chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: M
Vaccine: RV5
Symptoms: Skin exfoliation, Sleep disorder, Speech disorder, Swelling, Swollen tongue
Clinical narrative: Kawasaki disease complete vascular system swollen his body attacks itself he was in the hospital for 2 weeks he received two treatments of IVIG treatment he was on high-dose aspirin to control the swelling in his heart he couldn't walk he couldn't talk he couldn't eat his urine look like orange juice he had started off with a rash and it started for me very quickly throughout his whole body even his testicles were peeling off skin and feet peeling off layers of skin his tongue was extremely swollen lips swollen can it started the beginning of February of 2015 and we got him in the hospital but it was a very long process he suffers extreme anxiety because obviously he was young when he started it it was a very traumatizing event for him and for I especially when not much is known about Kawasaki disease his vaccines were received in December and he started getting sick like I said about the beginning of February the high fevers cause them to have rheumatoid arthritis he has bad sleeping patterns it's just been very bad he still goes for echograms of his heart he can't do a lot of activities because his legs begin to hurt and his heart begins to pound because he was going to have an aneurysm in his heart these magazines are filled with poisons that are killing our children.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication were not reported. On 24-JAN-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412 with expiration date 30-JUN-2019, for prophylaxis (dose and route of administration was not reported). No adverse effects were reported in any patient. It was reported that the vaccine was exposed to a temperature between 32 to 35 degrees Fahrenheit for 8 hours. A digital data logger was involved. No previous temperature excursion was reported. There was no product quality complaint (PQC) reported. Follow up information has been received from the nurse on 26-FEB-2018, referring to a 17 years old female patient. On 24-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right deltoid. The refrigerator temperature was at 35 degrees Fahrenheit on 18-JAN-2018. No adverse reaction reported for the patient. The patient tolerated well. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA006840.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse referring to a 19 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 09-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # N022728 with expiration date of 31-MAY-2020, 0.5 ml, by intramuscular route for prophylaxis. On an unknown date in 2018, the patient was "experiencing queasiness". On 13-MAR-2018, an unspecified test was performed which showed that the patient was 7 weeks pregnant. The outcome of nausea was unknown. The causality assessment between therapy with GARDASIL 9 and the event was not reported.
Sex: M
Vaccine: PPV
Symptoms: Cardiac pacemaker insertion
Clinical narrative: This spontaneous report was received from an elderly male patient in his 80s (reported as "north of 80) regarding himself. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date in 2010, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot number and expiry date not reported) for prevention of pneumococcal disease. On an unknown date in March 2017 (reported as "an year ago"), the patient had a pacemaker implantation (Cardiac pacemaker insertion) (medically significant). The outcome of pacemaker implantation insertion was not reported. Causality assessment was not provided. No further information was provided. A product quality complaint was not present. Upon internal review the event of pacemaker implantation was determined as medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Infectious mononucleosis, Liver function test, Malaise
Clinical narrative: This spontaneous report was received from a nurse via company representative, referring to a currently 14 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. The patient did not have any drugs allergies. In approximately March 2016 (reported as "2 years ago"), when the patient was 12 year old, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On unspecified dates, the patient received unspecified doses of GARDASIL 9. On an unspecified date (reported as "on a later unspecified date"), the patient developed mononucleosis after receiving a dose of GARDASIL 9. On an unknown date, the patient was sick for 6 months (adverse event). The patient sought medical attention and received treatment. On an unknown date, a liver test was performed (results not provided). At the time of reporting, the outcome of mononucleosis and adverse event was recovered on an unknown date. Additionally, the causality assessment between mononucleosis and adverse event with GARDASIL 9 was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK) lot# N014021, expiration date 4-AUG-2018 (also reported as 04-AUG-2019). The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 14-MAR-2018, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M038863, expiration date 12-DEC-2017, for prophylaxis (anatomical location and route were not provided). No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 9 month old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 14-MAR-2018, the patient was vaccinated with VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Rash pruritic, Streptococcus test
Clinical narrative: This spontaneous report as received from an administrator refers to an 11 year old female patient. The patient had no pertinent medical history, drug reaction or allergies and concomitant therapies. On 09-MAR-2018, the patient was vaccinated with 1 injection of GARDASIL 9 (lot # N012093, expiry date: 13-JAN-2020) as part of 7th grade scheduled vaccinations. On approximately 10-MAR-2018, a day or two after receiving the vaccine, the patient developed an itchy rash on her chest, back, abdomen and legs and also complained of mild nausea. The patient returned to the office on the day of the report seeking treatment for the rash and underwent a strep screen culture, the results of which were not known. The patient was recommended treatment with unspecified doses of CLARITIN and BENADRYL to treat the rash and itching. The patient had not recovered from the events at the time of the report. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a 14 years old male patient. The patients' concurrent conditions and concomitant medication were not reported. No pre-existing physician-diagnosed allergies, birth defects and medical conditions. On 24-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose unknown, lot # M040412 with expiration date 30-JUN-2019) intramuscularly in the right deltoid. The refrigerator temperature was at 35 degrees Fahrenheit on 18-JAN-2018 (also reported as "the vaccine was exposed to a temperature between 32 to 35 degrees Fahrenheit for 8 hours"). No adverse reaction reported for the patient. The patient tolerated well. A digital data logger was involved. No previous temperature excursion was reported. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA008643.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood test normal, Dizziness, Malaise, Muscle spasms
Clinical narrative: Initial unsolicited report received from consumer (Patient's mother) on 07-Mar-2018. This case involves nine years old female patient who was vaccinated with 0.5 ml dose of FLUZONE NP QIV (batch number: U5958AA, expiry date not reported) once, intramuscularly in deltoid on 31 Jan 2018. Reporter stated her daughter was in gymnastics until Nov 2017 when she sustained an elbow injury. Concomitant medication was not reported. On 1 Feb 2018, 24 hours post vaccination patient had dizziness and general malaise. On an unspecified date, three days post vaccination patient had lower back pain. Patient was evaluated by her pediatrician on 03 Feb 2018 and orthopod on 12 Feb 2018 and diagnosis was lower back spasms and treated with MOTRIN and Physical Therapy. Patient had two emergency department visit for this as well. Reporter stated her daughter has about 2 episodes a day. Patient had blood work and an MRI with normal results. Other corrective treatment was not reported. Patient was not recovered from event. List of documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Initial unsolicited report received from consumer (Patient's mother) on 07-Mar-2018. This case involves nine years old female patient who was vaccinated with 0.5 ml dose of FLUZONE NP QIV (batch number: U5958AA, expiry date not reported) once, intramuscularly in deltoid on 31 Jan 2018. Reporter stated her daughter was in gymnastics until Nov 2017 when she sustained an elbow injury. Concomitant medication was not reported. On 1 Feb 2018, 24 hours post vaccination patient had dizziness and general malaise. On an unspecified date, three days post vaccination patient had lower back pain. Patient was evaluated by her pediatrician on 03 Feb 2018 and orthopod on 12 Feb 2018 and diagnosis was lower back spasms and treated with MOTRIN and Physical Therapy. Patient had two emergency department visit for this as well. Reporter stated her daughter has about 2 episodes a day. Patient had blood work and an MRI with normal results. Other corrective treatment was not reported. Patient was not recovered from event. List of documents held by sender: none.
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received on 06-Feb-2018, was reported by other non-health professional and concerns a female patient of unspecified age. The patient's relevant medical history and relevant  concomitant medications were not reported. On 10-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5mg,  route of administration: intramuscular, anatomical location: left deltoid, batch number: 195210, expiry date: not reported). On 06-Feb-2018, after 4 months 27 days of vaccination, the patient had flu. The patient consulted doctor in the evening and was diagnosed with type A influenza virus [explicitly coded as vaccination failure].  On the same day, the patient was treated with TAMIFLU. At the time of this report, the outcome of the event-  flu was not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 8th March 2018 16:35, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, insomnia and generalized pruritus. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the insomnia and generalized pruritus were unchanged. The reporter considered the influenza-like symptoms, insomnia and generalized pruritus to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. In the evening on the same day, the patient experienced flu-like symptoms, insomnia and tremendous itching all over her body. The reporter was unable to provide additional details.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Patient reported significant pain at the injection site, loss of motion and decreased range of motion for the entire left arm, fever reached 101.5 degrees. Patient reported that these symptoms began approximately 7 hours after the injection and continued the entire following day (Sunday). Patient said that fever broke Sunday night and range of motion was better Monday. She was able to play tennis on Tuesday but the injection site is still painful.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Local reaction, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX. Previously administered products included PREVNAR (experienced a reaction that lasted two days). On 3rd March 2018 10:00, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain and local reaction. On an unknown date, the outcome of the influenza-like symptoms, pain and local reaction were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain and local reaction to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The age at vaccination was not reported but could be 72 or 73 years. The patient experienced severe flu-like symptoms and severe local symptoms. The patient went to see her physician on 6th March 2018, and her symptoms were unchanged at the time of reporting. The patient required the emergency room visit. Additional information was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date the patient was vaccinated with improperly stored PROQUAD (rHA) (dose, units and frequency were unknown) (Lot# M046943 and expiration date 27-MAY-2018) at a temperature excursion from 14"C to -10"C (degree centigrade) (-13.5"C) for 1 hour 5 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. Lot number [M046943] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live].
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Adenovirus test, Blood test, Enterovirus test, Influenza virus test, Malaise
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Measles, Viral test
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Adenovirus test, Arthralgia, Conjunctivitis, Contusion, Cough
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Enterovirus test, Eye swelling
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Haematology test, Heart rate increased, Influenza virus test, Joint stiffness
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Laboratory test, Lethargy, Measles, Mouth ulceration, Photophobia
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea, Viral test, Vomiting
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Cough, Measles post vaccine, Morbillivirus test positive, Pyrexia
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Upper respiratory tract infection
Clinical narrative: Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Discomfort, Injection site pain, Nausea, Pain
Clinical narrative: Received tdap "BOOSTRIX" from my local pharmacy. A little over 24 hours later I kept experiencing vertigo and nausea and general unease. In the next 15 hours I developed increased pain at the injection site, severe chills for hours, major body aches, and a low grade/99.9 degree fever. I slept for 10 hours and began feeling better.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vertigo
Clinical narrative: Received tdap "BOOSTRIX" from my local pharmacy. A little over 24 hours later I kept experiencing vertigo and nausea and general unease. In the next 15 hours I developed increased pain at the injection site, severe chills for hours, major body aches, and a low grade/99.9 degree fever. I slept for 10 hours and began feeling better.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: A bad reaction to PNEUMOVAX 23 25 MCG/0.5ml inj Swelling upper left arm, severe. Pain, Redness, severe. Symptoms did not reduce until 2/24/18. I have never had a reaction nor allergy to any immunizations.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. presented on day 3 post-injection with a 2 x 2 area of redness and very warm to the touch. She complained of the warmness and some pain associated with the site.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Antinuclear antibody positive, Arthralgia, Decreased appetite, Fatigue
Clinical narrative: Since getting the vaccine, she has had fevers, body aches, joint pain, stomach pain, vomiting, lost of appetite, fatigue, and headaches.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Since getting the vaccine, she has had fevers, body aches, joint pain, stomach pain, vomiting, lost of appetite, fatigue, and headaches.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cyanosis, Eye movement disorder, Respiratory arrest, Seizure
Clinical narrative: 15 -20 seconds after 1st of 4 shots, our child stopped breathing, turned blue, eyes rolled behind head and he went into full convulsions for over 2.5 minutes. It has only been 3 days since the seizure so we do not know the full outcome or ramifications yet.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Immediate pain upon injection, followed by tremendous pain and inability to move the arm for 36 hours, chills, and fever for 36 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Immediate pain upon injection, followed by tremendous pain and inability to move the arm for 36 hours, chills, and fever for 36 hours.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Lip swelling, Presyncope, Rash generalised, Rash pruritic
Clinical narrative: Patient reported to emergency department after developing a circumoral pruritic disseminated body rash as well as lip swelling. Was noted to have near syncopal episode. In Ed, BP was 78/48. Patient was given epinephrine and IV fluids. Also received IV SOLU MEDROL, and IV ranitidine, and diphenhydramine.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 67-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Metformin and Pneumococcal vaccine. On 2nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching. On 3rd March 2018, the patient experienced injection site erythema, injection site tenderness and injection site warmth. The patient was treated with BACTRIM, ZYRTEC, BENADRYL and Ice Pack (NOS). On an unknown date, the outcome of the injection site itching, injection site erythema, injection site tenderness and injection site warmth were unknown. The reporter considered the injection site itching, injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGIRX vaccine on left deltoid and Pneumococcal vaccine on right arm. Later the same night on 2nd March 2018, the patient had a slight itching at the site of the injection. The next day the area at the injection site became red and tender with increased warmth and since then the area has expanded in size. The patient had no fever, no other rash, no shortness of breath. All of these symptoms were described as a local reaction at the injection site. On 5th March 2018 she was ordered an antibiotic BACTRIM DS twice daily for 10 days and recommended ice, ZYTREC, and BENADRYL. It was unknown what brand name or manufacturer for the pneumococcal vaccine documented in the patient's chart as had been administered on the same day as the SHINGRIX. No further details were provided during the call. The reporter was transferred to the GSK Medical Information team regarding the inquiry of whether or not this consumer should have the second dose in the series after having had the described reaction at the injection site. The reporter granted permission to be contacted and prefers to be contacted via telephone or email.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Pain in extremity, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX. Concomitant products included Multivitamin and VYVANSE. On 6th March 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, shivering, dizziness, headache and wrong injection technique. On an unknown date, the outcome of the pain in arm, shivering, dizziness and headache were not recovered/not resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the pain in arm, shivering, dizziness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the pharmacist initially injected her left arm, was unable to push in the vaccine, pulled out the needle, changed the needle, and injected the patient a second time into the left arm and was able to give the injection, which led to wrong injection technique. Limited information was provided by the patient. The patient disconnected while on hold to research her questions about side effects experienced.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by other health professional via call center representative and described the occurrence of sickness in a patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On 6th March 2018, the patient came with sick symptoms. The other healthcare professional did not have time to provide any additional information. The follow up information was requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: No concomitant medication details provided. The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 the patient had chills and shivers that lasted for about half an hour and then completely resolved. The patient had a fever at approximately 2 AM. He described the fever as a temperature of 105. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, the patient had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. The patient had muscles soreness in his entire body for approximately 24 to 36 hours and then completely resolved, no additional information provided. On 6th March 2018, 1 day after receiving SHINGRIX, the patient had nausea that completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 6th March 2018, no additional details provided. The soreness was still present but has improved. He denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: No concomitant medication details provided. The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 the patient had chills and shivers that lasted for about half an hour and then completely resolved. The patient had a fever at approximately 2 AM. He described the fever as a temperature of 105. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, the patient had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. The patient had muscles soreness in his entire body for approximately 24 to 36 hours and then completely resolved, no additional information provided. On 6th March 2018, 1 day after receiving SHINGRIX, the patient had nausea that completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 6th March 2018, no additional details provided. The soreness was still present but has improved. He denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd March 2018 13:46, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site itching, injection site swelling and injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. On 6th March 2018, all symptoms were started.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased. Concomitant products included simvastatin. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 he had chills and shivers that lasted for about half an hour and then completely resolved. Less than a day after receiving SHINGRIX, at approximately 2 AM, the patient had a fever. He described the fever as a temperature of 100. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, he had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. He had muscle soreness in his entire body for approximately 24 to 36 hours and then completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 7th March 2018. The soreness was still present but had improved. No start date for high cholesterol provided. The patient denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased. Concomitant products included simvastatin. On 5th March 2018, the patient received the 1st dose of SHINGRIX. On 5th March 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2018, the patient experienced nausea. In March 2018, the patient experienced shivers, leg cramps, generalized muscle aches and fever. On 6th March 2018, the outcome of the shivers and leg cramps were recovered/resolved. In March 2018, the outcome of the generalized muscle aches, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain, shivers, leg cramps, generalized muscle aches, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The reporter did not have the lot number, expiration date, or exact dosage details. The reporter noted at approximately midnight of 6th March 2018 he had chills and shivers that lasted for about half an hour and then completely resolved. Less than a day after receiving SHINGRIX, at approximately 2 AM, the patient had a fever. He described the fever as a temperature of 100. The fever resolved the next day, no exact date provided. The rest of the night, which he described as after midnight on 6th March 2018, he had leg and foot cramps and muscle spasms. The cramps and spasms completely resolved by 6 AM on 6th March 2018. He had muscle soreness in his entire body for approximately 24 to 36 hours and then completely resolved within 24 hours, no additional details provided. He described nausea as intermittent. The patient experienced pain at the injection site that began immediately after the injection, worsened approximately six hours later, and began improving on 7th March 2018. The soreness was still present but had improved. No start date for high cholesterol provided. The patient denied hospitalization to treat any of the events provided. The vaccine administration facility was a pharmacy. The reporter did not know the name of the Pharmacist that administered the vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old female patient who received SHINGRIX. Concomitant products included ibuprofen and TYLENOL. On 6th March 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, 14 hrs after receiving SHINGRIX, the patient experienced chills, headache, general body pain and itchy rash. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the chills, headache, general body pain and pain in arm were recovering/resolving and the outcome of the itchy rash was unknown. It was unknown if the reporter considered the chills, headache, general body pain, pain in arm and itchy rash to be related to SHINGRIX. Additional information was reported as follows: On 7th March 2018 at 4:00, the patient experienced the events chills, headache, general body pain. In March 2018, 24 hours after vaccination, before noon (in AM) the rash appeared on the patient's chest. The rash blanches with pressure and was not raised. The rash was slightly itchy. In March 2018, less than a week after vaccination, the patient experienced pain in arm. The reporter was not able to collect any additional details on sore arm. The batch number and the expiry date for SHINGRIX was not reported. No other additional details were available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Interchange of vaccine products, Neuralgia, Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 68-year-old female patient who received SHINGRIX (batch number EK279, expiry date unknown). The patient's past medical history included shingles. Previously administered products included ZOSTAVAX (received in 2009). Concomitant products included Atorvastatin, Vitamin D3, CREON, calcium, FLORASTOR Probiotic, Flax Seed Oil and trazodone. On 21st February 2018, the patient received the 1st dose of SHINGRIX 1 ml. In February 2018, 5 days after receiving SHINGRIX, the patient experienced burning sensation, scalp pain, nerve pain, temporal headache and interchange of vaccine products. On an unknown date, the outcome of the burning sensation, scalp pain, nerve pain and temporal headache were recovered/resolved and the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the burning sensation, scalp pain, nerve pain and temporal headache to be related to SHINGRIX. Additional information was received as follows: The concomitant products included OTC Senior MTV. The reporter requested the SHINGRIX without a prescription to prevent shingles. On 22nd January 2018, the patient was diagnosed with shingles on the right side of her back at the T3 and T4 area. The patient's pharmacist told her she could have the SHINGRIX after her shingles symptoms resolved. The patient received SHINGRIX vaccine, (left deltoid), after receiving ZOSTAVAX, which led to interchange of vaccine products. At times there was slight, mild burning sensation at the left scalp near the temple area under her hair near the hairline. The patient suspected the left scalp and left temple pain was mild nerve pain. The scalp and temple tenderness was mild and described as getting better. The pharmacy might be contacted. The reporter didn't know the zip code or name of pharmacist.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenopia, Back pain, Ear pain, Fatigue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local swelling in a 49-year-old female patient who received BOOSTRIX (batch number 3K44J, expiry date unknown). On 28th February 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 2nd March 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in elbow. On 6th March 2018, the patient experienced ear pain, neck pain, shoulder pain, back pain, feeling hot and cold and exhaustion. In March 2018, the patient experienced eyes heavy feeling of. On an unknown date, the patient experienced local swelling and feeling of warmth. On an unknown date, the outcome of the local swelling was recovering/resolving and the outcome of the feeling of warmth, ear pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow were unknown and the outcome of the neck pain was not recovered/not resolved. It was unknown if the reporter considered the local swelling, feeling of warmth, ear pain, neck pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX vaccine on left deltoid. The patient reported that the patient came to the office on 5th March 2018, because the patient still had a large lump on arm that was warm to touch. The patient emailed the reporter to report that on 6th March 2018, the day after coming in to the office, the patient's ear, neck, shoulders, and back began to hurt. She started to get hot and cold and felt exhausted all of the time. In the email she also described that two days after the injection, she felt like a cold had settled in her left elbow because it felt achy and sore. Unable to obtain additional information.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Feeling of body temperature change, Limb mass, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local swelling in a 49-year-old female patient who received BOOSTRIX (batch number 3K44J, expiry date unknown). On 28th February 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 2nd March 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in elbow. On 6th March 2018, the patient experienced ear pain, neck pain, shoulder pain, back pain, feeling hot and cold and exhaustion. In March 2018, the patient experienced eyes heavy feeling of. On an unknown date, the patient experienced local swelling and feeling of warmth. On an unknown date, the outcome of the local swelling was recovering/resolving and the outcome of the feeling of warmth, ear pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow were unknown and the outcome of the neck pain was not recovered/not resolved. It was unknown if the reporter considered the local swelling, feeling of warmth, ear pain, neck pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX vaccine on left deltoid. The patient reported that the patient came to the office on 5th March 2018, because the patient still had a large lump on arm that was warm to touch. The patient emailed the reporter to report that on 6th March 2018, the day after coming in to the office, the patient's ear, neck, shoulders, and back began to hurt. She started to get hot and cold and felt exhausted all of the time. In the email she also described that two days after the injection, she felt like a cold had settled in her left elbow because it felt achy and sore. Unable to obtain additional information.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local swelling in a 49-year-old female patient who received BOOSTRIX (batch number 3K44J, expiry date unknown). On 28th February 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 2nd March 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in elbow. On 6th March 2018, the patient experienced ear pain, neck pain, shoulder pain, back pain, feeling hot and cold and exhaustion. In March 2018, the patient experienced eyes heavy feeling of. On an unknown date, the patient experienced local swelling and feeling of warmth. On an unknown date, the outcome of the local swelling was recovering/resolving and the outcome of the feeling of warmth, ear pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow were unknown and the outcome of the neck pain was not recovered/not resolved. It was unknown if the reporter considered the local swelling, feeling of warmth, ear pain, neck pain, shoulder pain, back pain, feeling hot and cold, exhaustion, eyes heavy feeling of and pain in elbow to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX vaccine on left deltoid. The patient reported that the patient came to the office on 5th March 2018, because the patient still had a large lump on arm that was warm to touch. The patient emailed the reporter to report that on 6th March 2018, the day after coming in to the office, the patient's ear, neck, shoulders, and back began to hurt. She started to get hot and cold and felt exhausted all of the time. In the email she also described that two days after the injection, she felt like a cold had settled in her left elbow because it felt achy and sore. Unable to obtain additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy technician who was relative of the patient. The age at vaccination was not reported. The pharmacy technician stated on online chat that, the patient received the SHINGRIX vaccine about 7 to 10 days ago in right deltoid. The patient claimed to have had a reaction (not anaphylaxis) to the SHINGRIX vaccine. The patient experienced arm pain and could not move it because it hurted. The reporter could not provide address of facility, patient details, or other information and closed the chat before information could be given.