction after receiving an immunization, including fainting or feeling dizzy. The patient did not ever had a seizure disorder for which the patient was on seizure medication(s), a brain disorder, Guillain-Barre Syndrome. The age at vaccination was not reported. The patient received SHINGRIX in the left arm, which caused a cellulitis.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Angiotensin converting enzyme decreased, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Bartonella test negative, Blood electrolytes normal
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Diabetic retinopathy, Differential white blood cell count normal, Discomfort, Full blood count normal
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Fungal test negative, HIV test negative, Lumbar puncture normal, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Optic neuropathy, Pain, Papilloedema, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pupil dilation procedure, Pyrexia, Red blood cell sedimentation rate normal, Toxoplasma serology negative, Treponema test negative
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Cellulitis, Injection site pain, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 45.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Optic neuritis, Pain, Pain in extremity, Visual impairment
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 23-May-2018. This case involves a 45-year-old male patient who was vaccinated with a 0.5 ml dose of ADACEL (batch number: U5603AA, expiry date not reported) intramuscularly in the right arm on 23-Jan-2018. The patient's medical history and concomitant medications were not reported. On 23-Jan-2018, few minutes after vaccination, the patient had shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side. On an unspecified date, the patient was diagnosed with cellulitis (latency unknown). On an unspecified date (latency unknown) after receiving vaccine the patient was undergoing an eye evaluation, he saw an optician who recommended him to visit an ophthalmologist, as he was having visual changes. Five days after receiving vaccine, the patient had Optic neuritis and since then he had a 60% vision loss in his right eye that is now resolving and is about 95% vision in the right eye. Laboratory data included multiple blood a diagnostic test and even a spinal tap that was negative for disease process. The patient received corrective treatment with Antibiotics for arm pain. The patient recovered from shooting pains in his right arm radiating from the injection site which became worse and was radiating on his whole right side and cellulitis and recovering from optic neuritis and Visual disturbance. The reporter assessed the causal relationship with ADACEL as related (reported that He was told that it must have been a vaccine reaction). List of documents held by sender: none. Sender's Comments: This case concerns a patient who developed cellulitis, injection site pain, visual changes, optic neuritis and temporary visual loss post-vaccination with ADACEL vaccine. Time to onset is compatible with the role of vaccine. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations, previous vaccinations and tolerance, lab test ruling out other etiologies were missing for further assessment of the case. Based on limited information reported, assessment cannot be done.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: First slight itching, then swelling and hard area on arm below injection site; warm to touch. Became larger the next day making a larger area on arm continuing down below the site and around on inside of arm, still swollen and warm to touch. Still noticeable third day, but not as tender to touch, swollen, hard or warm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Influenza like illness, Injection site rash, Myalgia, Pain
Clinical narrative: As per stated as side effects, I had general flu like symptoms early morning on 6/5/18 which worsened into 6/6/18 when a rash appeared at the site of injection but also 2"(now1") from that site. I took ADVIL for aches and BENADRYL for what looked like hives forming. Arm is rock hard and painful to lightest touch but this is part of normal side effects. Muscle aches have for most part subsided as of today 6/7/18.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: As per stated as side effects, I had general flu like symptoms early morning on 6/5/18 which worsened into 6/6/18 when a rash appeared at the site of injection but also 2"(now1") from that site. I took ADVIL for aches and BENADRYL for what looked like hives forming. Arm is rock hard and painful to lightest touch but this is part of normal side effects. Muscle aches have for most part subsided as of today 6/7/18.
Sex: F
Vaccine: PPV
Symptoms: Laceration, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a Registered Nurse reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. Nurse reported she cut an unspecified finger (limb injury) on an unspecified hand while reporting a Product Quality Complaint on a broken Luer lock on a PNEUMOVAX 23 syringe (syringe issue). Nurse did not want to report the incident stating she was reporting it as a paper cut. At the time of the report, the outcome of syringe issue and limb injury was unknown. The reporter did not mention the causality assessment between events and PNEUMOVAX 23.
Sex: U
Vaccine: HEP, HEPA, HIBV, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unknown age patients of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, unspecified patients were administered with an improperly stored dose of M-M-R II lot# reported as N01105 and 05-APR-2019 expiration date and lot# N00153 with 13-JAN-2019 expiration date for prophylaxis (strength, frequency and route of administration were not reported); LIQUID PEDVAXHIB lot#N016992 and 07-MAR-2020 expiration date for prophylaxis (strength, frequency and route of administration were not reported); PNEUMOVAX 23 lot# M042324 with 10-JUN-2018 expiration date for prophylaxis Pneumococcal Vaccine, Polyvalent (23-valent); RECOMBIVAX HB lot# reported as M02926 with 11-AUG-2019 expiration date for prophylaxis (strength, frequency and route of administration were not reported); ROTATEQ, orally, lot# N022174 with 16-MAR-2019 expiration date for prophylaxis (dose, strength and frequency were not reported); VAQTA lot#N030286 and 10-NOV-2018 expiration date for prophylaxis (strength, frequency and route of administration were not reported). Data logger was reported. The temperature excursion and time frame for both vaccines was between 9°C and 25°C for a cumulative time of 61 hours. No previous temperature excursion was present. No adverse event was reported. No product quality complain was present.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was given a dose of PROQUAD subcutaneous route, lot# N012616 and 18-OCT-2018 expiration date for prophylaxis (strength and frequency were not reported) 5 days before their first birthday. No adverse effect was reported. No product quality complain was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Herpes zoster, Mobility decreased, Multifocal motor neuropathy, Pain in extremity
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at his primary care physician, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient began to experience trouble in raising his right foot, and pain traveling up his right leg emanating from his right foot. The patient presented to a neurologist and was diagnosed with multifocal motor neuropathy. Thereafter (exact date not provided), the patient presented to a pathologist and was diagnosed as suffering from polyradiculoneuropathy and chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, multifocal motor neuropathy and polyradiculoneuropathy/chronic inflammatory demyelinating polyneuritis were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Polyneuropathy
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at his primary care physician, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient began to experience trouble in raising his right foot, and pain traveling up his right leg emanating from his right foot. The patient presented to a neurologist and was diagnosed with multifocal motor neuropathy. Thereafter (exact date not provided), the patient presented to a pathologist and was diagnosed as suffering from polyradiculoneuropathy and chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, multifocal motor neuropathy and polyradiculoneuropathy/chronic inflammatory demyelinating polyneuritis were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Immunisation, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 16-JAN-2018, the the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001555: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HPV9
Symptoms: Immunisation, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 02-FEB-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot # and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HPV9
Symptoms: Immunisation, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 26-JAN-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot # and expiration date were not provided). On 25-JAN-2018, the patient was re-vaccinated with a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001556: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 24-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001558: US-009507513-1806USA001557: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 02-FEB-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Age: 1.42
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician assistant regarding an 17 months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 04-JUN-2018, the patient was inadvertently given a dose of PNEUMOVAX 23 intramuscular route for prophylaxis (strength, frequency, lot# and expiration date were not reported) instead of PREVNAR 13. No product quality complain was present.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 04-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 intramuscular route, lot# M038359 and 13-MAY-2018 expiration date for prophylaxis (strength and frequency were not reported). No adverse effects were reported. No product quality complain was involved.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician via other company letter (Pfizer) refers to a currently 39 years old female patient. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced allergy to PNEUMOVAX 23 (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to PNEUMOVAX 23.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Nausea, Seizure, Vomiting
Clinical narrative: Immediately after injection, patient had a short(3-5 second) seizure. I held her head up and N/A started talking to her and she came back around quickly and complained of nausea. A few minutes later she vomited a small amount and then said she felt better. I had 911 called when seizure first started and they arrived a few minutes later and took patient to ER. I had asked her prior to shot if she ever had a reaction to a shot. She said a few years ago she had gotten nauseated. Patient is employee in deli.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site pain, Myalgia, Pain
Clinical narrative: Injection hurt going into muscle. 3 hours later, felt like flu was coming on and the next day had severe muscle aches and body aches. 12 days later, still sore to touch and red.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Blister, Emotional distress, Gait disturbance, Incorrect route of drug administration
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Insomnia, Limb injury, Muscle spasms, Musculoskeletal disorder
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Musculoskeletal stiffness, Myalgia, Nerve injury, Pain, Pain in extremity
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.