chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Injection site reaction, Needle issue, Skeletal injury
Clinical narrative: Per patient, pharmacist inserted needle, claimed to have hit the bone and broke the needle and took the needle out, got a new syringe and inserted in upper arm again.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received Shingrix dose in left arm. At the time of reporting, the patient experienced redness at the injection site. The reporter did not consent to follow-up. No further details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Milk allergy
Clinical narrative: milk nausea and dizziness, weakness, fatigue, feel wired, una
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: milk nausea and dizziness, weakness, fatigue, feel wired, una
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given injection with sterile diluent expired. It was in the refrigerator with some that weren't expired and thought it was not expired. Patient has not had any reaction to it. Was wanting to inform about the injection given. We will repeat the injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Malaise
Clinical narrative: General malaise, light headed, upset stomach, dizziness
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 20-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: 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-009507513-1907USA000909: 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-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000862: US-009507513-1906USA011674:
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 09-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 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: 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-009507513-1907USA000909: 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-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000862: US-009507513-1906USA011674:
Sex: F
Vaccine: HPV4
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: Gardasil used for treatment of anogenital verrucae;   This literature marketed report has been received from the authors of a published literature article and refers to an 8-year-old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included imiquimod and cimetidine. Historical drug included podophyllin.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, dose #, route of administration, lot number and expiration date were not reported) for perianal anogenital verrucae. The duration of therapy was reported as 11.5 months. Due to combinations of topical and systemic therapies (quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), imiquimod and cimetidine), the patient had partial response to the treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; died; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient that currently would be 76 years old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2009, the patient (pt) was inoculated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions by a pharmacist at the pharmacy.On an unknown date, the pt suffered from the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: shingles. Pt received unspecified treatment from a healthcare provider at a hospital. Pt died due to unknown reason on 24-AUG-2017. It was unknown if autopsy was performed. The outcome of shingles was unknown. The events were considered to be related to the suspect therapy.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission, Product quality issue, Syringe issue
Clinical narrative: patient did not suffer any adverse affect; the syringe broke at the finger flange while attempting to press the plunger; patient did miss GARDASIL 9 dose; syringe broke at the finger flange while attempting to press the plunger and medication into patient; This spontaneous report as received from a nurse, via a company representative, refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 19-JUL-2019, during the administration of one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # 1602283 and expiration date 18-AUG-2021 (strength, dose and route of administration were not reported), for prophylaxis, the syringe broke in two pieces at the finger flange while attempting to press the plunger and put medication into patient (poor quality device used and product quality issue). The reporter stated that the staff did not report having dropped it or any report of mishandling prior to administration. The patient did not suffer any adverse affects, but missed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose (product dose omission) and refused to have another injection administered.  The outcome of product quality issue and the action taken with the suspect therapy were unknown. Causality assessment for product quality issue was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; The patient was vaccinated with VARIVAX in 2017 and on 19-JUL-2019, the patient completed the dosage schedule; This spontaneous report was received from a pharmacist referring an around 38 years old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not reported.     On an unspecified date in 2017, the patient was vaccinated for prophylaxis with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not reported). It was reported that the patient did not received any additional doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) in the meantime. On 19-JUL-2019, the patient was vaccinated for prophylaxis with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) and completed the dosage schedule (inappropriate schedule of vaccine administered). No adverse effects reported. No additional information was provided.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; the patient was administered a dose of PROQUAD instead of MMR II; the patient was administered a dose of PROQUAD instead of MMR II; This spontaneous report has been received from a nurse concerning to a 15-months-old patient of unknown gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 23-JUL-2019, the patient received one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) using sterile diluent for reconstitution (dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis, instead of measles virus vaccine live (Enders-Edmonston), mumps virus vaccine live (Jeryl Lynn), rubella virus vaccine live (Wistar RA 27/3) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (interchange of vaccine products) (wrong product administered). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; the patient received one dose of ROTATEQ following temperature excursions; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 23-JUL-2019, the patient received one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) following temperature excursion (product storage error), administered orally (dose number was not reported) (lot#: R016790, expiration date: 20-APR-2019) for prophylaxis. No adverse effects were reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Headache
Clinical narrative: slight headache; chills; fatigue; heaviness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th July 2019, 6 hrs after receiving Shingrix, the patient experienced headache, chills, fatigue and sensation of heaviness. On an unknown date, the outcome of the headache, chills, fatigue and sensation of heaviness were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fatigue and sensation of heaviness to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on left deltoid yesterday, the day of reporting and reported the side effects as noted. The patient reported that the side effects have now resolved and they only lasted for 24 hours. The reporter was consented to follow up. This case has been linked to US2019127871, reported by same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Hot to Touch; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019127842).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than an hour after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in late February and second dose in 11th July 2019. Following vaccination of both doses, caller experienced swelling, redness, itching, pain, and hot to touch at the injection site however, after the 2nd dose. The reporter had same side effects have lasted longer and reports more swelling and larger area of redness. The reporter stated that following the second dose today it appears it was beginning to clear but not fully resolved. The reporter was consented to follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Hot to Touch; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019127842).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than an hour after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in late February and second dose in 11th July 2019. Following vaccination of both doses, caller experienced swelling, redness, itching, pain, and hot to touch at the injection site however, after the 2nd dose. The reporter had same side effects have lasted longer and reports more swelling and larger area of redness. The reporter stated that following the second dose today it appears it was beginning to clear but not fully resolved. The reporter was consented to follow up.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Pain
Clinical narrative: severe reaction; pain/ Painful; This case was reported by a consumer and described the occurrence of adverse reaction in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2019, the patient received Shingrix. On 29th June 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction and pain. On an unknown date, the outcome of the adverse reaction and pain were not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction and pain to be related to Shingrix.  Additional details were provided as follows: The patient had a severe reaction since receiving vaccination and it was so painful. The reporter asked how long does a shingle vaccine side effect last.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's friend. The case has been linked to the case US2019127843, reported by same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: injection site pain; injection site warmth; redness; itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received Shingrix. On 15th July 2019, 3 days after receiving Shingrix, the patient experienced injection site warmth, erythema and pruritus. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, erythema and pruritus to be related to Shingrix.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: pain; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm and accidental underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 6th July 2019, the patient received the 2nd dose of Shingrix. On 12th July 2019, 6 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the office manager. The batch number was not available due to the patient received the vaccine elsewhere. At the time of reporting, the patient had symptoms. The reporter consented to follow up.
Sex: U
Vaccine: UNK
Symptoms: Death, Ill-defined disorder
Clinical narrative: Health Problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender.  On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown whether autopsy was performed.  The reporter assessed the case as serious (death).  Significant case amendment (03-Jul-2019): The report type of the case was changed from invalid to valid in the general tab. The determined causality and reported causality in the event assessment tab were amended accordingly. The narrative was amended accordingly.; Reporter's Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems
Sex: U
Vaccine: UNK
Symptoms: Death, Ill-defined disorder
Clinical narrative: Health problems; This is a spontaneous case, initial and follow up versions, received on 03-Jul-2019 (both versions being processed together), concerning a patient of unspecified age (reported as sixties) and gender.  On an unspecified date, the patient was administered INN Flu Vaccine Pandemic (reported as swine flu vaccine) [influenza virus vaccine monovalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication.  On an unspecified date after vaccination, the patient developed unspecified health problems (ill-defined disorder). It was reported that the patient was in 60s and ended up dying. It was unknown, whether autopsy was performed.  The reporter assessed the case as serious (death).; Reporter's Comments: A patient of unspecified age (reported as sixties) and gender developed unspecified health problems (ill-defined disorder), on an unknown day after administration of INN Flu Vaccine. The case lacks information important for the causality assessment, such as onset latency between the vaccination and reported event, vaccination details, concurrent medical conditions, autopsy report and investigations to provide alternate aetiologies. Hence the causal role of suspect vaccine was assessed as unassessable. The case will be reassessed upon receipt of follow-up information.; Reported Cause(s) of Death: Health problems
Sex: U
Vaccine: DTAP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given vaccine that was expired. Patient is not acting out of the ordinary.
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: The right thigh was swollen, red, guarded to touch. No fever per dad. Patient started on Keflex 3 ml for 10 days for infection/possible cellulitis per MD.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia, Vertigo
Clinical narrative: Flu like symptoms with fever and chills soon after the vaccination and for 2 days.  Extreme vertigo and nausea a couple of days afterwards
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: when patient was receiving vaccines , he was moving a lot when getting the vaccines. He moved and needle came out  then ma re inserted the needle without cleansing site again. 4 hours later he had a warm red  reaction on arm, 2 days later he come to the clinic and it is cellulitis, Doctor is Rx antibiotics.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain, Pyrexia, Screaming
Clinical narrative: Approximatley 24 hours after being given Prevnar 13 patient had fever up to 103.5, body aches, screamed and held head multiple times for about 48 hours. This was the patient's last Prevnar.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Parents noticed redness around the Pneumovax injection site on her left leg, at which time pt complained of pain (complaining is very atypical for her) and was unwilling to walk or bear weight on leg.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Muscle rigidity, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient seated in chair. Patient visibly nervous prior to vaccine, squeezing on stress ball to help relax. Gardasil booster given in left deltoid. Vaccine given and patient stated, "I did it!" and then stated she felt dizzy. Nurse had patient remain seated and as nurse was explaining possible syncope after vaccines patient slumped over onto nurse. Nurse attempted to lift patients head while calling her name and patient did not respond. Patients mouth clamped shut, extremities shot out rigid,  and started jerky movements (lasted ~7 seconds). Nurse instructed mother to open the door and call for help while nurse gently moved patient to a supine position on the floor. Once placed on cool tile floor patient immediately opened her mouth and took a breath, Jerky movements stopped, patients extremities softened and patient opened her eyes with confused look. Patient able to respond to nurses questions appropriately. Nurse explained to patient what was going on and asked her to remain in supine position on the floor. Dr. entered the room and examined patient. Nurse applied wet cloth to patients neck and patient reported that helped. Patient denies any continued dizziness or other symptoms. Patient moved to sitting position without issue. After examined Patient moved up to chair without issue. Mother reports patient had just eaten breakfast, no known history of seizure activity or issues with vaccines other than "she usually cries due to extreme nervousness". Limited family history available as patient is adopted. Vitals taken and stable. Patient continued to state she feels fine and was able to walk out of clinic without issue.
Age: 11.0
Sex: M
Vaccine: DTAP, MENB
Symptoms: Eye pain, Headache, Neck pain, Vision blurred
Clinical narrative: Excruciating headache, eye pain, neck pain , blurred vision
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chills, Diarrhoea
Clinical narrative: As soon as shot was given, 7/23/19 at about 9:45 AM, my arm was hurting. Within about 3 hours I started to feel weak and tired, then the muscle aches over entire body began. Headache, stomach ache and backache were flu like. Body chills severe by 9 PM  and nausea by 4 AM the next morning.  All the symptoms described above continued into the next day. At about 7 PM on 7/24/19, I was feeling about seventy five percent better. On 7/25/19 diarrhea began in the morning by Noon it had cleared.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: As soon as shot was given, 7/23/19 at about 9:45 AM, my arm was hurting. Within about 3 hours I started to feel weak and tired, then the muscle aches over entire body began. Headache, stomach ache and backache were flu like. Body chills severe by 9 PM  and nausea by 4 AM the next morning.  All the symptoms described above continued into the next day. At about 7 PM on 7/24/19, I was feeling about seventy five percent better. On 7/25/19 diarrhea began in the morning by Noon it had cleared.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: As soon as shot was given, 7/23/19 at about 9:45 AM, my arm was hurting. Within about 3 hours I started to feel weak and tired, then the muscle aches over entire body began. Headache, stomach ache and backache were flu like. Body chills severe by 9 PM  and nausea by 4 AM the next morning.  All the symptoms described above continued into the next day. At about 7 PM on 7/24/19, I was feeling about seventy five percent better. On 7/25/19 diarrhea began in the morning by Noon it had cleared.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: By afternoon arm stated getting painful and felt feverish.  Symptoms lasted 3 days, did not take any medication or call the doctor.   On 7/17 arm was very warm, there was redness, had white circle below and around vaccination site.  Redness and stiffness started to spread.  Went to doctor and diagnosed with mild case of cellulitis. Received antibiotic (Clindamycin 300mg) for 7 days so today is done.  By Saturday, started seeing improvement in arm.   Feels fine now.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Vaccination site pallor
Clinical narrative: By afternoon arm stated getting painful and felt feverish.  Symptoms lasted 3 days, did not take any medication or call the doctor.   On 7/17 arm was very warm, there was redness, had white circle below and around vaccination site.  Redness and stiffness started to spread.  Went to doctor and diagnosed with mild case of cellulitis. Received antibiotic (Clindamycin 300mg) for 7 days so today is done.  By Saturday, started seeing improvement in arm.   Feels fine now.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Cough, Insomnia, Pyrexia, Respiratory tract congestion, Wheezing
Clinical narrative: Mother stated on 7/22/19 at night client had a fever of 101 degrees. And that client had a fever at noon 7/24/19. And the client on 7/24/19 at night had difficulty sleeping due to congestion and wheezing and coughing
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Eye pain, Ocular discomfort, Pain in extremity
Clinical narrative: Elevated temp, pain in bilateral lower extremities. Employee took Ibuprofen for her symptoms drank water and rested. Employee reports pain/pressure around eyes upon awaking this morning with decrease in pain to bilateral lower extremities, temperature is normal.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Vaccination site pain
Clinical narrative: One day after vaccine, paientt  reports he had pain and redness to vaccine sight as well as a rash to left arm and torso.  States rash lasted one week.  Rash resolved on it's own after one week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Vision blurred
Clinical narrative: I went to check on patient around 1:20 pm and she stated she was feeling fine, I then went to check on her around 1:30 pm and she was not sitting there anymore, She came back around 1:50 pm and said she wasn't feeling well and was having some dizziness and blurred vision, I checked her BP at 1:55 pm it was 130/83 and her pulse was 88, patient states that this is high for her. II called her regular physician who had no available appointments so I referred her to the ER
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Induration, Local reaction, Pain
Clinical narrative: He had a local reaction 7.5 cm x 6  cm with severe induration, pain , no generalized reaction
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Arm swelled to double size for 3 to 4 weeks. It was red and hot and you could not touch it.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Pain; Injection site Warm to Touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 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 swelling, injection site erythema, injection site itching, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter husband received 1st dose Shingrix late February. The patient experienced swelling, redness, itching, pain, and warm to touch all at the injection site for approximately 2 days following both doses. By the third day, all symptoms reported as resolved. For tolerance to the 2nd dose of Shingrix, refer case US2019127857.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In July 2019, less than a month after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as 465HX, which was corrected to 4G5HX as per sales data sheet.  After 1st Shingrix dose, the patient had fever of 103 degree F for 2 days.  The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes ophthalmic, Pyrexia
Clinical narrative: herpetic keratitis; chills; fever; This case was reported by a other health professional via call center representative and described the occurrence of herpetic keratitis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 6 years ago).   On 18th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 2 days after receiving Shingrix, the patient experienced herpetic keratitis (serious criteria GSK medically significant), chills and fever. On an unknown date, the outcome of the herpetic keratitis, chills and fever were unknown.   It was unknown if the reporter considered the herpetic keratitis, chills and fever to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced severe chills, fever, and herpetic keratitis. The reporter did not have the lot number and expiry date.  The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 20th September 2021) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. The patient experienced blisters on her hand and her back.  The patient at the time of reporting had recovered from the blisters.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction
Clinical narrative: Injection site reaction; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported but it could be 68 years or 69 years. The reporter administered Shingrix vaccine to the patient, in the back of her left arm deltoid subcutaneously, which led to inappropriate route of vaccination. The patient experienced injection site reactions. The reporter consented to follow up. No additional details were provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Patient described feeling fatigued and flu like symptoms. Denies fever
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccines were administered at 11 year wcc (Tdap and Menveo given in left arm) on 7/23/19. Mom states she noticed the injection site on her left arm was "a little yellow looking" the following morning (7/24/19). By that afternoon (on 7/24/19), the area was reddened and warm to the touch. The area of redness was approx. 3 inches in diameter. Pt seen on 7/25/19 in the office at 1115. The area of redness was lighter than it was on 7/24, but still 3 inches in diameter and a little sore. Denies any other symptoms beyond the local reaction on her left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: MINIMAL TENDERNESS AT SITE AND YET NO WARMTH AND NOT INDURATED YET REDNESS ODDLY IS IMPRESSIVE --5 X 6 CM
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm after tetanus immunization, onset about 20 hours post immunization,  donor had chills and a fever up to 101.3 F that lasted about 2 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: A lump that was the shape of 1/2 of a tennis ball formed at the injection site. It was covered with a red rash and it hurt. It lasted about 2 weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness and Swelling ? 70 mm x 70 mm Slightly warm to the touch
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu-like symptoms: chills, muscle aches, nausea, extreme fatigue
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given an adult dose of Hep A instead of a Peds dose. Family was notified.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Body temperature increased, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Symptoms of event included: soreness in the area of injection, upset stomach, nausea, vomiting, diarrhea, elevated temperature (reported by recipient of vaccine as 99.9 degrees Fahrenheit). At the time of this report, recipient of vaccine has treated herself with rest and Pepto Bismol, which she states have alleviated a majority of her symptoms. Recipient of vaccine was referred to nursing hotline for additional treatment options and follow up care. Further result or outcome of adverse event is unknown at the time of this report.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Symptoms of event included: soreness in the area of injection, upset stomach, nausea, vomiting, diarrhea, elevated temperature (reported by recipient of vaccine as 99.9 degrees Fahrenheit). At the time of this report, recipient of vaccine has treated herself with rest and Pepto Bismol, which she states have alleviated a majority of her symptoms. Recipient of vaccine was referred to nursing hotline for additional treatment options and follow up care. Further result or outcome of adverse event is unknown at the time of this report.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site rash
Clinical narrative: Fatigue, headache, loose stools, rash at injection site
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site reaction, Rash papular
Clinical narrative: popular rash to BUE UE lateral aspect extending to upper arm to elbow
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pain, Face injury, Fall, Laboratory test, Lip pain
Clinical narrative: 20 year old female presents for physical for college. Has lab, TB and TDap injection. Upon checking out, patient states she feels nausea and asks for the restroom. She turns and the next thing she remembers she is lying face down on the floor Vitals at time 111/68 P- 58 O2 sat 98%. No neurological defects on examination, Talking and alert X3 with c/o pain to Left upper eye and left upper lip. Areas cleansed with normal saline and steri strips placed. Patient monitored for greater than 30 minutes with last vitals 117/76 Pulse 80, 02 sat 98%. Patient up and ambulating with boyfriend out of facility home. Return to clinic 07/26/2019 for follow up.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Tuberculin test
Clinical narrative: 20 year old female presents for physical for college. Has lab, TB and TDap injection. Upon checking out, patient states she feels nausea and asks for the restroom. She turns and the next thing she remembers she is lying face down on the floor Vitals at time 111/68 P- 58 O2 sat 98%. No neurological defects on examination, Talking and alert X3 with c/o pain to Left upper eye and left upper lip. Areas cleansed with normal saline and steri strips placed. Patient monitored for greater than 30 minutes with last vitals 117/76 Pulse 80, 02 sat 98%. Patient up and ambulating with boyfriend out of facility home. Return to clinic 07/26/2019 for follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Achy, fatigued, feverish for two days after administration