chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 28 year old female patient with an allergy to aspirin. The patient's medical history included urticaria. Concomitant therapies included unspecified birth control pills. On an unknown date, the patient was vaccinated with VARIVAX for prevention of chicken pox (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, 20 min after vaccination the patient developed hives on both arms. The patient self-medicated with BENADRYL and the hives resolved within 24 hours. The patient was seen at the physician's office 10 days after receiving the vaccine and presented with induration and erythema at the injection site. The physician did not specify if treatment was provided. No studies or laboratory tests were performed to the patient. The outcome of induration and erythema at the injection site was reported as not recovered. Causality assessment was not provided.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 7 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 25-MAY-2018, the patient was accidentally vaccinated with one dose of GARDASIL 9 intramuscularly, lot# M028323, expiration date 26-SEP-2018, for prophylaxis (strength, dose, route and frequency were not reported). The medical assistant reported it was her mistake and had nothing to do with the vaccine. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1805USA013148.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 24 hours later then left arm pain in similar distribution to prior rash from shingles vs cervical radiculopathy- pain lasted several weeks - seen 04/11/2018 in the office for these symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Infection, Ophthalmic herpes zoster
Clinical narrative: Patient developed shingles after receiving the shingles vaccination. She received the vaccination on 9/3/2017 at the recommendation of her oncologist. Patient saw an express clinic on 10/11/2017 for the infection and received valacyclovir 1 gm three times daily at that time. The shingles blinded the patient in her left eye.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chest discomfort, Chills, Headache, Nausea
Clinical narrative: Symptoms started at around 3AM. Pt couldn't sleep because of headache, neck pain, chills, slight fever, nausea, moderate chest tightness. Pt took TYLENOL. As of 830am pt had only mild headache and neck pain. Other symptoms subsided. Blood sugar was 159 and blood pressure were normal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: Symptoms started at around 3AM. Pt couldn't sleep because of headache, neck pain, chills, slight fever, nausea, moderate chest tightness. Pt took TYLENOL. As of 830am pt had only mild headache and neck pain. Other symptoms subsided. Blood sugar was 159 and blood pressure were normal.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 13 year old patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 30-JUN-2017, the patient was vaccinated with a first dose of GARDASIL 9 1 dose, intramuscular (lot number and expiration date were not provided), for prophylaxis. The patient was going to be administrated the second dose of GARDASIL 9 on 04-MAY-2018. No adverse effects was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eye irritation, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report has been received from a physician (internal medicine) via a company representative, referring to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unspecified date (reported as a couple years ago), the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that on an unspecified date in May 2018 (reported as sometime this month), the patient developed a mild shingles breakthrough further described as three blisters above his eye which was red and irritated (ophthalmic herpes zoster). The patient received an unspecified dose of VALTREX as treatment for the event. At the time of this report, the outcome of ophthalmic herpes zoster and the causality between the aforementioned event and ZOSTAVAX was not reported. Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old patient of unknown gender. The patient's concomitant medications, medical history and allergies were not reported. On 04-MAY-2017, the patient was vaccinated with a first dose of GARDASIL 9, via intramuscular (dose, anatomical location, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 30-JUL-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), administered at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician at a medical facility/office for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), administered at a clinic as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. During 2014, the patient was treated by a physician, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-SEP-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-DEC-2015, the patient was treated by a physician assistant for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAY-2018,the patient was vaccinated with and expired dose of PNEUMOVAX 23 (lot # M032635 and expiration date 05-MAY-2018) (dose, frequency and route of administration were not provided) for prophylaxis.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated for prophylaxis with GARDASIL.On an unknown date, the patient experienced abnormal Papanicolaou (PAP) smear. The outcome of abnormal PAP smear was unknown. Causality assessment was not provided.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Adverse event, Dyspnoea
Clinical narrative: This spontaneous report was received from a nurse practitioner, via company representative, referring to a 67 year old male patient. The patient's historical drugs, drug allergies/reactions, medical history and concomitant therapies were not reported. The patient's medical condition included other comorbidities related to lung function. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On the same date, after the patient got home the day he received the PNEUMOVAX 23, the patient began experiencing shortness of breath. On an unspecified date, the reporter stated that the patient went to an unspecified emergency room after receiving the vaccine for treatment of shortness of breath (dyspnoea). The patient came back to physician office after going to the emergency room and was seen by a separate unspecified physician in the same practice for an unspecified reason (adverse event). At the time of reporting, the outcome of dyspnoea and adverse event was unknown. Additionally, the causality assessment between dyspnoea and adverse event with PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 08-MAR-2016, the patient received a dose of VAQTA 0.5ml, intramuscularly, lot # L023232, expiration date 02-JUN-2017, for prophylaxis. On 08-03-2016, slightly less than 6 months, the patient received another dose of VAQTA 0.5ml, intramuscularly, lot # L023232 (expiration date was not reported). No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 18-MAY-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23, intramuscular route (dose, frequency and anatomical location were unknown) with lot # M038359, and expiration date 13-MAY-2018 for prophylaxis. No known adverse effects were reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site haematoma, Injection site mass, Injection site pain
Clinical narrative: 05/18/2018 Phone call received from HCP with concern for "possible vaccine reaction" from HPV vaccine given on 04/18/2018. Patient has been seen in the office for soreness and lump in area of injection on Lt arm. HCP advised to notify Health Department for any further updates. 05/29/2018 Received voicemail from Dr (Infectious Disease) who reports small hematoma in Lt arm was evaluated and reviewed by radiology and no intervention is needed at this point. Dr. did not feel "was a vaccine reaction".
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Aspartate aminotransferase increased, Blood potassium increased, Headache, Hepatitis A virus test, Hepatitis acute
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hepatitis acute in a 67-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced hepatitis acute (serious criteria GSK medically significant), influenza-like symptoms, headache, general body pain and feeling unwell. On 17th May 2018, the patient experienced liver function test increased. On an unknown date, the outcome of the hepatitis acute, influenza-like symptoms, feeling unwell and liver function test increased were unknown and the outcome of the headache and general body pain were recovering/resolving. It was unknown if the reporter considered the hepatitis acute, influenza-like symptoms, headache, general body pain, feeling unwell and liver function test increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On the next day, the patient developed flu like symptoms which included headache and body aches. The reporter reported that the patient had symptoms for 3 to 4 days. These symptoms were improving. On the 5th day, after vaccination with the dose of SHINGRIX, the patient felt worse. At the time of reporting, after 2 weeks the patient was still not feeling well. The reporter stated that blood work was done with results which included Aspartate aminotransferase (AST) 400, absolute lymphocyte counts (ALC) 540, Potassium 406, platelets 94 and inflammation marker of 53 and reporter diagnosed acute hepatitis. Blood work showed elevated liver function tests, Aspartate aminotransferase (AST) 400 and alanine aminotransferase (ALT) 590. The call center representative noted that he was not able to confirm and clarify these lab values with the reporter. On 17th May 2018, 14 days after vaccination, the patient went to the emergency room, and was tested for liver function test (LFT's) which were found to be 800. The patient was screened for hepatitis A infection, which was found to be negative. The physician reported that the patient was sent home and referred to follow up with his physician on 21st May 2018. The vaccination date could be 3rd May 2018 or 4th May 2018, however, no clarification could be obtained.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatitis viral test negative, Inflammatory marker increased, Influenza like illness, Liver function test increased, Lymphocyte count decreased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hepatitis acute in a 67-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced hepatitis acute (serious criteria GSK medically significant), influenza-like symptoms, headache, general body pain and feeling unwell. On 17th May 2018, the patient experienced liver function test increased. On an unknown date, the outcome of the hepatitis acute, influenza-like symptoms, feeling unwell and liver function test increased were unknown and the outcome of the headache and general body pain were recovering/resolving. It was unknown if the reporter considered the hepatitis acute, influenza-like symptoms, headache, general body pain, feeling unwell and liver function test increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On the next day, the patient developed flu like symptoms which included headache and body aches. The reporter reported that the patient had symptoms for 3 to 4 days. These symptoms were improving. On the 5th day, after vaccination with the dose of SHINGRIX, the patient felt worse. At the time of reporting, after 2 weeks the patient was still not feeling well. The reporter stated that blood work was done with results which included Aspartate aminotransferase (AST) 400, absolute lymphocyte counts (ALC) 540, Potassium 406, platelets 94 and inflammation marker of 53 and reporter diagnosed acute hepatitis. Blood work showed elevated liver function tests, Aspartate aminotransferase (AST) 400 and alanine aminotransferase (ALT) 590. The call center representative noted that he was not able to confirm and clarify these lab values with the reporter. On 17th May 2018, 14 days after vaccination, the patient went to the emergency room, and was tested for liver function test (LFT's) which were found to be 800. The patient was screened for hepatitis A infection, which was found to be negative. The physician reported that the patient was sent home and referred to follow up with his physician on 21st May 2018. The vaccination date could be 3rd May 2018 or 4th May 2018, however, no clarification could be obtained.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Platelet count decreased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of hepatitis acute in a 67-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced hepatitis acute (serious criteria GSK medically significant), influenza-like symptoms, headache, general body pain and feeling unwell. On 17th May 2018, the patient experienced liver function test increased. On an unknown date, the outcome of the hepatitis acute, influenza-like symptoms, feeling unwell and liver function test increased were unknown and the outcome of the headache and general body pain were recovering/resolving. It was unknown if the reporter considered the hepatitis acute, influenza-like symptoms, headache, general body pain, feeling unwell and liver function test increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On the next day, the patient developed flu like symptoms which included headache and body aches. The reporter reported that the patient had symptoms for 3 to 4 days. These symptoms were improving. On the 5th day, after vaccination with the dose of SHINGRIX, the patient felt worse. At the time of reporting, after 2 weeks the patient was still not feeling well. The reporter stated that blood work was done with results which included Aspartate aminotransferase (AST) 400, absolute lymphocyte counts (ALC) 540, Potassium 406, platelets 94 and inflammation marker of 53 and reporter diagnosed acute hepatitis. Blood work showed elevated liver function tests, Aspartate aminotransferase (AST) 400 and alanine aminotransferase (ALT) 590. The call center representative noted that he was not able to confirm and clarify these lab values with the reporter. On 17th May 2018, 14 days after vaccination, the patient went to the emergency room, and was tested for liver function test (LFT's) which were found to be 800. The patient was screened for hepatitis A infection, which was found to be negative. The physician reported that the patient was sent home and referred to follow up with his physician on 21st May 2018. The vaccination date could be 3rd May 2018 or 4th May 2018, however, no clarification could be obtained.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Rash pruritic, Skin warm, Swelling
Clinical narrative: Flu like symptoms for two days. Raised, red, erythematous area about 2.5 inches in diameter. After two days the rash became more diffuse, but it is still hot and itchy.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Seizure
Clinical narrative: Pale skin, Seizures (2). IV and observation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient is showing signs of cellulitis in the upper right arm, swelling, redness and bruising.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Baseball sized redness, warm to the touch, itching.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Given dose of influenza, quadrivalent, Pfree, 3yr + along with routine vaccinations for 6 month old as listed above. Error recognized. Dr. and parent informed. No symptoms, concerns. Advised to call if needed- with any questions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Flu-like symptoms 18 hours after SHINGRIX booster. Fever, headache, fatigue, muscle ache, ache at site of injection. Symptoms resolved in 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms 18 hours after SHINGRIX booster. Fever, headache, fatigue, muscle ache, ache at site of injection. Symptoms resolved in 24 hours.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Pt has vaccine at pharmacy at approximately 3.54PM, adverse effects did not occur until approximately 2:00AM 05/28/2018. Symptoms include (per wife) uncontrollable shivers, temperature (no documentation of temp), sweats, rapid heartbeat, nausea, hardening around injection site, heard 'raining' in the ears for several hours and headache.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Nausea, Tinnitus
Clinical narrative: Pt has vaccine at pharmacy at approximately 3.54PM, adverse effects did not occur until approximately 2:00AM 05/28/2018. Symptoms include (per wife) uncontrollable shivers, temperature (no documentation of temp), sweats, rapid heartbeat, nausea, hardening around injection site, heard 'raining' in the ears for several hours and headache.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Dehydration, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea beginning 3-4 days following the vaccine leading to hospital admission for dehydration.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Aggression, Dyskinesia, Electroencephalogram abnormal, Laboratory test normal, Muscle twitching
Clinical narrative: The patient started with abnormal jerking movements during sleep that night, about 6 hours after getting the vaccine. The movements were interrupting his sleep. The twitching became severe over the next few days, but was only during sleep. He was also aggressive and hyperactive on the days following the vaccine.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Psychomotor hyperactivity, Sleep disorder
Clinical narrative: The patient started with abnormal jerking movements during sleep that night, about 6 hours after getting the vaccine. The movements were interrupting his sleep. The twitching became severe over the next few days, but was only during sleep. He was also aggressive and hyperactive on the days following the vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative, and refers to a 11 year old female patient. The patient's concurrent conditions included "heavy menstrual flow".  The patient's pertinent medical history, drug reactions or allergies were not reported. On "May 14th or 15th" 2018, the patient was vaccinated in the doctor's office with GARDASIL 9 (dose, route, lot number and expiration date were not reported) and with MENACTRA (dose, route, lot number and expiration date were not reported) for "11 years old vaccination to enter 7th grade". On the same day, after vaccination, the patient fainted. After resting a short while, the patient left the office. The patient received an unspecified treatment for the event. No further adverse effect reported. The causal assessment between the event syncope and the suspect therapies was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (exact dose, route of administration, lot# and expiry date were not reported) for routine vaccine. On two unspecified dates, the patient received doses of GARDASIL 9 injection (exact dose, route of administration, lot# and expiry date were not reported) for routine vaccine to complete the human papillomavirus (HPV) vaccination series. On an unknown date, the patient experienced genital warts. It was unknown if the patient received treatment. The outcome of the event was not reported. Causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received 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 an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date during 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUN-2016, the patient was treated by a physician at an urgent care center for a blistering vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In June 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAY-2015, the patient was treated by a physician for symptoms of a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a 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. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Influenza like illness, Pain, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history included asthma from an unknown date and ongoing,  cholesterol. Concomitant medications were not reported. Long time ago prescribed for cholesterol, had pain all over body (patient does not remember name of medication). Two hours after having the vaccination (on unknown date), the patient experienced heart palpitations lasting about 1 hour with outcome of recovered, aches and pains all over with outcome of recovering, felt like she was getting flu with outcome of unknown, difficulty breathing, like pneumonia or worsening of my asthma with outcome of unknown. Therapeutic measures were taken as a result of difficulty breathing, like pneumonia or worsening of my asthma included VENTOLIN 10 times a day. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a contactable Other Healthcare Professional via Pfizer sales representative. An 89-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2018 at single dose for immunisation. The patient's medical history and medications were not reported. The patient previously took pneumococcal polysaccharide vaccine, 23-valent (PPSV23) for immunization in 2017. It was reported that the patient was given pneumococcal 13-val conj vac (dipht crm197 protein) 1 year following dose of pneumococcal polysaccharide vaccine, 23-valent, and experienced bruise on upper arm (From shoulder down to elbow) in 2018. The outcome of the event was unknown. No follow-up attempts are Possible. No further information is expected.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood pressure abnormal, Syncope, Tuberculin test
Clinical narrative: This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. A 16-year-old male patient received first dose of TRUMENBA, (Lot number and Expiry date not provided), via an unspecified route of administration on an unspecified date at single dose indicated for age, MENACTRA, via an unspecified route of administration on an unspecified date at unknown dosage for immunization. Medical history included history of fainting. No concomitant medication information was provided. The patient fainted after he left the clinic after receiving the TRUMENBA vaccine. This occurred in the alley way before stepping onto the street. The patient had a history of fainting spells. This was the first dose of TRUMENBA that he had received. He also received MENACTRA and TB screening the same day. The mother walked the patient back in clinic and he was kept for an additional 15 minutes and his blood pressure normalized. The reporter did not have blood pressure readings. The outcome of the event was unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives to left upper arm, seen for office visit, prescribed prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling to site with peeling blister like sores, pain to site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, fever of 100 degrees, fatigue, muscle pain, nauseous next day. Lasting muscle pain in hips, upper legs, buttocks that has not gone away.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received vaccine on 5/21/2018 and came to clinic on 5/24/2018 to have PPD read and stated would like for me to look at arm where got vaccine at, states is tender and red but states arm is better than it was yesterday (5-23-2018). NP also look at arm, was instructed to apply warm compress to it and if worsens or feels hard to return to clinic. Patient voices understanding.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: On 5/22/18, developed small red bumps on face, neck, injection site.
Age: 60.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Rash
Clinical narrative: GOT SHINGLES, (BAD RASH AND EXTREME PAIN IN CHEST AND BACK), TREATMENT VALACYCLOVIR HCL 1 GRAM 3 TIMES DAY FOR 7 DAYS.
Age: 60.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Herpes zoster, Immunodeficiency, Pain, Rash
Clinical narrative: GOT SHINGLES, (BAD RASH AND EXTREME PAIN IN CHEST AND BACK), TREATMENT VALACYCLOVIR HCL 1 GRAM 3 TIMES DAY FOR 7 DAYS.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: The client passed out losing consciousness for approximately 30 seconds after receiving vaccine. After rest and juice she fully recovered .
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-AUG-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient contracted a persistent strain of herpes zoster almost immediately after being vaccinated. On or about 25-AUG-2014, she was treated by a physician at a clinic for a blistering vesicular outbreak, which was diagnosed as severe shingles. The patient was prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Dyspnoea, Laboratory test abnormal, Pallor, Retching
Clinical narrative: Our infant began vomiting uncontrollably for an hour - gagging - diarrhea - we hour-gagging-diarrhea-we  rushed him to the ER b/ce b/c  he wouldn't stop and then turned pale white and had trouble breathing. I would love for VAERS to cover our medical bill for this ER visit! We needed to be transported from hospital to hospital. I pray that no other child experiences this type of serious reaction!
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccination complication, Viral infection, Vomiting
Clinical narrative: Our infant began vomiting uncontrollably for an hour - gagging - diarrhea - we hour-gagging-diarrhea-we  rushed him to the ER b/ce b/c  he wouldn't stop and then turned pale white and had trouble breathing. I would love for VAERS to cover our medical bill for this ER visit! We needed to be transported from hospital to hospital. I pray that no other child experiences this type of serious reaction!
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Screaming, Swelling
Clinical narrative: Screamed at injection. Worst pain at live. Extreme swelling.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported: tender, sore, red below site of inject. No swelling. No rash.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms - mild fever, chills, all-over pain in joints and muscles, extreme fatigue, eyes sensitive to light. Was in bed for an entire day. Took ALEVE, aspirin, extra strength TYLENOL over the 24 hour period with no lessening of symptoms. Symptoms subsided after 24 hours. Had a similar response to the first dose received in March, but this was much more severe.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: Flu-like symptoms - mild fever, chills, all-over pain in joints and muscles, extreme fatigue, eyes sensitive to light. Was in bed for an entire day. Took ALEVE, aspirin, extra strength TYLENOL over the 24 hour period with no lessening of symptoms. Symptoms subsided after 24 hours. Had a similar response to the first dose received in March, but this was much more severe.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Albumin CSF increased, Anal sphincter atony, Asthenia, CSF protein increased, Chest X-ray normal
Clinical narrative: Adverse Event: Guillain Barre Syndrome - symptoms - eight days after administration of the SHINGRIX vaccine, the patient had gradual weakening of bilateral lower extremities in a proximal to distal distribution. This weakness progressed to inability to ambulate on one's own, falling, and loss of sensation of the distal four toes bilaterally. Strength was diminished to be 3/5 in bilateral lower extremities compared to baseline of 5/5. No symptoms in upper extremities or Cranial Nerve distribution. Additionally, patient complained of decreased anal sphincter activity, but denies incontinence. Patient denied shortness of breath, difficulty breathing, and cough. Treatment: IVIG. Outcome: cessation of symptom progression. Patient still had decreased strength and required intense outpatient Physical Therapy 5 times a week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Fall, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Adverse Event: Guillain Barre Syndrome - symptoms - eight days after administration of the SHINGRIX vaccine, the patient had gradual weakening of bilateral lower extremities in a proximal to distal distribution. This weakness progressed to inability to ambulate on one's own, falling, and loss of sensation of the distal four toes bilaterally. Strength was diminished to be 3/5 in bilateral lower extremities compared to baseline of 5/5. No symptoms in upper extremities or Cranial Nerve distribution. Additionally, patient complained of decreased anal sphincter activity, but denies incontinence. Patient denied shortness of breath, difficulty breathing, and cough. Treatment: IVIG. Outcome: cessation of symptom progression. Patient still had decreased strength and required intense outpatient Physical Therapy 5 times a week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Oesophageal motility disorder, Oesophagogastroduodenoscopy abnormal, Oesophagram
Clinical narrative: Adverse Event: Guillain Barre Syndrome - symptoms - eight days after administration of the SHINGRIX vaccine, the patient had gradual weakening of bilateral lower extremities in a proximal to distal distribution. This weakness progressed to inability to ambulate on one's own, falling, and loss of sensation of the distal four toes bilaterally. Strength was diminished to be 3/5 in bilateral lower extremities compared to baseline of 5/5. No symptoms in upper extremities or Cranial Nerve distribution. Additionally, patient complained of decreased anal sphincter activity, but denies incontinence. Patient denied shortness of breath, difficulty breathing, and cough. Treatment: IVIG. Outcome: cessation of symptom progression. Patient still had decreased strength and required intense outpatient Physical Therapy 5 times a week.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory loss, Spondylolisthesis
Clinical narrative: Adverse Event: Guillain Barre Syndrome - symptoms - eight days after administration of the SHINGRIX vaccine, the patient had gradual weakening of bilateral lower extremities in a proximal to distal distribution. This weakness progressed to inability to ambulate on one's own, falling, and loss of sensation of the distal four toes bilaterally. Strength was diminished to be 3/5 in bilateral lower extremities compared to baseline of 5/5. No symptoms in upper extremities or Cranial Nerve distribution. Additionally, patient complained of decreased anal sphincter activity, but denies incontinence. Patient denied shortness of breath, difficulty breathing, and cough. Treatment: IVIG. Outcome: cessation of symptom progression. Patient still had decreased strength and required intense outpatient Physical Therapy 5 times a week.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Aphasia, Blood electrolytes, Cardiac monitoring, Dizziness, Dysphemia
Clinical narrative: A few hours after the vaccine (under 3 hours,) he became lightheaded/ felt faint, his arms/hand and legs/feet began to tingle/ become numb, he became pale, he developed a significant stutter/ trouble coming up with words/ difficulty speaking; was in sinus tachycardia. He had to be hospitalized.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Electrocardiogram, Full blood count, Hypoaesthesia, Laboratory test, Pallor
Clinical narrative: A few hours after the vaccine (under 3 hours,) he became lightheaded/ felt faint, his arms/hand and legs/feet began to tingle/ become numb, he became pale, he developed a significant stutter/ trouble coming up with words/ difficulty speaking; was in sinus tachycardia. He had to be hospitalized.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Paraesthesia, Sinus tachycardia, Speech disorder
Clinical narrative: A few hours after the vaccine (under 3 hours,) he became lightheaded/ felt faint, his arms/hand and legs/feet began to tingle/ become numb, he became pale, he developed a significant stutter/ trouble coming up with words/ difficulty speaking; was in sinus tachycardia. He had to be hospitalized.