chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: burning in feet; pins and needles; pain in her arm; Difficulty in moving arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes virus infection.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, mobility decreased, burning foot and pins and needles. On an unknown date, the outcome of the pain in arm, mobility decreased, burning foot and pins and needles were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased, burning foot and pins and needles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix a little over 2 months prior to the 2nd dose of Shinrix. After the 1st dose, that evening she started experiencing pain in her arm that lasted for 4 days. The pain was severe and prevented her from moving her arm. About 1.5 weeks after getting the Shingrix she started having a burning sensation in her feet. Almost like pins and needles in her toes and the pads of her feet. This lasted for over 2 weeks until resolving. The reporter did not give consent to follow up. The request has been placed to the HUB for creation of additional case for The same patient who experienced an adverse event after 2nd dose as well. For tolerance to next dose, refer case US2019AMR120166.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: inappropriate route at vaccination; localized reactions; This case was reported by a nurse via call center representative and described the occurrence of local reaction in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th June 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 6th June 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2019, the patient experienced local reaction. On an unknown date, the outcome of the local reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix via subcutaneous route instead of receiving intramuscularly, which led to intramuscular formulation administered by other route. The patient had also experienced localized reactions.  The nurse proceeded to call GSK medical information for directions on next steps. The reporter did not consent to follow-up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failurew; Shingles; inappropriate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2018, the patient received the 1st dose of Shingrix. On 27th March 2019, the patient received the 2nd dose of Shingrix. On 27th March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shigrix later than the recommended schedule, which led to lengthening of vaccination schedule. After receiving the 2nd dose of the Shingrix, the patient developed shingles (dates were unknown) and current status was also not known.  This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for herpes zoster were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine; shivering; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the shivering and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shivering and feeling bad for 2 days. The patient had missed the 6 month window for the second dose which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter declined to provide any demographics and declined any follow up. This case been linked with the case US2019115946, reported by same reporter. There is a discrepancy between the outcome reported in the structured field "resolved with sequel" and the outcome reported in the sender's comment " shivering and feeling bad for 2 days
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine; shivering; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the shivering and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering and feeling bad to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced shivering and feeling bad for 2 days. The patient had missed the 6 month window for the second dose which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter declined to provide any demographics and declined any follow up. This case been linked with the case US2019115941, reported by same reporter. There is a discrepancy between the outcome reported in the structured field "resolved with sequel" and the outcome reported in the sender's comment " shivering and feeling bad for 2 days".
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: adverse event; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that a patient had an unspecified reaction to a flue vaccine.  No details given. The reporter declined to provide information.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: Vaccination Failure; Diarrhea; Vomiting; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Y5CZ7, expiry date 28th February 2019) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 9R3ZC, expiry date 14th October 2019) for prophylaxis.   On 13th March 2018, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 29th May 2018, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 11th June 2019, 1 year and 90 days after receiving Rotarix lyophilized formulation and 1 year and 13 days after receiving Rotarix lyophilized formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria GSK medically significant) and vomiting. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus and vomiting were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and vomiting to be related to Rotarix lyophilized formulation and Rotarix lyophilized formulation.  Additional details were provided as follows: The patient developed symptoms but was seen in the office for a rectal swab which returned positive for rotavirus. The reporter was okay for follow-up. This case was linked to case US2019117690 reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: presents with neuropathy since December 2017 from chemo with vaccination reaction. She had the shingles shot on May 6 th  And then 2 hours later she started getting pains in her legs . It was into her shins and feet . It's especially at night. The location of the pain is from the hips down . The quality of the pain is cramping and with paresthesia  ( since 2017 dec). The severity of the pain is 8/10.The onset of pain was approximately  6weeks ago. The timing of the pain is constant . The pain is worse with  nothing she can think of . The pain is made better with alleve twice a day , biofreeze .  She hasn't been able to do the gym or climb the stairs .  She walks up side step because of pain and weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: presents with neuropathy since December 2017 from chemo with vaccination reaction. She had the shingles shot on May 6 th  And then 2 hours later she started getting pains in her legs . It was into her shins and feet . It's especially at night. The location of the pain is from the hips down . The quality of the pain is cramping and with paresthesia  ( since 2017 dec). The severity of the pain is 8/10.The onset of pain was approximately  6weeks ago. The timing of the pain is constant . The pain is worse with  nothing she can think of . The pain is made better with alleve twice a day , biofreeze .  She hasn't been able to do the gym or climb the stairs .  She walks up side step because of pain and weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Bone pain, Dysstasia, Electromyogram, Gait disturbance
Clinical narrative: presents with neuropathy since December 2017 from chemo with vaccination reaction. She had the shingles shot on May 6 th  And then 2 hours later she started getting pains in her legs . It was into her shins and feet . It's especially at night. The location of the pain is from the hips down . The quality of the pain is cramping and with paresthesia  ( since 2017 dec). The severity of the pain is 8/10.The onset of pain was approximately  6weeks ago. The timing of the pain is constant . The pain is worse with  nothing she can think of . The pain is made better with alleve twice a day , biofreeze .  She hasn't been able to do the gym or climb the stairs .  She walks up side step because of pain and weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nerve conduction studies, Neuralgia, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: presents with neuropathy since December 2017 from chemo with vaccination reaction. She had the shingles shot on May 6 th  And then 2 hours later she started getting pains in her legs . It was into her shins and feet . It's especially at night. The location of the pain is from the hips down . The quality of the pain is cramping and with paresthesia  ( since 2017 dec). The severity of the pain is 8/10.The onset of pain was approximately  6weeks ago. The timing of the pain is constant . The pain is worse with  nothing she can think of . The pain is made better with alleve twice a day , biofreeze .  She hasn't been able to do the gym or climb the stairs .  She walks up side step because of pain and weakness.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Quality of life decreased, Spinal X-ray, X-ray of pelvis and hip
Clinical narrative: presents with neuropathy since December 2017 from chemo with vaccination reaction. She had the shingles shot on May 6 th  And then 2 hours later she started getting pains in her legs . It was into her shins and feet . It's especially at night. The location of the pain is from the hips down . The quality of the pain is cramping and with paresthesia  ( since 2017 dec). The severity of the pain is 8/10.The onset of pain was approximately  6weeks ago. The timing of the pain is constant . The pain is worse with  nothing she can think of . The pain is made better with alleve twice a day , biofreeze .  She hasn't been able to do the gym or climb the stairs .  She walks up side step because of pain and weakness.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Headache, Nausea
Clinical narrative: 4-5 hours after vaccination I got dizzy, nauseous, vomited multiple time, shaking, hot then cold, fatigued, terrible headache. adverse  reactions lasted at least 24 hours after onset and slowly went away over next 24 hours. Approximately 48 hours of misery
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: 4-5 hours after vaccination I got dizzy, nauseous, vomited multiple time, shaking, hot then cold, fatigued, terrible headache. adverse  reactions lasted at least 24 hours after onset and slowly went away over next 24 hours. Approximately 48 hours of misery
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Body temperature decreased, Body temperature increased, Decreased appetite
Clinical narrative: Dizzy, off-balance, nausea, low temp (95.9) followed later by high temp (100.3)  complete fatigue, unable to eat/keep food down..shaking, normal sleep/wake pattern turned upside down, pain and swelling at injection site, exhausted and weak.  Adverse events started 3-4 hours after shot. peaked between approx 36-48 hours post shot, slowly diminished and episode ended approx 72 hours after shot.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Dizzy, off-balance, nausea, low temp (95.9) followed later by high temp (100.3)  complete fatigue, unable to eat/keep food down..shaking, normal sleep/wake pattern turned upside down, pain and swelling at injection site, exhausted and weak.  Adverse events started 3-4 hours after shot. peaked between approx 36-48 hours post shot, slowly diminished and episode ended approx 72 hours after shot.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder, Tremor, Vomiting
Clinical narrative: Dizzy, off-balance, nausea, low temp (95.9) followed later by high temp (100.3)  complete fatigue, unable to eat/keep food down..shaking, normal sleep/wake pattern turned upside down, pain and swelling at injection site, exhausted and weak.  Adverse events started 3-4 hours after shot. peaked between approx 36-48 hours post shot, slowly diminished and episode ended approx 72 hours after shot.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site plaque, Injection site pruritus
Clinical narrative: Pt reports a "bruise" that developed at the site of the MMR injection shortly after receiving the injection (time frame unclear).  The bruise then became a patch of red, itchy, scaly skin.  Pt reported 1 month later for her 2nd dose of MMR.  On exam, at the site of the MMR injection, pt had a 4 cm well demarcated raised plaque with fine-to-medium size scale.  The plaque was surrounded by hyperpigmentation.  There was underlying tissue edema.  Pt denies prior hx of skin conditions.  Denied systemic symptoms following injections.  Pt was given triamcinolone 0.1% cream for BID use to help resolve the presumed fixed drug reaction.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site reaction, Skin exfoliation
Clinical narrative: Pt reports a "bruise" that developed at the site of the MMR injection shortly after receiving the injection (time frame unclear).  The bruise then became a patch of red, itchy, scaly skin.  Pt reported 1 month later for her 2nd dose of MMR.  On exam, at the site of the MMR injection, pt had a 4 cm well demarcated raised plaque with fine-to-medium size scale.  The plaque was surrounded by hyperpigmentation.  There was underlying tissue edema.  Pt denies prior hx of skin conditions.  Denied systemic symptoms following injections.  Pt was given triamcinolone 0.1% cream for BID use to help resolve the presumed fixed drug reaction.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash pruritic
Clinical narrative: On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; On 6/21/2019 and was "seen for sore throat, fever from an unspecified cause, and a pruritic rash, with an unspecified etiology"; This spontaneous report was received from a nurse practitioner and refers to a 49-year-old non-pregnant female patient. The patient's pertinent medical history and concomitant therapies were not provided. She had no drug reactions or allergies.  On 07-JUN-2019, the patient was vaccinated with a one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously (lot # R031628 has been verified to be a valid lot number, expiration date was reported as 01-NOV-2020 and was confirmed to be valid expiration date; albumin status: rHA; exact dose and anatomical location were not reported) for measles, mumps, rubella protection. On 21-JUN-2019, she experienced sore throat, fever of unknown origin (reported as unspecified cause) and pruritic rash with an unspecified etiology. On the same date, the patient visited clinic where she received treatment and on the same date, was released. On 22-JUN-2019, the patient was on follow up visit and reported similar complains. During this visit, she was treated and on the same date, was released. On the same date later, the patient visited emergency room (ER) and was admitted to the hospital (the reporter did not know what treatment was given upon admittance). On 25-JUN-2019, she recovered from reported symptoms and was discharged from the hospital.  Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA010772:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000862: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000928: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000862: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Sex: M
Vaccine: MENB
Symptoms: Erythema, Influenza like illness, Lethargy, Mobility decreased, Musculoskeletal pain
Clinical narrative: shoulder pain; lethargy; flu like symptoms; fever; softball-size redness; unable to lift arm; unable to lift arm past 45° without pain; This case was reported by a physician via sales rep and described the occurrence of shoulder pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement. On an unknown date, the outcome of the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement were unknown.   It was unknown if the reporter considered the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Bexsero vaccine, the patient experienced extreme shoulder pain, lethargy, flu like symptoms, 100.9 degree C fever, softball size redness, unable to lift arm past 45° without pain. It was unknown, if the reporter consented for follow up.      Lab Comments: On an unknown date, lab test was performed.
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: shoulder pain; lethargy; flu like symptoms; fever; softball-size redness; unable to lift arm; unable to lift arm past 45° without pain; This case was reported by a physician via sales rep and described the occurrence of shoulder pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement. On an unknown date, the outcome of the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement were unknown.   It was unknown if the reporter considered the shoulder pain, lethargy, influenza-like symptoms, fever, erythema, mobility decreased and pain upon movement to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Bexsero vaccine, the patient experienced extreme shoulder pain, lethargy, flu like symptoms, 100.9 degree C fever, softball size redness, unable to lift arm past 45° without pain. It was unknown, if the reporter consented for follow up.      Lab Comments: On an unknown date, lab test was performed.
Sex: F
Vaccine: MENB
Symptoms: Gait inability, Pain in extremity, Product administered at inappropriate site
Clinical narrative: inappropriate injection site; pain; unable to walk proprerly; This case was reported by a nurse via sales rep and described the occurrence of leg pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2018, the patient received Bexsero .5 ml. In July 2018, unknown after receiving Bexsero, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced leg pain and unable to walk. On an unknown date, the outcome of the leg pain and unable to walk were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the leg pain and unable to walk to be related to Bexsero.  Additional details were provided as follows: The reporter gave consent to follow up. The patient received a dose of Bexsero in the leg per her mother's request. The patient declined to receive the 2nd dose of Bexsero. The patient did not notify the clinic until 27th June 2019.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever; Body ache; Soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (at 25 years old).   On 15th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th April 2019, less than a day after receiving Shingrix, the patient experienced general body pain and injection site pain. On 16th April 2019, the patient experienced fever. On 17th April 2019, the outcome of the fever and general body pain were recovered/resolved. On 18th April 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the fever, general body pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The patient expereinced fever which lasted for 24 hours after receiving 1st dose of Shingrix. The patient also experienced soreness at injection site which lasted for 3 days and body ache which lasted for 2 days after receiving 1st dose of Shingrix vaccine. No further details were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: red lump at injection site; raised lump that's hot.; Injection site raised; Injection site redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KR7G2, expiry date 2nd June 2021) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th June 2019, 1 days after receiving Shingrix, the patient experienced injection site lump, injection site warmth, injection site swelling and injection site erythema. On 1st July 2019, the outcome of the injection site lump, injection site warmth, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient experienced raised red lump that was hot at the injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Itching on Right Arm up; Tingling sensation on Right Arm; Rash on Right Arm; Red spots rash; raised spots rash; Red rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy upper limbs in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 5th March 2019, the patient received the 2nd dose of Shingrix. In April 2019, 30 days after receiving Shingrix, the patient experienced itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash. On an unknown date, the outcome of the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash were unknown.   It was unknown if the reporter considered the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. One month after receiving Shingrix, the patient experienced itching, tingling sensation on right arm up and down. The rash appeared as isolated spots, red and slightly raised with the size of 1 quarter of a dime size. The rash appeared and disappeared on and off.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Itching on Right Arm up; Tingling sensation on Right Arm; Rash on Right Arm; Red spots rash; raised spots rash; Red rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy upper limbs in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 5th March 2019, the patient received the 2nd dose of Shingrix. In April 2019, 30 days after receiving Shingrix, the patient experienced itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash. On an unknown date, the outcome of the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash were unknown.   It was unknown if the reporter considered the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. One month after receiving Shingrix, the patient experienced itching, tingling sensation on right arm up and down. The rash appeared as isolated spots, red and slightly raised with the size of 1 quarter of a dime size. The rash appeared and disappeared on and off.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain
Clinical narrative: pain; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site pain and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The reporter reported adverse event for her husband. The patient received 1st dose of Shingrix in his left arm. When the patient got the injection, it hurt at the injection site and had some redness on the left arm which resolved in a few days.  The patient was planning to not to receive the 2nd dose of the Shingrix vaccine. The patient consented to follow up and provided his physician's details. Additional information was not specified.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: pain at injection site /soreness at injection site; small knot at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number LE55F, expiry date 13th September 2021) for prophylaxis.   On 12th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site lump to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received first dose of Shingrix and experienced pain and soreness at injection site that was resolved. The patient reported that he had a small knot at the site of the injection that had not resolved. There was a discrepancy in the outcome of the event in the source document it was reported as recovered/ /resolved with sequel, but in the database it reported as recovered.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Nausea, Pain in jaw
Clinical narrative: After Tdap injection in left arm, pt complained of left jaw pain. Then after a few minutes, felt faint and sick to stomach with headache.  Pt laid on table x 20 min and given ice on back of neck to cool down, along with cold water. Pt was able to ambulate and leave with parent.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient did not consult until well after the initial reaction occurred but I observed diffuse redness of the left  deltoid area.  Patient stated that that area in days previous was swollen, warm to the touch, and red.  Patient did experience pain possibly due to inflammation.  Patient did not treat herself or seek treatment for reaction.  Reaction was subsiding by the time I was notified
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Patient did not consult until well after the initial reaction occurred but I observed diffuse redness of the left  deltoid area.  Patient stated that that area in days previous was swollen, warm to the touch, and red.  Patient did experience pain possibly due to inflammation.  Patient did not treat herself or seek treatment for reaction.  Reaction was subsiding by the time I was notified
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Decreased appetite, Dizziness, Nausea
Clinical narrative: Within 30-60 min post vaccination had dizziness and nausea. Denied SOB, rash, swelling, problems breathing or swallowing. Denied problems with previous immunizations to include influenza vaccine. The symptoms persisted and the following day he also reported that he was feeling weak, shaky and had a decrease in appetite. He sought medical care and was assessed as having an adverse effect of the flu vaccine.Was reevaluated on 23 Oct for persistence of symptoms. No worsening. Reported that he would have waves of intermittent dizziness and a sensation that his balance is not right. Denies fever. Follow up on 26 Oct noted improvement but has not returned to baseline. Episodes of dizziness persisted, no weakness and has been able to run 3 miles without difficulty. On 29 Oct he underwent a neurology evaluation. No pathologic process could be identified, and his neuro exam was normal. Ordered MR was not performed as symptoms resolved before it could be scheduled  Symptoms: DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), WEAKNESS(R531).
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Neurological examination normal, Tremor
Clinical narrative: Within 30-60 min post vaccination had dizziness and nausea. Denied SOB, rash, swelling, problems breathing or swallowing. Denied problems with previous immunizations to include influenza vaccine. The symptoms persisted and the following day he also reported that he was feeling weak, shaky and had a decrease in appetite. He sought medical care and was assessed as having an adverse effect of the flu vaccine.Was reevaluated on 23 Oct for persistence of symptoms. No worsening. Reported that he would have waves of intermittent dizziness and a sensation that his balance is not right. Denies fever. Follow up on 26 Oct noted improvement but has not returned to baseline. Episodes of dizziness persisted, no weakness and has been able to run 3 miles without difficulty. On 29 Oct he underwent a neurology evaluation. No pathologic process could be identified, and his neuro exam was normal. Ordered MR was not performed as symptoms resolved before it could be scheduled  Symptoms: DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), WEAKNESS(R531).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Heart rate decreased, Hypotension, Loss of consciousness, Skin laceration
Clinical narrative: passed out
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Suture insertion
Clinical narrative: passed out
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site vesicles, Pyrexia
Clinical narrative: Vaccine given on 07/01/19. Redness and itching at the injection site, fever, and vomiting started on 07/02/19. Patient returned to office on 07/03/19. Site had a 4x5 cm area of erythema with a papular rash. On 07/04/19 vesicles appeared. On 07/05/19 patient returned to the office with 13x12 cm area of erythema to the medial aspect of the right leg with intact vesicles in a semicircular/ lunar configuration on the left side of vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash papular, Vomiting
Clinical narrative: Vaccine given on 07/01/19. Redness and itching at the injection site, fever, and vomiting started on 07/02/19. Patient returned to office on 07/03/19. Site had a 4x5 cm area of erythema with a papular rash. On 07/04/19 vesicles appeared. On 07/05/19 patient returned to the office with 13x12 cm area of erythema to the medial aspect of the right leg with intact vesicles in a semicircular/ lunar configuration on the left side of vaccine site.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: injection pain, swelling, headache, fever-like aches, nausea
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: injection pain, swelling, headache, fever-like aches, nausea
Age: 9.0
Sex: M
Vaccine: RAB
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever (Tmax 102.5F) w/ myalgias. fever resolved with 1 dose of Tylenol. no ongoing symptoms
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: titers for measles were low; This spontaneous report was received from a nurse and refers to a 58-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, as a child, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection for prophylaxis (dose, route of administration, injection site, lot # and expiration date were not reported). On an unknown date, the patient's titers for measles were low(exact results were not provided). The outcome the event was unknown. The relatedness between the event and the suspect product was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Keratitis interstitial, Ophthalmic herpes zoster, Rash, Rash vesicular
Clinical narrative: interstitial keratitis; Shingles; visual disturbance in left eye due to shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, reported as after injection, the patient suffered a painful blistering rash on the left side of his face, forhead and scalps. As a result of his symptoms, the pt presented to a medical provideder and was diagnosed with shingles, as well as, visual disturbance in left eye due to shingles and interstital keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcomes of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the events of keratitis interstitial and visual disturbance in left eye due to shingles were determined to be medically significant.