chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-DEC-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-DEC-2015, the patient was treated for an infection caused by the blistering vesicular outbreak of herpes zoster or shingles, which was diagnosed as peripheral neuropathy. On or about 22-JAN-2016, the patient sought subsequent treatment for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR and acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, peripheral neuropathy was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at a clinic for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-JUN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a nurse practitioner, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2013, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine "did" function as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at the same medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site numbness, injection site tingling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site numbness, injection site tingling and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site numbness, injection site tingling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The reporter was not at the administration site and did not have access to the patient's details, lot number or expiration data. The patient experienced pain, redness, numbness and tingling at the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary mass, Contusion, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a adult patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day 12 hrs after receiving SHINGRIX, the patient experienced contusion, tenderness and axillary lump. On an unknown date, the outcome of the contusion, tenderness and axillary lump were unknown. It was unknown if the reporter considered the contusion, tenderness and axillary lump to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Beginning 36 hours after receiving the vaccine, the patient developed a knot under the armpit, bruising under the armpit, and the armpit area was tender. The patient was seen by here primary doctor, but not emergency room visit or hospitalization was required. The health care professional reported that the patient's primary doctor believed, a blood vessel may had been hit during administration of the vaccine.
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 female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month 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 age at vaccination was not reported. The patient received first dose of SHINGRIX recently. The caller reported that the patient experienced arm pain that had lasted for a week now after receiving the shot. The caller declined to provide demographics or answer questions for the safety report. The patient had denied permission to contact their physician.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included PRAVACHOL, CARDIA, XANAX and XARELTO. On 22nd April 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent. On 22nd April 2018 12:00, the patient experienced general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced injection site pain as the vaccine was administered. By noon, 1 hour after receiving SHINGRIX, the patient experienced to ache all over her body from head to toe and felt weak and tired. The patient stayed in bed for 3 or 4 days. The patient never gets a headache, but less than a day after receiving SHINGRIX, the patient had a severe headache and felt nauseated and did not want to eat. The patient generally feels cold all the time anyway but less than a day after receiving SHINGRIX, she experienced shivering. The patient did not have a fever or swelling.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included PRAVACHOL, CARDIA, XANAX and XARELTO. On 22nd April 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent. On 22nd April 2018 12:00, the patient experienced general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent were recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The reporter considered the general body pain, tiredness, nausea, upset stomach, shivering, muscle pain, headache, feelings of weakness and appetite absent to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced injection site pain as the vaccine was administered. By noon, 1 hour after receiving SHINGRIX, the patient experienced to ache all over her body from head to toe and felt weak and tired. The patient stayed in bed for 3 or 4 days. The patient never gets a headache, but less than a day after receiving SHINGRIX, the patient had a severe headache and felt nauseated and did not want to eat. The patient generally feels cold all the time anyway but less than a day after receiving SHINGRIX, she experienced shivering. The patient did not have a fever or swelling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Product administered at inappropriate site, Serum sickness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of serum sickness in a 66-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 24th June 2018, the patient received SHINGRIX (subcutaneous). In June 2018, 3 days after receiving SHINGRIX, the patient experienced serum sickness. On 24th June 2018, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The patient was treated with prednisone. On an unknown date, the outcome of the serum sickness was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. The reporter considered the serum sickness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX subcutaneously in the triceps muscle instead of intramuscular route in deltoid region, which led to. Three days after receiving SHINGRIX, the patient visited her doctor and was diagnosed with serum sickness and prescribed prednisone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number C523T, expiry date 7th July 2020) for prophylaxis. Concomitant products included Atorvastatin, Metformin) NITROSTAT, PLAVID, hydrochlorothiazide, MYRBETRIQ, trandolapril and verapamil. On 6th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, blister and erythema of extremities. On an unknown date, the outcome of the shingles, blister and erythema of extremities were recovering/resolving. The reporter considered the shingles, blister and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on left arm. The concomitant products included EBSE vitamin. The pharmacist reported that the patient experienced a patch on back of left arm close to elbow about the size of her palm, which looked like a shingles outbreak with small blisters and redness.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea, Pallor, Presyncope, Visual impairment
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of presyncope in a 16-year-old male patient who received BEXSERO (batch number U5752AB, expiry date 16th November 2018) for prophylaxis. Concomitant products included MENACTRA. On 22nd June 2018, the patient received BEXSERO. In June 2018, less than a day after receiving BEXSERO, the patient experienced presyncope, lightheadedness, pallor, visual disturbance and nausea. On an unknown date, the outcome of the presyncope, lightheadedness, visual disturbance and nausea were recovered/resolved and the outcome of the pallor was unknown. The reporter considered the presyncope to be related to BEXSERO It was unknown if the reporter considered the lightheadedness, pallor, visual disturbance and nausea to be related to BEXSERO. Additional details were reported as follows: The patient experienced pre-syncope episode. The physician reported the patient became very lightheaded, pale and had brief vision changes and some nausea. The patient recovered fully from the episode after sitting down and drinking some water. The physician reported that the patient received MENACTRA in the other arm at the same time as BEXSERO dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 22nd June 2018 12:00, the patient received SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, rash and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling, rash and injection site warmth were unknown. The reporter considered the injection site pain, injection site swelling and injection site warmth to be related to SHINGRIX. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed pain, warmth at the injection site. The patient's injection site was raised. Sometime later, the patient developed an elongated rash on the front of her left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was unknown. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that she did not have any local adverse reactions with SHINGRIX after the first dose. However, the patient just received her 2nd dose of SHINGRIX and had tenderness and soreness at the injection site. No further information was provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On 27th June 2018, 2 days after receiving SHINGRIX, the patient experienced rash, muscle pain, fatigue and headache. The patient was treated with ALLEGRA. On an unknown date, the outcome of the rash, muscle pain, fatigue and headache were recovering/resolving. The reporter considered the rash, muscle pain, fatigue and headache to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient developed a rash on her trunk, back, stomach and shoulder that was creeping down to her elbow. She would send a picture of the rash via email.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site discolouration, Injection site erythema, Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included PNEUMOCOCCAL VACCINE. On 25th May 2018, the patient received SHINGRIX (intramuscular). On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever. On 18th June 2018, the patient experienced rash. On an unknown date, the patient experienced injection site reaction. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the rash was recovering/resolving. The reporter considered the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: Three weeks prior to getting SHINGRIX, the patient received a Pneumonia shot when she was at her physician's office for a physical. In the night of vaccination day, the patient experienced redness and swelling at the injection site. The patient also had a lot of shivering and because of the shivering thought she must have had a fever, though she did not get up to take it. The patient had severe body aches as well. The patient did not feel good for a couple of days after, feeling run down and fatigued. Less than a month after vaccination, the patient experienced mark at injection site. All symptoms were resolved other than a mark on her arm at the injection site. Around 18th June 2018, 24 days after vaccination, the patient experienced a rash on ankle. It was not itchy or painful and she put Hydrocortisone on it and it had mostly resolved. The patient thought it was probably not related to the vaccine and she must have picked it up outside.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Concomitant products included PNEUMOCOCCAL VACCINE. On 25th May 2018, the patient received SHINGRIX (intramuscular). On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever. On 18th June 2018, the patient experienced rash. On an unknown date, the patient experienced injection site reaction. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever were recovered/resolved and the outcome of the injection site reaction was not recovered/not resolved and the outcome of the rash was recovering/resolving. The reporter considered the injection site erythema, shivering, general body pain, fatigue, feeling unwell, injection site swelling and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: Three weeks prior to getting SHINGRIX, the patient received a Pneumonia shot when she was at her physician's office for a physical. In the night of vaccination day, the patient experienced redness and swelling at the injection site. The patient also had a lot of shivering and because of the shivering thought she must have had a fever, though she did not get up to take it. The patient had severe body aches as well. The patient did not feel good for a couple of days after, feeling run down and fatigued. Less than a month after vaccination, the patient experienced mark at injection site. All symptoms were resolved other than a mark on her arm at the injection site. Around 18th June 2018, 24 days after vaccination, the patient experienced a rash on ankle. It was not itchy or painful and she put Hydrocortisone on it and it had mostly resolved. The patient thought it was probably not related to the vaccine and she must have picked it up outside.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site discolouration, Injection site erythema, Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020) for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms were unknown. The reporter considered the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient was also a nurse. The patient received SHINGRIX on right arm and experienced a number of reactions such as; redness, heat, and the color orange knot the size of an orange at the injection site. The patient also experienced flu-like symptoms such as nausea, chills, and fever. It started at 3 AM and lasted for 24 hours. The healthcare professional (HCP) was not aware if there was a doctor visit.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Nodule, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 29th August 2020) for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms were unknown. The reporter considered the injection site erythema, chills, nausea, fever, injection site warmth, injection site discoloration, injection site lump and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient was also a nurse. The patient received SHINGRIX on right arm and experienced a number of reactions such as; redness, heat, and the color orange knot the size of an orange at the injection site. The patient also experienced flu-like symptoms such as nausea, chills, and fever. It started at 3 AM and lasted for 24 hours. The healthcare professional (HCP) was not aware if there was a doctor visit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Oral pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of oral pain in a 61-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHRINGIX. On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced oral pain and blistering of mouth. On an unknown date, the outcome of the oral pain and blistering of mouth were recovered/resolved. It was unknown if the reporter considered the oral pain and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: At 15:00 hours, the patient received SHINGRIX on left arm. The patient reported that she experienced pain and blisters in her mouth on the same day following the vaccination.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Secretion discharge
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of groggy in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received SHINGRIX. On 15th June 2018, 1 days after receiving SHINGRIX, the patient experienced groggy. On 18th June 2018, the patient experienced common cold and sore throat. On 21st June 2018, the patient experienced cough, fever and mucus discharge. The patient was treated with levofloxacin and MUCINEX DM. On an unknown date, the outcome of the groggy, common cold and sore throat were unknown and the outcome of the cough and mucus discharge were recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the groggy, common cold, sore throat, cough, fever and mucus discharge to be related to SHINGRIX. Additional details were provided as follows: On 14th June 2018, the patient received SHINGRIX about the noon time. 4 days after receiving SHINGRIX, the patient experienced cold symptoms and sore throat. 7 days after receiving SHINGRIX, the symptoms were worsened and the patient also experienced cough, cold symptom increase with discharge from coughing, groggy. The patient's body temperature was recorded as 99.4 to 99.9 degree F. On 22nd June 2018, the symptoms were worsened with uncontrollable coughing along with body temperature was up 100.4 degree F and on the same day, the patient called doctor to cure symptoms. On 23rd June 2018, the patient's body temperature was recessed and coughing reduced but still not normal.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of groggy in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received SHINGRIX. On 15th June 2018, 1 days after receiving SHINGRIX, the patient experienced groggy. On 18th June 2018, the patient experienced common cold and sore throat. On 21st June 2018, the patient experienced cough, fever and mucus discharge. The patient was treated with levofloxacin and MUCINEX DM. On an unknown date, the outcome of the groggy, common cold and sore throat were unknown and the outcome of the cough and mucus discharge were recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the groggy, common cold, sore throat, cough, fever and mucus discharge to be related to SHINGRIX. Additional details were provided as follows: On 14th June 2018, the patient received SHINGRIX about the noon time. 4 days after receiving SHINGRIX, the patient experienced cold symptoms and sore throat. 7 days after receiving SHINGRIX, the symptoms were worsened and the patient also experienced cough, cold symptom increase with discharge from coughing, groggy. The patient's body temperature was recorded as 99.4 to 99.9 degree F. On 22nd June 2018, the symptoms were worsened with uncontrollable coughing along with body temperature was up 100.4 degree F and on the same day, the patient called doctor to cure symptoms. On 23rd June 2018, the patient's body temperature was recessed and coughing reduced but still not normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (not quite as bad as after the 2nd dose. For tolerance after 1st dose, refer case US2018GSK120405). On 27th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th June 2018, several hours after receiving SHINGRIX, the patient experienced headache, general body pain and queasy. On an unknown date, the outcome of the headache, general body pain and queasy were unknown. It was unknown if the reporter considered the headache, general body pain and queasy to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The patient was in good health condition before receiving the vaccine. The patient received SHINGRIX in the afternoon. The patient experienced headache, body aches and general queasiness on the night of vaccination and the next day morning as well. The patient asked if she can take TYLENOL or ibuprofen for this reaction and stated that, she could not find this information in the paperwork of the vaccine. The patient was advised to discuss medical concerns and symptoms with a physician or other healthcare provider to evaluate the medical conditions and treatment. The patient stated, she would call the pharmacy to seek advice. This case was linked with the case US2018GSK120405, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced fever, fatigue and shivering. On an unknown date, the outcome of the fever, fatigue and shivering were unknown. It was unknown if the reporter considered the fever, fatigue and shivering to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the physician assistant (PA). The age at vaccination was not reported.
Sex: U
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 adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, 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: The age group was not reported, but was captured based on the product indication. The healthcare professional called to report that 4 out of 18 patients have report flu-like symptoms after receiving the SHINGRIX vaccine. The reporter did not have SHINGRIX information or patient information to provide me. This case is 1 of the 4 linked cases reported by the same reporter for same event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Extreme redness and heat at injection site. Complaint of fever and chills. RPh advised pt. to apply cold compress at injection site, TYLENOL and BENADRYL. Referred to PCP. PCP notified via RPh 7/6/18.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 2 days starting 5 days after receipt of vaccine and rash started 10 days after receipt of vaccine.
Age: 68.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Joint stiffness, Rash erythematous
Clinical narrative: Vaccine Given: 6/21/2018 1st symptoms (R)ight knee jt. very stiff on 7/3/2018. 2nd symptom (L)eft knee jt. also stiff on 7/4/18. 3rd symptom red rash, not itchy, both arms 7/4 and 5/2018.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Eye irritation, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, swollen glands, swollen legs and hands and eye irritation.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Leukocytosis, Viral infection, White blood cell count increased
Clinical narrative: Pt returned the ED on 08/21/2017 reporting viral symptoms that started the day of immunization (4 days).
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Blood test, Bone pain, Computerised tomogram, Malaise
Clinical narrative: Developed symptoms severe debilitating bone pain "down into the marrow" and joint pain and feeling "sick".  Started the evening or the next day (1/6/18) after the shot. Waited a couple of days to go to the ER. When it didn't resolve went to the ER where "ER tests were done such as x-rays, CT, bloodwork for inflammation". States they couldn't figure out what was wrong and suggested she see a rheumatologist. They started he on Steroids. Symptoms resolved after about 3 weeks.  Then she received another dose in June "at my work" and same symptoms occurred starting within 2 hours--ended up in ER sooner and started on Steroids sooner. Symptoms lasted about 1 1/2 weeks this time. She was giving the same vaccine at her work to a patient and developed allergic reaction symptoms while handling it to hands, up arms, into throat and she discovered the vaccine had latex. This is the same vaccine she received. She then found out her second dose also had latex. After the first dose she had no symptoms and it was a latex-free Hep B vaccine. She feels the symptoms were due to the latex in the vaccine.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: X-ray
Clinical narrative: Developed symptoms severe debilitating bone pain "down into the marrow" and joint pain and feeling "sick".  Started the evening or the next day (1/6/18) after the shot. Waited a couple of days to go to the ER. When it didn't resolve went to the ER where "ER tests were done such as x-rays, CT, bloodwork for inflammation". States they couldn't figure out what was wrong and suggested she see a rheumatologist. They started he on Steroids. Symptoms resolved after about 3 weeks.  Then she received another dose in June "at my work" and same symptoms occurred starting within 2 hours--ended up in ER sooner and started on Steroids sooner. Symptoms lasted about 1 1/2 weeks this time. She was giving the same vaccine at her work to a patient and developed allergic reaction symptoms while handling it to hands, up arms, into throat and she discovered the vaccine had latex. This is the same vaccine she received. She then found out her second dose also had latex. After the first dose she had no symptoms and it was a latex-free Hep B vaccine. She feels the symptoms were due to the latex in the vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have developed a rash above my waistline and is more prominent on my left side, including under my breast, as it wraps around to part of my back. I am thinking this may be a delayed reaction to the SHINGRIX intramuscular vaccine administered at Dr. office on 6/7/2018. A nurse friend looked at it on July 4 and told me to keep hydro-cortisone cream on it and take BENADRYL which I have been doing. I have also used aloe vera gel at night airing it out. For daytime, I've been putting cornstarch baby powder on after the hydro-cortisone or aloe vera gel has had time to dry. It itches. No blisters yet. Trying not to scratch. I wasn't sure if it might be a heat rash or if somewhere I ate didn't clean their utensils/pans from shellfish. But usually with a shellfish allergic reaction it appears on multiple places on my body. What else do I need to do to push on with this pain? I have contacted my doctor through the patient portal but have not gotten a response back yet. His office closes at noon on Friday. After about 36 hours, I had such a headache and fever; and the injection arm hurt for almost 2 weeks. I developed a rash at the onset of the injection site as well. I am thinking this is a reaction to this vaccine as I have never had this type of rash before. Thanks for a reply.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: I have developed a rash above my waistline and is more prominent on my left side, including under my breast, as it wraps around to part of my back. I am thinking this may be a delayed reaction to the SHINGRIX intramuscular vaccine administered at Dr. office on 6/7/2018. A nurse friend looked at it on July 4 and told me to keep hydro-cortisone cream on it and take BENADRYL which I have been doing. I have also used aloe vera gel at night airing it out. For daytime, I've been putting cornstarch baby powder on after the hydro-cortisone or aloe vera gel has had time to dry. It itches. No blisters yet. Trying not to scratch. I wasn't sure if it might be a heat rash or if somewhere I ate didn't clean their utensils/pans from shellfish. But usually with a shellfish allergic reaction it appears on multiple places on my body. What else do I need to do to push on with this pain? I have contacted my doctor through the patient portal but have not gotten a response back yet. His office closes at noon on Friday. After about 36 hours, I had such a headache and fever; and the injection arm hurt for almost 2 weeks. I developed a rash at the onset of the injection site as well. I am thinking this is a reaction to this vaccine as I have never had this type of rash before. Thanks for a reply.
Age: 13.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity, Rash
Clinical narrative: Symptoms vary in each patient, rash, sore arm.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Patient left clinic almost immediately after vaccine, felt light-headed within 5 - 10 minutes, returned to clinic, but collapsed with syncope in parking lot. She hit her head on parking lot. Brought back into clinic by father and put in exam room. Vitals were stable, neurologically normal. She waited another 15 minutes with stable exam and vital signs. Had water and apple juice. She left feeling normal.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: 3 days after getting both vaccines at same time patient experienced some lip tingling and question some numbness in lips. No facial weakness, no lip swelling, no breathing issues or rashes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left outer thigh large indurated erythematous area 10 cm, mildly tender. Swelling at site of KINRIX shot two days ago - no fever. Imp Local reaction to immunization. TYLENOL or MOTRIN for discomfort. Apply ice pack - should resolve in 2-3 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Left outer thigh large indurated erythematous area 10 cm, mildly tender. Swelling at site of KINRIX shot two days ago - no fever. Imp Local reaction to immunization. TYLENOL or MOTRIN for discomfort. Apply ice pack - should resolve in 2-3 days.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Be very careful and not give the wrong vac.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported painful arm and swollen hands, difficulty with movement, chills, fever, aches.  Patient did not report to the physician.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported painful arm and swollen hands, difficulty with movement, chills, fever, aches.  Patient did not report to the physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Impaired work ability, Influenza like illness, Nausea
Clinical narrative: Flu-like fatigue, slight nausea, all-over achiness - debilitating enough to keep me out of work one day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Flu-like fatigue, slight nausea, all-over achiness - debilitating enough to keep me out of work one day.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Disorientation, Dizziness, Hyperhidrosis
Clinical narrative: Patient received vaccine on 7/5/18, reported about ADER on 7/6/18 am- he reported that he had severe chills on night and in morning he had sweating, high temperature, weakness and ultimately syncope. He felt dizziness and disoriented whole time. Also he has injection site redness and swelling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Syncope
Clinical narrative: Patient received vaccine on 7/5/18, reported about ADER on 7/6/18 am- he reported that he had severe chills on night and in morning he had sweating, high temperature, weakness and ultimately syncope. He felt dizziness and disoriented whole time. Also he has injection site redness and swelling.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Be very careful and make sure the right vac is given.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Migraine, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever to 102 degrees with medication; severe all-over body pain, severe migraine, vomiting/nausea, sore/swollen arm at site of vaccination.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Fever to 102 degrees with medication; severe all-over body pain, severe migraine, vomiting/nausea, sore/swollen arm at site of vaccination.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Anxiety, Vomiting
Clinical narrative: The patient started to sweat right before I was about to give the vaccine. The patient claimed she wanted me to go ahead and give it. After I gave the vaccine, the patient seemed fine but started vomiting 2 minutes later. She expressed that it was probably just due to having anxiety of receiving the vaccine. The patient sat down for about 15 minutes and left with no issues.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Night sweats, Pain in extremity, Rash
Clinical narrative: Patient received 2nd shot in series on 7/3/18 said she had arm soreness, and discomfort, also chills and night sweats for 48 hours, and I told her that was ok and expected, but the main concern was a rash that the patient has developed around her neck. Patient did not have rash after 1st dose of SHINGRIX that she received at pharmacy on 3/8/18 that was confirmed by patient before dose was administered. Confirmed No other symptoms or reactions except rash around neck. Advised patient to reach out to her physician if other symptoms arise. Patient said that she is feeling fine now (7/6/18), no more fever or chills just the rash. Of note patient said she has gotten a similar rash in the past when she has had a viral infection in the past.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Eye movement disorder, Hypotonia
Clinical narrative: Patient was given ROTATEQ before giving shots, but after giving him ROTATEQ he went limb and his eyes started to roll back.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Rash consistent with Varicella developed 7/2/18, states mild fever sx as well, but no objective temperature taken. No other URI sx or viral syndrome sx.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: Patient's mother reported ther her daughter (the patient) is still sore on the injection site as of 7/6/18. Patient can rotate her shoulder with no difficulty and also taken OTC Ibuprofen.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Groin pain
Clinical narrative: I had two reactions. The first was the night of the inoculation during sleep. I woke up to a stabbing pain in my lower right abdomen. It came and went very quickly. It occurred twice. The second occurred the following day. It felt like I had a groin pull on my left side. The pain was intermittent.