chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a GARDASIL 9 inadvertently given to a 5 month old.; This spontaneous report was received from a physician referring to a 5 months old patient of unknown gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.     On 24-AUG-2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). The outcome of product administered to patient of inappropriate age was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications.   On or about 25-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location of vaccine, lot # and expiration date were not provided) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. At the reporting time, the outcome for the event was unknown.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 8/13/2020; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history,concomitant medications, concurrent conditions, and drug reactions or allergies.  On 13-AUG-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1660981, has been verified to be a valid lot number, expiration date reported and validated as 13-APR-2021) for prophylaxis (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion above 47 degrees Fahrenheit/ 9 degrees Celsius (8.9 degrees Celsius) for 33 minutes, as recorded by a data logger. No previous temperature excursion was reported. No additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender.   Information regarding the patient's pertinent medical histoy, concurrent conditions, known allergies and concomitant therapies was not provided.       On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHa 0.5milliliters (ml), with lot # T007396 has been verified to be valid, expiration date on 29-AUG-2010 (anatomical route of vaccination and dose number were not provided) for prophylaxis. It was reported that the vaccine was exposed to a temperature o 16.07 degrees Fahrenheit (F) for 25 minutes.   Additionally, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not expose to any previous temperature excursion and was call due to a data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: On an unknown dates an unspecified number of unspecified patients received VARIVAX or PROQUAD that wasimproperly stored; No additional adverse events reported; This spontaneous report was received from a medical assistant and  refers to an unknown number of patients of unknown age and gender. Concomitant therapies, medical history and historical drugs were not provided.  On an unknown date, the patients were vaccinated with an improperly stored  dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006019 (expiration date 27-FEB-2021) and lot  S021928 (expiration date 15-JUL-2021) for prophylaxis.  Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot S013715 (expiration date 01-NOV-2020); lot T009930 expiration date (16-SEP-2021) for prophylaxis. Strength, dose, frequency, and route of administration were not reported for any of the vaccines involved.   On 06-AUG-2020, the improperly stored suspect vaccines experienced all a temperature of  -10.1 degrees Celsius (°C)  for 15 minutes and -7.21°C for 5 minutes.  On 10-AUG-2020: -10.87°C for 45 minutes.  On 14-AUG-2020: -13.97°C for 15 minutes.  On 19-AUG-2020: -14.25°C  for 45 minutes.  The call was made due to a digital data logger. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored vaccine administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0,5 ml, lot# S036635, expiration date 14-NOV-2021, for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of -16.07 Fahrenheit degrees (°F) for 25 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received two doses of GARDASIL 9 but never received the third dose; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown dates, the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient had not received the third dose (inappropriate schedule of product administration).
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: VAQTA was administered three days after it expired.; This spontaneous report has been received from a medical assistant, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported.      On 26-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml, lot # S019435 and expiration date 23-AUG-2020 (route of administration was not provided) for prophylaxis. The vaccine was administered 3 days after it expired. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S 019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: another bad reaction to part 2 / side effects from second shot; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix. On 20th August 2020, 1 days after receiving Shingrix, the patient experienced fever, chills and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had reactions fever chills headache. As the day went the fever got higher and higher up to 103.4. The reporter Doctor told to take Ibuprofen and slowly the fever went away. The patient asked would had the same reaction to the second shot. For tolerances of 2nd dose, refer case US2020AMR169942, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR169942:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Myalgia; flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and influenza-like symptoms. On an unknown date, the outcome of the myalgia and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the myalgia and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced myalgia and influenza-like symptoms. For the tolerance of 2nd dose, refer linked case US2020AMR172256. This was 1 of 3 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR172064:same reporter US-GLAXOSMITHKLINE-US2020AMR172256:2nd Dose, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: enormous red rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed an enormous red rash.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient Bexsero completed series. The patient experienced low grade fever. This case has been linked with case US2020AMR171971 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR171971:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Myalgia; flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on an unknown date and experianced flu like symptoms. For the tolerance of 1st dose, refer linked case US2020AMR171971).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia and influenza-like symptoms were unknown.   It was unknown if the reporter considered the myalgia and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced myalgia and influenza-like symptoms. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR172064:same reporter US-GLAXOSMITHKLINE-US2020AMR171971:1st Dose, same patient
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Chills, Hypersensitivity, Hypoaesthesia, Pain in extremity
Clinical narrative: unable to fell left foot; Supected COVID; chills / shivering / bone chills; arm pain / lost of pain in arm; Fever; Allergic reaction; This case was reported by a consumer via patient support programs and described the occurrence of hypoesthesia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2020 13:30, the patient received Shingrix. In August 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced hypoesthesia (serious criteria other: serious per reporter), suspected covid-19, chills, pain in arm, fever and allergic reaction. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction were unknown.   The reporter considered the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on left arm on 22 August 2020 approximately 1:30 pm. The patient went to emergency room due to chills, shivering and arm pain. The patient described it as bone chills.  The patient was unable to feel to her foot. The patient was running a fever and felt lot of of pain in her left arm. The patient had taken Benadryl and ibuprofen for pain and allergic reaction. The thought it might be CCOVID. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: unable to fell left foot; Supected COVID; chills / shivering / bone chills; arm pain / lost of pain in arm; Fever; Allergic reaction; This case was reported by a consumer via patient support programs and described the occurrence of hypoesthesia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2020 13:30, the patient received Shingrix. In August 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced hypoesthesia (serious criteria other: serious per reporter), suspected covid-19, chills, pain in arm, fever and allergic reaction. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction were unknown.   The reporter considered the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on left arm on 22 August 2020 approximately 1:30 pm. The patient went to emergency room due to chills, shivering and arm pain. The patient described it as bone chills.  The patient was unable to feel to her foot. The patient was running a fever and felt lot of of pain in her left arm. The patient had taken Benadryl and ibuprofen for pain and allergic reaction. The thought it might be CCOVID. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Flushing, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: blurry vision / eyes could not focus; second shingrix vaccine yesterday / first Shingrix vaccine in 2018; shivering; fever; flushing of the face; felt both cold and hot; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 20th August 2020, the patient received the 2nd dose of Shingrix. On 20th August 2020, less than a day after receiving Shingrix, the patient experienced shivering, fever, facial flushing, feeling hot and cold and drug dose administration interval too long. On 21st August 2020, the patient experienced blurred vision. On an unknown date, the outcome of the shivering, fever and feeling hot and cold were recovered/resolved and the outcome of the facial flushing and blurred vision were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shivering, fever, facial flushing, feeling hot and cold and blurred vision to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shivering, fever, flushing of the face and he felt both cold and hot.  When the patient got up in morning his vision was blurry, his eyes could not focus.  At the time of reporting blurry vision has not resolved, face was still flushed, and other symptoms have resolved.  The patient received 2nd dose late, which led to lengthening og vaccination schedule. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: blurry vision / eyes could not focus; second shingrix vaccine yesterday / first Shingrix vaccine in 2018; shivering; fever; flushing of the face; felt both cold and hot; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 20th August 2020, the patient received the 2nd dose of Shingrix. On 20th August 2020, less than a day after receiving Shingrix, the patient experienced shivering, fever, facial flushing, feeling hot and cold and drug dose administration interval too long. On 21st August 2020, the patient experienced blurred vision. On an unknown date, the outcome of the shivering, fever and feeling hot and cold were recovered/resolved and the outcome of the facial flushing and blurred vision were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shivering, fever, facial flushing, feeling hot and cold and blurred vision to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shivering, fever, flushing of the face and he felt both cold and hot.  When the patient got up in morning his vision was blurry, his eyes could not focus.  At the time of reporting blurry vision has not resolved, face was still flushed, and other symptoms have resolved.  The patient received 2nd dose late, which led to lengthening og vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness and warmth around the injection site; soreness, redness and warmth around the injection site; warmth around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced soreness, redness and warmth around the injection site. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Derealisation, Dizziness, Fatigue
Clinical narrative: rash at the site of injection on her arm; at the site of injection on her arm that was painful; at the site of injection on her arm that was painful and warm to the touch; Armpit Pain; Arm Weakness; arm tingling; Hallucinating/Spacey Head Feeling; Low Grade Fever; Chills; Nausea; Fatigue; Headache; muscle/body aches; muscle/body aches; dizziness; not feeling herself; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unreal. On 18th August 2020, the patient experienced hallucination (serious criteria GSK medically significant), fever, chills, nausea, fatigue, headache, general body pain, myalgia and dizziness. On 22nd August 2020, the patient experienced injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms and tingling of extremity. On an unknown date, the outcome of the hallucination, injection site rash, weakness of arms and tingling of extremity were not recovered/not resolved and the outcome of the fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site pain, injection site warmth and axillary pain were recovered/resolved and the outcome of the feeling unreal was unknown.   It was unknown if the reporter considered the hallucination, fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms, tingling of extremity and feeling unreal to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm. After receiving Shingrix, the patient had low grade fever, chills, nausea, fatigue, "spacey head"/hallucinating, headache, muscle/body aches, and dizziness.  On day 5 from the date of receiving vaccine, the patient noticed there was a rash at the site of injection on her arm that was painful and warm to the touch and there was pain in her armpit.  The pain under the armpit had resolved and the rash on her arm had gotten smaller but had not fully resolved.  Caller confirmed all symptoms have resolved except arm weakness, arm tingling, rash, and the "spacey head" and just not feeling herself. The reporter consented to follow up. This case was linked with case US2020170268, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170268:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: rash at the site of injection on her arm; at the site of injection on her arm that was painful; at the site of injection on her arm that was painful and warm to the touch; Armpit Pain; Arm Weakness; arm tingling; Hallucinating/Spacey Head Feeling; Low Grade Fever; Chills; Nausea; Fatigue; Headache; muscle/body aches; muscle/body aches; dizziness; not feeling herself; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unreal. On 18th August 2020, the patient experienced hallucination (serious criteria GSK medically significant), fever, chills, nausea, fatigue, headache, general body pain, myalgia and dizziness. On 22nd August 2020, the patient experienced injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms and tingling of extremity. On an unknown date, the outcome of the hallucination, injection site rash, weakness of arms and tingling of extremity were not recovered/not resolved and the outcome of the fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site pain, injection site warmth and axillary pain were recovered/resolved and the outcome of the feeling unreal was unknown.   It was unknown if the reporter considered the hallucination, fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms, tingling of extremity and feeling unreal to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm. After receiving Shingrix, the patient had low grade fever, chills, nausea, fatigue, "spacey head"/hallucinating, headache, muscle/body aches, and dizziness.  On day 5 from the date of receiving vaccine, the patient noticed there was a rash at the site of injection on her arm that was painful and warm to the touch and there was pain in her armpit.  The pain under the armpit had resolved and the rash on her arm had gotten smaller but had not fully resolved.  Caller confirmed all symptoms have resolved except arm weakness, arm tingling, rash, and the "spacey head" and just not feeling herself. The reporter consented to follow up. This case was linked with case US2020170268, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170268:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: rash at the site of injection on her arm; at the site of injection on her arm that was painful; at the site of injection on her arm that was painful and warm to the touch; Armpit Pain; Arm Weakness; arm tingling; Hallucinating/Spacey Head Feeling; Low Grade Fever; Chills; Nausea; Fatigue; Headache; muscle/body aches; muscle/body aches; dizziness; not feeling herself; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unreal. On 18th August 2020, the patient experienced hallucination (serious criteria GSK medically significant), fever, chills, nausea, fatigue, headache, general body pain, myalgia and dizziness. On 22nd August 2020, the patient experienced injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms and tingling of extremity. On an unknown date, the outcome of the hallucination, injection site rash, weakness of arms and tingling of extremity were not recovered/not resolved and the outcome of the fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site pain, injection site warmth and axillary pain were recovered/resolved and the outcome of the feeling unreal was unknown.   It was unknown if the reporter considered the hallucination, fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms, tingling of extremity and feeling unreal to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm. After receiving Shingrix, the patient had low grade fever, chills, nausea, fatigue, "spacey head"/hallucinating, headache, muscle/body aches, and dizziness.  On day 5 from the date of receiving vaccine, the patient noticed there was a rash at the site of injection on her arm that was painful and warm to the touch and there was pain in her armpit.  The pain under the armpit had resolved and the rash on her arm had gotten smaller but had not fully resolved.  Caller confirmed all symptoms have resolved except arm weakness, arm tingling, rash, and the "spacey head" and just not feeling herself. The reporter consented to follow up. This case was linked with case US2020170268, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170268:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: rash at the site of injection on her arm; at the site of injection on her arm that was painful; at the site of injection on her arm that was painful and warm to the touch; Armpit Pain; Arm Weakness; arm tingling; Hallucinating/Spacey Head Feeling; Low Grade Fever; Chills; Nausea; Fatigue; Headache; muscle/body aches; muscle/body aches; dizziness; not feeling herself; This case was reported by a consumer via call center representative and described the occurrence of hallucination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unreal. On 18th August 2020, the patient experienced hallucination (serious criteria GSK medically significant), fever, chills, nausea, fatigue, headache, general body pain, myalgia and dizziness. On 22nd August 2020, the patient experienced injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms and tingling of extremity. On an unknown date, the outcome of the hallucination, injection site rash, weakness of arms and tingling of extremity were not recovered/not resolved and the outcome of the fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site pain, injection site warmth and axillary pain were recovered/resolved and the outcome of the feeling unreal was unknown.   It was unknown if the reporter considered the hallucination, fever, chills, nausea, fatigue, headache, general body pain, myalgia, dizziness, injection site rash, injection site pain, injection site warmth, axillary pain, weakness of arms, tingling of extremity and feeling unreal to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm. After receiving Shingrix, the patient had low grade fever, chills, nausea, fatigue, "spacey head"/hallucinating, headache, muscle/body aches, and dizziness.  On day 5 from the date of receiving vaccine, the patient noticed there was a rash at the site of injection on her arm that was painful and warm to the touch and there was pain in her armpit.  The pain under the armpit had resolved and the rash on her arm had gotten smaller but had not fully resolved.  Caller confirmed all symptoms have resolved except arm weakness, arm tingling, rash, and the "spacey head" and just not feeling herself. The reporter consented to follow up. This case was linked with case US2020170268, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170268:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash, Tooth infection
Clinical narrative: Rash; Tooth infection; was received in October of 2019 and has not received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, tooth infection and incomplete course of vaccination. On an unknown date, the outcome of the rash and tooth infection were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and tooth infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tooth infection and rash, both of which have resolved. Limited information was available. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Malaise, Pneumonia
Clinical narrative: ended up with pneumonia; could not breathe; becomes ill/Sick; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included lung disease and drug allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia (serious criteria GSK medically significant), difficulty breathing (serious criteria other: serious by reporter) and malaise. Influenza vaccine Quadrivalent unspecified season was discontinued. On an unknown date, the outcome of the pneumonia and malaise were recovered/resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the pneumonia, difficulty breathing and malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient became ill because the flu shot was made with a chicken protein.  The patient stated that, she would stay sick for months. She said this happened 2 years in a row and she ended up going to the emergency room by ambulance because she could not breathe.  The patient also ended up with pneumonia which she got 3 times in a year and a half after the flu shots were received.  The patient had since recovered from all of these events, but she stated, she was not going to get a flu shot again.  The patient did not know the name of the flu shots she received but said we could contact her doctor for that information.  The patient was calling GlaxoSmithKline, because she wanted to know if Shingrix had any chicken or fowl protein in it.  She stated, she had the first shot of Shingrix on Friday 21st August 2020 and the last few days she was coughing a lot.  For the tolerance of dose of Shingrix, refer the linked case US2020AMR170918. This was 1 of 3 linked cases reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR170986:same patient US-GLAXOSMITHKLINE-US2020AMR170918:same patient
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus
Clinical narrative: experienced a breakout that she described as shingles; is bright red; itches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th August 2020, less than a day after receiving Shingrix, the patient experienced shingles, erythema and pruritus. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the shingles, erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced a breakout that she described as shingles which started on her left hand either 20th August 2020 evening or 21st August 2020 morning.  The breakout was on her neck from her chin to her chest and is bright red and itches so bad and feels like needles.  The shingles were on both arms, waist, both hands, legs and her face.  The reporter consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: and redness.; develop swelling; the injection site was warm; and painful,; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient received the 1st dose of Shingrix and the next day started to develop swelling and redness. The patient still had these symptoms (Registered Pharmacist saw her in the morning at the time of reporting) and the injection site was warm to touch and painful, but she said that according to the patient symptoms were getting better. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness; swelling at the site of injection/swelling became present/swelling was getting; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. On 22nd August 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and complaining about the swelling at the site of injection. The patient mentioned that after the vaccine was administered, redness and swelling became present.  The redness was subsiding, but the swelling was getting bigger.  The Pharmacist provided vaccine and as much patient information as available. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Social problem
Clinical narrative: had pain from his first dose; Covid-19, he did not get the second dose; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain and social problem. On an unknown date, the outcome of the pain and social problem were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose and had pain and because of other plans, not being able to locate more vaccine, and the lockdown from Covid-19, he did not get the second dose.   The reporter wanted to get the second dose at the time of reporting but wanted to know if there were any contraindications.   The reporter but did not say exactly where he had pain but wanted to know if the side effects from second dose would be worse than from the first dose.   The reporter provided the caller with the medical disclaimer and referred him to his healthcare provider and offered to provide the MI number so that the caller could give it to his healthcare provider.   The reporter read the information in content regarding Shingrix consumer and PI.   The PI for Shingrix was emailed to the caller. The reporter did not consent to follow up. There was no HCP information provided by the caller.
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness / light head feeling; Nausea; This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 28th April 2019, the patient received Boostrix. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and nausea to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. Sales representative reported on behalf of a Doctor of medicine a patient who after receiving Boostrix, the patient developed dizziness, nausea, light head feeling and the symptoms persisted after 1 year now. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: rash (with redness) at site of injection.; rash (with redness) at site of injection/rash was spreading down and it went from the right deltoid to the area around the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 19th September 2022) and (batch number 5C55P, expiry date 19th September 2022) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 20th August 2020, 1 day after receiving Shingrix, the patient experienced injection site erythema and red rash. On 26th August 2020, the outcome of the injection site erythema and red rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. After receiving Shingrix, the patient started to develop a rash with redness at the site of injection.  The patient noticed that, the rash was spreading down and it went from the right deltoid to the area around the elbow. Pharmacist confirmed the status of the patient on 26th August 2020 and wondered about the safety of a 2nd dose given the reaction of the 1st dose. The reporter did not consent to follow up. This case was linked with case US2020172527, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172527:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced a little redness after getting first Shingrix vaccination, but did not experience anything after getting second vaccination. The reporter consented to follow up. The case has been linked with the case US2020172512.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172512:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer in remission.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovered/resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age was estimated to be over 55 years old since reporter did not have specific patient information. Patient was a cancer survivor and undergoing treatment.  After receiving Shingrix, the patient experienced joint pain. Pharmacist called to report about the safety profile for a second dose of Shingrix for a patient under treatment with estrogen blockers. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tiredness, Fatigue; Experienced 101 Fever; This is a spontaneous report from a contactable nurse. This report was received via a sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) for immunization, montelukast sodium (SINGULAIR) and Birth Control Pill. The patient experienced 101 Fever, Tiredness, Fatigue for 2 days after dose on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.