chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: did not receive the full recommended VARlVAX dose as patient moved his leg during administration; This spontaneous report as received from a nurse and refers to a 17-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 13-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient did not receive the full recommended dose as patient moved his leg during administration. The reporter did not know the exact quantity patient may have received. This was patient's first dose in the series.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 19-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown and the reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevenion of shingles and zoster-related conditions. Subsequent on an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 19-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter, lot # R033080 with expiration date 06-JUN-2020; frequency and route were not reported) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Influenza like illness, Local reaction, Pyrexia
Clinical narrative: "typical flu-like side effects"; fevers; Local reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of  patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season, the patient experienced influenza-like symptoms, fever and local reaction. On an unknown date, the outcome of the influenza-like symptoms, fever and local reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and local reaction to be related to Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Fluarix Quadrivalent 2020-2021 season and experienced influenza-like symptoms and fever. The reporter's clinic group has administered 975 flu vaccines to patients in 4 days.  The reporter stated that normally it is spread out and his gut is it's a combo of a high vaccination rate and hyperawareness of what symptoms to look for. The reporter will get additional information regarding the 2nd reaction and others specific cases as well, brand administered/lot numbers, and provide to Agency within the next week. The reporter consented to follow up. No further information was available. This case was linked with case US2020AMR206412 and US2020AMR206466 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206412:same reporter US-GLAXOSMITHKLINE-US2020AMR206466:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Pneumonia due to flu shots; This case was reported by a consumer via other manufacturer and described the occurrence of pneumonia in a 47-year-old male 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 pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown.   The reporter considered the pneumonia to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had pneumonia due to flu shots.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: fever of 100.8 degrees; diarrhea; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020205665).   On 11th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 12 hrs after receiving Shingrix, the patient experienced fever, diarrhea and general body pain. Rechallenge with Shingrix was positive. In October 2020, the outcome of the fever, diarrhea and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, diarrhea and general body pain to be related to Shingrix.  Additional details were provided as follows: It was reported that on 12th October 2020, 12 hours after the 2nd dose ,the patient experienced fever of 100.8 degrees and experienced diarrhea.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205665:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Illness, Pain in extremity, Tenderness
Clinical narrative: sick; arm feels tender due to flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 59-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. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness and pain in arm were unknown.   It was unknown if the reporter considered the sickness and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine and was sick and arm feels tender.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Heart rate increased, Hypertension, Oedema peripheral, Pain
Clinical narrative: my entire body was aching/sore; my shot arm I had a swollen area just under my armpit / puffiness is still there; rapid heart rate; my blood pressure was off / Both higher than normal for me; This case was reported by a consumer and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced heart rate increased and blood pressure high. On 14th October 2020, the patient experienced general body pain and local swelling. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the heart rate increased, blood pressure high, general body pain and local swelling were unknown.   It was unknown if the reporter considered the heart rate increased, blood pressure high, general body pain and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had blood pressure was off. The first time checked the diastolic was off and then systolic number was off both higher than normal. The patient experienced rapid heart rate. The patient entire body was aching but under shot arm had swollen area under just armpit and was very sore. The patient showed it to endocrinologist as the puffiness was still there and had never seen that reaction before. The patient thought was going to see lymph nodes but was not what saw. The patient suggested warm compress and to monitor it for a week. The reporter asked if this had happened before and whether need to get 2nd dose after the body handled the 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: my entire body was aching/sore; my shot arm I had a swollen area just under my armpit / puffiness is still there; rapid heart rate; my blood pressure was off / Both higher than normal for me; This case was reported by a consumer and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced heart rate increased and blood pressure high. On 14th October 2020, the patient experienced general body pain and local swelling. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the heart rate increased, blood pressure high, general body pain and local swelling were unknown.   It was unknown if the reporter considered the heart rate increased, blood pressure high, general body pain and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had blood pressure was off. The first time checked the diastolic was off and then systolic number was off both higher than normal. The patient experienced rapid heart rate. The patient entire body was aching but under shot arm had swollen area under just armpit and was very sore. The patient showed it to endocrinologist as the puffiness was still there and had never seen that reaction before. The patient thought was going to see lymph nodes but was not what saw. The patient suggested warm compress and to monitor it for a week. The reporter asked if this had happened before and whether need to get 2nd dose after the body handled the 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle aches; Extreme fatigue; Became ill after the first dose; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, muscle pain, fatigue and feeling unwell. On an unknown date, the outcome of the fever, muscle pain, fatigue and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain, fatigue and feeling unwell to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per product indication. After the 1st dose of Shingrix the patient became ill, fever, muscle ache, extreme fatigue for 48 hour. For tolerance in 2nd dose refer case US2020AMR208102.
Sex: U
Vaccine: MEN
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received autoimmune disorder in high school. After receiving Meningococcal B vaccine, the patient had autoimmune disorder. The patient never had another vaccine of any kind in 22 years.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: The bump was measured: 6 inches long and 11 inches wide; very red,hot, hard bump on the right thigh which is swollen and growing; very red,hot, hard bump on the right thigh which is swollen and growing; very red,hot, hard bump on the right thigh which is swollen and growing; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE VACCINE) for prophylaxis.   On 28th September 2020, the patient received Kinrix and FLUZONE VACCINE. On an unknown date, less than 3 weeks after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration to be related to Kinrix.  Additional details were reported as follows: Reporter was medical assistant. On 28th September 2020, the patient received both Kinrix and Flu vaccine (Fluzone) on the same day, on the thigh. The patient developed a very red, hot and hard bump on the right thigh which was swollen and growing, the bump was measured 6 inches long and 11 inches wide, it goes from the top of the thigh to almost reach the knee. The reporter consented to follow up. This case had been linked with US2020203021, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203021:same reporter
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site rash, Rash
Clinical narrative: Neck is red; Rash / Waist / Spread to her hips and thighs; Rash at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2J3TT, expiry date 30th June 2021) for prophylaxis.   On 9th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 10th October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site rash. On 12th October 2020, the patient experienced rash. On 15th October 2020, the patient experienced red neck. On an unknown date, the outcome of the injection site rash, rash and red neck were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, rash and red neck to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient was vaccinated with Flulaval. On next day after vaccination patient developed a rash at the injection site that later went to her waist and on day 3 it spread to her hips and thighs. On 15th October 2020 patient had red neck. Till the time of reporting events were ongoning. This report was given via web chat by an LPN who received a call from the patient reporting the event. At time of reporting physician had not seen the patient rash. The reporter consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood glucose increased, Blood lactate dehydrogenase increased
Clinical narrative: values were elevated compared to previous lab tests; Alanine Aminotransferase; Lactate Dehydrogenase (LDH); Non fasting glucose; This case was reported by a consumer via call center representative and described the occurrence of aspartate aminotransferase increased in a 57-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included cancer.   On 29th September 2020, the patient received the 1st dose of SHINGRIX. In September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 12th October 2020, 13 days after receiving SHINGRIX and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased. On an unknown date, the outcome of the aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased were unknown.   It was unknown if the reporter considered the aspartate aminotransferase increased, alanine aminotransferase increased, lactate dehydrogenase increased and blood glucose increased to be related to SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by patient's husband. The patient had a diagnosis of cancer and was taking oral chemotherapy medication (name not provided). The patient got the first dose of the SHINGRIX vaccine and had gotten a lab test done on 12th October 2020 and the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Lactate Dehydrogenase (LDH) and non fasting glucose values were elevated compared to previous lab tests. The HCP would be repeating the lab test in two weeks. In addition the reporter stated that, the patient received a flu vaccine (unknown name) about 2 weeks before receiving the SHINGRIX vaccine. The reporter consented to follow up. The case US2020AMR208127, should be deleted from argus core and all the information was captured in the case US2020206840
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pyrexia
Clinical narrative: Fever; injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not applicable. A pharmacist reported that over the years, some patients experienced injection site soreness and a fever in the few days immediately after the immunization with Shingrix. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Sore arm; Weak muscle; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2020, the patient received the 1st dose of Shingrix. On 18th October 2020, several days after receiving Shingrix, the patient experienced pain in arm and muscle weakness. On an unknown date, the outcome of the pain in arm and muscle weakness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and muscle weakness to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that the patient was administrated on the left arm with the dose of Shingrix.  The patient reported weak muscle and sore arm hours after the administration. The reporter consented to follow up. Lot number and expiration date are not available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: arthralgia; muscle soreness; This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced arthralgia and muscle soreness. On an unknown date, the outcome of the arthralgia and muscle soreness were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia and muscle soreness to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced arthralgia and muscle soreness. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives / still has it; This case was reported by a physician via call center representative and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2020, the patient received the 1st dose of Shingrix. On 7th September 2020, less than a day after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced hives within hours which was not recovered till the time of reporting. The reporter consented to follow up. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: feeling dizzy; vertigo; tired; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In October 2020, 1 week after receiving Shingrix, the patient experienced dizziness, vertigo and tiredness. On an unknown date, the outcome of the dizziness, vertigo and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, vertigo and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's daughter. The age at vaccination was not reported. The patient received dose 1 of Shingrix three weeks before the date of reporting.  It was reported that two weeks before the date of reporting the patient was feeling dizzy, vertigo, and tired.  The reporter did not consent to follow-up. The reporter stated she might call back later to provide more information.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye pain, Headache, Intraocular pressure increased, Keratitis
Clinical narrative: increased intraocular pressure; corneas were inflamed; bilateral eye pain; achiness; headaches; Sore throat; coughing; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional (patient).  This case involves a 65 year old female patient who experienced increased intraocular pressure (with symptoms of eye pain and headache), corneal inflammation (Keratitis), achiness (pain), sore throat (oropharyngeal pain) and coughing (cough), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient had received the INFLUENZA VACCINE [flu shot] for many years and the first time she received the regular dose she reacted to it, just felt achy (pain) and had a sore throat (oropharyngeal pain). It was reported that patient had received FLUZONE HIGH DOSE [lot number: UJ243AD, expiry date not reported] in 2019. Medical history, medical treatment, concomitant medication and family history were not provided. It was reported that, the patient was allergic to formaldehyde [Drug hypersensitivity].  On an unknown date, the patient received a 0.5 (unit unspecified) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at the left arm for prophylactic vaccination.  On 13-Sep-2020, the patient developed a non-serious sore throat (oropharyngeal pain), achiness (pain) and coughing (cough) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient took some ALEVE [NAPROXEN SODIUM] and felt decreased these events.  On 13-Sep-2020, the patient felt severe bilateral eye pain (eye pain), headaches, corneal inflammation (Keratitis) and had increased intraocular pressure, (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Prednisolone eye drops.  It was reported that, the patient was recovering from reported events.   There will be no information available on the batch number for this case.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: increased intraocular pressure; corneas were inflamed; bilateral eye pain; achiness; headaches; Sore throat; coughing; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional (patient).  This case involves a 65 year old female patient who experienced increased intraocular pressure (with symptoms of eye pain and headache), corneal inflammation (Keratitis), achiness (pain), sore throat (oropharyngeal pain) and coughing (cough), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient had received the INFLUENZA VACCINE [flu shot] for many years and the first time she received the regular dose she reacted to it, just felt achy (pain) and had a sore throat (oropharyngeal pain). It was reported that patient had received FLUZONE HIGH DOSE [lot number: UJ243AD, expiry date not reported] in 2019. Medical history, medical treatment, concomitant medication and family history were not provided. It was reported that, the patient was allergic to formaldehyde [Drug hypersensitivity].  On an unknown date, the patient received a 0.5 (unit unspecified) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at the left arm for prophylactic vaccination.  On 13-Sep-2020, the patient developed a non-serious sore throat (oropharyngeal pain), achiness (pain) and coughing (cough) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient took some ALEVE [NAPROXEN SODIUM] and felt decreased these events.  On 13-Sep-2020, the patient felt severe bilateral eye pain (eye pain), headaches, corneal inflammation (Keratitis) and had increased intraocular pressure, (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Prednisolone eye drops.  It was reported that, the patient was recovering from reported events.   There will be no information available on the batch number for this case.
Age: 17.0
Sex: F
Vaccine: FLU4, MENHIB
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: itching, 6cm circular area of pink/red skin and subcutaneous nodule to injection area
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: 10/12/20 had some discomfort (R) deltoid  after shot.  10/13/20 couldn't move right arm, weakness.  Went to ED  states arm feels "numb" today 10/14/20
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site paraesthesia, Joint swelling
Clinical narrative: PT called clinic on 8-14-2020 reporting redness, tingling, swelling @ injection site extending on lateral surface -> elbow. Injection given on 8-12-2020, sx started 8-13-2020 and progressed. Dr provided a T/O of Doxycycline 100mg PO BID x10 Days. Dr. also suggested cool compresses and Ibuprofin PRN. On 8-17-2020, pt called reporting by 8-16-2020, swelling resolved and discomfort decreased significantly - 0 tingling.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red, warm, sore
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received flublok flu shot 10/21/20, woke up 10/22/20 with some redness swelling and heat around the injection site, at 12:45pm it has spread and is a larger area
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red & swollen at the injection site
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had a fever of 100.4, sore shoulder, tricep hurt, legs were sore, body aches
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in right shoulder joint.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: upon adminsitration a little leaked from injection site no adverse effect noted
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: The patient reports that about an hour after vaccination the shoulder of the arm where she was vaccinated started hurting and she couldn't lift her arm. She reports that the bandage was much higher on her arm than she is accustomed to. She reports that as of today her shoulder still hurts.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There has been no symptoms or sign . Call patient and informed them. Patient is to return within 4-6 weeks to give adol/adult dose
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain and soreness on her arms
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Balance disorder, Blister, Disorientation, Feeling abnormal
Clinical narrative: By the evening pt was feeling lethargic, out of it, could barely get into the shower. Pounding headache,  patient was cold and had to cover with double blankets and was in and out of sleep. Patient was feverish and had nausea for 2 days.  Today; day 3 patient has itchy blisters on her RT hand by her thumb area.  Entire body is extremely sensitive to touch aside from the weakness and she looses her balance and is close to falling.    Patient feels foggy, can not keep a thought together and can not focus.  Having problems focusing her eyes.  Shoulder where injection was given is red, very painful and swollen since day 1 to the point she can't lay on it.   FLU Shot given same day at same location.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: By the evening pt was feeling lethargic, out of it, could barely get into the shower. Pounding headache,  patient was cold and had to cover with double blankets and was in and out of sleep. Patient was feverish and had nausea for 2 days.  Today; day 3 patient has itchy blisters on her RT hand by her thumb area.  Entire body is extremely sensitive to touch aside from the weakness and she looses her balance and is close to falling.    Patient feels foggy, can not keep a thought together and can not focus.  Having problems focusing her eyes.  Shoulder where injection was given is red, very painful and swollen since day 1 to the point she can't lay on it.   FLU Shot given same day at same location.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Lethargy, Mental impairment, Nausea, Poor quality sleep, Pruritus
Clinical narrative: By the evening pt was feeling lethargic, out of it, could barely get into the shower. Pounding headache,  patient was cold and had to cover with double blankets and was in and out of sleep. Patient was feverish and had nausea for 2 days.  Today; day 3 patient has itchy blisters on her RT hand by her thumb area.  Entire body is extremely sensitive to touch aside from the weakness and she looses her balance and is close to falling.    Patient feels foggy, can not keep a thought together and can not focus.  Having problems focusing her eyes.  Shoulder where injection was given is red, very painful and swollen since day 1 to the point she can't lay on it.   FLU Shot given same day at same location.
Age: 53.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pyrexia, Tenderness, Vision blurred
Clinical narrative: By the evening pt was feeling lethargic, out of it, could barely get into the shower. Pounding headache,  patient was cold and had to cover with double blankets and was in and out of sleep. Patient was feverish and had nausea for 2 days.  Today; day 3 patient has itchy blisters on her RT hand by her thumb area.  Entire body is extremely sensitive to touch aside from the weakness and she looses her balance and is close to falling.    Patient feels foggy, can not keep a thought together and can not focus.  Having problems focusing her eyes.  Shoulder where injection was given is red, very painful and swollen since day 1 to the point she can't lay on it.   FLU Shot given same day at same location.
Age: 59.0
Sex: F
Vaccine: FLUC4, TDAP, VARZOS
Symptoms: Haemorrhage, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: After 10 days of receiving vaccine, patient experienced red, zit like bumps on abdomen. The bumps were itchy and bled when scratched. It spread to her arms and legs and is still reoccurring in random spots throughout her abdomen, arms, and legs.
Sex: U
Vaccine: FLU4
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Cheeks & inside underneath the tongue's swollen. 10/14/20 9pm - she took Benadryl at night. It's gone in the morning.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Injection site erythema, Injection site reaction, Injection site warmth, Myalgia
Clinical narrative: Woke up day after injection with severe body/muscle aches /weakness.  Hot red welt at site of injection.  time of illness - 24 hrs.  still have red welt at site of injection
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Woke up day after injection with severe body/muscle aches /weakness.  Hot red welt at site of injection.  time of illness - 24 hrs.  still have red welt at site of injection
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complained about a sore arm upon moving her shoulder after received the vaccine
Age: 0.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was accidentally given hepatitis A vaccine in place of Hep B vaccine
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingrix 2 doses completed/Shingles / Suspected vaccination failure; Singles; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had completed Shingrix 2 doses in less than a year. The patient had singles. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: MMR
Symptoms: Arthropathy, Frustration tolerance decreased, Injection site discomfort, Injection site pain, Injection site reaction
Clinical narrative: Indication as potential COVID prevention; He mentioned that he did not know if this was a joint issue; The HCP's wife was frustrated that she was experiencing this for over a month; And it was a prolonged injection site reaction; patient began experiencing aching pain and disconfort on and around injection site; patient began experiencing aching pain and disconfort on and around injection site; This spontaneous report was received from a pharmacist and refers to a 73 year old female patient with sulfonamide  (BACTRIM) allergy, nitrofurantoin (MACRODANTIN) allergy  and Gastrointestinal upset. Concomitant therapies included herbs (unspecified), levothyroxine sodium(SYNTHROID) and raloxifene hydrochloride(EVISTA).  Information regarding the patient's medical history and historical drugs was not provided.  On 09-SEP-2020 , the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) lot # S023654, expiration date 30-JUL-2021, subcutaneously in her left arm for potential COVID 19 prevention (prophylaxis) (product use in unapproved indication).  On 11-SEP-2020, patient began experiencing aching pain and discomfort on and around injection site (injection site pain and injection site discomfort).  On an unknown date in October 2020, the patient  experienced a prolonged injection site reaction, she was frustrated that she was experiencing this for over a month(frustration tolerance decreased) and her husband mentioned that he did not know if this was a joint issue (Arthropathy).   On 05-OCT-2020, the patient sought medical attention due to the events.   The outcome of injection site pain, frustration tolerance decreased, injection site reaction, arthropathy and injection site discomfort was unknown.     The causality between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) was not provided.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Incorrect dose administered
Clinical narrative: adult patient received  a pediatric dose of VAQTA; pediatric dose of VAQTA was administered to an adult patient; This spontaneous report has been received from a physician refers to an adult patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported.    On 08-OCT-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S037574, expiration date 10-APR-2021) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation, regarding a currently approximately 67 year old male patient.  The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On (or about) 29-APR-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: revaccination with PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       In October 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 15-OCT-2020, the patient was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter) for prophylaxis (inappropriate schedule of product administration).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 13-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).