chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: injection site pain; Redness / dime-sized surrounding the injection site; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number PR5B2, expiry date 8th November 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th November 2019, 5 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient receive the 2nd dose of Shingrix vaccine and after 5 hours, she experienced injection site pain, redness, and a sore arm. The redness was described as dime-sized surrounding the injection site. The site was still red and the arm  was still sore 1 week after the injection and at time of report. There was no adverse event reported for the 1st dose of Shingrix vaccine. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: "extreme pain at injection site"; hallucinations; inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th November 2019, less than a day after receiving Shingrix and 38 days after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization) and drug dose administration interval too short. In December 2019, the patient experienced hallucination (serious criteria GSK medically significant). On an unknown date, the outcome of the hallucination was not recovered/not resolved and the outcome of the injection site pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the hallucination and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 22nd October 2019, the patient received 1st dose of Shingrix. The patient received dose of Shingrix in the right arm. The health care professional reported that, less than recommended 2 months schedule from 1st dose of Shingrix, the patient received 2nd dose earlier, which led to shortening of vaccination schedule. The patient's daughter called to report that, within hours after vaccination, the patient had extreme arm pain at the injection site. Less than a day after vaccination, the patient had injection site pain. The reporter stated that, called on the day of reporting to check on the patient and the patient's daughter reported that, the patient was admitte in the hospital on 29th November 2019 and was now hallucinating. Less than a week after vaccination, the patient had hallucination. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: "extreme pain at injection site"; hallucinations; inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of hallucination in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th November 2019, less than a day after receiving Shingrix and 38 days after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization) and drug dose administration interval too short. In December 2019, the patient experienced hallucination (serious criteria GSK medically significant). On an unknown date, the outcome of the hallucination was not recovered/not resolved and the outcome of the injection site pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the hallucination and injection site pain to be related to Shingrix.  Additional details were provided as follows: On 22nd October 2019, the patient received 1st dose of Shingrix. The patient received dose of Shingrix in the right arm. The health care professional reported that, less than recommended 2 months schedule from 1st dose of Shingrix, the patient received 2nd dose earlier, which led to shortening of vaccination schedule. The patient's daughter called to report that, within hours after vaccination, the patient had extreme arm pain at the injection site. Less than a day after vaccination, the patient had injection site pain. The reporter stated that, called on the day of reporting to check on the patient and the patient's daughter reported that, the patient was admitte in the hospital on 29th November 2019 and was now hallucinating. Less than a week after vaccination, the patient had hallucination. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site exfoliation, Injection site reaction, Rash erythematous
Clinical narrative: "Bruise or a red rash" at the injection; "Bruise or a red rash" at the injection; Peeling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number M57C5, expiry date 9th April 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 10 days after receiving Shingrix, the patient experienced injection site bruising, injection site rash and injection site exfoliation. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved and the outcome of the injection site rash and injection site exfoliation were unknown.   It was unknown if the reporter considered the injection site bruising, injection site rash and injection site exfoliation to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the left arm and developed a bruise or a red rash at the injection site 1.5 weeks later. She stated the site looked better but was peeling. The reporter did not consent to follow up. The reporter did not have further information.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: upset stomach; diarrhea; fever; chills; aches; tired; arm sorness; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. In December 2019, 36 hrs after receiving Shingrix, the patient experienced upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm. On an unknown date, the outcome of the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. On 3rd December 2019, the patient experienced upset stomach, diarrhea, fever, chill, aches, tired and arm soreness. The outcome of events were reported as not recovered/not resolved in the database however in source document, it was mentioned as recovering/resolving.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: upset stomach; diarrhea; fever; chills; aches; tired; arm sorness; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. In December 2019, 36 hrs after receiving Shingrix, the patient experienced upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm. On an unknown date, the outcome of the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. On 3rd December 2019, the patient experienced upset stomach, diarrhea, fever, chill, aches, tired and arm soreness. The outcome of events were reported as not recovered/not resolved in the database however in source document, it was mentioned as recovering/resolving.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site pain, Pain, Skin lesion
Clinical narrative: She knows that it is Shingles; Soreness at the injection site; Developed a lesion on skin; Lesions are painful; Lesions burn; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received vaccine on an unknown date).   On 23rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles, injection site pain, skin lesion, pain and burning sensation. On an unknown date, the outcome of the shingles and skin lesion were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the pain and burning sensation were unknown.   It was unknown if the reporter considered the shingles, injection site pain, skin lesion, pain and burning sensation to be related to Shingrix.  Additional details were received as follows: The patient received the 1st dose of Shingrix and experienced soreness at the injection site. The patient also developed lesion on her skin, the lesions were painful and burn and patient knew that it was Shingles because she has had Shingles in the past. The patient consented to follow up.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Pt developed hives that did spread to  a full body rash. Rash started the next day and progressed for several days. Pt was seen  in clinic on Monday November 18th. Dx was discussed as possible allergy to HPV vaccine or possibly unrelated to vaccine as pt was developed hives several times prior from an unknown source. Pt sent home and was to continue to monitor signs and symptoms and was also encouraged to follow up with an Allergist.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain
Clinical narrative: Pain at injection site, ongoing muscle pain. Difficulty using left arm, raising it or laying on while in bed. A dull  throbbing pain that has never stopped to date.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, IPV, PNC13
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Febrile convulsion, Generalised tonic-clonic seizure, Human rhinovirus test positive
Clinical narrative: complex febrile seizure lasting over 45 min, medical helicopter to hospital, 102 fever in ER, seizure stopped in ER when given Ativan, had second seizure 8/09/19 with no fever, clinic tonic lasted 5-6 min
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, IPV, PNC13
Symptoms: Lumbar puncture normal, Pyrexia
Clinical narrative: complex febrile seizure lasting over 45 min, medical helicopter to hospital, 102 fever in ER, seizure stopped in ER when given Ativan, had second seizure 8/09/19 with no fever, clinic tonic lasted 5-6 min
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Product administered at inappropriate site
Clinical narrative: patient states that immunization was not given in the muscle and was given higher in the shoulder. accoring to her pcp patient states that it hit a nerve and she does not have full range of motion in her arm since
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient came in to get her second dose. Said that she had muscle soreness for over 1 month.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Influenza, Pain, Swollen tongue, Tremor
Clinical narrative: First night (12/14) Flu symptoms, shaking body aches. Second night (12/15) Tongue swelled up almost to point of closure. swallowed 3  dissolved Benadryls (with difficulty) and stayed upright.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: One month following senior flu shot, I woke with severe pain in left arm.  My range of motion was severely limited.   The pain lasted over 24 hours, into the next day.  While in pain, I took 1 extra strength Tylenol every 4 hours.  Did not notify my doctor.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling cold, Tremor
Clinical narrative: Later in the day maybe 5 to 6 hours after getting the shot I began to uncontrollably shake and got extremely cold for a period of two plus hours. Other things but do not remember exactly and called the doctor as my chest for giving me some problems thought I might be having a heart attack of which he assured me was not the case.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Myopericarditis
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle aches, fatigue, shivers
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: TDAP was given instead of Kinrix.  There was no adverse effect. and pt was able to get Kinrix same day while still in clinic
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Parent reports softball sized lump at injection site. Mom did not specify which side. Area was reported to be hot to touch. Gave Motrin and next morning size of lump had decreased markedly. Afebrile
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Had a hive about  3 inches wide that lasted 10 or more days. Doctor prescribes over the counter medications: oral Benadryl 75mg and topical hydrocortisone cream.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Skin warm, Swelling
Clinical narrative: PATIENT CALLED AND REPORTED SWELLING, REDNESS, WARMTH, AND DIFFICULTY MOVING ARM
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Rash
Clinical narrative: she had the systemic reaction at site of injection and then ended up developing shingles on her lower back, she covered the rash and put betadine on it, then went to urgent care and got a Valtrex 1gram prescription
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt called on 12/16/19 stating she had arm swelling at injection site where vaccine as administrated
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV administered no adverse reaction
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Anxiety disorder, Arthralgia, Depression, Fatigue
Clinical narrative: Depression, anxiety disorder, panic disorder, ibs, joint pain, chronic fatigue, short term memory loss, food allergies, exercise induced urticaria. Treatment with antidepressants 10 years after symptoms started and with xozal at times when needed.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Food allergy, Irritable bowel syndrome, Panic disorder, Urticaria
Clinical narrative: Depression, anxiety disorder, panic disorder, ibs, joint pain, chronic fatigue, short term memory loss, food allergies, exercise induced urticaria. Treatment with antidepressants 10 years after symptoms started and with xozal at times when needed.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse events; that patient received VAQTA pediatric dose instead of adult dose.; This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, frequency, route of admiistration and anatomical location were not reported) lot # S021092, expiration date 18-MAY-2020, for prophylaxis, instead of an adult dose.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: medicine squirted out underneath the skin with no AE; Most of the vaccine squirted out underneath where the needle was attached to the shot, so I don't think the patient got much of it with no AE; pharmacist confirmed that the vaccine was leaking where the needle was attached with no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who reported medicine squirted out underneath the skin (Exposure via skin contact), most of the vaccine squirted out underneath where the needle was attached to the shot, so i dont think the patient got much of it (Underdose) and pharmacist confirmed that the vaccine was leaking where the needle was attached (Syringe issue), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ251AD Expiry date: 01-May-2020) via unknown route used for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of FLUBLOK HIGH DOSE VACCINE, patient reported that medicine squirted out underneath the skin (Exposure via skin contact), most of the vaccine squirted out underneath where the needle was attached to the shot, so i did not think the patient got much of it (Underdose) and pharmacist confirmed that the vaccine was leaking where the needle was attached (Syringe issue).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was not applicable.  At the time of the report, no adverse event was reported.   No further information was reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: some of the Fluzone High-Dose leaked out  with no AE; she didnt see a crack and the needle tip was on tight but a fair amount of liquid leaked out and she wanted to know should she re-inject because she is not sure if the patient received all of the injection  with no AE; I felt a little (liquid) on my glove and I saw a little (liquid) on her arm with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who reported some of the fluzone high-dose leaked out, she didnt see a crack and the needle tip was on tight but a fair amount of liquid leaked out (Syringe issue) and she wanted to know should she re-inject because she is not sure if the patient received all of the injection (Underdose) and i felt a little (liquid) on my glove and i saw a little (liquid) on her arm (Exposure via skin contact), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ285AB, Expiry date: 02-Jun-2020) via unknown route used for prophylactic vaccination.  On an unknown date, (Unknown latency) at the administration of FLUBLOK HIGH DOSE VACCINE, patient reported that some of the fluzone high-dose leaked out, she did not see a crack and the needle tip was on tight but a fair amount of liquid leaked out (Syringe issue) and she wanted to know should she re-inject because she was not sure if the patient received all of the injection (Underdose) and i felt a little (liquid) on my glove and i saw a little (liquid) on her arm (Exposure via skin contact).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Events outcome was not applicable.  At the time of the report, no adverse event was reported.   No further information was reported.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: vaccine was leaking out with no AE; a Fluzone Quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out with no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age patient who reported vaccine was leaking out (Syringe issue) and a fluzone quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out (Underdose), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a dose of suspect vaccine INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ285AB, Expiry date: 02-Jun-2020) via unknown route used for prophylactic vaccination.  On an 22-Oct-2019, on the same day at the administration of FLUBLOK QUADRIVALENT VACCINE, patient reported that vaccine was leaking out (Syringe issue) and a fluzone quadrivalent immunization was being administered in the employee health clinic and it was noted that the vaccine was leaking out (Underdose).   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Events outcome was not applicable.  At the time of the report, no adverse event was reported.   Disclaimer: 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.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: nauseous; pain in my arm from the shot was unbearable; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 68 years old female patient who experienced unable to use my right arm or lift it above my waist without terrible pain. (nausea) and pain in my arm from the shot was unbearable (pain in extremity), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious unable to use my right arm or lift it above my waist without terrible pain. (nausea) and pain in my arm from the shot was unbearable (pain in extremity) 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was Pain in arm and nauseous.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for nauseous. and as Not Recovered for Pain in arm.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: arm was very red, red area was large, covering a big portion of shoulder and upper arm; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient (age not reported) who experienced redness on arm and the red area was large and was covering a big portion of shoulder and upper arm (erythema), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], lot number and expiration date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious redness on arm and the red area was large and was covering a big portion of shoulder and upper arm (erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE for few days.  (Other relevant tests included no lab data.)  Final diagnosis was erythema.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event.   Information on batch number was requested.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired product was administered to a consume/no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case concerns a patient of unknown demographi9cs who received an expired doe of vaccine IPV (VERO) [IPOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was of actual medication error case due to expired vaccine used..  It was unknown whether adverse event was noted or not.  Information on the batch number was requested.  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.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: some of the shot leaked out and some went in the patient; the needle might have failed or was not on correctly, Leakage appear to come from the between the syringe tip and needle port; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that some of the shot leaked out and some went in the patient (vaccine underdose) and the needle might have failed or was not on correctly, leakage appear to come from the between the syringe tip and needle port (syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AB and expiry date: 30-Jun-2020 via unknown route in unknown administration site.  It was a case of actual medication error case due to vaccine underdose.  It was also a case of syringe issue.  It was unknown whether adverse event was experienced or not.  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: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain
Clinical narrative: 2 days after the vaccination, patient developed pain behind left ear. She was seen by the MD and suggested to take Tylenol, which helps relieve the pain but then it would come back again. Pain and sensitivity on left side around ear still persists until today, being a little better now.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Dysarthria, Eye movement disorder, Loss of consciousness
Clinical narrative: Patient's anxiety increased post-immunization. She stated she could feel herself getting faint and trying to take deep breaths to try to calm herself down. Her eyes rolled back, she started to moan/slur speech and then displayed seizure-like convulsions while slumping over. Pharmacist caught her head before it hit table in room and called 911. Prior to paramedics arriving patient awoke and asked what happened and if she fainted. She did not have any issues with speech,  swallowing, was lucid and stated she felt fine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Moaning, Posture abnormal, Seizure like phenomena
Clinical narrative: Patient's anxiety increased post-immunization. She stated she could feel herself getting faint and trying to take deep breaths to try to calm herself down. Her eyes rolled back, she started to moan/slur speech and then displayed seizure-like convulsions while slumping over. Pharmacist caught her head before it hit table in room and called 911. Prior to paramedics arriving patient awoke and asked what happened and if she fainted. She did not have any issues with speech,  swallowing, was lucid and stated she felt fine.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Chills, Injection site pain, Muscle spasms
Clinical narrative: soreness since 9/29, 10/10 numeric pain scale, sharp, burning, sore pain in L shoulder that radiates to hand, now radiated to elbow in termittently. only occurs at night. 11/9 chills, bull body spasms
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness since 9/29, 10/10 numeric pain scale, sharp, burning, sore pain in L shoulder that radiates to hand, now radiated to elbow in termittently. only occurs at night. 11/9 chills, bull body spasms
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patient given adult dose of Hep A
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Hyperhidrosis, Immediate post-injection reaction, Posture abnormal, Seizure
Clinical narrative: Was receiving flu shot here at clinic around 11:53 AM. Immediately after flu shot was administered pt was slumped over and seemed to be convulsing for about 3 seconds. Pt was also noted to be diaphoretic s/p sx. Per pt, no hx of seizures or seizures after shots, but does have hx of feeling faint after receiving shots. Pt also notes he was at the gym 20 minutes before and did not eat. Last meal was fried rice and a sausage at 7 AM.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: patient had ppsv23 on 12/13/2019 on left deltoid, patient had slight pinkness on inner left arm with skin warm to the touch. patient had no swelling on arm. patient did report the area feeling itchy. patient advised to take over the counter Benadryl to help subside itching. patient told if symptoms doesn't subside by Friday ( 12/20/2019) to contact Primary Care Doctor.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Pain, Tremor
Clinical narrative: -sore arm of injection site -shivering/shaking at night time -body aches -sweating (on 12/11/2019 and 12/14/2019)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: -sore arm at the injection site -shivering/shaking at night time -body aches -neck "felt like on fire" -sweating (12/11/2019 to 12/14/2019)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: -sore arm at the injection site -shivering/shaking at night time -body aches -neck "felt like on fire" -sweating (12/11/2019 to 12/14/2019)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Immediate post-injection reaction, Loss of personal independence in daily activities, Rheumatoid arthritis
Clinical narrative: PATIENT SOUGHT TREATMENT FOR AN ACUTE FLARE-UP OF HER RA SYMPTOMS, WHICH SHE CLAIMS BEGAN ALMOST IMMEDIATELY AFTER HER VACCINATION. MD PRESCRIBED A COURSE OF PREDNISONE. PATIENT HAS BEEN UNABLE TO COMPLETE HER 2-3 MILES OF WALKING TO CONTROL HER RA SYMPTOMS SINCE RECEIVING HER VACCINE. PATIENT DOES REPORT THAT SHE IS NOW RETURNING TO NORMAL AS OF TODAYS DATE, 12/16/2019.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Tinnitus
Clinical narrative: Xtreme headaches continuing now for 2 months. Ringing in ears
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: 2 days after receiving shot, patient began having reduced range of motion (cannot lift above head or move arm behind her) without extreme pain.  It is now 3 days post shot.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: PT CALLED PHARMACY TODAY (12/16/19)- SAID SHE WAS CONCERNED ABOUT THE ARM SHE HAD HER FLU SHOT IN.  IT STILL IS SORE SOMETIMES, ESPECIALLY WHEN SHE REACHES FOR SOMETHING.  SHE HAS NOT GONE ANYWHERE TO BE SEEN.  I TOLD HER SHE MIGHT WANT TO GO SEE HER PRIMARY PROVIDER , BUT SAID SHE HAS AN APPOINTMENT IN JANUARY  AND WILL SEE HIM THEN
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Discomfort, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient stated the day she received the vaccine she developed a fever for about 3 hours which she thinks put her into a-fib (which she was able to get under control she said). She also had lots of discomfort and soreness in that arm which has gotten better since but said she is still having muscle aches and pains.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had prominent redness and swelling of the L deltoid traveling down to the mid upper arm by report
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen and inflammed area of vaccination about 3-4 inches in diameter, hot to the touch and soreness
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: customer complained of rash on arm down to elbow,  hot to touch, swollen,  had been itchy earlier in the day
Age: 63.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Arthralgia, Joint swelling, Myalgia
Clinical narrative: Generalized muscle aches, lasted about a day, but right knee got worse, painful, swollen and still is problematic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction of redness and swelling at injection site
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion, Insomnia, Malaise, Nausea, Retching
Clinical narrative: Patient reported that approximately 12 hours after receiving the flu shot he became ill which he described as being unable to sleep and having a constant urge to vomit. He did not actually vomit, but it seems that he was on wretching all night. He did recover and is feeling better. He also reported having some bruises up his arm that he feels showed up after the flu shot was given. The small bruises are not near the site of the injection and are on the forearm.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient presented to the office with a very swollen and red left upper arm. The swelling extended almost to her shoulder and slightly below her elbow. It was almost completely encircling the upper arm
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complains of red area around vaccine site, no where else. States the area about 1 inch around where the vaccine was given 2 days ago is still very red. Concerned with redness not going away. Hurts if she touches it, otherwise does not cause her any discomfort through daily routine.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: fever more than 102.6  on and off every four five hours,  ough. sore throat.  body aches. fatigue (tiredness)  diarrhea,
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: fever more than 102.6  on and off every four five hours,  ough. sore throat.  body aches. fatigue (tiredness)  diarrhea,
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Cheilitis, Injection site pain, Injection site rash
Clinical narrative: Very sore arm and rash at injection site, swelling, high fever,  puffy itchy blisters all over back, Insomnia, sore on lip. Required a clinic visit with the PCP. Symptoms lasted for a weak.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Pruritus, Pyrexia, Swelling
Clinical narrative: Very sore arm and rash at injection site, swelling, high fever,  puffy itchy blisters all over back, Insomnia, sore on lip. Required a clinic visit with the PCP. Symptoms lasted for a weak.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Shoulder where injection was given was very painful for over two months
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Nasal congestion, Nausea
Clinical narrative: Red lump at site, sick to stomach Sunday, body aches, nasal congestion; headaches
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Red lump at site, sick to stomach Sunday, body aches, nasal congestion; headaches
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Inflammation
Clinical narrative: Mother of patient specifies that she took her daughter to the pediatrician because she had inflammation on the arm and cellulitis developed.  She was given antibiotics, anti-inflammatory medications and instructions to go to the ER if there is no improvement.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt had proquad on Wednesday 12/11. pt woke up Next morning with redness and swollen in the left upper arm the size of silver dollar.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Gave flu shot in deltoid, IM Patient said arm hurt the next day and got progressively worse to the point he could not lift it. He saw family doctor and received steroid shot. Arm is still hurting.
Age: 48.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This patient was given MMRV (Proquad) by mistake. This patient is not in the age range for Proquad. The provider had this patient come back to the office to get a titers blood test. We are waiting to see if the patient is vaccinated or if she will need to get another vaccination.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain
Clinical narrative: REDNESS,SORENESS AND FLU LIKE SYMPTOMS
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic, Haematochezia
Clinical narrative: Pt received 4 mo immunization on 12/11/19, less than 12 hours later began having bloody diarrhea. Had 2 bloody stools total. No vomit. No fever. Not ill otherwise. Then stools returned to normal.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reported on 12-12-2019 that she has around a 50% reduction in arm movement. Pain with lifting items. Hard to raise arm above head.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain
Clinical narrative: REDNESS,SORENESS AND FLU LIKE SYMPTOMS
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left leg was red, swollen to the size of a pop can and hot and hard to the touch. No fever. No SOB. This happened the next day at noon. Advised to use cold packs 3-4 times/day for 10 minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema, warmth, increase in arm circumference (upper right)  area of erythema : 14 cm x 16 cm
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reaction (L) thigh with 2 inch circular, red area, central blush component. No induration
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area around vaccine was red, raised and warm. Advised to administer Zyrtec, use cold compress and hydrocortison cream.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3x3 erythema, warm, location: Deltoid, side: right.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Limb operation, Magnetic resonance imaging, Musculoskeletal disorder, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine was incorrectly given by a Medical Assistant--evidently given into the biceps tendon.  After the severe pain, venous study and MRI was done.   Visits to ortho physicians, PT, all year 2018.  Surgery in December 2018 to release the tendon after treatment and therapy and no improvement.  Pain has continued since then.  Unable to completely use left arm since the injection.  Surgery found a football-shaped white strange items inside the arm that was thought to possibly be the vaccine encapsulated.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Shoulder operation, Ultrasound Doppler
Clinical narrative: Vaccine was incorrectly given by a Medical Assistant--evidently given into the biceps tendon.  After the severe pain, venous study and MRI was done.   Visits to ortho physicians, PT, all year 2018.  Surgery in December 2018 to release the tendon after treatment and therapy and no improvement.  Pain has continued since then.  Unable to completely use left arm since the injection.  Surgery found a football-shaped white strange items inside the arm that was thought to possibly be the vaccine encapsulated.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Enuresis, Fatigue, Headache, Lethargy, Local reaction
Clinical narrative: Fatigue; wet bed; injection site swelling x one month; Lethargy; Site redness; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 800439) under the Freedom of Information Act refers to a 12 year old female patient. The patient's historical drug included nystatin and concurrent condition included nystatin local allergy. Historical condition and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date was not reported, but upon internal validation established as 12-JUL-2020 (strength and dose not reported) via intramuscular route in unspecified arm for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (also reported as "TDAP"), lot # TB2R2, expiration date was not reported and meningococcal vaccine (unspecified), lot # U5848AA, expiration date was not reported (strength, dose and indication not reported) via intramuscular route in unspecified arm on 03-JUL-2018. On 04-JUL-2018 (also reported as following day of vaccination), the patient experienced fatigue, lethargy, local reaction as arm swelling for month (injection site swelling) and had wet bed (enuresis). The outcome of fatigue, lethargy, injection site swelling and enuresis was reported as resolved.  The causality assessment was not provided by the reporter.   Follow up information was received from a nurse (vaccine provider) on 13-DEC-2019. The patient was 11 years old at the time of vaccination and onset of the events (previously reported as 12 years old). The patient did not have any illness at the time of vaccination. On 03-JUL-2018, the patient was vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (previously reported as "meningococcal vaccine (unspecified)"). It was reported that vaccines were purchased with private funds. On 04-JUL-2018, the patient experienced "site redness" (injection site redness). On an unknown date, the patient recovered from the event injection site redness (reported as "event abated after stopping drug").  The relatedness between the events and the suspect therapies was unknown.