chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 26th July 2018, the patient received SHINGRIX. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site warmth. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a physician. The patient received SHINGRIX on the left arm. The injection site was warm to touch. The patient was seen by a physician who treated with hydrocortisone cream. This case was one of the 3 cases, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 11-year-old male patient who received MENVEO for prophylaxis. In August 2018, the patient received MENVEO. In August 2018, less than a week after receiving MENVEO, the patient experienced injection site erythema, injection site swelling and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling and pain in arm were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and pain in arm to be related to MENVEO. Additional details were reported as follows: A week prior to reporting date, the patient received a dose of MENVEO and had redness and swelling at the injection site. The patient had arm soreness lasting for more than 5 days.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with the 1st dose of SHINGRIX in the left arm. The patient experienced injection site pain that lasted for a couple of days. This case was linked to case US2018146959, reported by the same reporter for the same patient.
Age: 77.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Patient reported extremely swollen arm starting the evening of the shot, to the point where his shirt fell tight on the area. He also said it was extremely bruised. He had to go to the hospital where they are currently checking it out.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Psoriasis, Rash
Clinical narrative: Patient got a rash on both sides of the neck (she was seen by PCP and was told it's psoriasis), then it spread to elbow and navel started about 10-14 days after getting the shot and still has it. Patient also had soreness in the arm and a little tingling in the hand for 2-3 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Dyspnoea, Laboratory test, Muscle spasms, Muscle tightness
Clinical narrative: 8/13 PM: L sided back, abd stiffness; R neck spasm/torsion, SOB, pain; T100, hydrates, uses TYLENOL. 8/17/18 Seen in office: VSS, neck tension L to R, Labs ordered. Cyclobenzaprine ordered. 8/20 labs rec. Advised to see neurologist for cervical symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: 8/13 PM: L sided back, abd stiffness; R neck spasm/torsion, SOB, pain; T100, hydrates, uses TYLENOL. 8/17/18 Seen in office: VSS, neck tension L to R, Labs ordered. Cyclobenzaprine ordered. 8/20 labs rec. Advised to see neurologist for cervical symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient reported a fever and body aches day after administration. Symptoms resolved on their own.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: About 3 hrs after vaccination I became dizzy, weak, nauseous, and had severe  pain that started distal to the injection site and radiated to my fingertips.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ITCHY, HOT AND SWOLLEN AT INJECTION SITE.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: The patient came into the pharmacy two days after the vaccine administration and presented with a rash developed around the injection site. The affected area was hot to the touch. He said he noticed it the next day after vaccine administration. The patient did not complain of any other symptoms. The rash was slightly itchy and the arm was also sore. The patient was advised to apply cold compress and to Benadryl. He will continue to monitor his symptoms and was instructed to call the pharmacy if it got worse and to seek medical attention.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Asthenia, Burning sensation, Discomfort, Feeling abnormal, Injected limb mobility decreased
Clinical narrative: Issue is anthrax in the right arm. Usual painful right arm in the first few days, but my shoulder has been having issues ever since. Initial burn a few seconds after administration, diminished a few minutes later. Hurt more 1 day later, and the pain faded again. Since then, my shoulder has been fine except formovements I can no longer do without pain or discomfort and sometimes weakness. The most problematic is a cross-body motion to remove T-shirts. I cannot lift my right arm from my left hip up towards my head.  It gets stuck when my right hand is near my left elbow, I also experienced pressure in my right shoulder while doing mountain climbers--it wasn't pain, but it wasn't feeling right. Other arm positions I can do but there is discomfort.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: Issue is anthrax in the right arm. Usual painful right arm in the first few days, but my shoulder has been having issues ever since. Initial burn a few seconds after administration, diminished a few minutes later. Hurt more 1 day later, and the pain faded again. Since then, my shoulder has been fine except formovements I can no longer do without pain or discomfort and sometimes weakness. The most problematic is a cross-body motion to remove T-shirts. I cannot lift my right arm from my left hip up towards my head.  It gets stuck when my right hand is near my left elbow, I also experienced pressure in my right shoulder while doing mountain climbers--it wasn't pain, but it wasn't feeling right. Other arm positions I can do but there is discomfort.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Two days after vaccine patient noticed left arm swollen, red and warm to touch. Diagnosed by physician assistant with cellulitis of left arm. 500mg of ZITHROMAX given in office and script for KEFLEX 500mg three times a day sent to pharmacy. Patient informed if not getting better to follow up.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Hypotonia, Loss of consciousness, Pallor, Vision blurred
Clinical narrative: Pt to clinic for immunizations. NKA. Immunizations given per PHN protocol. Pt and mother educated on need to remain in clinic for at least 15 minutes after immunizations. Pt and mother chose to wait in waiting room instead of exam room. Pt and mother walked to front of clinic, mother stopped at clerical window to check out, pt proceeded to restroom. Clerical staff heard pt bump against front window next to bathrooms and fall to floor. Clerical staff called for nurse, when I arrived pt was sitting in floor, pale in color but alert and oriented x 3. Two other clinic nurses and her mother arrived within 1 to 2 seconds of my arrival. Pt stood and was assisted to a chair and was rolled to an examination room. Pt was talking while being transferred to exam room. Approximately a minute after arriving in the exam room while speaking with mother pt began to pass out again. Pt lost muscle tone and eyes lost focus for 2 to 3 seconds then the patient regained facilities and was alert and oriented x 3. Pt drank 2 sips of apple juice then stood and was assisted to bed in exam room. 911 had been called and paramedics were in route. Cold, wet paper towels were applied to neck and chest, legs were elevated above head. VS were assessed. Paramedics arrived on scene and transported pt and mother to nearest ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: 6 hours after vaccine was given, fever, fatigue, chills, weakness, body aches and headache began.  Tylenol and rest were used. Lasted for 24 hours. Patient is starting to feel better today.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 6 hours after vaccine was given, fever, fatigue, chills, weakness, body aches and headache began.  Tylenol and rest were used. Lasted for 24 hours. Patient is starting to feel better today.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Swelling
Clinical narrative: Headache and nausea day after. Swelling below injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein, Full blood count normal, Haematocrit normal, Joint swelling
Clinical narrative: Within 24 hours of receiving the vaccine the patient started having joint aches and pain as well as swelling starting with wrist  then involved all major joints (shoulders, ankles, elbows knees etc).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean cell haemoglobin concentration normal, Metabolic function test normal, Pain, Red blood cell sedimentation rate increased
Clinical narrative: Within 24 hours of receiving the vaccine the patient started having joint aches and pain as well as swelling starting with wrist  then involved all major joints (shoulders, ankles, elbows knees etc).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dry mouth, Eye pain, Fall
Clinical narrative: Chills for several hours, dry mouth, sweating, slammimg headach on top of head and pounding behind eyes, dizziness. Fell to floor when going to get water.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Chills for several hours, dry mouth, sweating, slammimg headach on top of head and pounding behind eyes, dizziness. Fell to floor when going to get water.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Deafness, Headache, Hypoacusis, Influenza
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of deafness in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced deafness (serious criteria GSK medically significant), hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the deafness, hearing decreased, influenza, upper respiratory tract infection and fluid in middle ear were unknown and the outcome of the pain, headache, debility and vertigo were recovered/resolved. It was unknown if the reporter considered the deafness, hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hearing difficulties further explained as muffled hearing in left ear and almost deaf after flying with an upper respiratory tract infection and after 2 bouts with flu. There was no specific timing of events known. The consumer was seen by and ENT 6 weeks later and treated with steroids and then 3 weeks after that visit a myringotomy was performed to release fluid in the ear. GlaxoSmithKline would reach out for additional information and encouraged consumer to call. All issues were reported, it was unknown what events occurred first. Follow up received on 21st August 2018 from consumer, the patient reported that after her 1st SHINGRIX vaccine she was laid out for 3 to 4 days with symptoms similar to previous cases of the flu. The patient had severe aches and pains, headaches, debilitation and vertigo for a full day. Shortly after this she flew on an airplane when traveling and since then had problems with fluid in her ear. She still had depleted hearing in her left ear. For tolerance to 2nd dose of SHINGRIX, refer linked US2018GSK152734 ( for same patient).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Middle ear effusion, Myringotomy, Pain, Upper respiratory tract infection
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of deafness in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced deafness (serious criteria GSK medically significant), hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the deafness, hearing decreased, influenza, upper respiratory tract infection and fluid in middle ear were unknown and the outcome of the pain, headache, debility and vertigo were recovered/resolved. It was unknown if the reporter considered the deafness, hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hearing difficulties further explained as muffled hearing in left ear and almost deaf after flying with an upper respiratory tract infection and after 2 bouts with flu. There was no specific timing of events known. The consumer was seen by and ENT 6 weeks later and treated with steroids and then 3 weeks after that visit a myringotomy was performed to release fluid in the ear. GlaxoSmithKline would reach out for additional information and encouraged consumer to call. All issues were reported, it was unknown what events occurred first. Follow up received on 21st August 2018 from consumer, the patient reported that after her 1st SHINGRIX vaccine she was laid out for 3 to 4 days with symptoms similar to previous cases of the flu. The patient had severe aches and pains, headaches, debilitation and vertigo for a full day. Shortly after this she flew on an airplane when traveling and since then had problems with fluid in her ear. She still had depleted hearing in her left ear. For tolerance to 2nd dose of SHINGRIX, refer linked US2018GSK152734 ( for same patient).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of deafness in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced deafness (serious criteria GSK medically significant), hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the deafness, hearing decreased, influenza, upper respiratory tract infection and fluid in middle ear were unknown and the outcome of the pain, headache, debility and vertigo were recovered/resolved. It was unknown if the reporter considered the deafness, hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hearing difficulties further explained as muffled hearing in left ear and almost deaf after flying with an upper respiratory tract infection and after 2 bouts with flu. There was no specific timing of events known. The consumer was seen by and ENT 6 weeks later and treated with steroids and then 3 weeks after that visit a myringotomy was performed to release fluid in the ear. GlaxoSmithKline would reach out for additional information and encouraged consumer to call. All issues were reported, it was unknown what events occurred first. Follow up received on 21st August 2018 from consumer, the patient reported that after her 1st SHINGRIX vaccine she was laid out for 3 to 4 days with symptoms similar to previous cases of the flu. The patient had severe aches and pains, headaches, debilitation and vertigo for a full day. Shortly after this she flew on an airplane when traveling and since then had problems with fluid in her ear. She still had depleted hearing in her left ear. For tolerance to 2nd dose of SHINGRIX, refer linked US2018GSK152734 ( for same patient).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of deafness in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced deafness (serious criteria GSK medically significant), hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the deafness, hearing decreased, influenza, upper respiratory tract infection and fluid in middle ear were unknown and the outcome of the pain, headache, debility and vertigo were recovered/resolved. It was unknown if the reporter considered the deafness, hearing decreased, influenza, upper respiratory tract infection, pain, headache, debility, vertigo and fluid in middle ear to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hearing difficulties further explained as muffled hearing in left ear and almost deaf after flying with an upper respiratory tract infection and after 2 bouts with flu. There was no specific timing of events known. The consumer was seen by and ENT 6 weeks later and treated with steroids and then 3 weeks after that visit a myringotomy was performed to release fluid in the ear. GlaxoSmithKline would reach out for additional information and encouraged consumer to call. All issues were reported, it was unknown what events occurred first. Follow up received on 21st August 2018 from consumer, the patient reported that after her 1st SHINGRIX vaccine she was laid out for 3 to 4 days with symptoms similar to previous cases of the flu. The patient had severe aches and pains, headaches, debilitation and vertigo for a full day. Shortly after this she flew on an airplane when traveling and since then had problems with fluid in her ear. She still had depleted hearing in her left ear. For tolerance to 2nd dose of SHINGRIX, refer linked US2018GSK152734 ( for same patient).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Deafness, Headache, Hypoacusis, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of deafness (1st dose received on 2nd April 2018, for reference see the case US2018144839). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose and had a sore arm.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Middle ear effusion, Myringotomy, Pain, Upper respiratory tract infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of deafness (1st dose received on 2nd April 2018, for reference see the case US2018144839). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose and had a sore arm.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of deafness (1st dose received on 2nd April 2018, for reference see the case US2018144839). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose and had a sore arm.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: 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 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of deafness (1st dose received on 2nd April 2018, for reference see the case US2018144839). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the 2nd dose and had a sore arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 12th August 2018 11:30, the patient received the 2nd dose of SHINGRIX (intramuscular). On 12th August 2018 18:30, 7 hrs after receiving SHINGRIX, the patient experienced injection site pain, appetite lost, fatigue, general body pain and fever. On an unknown date, the outcome of the injection site pain, appetite lost, fatigue, general body pain and fever were recovering/resolving. It was unknown if the reporter considered the injection site pain, appetite lost, fatigue, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient stated that the representative could not resolve his problem, because he still had achy pain and sort of a miasma. So to say that he resolved the problem with respect to the physical, how he felt physically, was an incorrect question. The patient had denied permission to contact their physician.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Oropharyngeal pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. 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 headache, sore throat, upset stomach, feeling bad and product supply issue. On an unknown date, the outcome of the headache, sore throat, upset stomach, feeling bad and product supply issue were unknown. It was unknown if the reporter considered the headache, sore throat, upset stomach and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not remember the exact date of her 1st vaccination but thought it was in April.  She said she felt lousy, which included a headache, sore throat and upset stomach. However she did not remember how soon after the vaccine she developed these symptoms. The patient had denied permission to contact their physician. She called because of the availability issue of the SHINGRIX.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shoulder pain in a 18-year-old male patient who received BEXSERO (batch number 16B401, expiry date 28th February 2019) for prophylaxis. On 3rd August 2018, the patient received the 1st dose of BEXSERO (intramuscular). In August 2018, less than a week after receiving BEXSERO, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.  It was unknown if the reporter considered the shoulder pain to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left deltoid and experienced shoulder pain (with movement) following vaccination. The pain did not limit his range of movement or degree of physical activity. This was reported to the healthcare professional by patient's mother on 10th August 2018 but the healthcare professional was uncertain when the symptoms began. She also has not yet heard back from the mother, regarding whether the symptoms have resolved or not.
Age: 52.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Chest discomfort, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 52-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX .5 ml, BOOSTRIX and PREVNAR 13. On 8th August 2018, less than a day after receiving SHINGRIX and BOOSTRIX, the patient experienced fever, headache, myalgia, dry cough and chest heaviness. On an unknown date, the outcome of the fever, headache, myalgia, dry cough and chest heaviness were not recovered/not resolved. It was unknown if the reporter considered the fever, headache, myalgia, dry cough and chest heaviness to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: After receiving SHINGRIX, BOOSTRIX and PREVNAR 13, the patient experienced symptoms on the same day he received the vaccine. On 8th August 2018, the patient had a fever with a high of 101 degree F. On the date of reporting the patient's fever went down to 98.8 degree F. It was unknown if the reporter considered the fever, headache, myalgia, dry cough and chest heaviness to be related to PREVNAR 13 as well. It transferred to medical information for questions.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, pain in arm and influenza-like symptoms. On an unknown date, the outcome of the chills, pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the chills, pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's daughter. The patient received SHINGRIX in left arm. The patient experienced flu like symptoms and pain in the upper arm. The events lasted for couple days and she recovered. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK152045.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of increased blood pressure in a 81-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th August 2018 13:00, the patient received SHINGRIX (intramuscular) .5 ml. On 14th August 2018, 1 days after receiving SHINGRIX, the patient experienced increased blood pressure and pulse rate increased. On an unknown date, the outcome of the increased blood pressure and pulse rate increased were unknown. It was unknown if the reporter considered the increased blood pressure and pulse rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient was given the vaccination on 13th August 2018 and on 14th August 2018 he called the pharmacist to report an increase in his blood pressure and his pulse.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain, fever and hot feeling in feet. On an unknown date, the outcome of the general body pain, fever and hot feeling in feet were unknown. It was unknown if the reporter considered the general body pain, fever and hot feeling in feet to be related to SHINGRIX. Additional details reported as follows: The patient experienced some achiness and fever, along with her feet was feeling hot. For tolerance after 2nd dose refer case US2018GSK150555. This case has been linked with US2018147868 and , reported by same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 73-year-old male patient who received SHINGRIX for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details reported as follows: The reporter was the patient's wife. The patient received 1st dose and experienced a sore arm. For tolerance after 2nd dose refer case US2018GSK151123. This case has been linked with US2018147867 and US2018GSK150555, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 70-year-old female patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows. The only event she experienced with that SHINGRIX was a sore arm which resolved. This case has been linked with case US2018GSK151145 reported by the same reporter for the same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a 75-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On 8th August 2018, 4 days after receiving SHINGRIX, the patient experienced tingling and generalized pruritus. On an unknown date, the outcome of the tingling and generalized pruritus were unknown.  The reporter considered the tingling and generalized pruritus to be possibly related to SHINGRIX.  Additional details were provided as follows: The patient experienced tingling and itching over the entire body. At this point it was unknown whether these reactions were subsided. No additional information was provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On 4th April 2018, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: They symptoms lasted 24 hours then resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of discomfort (1st dose received on an unknown date-refer case US2018GSK152830). On 20th July 2018, the patient received the 2nd dose of SHINGRIX. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After receiving 2nd dose of SHINGRIX, the patient came back into the clinic later that day and complained of extreme arm pain. The patient followed up at clinic on 26th July 2018 and she still had arm pain but was subsiding. This case has been linked with case US2018GSK152830, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. Concomitant products included adalimumab (Humira). 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 nausea, vomiting and pain in arm. On an unknown date, the outcome of the nausea, vomiting and pain in arm were unknown. It was unknown if the reporter considered the nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced intense arm pain. For the tolerance after 2nd dose refer case US2018GSK151204, for same patient.
Sex: M
Vaccine: MENB
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site reaction in a adult male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient had mild local reaction at injection site and was concerned if this was beacause of the latex or product.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired work ability, Peripheral swelling
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, inability to work and joint pain. On an unknown date, the outcome of the swelling arm, inability to work and joint pain were unknown. It was unknown if the reporter considered the swelling arm, inability to work and joint pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the field representative who is the patient's neighbour. The age at vaccination was not reported. The patient received initial vaccination of SHINGRIX. The patient's arm swelled up double its size and experienced severe pain in joints. The patient told that he still had joint pain so severe that he was unable to work. The patient had been referred to a Rheumatologist. The reporter said that the patient received SHINGRIX vaccination from a Veterans administration clinician. No further adverse event information was provided.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in May 2018, refer case US2018147868). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details reported as follows: The reporter was the patient's wife. The patient experienced a sore arm. This case has been linked with US2018147867 and US2018GSK150555, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of nausea (vomiting and intense arm pain after 1st dose, refer case US2018GSK148194). Concomitant products included adalimumab (Humira). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, vomiting and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nausea, vomiting and pain in arm were unknown. It was unknown if the reporter considered the nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient experienced intense arm pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose, refer case US2018146939).  On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 30 days after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the patient experienced chills, pain in arm, influenza-like symptoms and tremor. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, pain in arm, influenza-like symptoms and tremor were recovered/resolved and the outcome of the injection site pain and injection site lump were unknown. It was unknown if the reporter considered the chills, pain in arm, injection site pain, injection site lump, influenza-like symptoms and tremor to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's daughter.  The patient received SHINGRIX in left arm. The patient experienced shaking all night, flu like symptoms, and sore arm. The events lasted for total of 4 to 5 days. After a month later patient was experiencing a lump at the injection site which was about the size of 0.5 by 0.5 inches and the site of injection was sore covering 4 inches of circular area. No further details were provided. The patient was referred to health care provider.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose, refer case US2018146939).  On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 30 days after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the patient experienced chills, pain in arm, influenza-like symptoms and tremor. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, pain in arm, influenza-like symptoms and tremor were recovered/resolved and the outcome of the injection site pain and injection site lump were unknown. It was unknown if the reporter considered the chills, pain in arm, injection site pain, injection site lump, influenza-like symptoms and tremor to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's daughter.  The patient received SHINGRIX in left arm. The patient experienced shaking all night, flu like symptoms, and sore arm. The events lasted for total of 4 to 5 days. After a month later patient was experiencing a lump at the injection site which was about the size of 0.5 by 0.5 inches and the site of injection was sore covering 4 inches of circular area. No further details were provided. The patient was referred to health care provider.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of discomfort 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, less than a year after receiving SHINGRIX, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.  It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had received first dose of SHINGRIX with minimal discomfort. This case has been linked with case US2018GSK147353, reported by same reporter for same patient for the tolerance of 2nd dose.
Age: 39.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received the VARIVAX on 7/16/2018. Found out she was pregnant at the end of July after her visit.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Blood alkaline phosphatase increased
Clinical narrative: Patient received SHINGRIX vaccine on 7/25. On 8/7 he had fevers, chills, and sweats. But he recalls not feeling "right" from the moment he got the injection. My workup found elevated LFTs, acute renal insufficiency, and anemia. Hepatitis A, B, C serologies negative. US of abdomen showed fatty liver disease. His LFTs began to improve after a week, as did his clinical status.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine increased, Chills, Feeling abnormal, Hepatic steatosis, Hepatitis A virus test
Clinical narrative: Patient received SHINGRIX vaccine on 7/25. On 8/7 he had fevers, chills, and sweats. But he recalls not feeling "right" from the moment he got the injection. My workup found elevated LFTs, acute renal insufficiency, and anemia. Hepatitis A, B, C serologies negative. US of abdomen showed fatty liver disease. His LFTs began to improve after a week, as did his clinical status.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatitis B test negative, Hepatitis C test negative, Hepatitis viral test negative, Hyperhidrosis, Liver function test increased
Clinical narrative: Patient received SHINGRIX vaccine on 7/25. On 8/7 he had fevers, chills, and sweats. But he recalls not feeling "right" from the moment he got the injection. My workup found elevated LFTs, acute renal insufficiency, and anemia. Hepatitis A, B, C serologies negative. US of abdomen showed fatty liver disease. His LFTs began to improve after a week, as did his clinical status.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Ultrasound abdomen abnormal
Clinical narrative: Patient received SHINGRIX vaccine on 7/25. On 8/7 he had fevers, chills, and sweats. But he recalls not feeling "right" from the moment he got the injection. My workup found elevated LFTs, acute renal insufficiency, and anemia. Hepatitis A, B, C serologies negative. US of abdomen showed fatty liver disease. His LFTs began to improve after a week, as did his clinical status.
Age: 11.0
Sex: M
Vaccine: DTAP, FLU4, HPV9, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Medication Error. Patient was given DTaP instead of the Tdap that was ordered. Parent notified.