chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient came down approx., 3 hours after vaccine and had a slight rash on left arm and shoulder around injection site, Was told to take benadryl  and if it got worse to let us know or report to local ER. The next morning around 8:30am the patient came in and her left upper arm now was red, swollen and hot to touch with a rash around the shoulder area. She was told to ice the area and take benadryl for the localized reaction. Note and pictures were documented in patients chart but patient was not seen for an office visit after the reaction.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Dyskinesia, Lacrimation increased, Tension
Clinical narrative: Mom called concerned that patient possibly had a reaction to the PREVNAR she had the previous day. She was holding her mouth open very widely and tensing her entire body. This happened 4 times within a few minutes. Mom described the tensing as if she was having a BM but she didn't have a BM. She didn't cry afterwards. She didn't run a fever. When it occurred, her eyes were open and a little watery but not staring, she tensed but no posturing. Dad was the one who was home with patient when it happened and called mom. Since then she has been eating and drinking  and acting normally. The reaction occurred at 1:30p in the afternoon the day after the vaccine. I instructed mom to go to the ED or come to the office if another episode should occur. I spoke to mom again on 3/29/2019 and she states patient continues to act normal and has not had anymore episodes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood count normal, Chills, Hyperhidrosis, Injection site pruritus
Clinical narrative: Severe leg pain the evening of shot, shooting muscle pains and fever. Fever, body aches, joint paint, muscle pain, fevers (chills and sweating) and lump under skin hot, itchy and sore (size of an orange).  Fever, body aches etc continued or 3-4 days. Continued to feel ill for a week and a half. Now 4 weeks later injection site still itching with a raised spot. In addition wide spread muscle/joint pain continues.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Mass, Myalgia, Pain
Clinical narrative: Severe leg pain the evening of shot, shooting muscle pains and fever. Fever, body aches, joint paint, muscle pain, fevers (chills and sweating) and lump under skin hot, itchy and sore (size of an orange).  Fever, body aches etc continued or 3-4 days. Continued to feel ill for a week and a half. Now 4 weeks later injection site still itching with a raised spot. In addition wide spread muscle/joint pain continues.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rheumatoid factor negative, Skin warm
Clinical narrative: Severe leg pain the evening of shot, shooting muscle pains and fever. Fever, body aches, joint paint, muscle pain, fevers (chills and sweating) and lump under skin hot, itchy and sore (size of an orange).  Fever, body aches etc continued or 3-4 days. Continued to feel ill for a week and a half. Now 4 weeks later injection site still itching with a raised spot. In addition wide spread muscle/joint pain continues.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroid function test normal
Clinical narrative: Severe leg pain the evening of shot, shooting muscle pains and fever. Fever, body aches, joint paint, muscle pain, fevers (chills and sweating) and lump under skin hot, itchy and sore (size of an orange).  Fever, body aches etc continued or 3-4 days. Continued to feel ill for a week and a half. Now 4 weeks later injection site still itching with a raised spot. In addition wide spread muscle/joint pain continues.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly 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 by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In October 2014, at age 65, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an urgent care center for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-MAR-2019 the patient was vaccinated with ROTATEQ, lot # R002805, oral for prophylaxis. On 18-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported that the patient received SHINGRIX 8 months ago and had a little soreness that went away after about 1 day. The reporter did not consent to follow up. This case linked with US2019050314, reported by same reporter for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, 2 days after receiving SHINGRIX, the patient experienced general body pain, headache, fatigue and dizziness. On an unknown date, the outcome of the general body pain, headache, fatigue and dizziness were not recovered/not resolved. It was unknown if the reporter considered the general body pain, headache, fatigue and dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Retired physician. The patient experienced reaction to the 2nd dose of SHINGRIX in the unknown deltoid. The person got the injection a week ago, and they started with symptoms 48 or might be 72 hours later. Clarified the patient experienced aching all over, headache, fatigue, and a little bit of dizziness, which all started around the same time and are ongoing. They had seemed to stabilize, but are not getting better. No fever or if there was it was low grade. The headache was quite pronounced and continuing. The responsible physician, location of vaccination, information pertaining to actual vaccine administered, including lot number and expiry date were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site 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, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site rash and injection site itching were unknown. It was unknown if the reporter considered the injection site swelling, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and developed swelling and a rash directly under the injection site. Swelling and rash developed approximately two days after the dose was given. The healthcare professional described rash as itchy. The healthcare professional did not have date of vaccination, lot number and expiration date to provide.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of shoulder pain in a 18-year-old male patient who received BEXSERO (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis. On 13th March 2019, the patient received the 1st dose of BEXSERO. In March 2019, less than a week after receiving BEXSERO, the patient experienced shoulder pain, injection site pain, joint range of motion decreased and radiating pain. On an unknown date, the outcome of the shoulder pain, injection site pain, joint range of motion decreased and radiating pain were recovering/resolving. It was unknown if the reporter considered the shoulder pain, injection site pain, joint range of motion decreased and radiating pain to be related to BEXSERO. Additional details were provided as follows: The medical assistant reported that the patient experienced shoulder and injection site pain, limited range of motion, and pain radiating into the neck after receiving 1st dose of BEXSERO. The reporter stated that the patient was seen in the office on 19th March 2019 for events. This case has been linked with case US2019GSK054990, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number ZP3P9, expiry date unknown) for prophylaxis. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site blisters were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site blisters to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on right arm. The patient experienced redness, swelling and 2 blisters right below injection site. There was consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 65-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX. On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad. On an unknown date, the outcome of the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follows: On 19th March 2019, 2 days ago (from the date of reporting), the patient got her 1st dose of SHINGRIX. On 20th March 2019, the patient did not feel too bad, but on 21st March 2019, she felt worse. The patient felt cold, tired, shivering and muscles aches. Her arm was also red and swollen and hurts when she touched it. The patient gave consent to follow up. Note: The patient felt bad on 20th March 2019 (on the next day), and on the date of reporting she felt worse. Therefore, we have considered time to onset for all reported events as 1 days, as it starts on next day and was worse on the day of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 65-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX. On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad. On an unknown date, the outcome of the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follows: On 19th March 2019, 2 days ago (from the date of reporting), the patient got her 1st dose of SHINGRIX. On 20th March 2019, the patient did not feel too bad, but on 21st March 2019, she felt worse. The patient felt cold, tired, shivering and muscles aches. Her arm was also red and swollen and hurts when she touched it. The patient gave consent to follow up. Note: The patient felt bad on 20th March 2019 (on the next day), and on the date of reporting she felt worse. Therefore, we have considered time to onset for all reported events as 1 days, as it starts on next day and was worse on the day of reporting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Whole anterior portion of deltoid red, swollen, and tender to palp.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, PPV
Symptoms: Contusion, Erythema, Pain, Rash
Clinical narrative: Mom called on 3/10 to state that daughter's leg had a red spot and it is growing. Patient is a 5 yo female who had immunizations 2 days ago. The site on the right thigh is where she got her KINRIX vaccine. Mom says she had red and rashey as soon as they were home and it has progressed. Today it is 2 x the size and hurts - has more bruising than rash.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Dtap Immunization instead of a Tdap Immunization.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Discomfort, Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Mother reports several hours following his immunizations patient became very irritable and fussy and seemed to be very uncomfortable. Mom noted a rash on his right leg, abdomen, back and face. She described the rash as red, warm, raised, and hive-like. She reports patient seemed to be trying to scratch at the rash. He did not sleep well during the night. The rash seemed to resolve through the night and into the next day, with the exception of one area on his right thigh which remained red, raised, hive-like macluo-papular irregular shaped rash. No fever, no cough or congestion, no abdominal pain, eating well. no ear pulling.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Irritability, Poor quality sleep, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Mother reports several hours following his immunizations patient became very irritable and fussy and seemed to be very uncomfortable. Mom noted a rash on his right leg, abdomen, back and face. She described the rash as red, warm, raised, and hive-like. She reports patient seemed to be trying to scratch at the rash. He did not sleep well during the night. The rash seemed to resolve through the night and into the next day, with the exception of one area on his right thigh which remained red, raised, hive-like macluo-papular irregular shaped rash. No fever, no cough or congestion, no abdominal pain, eating well. no ear pulling.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: Mother reports several hours following his immunizations patient became very irritable and fussy and seemed to be very uncomfortable. Mom noted a rash on his right leg, abdomen, back and face. She described the rash as red, warm, raised, and hive-like. She reports patient seemed to be trying to scratch at the rash. He did not sleep well during the night. The rash seemed to resolve through the night and into the next day, with the exception of one area on his right thigh which remained red, raised, hive-like macluo-papular irregular shaped rash. No fever, no cough or congestion, no abdominal pain, eating well. no ear pulling.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Dizziness, Throat tightness
Clinical narrative: Tightness in the chest and throat, some dizziness. As soon as I returned home I took 3 Claritin pills.
Age: 8.0
Sex: F
Vaccine: FLU4, HEP, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Patient had a reaction immediately after receiving 4 vaccines. RN noticed patient looked pale and felt dizzy. Patient's father reported patient had no breakfast before vaccines were administered. Patient was given juice, oatmeal and water before leaving office in stable condition and patient also reported  she felt better.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-MAR-2019, the patient was vaccinated with expired dose of VAQTA injection 50/1.0 U/ml (lot # N032753, expiry date: 23-MAR-2019) (dose and frequency were not reported) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-MAR-2019 the patient was vaccinated with ROTATEQ, lot # R002805, oral for prophylaxis. On 25-MAR-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abdominal distension, Appetite disorder, Food intolerance, Gastrointestinal disorder, Infantile spitting up
Clinical narrative: Vertigo and GI changes after rota vaccine; significant change in appetite as well; intolerance of feeds. Patient is a 10 week old male here with his mom for concerns about excessive spit ups and not able to sleep or keep anything down since having immunizations. No fever. He has had a swollen belly and asks as if in pain for the past few days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Insomnia, Pain, Vertigo
Clinical narrative: Vertigo and GI changes after rota vaccine; significant change in appetite as well; intolerance of feeds. Patient is a 10 week old male here with his mom for concerns about excessive spit ups and not able to sleep or keep anything down since having immunizations. No fever. He has had a swollen belly and asks as if in pain for the past few days.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear, nose and throat examination, Nuclear magnetic resonance imaging normal
Clinical narrative: Unilateral hearing loss 2 weeks after receipt of flu vaccine, idiopathic, being followed by ENT.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Site of injection extremely sore after approximately 6 hours. The first night, migraine headache. 2nd day into 2nd night, headache, fever (101), chills, malaise, extreme tiredness, injection site is a tennis ball welt (flu-like symptoms, took ibuprofen all day). 3rd day, better, but injection site is still sore and tennis ball size welt, some itchiness around welt. 4th day, injection site still sore and tennis ball size welt, some itchiness around welt. 5th day, unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Malaise, Migraine, Pyrexia
Clinical narrative: Site of injection extremely sore after approximately 6 hours. The first night, migraine headache. 2nd day into 2nd night, headache, fever (101), chills, malaise, extreme tiredness, injection site is a tennis ball welt (flu-like symptoms, took ibuprofen all day). 3rd day, better, but injection site is still sore and tennis ball size welt, some itchiness around welt. 4th day, injection site still sore and tennis ball size welt, some itchiness around welt. 5th day, unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Site of injection extremely sore after approximately 6 hours. The first night, migraine headache. 2nd day into 2nd night, headache, fever (101), chills, malaise, extreme tiredness, injection site is a tennis ball welt (flu-like symptoms, took ibuprofen all day). 3rd day, better, but injection site is still sore and tennis ball size welt, some itchiness around welt. 4th day, injection site still sore and tennis ball size welt, some itchiness around welt. 5th day, unknown.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Muscle pain at injection site (can't raise arm), fever (101.5 F), fatigue, chills, restlessness.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Muscle pain at injection site (can't raise arm), fever (101.5 F), fatigue, chills, restlessness.
Age: 57.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had previously received the HEPLISAV-B for first Hep B dose on 2/21/2019. At this visit RN gave the ENGERIX-B not realizing the HEPLISAV-B was given previously. RN called Regulatory Authority for advice and was told Patient could either receive the HEPLISAV-B today, which would finish that series or continue to receive the two subsequent doses of ENGERIX-B at regular intervals. Patient decided to receive the HEPLISAV-B at this visit to finish the series.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2016, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). On an unspecified date, the patient was treated by her healthcare provider at a medical office for the following injuries resulting from her ZOSTAVAX use: shingles. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered ZOSTAVAX by a physician at an internal medicine clinic (dose, route, and lot # not provided). On an unspecified date, the patient was treated by the same physician at the internal medicine clinic for the following injuries resulting from her ZOSTAVAX use: shingles. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly 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 by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-JAN-2015, at age 64, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient, history not provided. In 2016, at approximate age of 68, the patient was administered ZOSTAVAX by a healthcare provider. On an unknown date, the patient was treated by a physician for the following injuries resulting from ZOSTAVAX user: shingles. Outcome of shingles was not provided.  Additional information has been requested.
Sex: U
Vaccine: HEPAB
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received TWINRIX for prophylaxis. On an unknown date, the patient received the 1st dose of TWINRIX. On an unknown date, less than a year after receiving TWINRIX, the patient experienced headache, fever, vomiting and general body pain. On an unknown date, the outcome of the headache, fever, vomiting and general body pain were recovered/resolved. It was unknown if the reporter considered the headache, fever, vomiting and general body pain to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not provided. On unknown date in the spring of 2008, the patient was vaccinated with the dose of TWINRIX, when the patient was a student at state university. The patient had a pretty significant reaction after the receiving the vaccine that caused a severe headache, fever, vomiting and body ache all of which lasted for around 7 days. For which, the patient had the multiple trips to physician at hospital. At the time of reporting, the patient works in the public health field now at a local health department dealing with restaurants, nursing homes, and child care centers. The patient had always been exempted for not being vaccinated due to its past reaction in 2008. The patient would like to be vaccinated against both but would never take the TWINRIX vaccine, due to the history and fear of another reaction as being more severe next time. The patient had done inquiry that does that vaccine contain an ingredient or preservative that were not in separate Hepatitis A and Hepatitis B vaccines. The patient could possibly be immunized with or do the physician recommend any other Hepatitis A and Hepatitis B vaccines to people who like myself had adverse reactions to TWINRIX. The reporter had given the permission for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Local reaction, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included hyperimmunitiy and swelling (a bee sting on his bottom caused his buttocks to swell). Previously administered products included ZOSTAVAX with an associated reaction of blister (zostavax gave him blisters). Concurrent medical conditions included rhinitis, eczema and immunoglobulin e increased (stated he has a high IGE). On 17th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, fever, itchy upper limbs and extensive swelling of vaccinated limb. The patient was treated with paracetamol (Acetaminophen), ulobetasol (Halobetasol), celecoxib (Celebrex) and clobetasol. On an unknown date, the outcome of the pain in arm, fever, itchy upper limbs and extensive swelling of vaccinated limb were unknown. It was unknown if the reporter considered the pain in arm, fever, itchy upper limbs and extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years. The physician reporting that he had a terrible local reaction after getting a SHINGRIX vaccination at a local pharmacy. The reporter did not know the lot number or expiration date of the SHINGRIX. The patient whole left arm is painful and swollen down to his fingers. The patient took Celebrex. The patient took acetaminophen for the fever. His arm is crazy itching like scabies. The patient used both clobetasol and halobetasol, and neither helped with the itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Condition aggravated, Cough, Madarosis, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eyebrow loss of in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eyebrow loss of (history of eyebrow alopecia, but the condition was improving until she received SHINGRIX). In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced eyebrow loss of, condition aggravated, itchy rash, chronic cough and upset stomach. On an unknown date, the outcome of the eyebrow loss of, condition aggravated and upset stomach were unknown and the outcome of the itchy rash and chronic cough were not recovered/not resolved. It was unknown if the reporter considered the eyebrow loss of, condition aggravated, itchy rash, chronic cough and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient developed itchy spots of rashes on various parts of her body. She also developed a chronic cough that was causing stomach issues. This case linked with US2019GSK054186, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles in December 2017 and took antiviral medication) and rash (cleared in 2 weeks). Concurrent medical conditions included nerve pain (had nerve pain for a year but it was improving). In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nerve pain and condition aggravated. On an unknown date, the outcome of the nerve pain and condition aggravated were unknown. It was unknown if the reporter considered the nerve pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles and took antiviral medication. The rash cleared in 2 weeks, but she developed nerve pain. The pain was improving but after the patient got 1st dose of SHINGRIX, the nerve pain got bad again. The patient was in a hurry and did not provide any contact information. The reporter did not give consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Malaise, Nocturia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included difficulty sleeping. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2019, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, urinary frequency and difficulty sleeping. On 21st March 2019, the patient experienced feeling unwell. On 21st March 2019, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm and feeling unwell were not recovered/not resolved and the outcome of the urinary frequency and difficulty sleeping were unknown. The reporter considered the pain in arm and chills to be related to SHINGRIX. It was unknown if the reporter considered the urinary frequency, difficulty sleeping and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and about two hours later, his right arm became sore. About eight hours after the injection, he developed chills and had difficulty sleeping through the night. The patient had to get up to urinate often during the night. On the day of reporting the chills were gone but the patient felts cruddy. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction 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, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 55 or 56 years. The reporter stated she had a little symptom after receiving the 1st dose of SHINGRIX. The reporter gave consent to follow up. For tolerance to next dose, refer case US2019GSK055804.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male 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 pain in arm, tenderness and fever. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved and the outcome of the tenderness was unknown. It was unknown if the reporter considered the pain in arm, tenderness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional could not provide lot number or expiration date. The arm pain was described as tender to the touch and the fever was described as high. The healthcare professional confirmed arm pain and high fever have fully resolved, no date of resolution was provided.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There wasn't any adverse effects.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to the injection site of L thigh 1 week after vaccine administration.  Increasing over 2 days. Evaluated and Dx w/ cellulitis and given antibiotic treatment.
Age: 39.0
Sex: F
Vaccine: DT
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Shoulder joint pain and stiffness. Started 2 days after injection and is still present.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother refers her child began to have pain, swelling, redness and discomfort in injection site (left arm) at 7pm the same day. she was vaccinated. She was taken to ER the following day for evaluation.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Anxiety, Asthenia, Chills, Dizziness
Clinical narrative: Client reports and adverse reaction to SHINGRIX dose 1. "At 11:00 PM I was sitting on couch and had like an anxiety attack, client reports her heart rate increased and she felt dizzy and tried to move to the bedroom and nearly passed out on her way. She reports putting her head between her knees and prevented herself from passing out. Client reports her husband helped her into bed and she felt a rush of hotness like a fever for a minute of two and then felt really cold and was shivering. Client reports her husband took her temperature and it was 97.4 and they continued to try to get her warm with blankets, not pad etc which took over one hour. She took 2 advils and was able to sleep through the night. 03/28/2019 she woke up and took 3 more advil and states she feels very weak today and tingling in her arm. She states she has a very sore arm as she expected to have but just feel terrible today. Client denies and gastrointestinal adverse effects.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Heart rate increased, Pain in extremity, Paraesthesia
Clinical narrative: Client reports and adverse reaction to SHINGRIX dose 1. "At 11:00 PM I was sitting on couch and had like an anxiety attack, client reports her heart rate increased and she felt dizzy and tried to move to the bedroom and nearly passed out on her way. She reports putting her head between her knees and prevented herself from passing out. Client reports her husband helped her into bed and she felt a rush of hotness like a fever for a minute of two and then felt really cold and was shivering. Client reports her husband took her temperature and it was 97.4 and they continued to try to get her warm with blankets, not pad etc which took over one hour. She took 2 advils and was able to sleep through the night. 03/28/2019 she woke up and took 3 more advil and states she feels very weak today and tingling in her arm. She states she has a very sore arm as she expected to have but just feel terrible today. Client denies and gastrointestinal adverse effects.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Drug hypersensitivity, Flushing, Madarosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cough (1st dose refer case US2019051652). Concurrent medical conditions included eyebrow loss of (history of eyebrow alopecia, but the condition was improving until she received SHINGRIX.). On 22nd November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash aggravated, blister, facial flushing and drug hypersensitivity. The patient was treated with antihistamine. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rash aggravated, blister and facial flushing were not recovered/not resolved and the outcome of the drug hypersensitivity was unknown. It was unknown if the reporter considered the rash aggravated, blister, facial flushing and drug hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and the rashes worsened at the time of reporting and has streaky rashes on her legs, patches between her fingers and flushing and blisters on her face. She did not take any other medicine and has been healthy. She was sensitive to chemicals. She has been treated with antihistamines so far but her condition has not improved. The rashes at the time of reporting getting worse. This case linked with US2019051652, reported by same reporter for the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cough (1st dose refer case US2019051652). Concurrent medical conditions included eyebrow loss of (history of eyebrow alopecia, but the condition was improving until she received SHINGRIX.). On 22nd November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash aggravated, blister, facial flushing and drug hypersensitivity. The patient was treated with antihistamine. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rash aggravated, blister and facial flushing were not recovered/not resolved and the outcome of the drug hypersensitivity was unknown. It was unknown if the reporter considered the rash aggravated, blister, facial flushing and drug hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and the rashes worsened at the time of reporting and has streaky rashes on her legs, patches between her fingers and flushing and blisters on her face. She did not take any other medicine and has been healthy. She was sensitive to chemicals. She has been treated with antihistamines so far but her condition has not improved. The rashes at the time of reporting getting worse. This case linked with US2019051652, reported by same reporter for the same patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site macule, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (received 1st dose on an unknown date, refer case US2019052024). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, headache and injection site macule. On an unknown date, the outcome of the fever, chills, headache and injection site macule were unknown. It was unknown if the reporter considered the fever, chills, headache and injection site macule to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a spot the size of a grapefruit at the injection site of her left shoulder. The vaccine was administered at the clinic at which the patient works.  The reporter also stated that she was speaking with her local field representative about the event who told her that the representative could report it for her but it would be best if the patient called so that she could provide all the answers to the questions. The batch numbers were unavailable at the time of the reporting as the office manager could not access her own records and the nurse who could assist was with the other patients at the time of the initial contact. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a adult female patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced muscle weakness and general body pain. On an unknown date, the outcome of the muscle weakness and general body pain were not recovered/not resolved. It was unknown if the reporter considered the muscle weakness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine and was experiencing muscle weakness and aching all over. The reporter declined to provide any contact information. The reporter did not give consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Headache, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, immediately after receiving SHINGRIX, the patient experienced skin warm, injected limb mobility decreased and pain in arm. On 14th March 2019, the patient experienced headache, diarrhea, appetite absent and weight loss. On 15th March 2019, the patient experienced sleepiness. On 19th March 2019, the patient experienced swelling of eyelid, facial swelling and allergic reaction. On 20th March 2019, the patient experienced periocular swelling. In March 2019, the outcome of the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea and appetite absent were recovered/resolved and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the weight loss was unknown and the outcome of the swelling of eyelid, facial swelling, allergic reaction and periocular swelling were recovering/resolving. It was unknown if the reporter considered the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea, appetite absent, weight loss, sleepiness, swelling of eyelid, facial swelling, allergic reaction and periocular swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her upper left arm. Immediately following the vaccination, the patient started having fever in her arm and had trouble lifting it. On 13th March 2019 at night, the patient could not sleep on her left side because her arm hurt too bad. On the next day, the patient had a headache and severe diarrhea. She had no appetite over the next few days and lost 5 pounds. On 15th March 2019, 2 days later, the patient slept for 6 hours during the day. On 19th March 2019, after 6 days, the patient's left eyelid began swelling and the bottom of her face. On 20th March 2019, there was swelling all around her eye and down her cheek. She saw her eye doctor and was told it was an allergic reaction. The patient's arm was no longer hurting, but she could felt where she got the injection if she rub it. Emergency room visit was required. The consent to follow up was given.