chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a female patient (unknown demographics) who experienced cellulitis, nausea, and left arm was very sore and red and there were all over joint pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 05-Oct-2018 at 12:45, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UJ011AG, exp date: 30 June 2019 via unknown route in the upper left arm. On 06-Oct-2018, the patient developed a serious cellulitis, left arm was very sore and red and there were all over joint pain one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE . It was reported that reporter believes that the Vaccine was contaminated with bacteria. This was assessed as serious due to medically significant event. On 06-Oct-2018, the patient developed a non-serious nausea one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was an actual medication error case due to Inadequate aseptic technique in use of product. It was reported that the nurse opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering. (Other relevant tests included no lab data.) Final diagnosis was cellulitis, nausea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none; Sender's Comments: This case involves a female patient (unknown demographics) who presented with nausea, redness, sore arm with joint pain and was diagnosed with cellulitis one day post vaccination with FLUZONE QUADRIVALENT. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, and lab tests ruling out alternate etiologies. Moreover, it was reported as adequate aseptic measures were not taken during vaccination (opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering). Hence there is a possibility that the cellulitis is due to introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Headache, Injection site pain
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 60 years old patient (gender not reported) who experienced pain at the injection site and headache, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI975AC and Exp. Date 30-JUN-2019) via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious pain at the injection site and headache following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of lab data not provided. Final diagnosis was headache and pain at the injection site. It was not reported whether the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Decreased appetite
Clinical narrative: Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an 84 years old female patient who experienced feel sick to her stomach and decreased appetite, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included gastric polyps that was diagnosed in March 2018, Breast cancer and she was treated with radiation in August to 25-Sep-2018 and abdominal discomfort that patient self-reported. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the upper left arm. On 27-Oct-2018, the patient developed a non-serious feel sick to her stomach and decreased appetite, eight-days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was decreased appetite and feel sick to her stomach. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for feel sick to her stomach and as Unknown for decreased appetite.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Limb injury, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Day of administration: sore arm and pain when lifting arm. Continued pain and worsening day after administration. Days later no pain improvement, trouble with basic mobility, wincing from basic movements. Shoulder injury related to vaccine administration.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Day of administration: sore arm and pain when lifting arm. Continued pain and worsening day after administration. Days later no pain improvement, trouble with basic mobility, wincing from basic movements. Shoulder injury related to vaccine administration.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: Please note: The symptoms I describe occurred with both doses of SHINGRIX. The second dose was administered at the same facility on Oct. 30, 2018. Adverse events began more quickly the second time- vaccine at 10:30 a.m.; fever began by 3 p.m. Symptoms with each does included fever (peaking at 101.5 degrees) headache, joint aches and nausea. In both cases duration of adverse impact approximately 30 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Extreme chills with body shaking which lasted 3 hours, accompanied with fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Incoherent
Clinical narrative: Patient received the SHINGRIX vaccine during a routine visit. Patient's wife later reported the patient was "incoherent, lightheaded, blood pressure dropped. He was hospitalized for thirty hours and taken off of his blood pressure pill until his blood pressure came back up." adverse event was the same day as vaccination day.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fatigue, Glassy eyes, Headache, Nausea, Pain
Clinical narrative: Overnight my son developed nausea, headache, body aches and a fever. We didn't have working thermometer but it was easy to recognize the telltale signs, glassy eyes when we woke him up for school at 6am 10/30/2018. These symptoms continued for 36 hours. I did get a thermometer midday on the 30th to take his temperature. At one point it went as high as 103.5, it lasted at 102.8 for most of the afternoon/early evening until some Ibuprofen kicked in around 8pm. The next day my sons temp hoovered just at 99.5 for the day but he looked much better. He still had a headache and body aches on the 31st until about 12 noon. By 4pm, he seemed back to himself with just some minor body aches and fatigue.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pyrexia
Clinical narrative: Overnight my son developed nausea, headache, body aches and a fever. We didn't have working thermometer but it was easy to recognize the telltale signs, glassy eyes when we woke him up for school at 6am 10/30/2018. These symptoms continued for 36 hours. I did get a thermometer midday on the 30th to take his temperature. At one point it went as high as 103.5, it lasted at 102.8 for most of the afternoon/early evening until some Ibuprofen kicked in around 8pm. The next day my sons temp hoovered just at 99.5 for the day but he looked much better. He still had a headache and body aches on the 31st until about 12 noon. By 4pm, he seemed back to himself with just some minor body aches and fatigue.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Throat tightness, Urticaria
Clinical narrative: Pt started with small hives early on 10/31/2018 and during the day the pt started to have systemic hives. Patient only had exposure to deodorant with no reaction to application site. Pt presented to the clinic today with systemic hives as well as a "tightness" in his throat.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Feeling abnormal
Clinical narrative: Patient started feeling off on Sunday (October 21, 2018) and more yesterday with chills and diarrhea and still today. His shot was last Tues. (October 16, 2018).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient said her arm was red from shoulder to elbow.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pruritic 5 cm raised pink wheal that appears like one large hives lesion. Low grade fever between 99-100.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Pyrexia, Rash
Clinical narrative: 10/29/18 AFTER CHILD RECEIVED VACCINES MOM STATED CHILD HAD TO BE RUSHED TO ER THAT EVENING AND AGAIN 10/31 WEDNESDAY FOR RASH ON ARMS, STOMACH, FACE, BACK AND LEGS, FEVER 104.7. AND CRIED FOR 3 HOURS AND WOULD NOT STOP. PER MOM ON 11/1 THURSDAY.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site pain, Mobility decreased, Pain
Clinical narrative: Soreness at site began few hours after injection. Not given by this reporting RN but by another. May have been given a little low, tip of deltoid or bicep/ tricep area. Pain with arm movement over her head. ADLs effected. Now two weeks out and still can't put pull-on shirt over her head. Too painful to push off chair when arising  with rt arm, instead rolls to side to get up. Today no redness or swelling. To palpable mass in tissue. Painful to deep touch. Tried heat, massage, and aleve. Aleve helps pain temporarily. Constant ache of 3/10 but with movement as described as 8/10 pain. Changes how she does her job, has to lift with arm in a different matter. Encouraged to see her PCP. She is declining at this time.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Five hours after injection pt had chills, fever up to 102, injection site with 4x5cm of erythema with warmt and tenderness.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 month old patient administered flu vaccine, approved for use in 6 months and over.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2012, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 17-MAR-2016, the patient was treated by a walk-in clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of his 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-MAY-2013, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-NOV-2016, the patient was treated by the physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Wrong technique in device usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 6th September 2018, the patient received SHINGRIX (subcutaneous). On 6th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient received SHINGRIX vaccine with a 5/8 inch needle, so it is possible that they received the vaccine subcutaneously, which led to inappropriate route of vaccine administration. The pharmacist was in a hurry and did not want to share additional information. Follow up information received from pharmacist on 17th October 2018: The patient's demographic details was updated. On 6th September 2018, the patient received the 1st 0.5 ml dose of SHINGRIX intramuscularly. Thus, the event intramuscular formulation administered by other route was deleted. The patient vaccinated with SHINGRIX with 5-8 inch needle instead of 1 inch. This led to wrong technique used in device usage process. There were no harm to the patient except possible extra soreness at injection site. On an unknown date, the outcome of the injection site pain and wrong technique in device usage process were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. The VAERS details were updated.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hot flush, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Tetanus vaccine with an associated reaction of lymphadenopathy (approximately 30 years ago, he got a Tetanus shot (unknown manufacturer)). On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, hot flashes, chills, pain and injection site tenderness. On an unknown date, the outcome of the influenza-like symptoms, hot flashes, chills, pain and injection site tenderness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, hot flashes, chills, pain and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that he experienced flu-like symptoms, hot flashes, chills, and aches. The patient stated that the injection site was also tender. For the tolerability of 2nd dose, refer case US2018GSK195505 reported for same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Decreased appetite, Diarrhoea, Dysphonia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 5 days after receiving SHINGRIX, the patient experienced chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the chest tightness, muscle pain, hoarseness, sore throat, weakness, headache, fever, diarrhea, nausea and appetite lost were recovered/resolved and the outcome of the tiredness, tremor and general body pain were not recovered/not resolved. It was unknown if the reporter considered the chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she received SHINGRIX on the right arm and around 1st September 2018 0r 2nd September 2018, she started to experience chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, shakiness, headache, fever, diarrhea, nausea, body aches and loss of appetite. The patient stated that the hoarseness and sore throat lasted for a couple of days before resolving. The patient stated that the fever lasted for a few days before resolving. The patient stated that the diarrhea lasted for 4 weeks and patient had been to the doctor 3 times in the last six weeks. The patient stated that all other symptoms had resolved, however, she still felt a little shaky and tired and still had some body aches at the time of reporting. The contact details of the physician was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 5 days after receiving SHINGRIX, the patient experienced chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the chest tightness, muscle pain, hoarseness, sore throat, weakness, headache, fever, diarrhea, nausea and appetite lost were recovered/resolved and the outcome of the tiredness, tremor and general body pain were not recovered/not resolved. It was unknown if the reporter considered the chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she received SHINGRIX on the right arm and around 1st September 2018 0r 2nd September 2018, she started to experience chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, shakiness, headache, fever, diarrhea, nausea, body aches and loss of appetite. The patient stated that the hoarseness and sore throat lasted for a couple of days before resolving. The patient stated that the fever lasted for a few days before resolving. The patient stated that the diarrhea lasted for 4 weeks and patient had been to the doctor 3 times in the last six weeks. The patient stated that all other symptoms had resolved, however, she still felt a little shaky and tired and still had some body aches at the time of reporting. The contact details of the physician was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 5 days after receiving SHINGRIX, the patient experienced chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the chest tightness, muscle pain, hoarseness, sore throat, weakness, headache, fever, diarrhea, nausea and appetite lost were recovered/resolved and the outcome of the tiredness, tremor and general body pain were not recovered/not resolved. It was unknown if the reporter considered the chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, tremor, headache, fever, diarrhea, nausea, general body pain and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she received SHINGRIX on the right arm and around 1st September 2018 0r 2nd September 2018, she started to experience chest tightness, muscle pain, hoarseness, sore throat, tiredness, weakness, shakiness, headache, fever, diarrhea, nausea, body aches and loss of appetite. The patient stated that the hoarseness and sore throat lasted for a couple of days before resolving. The patient stated that the fever lasted for a few days before resolving. The patient stated that the diarrhea lasted for 4 weeks and patient had been to the doctor 3 times in the last six weeks. The patient stated that all other symptoms had resolved, however, she still felt a little shaky and tired and still had some body aches at the time of reporting. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu unspecified for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX .5 ml and Influenza vaccine. On 18th October 2018, 1 days after receiving SHINGRIX and Influenza vaccine, the patient experienced rash, fever, injection site swelling, injection site pain, erythematous rash and pain in arm. On 19th October 2018, the patient experienced injection site itching. The patient was treated with naproxen. On 19th October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the rash, injection site swelling, erythematous rash and injection site itching were unknown and the outcome of the injection site pain and pain in arm were recovering/resolving. It was unknown if the reporter considered the rash, fever, injection site swelling, injection site pain, erythematous rash, injection site itching and pain in arm to be related to SHINGRIX and Influenza vaccine. Additional details were provided as follows: The patient received SHINGRIX and Flu shot right arm. One day after receiving SHINGRIX, the patient developed a rash that was 3 inches below the injection site, which was red and covered 3 inch circle area. The patient has also developed pain and swelling at the injection site, and he had pain while moving his arm. The patient experienced fever and took naproxen. Two days after receiving SHINGRIX, the rash has turned from red to pink. The pain was less while moving his arm around, and he was also experiencing itching at the injection site. At the date of reporting, the fever had subsided. The patient had denied permission to contact their physician. No further details were provided.
Age: 56.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu unspecified for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX .5 ml and Influenza vaccine. On 18th October 2018, 1 days after receiving SHINGRIX and Influenza vaccine, the patient experienced rash, fever, injection site swelling, injection site pain, erythematous rash and pain in arm. On 19th October 2018, the patient experienced injection site itching. The patient was treated with naproxen. On 19th October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the rash, injection site swelling, erythematous rash and injection site itching were unknown and the outcome of the injection site pain and pain in arm were recovering/resolving. It was unknown if the reporter considered the rash, fever, injection site swelling, injection site pain, erythematous rash, injection site itching and pain in arm to be related to SHINGRIX and Influenza vaccine. Additional details were provided as follows: The patient received SHINGRIX and Flu shot right arm. One day after receiving SHINGRIX, the patient developed a rash that was 3 inches below the injection site, which was red and covered 3 inch circle area. The patient has also developed pain and swelling at the injection site, and he had pain while moving his arm. The patient experienced fever and took naproxen. Two days after receiving SHINGRIX, the rash has turned from red to pink. The pain was less while moving his arm around, and he was also experiencing itching at the injection site. At the date of reporting, the fever had subsided. The patient had denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: RAB
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine. Additional details were reported as follows: It was unknown if the patient was following Rabies vaccine series of pre-exposure or post-exposure prophylaxis. The age at vaccination was not reported. The health care professional (HCP) stated that the patient received full rabies vaccine series (unspecified) and the titers were found to be low. It was unknown when titers were drawn in reference to receipt of the vaccine series. It was not known which vaccine the patient received. The patient had denied permission to contact their physician. This HCP did not want to be contacted via mail, she did not have details about the information around the prior series as the patient did not get it from them and didn't know either.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in an 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. The healthcare provider reported that a customer stated their neighbor had a golf ball size swelling on their arm after receipt of SHINGRIX. The healthcare provider was calling to ask how to handle symptom management questions. This patient was not hers. She had no information about the patient or vaccine. It was a customer's neighbor who had the complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable. This case was previously reported to the physician. The age group was not provided, but was selected as adult as per the vaccine indication. The reporter stated that, she heard about 3 people while in line at her local pharmacy mention that they all had terrible reaction to the SHINGRIX vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018192637, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced chills, injection site warmth and injection site induration. On 18th October 2018, the patient experienced injection site pain. On an unknown date, the patient experienced feeling unwell, feeling hot and fever. In October 2018, the outcome of the chills and injection site induration were recovered/resolved. On an unknown date, the outcome of the injection site pain, feeling unwell and injection site warmth were not recovered/not resolved and the outcome of the feeling hot and fever were unknown. It was unknown if the reporter considered the injection site pain, chills, feeling unwell, feeling hot, injection site warmth, fever and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. Within the 24 hours after receiving the vaccine the patient began to experience soreness at the injection site. In October 2018, less than a week after receiving SHINGRIX, the injection site of the patient was also hard and warm. He also began to experience fever and chills. The patient took his temperature at night on 21st October 2018 and it is was 99.1 C.  The patient took his temperature while on the phone call at the time of reporting on 22nd October 2018, at 10:20am and his temperature was 98.1 C. The patient said that he still just did not feel right. The contact details of the physician was provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced chills, injection site warmth and injection site induration. On 18th October 2018, the patient experienced injection site pain. On an unknown date, the patient experienced feeling unwell, feeling hot and fever. In October 2018, the outcome of the chills and injection site induration were recovered/resolved. On an unknown date, the outcome of the injection site pain, feeling unwell and injection site warmth were not recovered/not resolved and the outcome of the feeling hot and fever were unknown. It was unknown if the reporter considered the injection site pain, chills, feeling unwell, feeling hot, injection site warmth, fever and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. Within the 24 hours after receiving the vaccine the patient began to experience soreness at the injection site. In October 2018, less than a week after receiving SHINGRIX, the injection site of the patient was also hard and warm. He also began to experience fever and chills. The patient took his temperature at night on 21st October 2018 and it is was 99.1 C.  The patient took his temperature while on the phone call at the time of reporting on 22nd October 2018, at 10:20am and his temperature was 98.1 C. The patient said that he still just did not feel right. The contact details of the physician was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 19th October 2018, the patient received SHINGRIX. In October 2018, less than a week 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: This case came in via chat. The age at vaccination was not reported.  The healthcare professional stated that the patient had a traveling reaction to the SHINGRIX reporting the reaction was in the neck and below the deltoid. The healthcare professional did not give any more specific details about patient or reaction.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site inflammation, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK198909). On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 19th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills and fever. On 20th October 2018, the patient experienced injection site rash and painful rash. On 21st October 2018, the patient experienced vomiting. The patient was treated with BENADRYL and meloxicam. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site rash, chills, vomiting, fever and painful rash were unknown. It was unknown if the reporter considered the injection site rash, chills, vomiting, fever and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. About 24 hours after receiving SHINGRIX, the patient experienced 2 by 3 inches rash around the injection site. The rash was inflamed and painful to the touch. The rash seems to be expanding and getting worse. The patient also had fever and chills the night he received SHINGRIX. Two days after receiving SHINGRIX, the patient experienced vomiting. This case has been linked with case US2018GSK198909, reported by same reporter for same patient.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2018GSK198909). On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 19th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills and fever. On 20th October 2018, the patient experienced injection site rash and painful rash. On 21st October 2018, the patient experienced vomiting. The patient was treated with BENADRYL and meloxicam. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site rash, chills, vomiting, fever and painful rash were unknown. It was unknown if the reporter considered the injection site rash, chills, vomiting, fever and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. About 24 hours after receiving SHINGRIX, the patient experienced 2 by 3 inches rash around the injection site. The rash was inflamed and painful to the touch. The rash seems to be expanding and getting worse. The patient also had fever and chills the night he received SHINGRIX. Two days after receiving SHINGRIX, the patient experienced vomiting. This case has been linked with case US2018GSK198909, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Overdose, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX 1 ml. In July 2018, unknown after receiving SHINGRIX, the patient experienced overdose. On an unknown date, the patient experienced fever and injection site erythema. On an unknown date, the outcome of the fever, injection site erythema and overdose were unknown. It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The physician's office reported that the patient received a 1.0 ml dose of SHINGRIX vaccine in left deltoid, which led to overdose. The patient experienced redness at the injection site. This case was linked with case US2018192689, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX 1 ml. In July 2018, unknown after receiving SHINGRIX, the patient experienced overdose. On an unknown date, the patient experienced fever and injection site erythema. On an unknown date, the outcome of the fever, injection site erythema and overdose were unknown.  It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The physician's office reported that the patient received a 1.0 ml dose of SHINGRIX vaccine in left deltoid, which led to overdose. The patient experienced redness at the injection site. This case was linked with case US2018192687, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. The patient reported that, the fever was went as high as 103.4 degrees F. In June 2018, less than month after vaccination the patient experienced injection site pain. In 2018, the fever and injection site pain were resolved. The patient was planned to continue the follow-up with his pharmacist.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: This case was reported by a pharmacist via patient support programs and described the occurrence of pain in arm in a 61-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number M73CE, expiry date unknown) for prophylaxis. On 3rd October 2018 11:30, the patient received FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 4th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm, localized erythema, tenderness and skin warm. On an unknown date, the outcome of the pain in arm, localized erythema, tenderness and skin warm were unknown. It was unknown if the reporter considered the pain in arm, localized erythema, tenderness and skin warm to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporter stated that he would say it was a product complaint. However, she did not know how to classify it as she was experiencing an adverse reaction. The reporter could not find anything to indicate that was typical. The patient stated on the morning of reporting date, her entire arm was sore. There was a red tender hot circle an inch below the injection site was a red hot tender circle. She did not indicate an exact time. She consulted her primary care and they referred her to the reporting pharmacist who administered the vaccine. The reporter stated that they had administered several hundred vaccines and this was the first such event.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week 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 details were provided as follows: This case was received via click to chat. The patient was recommended by my physician for SHINGRIX vaccination. The patient experienced nearly every side effect. The patient did not have information about prescribing doctor's name, phone number, and address at hand. The patient had to go to a meeting but would contact again later in afternoon, at the date of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema of extremities in a female patient who received SHINGRIX (batch number ZJ4P2, expiry date unknown) for prophylaxis.  On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the erythema of extremities, pain in arm and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was curious that a side effect that was normal. On Monday morning, the patient received SHINGRIX on left deltoid. The patient experienced redness, soreness and heat from the injection site to the elbow. The redness, heat and soreness had moved her arm approximately from Tuesday evening to the evening of the reporting date. The reporter will provide pictures if they wish to see them.