chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient received Fluzone Quadrivalent instead of Fluzone High Dose/ NO AE; Initial information received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 78-years-old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ428AA, expiry date: 30-Jun-2021 via an unknown route in left deltoid) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered) on 26-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, 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 and Module VI of the 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.
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Cough, Eye swelling, Headache, Injection site pain, Lip swelling
Clinical narrative: Feeling of throat closure, swelling of face (eyes, and Lips). urge to cough, light headache, light soreness at injection site (R/upper arm).
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Swelling face, Throat tightness
Clinical narrative: Feeling of throat closure, swelling of face (eyes, and Lips). urge to cough, light headache, light soreness at injection site (R/upper arm).
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Chest discomfort, Hyperhidrosis, Ocular hyperaemia, Swelling face, Throat tightness
Clinical narrative: Feeling of throat closure, swelling of face (eyes, and Lips). urge to cough, light headache, light soreness at injection site (R/upper arm).
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Cough, Eye swelling, Headache, Injection site pain, Lip swelling
Clinical narrative: Reported by patient on 9/23/20: throat tightness began around dinner time on 9/22, chest felt tight, patient experienced episode of sweating with no fever overnight and her face was generally swollen in the morning (photo taken).  At time of presentation to pharmacy in the morning patient appeared normal although she had red eyes.
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Swelling face, Throat tightness
Clinical narrative: Reported by patient on 9/23/20: throat tightness began around dinner time on 9/22, chest felt tight, patient experienced episode of sweating with no fever overnight and her face was generally swollen in the morning (photo taken).  At time of presentation to pharmacy in the morning patient appeared normal although she had red eyes.
Age: 35.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Chest discomfort, Hyperhidrosis, Ocular hyperaemia, Swelling face, Throat tightness
Clinical narrative: Reported by patient on 9/23/20: throat tightness began around dinner time on 9/22, chest felt tight, patient experienced episode of sweating with no fever overnight and her face was generally swollen in the morning (photo taken).  At time of presentation to pharmacy in the morning patient appeared normal although she had red eyes.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Malaise
Clinical narrative: Patient did not feel well the next day and stated her upper lip was swollen.  She did not have any difficulty swallowing or breathing, just had a swollen upper lip.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: generalized body rash-seen by Employee Health physician-no further treatment given
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal rigidity, Asthenia, Balance disorder, Decreased appetite, Nocturia
Clinical narrative: night of 9/23/2020 repeated bathroom trips 10-20 minutes apart   signaled by spasm in abdomen   weakness   compromised balance   not wanting to get out of bed all day 9/23/2020   no hunger   persistent soreness in left arm
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: night of 9/23/2020 repeated bathroom trips 10-20 minutes apart   signaled by spasm in abdomen   weakness   compromised balance   not wanting to get out of bed all day 9/23/2020   no hunger   persistent soreness in left arm
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Chills, Dizziness, Heart rate increased
Clinical narrative: Increased heart rate, increased blood pressure, chills;dizziness
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Musculoskeletal chest pain, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: High pulse, freezing, fever, feels like ribs are broken when I breathe, severe body aches.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site urticaria
Clinical narrative: Has a hive on arm where shot was given.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Tdap expired on 9/12/20 and was inadvertently given. There were no complications. The patient will come in for another Tdap, ASAP, and education was provided for the staff.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Mobility decreased, Neuralgia, Pain, Pain in extremity
Clinical narrative: Shortly after administration I started to lose ability to move my arm. When moving arm in certain directions, I get shooting excruciating nerve pain through the entirety of my arm. The pain is so sporadic it will randomly wake me up in the middle of the night. I cannot put any amount of weight on my shoulder. I cannot lift my arm past a 45 degree angle.  I am a registered dental assistant and it effects my ability to perform my duties on a daily bases. I have had to miss work and have not been preforming to my utmost capability, thereby negatively influencing  my work place. The pain is progressing and only getting worse as time goes on.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder, Weight bearing difficulty
Clinical narrative: Shortly after administration I started to lose ability to move my arm. When moving arm in certain directions, I get shooting excruciating nerve pain through the entirety of my arm. The pain is so sporadic it will randomly wake me up in the middle of the night. I cannot put any amount of weight on my shoulder. I cannot lift my arm past a 45 degree angle.  I am a registered dental assistant and it effects my ability to perform my duties on a daily bases. I have had to miss work and have not been preforming to my utmost capability, thereby negatively influencing  my work place. The pain is progressing and only getting worse as time goes on.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient received bruise that turned black and blue at injection site within 2 hours after vaccine administration. Contributing factors include vaccine being administered with a 1 1/2 inch needle based on patient weight and patient being on warfarin. Patient was advised to seek out treatment at urgent care.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored PROQUAD that was administered; This spontaneous report has been received from a nurse referring to a currently 1 years old patient of unknown gender. Information about concomitant therapy, pertinent medical history or drug reactions/allergies was not provided.  On an unknown date, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # T003833 and expiration date 01-AUG-2021) for prophylaxis (product storage error).   The administered doses of the vaccines experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-11.84 degree Celsius) for 45 minutes and a temperature in the range -9 degree Celsius to 8 degree Celsius (-4.12 degree Celsius) for 30 minutes recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Itchy around ear; Itchy around ear, raised; Itchy around ear, raised, red; itchy around ear, raised, red and painful; This case was reported by a other health professional via sales rep and described the occurrence of localized itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced localized itching, local swelling, erythema and pain. On an unknown date, the outcome of the localized itching, local swelling, erythema and pain were unknown.   It was unknown if the reporter considered the localized itching, local swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced itchy around ear, raised, red and painful 2 weeks after vaccination with Shingrix. The reporter was willing to provide additional information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first dose / 21Aug2020 / attended / clinic / 01Sep2020 / symptoms / 1 or 2 days before; This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The reporter called to request information of how often did patients have a shingles outbreak after a first dose of Shingrix administration. On 1st Sep 2020 patient attended physician clinic and mentioned that symptoms could have been there 1 or 2 days before the consult.  Patient had the vaccine administered at another location. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: 66 year old female patient inadvertently received an expired dose of Fluzone high dose, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involves a 66 year old female patient who vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] inadvertently (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation.  On 16-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ306AA and expiry date: 24-Jun-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  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.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swelling on left hand and left wrist
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Chills
Clinical narrative: Shaking chills  (rigors)  Chills began at 7 PM,  rigors began about 9 PM lasting 10-15 minutes.  Chills lasted until after midnite .  He fell asleep and awakened at 4 AM the chills had resolved.  Still feeling malaise and weakness. Left arm(shingles) had become sore about 2PM.  Soreness was so severe as to preclude lifting it without severe pain.  it began to resolve overnight.   Right arm (pneumonia) became sore about 2 PM.  It was slower in onset and not so severe.  It is mild this morning.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysstasia, Headache
Clinical narrative: dizziness that lasted about 10-15 minutes when I could not stand.  And a headache.   No lingering effects the next morning.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chest pain, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Vomiting -From 6 pm-10pm same day as vaccine  Nausea, Chills, Upper Chest Pain- 1st -2nd day Headache,  1st - 3rd day  Arm sore at area of shot-1st-3rd day
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting -From 6 pm-10pm same day as vaccine  Nausea, Chills, Upper Chest Pain- 1st -2nd day Headache,  1st - 3rd day  Arm sore at area of shot-1st-3rd day
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: One week after receiving the vaccination I got shingles.  They were located on the right side of my head.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Left deltoid red, warm to the touch, swollen and feels tight. Employee complains of pain with touch or pressure to the area.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Skin tightness
Clinical narrative: Left deltoid red, warm to the touch, swollen and feels tight. Employee complains of pain with touch or pressure to the area.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: This was an employer provided flu shot.  Symptoms were body chills (extreme cold), headache, fatigue, dizziness. Symptoms onset roughly 6 hours after shot and resolved after 12 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Eye irritation, Malaise, Migraine
Clinical narrative: Pt states she got her Shingrix and Flu shot Monday around 10. She woke up Tuesday AM feeling very sick. Symptoms included muscle aches, migraine, chills, face was red, eyes burning, and a rash on her neck, chin, back and groin area. She describes the rash as blotchy with some red pin prick looking spots.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Rash erythematous, Rash macular
Clinical narrative: Pt states she got her Shingrix and Flu shot Monday around 10. She woke up Tuesday AM feeling very sick. Symptoms included muscle aches, migraine, chills, face was red, eyes burning, and a rash on her neck, chin, back and groin area. She describes the rash as blotchy with some red pin prick looking spots.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: On 9/17, client woke up with hot, red swollen arm- from shoulder to wrist. Mom gave motrin and sent child to school. After school on  9/17, symptoms persisting, Mom gave Benadryl and Motrin. Cool compresses were recommended- not sure if this was applied.  On 9/18, arm was still tight and swollen, not as red and didn't hurt as much.  Continued to attend school.  Final call on 9/23- signs and symptoms resolved fully by Saturday, 9/19. Also noted- this client has a similar reaction to a PCV 13, # 3 in series, on 4/25/12, which was administered to right leg.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Erythema, Fatigue
Clinical narrative: 1600: Received flu vaccine in clinic today.  Family exited building and getting into car.  1610:  Pt within a couple of minutes of receiving vaccine started having difficulty breathing. He said he felt like he couldn't breathe and he was having swelling in his neck.   Patient started to cough and turned very red.  Said he throat felt tight.  Complained of nausea.  Felt like this came over him like a "lighting bolt".  Stomach feels as if someone is pushing on it.   Tired appearing.  He denies dizziness. He has not had similar feelings in the past. He has no known allergies to egg.  1627:  Epi 0.3 mg given IM  with improved symptoms within 3-5 minutes.   1635:  EMS arrived and transported patient to Hospital.  observed for 3 hours.  Send home on Prednisone, Pepcid and Benadryl.  Given epi pen for home use, if needed.   09/23/2020  Mom reports the patient is doing well and has no concerns.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Swelling, Throat tightness
Clinical narrative: 1600: Received flu vaccine in clinic today.  Family exited building and getting into car.  1610:  Pt within a couple of minutes of receiving vaccine started having difficulty breathing. He said he felt like he couldn't breathe and he was having swelling in his neck.   Patient started to cough and turned very red.  Said he throat felt tight.  Complained of nausea.  Felt like this came over him like a "lighting bolt".  Stomach feels as if someone is pushing on it.   Tired appearing.  He denies dizziness. He has not had similar feelings in the past. He has no known allergies to egg.  1627:  Epi 0.3 mg given IM  with improved symptoms within 3-5 minutes.   1635:  EMS arrived and transported patient to Hospital.  observed for 3 hours.  Send home on Prednisone, Pepcid and Benadryl.  Given epi pen for home use, if needed.   09/23/2020  Mom reports the patient is doing well and has no concerns.
Age: 4.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported at this time; 4 year old patient received GARDASIL 9 vaccine; This spontaneous report as received from a nurse refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 14-SEP-2020, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # S010729, expiration date 01-DEC-2021 (exact dose and route of administration were not reported) for prophylaxis. At the time of the report, no side effects were 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: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: an injection of MMR II vaccine was given IM instead of SQ; This spontaneous report was received from a pharmacist and refers to a 63-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 16-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # S035356, expiration date 05-NOV-2021, intramuscularly instead of subcutaneously for prophylaxis (exact dose was not reported).
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects reported; 6 year old patient was inadverently administered Gardasil 9; This spontaneous report was received from a nurse via the office manager and refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-SEP-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S023476, expiration date was reported as 26-MAR-2020, but upon internal validation was established as 26-MAR-2022; exact dose, site and route of administration were not reported) for prophylaxis. No additional adverse effects were 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; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S023476; 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 meet the criteria for Reportability
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Chills, Gastric dilatation, Nausea, Regurgitation
Clinical narrative: nausea; Felt like regurgitating; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diverticulosis. Previously administered products included Shingles vaccine (received previous shingles vaccine in 2016) and Shingrix with an associated reaction of abdominal pain lower (1st dose received on 2nd July 2020, refer case- US2020186285).   On 2nd September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, 14 days after receiving Shingrix, the patient experienced nausea and regurgitation. On an unknown date, the outcome of the nausea and regurgitation were not recovered/not resolved.   It was unknown if the reporter considered the nausea and regurgitation to be related to Shingrix.  Additional information was provided as follows: The patient was feeling nauseous for the first time and felt like regurgitating on the day of reporting. The patient after the 1st dose of Shingrix experienced lower abdominal pain especially when she had a bowel movements and also as of 08/2020, she was stating that her stomach was swollen, large and firm to touch. The lower abdominal pain and swollen stomach was ongoing and had not resolved. She had felt a shiver one time when she heard two people take in anger, which she has not felt before. The patient was daignosed with diverticulosis and was not taking any medication for it. The reporter consented to follow up. The case was considered as medication error with harm. The case is linked with case-US2020186285, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186285:1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate abnormal
Clinical narrative: atrial fibrillation symptoms; heart rate variance; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol succinate (Toprol).   On 12th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2020, less than a day after receiving Shingrix and flecainide and less than a day after starting Shingrix and flecainide, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant) and heart rate abnormal. The patient was treated with flecainide. On 15th June 2020, the outcome of the heart rate abnormal was recovered/resolved. On an unknown date, the outcome of the atrial fibrillation aggravated was unknown.   The reporter considered the atrial fibrillation aggravated and heart rate abnormal to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported  The patient had a history of atrial fibrillation.  The patient stated he states that on 12th June 2020, the patient took dose 1 of Shingrix and started a new medication for atrial fibrillation, flecainide. On the same day patient had heart rate variance, atrial fibrillation symptoms that lasted till 15th June 2020. The cardiologist told her the atrial fibrillation symptoms were related to receiving the vaccine. The reporter consented to HCP follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 3 consumer experienced a medication error with the Flu zone Quadrivalent described as receiving an expired vaccine, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves three patients of unknown demographics who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UJ304AA and expiration date 30-Jun-2020) that was expired (PT: expired product administered), via unknown route in unknown administration site as prophylactic vaccination on an unknown date.it was also reported that while receiving a flu vaccine for the wrong flu season year and that the vaccine was for the flu season 2019-2020.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Erythema, Limb mass, Pain
Clinical narrative: temperature for a week,  was up to 102 with tylenol at one point, red lump on arm still noticeable after one week,  arm sore when lifting still,
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: on and off complaints of headache with recurrent low grade fever since last night. Had diarrhea yesterday afternoon.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Heart rate increased, Injection site erythema, Injection site mass
Clinical narrative: Fever, vertigo, headache, chills, increased heart rate, pain , redness and large lump at site of injection (upper arm).
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pyrexia, Vertigo
Clinical narrative: Fever, vertigo, headache, chills, increased heart rate, pain , redness and large lump at site of injection (upper arm).
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Body temperature increased, Swelling
Clinical narrative: On 9/22/2020 noticed a area under his right arm (pit) swollen the size of a golf ball that wasn't present previously. Had a temp of 99.6  that evening, no temp today 9/23/2020.  Mother called the Dr and she informed to apply warm compresses and to take tylenol for for pain or temp.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Symptoms of pain and swelling at around 5pm on 9/21/2020. Took Ibuprofen of 400mg. Applied ice pack at around 8pm on 9/21/20. Redness and burning sensation developed on 9/22/2020.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Per mom, the patient was fussy and screamed for hours after receiving vaccines. Mom feels this was from the Rotavirus vaccine. She reported during the August 20th visit that a similar reaction was noted after the 2 month dosage on April 23rd, although she did not bring this to my attention until the August 20th visit.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT CAME TO THE PHARMACY ON 09/07/20 WITH A RX FROM THE EMERGENCY ROOM AND STATED SHE HAD SWOLLEN AND REDNESS AT THE SITE OF INJECTION. RX (BACTRIM DS). PHARMACIST ON DUTY AND NOTICE REDNESS AT THE SITE AND RECOMMENDED WARM COMPRESS AT THE SITE OF INJECTION AND INSTRUCTED PATIENT TO TAKE TYLENOL IF NEEDED FOR THE PAIN.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Blood glucose increased, Cellulitis, Diabetes mellitus, Headache, Inflammation
Clinical narrative: PATIENT CAME TO THE PHARMACY ON 09/07/20 WITH A RX FROM THE EMERGENCY ROOM AND STATED SHE HAD SWOLLEN AND REDNESS AT THE SITE OF INJECTION. RX (BACTRIM DS). PHARMACIST ON DUTY AND NOTICE REDNESS AT THE SITE AND RECOMMENDED WARM COMPRESS AT THE SITE OF INJECTION AND INSTRUCTED PATIENT TO TAKE TYLENOL IF NEEDED FOR THE PAIN.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Nausea, Pyrexia, Ultrasound scan
Clinical narrative: PATIENT CAME TO THE PHARMACY ON 09/07/20 WITH A RX FROM THE EMERGENCY ROOM AND STATED SHE HAD SWOLLEN AND REDNESS AT THE SITE OF INJECTION. RX (BACTRIM DS). PHARMACIST ON DUTY AND NOTICE REDNESS AT THE SITE AND RECOMMENDED WARM COMPRESS AT THE SITE OF INJECTION AND INSTRUCTED PATIENT TO TAKE TYLENOL IF NEEDED FOR THE PAIN.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Malaise, Pyrexia
Clinical narrative: Sore shoulder, redness and a red streak, malaise, low grade fever
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: PATIENT HAD VERY,  VERY  SORE ARM FROM ELBOW ON UP TO THE SHOULDER. PATIENT HAD LOSS OF USE OF THE ARM FOR 2 DAYS ACCORDING TO THE PATIENT
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, red that appears to be spreading, and hot to the touch. Getting worse each day, advised to be checked by urgent care, use ice and Tylenol as well
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse outcomes
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: severe muscle aches, headache, sore throat, joint pain, chills,
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: severe muscle aches, headache, sore throat, joint pain, chills,
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever of 102.  Chills at 1800 and fever at 2100.  She has a history of reaction.  Last year she was hospitalized.  She also missed a night of work.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Arthralgia, Chills, Fatigue, Flank pain, Headache
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Myalgia
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Pain, Paraesthesia, Pyrexia, Rash macular
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Hypersomnia, Hypoaesthesia, Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site rash, Lip discolouration, Pain, Paraesthesia, Pyrexia
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 36.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Rash macular
Clinical narrative: Low grade fever from 11pm 9/19 to approx 1am 9/22, chills, body ache, flank pain with normal urine output and coloration, muscle ache, joint pain intermittent, headache, exhaustion, soreness at injection site preventing use of arm, tingling in right fingertips at thumb, point, and half of middle finger at upper digit ventral side, on 9/22 development of blotchy flat rash above injection site first observed approx 2pm. On 9/23 pain at injection site was mild, mild headache and body ache, no fever, pins-needles sensation on tops of feet, and rash on left shoulder (blotchy flat pinkish and warm to touch versus non-reddened areas.)
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Anosmia
Clinical narrative: lost sense of smell for weeks after both doses of Shingrix.  Sense of smell later returned.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently administered Tdap instead of flu vaccine.  Patient reported during infancy she had allergic reaction to pertussis but cannot recall reaction and was told she would likely grow out of it.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: none
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Condition aggravated, Hip fracture, Injury, Magnetic resonance imaging
Clinical narrative: FLU SHOT WAS GIVEN BY PHARMACIST AFTER A LEGAL HOLIDAY , SOON AFTER THE SHOT SOMEWHERE AFTER SEPTEMBER 07 , MY MOM HAD TO START USING A WALKER , VERY MUCH PAIN ON RIGHT UPPER LEG & BUTTOCKS , SOON MOVED OVER TO THE RIGHR BUTTOCKS , THEN ALMOST COMPLETELY IMMOBILIZED HER  , 5 TOTAL E/R VISITS WITH THE 5TH VISIT ENTERING TO HOSPITAL
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Stress fracture, Walking aid user
Clinical narrative: FLU SHOT WAS GIVEN BY PHARMACIST AFTER A LEGAL HOLIDAY , SOON AFTER THE SHOT SOMEWHERE AFTER SEPTEMBER 07 , MY MOM HAD TO START USING A WALKER , VERY MUCH PAIN ON RIGHT UPPER LEG & BUTTOCKS , SOON MOVED OVER TO THE RIGHR BUTTOCKS , THEN ALMOST COMPLETELY IMMOBILIZED HER  , 5 TOTAL E/R VISITS WITH THE 5TH VISIT ENTERING TO HOSPITAL
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: FLU SHOT WAS GIVEN BY PHARMACIST AFTER A LEGAL HOLIDAY , SOON AFTER THE SHOT SOMEWHERE AFTER SEPTEMBER 07 , MY MOM HAD TO START USING A WALKER , VERY MUCH PAIN ON RIGHT UPPER LEG & BUTTOCKS , SOON MOVED OVER TO THE RIGHR BUTTOCKS , THEN ALMOST COMPLETELY IMMOBILIZED HER  , 5 TOTAL E/R VISITS WITH THE 5TH VISIT ENTERING TO HOSPITAL
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: Patient reports "swollen lips, hives, and difficulty breathing.  Patient states she received 2 steroid shots in the ED.  Patient was discharged home.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Eye movement disorder, Syncope, Tremor
Clinical narrative: Patient had a syncope episode with mild shaking. Eye rolled to the back of her head.  This lasted about 10 seconds. This happened 19 minutes after vaccine was given.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Administration site erythema, Administration site swelling, Injection site erythema, Injection site pain
Clinical narrative: Patient vaccinated on September 7/ 2020 presents the day after to report redness, swelling, tenderness and erythema from the shoulder at the administration site to the elbow.  Was instructed to put ice on the affected area and if not subsides or get worse to consult her primary care physician.  On September 9/ 2020 patient returned to the pharmacy to pick up electronic prescription for Septra DS #20 take one twice a day for 10 days, after MD visit for the symptoms earlier described.  Patient contacted on September 11, 2020 11 45AM and reported significant improvement on symptoms
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Aspiration joint, Bursitis, Swelling, Ultrasound scan
Clinical narrative: pt had a swollen shoulder and pain shortly after the shot.  pt went to er on Sun 9/20.  pt got an xray an unltrasound and they aspirated fluid.  pt was told she has bursitis.  pt was released on no other med or instruction.  pt came to pharmacy on 9/23 to alert us to the issue.  pt is doing better but still has some residual pain.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: X-ray
Clinical narrative: pt had a swollen shoulder and pain shortly after the shot.  pt went to er on Sun 9/20.  pt got an xray an unltrasound and they aspirated fluid.  pt was told she has bursitis.  pt was released on no other med or instruction.  pt came to pharmacy on 9/23 to alert us to the issue.  pt is doing better but still has some residual pain.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Patient described symptoms of very painful, red and itching at the injection site. She also stated that the itching went down her upper arm a little bit. Patient was advised to take benadryl for itching, ibuprofen and/or a cold compress for the pain and inflammation.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Repetitive vomiting and diarrhea (nonbloody) for several hours on the morning following vaccination.  Symptoms had resolved by the afternoon
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Gait disturbance, Mobility decreased, Somnolence
Clinical narrative: About 1 day after the vaccine was received, the patient stated he had a hard time getting out of bed, he was extremely tired and sleepy, and also had trouble walking. All of this was unusual for him and lasted for about a day. He also stated that he almost went to the hospital due to these reactions. He did not have any skin irritation or local reaction. He also stated he has never had a bad reaction to any flu shots in the past.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Muscle spasms, Nausea
Clinical narrative: Shivering, Chills, Headache, nausea, dizziness, Muscle Spasms. Lasted about 2 hours. No lasting side effects.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: Recieved the flu vaccine on  9/21/2020, he started complaining of pain in the arm that night and the next day and he would not let guardian look at or touch the area, guardian said it looked red at shower time on  9/22/2020 and was red and hard, there is more redness/ larger area of redness this morning than last night,and the redness is spreading away from flu vaccination site.  It was reported he was nervous for the vaccine and squirmed and tensed up but  then was fine. Afebrile. Was seen by staff on 9/23/2020  at 11:30 am, and she diagnosed cellulitis , went over symptom care, and prescribed cephalexin 250 mg/5ml oral suspension reconstituted 9 ml orally twice a day for 7 days.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced fever approaching 103 degrees Fahrenheit beginning approx 6 hours post vaccination and continued unabated until 48 hours post vaccination.   Patient had very mild pain in left arm upon contact to go along with 42 hours of fatigue and lethargy.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3, PPV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of Fluad vaccine at the same time.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: rash at injection site and itching on arms
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed the injection site was red the first day after getting the injection, the next morning it was swollen, very red & warm to the touch. Today, 9/23/20 the swelling is increased to her elbow and is still warm to the touch after using Benadryl. Treatment Plan: Advised mother to apply warm compress to the area. Use Benadryl (oral or topical) as needed for itching. Discussed signs & symptoms that would prompt follow-up.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # T002848, expiration date 23-JAN-2022, site and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine underwent a temperature excursion of -14 degrees Celsius (C) to 10 degrees C (-12.1 degrees C) for 3 hours and -9 degrees C to 8 degrees C (-7.5 degrees C) for 8 hours 30 minutes (multiple excursion). There was no previous temperature excursion. Data logger was involved.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: THE patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # T002848, expiration date 23-JAN-2022, site and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine underwent a temperature excursion of -14 degrees Celsius (C) to 10 degrees C (-12.1 degrees C) for 3 hours and -9 degrees C to 8 degrees C (-7.5 degrees C) for 8 hours 30 minutes (multiple excursion). There was no previous temperature excursion. Data logger was involved.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered to a consumer; This spontaneous report was received from a nurse, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 14-SEP-2020, the patient was vaccinated with improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot # S005249 was confirmed to be valid, expiration date 20-FEB-2021 (albumin status rHA) (exact dose, route of administration and anatomical location were not provided).  The temperature excursions were above 47 degrees Fahrenheit (F) (48.38 F) for 55 minutes, and above 47 degrees Fahrenheit (F) (54.32 F) for 7 hours and 14 minutes. There were no previous excursions reported. The digital data logger was involved.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: his second dose of GARDISAL 9 was over a year late; This spontaneous report was received from a male pharmacist of unknown age, who refers to himself, via agent. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  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) (lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis. On an unknown date, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis, which was over a year late (inappropriate schedule of product administration).