chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Toothache, Viral infection
Clinical narrative: The day after the SHINGRIX, 01/11/2019, I felt tired and soreness of the injection site, which was expected. It was 6 days after the injection, 01/16/2019, that I developed a headache above my right eye, reddness at the base of my right nostril followed by swelling and redness of my right upper lip with pain along the upper right gumline and teeth, radiating to my right ear. It is currently painful, swollen and tender to the touch in all the above mentioned areas. I saw my dentist to rule out a dental issue an she diagnosed me with a viral infection, likely Herpes. I have been using over the counter ABREVA Cream (docosanol 10%) and KANKA softbrush antiseptic/astringent. My Oncologist Dr. will see me on 01/22/2019 if I am still having problems or worse.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Fatigue, Pain, Paraesthesia
Clinical narrative: Massive spike in blood pressure, tingling in arms and legs, random body aches, fatigue that lasted better part of 6 weeks.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass
Clinical narrative: On day after immunizations felt lump at injection site. Size of lump increased in the next 24 hours and was described as the size of an avocado. Area around site was reddened. No fever or streaking. To ED to R/O cellulitis. No cellulitis appreciated by MD in ED. Phone call to family today with report of improvement of symptoms decrease of redness and discomfort.
Age: 2.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Febrile convulsion, Heart rate increased, Pyrexia
Clinical narrative: Febrile seizure with fever over 104. No other symptoms present. Taken by ambulance to ER, IV fluids, TYLENOL administered. Rapid heartbeat over 190 bpm observed. Released after normalization of temperature and heart rate lowered.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Patient with sudden onset severe pain in shoulder 10 days after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Impaired work ability, Influenza like illness, Pain
Clinical narrative: Extreme flu like symptoms. Achy all over, dizzy, could not get out of bed for about 12 hours. Felt like hit by a truck! I never miss work, but took a full sick day. Then a quick recovery.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Incomplete course of vaccination, Malaise, Nausea
Clinical narrative: After the first dose of SHINGRIX my body reacted within 24 hours. I was sick, flat in bed for 10 days. Mild fever, headache, nausea, rash over much of my body. Partially sick for much of the next three weeks. Determined not to get the 2nd dose of the drug (to be done within 6 months). About six months after the initial dose, (in Oct 2018) I gradually developed a chicken pox- like rash over my back, and upper arms. This rash has a slight burn to it. Have tried CORTIZONE, Calamine lotion, regular body lotion to treat it with no impact.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash generalised, Rash vesicular
Clinical narrative: After the first dose of SHINGRIX my body reacted within 24 hours. I was sick, flat in bed for 10 days. Mild fever, headache, nausea, rash over much of my body. Partially sick for much of the next three weeks. Determined not to get the 2nd dose of the drug (to be done within 6 months). About six months after the initial dose, (in Oct 2018) I gradually developed a chicken pox- like rash over my back, and upper arms. This rash has a slight burn to it. Have tried CORTIZONE, Calamine lotion, regular body lotion to treat it with no impact.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching. Majority of hives located on the left side of patient's body.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Dyspnoea, Fatigue, Feeling cold, Headache
Clinical narrative: Arm was immediately sore and that increased as the day wore on. By evening he was not feeling well - tired and feeling a big chilly. By 11:45 my husband began to shake violently, from head to toe,  and that lasted for 1 hr. and 45 min. If he had not been awake and able to speak to me I would have thought he was having a seizure, that's how violently he was shaking. He didn't have trouble breathing per se, but it was hard to catch his breath because of all the violent movement.  When the shaking stopped he was sore, especially in his head and neck area. He was unable to sleep that night. By morning he had a temp of 100.2. He took Ibuprofen and that helped. He felt tired and dragging the rest of that day, but by the third day he was feeling well again.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Insomnia, Malaise, Neck pain, Pain
Clinical narrative: Arm was immediately sore and that increased as the day wore on. By evening he was not feeling well - tired and feeling a big chilly. By 11:45 my husband began to shake violently, from head to toe,  and that lasted for 1 hr. and 45 min. If he had not been awake and able to speak to me I would have thought he was having a seizure, that's how violently he was shaking. He didn't have trouble breathing per se, but it was hard to catch his breath because of all the violent movement.  When the shaking stopped he was sore, especially in his head and neck area. He was unable to sleep that night. By morning he had a temp of 100.2. He took Ibuprofen and that helped. He felt tired and dragging the rest of that day, but by the third day he was feeling well again.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tremor
Clinical narrative: Arm was immediately sore and that increased as the day wore on. By evening he was not feeling well - tired and feeling a big chilly. By 11:45 my husband began to shake violently, from head to toe,  and that lasted for 1 hr. and 45 min. If he had not been awake and able to speak to me I would have thought he was having a seizure, that's how violently he was shaking. He didn't have trouble breathing per se, but it was hard to catch his breath because of all the violent movement.  When the shaking stopped he was sore, especially in his head and neck area. He was unable to sleep that night. By morning he had a temp of 100.2. He took Ibuprofen and that helped. He felt tired and dragging the rest of that day, but by the third day he was feeling well again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Nausea, Tremor
Clinical narrative: I developed a minor headache before going to bed at 11:00 p.m. The bedroom temperature was a comfortable 71 degrees but I suddenly developed chills and could not warm myself, even with additional bedding. The chills lasted about an hour and then I got up to get more bedding as I was uncomfortably cold. Once up, my entire body shook violently with chills including chattering teeth. I've never experienced shivering so extreme involving my entire body. I returned to bed under even more bedding and the shivering/chills eventually subsided after about an additional hour. My other symptoms included worsening headache and nausea. After a poor night's sleep, the chills were gone but I was left with a headache and mild nausea.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Tremor
Clinical narrative: Patient reported severe trembling and uncontrollable "shivering" around 12 hours after receiving the vaccination. She reported flu like symptoms the following day and feeling drained for about 24 hours.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: HIB dose was given to patient with an expired diluent. Per health dept, instructed to reimmunize patient.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Tingling in arm and hand-treated with Gabapentin.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Inappropriate schedule of product administration, Stent placement
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 23 year old non pregnant female patient. No information regarding the patient's medical history, concurrent conditions, previously drug reactions, allergies, or concomitant therapies was unknown by the reporter. On an unspecified date in June 2011, the patient was vaccinated with the first dose of GARDASIL (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis, then on unspecified date in June 2014, the patient received the second dose of GARDASIL (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On unspecified date, the patient experienced unspecified adverse event which required a unspecified stent placement. At the time of the report, the outcome of adverse event was not provided. The reporter did not assess the relatedness between the event and suspect therapy. Upon internal review, the adverse event was considered to be medical significant since stent placement was required.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 year old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/ allergies. On an unknown date, patient received the first dose of GARDASIL 9 of the HPV vaccination series for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, 3 months after the first dose of GARDASIL 9 was administered, the patient received the second dose GARDASIL 9 in the HPV vaccination series (Inappropriate schedule of vaccine administered). On unspecified date, 6 months after receiving first dose of GARDASIL 9, the patient received the third dose of GARDASIL 9 in the HPV vaccination series. The outcome of inappropriate schedule of vaccine administered was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-FEB-2009, the male patient was administered the ZOSTAVAX by a physician (lot number, dosage and route of administration not provided). On or about 05-OCT-2015, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer 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. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-AUG-2015, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 24-AUG-2015, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Based on additional information received on 14-Jan-2019, this case becomes medically confirmed. (Nurse reported). Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a non-health professional. This case involves a 4 months old male patient who received an expired dose of vaccine PENTACEL (batch number: C5449AA, expiry date: 7-Dec-2018), dose, dose in series, route and site of administration were not reported) on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to expired vaccine administered. It was not reported if any adverse event was experienced or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received on 14-Jan-2019 from a nurse. Case becomes medically confirmed. Patient demographics, suspect vaccine administered date, batch number was updated. List of documents held by sender- none.
Age: 0.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 3 months old patient of unknown gender who received immunization with IPV component only of intended vaccine PENTACEL (Liquid portion batch number: C5447AA, HIB Component batch number: C5576AD) (expiry date: 18-Oct-2019) (dose, dose in series, route and site of administration were not reported) on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccines were given concomitantly. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was experienced. Reported as no ill effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: HPVX, MENB, MNQ, TDAP
Symptoms: Back pain, Extra dose administered, Swelling
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a male patient (age unknown) who experienced back pain and bump on the head, while he received vaccines MENACTRA, ADACEL, HPV Vaccine and TRUMENBA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2019, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine lot number, expiry date not reported via intramuscular route in the right arm. On 09-Jan-2019, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via intramuscular route in the right arm. On 09-Jan-2019, the patient received a dose of suspect HPV Vaccine and TRUMENBA not produced by Sanofi Pasteur lot number, expiry date not reported via unknown route in the left arm. On an unknown date, the patient experienced a non-serious back pain and bump on the head (swelling) (Unknown latency) following the administration of MENACTRA, ADACEL, HPV Vaccine and TRUMENBA. Lab data not reported. Final diagnosis was bump on the head and back pain. It was an actual medication error due to extra dose administered. Child was administered MENACTRA and TRUMENBA at the same time. It was not reported if the patient received a corrective treatment. The event outcome was not reported for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. In this case, the nurse did not mix up the HIB portion of the PENTACEL and injected of unknown batch no. via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate reconstitution technique. it was reported that the child patient was received half portion of PENTACEL. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pruritus generalised
Clinical narrative: 1/17/19 Developed itching of neck within minutes that then spread to face and rest of body and then tingling of lips and face by end of 1st hour post vaccine. BENADRYL helped with symptoms. Itching (mild) returned 1/18/19. PCP notified by client 1/17/19 and clinic notified PCP 1/18/19 with additional report that client had experienced same reaction but milder in 4/2014 after Hep B and Tdap. Immunization program notified.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dyspnoea, Feeling abnormal, Malaise
Clinical narrative: SHINGRIX vaccine- About 4 1/2 hours after receiving vaccine I started having body aches and chills. Was miserable all night with significant body aches, chills and feeling a little short of breath. (I have a lung disease IPF). The next day at 11:45 am on 1/17/2019 I had temperature of 99.9 orally at a doctor's appointment and still had significant body aches and malaise. I took three ibuprofen at 2:30 pm on 1/17/2019 and felt some better. That evening around 8 pm I started feeling more achy again and took three more ibuprofen. Still felt achy and bad at 11pm and took Tramadol at 11 pm. Woke up 1/18/2019 and felt some achy and check my temperature and it was 99.4 orally. Still having as I type this some body aches and malaise. I took three ibuprofen at 9 am and it is 12:30 pm on 1/18/2019 and feeling better. I hope I don't have this reaction to the second part of the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: SHINGRIX vaccine- About 4 1/2 hours after receiving vaccine I started having body aches and chills. Was miserable all night with significant body aches, chills and feeling a little short of breath. (I have a lung disease IPF). The next day at 11:45 am on 1/17/2019 I had temperature of 99.9 orally at a doctor's appointment and still had significant body aches and malaise. I took three ibuprofen at 2:30 pm on 1/17/2019 and felt some better. That evening around 8 pm I started feeling more achy again and took three more ibuprofen. Still felt achy and bad at 11pm and took Tramadol at 11 pm. Woke up 1/18/2019 and felt some achy and check my temperature and it was 99.4 orally. Still having as I type this some body aches and malaise. I took three ibuprofen at 9 am and it is 12:30 pm on 1/18/2019 and feeling better. I hope I don't have this reaction to the second part of the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pruritus, Pyrexia
Clinical narrative: Muscle pain, headache, tired, fever for about 24 hours. 4" X 5" warm, itchy spot on my arm for 8 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Muscle pain, headache, tired, fever for about 24 hours. 4" X 5" warm, itchy spot on my arm for 8 days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pyrexia, Vaccination site induration, Vaccination site rash
Clinical narrative: Patient was in clinic 01/18/2019 and was given an influenza vaccine around @1650. He presented to the school nurse today 1/18/2019 around @1000 he had a rash around the vaccine site and had fever of 100.9. Patient then presented the Clinic and still had a fever of 100.4 and the vaccine site was red and firm. He did not have any other symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Nuclear magnetic resonance imaging brain
Clinical narrative: Day after vaccination patient developed stroke.  No treatment given and symptoms resolved.  Unclear if related in some way to vaccine since occurred day after administration of Shingrix.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypersomnia
Clinical narrative: Excessive Sleeping.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect by patient. Noted 1/15/2019 that KINRIX vaccine was given to 6 month old infant on 1/8/2019 when it is apparently only recommended for 4-6 year old.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect by patient. This vaccine was ordered by Dr. to be given to this 6 month old infant-the MA administered the vaccine (KINRIX to be given only to children 4-6 years). Error was noted on 01/14/2019 when insurance declined to pay for vaccine. Parent contacted. Health Department was consulted.
Age: 71.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DTap was incorrectly administered by Medical Assistant. Tdap should have been administered since patient was over the age of 7.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced headache, fever and injection site pain. On an unknown date, the outcome of the headache, fever and injection site pain were unknown. It was unknown if the reporter considered the headache, fever and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported via chat or live transcript. The age at vaccination was not reported. The day before reporting date, the patient received a dose of SHINGRIX vaccine in her pharmacy the in right arm. On the day of reporting, the patient woke up with a splitting headache and low grade fever. The patient was also reported that she had a very sore right arm at the injection site. The patient was asking, if this was a possible side effect of SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced localized erythema and localized feeling of warmth. On an unknown date, the outcome of the localized erythema and localized feeling of warmth were unknown. The reporter considered the localized erythema and localized feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced large, red and hot local adverse event on the upper left arm and the patient thought it was related to SHINGRIX. The reporter was agree to follow up from GlaxoSmithKline.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Ultrasound scan
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On 11th November 2018, the patient received the 2nd dose of SHINGRIX. On 20th December 2018, 39 days after receiving SHINGRIX, the patient experienced injection site mass. On an unknown date, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site mass was unknown and the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site mass and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was patient's husband. The patient received SHINGRIX in left arm. On 20th December 2018, the patient did have an ultrasound and they found a mass at the site. Less than a year after receiving SHINGRIX, the patient experienced severe muscle pain in the arm where the needle was inserted. The reporter wanted to know what should they do as the patient had bad side effects from the Shingles shot.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling, Pain, Swelling face
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of facial swelling in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced facial swelling, eye swelling, lip swelling and general body pain. On an unknown date, the outcome of the facial swelling, eye swelling, lip swelling and general body pain were unknown. It was unknown if the reporter considered the facial swelling, eye swelling, lip swelling and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, general body pain and tingling feet/hands. On an unknown date, the outcome of the shingles, general body pain and tingling feet/hands were unknown. It was unknown if the reporter considered the shingles, general body pain and tingling feet/hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed shingles a day after 1st dose of SHINGRIX, followed by months of persistent body aches and tingling of hands and feet. Has this been reported by others, The reporter was asking whether a reactive arthritis or autoimmune reaction to the vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (receive 1st dose on 30th August 2018 and experienced severe headache, difficulty sleeping, tiredness and pain, refer case US2019004237). On 4th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th January 2019, less than a day after receiving SHINGRIX, the patient experienced feeling hot and chills. On 6th January 2019, the outcome of the feeling hot and chills were recovered/resolved. It was unknown if the reporter considered the feeling hot and chills to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced side effects to the SHINGRIX after each injection. The patient reported that she received 2nd dose of SHINGRIX and experienced feeling hot and chills and the issues lasted for two days. The reporter gave consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Upper respiratory tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced upper respiratory tract infection and incomplete course of vaccination. On an unknown date, the outcome of the upper respiratory tract infection and incomplete course of vaccination were unknown. It was unknown if the reporter considered the upper respiratory tract infection to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX on the left arm. The patient stated that she had an upper respiratory infection 6 months ago from the date of reporting. The patient reported that she had been unable to get her 2nd dose and was now past the 6 month period, which led to incomplete course of vaccination. The reporter consented to follow up. No further information was given.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Neuralgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (repeated episodes of shingles). Concurrent medical conditions included osteoarthritis and neuropathy (in back due to continuous episodes of shingles). In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a month after receiving SHINGRIX, the patient experienced throbbing pain, nerve pain and pain in thigh. On an unknown date, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, throbbing pain, rash, nerve pain and pain in thigh were unknown. It was unknown if the reporter considered the shingles, throbbing pain, rash, nerve pain and pain in thigh to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm approximately four weeks before the date of reporting. One week before the date of reporting the patient developed shingles on her left hip along her panty line. There were approximately 5 to 6 bumps. The patient had throbbing nerve pain that radiated down in to her left thigh last night, causing her to not be able to sleep. She is still experiencing pain today but it is a little less than during the night. The reporter consented to follow up. The reporter gave permission for her physician to be contacted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (repeated episodes of shingles). Concurrent medical conditions included osteoarthritis and neuropathy (in back due to continuous episodes of shingles). In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a month after receiving SHINGRIX, the patient experienced throbbing pain, nerve pain and pain in thigh. On an unknown date, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, throbbing pain, rash, nerve pain and pain in thigh were unknown. It was unknown if the reporter considered the shingles, throbbing pain, rash, nerve pain and pain in thigh to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm approximately four weeks before the date of reporting. One week before the date of reporting the patient developed shingles on her left hip along her panty line. There were approximately 5 to 6 bumps. The patient had throbbing nerve pain that radiated down in to her left thigh last night, causing her to not be able to sleep. She is still experiencing pain today but it is a little less than during the night. The reporter consented to follow up. The reporter gave permission for her physician to be contacted.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of numbness in a 55-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 8th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced numbness and general body pain. On an unknown date, the outcome of the numbness and general body pain were not reported. It was unknown if the reporter considered the numbness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that the patient who received her 2nd dose of SHINGRIX in left deltoid, has complained of body aches and numbness in her hands feet and chin. The nurse was unable to provide further information of the patient's experience. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th August 2018, less than a day after receiving SHINGRIX, the patient experienced headache, difficulty sleeping, tiredness, pain and injection site pain. On 6th January 2019, the outcome of the headache, difficulty sleeping, tiredness and pain were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the headache, difficulty sleeping, tiredness, pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced side effects to the SHINGRIX after each injection. The patient reported that she received 1st dose of Shingrix and experienced severe headache, difficulty sleeping, tiredness and pain, and the issues lasted for two days. The reporter gave consent to follow up.For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK008002.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX. On 9th January 2019, 5 hrs after receiving SHINGRIX, the patient experienced headache, fever and chills. On an unknown date, the outcome of the headache, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and about 5 hours later, the patient experienced headache, fever and chills. It was not known if events has improved. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Joint swelling, Movement disorder, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced general body pain, swollen joints, movement disorder and numbness. On an unknown date, the outcome of the general body pain, swollen joints and movement disorder were recovered/resolved and the outcome of the numbness was unknown. It was unknown if the reporter considered the general body pain, swollen joints, movement disorder and numbness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The nurse practitioner did not have the batch number and expiry date. Twenty four hours after vaccination, the patient experienced full body aches, joint swelling and could not close her hands. The events were lasted for 10 days. The patient had residual numbness in both hands. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood test, Feeling hot, Headache, Injection site pain
Clinical narrative: On 1/1/19 I felt warm, injection site was hot and sore. Stomach upset, headache. On 1/2/19 at 10AM I had a second seizure for approximately 1-1 1/2 min. I have been controlled for 9 1/2 mo. This is the first two seizures I had and only since the shot. No adverse effect on first shot.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Seizure
Clinical narrative: On 1/1/19 I felt warm, injection site was hot and sore. Stomach upset, headache. On 1/2/19 at 10AM I had a second seizure for approximately 1-1 1/2 min. I have been controlled for 9 1/2 mo. This is the first two seizures I had and only since the shot. No adverse effect on first shot.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4x4CM red, warm at injection site.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt brought in to clinic by mother states swelling at injection site. Thigh assessed and erythema and induration noted greater than 3.5". Site marked with surgical pen. Pt tender to touch. Pt's mother advised to use cold compresses as needed and to take MOTRIN suspension for pain. Pt scheduled for follow-up on 1/22/19.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Erythema, Mycoplasma test negative, Peripheral swelling, Rash macular
Clinical narrative: Approximately 2 weeks post dosing child broke out in severe hives on head, face, torso, hands, arms, legs and feet. Hives were large raised blotches, red and noticeable swelling in hands, face and feet. Reaction lasted approximately 6-7 days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Urticaria, Viral infection
Clinical narrative: Approximately 2 weeks post dosing child broke out in severe hives on head, face, torso, hands, arms, legs and feet. Hives were large raised blotches, red and noticeable swelling in hands, face and feet. Reaction lasted approximately 6-7 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal pain, Blood test abnormal, Crying, Diarrhoea, Eating disorder
Clinical narrative: 2 days after receiving first Rotavirus vaccine, baby had projectile emesis (with no prior history of emesis) and diarrhea (no prior history of diarrhea on formula). Patient also became extremely gassy and would show signs of abdominal pain evidenced by crying after eating and drawing legs up to guard abdomen. Patient not eating well. Patient continued to have symptoms for a few days, at which time he went to see his PCP. Patient went to Emergency Department for symptoms 8 days after receiving vaccination on 11/02/17. Patient had to change formula to Gerber Soothe, the most broken down form of dairy, for alleviation of symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Flatulence, Milk allergy, Vomiting projectile
Clinical narrative: 2 days after receiving first Rotavirus vaccine, baby had projectile emesis (with no prior history of emesis) and diarrhea (no prior history of diarrhea on formula). Patient also became extremely gassy and would show signs of abdominal pain evidenced by crying after eating and drawing legs up to guard abdomen. Patient not eating well. Patient continued to have symptoms for a few days, at which time he went to see his PCP. Patient went to Emergency Department for symptoms 8 days after receiving vaccination on 11/02/17. Patient had to change formula to Gerber Soothe, the most broken down form of dairy, for alleviation of symptoms.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Expired product administered, Feeling abnormal, Hospitalisation, Hypoaesthesia
Clinical narrative: Pt received shot on Wednesday 1/16/18, that night got diarrhea, not feeling good. Thursday, pt said her throat started swelling, taking by ambulance from work, left side/arm swollen, numb. Hospital overnight, discharged Friday am 1/18/19. Claims the vaccine was expired, because doctor said it was expired. Claims injected incorrectly. Confirmed with patient that it was injected below the shoulder. Claims injected into the nerve.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pharyngeal oedema
Clinical narrative: Pt received shot on Wednesday 1/16/18, that night got diarrhea, not feeling good. Thursday, pt said her throat started swelling, taking by ambulance from work, left side/arm swollen, numb. Hospital overnight, discharged Friday am 1/18/19. Claims the vaccine was expired, because doctor said it was expired. Claims injected incorrectly. Confirmed with patient that it was injected below the shoulder. Claims injected into the nerve.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 76 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2011, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 10-JUL-2012, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an approximately 57 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, the female patient was administered the ZOSTAVAX by a healthcare provider at a hospital (lot number, dosage and route of administration not provided). On an unknown date in 2014, the patient was treated by a physician at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, the male patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-JUN-2015, the female patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 24-JAN-2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-JUN-2015, the patient was administered the ZOSTAVAX by a healthcare provider at a hospital (lot number, dosage and route of administration not provided). On or about 06-MAR-2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.