chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The pt received the first dose at age 13, and the second dose at age 17; no additional AE reported; Information has been received from a registered nurse, concerning a 17-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient was 13-year old when she received the first dose.  At the time of the report, on 16-OCT-2020, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), Lot # S023475, expiration date on 26-MAR-2022, 0.5 milliliter, (route of administration, and anatomical location was not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; An office manager reported that VARIVAX had a temperature excursion on 10-OCT-2020 and was administered.; This spontaneous report as received from  an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On 14-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S038700, which has been verified to be valid, expiration date reported as "30-NOV-2021", but upon internal validation established as 01-DEC-2021), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). No additional adverse event (AE) were reported.  Additionally, it was reported that the suspect vaccine was exposed to a temperature between minus 14 degrees Celcius (C) to minus 10 degrees C for a time frame of 1 hour and 15 minutes; and minues 9 degrees C to 8 degrees C (minus 9.3 degrees C) for 32 minutes for a time frame of 1 hour and 47 miinutes, as recorded by digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007367: US-009507513-2010USA007667:
Sex: F
Vaccine: FLUX, MENB
Symptoms: Head discomfort, Muscle strain, Neck pain
Clinical narrative: neck pain / mimicking soreness / still has the pain on the left side of her neck; strain; head feeling heavy to pick up off the pillow'.; This case was reported by a other health professional via sales rep and described the occurrence of neck pain in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received the 2nd dose of Bexsero and Influenza vaccine Quadrivalent 2020-2021 season. On 10th October 2020, 3 days after receiving Bexsero and Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting ibuprofen, the patient experienced neck pain, strain and heaviness of head. The patient was treated with ibuprofen. On an unknown date, the outcome of the neck pain, strain and heaviness of head were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, strain and heaviness of head to be related to Bexsero and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the dose of Bexsero and Influenza vaccine Quadrivalent unspecified season and experienced neck pain mimicking soreness or a strain as well as her head feeling felt heavy to pick up off the pillow',which was not recovered. The patient has been taking Ibuprofen. has the pain on the left side of her neck. Till the time of reporting the pain on the left side of her neck was not recovered. The reporter consented to follow up. No further information was available
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Tenderness, Tension
Clinical narrative: pain with tenderness of the left arm; redness in the left arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 8-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of erythema (received for several seasons). Concomitant products included ibuprofen, paracetamol (Tylenol) and benadryl (nos) (Benadryl).   On 10th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 10th October 2020, less than a day after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced pain in arm. In October 2020, the patient experienced erythema. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema to be related to Fluarix Quadrivalent 2020-2021 season.   Additional details were provided as follows: The reporter stated that the patient has received flu vaccine in past seasons (several years).  The patient received Fluarix Quadrivalent 2020-2021 season and experienced pain with tenderness of the left arm, about 24 hours after experienced redness in the left arm from the accromium to the elbow and was tensed and unhappy when vaccine was administered. The redness was resolved in 72 hours. The patient was treated with Tylenol, ibuprofen, and Benadryl. The reporter contacted the patient's primary doctor via phone or text and primary doctor did not advise that the patient avoid future flu vaccinations based on this reaction. The reporter consented to follow up. This case was linked with case US2020AMR206466 and US2020AMR206465 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206466:same reporter US-GLAXOSMITHKLINE-US2020AMR206465:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever all day after 1st dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever all day. The patient did not provide many details and reported the adverse events via chat and disconnected. For tolerances of 2nd dose, refer case US2020204763, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020204763:same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site was red; Injection site was firm; Injection site / hot to the touch; This case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 12th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 13th October 2020, 1 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration and injection site warmth to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix 2020-2021 vaccine via the intramuscular route in the left arm.  It was performed by the pharmacist.  The injection site was swiped once with an alcohol wipe 5 seconds before the injection.  The patient experienced injection site was red, firm and hot to the touch in an area about the size of a deck of cards.  That symptom persists, with the addition of a track mark going up and down the arm.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Redness / at injection site on left arm; swelling at injection site on left arm; swelling for both lower arms; redness / for both lower arms; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Fluarix. On an unknown date, unknown after receiving Fluarix, the patient experienced injection site erythema, injection site swelling, swelling arm and erythema. On an unknown date, the outcome of the injection site erythema, injection site swelling, swelling arm and erythema were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, swelling arm and erythema to be related to Fluarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix in left deltoid and had redness and swelling at injection site on left arm as well as redness and swelling for both lower arms. The reporter stated that the office was bringing the patient in to be seen it was reported to GSK rep over the phone before the patient was seen.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: pulse rate was elevated; This case was reported by a consumer via interactive digital media and described the occurrence of pulse rate increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received Shingrix. On 17th October 2020, 1 days after receiving Shingrix, the patient experienced pulse rate increased. On an unknown date, the outcome of the pulse rate increased was unknown.   It was unknown if the reporter considered the pulse rate increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient received Shingrix and experienced pulse rate elevated all day. The information regarding consent to follow was not reported. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Blood lactate dehydrogenase increased, Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; elevated LDH; This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a adult female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 days after receiving SHINGRIX, the patient experienced elevated liver enzymes and lactate dehydrogenase increased. On an unknown date, the outcome of the elevated liver enzymes and lactate dehydrogenase increased were unknown.   It was unknown if the reporter considered the elevated liver enzymes and lactate dehydrogenase increased to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's husband. The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX vaccine and 12 days post shot had bloodwork with elevated liver enzymes and elevated lactate dehydrogenase. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nasal oedema, Pain, Rhinalgia
Clinical narrative: Nose pain; Body ache; Tiredness; Swollen Nose; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 3 weeks after receiving Shingrix, the patient experienced nasal edema. On 21st September 2020, the patient experienced general body pain and tiredness. On an unknown date, the patient experienced nasal pain. The patient was treated with paracetamol (Tylenol). On 10th October 2020, the outcome of the nasal edema was recovered/resolved. On an unknown date, the outcome of the general body pain, tiredness and nasal pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, tiredness, nasal pain and nasal edema to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced feeling tired,body aches,nose pain and swollen nose which was recovered till the time of reporting. The patient's nose was swollen on both sides for 2 and half weeks. The patient had taken tylenol for pain. The customer inquired has this reaction been reported before? Patient stated, "no one could explain why this happened. The patient informed that the pain and swelling resolved on 10th October 2020.  The batch lot numbet and expiration date was unknown. The patient wanted to consult with HCP before providing consent to follow up. The patient was provided medical information phone number for her HCP. No further information was available. This case as linked with case US2020206847 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206847:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster queratitis; This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster keratitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 26th June 2020, 3 days after receiving Shingrix, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster keratitis was unknown.   It was unknown if the reporter considered the herpes zoster keratitis to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that a patient received the Shingrix and experienced herpes zoster queratitis /kertitis. The patient was currently being treated with Valtrex.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: infection was cellulitis at the site of injection; swelling at the injection site / shelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   On 8th October 2020, the patient received the 1st dose of Shingrix. On 8th October 2020, less than a day after receiving Shingrix, the patient experienced injection site cellulitis and injection site swelling. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site cellulitis and injection site swelling were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced swelling at the injection site.  The patient visited their doctor where it was diagnosed as a possible cellulitis infection.  The patient was prescribed antibiotics for the infection.  After transfer of pharmacist from first line specialist, second line specialist further clarified with pharmacist that the reported infection was cellulitis at the site of injection. No further details were provided. The reporter consented to follow up. The case US2020206883 was deleted and all the information was merged into the case US2020206879.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Paraesthesia, Pyrexia, Rash
Clinical narrative: Tingling in the upper limb; Rash in the hand; Shaking; Fever; Headache; Shivering; This case was reported by a nurse via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date unknown) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, 12 hrs after receiving Shingrix, the patient experienced tremor, fever, headache and shivering. On 17th October 2020, the patient experienced tingling and rash. On an unknown date, the outcome of the tremor, fever, headache, shivering, tingling and rash were unknown.   It was unknown if the reporter considered the tremor, fever, headache, shivering, tingling and rash to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient received the 1st dose of Shingrix and within 12 hours she developed side effects such as shaking, fever, headache, shivering.  On 17th October 2020 she developed a rash in her hand and tingling in her upper limb. Nurse did not have the expiration date of the dose and mentioned that she did not administer so she didn´t know if it was given by the IM route. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Tingling in the upper limb; Rash in the hand; Shaking; Fever; Headache; Shivering; This case was reported by a nurse via call center representative and described the occurrence of tremor in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date unknown) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, 12 hrs after receiving Shingrix, the patient experienced tremor, fever, headache and shivering. On 17th October 2020, the patient experienced tingling and rash. On an unknown date, the outcome of the tremor, fever, headache, shivering, tingling and rash were unknown.   It was unknown if the reporter considered the tremor, fever, headache, shivering, tingling and rash to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient received the 1st dose of Shingrix and within 12 hours she developed side effects such as shaking, fever, headache, shivering.  On 17th October 2020 she developed a rash in her hand and tingling in her upper limb. Nurse did not have the expiration date of the dose and mentioned that she did not administer so she didn´t know if it was given by the IM route. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain 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 injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; pain in the dermatome; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th December 2019).   On 24th February 2020, the patient received the 2nd dose of Shingrix. On 24th February 2020, less than a day after receiving Shingrix, the patient experienced post herpetic neuralgia and nerve pain. On an unknown date, the outcome of the post herpetic neuralgia and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the post herpetic neuralgia and nerve pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced post herpetic neuralgia and pain in the dermatome after receiving the second dose of Shingrix. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received Flublok Quadrivalent instead of Fluzone High Dose, no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional.  This case involves a 66-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (dose, lot number expiry date, route and site were unknown) for prophylactic vaccination on 11-Sep-2020 (wrong product administered).   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  This was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Hypoaesthesia, Loss of personal independence in daily activities, Paralysis
Clinical narrative: Feeling paralyzed; Numbness in both arms and both hands; Couldn't shave or brush his teeth; Weakness; This spontaneous case was received on 14-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-03649) and concerned a male patient of unknown age.  The patient's medical history and concomitant medications details were not reported.  On 02-Oct-2020, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: left arm and route of administration: intramuscular) for flu prevention. The batch number reported was 276546, expiration date: 25-Jun-2021.  On the same day, some hours after vaccination with Flucelvax QIV, the patient started feeling paralyzed and numbness in both arms and both hands.  On an unspecified date in Oct-2020, the patient started therapy with prednisone on his own. He couldn't shave or brush his teeth. The patient developed weakness.  On an unspecified date in Oct-2020, the patient recovered from the event of 'paralysis'.  At the time of initial reporting on 14-Oct-2020, the patient had not recovered from the events 'numbness of upper extremities' and 'weakness', as it was reporter he was better, but still felt weakness and numbness in both arms.  The outcome of the events 'loss of personal independence in daily activities' was not reported.  The reporter did not provide the causality assessment.  The event of 'paralysis' and 'loss of personal independence in daily activities' was considered as serious due to criterion of medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: The patient developed paralysis and hypoesthesia several hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The events of the loss of personal independence in daily activities and asthenia occurred on an unknown date within same month, making temporal relationship compatible. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed paralysis and hypoesthesia several hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The events of the loss of personal independence in daily activities and asthenia occurred on an unknown date within same month, making temporal relationship compatible. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: Lower back pain radiating into both legs
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Lymphadenitis, Pruritus, Rash
Clinical narrative: Hands became pruritic and small bumps formed on them, headache, fatigue approx. 1 hour after receiving the Hepatitis B vaccine
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Hands became pruritic and small bumps formed on them, headache, fatigue approx. 1 hour after receiving the Hepatitis B vaccine
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: received flu quad and started breaking out in very red rash on face and chest around 8pm. slightly itchy. Went to HCP 10/21 and they prescribed Zyrtec.  Had steroid shot in knee day before vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patients left arm at the deltoid if red, swollen, painful.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: sub-q injections was given in the abdomen; No adverse outcome; per the CDC, the doses will count as valid and do not need to be repeated but this is seen as an error. A VAERs report needs to be completed.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PT HAD REDNESS, SWELLING, PAIN AND HEAT BELOW INJECTION SITE
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Swelling
Clinical narrative: Started to bother her on Friday with swelling and muscle pain which lasted about 2-3 days. Saw doctor today had no fever, no stomach pains or diarrhea, but feeling tired, some weakness and headache. Today makes seven days.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of a sore arm after the vaccination. Now two days later patient states that arm is now red and swollen and is still sore.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site infection, Injection site warmth, Pain in extremity
Clinical narrative: After influenza vaccine given on 10/8/2020 clients arm progressively became more and more sore to the point where the client could not lift their arm. Pain keeps client up at night.  Saw their PCP on 10/20/20 when a red spot was noticed and it was warm to the touch.  Client was told that the site is infected.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: After influenza vaccine given on 10/8/2020 clients arm progressively became more and more sore to the point where the client could not lift their arm. Pain keeps client up at night.  Saw their PCP on 10/20/20 when a red spot was noticed and it was warm to the touch.  Client was told that the site is infected.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Signs or  symptoms
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arm and neck pain two weeks after vaccine.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Pruritus, Throat irritation, Tongue pruritus
Clinical narrative: Approximately 20" after flu vaccine, pt was waiting/being monitored for possible side effects from the vaccine. After advising client she could leave, she stated her tongue was feeling itchy and throat was feeling weird. A few minutes later she also began to c/o her head itching. Returned her to the treatment room for further evaluation.AAOx3. Calm. Speech clear and appropriate. Ambulates without difficulty. Skin warm/dry. No obvious swelling of tongue or throat. Lungs clear to auscultation all fields. VS: 150/80-60-18-96.9F within normal range except for BP which was 150/80. Client reports she has a h/o HTN and she took her prescribed medication (HCTZ) this am. Also reports an allergy to lisinopril (hives)  Also reports an allergy to lisinopril (hives) and a sensitivity to wheat, cornmeal, aloe, avocado and gluten. Client reports her symptoms (itchy tongue and throat feeling weird) were beginning to subside. Administered Diphenhydramine 25mg as per RNP Flow Sheet 408.24. Continued to monitor pt for an additional 30 minutes. Denies any further symptoms. Advised to seek medical advice from her PCP, in follow up to this event which she agreed to do. Advised to call this clinic if symptoms begin to recur and not to walk back to the clinic with recurring symptoms. Assured pt had clinic phone number.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Low grade fever, muscle aches, feeling foggy, feeling tiered, moderate pain at injection site. Treated with Ibuprofen, bed rest. Felt better after three days.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia, Dizziness, Headache, Injection site pain, Muscle contractions involuntary
Clinical narrative: PATIENT REPORTS EXPERIENCING INTENSE HEADACHE W/ DIZZINESS, AND STIFFNESS/PAIN SHOOTING ALONG LEFT SIDE OF NECK WITHIN 2 MINUTES OF RECEIVING SHOT AS SHE WAS BROWSING STORE AISLES. PATIENT WENT TO HER CAR WANTING TO GO HOME, AND REPORTS LOSING SHORT-TERM MEMORY WITHIN 5 TO 10  MINUTES OF RECEIVING INJECTION. INVOLUNTARY FASCICULATIONS (TWITCHING) STARTED AROUND 8PM, AND ALL THESE SYMPTOMS CONTINUED UNTIL PATIENT FELL ASLEEP AROUND 10PM. SHE WOKE UP AT 5AM THE FOLLOWING MORNING AND REPORTS NO MORE SYMPTOMS OTHER THAN PAIN/TENDERNESS AT INJECTION SITE. PATIENT ONLY CONTACTED PHARMACY AT 3PM THE DAY AFTER RECEIVING SHOT.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: PATIENT REPORTS EXPERIENCING INTENSE HEADACHE W/ DIZZINESS, AND STIFFNESS/PAIN SHOOTING ALONG LEFT SIDE OF NECK WITHIN 2 MINUTES OF RECEIVING SHOT AS SHE WAS BROWSING STORE AISLES. PATIENT WENT TO HER CAR WANTING TO GO HOME, AND REPORTS LOSING SHORT-TERM MEMORY WITHIN 5 TO 10  MINUTES OF RECEIVING INJECTION. INVOLUNTARY FASCICULATIONS (TWITCHING) STARTED AROUND 8PM, AND ALL THESE SYMPTOMS CONTINUED UNTIL PATIENT FELL ASLEEP AROUND 10PM. SHE WOKE UP AT 5AM THE FOLLOWING MORNING AND REPORTS NO MORE SYMPTOMS OTHER THAN PAIN/TENDERNESS AT INJECTION SITE. PATIENT ONLY CONTACTED PHARMACY AT 3PM THE DAY AFTER RECEIVING SHOT.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Vaccine was administered in the Deltoid region, she called a week ago and spoke with my colleague and he suggested icing, taking tylenol and let us know in few days, she visited the pharmacy now (10/22/20) and informed that she started having pain at the ELBOW (not Shoulder) area, she said she started having the pain approximately a week or so after the vaccine.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Pain after injection that has worsened and pt now has reduced ROM and weakness 1 week later
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complained of soreness when moving arm laterally for a week post vaccination.  Pt was advised to use a heating pad and motrin as needed.  If pain continued to persist to visit PCP.  Patient's pain resolved. A month later the pain resumed. Patient was advised to make an appointment with PCP.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Myalgia
Clinical narrative: The following day I had a 100.8 degree temperature, was tired, and most of my muscles ached as though I had a heavy workout.  These symptoms were gone the next day, and I felt fine.  After the second dose, I had a 99 degree temperature and was a little tired, but these symptoms were also gone the next day.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: immediately after injecting the vaccine, swelling occured at the site of the injection.  the lump was ridgid, protruded about 1/4 inch from skin surface, and was the diameter of a dime.  Just a drop of blood was expressed from the site of injection.  A cold press was applied for about 5 minutes and the swelling went down. The patient called back about 20 minutes later and reported that the swelling came back.  She was advised to seek assistance at an urgent care facility.  the patient reported no discomfort or unusual feeling in the arm.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test, Chest X-ray, Dizziness, Dyspnoea, Injected limb mobility decreased
Clinical narrative: TOOK A NAP. WOKE UP SHAKING,NAUSEATED, DIFFICULTY BREATHING, DIZZY AND COULDN'T MOVE LEFT ARM. WENT TO HOSPITAL.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Tremor
Clinical narrative: TOOK A NAP. WOKE UP SHAKING,NAUSEATED, DIFFICULTY BREATHING, DIZZY AND COULDN'T MOVE LEFT ARM. WENT TO HOSPITAL.
Age: 96.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hiccups, Syncope, Vomiting
Clinical narrative: Patient had episode of syncope and vomiting 30 minutes after provider administered flu vaccine.  Patient started feeling weak and went outside on deck and fainted while sitting in a chair. Patient regained consciousness quickly and had 1 episode of emesis. Aide helped patient get to bed and stated he felt fine, and hiccups, and planned to rest. Patient did not wish to seek emergency care.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Extensive swelling of vaccinated limb, Induration, Injection site erythema, Injection site induration
Clinical narrative: left deltoid became red, warm, swollen, hard to touch around localized area of injection site about 2 hours after vaccination. Ice/cold pack applied. approx. 3 hours later, entire left upper arm was red, hot, swollen, hard to touch with itching present. employee stated like her arm was becoming tighter and felt hot and started intensely itching. employee took a Benadryl 25mg and APAP 650mg PO. several hours into reaction the swelling, redness, warmth, hardness spread to her left forearm. this caused moderate-severe pain/discomfort. on the next day, this nurse checked in with employee. left upper arm/forearm remains swollen, not as red/swollen. but reaction is still present.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: left deltoid became red, warm, swollen, hard to touch around localized area of injection site about 2 hours after vaccination. Ice/cold pack applied. approx. 3 hours later, entire left upper arm was red, hot, swollen, hard to touch with itching present. employee stated like her arm was becoming tighter and felt hot and started intensely itching. employee took a Benadryl 25mg and APAP 650mg PO. several hours into reaction the swelling, redness, warmth, hardness spread to her left forearm. this caused moderate-severe pain/discomfort. on the next day, this nurse checked in with employee. left upper arm/forearm remains swollen, not as red/swollen. but reaction is still present.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: localized injection site reaction, redness swelling on right arm
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: PC from patient's grandmother stating the day after the patient received the flu vaccine she started running a fever of 102.2, grandmother states the fever was brought down with liquid Tylenol. Grandmother states she ran a fever of low grade temp of 100 degrees yesterday and states she has not run a fever in 24 hours.  Grandmother asked RN if a fever was a side effect of the flu shot.  RN counseled grandmother that the influenza vaccine was a inactivated virus and should not cause a fever.  Grandmother reports no other symptoms that the fever.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Inflammation, Muscle tightness, Pain
Clinical narrative: Patient received her flu vaccination (Afluria Quadrivalent prefilled syringe) on 10/16/20.  The next morning patient awoke with pain in her lower back and progressed throughout the day. The mornings tend to be worse on pain level.  The pain is usually dull but with movement the pain can become very sharp.  Due to the pain she messaged the doctor on 10/19/20 and was scheduled for a telephone visit  on 10/20/20.  Patient was prescribed celecoxib for pain and inflammation and cyclobenzaprine for  muscle tension and tightness.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: On 10/9/20: Patient is a 5-year-old received a flu shot at school yesterday. Reaction started about 8 hours after the flu shot.  There is slight area of redness.  Today the redness is increased and has some swelling.  Is no pain but there is itching.  No fevers no chills.  Patient never had a similar reaction to any immunizations in the past.  Patient allergic to amoxicillin.  There is no sore throat no difficulty breathing or swallowing. Saw in ED and given Keflex for possible cellulitis. 10/12/20:  Suspected local skin reaction secondary to influenza vaccine  Unlikely a cellulitis as reaction occurred <12 hours after injection, but given no assessment by employee at time of swelling will continue as ordered by other physician (will only complete 7 days)  continue supportive care- PRN benadryl, cool compresses  Mom to call if not improving, worsening, or any other concerns  Follow up: PRN
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: fatigue sore muscles, joint pain, fever
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: developed a 2"x1" oval-shaped, raised pinkish-red area at the Menveo injection site. First noticed area 10.21.2020. Patient complains of continuous, achy pain, worsened by use of arm, especially when lifting objects. Has tried applying ice on two different occasions with no relief.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure abnormal, Head injury, Lethargy, Loss of consciousness
Clinical narrative: At 2:57pm on Oct 22, 2020, I gave Afluria to the patient in her right arm. No swelling or adverse reaction occurred at the time of vaccination. Approximately 15 minutes later, a coworker told me that the patient lost consciousness. When I arrived with the emergency kit, the patient was sitting up and speaking. Her mother who was with her did not want us to call 911. I checked the administration site, and there was no indication of an allergic reaction. Patient said she did not have any swelling in her face or mouth. An ice pack was given to her because she hit her head on the floor when she passed out. She seemed lethargic. We helped her into a wheelchair and I advised the mother to take her to the hospital to get checked out. I asked the patient if she had eaten, and she said yes. We got her some orange juice and she drank it. While she was drinking the juice, I tried to take her blood pressure twice, but both times I had an error message "ERR 5", which according to the manual meant that there was "an unacceptable difference between systolic and diastolic pressures".  The mother wheeled her out of the store and said they were going to the hospital. I asked her to call me and keep me updated.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose given to a 64 year old
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain, X-ray abnormal
Clinical narrative: After receiving the pneumovax23, it was a very sharp pain. The pain got worse. Came back saw her doctor, had xrays which showed a lot of inflammation. Had a lot of pain especially at night. Was given steroids for 2 weeks. The steroids decreased the pain but had a lot of side effects. Can not sleep on right side.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Approximately at 0200 on 10/08/2020, child fussy and fever (102 axillary). Child was fussy and crying. Fever and fussiness improved with Tylenol. Erythema at injection site, approximately 1-2 cm on right thigh, hot to the touch.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pain in extremity
Clinical narrative: leg hurt all day on Friday, patient didn't walk on it on Saturday.  redness to area started two nights ago from today 10-22-2020.
Age: 33.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass
Clinical narrative: Tdap was administered first. Site: upper right deltoid. Fluarix Quadrivalent was administered second intramuscularly. Site: lower deltoid. Immediately after administering Fluarix  a firm lump formed at injection site. It grew quickly to  about the size of about a quarter. The injection was given through a large tattoo so that it was difficult to assess the color of the lump. The lump bulged out from under the patient's skin. The reaction was localized to the Fluarix injection site. No signs or symptoms of anaphylaxis. This was the patient's first flu shot. Patient denies SOB/wheezing or any respiratory symptoms. No periorbital edema.  No history of prior injection reactions. Diphenhydramine 50 mg oral was administered. Ice pack applied to site.  Instructed to take cetirizine 10 mg daily for 5 to 7 days.  Ice 15-20 minutes several times daily.  Discharged ambulatory (mother driving him home) with no respiratory S&S.
Age: 89.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Dizziness, Posture abnormal, Urinary incontinence
Clinical narrative: patient was with age related weakness (her daughter brought her in with aid of a walker) and a reported mild dizziness  before administering vaccine. 10 minutes after administering vaccine, she felt more dizzy and couldn't keep sitting posture in chair and urinated while sitting in the chair and leaning on her daughter. Called 911 for an ambulance.  Laid her flat on the floor and observed for her breathing. Her breathing looked normal and she was responsive to verbal  conversation.  No CPR was administered as the patient is able to breath on her own and responsive to verbal conversation. During conversation she just reported severely dizzy.  EMS personnel arrived in about 10 minutes and took her to to the hospital
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Cellulitis, Peripheral swelling, Skin reaction
Clinical narrative: red swollen left arm, needed to be placed on medication for cellulitis
Age: 0.67
Sex: F
Vaccine: FLU4, HEP, PNC13, UNK, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction reported.   Patient was supposed to have been given Pentacel but instead only received the DTaP-IPV component.  Patient will be brought back in for single dose of Hib.  Pentacel was wasted and reported.  DTaP and IPV were listed historically for patient.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Pain
Clinical narrative: Patient was given Fluarix vaccine; afterward (within a few minutes), patient stood up and passed out; patient fell and hit his head on the wall in the immunization room; patient was experiencing headaches and pain; EMS services was called and patient was transported to Medical Center; Spoke to father today (10/22/20) and patient was discharged home with no adverse effects except some headache
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had flu shot in right deltoid on 10/19/20.  That night she started getting swelling, redness around the area.  On 10/20 MOC have Benadryl, then again 10/21 and it is getting better.  No associated fever, no associated pain and no limitation of movement.  Pt has received flu vaccine before without reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Pain
Clinical narrative: Chills, body aches and high rapid heart rate while resting for 9 hours consistently running 110-126.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient did not have any adverse reactions to this incorrect imm.