chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Neurological side effect of sensory neuropathy in the arms and legs; pins and needle sensation that goes and comes; Based on information received on 12-Oct-2020, the report previously considered as non-valid became valid: [events peripheral sensory neuropathy and paraesthesia added].  Initial information regarding an unsolicited non-valid non-serious case was received from a consumer (patient) via agency (Reference number- 00313675) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 61-years-old female patient who experienced neurological side effect of sensory neuropathy in the arms and legs (peripheral sensory neuropathy) and pins and needle sensation that goes and comes (paraesthesia), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included CIPRO [CIPROFLOXACIN] and had same neurological side effects that lasted 8 to 9 months.  The patient's medical history, past vaccinations, family history were not provided. The patient did not receive any concomitant medications.  On 30-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patient developed neurological side effect of sensory neuropathy in the arms and legs (peripheral sensory neuropathy) and pins and needle sensation that goes and comes (paraesthesia) two days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from the events.  There will be no information on the batch number for this case.  Follow up information regarding an unsolicited valid non-serious case was received from a consumer (patient) via agency (Reference number- 00311975) and transmitted to Sanofi on 12-Oct-2020 (as per source).  Case became valid, events (peripheral sensory neuropathy and paraesthesia) along with as reported added, historical drug, suspect vaccine updated to FLUZONE QUADRIVALENT, vaccination date and dosing details, event onset date added and event outcome updated.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Burning sensation, Neurological symptom, Physical examination normal
Clinical narrative: Neurological side effect of sensory neuropathy in the arms and legs; pins and needle sensation that goes and comes; Based on information received on 12-Oct-2020, the report previously considered as non-valid became valid: [events peripheral sensory neuropathy and paraesthesia added].  Initial information regarding an unsolicited non-valid non-serious case was received from a consumer (patient) via agency (Reference number- 00313675) and transmitted to Sanofi on 13-Oct-2020.  This case involves a 61-years-old female patient who experienced neurological side effect of sensory neuropathy in the arms and legs (peripheral sensory neuropathy) and pins and needle sensation that goes and comes (paraesthesia), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included CIPRO [CIPROFLOXACIN] and had same neurological side effects that lasted 8 to 9 months.  The patient's medical history, past vaccinations, family history were not provided. The patient did not receive any concomitant medications.  On 30-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Suspension for injection, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patient developed neurological side effect of sensory neuropathy in the arms and legs (peripheral sensory neuropathy) and pins and needle sensation that goes and comes (paraesthesia) two days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from the events.  There will be no information on the batch number for this case.  Follow up information regarding an unsolicited valid non-serious case was received from a consumer (patient) via agency (Reference number- 00311975) and transmitted to Sanofi on 12-Oct-2020 (as per source).  Case became valid, events (peripheral sensory neuropathy and paraesthesia) along with as reported added, historical drug, suspect vaccine updated to FLUZONE QUADRIVALENT, vaccination date and dosing details, event onset date added and event outcome updated.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: localized reaction of redness, swelling of over the size of a golf ball and pain; Localized reaction of redness, swelling of over the size of a golf ball and pain; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a 74 years old male patient who experienced localized reaction of redness, swelling of over the size of a golf ball and pain (Inflammation and vaccination site reaction), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive other vaccine concomitantly.  On 21-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ483AB, expiration date 30-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  On 26-Oct-2020, the patient developed non-serious localized reaction of redness, swelling of over the size of a golf ball and pain (Inflammation and vaccination site reaction), 5 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient was held on observation, no breathing or any other issues were reported, so he was discharged the same day of the vaccine.    Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome for the events was unknown.
Sex: M
Vaccine: FLUR4
Symptoms: Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: 1cm nodule in left neck, 1 adjacent sub cm in size and palpable lump just above the clavicle which was a probable reactive lymph node; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00332508) and transmitted to Sanofi on 26-Oct-2020.  This case involves a male patient (unknown demography) who developed 1cm nodule in left neck, 1 adjacent sub cm in size and palpable lump just above the clavicle which was a probable reactive lymph node (lymphadenopathy),while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not get any concomitant vaccines.  On an unknown date (reported as on 19th), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2034, expiration date: 30-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination.  On an unknown date (also reported as through the night of the 20th and the 21st), the patient developed a non-serious palpable lump just above the clavicle and 1cm nodule in his left neck and 1 adjacent sub cm in size (lymphadenopathy) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (unknown latency).  Relevant laboratory test results included: Ultrasound scan performed after 48 hours of vaccination showed probable reactive lymph node.  It was not reported if the patient received any corrective treatment or not.  The reporter stated that they were not sure if it is a reaction but they wanted to check to see if this was a possible reaction or just incidental. Reporter also stated that the radiologist who did the ultrasound thought there was no correlation.  At the time of report, outcome of lymphadenopathy was unknown.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Hot flush, Loss of consciousness
Clinical narrative: having hot flashes; patient passed out; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case received from a nurse.  This case involves a 72 year-old female patient who experienced hot flashes (hot flush) and passed out after having another hot flash (loss of consciousness), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.   On 02-Nov-2020, the patient received (once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ511AA and expiry date 30-Jun-2021) via intramuscular route in the right arm (it was assumed that it was the patient's deltoid) for prophylactic vaccination.  On 02-Nov-2020, the patient had serious hot flashes (hot flush) two hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date in Nov-2020, the patient passed out after having another hot flash (loss of consciousness) more than 24 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   These events were assessed as medically significant.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.; Sender's Comments: This case involves a 72 year-old female patient who experienced hot flush and loss of consciousness after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Sensory disturbance
Clinical narrative: Patient reports the nurse used the upper 1/3 of deltoid region, had difficulty injecting. She felt immediate pain, and a "dead arm " sensation.  Has significant discomfort, right shoulder decreased rom.  Sought care 11/11/20.  Started aleve, ice.  Now has mild improving symptoms
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: Approximately 30 minutes after administration, patient reported swelling and erythema of L arm, starting with injection site (vaccine given in L deltoid). Swelling and erythema then spread to R arm. She developed erythematous rash across chest and nausea.  PO benadryl, PO zofran,  and IM solumedrol injection were administered in clinic.  Patient was monitored for > 1 hour. Swelling, rash, and nausea resolved. Vitals stable. Patient discharged home. She returned to clinic the next day for nurse visit for follow up and reported she was feeling well.  Tdap vaccine was also given in clinic the same day (opposite arm) but patient states that symptoms started before administration of Tdap and symptoms started at injection site for Flulaval vaccine. She also reports previous history of reaction to flu vaccines. She also reports history of egg intolerance and has been using protein powder with egg.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Approximately 30 minutes after administration, patient reported swelling and erythema of L arm, starting with injection site (vaccine given in L deltoid). Swelling and erythema then spread to R arm. She developed erythematous rash across chest and nausea.  PO benadryl, PO zofran,  and IM solumedrol injection were administered in clinic.  Patient was monitored for > 1 hour. Swelling, rash, and nausea resolved. Vitals stable. Patient discharged home. She returned to clinic the next day for nurse visit for follow up and reported she was feeling well.  Tdap vaccine was also given in clinic the same day (opposite arm) but patient states that symptoms started before administration of Tdap and symptoms started at injection site for Flulaval vaccine. She also reports previous history of reaction to flu vaccines. She also reports history of egg intolerance and has been using protein powder with egg.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Allergy to vaccine, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approximately 30 minutes after administration, patient reported swelling and erythema of L arm, starting with injection site (vaccine given in L deltoid). Swelling and erythema then spread to R arm. She developed erythematous rash across chest and nausea.  PO benadryl, PO zofran,  and IM solumedrol injection were administered in clinic.  Patient was monitored for > 1 hour. Swelling, rash, and nausea resolved. Vitals stable. Patient discharged home. She returned to clinic the next day for nurse visit for follow up and reported she was feeling well.  Tdap vaccine was also given in clinic the same day (opposite arm) but patient states that symptoms started before administration of Tdap and symptoms started at injection site for Flulaval vaccine. She also reports previous history of reaction to flu vaccines. She also reports history of egg intolerance and has been using protein powder with egg.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Approximately 30 minutes after administration, patient reported swelling and erythema of L arm, starting with injection site (vaccine given in L deltoid). Swelling and erythema then spread to R arm. She developed erythematous rash across chest and nausea.  PO benadryl, PO zofran,  and IM solumedrol injection were administered in clinic.  Patient was monitored for > 1 hour. Swelling, rash, and nausea resolved. Vitals stable. Patient discharged home. She returned to clinic the next day for nurse visit for follow up and reported she was feeling well.  Tdap vaccine was also given in clinic the same day (opposite arm) but patient states that symptoms started before administration of Tdap and symptoms started at injection site for Flulaval vaccine. She also reports previous history of reaction to flu vaccines. She also reports history of egg intolerance and has been using protein powder with egg.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: On 11/12/20, 47 yo F presented to clinic for annual physical exam. This was pt's first encounter at clinic after moving to the area. During this visit, pt requested immunization with "Flublok". CMA went to consult with RN, but RN was unavailable. CMA consulted with another colleague and it was determined that Flublok was a preservative free vaccine. [NOTE: it is also egg and thimeroal free]. CMA was directed to the preservative-free quadrivalent vaccine. CMA took the vaccine into the pt room and confirmed that pt wished to proceed. Pt declined waiting for RN and authorized vaccination. CMA cleaned the left deltoid with an alcohol wipe and injected 0.5 mL (FLULAVAL QUAD 2020-2021 (PF); NDC #19515-0816-52; Lot #ZK9TH; Exp: 6/30/2021). Pt c/o burning on injection and CMA reassured that this was likely from the alcohol. CMA then left room to attend to another pt. On return, pt c/o redness and swelling at the injection site. Provider notified and pt exam found that swelling spread to right arm and pt also developed erythematous patches on chest and complained of nausea. Pt was ordered and administered methylprednisolone 125 mg IM, diphenhydramine exilir 50 mg PO and ondansetron 4 mg PO. After interventions, pt reported symptom relief. Pt was held in observation x 1 hour. On 11/12, pt'a allergy profile was updated to include Flulaval Quad 2020-2021 (pf) [Flu Vacc Qs2020-21 6mos Up(pf)] (rxn: Anaphylaxis; severity: High; Reaction Type: Adverse Reaction) with comment "Pt needs to be given Flublok in the future." Flulaval is identified as latex free, preservative free, thimerosal free. Flulaval is not identified as egg free. Pt's allergy profile does NOT include egg, but it does include latex.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: On 11/12/20, 47 yo F presented to clinic for annual physical exam. This was pt's first encounter at clinic after moving to the area. During this visit, pt requested immunization with "Flublok". CMA went to consult with RN, but RN was unavailable. CMA consulted with another colleague and it was determined that Flublok was a preservative free vaccine. [NOTE: it is also egg and thimeroal free]. CMA was directed to the preservative-free quadrivalent vaccine. CMA took the vaccine into the pt room and confirmed that pt wished to proceed. Pt declined waiting for RN and authorized vaccination. CMA cleaned the left deltoid with an alcohol wipe and injected 0.5 mL (FLULAVAL QUAD 2020-2021 (PF); NDC #19515-0816-52; Lot #ZK9TH; Exp: 6/30/2021). Pt c/o burning on injection and CMA reassured that this was likely from the alcohol. CMA then left room to attend to another pt. On return, pt c/o redness and swelling at the injection site. Provider notified and pt exam found that swelling spread to right arm and pt also developed erythematous patches on chest and complained of nausea. Pt was ordered and administered methylprednisolone 125 mg IM, diphenhydramine exilir 50 mg PO and ondansetron 4 mg PO. After interventions, pt reported symptom relief. Pt was held in observation x 1 hour. On 11/12, pt'a allergy profile was updated to include Flulaval Quad 2020-2021 (pf) [Flu Vacc Qs2020-21 6mos Up(pf)] (rxn: Anaphylaxis; severity: High; Reaction Type: Adverse Reaction) with comment "Pt needs to be given Flublok in the future." Flulaval is identified as latex free, preservative free, thimerosal free. Flulaval is not identified as egg free. Pt's allergy profile does NOT include egg, but it does include latex.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Allergy to vaccine, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 11/12/20, 47 yo F presented to clinic for annual physical exam. This was pt's first encounter at clinic after moving to the area. During this visit, pt requested immunization with "Flublok". CMA went to consult with RN, but RN was unavailable. CMA consulted with another colleague and it was determined that Flublok was a preservative free vaccine. [NOTE: it is also egg and thimeroal free]. CMA was directed to the preservative-free quadrivalent vaccine. CMA took the vaccine into the pt room and confirmed that pt wished to proceed. Pt declined waiting for RN and authorized vaccination. CMA cleaned the left deltoid with an alcohol wipe and injected 0.5 mL (FLULAVAL QUAD 2020-2021 (PF); NDC #19515-0816-52; Lot #ZK9TH; Exp: 6/30/2021). Pt c/o burning on injection and CMA reassured that this was likely from the alcohol. CMA then left room to attend to another pt. On return, pt c/o redness and swelling at the injection site. Provider notified and pt exam found that swelling spread to right arm and pt also developed erythematous patches on chest and complained of nausea. Pt was ordered and administered methylprednisolone 125 mg IM, diphenhydramine exilir 50 mg PO and ondansetron 4 mg PO. After interventions, pt reported symptom relief. Pt was held in observation x 1 hour. On 11/12, pt'a allergy profile was updated to include Flulaval Quad 2020-2021 (pf) [Flu Vacc Qs2020-21 6mos Up(pf)] (rxn: Anaphylaxis; severity: High; Reaction Type: Adverse Reaction) with comment "Pt needs to be given Flublok in the future." Flulaval is identified as latex free, preservative free, thimerosal free. Flulaval is not identified as egg free. Pt's allergy profile does NOT include egg, but it does include latex.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea, Peripheral swelling
Clinical narrative: On 11/12/20, 47 yo F presented to clinic for annual physical exam. This was pt's first encounter at clinic after moving to the area. During this visit, pt requested immunization with "Flublok". CMA went to consult with RN, but RN was unavailable. CMA consulted with another colleague and it was determined that Flublok was a preservative free vaccine. [NOTE: it is also egg and thimeroal free]. CMA was directed to the preservative-free quadrivalent vaccine. CMA took the vaccine into the pt room and confirmed that pt wished to proceed. Pt declined waiting for RN and authorized vaccination. CMA cleaned the left deltoid with an alcohol wipe and injected 0.5 mL (FLULAVAL QUAD 2020-2021 (PF); NDC #19515-0816-52; Lot #ZK9TH; Exp: 6/30/2021). Pt c/o burning on injection and CMA reassured that this was likely from the alcohol. CMA then left room to attend to another pt. On return, pt c/o redness and swelling at the injection site. Provider notified and pt exam found that swelling spread to right arm and pt also developed erythematous patches on chest and complained of nausea. Pt was ordered and administered methylprednisolone 125 mg IM, diphenhydramine exilir 50 mg PO and ondansetron 4 mg PO. After interventions, pt reported symptom relief. Pt was held in observation x 1 hour. On 11/12, pt'a allergy profile was updated to include Flulaval Quad 2020-2021 (pf) [Flu Vacc Qs2020-21 6mos Up(pf)] (rxn: Anaphylaxis; severity: High; Reaction Type: Adverse Reaction) with comment "Pt needs to be given Flublok in the future." Flulaval is identified as latex free, preservative free, thimerosal free. Flulaval is not identified as egg free. Pt's allergy profile does NOT include egg, but it does include latex.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Pain, Pain in extremity
Clinical narrative: excruciating pain in arm (couldn't move arm for 5 days) bad headache, chills/shivering, fever, all-over body ache, no apetite - lasting 4 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: excruciating pain in arm (couldn't move arm for 5 days) bad headache, chills/shivering, fever, all-over body ache, no apetite - lasting 4 days
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: The patient experienced swelling and the inner triceps area of ??the left arm warm. She took APAP.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Computerised tomogram head normal, Full blood count normal, Headache, Immediate post-injection reaction, Metabolic function test normal
Clinical narrative: Almost immediately following the immunizations pt experienced extreme, debilitating headache with nausea.   Progressively became a 10 out of 10 on pain scale.  Mom called EMS and patient was transported to ED.  Pt was given a CT scan which was negative.  In ED pt received Ketorolac 30mg IV as well as Ondansetron 4mg IV.   Symptoms resolved after a few hours.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Nausea
Clinical narrative: Almost immediately following the immunizations pt experienced extreme, debilitating headache with nausea.   Progressively became a 10 out of 10 on pain scale.  Mom called EMS and patient was transported to ED.  Pt was given a CT scan which was negative.  In ED pt received Ketorolac 30mg IV as well as Ondansetron 4mg IV.   Symptoms resolved after a few hours.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller is a nurse reporting a temperature excursion, requesting stability data; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.      On 21-OCT-2020, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot number was T009929, expiration date was 16-SEP-2021, strength and route were not reported) for prophylaxis (improper storage of product in use).     Temperature excursion of this vaccine was -6.6 degrees Celsius for 1 hour and 45 minutes without any previous temperature excursion. The digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010348: US-009507513-2010USA010299: US-009507513-2010USA010518: US-009507513-2010USA010508: US-009507513-2010USA010598: US-009507513-2010USA010384: US-009507513-2010USA010735: US-009507513-2010USA010299: US-009507513-2010USA010348: US-009507513-2010USA010526: US-009507513-2010USA010709:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nightmare, Pain, Vaccination failure, Visual impairment
Clinical narrative: Got the shingles shot, then got shingles/ Suspected vaccination failure; Shingles; Pain; Visual symptoms were vague; nightmare; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, visual impairment and nightmare. On an unknown date, the outcome of the vaccination failure, visual impairment and nightmare were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, visual impairment and nightmare to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced shingles and the visual symptoms were vague, pain made him want to end it all, because no one could figure it out. it was a nightmare. The patient was ok at the time of reporting. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Diplegia
Clinical narrative: Paralyzed her legs; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis legs in a female 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. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced paralysis legs (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis legs was unknown.   The reporter considered the paralysis legs to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had no no any issues either, untill she got flu shot and it paralyzed her legs. This case is one of the 4 cases reported by same reporter out of which 2 were invalid.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225484:same reporter US-GLAXOSMITHKLINE-US2020AMR225504:same reporter US-GLAXOSMITHKLINE-US2020AMR225505:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: Flu/Probably coming down with the flu; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of influenza 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. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza and sickness. On an unknown date, the outcome of the influenza and sickness were unknown.   It was unknown if the reporter considered the influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient herself/himself via interactive digital media. The age at vaccination was not reported. The patient never got the flu vaccine but he/she was working at a nursing home. They suggested the patient to take the flu shot. The patient was sick and was told that he/she was probably coming down with the flu at the time of getting the flu shot.  No other information was reported. For tolerance of next years flu vaccination, refer case US2020AMR225528.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225528:Same patient
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: muscles aches; fatigue; headache; injection site became sore; injection site became sore, red; injection site became sore, red, and hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On 31st October 2020, the patient experienced muscle pain, fatigue and headache. On 5th November 2020, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved. On 7th November 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, muscle pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received blood thinner concomitantly. The patient received Shingrix in left arm. The patient stated that later that day her injection site became sore, red, and hot.  She also developed muscle aches and fatigue that both had improved but were still on going.  The patient also developed a headache on and resolved.  She stated she had COVID testing and results were pending. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: muscles aches; fatigue; headache; injection site became sore; injection site became sore, red; injection site became sore, red, and hot; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On 31st October 2020, the patient experienced muscle pain, fatigue and headache. On 5th November 2020, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved. On 7th November 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, muscle pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received blood thinner concomitantly. The patient received Shingrix in left arm. The patient stated that later that day her injection site became sore, red, and hot.  She also developed muscle aches and fatigue that both had improved but were still on going.  The patient also developed a headache on and resolved.  She stated she had COVID testing and results were pending. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Angina pectoris, Chest pain
Clinical narrative: angina; Initial information received on 02-Nov-2020 regarding an unsolicited valid serious case received from a physician.  This case involves female patient of an unknown age who experienced angina (angina pectoris), after she received vaccine INFLUENZA VACCINE.  Past vaccination included flu vaccine (last year) had experienced chest pain and angina. It was also reported that she was admitted to the emergency room and it was determined to be not an Immunoglobulin E (IgE) reaction.  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious angina (angina pectoris), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported that once again the patient was admitted to the emergency room for angina.   Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  Information on the batch number was requested.; Sender's Comments: This case involves a female patient of an unknown age who had angina pectoris, after vaccination with NFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased
Clinical narrative: Pt states recieved Flu shot on 10/08/2020 and has nit been able to move arm properly since
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphemia
Clinical narrative: Began Stuttering  3 days after receiving the Flu vaccine which
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: just in the arm that shingrix was administered, patient reported soreness and redness approximately 5 to 7 days after initial administration. also felt feverish.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Muscular weakness
Clinical narrative: weakness limbs hand and legs
Age: 53.0
Sex: F
Vaccine: FLU4, HEPAB, PNC13
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: nov 16 took shot at 10;00 am at 6;00 pm started with chills and fever and nausea 100.4 at 8:00 pm start severe headache lasted 24 hours nausea as well .Today November 18 no nausea ,fever or headaches but muscle pain in lower legs.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia
Clinical narrative: chills fever aches stomach pain
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Decreased appetite, Pain, Pyrexia
Clinical narrative: chills, fever, aches, cold sweats, lack of appetite
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fall, Feeling abnormal, Headache, Incontinence
Clinical narrative: Left gym felt ok. (worked for 20 mins). Picked up husband and started feeling sluggish with a small headache (around 4pm). Around 11, started feeling bad, went to use restroom, blacked out. Called husband to come help her in restroom. Started vomiting with diarrhea, urination on floor due to incapability to get up. Started feeling better around 6 am next morning. Tried to sleep but couldn't sleep. Still has sore arm and body sore from fall.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Loss of consciousness, Sluggishness, Vomiting
Clinical narrative: Left gym felt ok. (worked for 20 mins). Picked up husband and started feeling sluggish with a small headache (around 4pm). Around 11, started feeling bad, went to use restroom, blacked out. Called husband to come help her in restroom. Started vomiting with diarrhea, urination on floor due to incapability to get up. Started feeling better around 6 am next morning. Tried to sleep but couldn't sleep. Still has sore arm and body sore from fall.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Neck pain, Pain in extremity
Clinical narrative: Muscle aches in lower back and neck, sore arm, bad headache
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Rash
Clinical narrative: patient reported chills and soreness in arm as well as a rash
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Injection site swelling
Clinical narrative: SLIGHT HEADACHE, ACHY, COLD AND FATIGUE STARTED AROUND 8:00PM, 11/13/20.  OF COURSE, INJECTION SITE WAS RED, SWOLLEN AND WARM. WENT TO BED AT 9:30 WITH EXTRA COMFORTER AND CLOTHES. NEVER REALLY SLEPT, COULDN'T GET WARM, EVEN WITH THE ADDED HEATING PAD ON HIGH.  RIGHT HAD HURT BADLY.  GOT OUT OF BED AT 2:00AM TO USE BATHROOM AND GET MORE CLOTHES AND BLANKETS. TEETH CHATTERING, TOOK TEMP. NORMAL IS 96.6-97.8, IT WAS 100.6. FINALLY GOT LESS COLD AFTER HOT TEA.  STAYED IN BED UNTIL 11/15/20. GOT UP ONLY TO SIT IN RECLINER THE ENTIRE DAY.  FINALLY....MONDAY MORNING, WOKE UP FEELING 100% ME!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: SLIGHT HEADACHE, ACHY, COLD AND FATIGUE STARTED AROUND 8:00PM, 11/13/20.  OF COURSE, INJECTION SITE WAS RED, SWOLLEN AND WARM. WENT TO BED AT 9:30 WITH EXTRA COMFORTER AND CLOTHES. NEVER REALLY SLEPT, COULDN'T GET WARM, EVEN WITH THE ADDED HEATING PAD ON HIGH.  RIGHT HAD HURT BADLY.  GOT OUT OF BED AT 2:00AM TO USE BATHROOM AND GET MORE CLOTHES AND BLANKETS. TEETH CHATTERING, TOOK TEMP. NORMAL IS 96.6-97.8, IT WAS 100.6. FINALLY GOT LESS COLD AFTER HOT TEA.  STAYED IN BED UNTIL 11/15/20. GOT UP ONLY TO SIT IN RECLINER THE ENTIRE DAY.  FINALLY....MONDAY MORNING, WOKE UP FEELING 100% ME!
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Unevaluable event
Clinical narrative: Customer went to her physician complaining about her arm, prescribed ibuprofen and prednisone pack, mentioned she was having an MRI
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Nausea
Clinical narrative: muscle pain, tiredness, shivering, fever, nausea, insomnia that began the evening after my injection. they have continued for two days, although they were slightly less severe last night than the night before.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle pain, tiredness, shivering, fever, nausea, insomnia that began the evening after my injection. they have continued for two days, although they were slightly less severe last night than the night before.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient received DTap instead of Tdap.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: incorrect product storage; HCP calling to report patient was given PNEUMOVAX23 that was recalled; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug allergies/reactions were not reported.  On 22-OCT-2020, the patient was vaccinated with recalled dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter (lot # S036495, expiry date 13-SEP-2021), for prophylaxis.  On the same day, the patient experienced recalled product administered and product storage error.  It was also reported that the aforementioned vaccine was incorrectly stored (temperature excursion details were not reported) and administered to the patient before being recalled. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: had life long injuries; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injury. On an unknown date, the outcome of the injury was not recovered/not resolved.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.  Additional details were received as follows: The case was reported by the reporter for the father. The age at vaccination was not reported. The reporter stated that my father had life long injuries due to the shingles vaccine and was now in the law suit against the company.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked how long headache would last from Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles / I have broken out again; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the shingles vaccine 2 months ago and broke out with shingles.  The reporter wanted to know It's time to take the second shot and had broken out again. Should the second shingle shot be taken.
Sex: U
Vaccine: RV1
Symptoms: Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; Diarrhea that had been vaccinated; Tested positive for Rotavirus; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria GSK medically significant) and rotavirus infection. On an unknown date, the outcome of the vaccination failure, diarrhea rotavirus and rotavirus infection were unknown.   It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and rotavirus infection to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she had couple of patients who had been vaccinated and experienced diarrhea. She did a lab test and they tested positive for Rotavirus. The reporter did not consent to follow-up . This case is considered as suspected vaccination failure as time to onset and completion of primary schedule are unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Bad headache; muscle aches; shivering / shivers; 99.9 fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, shivering and fever. On an unknown date, the outcome of the headache, muscle pain, shivering and fever were unknown.   It was unknown if the reporter considered the headache, muscle pain, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix dose yesterday at 9:30 am. The patient experienced bad headache and muscle aches, shivering, fever temperature 99.9 degree F, shivers.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female 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 (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR224679:same reporter US-GLAXOSMITHKLINE-US2020222182:same reporter