chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Throat tightness, Tinnitus, Wheezing
Clinical narrative: White pustules on red spots; Diarrhea; red spots on the back of his throat; Sore throat; Coughing; Swelling in throat; Wheezing; tightness in throat; Trouble breathing; Hoarseness; Shivering; Ringing of the ears; Deep sleep; This case was reported by a consumer via call center representative and described the occurrence of sleep disorder in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th February 2020, 1 days after receiving Shingrix, the patient experienced sore throat, cough, throat swelling, wheezing, throat tightness, difficulty breathing, hoarseness and shivering. On 8th February 2020, the patient experienced red throat. On 10th February 2020, the patient experienced pustule and diarrhea. In February 2020, the patient experienced sleep disorder and ringing in ears. The patient was treated with prednisone and ambiguous medication nos (Cortisone (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sleep disorder, sore throat, cough, throat swelling, red throat, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears were unknown.   It was unknown if the reporter considered the sleep disorder, sore throat, cough, throat swelling, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears to be related to Shingrix. The reporter considered the red throat to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix vaccine and came home sat in a chair and was in deep sleep in such a deep sleep that he did not even wake up to vacuum cleaner noise.  The patient experienced sore throat, coughing, and swelling in his throat it got worse.He experienced red spots in his throat on Saturday evening. The patient called his united health care nurse but she was of no help to him. The patient reached out to his pulmonologist via text about his adverse reaction. The patient also noticed the red spots on the back of his throat had white pustules. His doctor mentioned to him that the red spots on his throat are due to Shingrix vaccine. The patient started on prednisone and would be tapered down in the next few days.The patient was scheduled to get a cortisone shot once he was done with prednisone.  After starting the prednisone, his throat swelling and red spots are present but better. He also experienced wheezing, tightness in throat, trouble breathing, and hoarseness that are still present. He was making loud noises due to his wheezing and coughing at night. The patient had diarrhea and shivering. He has also been experiencing ringing in his ears, but he did not know when that started.  The reporter did not consent to follow up. No further details were provided.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Asthenia, Myalgia
Clinical narrative: muscle aches; joint aches / pain in that knee; weakness; Prior to Shingrix vaccine she had arthritis in her left shoulder / Didn't have anything in her right shoulder and now she does; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis and knee replacement (had a knee replacement on her left knee prior to Shingrix).   On 25th February 2020, the patient received the 1st dose of Shingrix. In March 2020, 1 week after receiving Shingrix, the patient experienced muscle pain, joint pain, weakness and shoulder arthritis. On an unknown date, the outcome of the muscle pain, joint pain, weakness and shoulder arthritis were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, weakness and shoulder arthritis to be related to Shingrix.  Additional details were provided as follows: The reporter did not have the lot number or expiry date. Prior to Shingrix vaccine she had arthritis in her left shoulder and did not have anything in her right shoulder and now she does. The patient received Shingrix and a week later developed muscle aches, joint aches, and weakness. She did not have any problems with the knee prior to Shingrix and now had pain in that knee. The muscle aches, joint aches, and weakness are ongoing at the time of this report. Consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: the area became slightly itchy; soreness; redness is the size of a baseball and it has round spots; hot to touch; it has round spots in it; swelling is slight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes ophthalmic. Concomitant products included acyclovir.   On 26th March 2020, the patient received the 2nd dose of Shingrix. On 27th March 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site rash and injection site swelling. On 28th March 2020, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccination in the afternoon of Thursday. The injection site reactions did not present until Friday night.  The soreness increased over the weekend and the area became slightly itchy.  All reactions have improved but are not resolved.   The swelling was slight and she started to ice it yesterday (day of reporting).   The area of redness was the size of a baseball and it had round spots in it. Consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: the area became slightly itchy; soreness; redness is the size of a baseball and it has round spots; hot to touch; it has round spots in it; swelling is slight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes ophthalmic. Concomitant products included acyclovir.   On 26th March 2020, the patient received the 2nd dose of Shingrix. On 27th March 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site rash and injection site swelling. On 28th March 2020, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccination in the afternoon of Thursday. The injection site reactions did not present until Friday night.  The soreness increased over the weekend and the area became slightly itchy.  All reactions have improved but are not resolved.   The swelling was slight and she started to ice it yesterday (day of reporting).   The area of redness was the size of a baseball and it had round spots in it. Consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever; swelling at injection site; redness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, less than a day after receiving Shingrix, the patient experienced fever, injection site swelling and injection site erythema. On 2nd March 2020, the outcome of the fever, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the fever, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported from physician's (MD) office. The patient received Shingrix in the right arm. Outcome of adverse events fever, injection site swelling and injection site erythema was reported as recovered in the database while mentioned as recovered/resolved with sequel in the source document. The reporter gave consent to follow-up.
Sex: M
Vaccine: HPV4
Symptoms: Drug effective for unapproved indication, Therapeutic response unexpected
Clinical narrative: Left foot (plantar) warts resolved; HPV vaccine used for left foot (plantar) warts; Literature Report:   This literature marketed report has been received from the authors of the published article, concerning a 45-year-old male patient. The patient's pertinent medical history included therapy with liquid nitrogen (LN2), salicylic acid, candida albicans, duct tape and zinc (unspecified). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left foot (plantar) warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  The patient's immune status was reported as none. The patient was followed up for treatment for 6 months.  On an unspecified date, the patient's left foot (plantar warts) resolved (drug effective for unapproved indication).  The outcome of the event drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA012734: US-009507513-1912USA012735: US-009507513-1912USA012721: US-009507513-1912USA012722: US-009507513-1912USA012723: US-009507513-1912USA012724: US-009507513-1912USA012725: US-009507513-1912USA012726: US-009507513-1912USA012727: US-009507513-1912USA012728: US-009507513-1912USA012729: US-009507513-1912USA012730: US-009507513-1912USA012731: US-009507513-1912USA012732: US-009507513-1912USA012733:
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: temp of 99.5; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 4th March 2020, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporting day was the second day. The patient still had a temperture of 99.5 degree F and a headache. The patient enquired how long would the side effects last.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Peripheral swelling, Pruritus, Pyrexia, Swollen tongue
Clinical narrative: low-grade fever briefly after injection; itching; urticaria; swollen tongue; swollen hands; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, pruritus, urticaria, swollen tongue and hand swelling. On an unknown date, the outcome of the fever, pruritus, urticaria, swollen tongue and hand swelling were unknown.   It was unknown if the reporter considered the fever, pruritus, urticaria, swollen tongue and hand swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, briefly after vaccination the patient had Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: low-grade fever briefly after injection; itching; urticaria; swollen tongue; swollen hands; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, pruritus, urticaria, swollen tongue and hand swelling. On an unknown date, the outcome of the fever, pruritus, urticaria, swollen tongue and hand swelling were unknown.   It was unknown if the reporter considered the fever, pruritus, urticaria, swollen tongue and hand swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, briefly after vaccination the patient had Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Injection site is very sore; Low-grade fever; Slight headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 months before the time of reporting).   On 10th March 2020 18:00, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, headache and muscle pain. On an unknown date, the outcome of the injection site pain, fever, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, headache and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient received the shingles shot a day before reporting around 6 PM. The patient had a low-grade fever and a slight headache muscle aches and the injection site was very sore. The patient wanted to know how long should he/she expect the side effects to last.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: I have all of the reactions; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown 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. The age group was not reported but was captured as an adult as per vaccine indication. The patient had all of the reaction and was in bed. The patient did not want to provide other details.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Perhaps I had enough with ther first injection.; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that she had enough with ther first injection. For tolerance of 2nd dose, refer case US2020AMR045783.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain in extremity, Scab
Clinical narrative: Shingles blister; Arm was sore the next day; Small shingles blister also presented on her back; Nerve pain; Blister scabbed over; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix. On 7th September 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain in arm, blister, nerve pain and scab. The patient was treated with pregabalin (Lyrica). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles, pain in arm, blister, nerve pain and scab were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, blister, nerve pain and scab to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and her arm was sore the next day.  A small shingles blister also presented on her back with nerve pain.  She was treated with Lyrica for a few weeks.  The blister scabbed over and took several weeks to completely resolve. This case was linked to the case US2020033017, reported for the same patient for the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Gets cramps in his fingers when doing surgery; Little pathology in the area of his rotator cuff; arm was very sore / remained sore / pain is now going down his arm / arm is still sore; Pain in his shoulder; Perhaps the administration of the vaccine was given in the wrong muscle; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st November 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 22nd November 2019, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced finger cramps and rotator cuff injury. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the finger cramps was not recovered/not resolved and the outcome of the rotator cuff injury and vaccine administered at inappropriate site were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the shoulder pain, finger cramps and rotator cuff injury to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm, shoulder pain, finger cramps and rotator cuff injury after vaccination. The patient saw his doctor on 19th December 2019 who said perhaps the administration of the vaccine was given in the wrong muscle, which led to vaccine administered at inappropriate site. The patient was given some exercise, the exercises did not help so the patient returned to his doctor. The pain was now going down his arm and he gets cramps in his fingers when doing surgery. The patient referred to an orthopedic doctor who saw him and took x-rays and said there was a little pathology in the area of his rotator cuff. The patient was given an injection in the joint to help.  It has helped the pain in his shoulder but his arm is still sore even though it is a little better. The physician wanted advice on whether he should get the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Gets cramps in his fingers when doing surgery; Little pathology in the area of his rotator cuff; arm was very sore / remained sore / pain is now going down his arm / arm is still sore; Pain in his shoulder; Perhaps the administration of the vaccine was given in the wrong muscle; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st November 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 22nd November 2019, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced finger cramps and rotator cuff injury. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the finger cramps was not recovered/not resolved and the outcome of the rotator cuff injury and vaccine administered at inappropriate site were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the shoulder pain, finger cramps and rotator cuff injury to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm, shoulder pain, finger cramps and rotator cuff injury after vaccination. The patient saw his doctor on 19th December 2019 who said perhaps the administration of the vaccine was given in the wrong muscle, which led to vaccine administered at inappropriate site. The patient was given some exercise, the exercises did not help so the patient returned to his doctor. The pain was now going down his arm and he gets cramps in his fingers when doing surgery. The patient referred to an orthopedic doctor who saw him and took x-rays and said there was a little pathology in the area of his rotator cuff. The patient was given an injection in the joint to help.  It has helped the pain in his shoulder but his arm is still sore even though it is a little better. The physician wanted advice on whether he should get the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Head discomfort, Hyperhidrosis, Nausea
Clinical narrative: nausea; vomiting; could not lift his head; sweating; pale; watery diarrhea; stomach issues; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2020AMR044784). Concurrent medical conditions included drug hypersensitivity (had sensitivity to medication).   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced nausea, vomiting, head discomfort, sweating and pallor. In March 2020, the patient experienced watery diarrhea and stomach discomfort. On an unknown date, the outcome of the nausea, vomiting, head discomfort, sweating and pallor were recovered/resolved and the outcome of the watery diarrhea and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, head discomfort, sweating, pallor, watery diarrhea and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was sensitive to medication. The reporter stated that, after vaccination the patient had nausea, vomiting, head discomfort, sweating and pallor. The reporter stated that, after vaccination, the patient still had watery diarrhea till the ime of reporting. Till the time of reporting, the patient recovered from all symptoms except stomach issues. No other information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pallor, Vomiting
Clinical narrative: nausea; vomiting; could not lift his head; sweating; pale; watery diarrhea; stomach issues; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2020AMR044784). Concurrent medical conditions included drug hypersensitivity (had sensitivity to medication).   On 9th March 2020, the patient received the 2nd dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced nausea, vomiting, head discomfort, sweating and pallor. In March 2020, the patient experienced watery diarrhea and stomach discomfort. On an unknown date, the outcome of the nausea, vomiting, head discomfort, sweating and pallor were recovered/resolved and the outcome of the watery diarrhea and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, head discomfort, sweating, pallor, watery diarrhea and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was sensitive to medication. The reporter stated that, after vaccination the patient had nausea, vomiting, head discomfort, sweating and pallor. The reporter stated that, after vaccination, the patient still had watery diarrhea till the ime of reporting. Till the time of reporting, the patient recovered from all symptoms except stomach issues. No other information was provided.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Blood pressure increased, Dizziness, Overdose
Clinical narrative: lightheadedness; Increase in blood pressure; Intermittent stomach pain; Two injections of Shingrix on the same day; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2020, the patient received Shingrix and Shingrix. On 7th March 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced light headedness, increased blood pressure, stomach pain and overdose. On an unknown date, the outcome of the light headedness, increased blood pressure and stomach pain were not recovered/not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the light headedness, increased blood pressure and stomach pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient's brother reported this case. The patient received two doses of Shingrix on the same day, which led to overdose. No other specific details were known. The patient experienced lightheadedness, increase in blood pressure, and intermittent stomach pain. The symptoms have not yet resolved or improved. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: headache; nausea; shivers; cold; fever; fatigue; myalgia; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, nausea, shivers, cold, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, shivers, cold, fever, fatigue and myalgia were unknown.   It was unknown if the reporter considered the headache, nausea, shivers, cold, fever, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 101 degree F.  No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: headache; nausea; shivers; cold; fever; fatigue; myalgia; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, nausea, shivers, cold, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, shivers, cold, fever, fatigue and myalgia were unknown.   It was unknown if the reporter considered the headache, nausea, shivers, cold, fever, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 101 degree F.  No additional information was provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever , chills, severe body aches, neck stiffness, heal tenderness , back pain
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Fever , chills, severe body aches, neck stiffness, heal tenderness , back pain
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, max 102-103 x 2 days then generalized rash
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication, Therapeutic response unexpected
Clinical narrative: Bilateral foot warts (plantar warts) resolved; HPV vaccine for bilateral foot warts (plantar warts); .  This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 53 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, laser (PDL), sqaric acid, candida albicans, cimetidine, zinc (unspecified) and cidofovir. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for bilateral foot warts (plantar warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the bilateral foot warts (plantar warts) resolved (drug effective for unapproved indication).   The patient's immune status was reported as none. The patient was followed up for treatment for 7 months.  The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.   Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA001729:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 60-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. On 01-JUL-2016, the patient suffered shingles (herpes zoster). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be a disabling event.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Retinal detachment
Clinical narrative: shingles; Retinal detachment; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 61-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 24-JUL-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at physician office. On 10-DEC-2015, the patient suffered acute retinal detachment. On an unspecified date, the patient experienced shingles. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of acute retinal detachment and shingles (herpes zoster) were not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of retinal detachment was considered to be medically significant. And both events were considered disabling events.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: My arm is red below the shot site; warm below the shot site; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experienced arm red and warm below the shot site. It has been 6 days since shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Body aches; Nausea; Chills; Headache /dull headache; pain was so bad that she would gasp; excruciating pain in her lower back around her ribs and the pain was constant; and around her ribs; midway down to the tip of her spine; pain was so bad that she would gasp and could not sleep all night long; felt horrible; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020 11:23, the patient received the 1st dose of Shingrix (inhaled). On 11th February 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 11th February 2020 19:30, the patient experienced back pain, rib pain and pain in spine. On 11th February 2020 21:30, the patient experienced general body pain, nausea, chills, headache and gasping. In February 2020, the patient experienced feeling abnormal. On 13th February 2020, the outcome of the back pain, nausea, chills and headache were resolved with sequelae and the outcome of the general body pain, rib pain, pain in spine, insomnia and gasping were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the back pain, general body pain, nausea, chills, headache, rib pain, pain in spine, insomnia, gasping and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and in the evening started excruciating pain in her lower back around her ribs and the pain was constant by 9:30pm that same evening, she started having nausea, body aches, chills, and headache.  The patient said that what bothered her the most was that initial excruciating pain in lower back, midway down to the tip of her spine, and around her ribs.  The patient said that pain was so bad that she would gasp and could not sleep all night long. The following day, that excruciating lower back pain subsided but she still felt horrible because she continued to have dull headache, chills, and body aches.  The patient said that by the following Thursday (same week), all the symptoms had resolved, she felt fine and she was back to normal again. Reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal chest pain, Nausea, Pain, Spinal pain
Clinical narrative: Body aches; Nausea; Chills; Headache /dull headache; pain was so bad that she would gasp; excruciating pain in her lower back around her ribs and the pain was constant; and around her ribs; midway down to the tip of her spine; pain was so bad that she would gasp and could not sleep all night long; felt horrible; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020 11:23, the patient received the 1st dose of Shingrix (inhaled). On 11th February 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 11th February 2020 19:30, the patient experienced back pain, rib pain and pain in spine. On 11th February 2020 21:30, the patient experienced general body pain, nausea, chills, headache and gasping. In February 2020, the patient experienced feeling abnormal. On 13th February 2020, the outcome of the back pain, nausea, chills and headache were resolved with sequelae and the outcome of the general body pain, rib pain, pain in spine, insomnia and gasping were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the back pain, general body pain, nausea, chills, headache, rib pain, pain in spine, insomnia, gasping and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and in the evening started excruciating pain in her lower back around her ribs and the pain was constant by 9:30pm that same evening, she started having nausea, body aches, chills, and headache.  The patient said that what bothered her the most was that initial excruciating pain in lower back, midway down to the tip of her spine, and around her ribs.  The patient said that pain was so bad that she would gasp and could not sleep all night long. The following day, that excruciating lower back pain subsided but she still felt horrible because she continued to have dull headache, chills, and body aches.  The patient said that by the following Thursday (same week), all the symptoms had resolved, she felt fine and she was back to normal again. Reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had shingles 5 days after receiving Shingrix. Consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Feeling achy; shivering; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of pain (received 1st dose in October 2019, For the tolerance of 1st dose refer case US2020AMR041605). Concomitant products included acyclovir.   On 4th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced general body pain, shivering and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the general body pain, shivering and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and woke up around 2:00 am in morning with feeling achy, shivering and flu like symptoms. For the tolerance of 1st dose refer case US2020AMR041605, reported by same reporter for same patient. This case has been linked with case US2020040957, reported for the patient's husband. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: arm swelling; redness at injection site; warmness at injection site; pain at injection site; itchiness at injection site; brown spot on skin at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis and allergy.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration. On an unknown date, the outcome of the swelling arm, injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the injection site pain and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix experienced arm swelling, redness at injection site, warmness at injection site, pain at injection site, itching at injection site. Reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; redness at injection site; warmness at injection site; pain at injection site; itchiness at injection site; brown spot on skin at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis and allergy.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration. On an unknown date, the outcome of the swelling arm, injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the injection site pain and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, injection site warmth, injection site pain, injection site itching and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix experienced arm swelling, redness at injection site, warmness at injection site, pain at injection site, itching at injection site. Reporter consented to follow up.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: patient contracted pneumonia even after receiving pneumococcal vaccine; patient contracted pneumonia even after receiving pneumococcal vaccine; This is a spontaneous report from a contactable other HCP.  A 57-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) at single dose on an unspecified date for immunisation.  The patient medical history was and concomitant medications were not reported.  The patient contracted pneumonia even after receiving pneumococcal vaccine on an unspecified date.  The patient was hospitalized for pneumonia for 5 days in Nov2019. outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.