chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: Parents have not called office to report any AE.; gave PROQUAD and MMR II to a 12 month old at same time.; Route of administration: IM; This spontaneous report was received from a nurse via company representative, referring to a 52-week-old (also reported as "12-month-old") female patient. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were unknown by the reporter.     On 07-AUG-2020, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot number S020162, which has been verified to be valid, expiration date not reported but upon internal validation established as 30-JUN-2021, intramuscularly administered (incorrect route of product administration), additionally, it was reported that the patient was vaccinated at the same time with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot number T001188, which has been verified to be valid, expiration date not reported but upon internal validation established as 11-JUL-2021, by an unknown route of administration, both as prophylaxis (inappropriate schedule of product administration) (doses, dose numbers, vaccination schemes, and anatomical sites of vaccination were not provided for both vaccines). Furthermore, the reporter stated parents have not called office to report any adverse event (AE) (no adverse event).
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 30th July 2020, the patient received Bexsero. On an unknown date, less than a day after receiving Bexsero, 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 Bexsero.  Additional information was received as follows: The patient experienced bodyaches, headache, and chills after a dose of Bexsero. Healthcare Professional refered to the patients events as "flu like symptoms". HCP noted the events began the same evening the vaccine was received. No outcome of events was reported.  HCP noted there were multiple patients reporting "flu like symptoms" following doses of Bexsero. HCP could not provide these patients demographics, lot numbers, or expiration dates. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis; whole arm swollen; Redness in the Injection site; Swelling in the Injection site; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA201A, expiry date 30th October 2020), (batch number AMVA206A, expiry date 13th November 2020) and (batch number AMVA323A, expiry date 31st March 2020) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 10th August 2020, less than a day after receiving Menveo, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema and injection site swelling. On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Several patients experienced redness and swelling in the injection site, whole arm swolling and cellulitis after receiving a dose of Menveo. The symptoms started within hours.  The reporter reported 3 different lot numbers and expiration dates for the vaccines administered to different patients.  The reporter did not know how many patients experienced the symptoms but agreed to follow up and look up the information.  The reporter consented to follow up.  This case is one of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159654:same reporter US-GLAXOSMITHKLINE-US2020159650:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Pain, Pain in extremity
Clinical narrative: dry cough/a neighbor had similar symptoms; body aches/a neighbor had similar symptoms; fatigue/a neighbor had similar symptoms; fever was 98.9/a neighbor had similar symptoms; chills/a neighbor had similar symptoms; arm soreness/a neighbor had similar symptoms; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, general body pain, fatigue, fever, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: This case was reported for the neighbor.  The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. It was also reported that a neighbor had similar symptoms that lasted 3 days. There was no other information available for that person. Consented to follow up. This case has been linked with case US2020159662 and US2020159668, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020159668:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: dry cough/a neighbor had similar symptoms; body aches/a neighbor had similar symptoms; fatigue/a neighbor had similar symptoms; fever was 98.9/a neighbor had similar symptoms; chills/a neighbor had similar symptoms; arm soreness/a neighbor had similar symptoms; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, general body pain, fatigue, fever, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: This case was reported for the neighbor.  The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. It was also reported that a neighbor had similar symptoms that lasted 3 days. There was no other information available for that person. Consented to follow up. This case has been linked with case US2020159662 and US2020159668, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020159668:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Visual impairment
Clinical narrative: Dizziness; Vision Changes; Nausea; Headache; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, visual disturbance, nausea and headache. On an unknown date, the outcome of the dizziness, visual disturbance, nausea and headache were unknown.   It was unknown if the reporter considered the dizziness, visual disturbance, nausea and headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The caller was a health care professional field Representative called in the report on behalf of the certified medical assistant.   The patient received Bexsero and had complaints of dizziness, vision changes, nausea and headache. The reporter did not consent to follow up. The field representative had no information regarding the two reported patients as for their gender or names or medication lot Numbers or when the medication had been given.  This case linked with US2020159631, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159631:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: pain, swelling, and redness at the injection site; swelling, and redness at the injection site; redness at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stiff joint, drug allergy (prior history of allergic reaction to clopidogrel) and generalized rash.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had arthrosclerosis, prior history of allergic reaction to clopidogrel.  The patient stated she was on Clopidogrel for a blood clot about 2 to 3 years ago and after about 6 months using it she developed a body rash. The patient experienced pain, swelling, and redness at the injection site. For tolerance after 2nd dose of Shingrix, refer case US2020158029.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158029:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: felt Nauseous; dizzy; numbness on my left side; tingling on my left side; sores on my face; Also have had low; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell. On an unknown date, the outcome of the nausea and dizziness were recovering/resolving and the outcome of the numbness, tingling, skin ulcer and feeling unwell were unknown.   It was unknown if the reporter considered the nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. The patient had first dose of Shingrix on 6th August 2020 and immediately felt nauseous and dizzy, but it eventually passed. Last few days the patient had tingling and numbness on the left side and the patient was beaking out with sores on the face.  The patient also have had low. The patient questioned whether the patient was gettinng Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Skin ulcer
Clinical narrative: felt Nauseous; dizzy; numbness on my left side; tingling on my left side; sores on my face; Also have had low; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell. On an unknown date, the outcome of the nausea and dizziness were recovering/resolving and the outcome of the numbness, tingling, skin ulcer and feeling unwell were unknown.   It was unknown if the reporter considered the nausea, dizziness, numbness, tingling, skin ulcer and feeling unwell to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. The patient had first dose of Shingrix on 6th August 2020 and immediately felt nauseous and dizzy, but it eventually passed. Last few days the patient had tingling and numbness on the left side and the patient was beaking out with sores on the face.  The patient also have had low. The patient questioned whether the patient was gettinng Shingles.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: flu like symptoms; Body aches; Headache; Chills; This case was reported by a other health professional via call center representative and described the occurrence of flu like symptoms in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 30th July 2020, the patient received Bexsero. In July 2020, less than a day after receiving Bexsero, the patient experienced flu like symptoms, general body pain, headache and chills. On an unknown date, the outcome of the flu like symptoms, general body pain, headache and chills were unknown.   It was unknown if the reporter considered the flu like symptoms, general body pain, headache and chills to be related to Bexsero.  Additional inforamtion was received as follows: The patient experienced body aches, headache, and chills after a dose of Bexsero. The Healthcare Professional  refered to the patients events as flu like symptoms. The events began the same evening the vaccine was received. No outcome of events was reported. HCP notesd there were multiple patients reporting "flu like symptoms" following doses of Bexsero. HCP could not provide these patients demographics, lot numbers, or expiration dates. Consent to follow-up was granted by the reporter. This case was linked to cases US2020158056, US2020158060, US2020AMR159262 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158060:same reporter US-GLAXOSMITHKLINE-US2020AMR159262:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on her shin; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received dose of Shingrix and had developed a rash on her skin. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: fatigue; Pain injection site; headache; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, injection site pain, headache and myalgia. On an unknown date, the outcome of the fatigue, injection site pain, headache and myalgia were unknown.   It was unknown if the reporter considered the fatigue, injection site pain, headache and myalgia to be related to Shingrix.  Additional case details were reported as follows: While reviewing common adverse events of Shingrix, health care professional mentioned that she had experienced those adverse event post vaccine.  No additional information was provided. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160538:same reporter US-GLAXOSMITHKLINE-US2020160542:same reporter
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Local reaction, Myalgia
Clinical narrative: generalized myalgia; fatigue; low grade fever with low grade temps like 100-101; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 2nd of 3 reports. A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date, at 0.5 mL, single for routine vaccination for 16-year-old (immunization). Medical history included confirmed COVID-19, months prior and recovered. There were no concomitant medications. The patient had significant systemic reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as serious, medically significant. The physician considered the events to be related to meningococcal group b rlp2086. The patient recovered from the events in Aug2020.  Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the PFIZER product is evaluated as part of PFIZER procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : 2020314784 same reporter, suspect drug and adverse events in different patient; 2020315028 same reporter, suspect drug and adverse events in different patient
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: generalized myalgia; fatigue; low grade fever with low grade temps like 100-101; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 2nd of 3 reports. A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date, at 0.5 mL, single for routine vaccination for 16-year-old (immunization). Medical history included confirmed COVID-19, months prior and recovered. There were no concomitant medications. The patient had significant systemic reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as serious, medically significant. The physician considered the events to be related to meningococcal group b rlp2086. The patient recovered from the events in Aug2020.  Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the PFIZER product is evaluated as part of PFIZER procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : 2020314784 same reporter, suspect drug and adverse events in different patient; 2020315028 same reporter, suspect drug and adverse events in different patient
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel and Fluzone Quadrivalent were administered after being exposed to 30 degree F, No Ae; Initial information was received on 11-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient was administered with the  0.5 mL dose of vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in the left deltoid and dose of suspect  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination after being exposed to 30 degree F on 09-Aug-2020 (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pyrexia, Rash, Swelling
Clinical narrative: Fever, redness, swelling, rash
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient started with a rash.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose decreased, Seizure, Unresponsive to stimuli
Clinical narrative: Pt became unresponsive for a second and then stated having seizure for split of seconds woke up with out any treatment.  Was send to ED by ambulance and sent home from there after a couple of hours without any treatment or intervention per patient/father.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Asthenia, Headache, Nausea, Pain
Clinical narrative: When going home from well visit from dr. office patient started complaining of severe headache and holding head, nausea, vomiting, weakness, achy, rash on hands, abdominal cramping.  Patient was taken to the emergency room by mother where he was treated and released.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Vomiting
Clinical narrative: When going home from well visit from dr. office patient started complaining of severe headache and holding head, nausea, vomiting, weakness, achy, rash on hands, abdominal cramping.  Patient was taken to the emergency room by mother where he was treated and released.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional adverse event; A patient was administered an improperly stored Pneumovax23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # S036495, expiration date on 13-SEP-2021 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The temperature and time were of 47°F (70° F) for 12 hours, without previous temperature excursion and was not called by a digital data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: S036495; expirationdate: 13-SEP-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.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Intranasal hypoaesthesia
Clinical narrative: lip and nose numbness; nose numbness; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 5 min after receiving Shingrix, the patient experienced numb lips and intranasal numbness. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Inhaler (Nos)). On 30th July 2020, the outcome of the numb lips and intranasal numbness were recovered/resolved.   It was unknown if the reporter considered the numb lips and intranasal numbness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced lip and nose numbness. She took Benadryl and her inhaler as a precautionary measure.  The sensation lasted 6 to 8 hours and resolved.  She was considering whether to get the 2nd dose or not.  She reported this event online to Medwatch. The reporter consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: her injection arm is a little sore.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of malaise (injection arm was red and itchy but resolved') and pneumovax with an associated reaction of pruritus.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the 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 was talking about the past The patient stated that that after getting her yearly flu shot her injection arm was a little sore.  The reporter did not want to answer any further questions and did not provide the name of the flu shot.  The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling hot, Headache, Pyrexia
Clinical narrative: 101 fever about 12 hours after injection, headache, weakness, chills, body felt like it was on fire
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, severe muscle aches, nausea, joint pain all over, exploding headache
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypersensitivity, Hypoacusis
Clinical narrative: Patient presented to emergency clinic with hives/ itching on chest, arms, and shoulders.  He had trouble breathingg, was dizzy, nauseous.  Dr felt patient had an allergic reaction to the shingrix because he has had the flu shot for years without adverse effect.  They told the patient to stay hydrated.  Today, 4 days later he is still reporting fatigue, blurred vision, nausea, and issues with his hearing.  His home healthcare worker followed up with his primary care doctor.  Primary care doctor office is monitoring, but told him to stay hydrated as they feel the symptoms will pass.
Age: 51.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pruritus, SARS-CoV-2 test negative, Urticaria, Vision blurred
Clinical narrative: Patient presented to emergency clinic with hives/ itching on chest, arms, and shoulders.  He had trouble breathingg, was dizzy, nauseous.  Dr felt patient had an allergic reaction to the shingrix because he has had the flu shot for years without adverse effect.  They told the patient to stay hydrated.  Today, 4 days later he is still reporting fatigue, blurred vision, nausea, and issues with his hearing.  His home healthcare worker followed up with his primary care doctor.  Primary care doctor office is monitoring, but told him to stay hydrated as they feel the symptoms will pass.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Nausea, Pain
Clinical narrative: after patient returned home, she was on the porch talking to a neighbor, but then developed a headache 9/10 , and came inside the house and laid down on the tile floor, Mom took her temp via forehead 101.5. While laying on the floor felt nauseated and vomited several times until her stomach was empty. Did eat breakfast this morning prior to visit. At the same time she felt the headache, nausea and vomiting, also was aware of a sharp pain starting in the left arm, going up to her shoulder and radiating to her scapula.  After 5 mins after vomiting, felt better , headache 3/10 on the pain scale.Mom gave her BC powder ( contains aspirin) for the continues scapular pain . I spoke to mom at 220 pm, and she was feeling better and at the lab getting COVID 19 tested for college
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Vomiting
Clinical narrative: after patient returned home, she was on the porch talking to a neighbor, but then developed a headache 9/10 , and came inside the house and laid down on the tile floor, Mom took her temp via forehead 101.5. While laying on the floor felt nauseated and vomited several times until her stomach was empty. Did eat breakfast this morning prior to visit. At the same time she felt the headache, nausea and vomiting, also was aware of a sharp pain starting in the left arm, going up to her shoulder and radiating to her scapula.  After 5 mins after vomiting, felt better , headache 3/10 on the pain scale.Mom gave her BC powder ( contains aspirin) for the continues scapular pain . I spoke to mom at 220 pm, and she was feeling better and at the lab getting COVID 19 tested for college
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dtap (Infanrix) is generally given in our clinic at 12-15 months of age. It was inadvertently given today at the 6 month well visit instead of Pediarix. (Dtap,IPV,HBV) combination .  No adverse reaction or outcome occurred.  Patient will be given Pediarix combination at one year well appointment to catch up with scheduled vaccines.   Mom was notified by phone and voiced understanding of change in  vaccine schedule.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: vaccine received 8/15/20 and side effects started 8/16/20 including warmth, redness, swelling, pain and itching localized to the entire upper left arm. Seen in our clinic 8/18/20. Advised to ice the area and seek immediate medical attention for any respiratory distress.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discolouration, Injection site pain, Pain, Pain in extremity
Clinical narrative: Received vaccine in upper left arm and had only typical mild reaction, i.e soreness, black and blue, achy. Two days later severe pain developed centralized in my right inner elbow/arm and lasted for a few days then eventually disappeared. I took Tylenol which allowed me to sleep. Since this reaction is not mentioned on the list, I thought you should know..
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Crying, Dairy intolerance, Decreased eye contact, Diarrhoea, Gene mutation identification test
Clinical narrative: Mother states within 2 hours of vaccine, child had lethargy and mucous diarrhea that has been present intermittently since the 4th of August. He is hyper reactive to dairy now, where as he was not prior to vaccine. 2 days after when seen in  office child was still lethargic and staring off with minimal eye contact. He also would have mom hold him and whimper. This resolve about 2 days later when called to check on them.
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Lethargy, Staring
Clinical narrative: Mother states within 2 hours of vaccine, child had lethargy and mucous diarrhea that has been present intermittently since the 4th of August. He is hyper reactive to dairy now, where as he was not prior to vaccine. 2 days after when seen in  office child was still lethargic and staring off with minimal eye contact. He also would have mom hold him and whimper. This resolve about 2 days later when called to check on them.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: Small rash on right chest, sore pectoral muscle near right armpit, sore muscle on back of right shoulder, sore muscle on right side of lower abdomen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient got the vaccine and the next morning had an extremely sore arm and couldn't bear weight on it.  1 week later it was still a little sore and a small red spot at the site of injection.  She will call her md to report it and I asked her to let us know if any further problems.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: lightheadedness
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Genital rash, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Day 2 Rt leg swollen and red splotchy rash above knee that goes from inter-leg to outer-leg.  Day 3 Rt leg swelled up more, red solid rash goes from upper knee to groin area, warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: Day 2 Rt leg swollen and red splotchy rash above knee that goes from inter-leg to outer-leg.  Day 3 Rt leg swelled up more, red solid rash goes from upper knee to groin area, warm to touch.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Mother noticed hives that started this morning. Pt was evaluated and documented hives in office. Benadryl was administered and pt will follow up if symptoms continue/persist.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: PATIENT STATES THAT HE RECEIVED THE VACCINE ON FRIDAY AM, SATURDAY HIS LEFT ARM WAS SORE AND ON SUNDAY NIGHT HIS ARM WAS SO SORE HE HAD TROUBLE SLEEPING. ON TUESDAY AND WEDNESDAY HIS LEFT ARM STILL ACHED.  MOST PAINFUL WITH ARM MOVEMENT, NO PAIN WHEN ARM IS AT REST.  PAIN LOCALIZED TO THE INJECTION SITE. NO SIGNS OF REDNESS, HEAT OR SWELLING AT THE INJECTION SITE.  ADVISED PATEINT TO ICE THE AREA AND TRY AN OTC PAIN RELIVEVER SUCH AS APAP OR IBUPROFEN.  PATIENT WILL REPORT BACK IN A FEW DAYS IF NO IMPROVEMENT WILL CONSIDER SEEING HIS PCP.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: fever pain, redness  and swelling at injection site muscle aches nausea. Patient stated symptom stated 3 hours after receiving vaccine and lasted for 3 days Patient stated she took naproxen for fever and pain
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever pain, redness  and swelling at injection site muscle aches nausea. Patient stated symptom stated 3 hours after receiving vaccine and lasted for 3 days Patient stated she took naproxen for fever and pain
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling on left side of face, neck, arm to wrist
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Blood electrolytes normal, CSF culture negative, Computerised tomogram head normal, Culture urine negative
Clinical narrative: Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Enterovirus test negative, Herpes simplex test negative, Magnetic resonance imaging brain normal, Polymerase chain reaction, Respiratory viral panel
Clinical narrative: Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: SARS-CoV-2 test negative, Seizure like phenomena
Clinical narrative: Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Gene mutation identification test negative, Lumbar puncture normal, Magnetic resonance imaging normal
Clinical narrative: Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Patient had seizure-like episodes several hours after receiving her vaccines. EMS was called, transported the patient to the EC where she underwent in infectious evaluation, was started on antibiotics, underwent evaluation with a CT head which was normal and was admitted to the acute care floor. She remained on antibiotics for 48 hours while undergoing rule out of a serious bacterial infection. Urine, blood and CSF cultures were all obtained and were negative. MRI head was normal. Neurology was consulted who started the patient on Keppra. No further seizure episodes were noted following admission. Of note, mom has a diagnosis of epilepsy as well. She is being followed by Neurology.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Dissociation, Mania, Oral mucosal eruption, Purpura, Pyrexia
Clinical narrative: manic activity, purpura, dissociation, rash on trunk and perioral, ankles, fever
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: manic activity, purpura, dissociation, rash on trunk and perioral, ankles, fever
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Fatigue, Pain, Pruritus, Skin warm
Clinical narrative: Within 2 hours:  Itching, warmth and soreness.  After 4 hours 1? swollen, warmth red spot, continued soreness and itching.  After after 18 hours much warmer, 2? raised red area and a higher degree of soreness along with fatigue.  At 27 hours?no improvement and the  Spot is warm even through a thick t-shirt.   It is now 27.5 hours since inoculation.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Within 2 hours:  Itching, warmth and soreness.  After 4 hours 1? swollen, warmth red spot, continued soreness and itching.  After after 18 hours much warmer, 2? raised red area and a higher degree of soreness along with fatigue.  At 27 hours?no improvement and the  Spot is warm even through a thick t-shirt.   It is now 27.5 hours since inoculation.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PPSV23 on 8-10-20. 48 hours after vaccination patient returned to office with warm, red, swollen arm below injection site. Resolved with antihistamine administration. No further complaints or concerns from patient to date
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles rash on the right hip and lateral thigh in a dermatomal distribution.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Heart rate increased
Clinical narrative: I woke up the next morning with double-vision. It wasn't until the afternoon when I checked my fitness app that had said that I had burned over 900 calories and had 109 active minutes but I hadn't exercised at all that day. I knew that the only reason that it would show active minutes is because my heart rate was high. So I looked at the history and at midnight it was 117 and at 7 AM (when I woke up), it went up to 142 bpm. The flu vaccine was the only thing different that had happened.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Rash, Vaccination complication
Clinical narrative: Patient reported on 7/29/2020 that she had an adverse reaction to a Shingles vaccine (dead virus) given on 7/13/2020.  By day 3 she had chills and headaches. By day 8 she had bumps on her forehead.  By 14 days she had it all over her face/eyes.  Patient believes she has shingles and got it from the vaccination.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Mobility decreased, Nausea, Nodule, Pain in extremity
Clinical narrative: Pain from  shoulder joint to mid bicep,  heat but no redness, swollen knot about 3 inches in circumference. Unable to move arm from the shoulder. Lasted 3 days (Friday-Sun). Mild pain on Monday but able to move shoulder. Low grade fever (99.8) starting on Sun (injection was Friday) Nausea for about 2 days (Sun/Mon) Mild headache for about 2 days (Sat/Sun)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Pain from  shoulder joint to mid bicep,  heat but no redness, swollen knot about 3 inches in circumference. Unable to move arm from the shoulder. Lasted 3 days (Friday-Sun). Mild pain on Monday but able to move shoulder. Low grade fever (99.8) starting on Sun (injection was Friday) Nausea for about 2 days (Sun/Mon) Mild headache for about 2 days (Sat/Sun)
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: LEFT DELTOID: 7CM X 12 CM OF REDNESS AND INDURATION WITH ITCHING. NO PAIN REPORTED. ONSET:8/16/2020
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Posture abnormal, Screaming
Clinical narrative: As injecting medication, patient started screaming and yelling  stop. I with drew syringe and patient got very quit and slumped in chair. Patient breathing and alert but felt she was on verge of passing out. She said her head felt funny, maybe lightheaded. She did not want water or fan. She started feeling better. She sat in pharmacy for 25 minutes while daughter shopped. Daughter seemed to think she was anxious about getting immunization. She didn't tell her til she got her she was getting it. Patient also has dementia so thought of shot could have been scary for her.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patinet asked for a TwinRix, but nurse mid heard to pull a ShingRix. The encounter did not have the TwinRix circled and was not noticed until after injection.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: syncope
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient's wife stopped by the pharmacy to report that patient was having severe pain in his right arm the day after his Pneumovax 23, limited range of motion.  He has had flu shots in the past but said this was very different.  He could not raise above his head without significant soreness.  He was self treating with ice, over the counter pain medication, and rest.  Follow-up call the next day, patient doing much better-still a little sore but had his range of motion back.  Offered to follow up again but patient declined.  Wanted to submit the lot number in case there were any other issues with this lot. Patient will call us if any future side effects occur.