chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Dotted rash on arms, leg, and stomach; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number H47PB, expiry date unknown) for prophylaxis.   On 20th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in left deltoid and had dotted rash on arms, leg, and stomach.  The patient was treated with a steroid. The reaction has since resolved. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Diplegia, Gait inability, Headache, Monoplegia, Pain in extremity
Clinical narrative: Paralysis in both arms/Woke up with paralysys in both legs; Unable to walk; Severe pain in both arms; Severe headaches; This case was reported by a pharmacist via sales rep and described the occurrence of diplegia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019 06:00, the patient received Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced diplegia (serious criteria GSK medically significant), unable to walk, pain in arm and headache. On an unknown date, the outcome of the diplegia, unable to walk, pain in arm and headache were unknown.   It was unknown if the reporter considered the diplegia, unable to walk, pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 24 to 48 hous after, she had severe pain in both arm and severe headache. Around 6 days after, the patient woke up with paralysis in both legs and unable to walk, also had paralysis in both arms.
Sex: U
Vaccine: VARZOS
Symptoms: Multiple sclerosis relapse
Clinical narrative: MS relapse; This case was reported by a pharmacist and described the occurrence of multiple sclerosis relapse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). The patient was treated with prednisolone. On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   It was unknown if the reporter considered the multiple sclerosis relapse to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.applicable. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient recently received the Shingrix vaccinations and each time the patient got the vaccine and started in on an multiple sclerosis (MS) relapse the day after the vaccination. The relapses were curtailed by Prednisone. This left wondering the patient if other MS patients, or those with other autoimmune diseases, had been having similar adverse reactions to the Shingrix vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Sluggishness
Clinical narrative: nausea; dragginess; tired; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and experienced no side effects).   On 26th September 2019, the patient received the 2nd dose of Shingrix. On 27th September 2019, 1 days after receiving Shingrix, the patient experienced nausea, sluggishness and tiredness. On an unknown date, the outcome of the nausea, sluggishness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the nausea, sluggishness and tiredness to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix. On the reporting date, the patient experienced nausea, dragginess or feeling tired. The reporter did not consent to follow-up. The outcome of events in source document does not match with the reported outcome of events.
Age: 1.25
Sex: M
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: posed to give the consumers a flu shot, which is the Fluzone Quadrivalent (influenza vaccine) 0.25 mL, no AE; receiving Adacel, which is an adult tetanus vaccine, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272535 and 2019SA272536.  This case involves a 15 months old male patient who was vaccinated wit a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  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 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.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Fluzone Quadrivalent injected subcutaneously / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and Expiry date unknown) subcutaneous route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination.  It was reported that Fluzone Quadrivalent injected subcutaneously.  At a time of reporting no adverse effect 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.  Information on the batch number was requested  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4, FLUX
Symptoms: Malaise, Rash
Clinical narrative: rash from head to foot; sick; Initial information received on 30-Sep-2019 and Additional information was received on 02-Oct-2019 from same reporter regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 81 years old female patient who experienced rash from head to foot and sick, while she received vaccines INFLUENZA VACCINE and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Scoliosis. The patient's past vaccination(s) included FLUBLOK with past 3 or 4 years. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Lung disorder and Drug hypersensitivity with allergic to neomycin, "polymycin.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious rash from head to foot (rash generalised) and sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was sick and rash from head to foot.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for rash from head to foot and sick.  Information on the batch number was requested.  Documents held by sender: none.
Age: 0.33
Sex: U
Vaccine: FLUX, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medical assistant accidentally gave a Adacel vaccine to a 4 month old instead of a flu vaccine, no AE; medical assistant accidentally gave a Adacel vaccine to a 4 month old, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case is linked to cases 2019SA273063 and 2019SA273064 (same reporter).  This case involves a four months old patient who accidentally received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site instead of INFLUENZA VACCINE (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  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.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: FLUX, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medical assistant accidentally gave a Adacel vaccine to a 6 month old instead of a flu vaccine, no AE; medical assistant accidentally gave a Adacel vaccine to a 6 month old, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case is linked to cases 2019SA273055 and 2019SA273064 (same reporter).  This case involves a six months old patient who accidentally received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site instead of INFLUENZA VACCINE (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  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.  Information on the batch number was requested.  Documents held by sender: none.
Age: 1.25
Sex: U
Vaccine: FLUX, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave a Adacel vaccine to a 15 months patient instead of a flu vaccine/ No AE; accidentally gave a Adacel vaccine to a 15 months patient instead of a flu vaccine/ No AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA273063 and 2019SA273055 same reporter.  This case involves a 15 months old patient who accidentally received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site instead of INFLUENZA VACCINE (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  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.  Information on the batch number was requested.  Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: Overdose, Pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: body aches; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 61 years old patient who experienced body aches (pain) while received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   On 27-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AB, Expiration:05/06/2020 via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On an unknown date, the patient experienced Body aches (pain), unknown latency following vaccination with  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE .  It was a case of actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered.  No corrective treatment information was reported.  At the time of report outcome of he event was unknown and not applicable for rest of the events.  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  List of documents held by the sender: none
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection, no AE; while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection, no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection.  The patient's past vaccination(s) included Flu vaccine in JUN-2015. The patient's past medical history, medical treatment(s) and family history were not provided.  On 30-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ211AB, Jun 30, 2020 via intramuscular route in the right arm. It was reported that while withdrawing the needle a "lot of the medication shot out of the patient's skin" so they feel the patient didn't get much of the injection.  It was a case of actual medication error due to vaccine underdose. It was also a case of exposure via skin contact  At the time of the 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  List of documents held by the sender: none
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant administered flublok instead of standard dose to patient/no AE; Medical assistant administered flublok instead of standard dose to patient/no AE; Medical assistant administered flublok instead of standard dose to patient/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case involves Child female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported.  It was of actual medication error due to Inappropriate age at vaccine administration, incorrect dose administered and off label use..Medical assistant administered flublok instead of standard dose to patient.  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.  List of documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the consumer is due their third dose on 30Sep2019/no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 71 years old patient who was due for third dose of vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] on 30-Sep-2019;  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to Incomplete course of vaccination.  It was unknown whether vaccine was given or not later.  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.  List of documents held by sender: none. .
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Patient received her influenza vaccine at approximately 5 pm on 9/21.  Mom noticed redness at the site of the injection around 11 am on 9/22.  It did not seem to bother her, but looked red and a little swollen.  It got a little worse-spreading and a little more swollen throughout the day on 9/21.   She does not seem to be in a lot of pain. She does itch at it.  She is walking per normal. Acting fine.  She has 1 pinpoint spot that developed near the injection site. Mom saw a little drainage come from it this morning.  She has not had any fever, URI sx, cough, vomiting. She slept fine last night.  She is eating per normal. No evidence of pain anywhere.  Energy per normal. Mom was not terribly concerned, but sister developed similar reaction around the exact same time and hers seems much worse.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Patient started to complain of itching on the back and right arm. I checked her and noticed she has hives developing on the back and on right arm below the vaccine site.  Benadryl 10 ml PO was ordered. Patient received it and symptoms resolved around 30 min after.  Before leaving the clinic, patient was stable, itching resolved, only mild erythema below vaccine site on right arm. Rash on the back completely disappeared.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Breath holding, Cyanosis, Electroencephalogram normal, Eye movement disorder, Feeling abnormal
Clinical narrative: episode began like breath holding spell but stiffened, eyes rolled up, sans tonic clonic movements with cyanosis around the mouth lasting 30-40 seconds then seemed dazed but was screaming by the time the EMTs arrived 5 minutes later
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Musculoskeletal stiffness, Screaming, Tonic clonic movements
Clinical narrative: episode began like breath holding spell but stiffened, eyes rolled up, sans tonic clonic movements with cyanosis around the mouth lasting 30-40 seconds then seemed dazed but was screaming by the time the EMTs arrived 5 minutes later
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm became sore and started itching the next morning. Then became hard, red, warm and swelled.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Skin warm
Clinical narrative: Arm became sore and started itching the next morning. Then became hard, red, warm and swelled.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Pain in extremity, Skin warm
Clinical narrative: Patient states she has a knot in her arm that is painful and warm
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Diarrhoea, Dizziness, Laboratory test, Nausea
Clinical narrative: explosive diarrhea for 3 days, no nausea, dizzy  weak.  lasted 7 days
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash, Rash erythematous, Rash papular, Skin indentation
Clinical narrative: Pt. returned to pharmacy  approximately 1 week after receiving her first Shingrix vaccination to report a red, raised rash.  She raised her shirt sleeve to reveal the 'rash' and I looked at it very closely.  It was fairly large, approximately the size of an orange and had a very red and inflamed appearance.  It was noticeably raised and occupied a very circular area.  The affected area wasn't smooth, it had a slightly indented appearance, much like that of an orange peel.  It was slightly feverish to the touch.  I spoke with her a couple of weeks after the visit in which she showed me the rash and it had completely disappeared.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Pt. returned to pharmacy  approximately 1 week after receiving her first Shingrix vaccination to report a red, raised rash.  She raised her shirt sleeve to reveal the 'rash' and I looked at it very closely.  It was fairly large, approximately the size of an orange and had a very red and inflamed appearance.  It was noticeably raised and occupied a very circular area.  The affected area wasn't smooth, it had a slightly indented appearance, much like that of an orange peel.  It was slightly feverish to the touch.  I spoke with her a couple of weeks after the visit in which she showed me the rash and it had completely disappeared.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Electrocardiogram normal, Laboratory test normal, Loss of consciousness
Clinical narrative: Loss of consciousness for about 15 minutes, bystanders called an ambulance, get back to myself, transported to hospital.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Endotracheal intubation
Clinical narrative: Developed sudden onset anaphylaxis. Taken immediately to ER and intubated. Admitted to hospital.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Injection site pain, Injection site rash, Mobility decreased
Clinical narrative: I don't know if that is the vaccine number or not. I had the shot in my right arm and second shot in my left. First shot the site was extremely tender and sore, but I also felt like I had the flu. I stayed in bed all day long and nothing ever gets me down. The second shot the right arm hurt even though it wasn't in that arm (the other was tender if touched) and i was again in bed all day long. I had some minor rashing on my right upper shoulder area along with severe neck pain and right arm pain and then numbness in that arm. It still continues today from that date. My husband thinks it is a pinched nerve, but the other symptoms were the same. i just could not move or do anything and I deal with constant pain on a daily basis. With the rash on my shoulder neck area, figured that was from the shot. My husband was a little tired from both shots, but not at all like it knocked me down. Glad I got them though. Will see the chiropractor to see if my neck is out of alignment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rash
Clinical narrative: I don't know if that is the vaccine number or not. I had the shot in my right arm and second shot in my left. First shot the site was extremely tender and sore, but I also felt like I had the flu. I stayed in bed all day long and nothing ever gets me down. The second shot the right arm hurt even though it wasn't in that arm (the other was tender if touched) and i was again in bed all day long. I had some minor rashing on my right upper shoulder area along with severe neck pain and right arm pain and then numbness in that arm. It still continues today from that date. My husband thinks it is a pinched nerve, but the other symptoms were the same. i just could not move or do anything and I deal with constant pain on a daily basis. With the rash on my shoulder neck area, figured that was from the shot. My husband was a little tired from both shots, but not at all like it knocked me down. Glad I got them though. Will see the chiropractor to see if my neck is out of alignment.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Severe itching at the site where she had the flu shot and there is a little welt.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: hives
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: intussusception
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: 9-25-19 some local redness, 9-25-19 area itchy but was in PJ's already, 9-26-19 am getting ready for bath and mom noted swelling and redness, hurts w/ROM, continues to get more red as morning went on, has received Flu vaccine previously and only local reaction.  9-26-19 on exam Left upper arm swelling and erythema from above shoulder to elbow (L arm circ below shoulder 26; R arm 19; L arm at bicep 22.5; R arm 18.5) erythema almost circumference of arm, esp. closest to axilla - referred to ER d/t extent of swelling and erythema above shoulder and almost circumferential.  ER gave large dose of Benadryl and sent home with rx for Benadryl and Zyrtec as well as Cephalexin and was told only to give Cephalexin if not improving by that night, in afternoon of 9-26-19 redness was improving and still has swelling, was advised to return to ER if not improving.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: LARGE RED SOLID RASH AND QUARTER SIZED BLISTER.  URGENT CARE PRESCRIBED PREDNISONE AND KEFLEX.  1 DAY AFTER THE VACCINE THERE WAS A RED BASEBALL SIZED RASH.  2 DAYS AFTER THE VACCINE THE RASH WAS SOFTBALL SIZED.  3 DAYS AFTER THE VACCINE THE RASH COVERS THE MAJORITY OF THE UPPER ARM AND A QUARTER SIZED BLISTER APPEARED.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: LARGE RED SOLID RASH AND QUARTER SIZED BLISTER.  URGENT CARE PRESCRIBED PREDNISONE AND KEFLEX.  1 DAY AFTER THE VACCINE THERE WAS A RED BASEBALL SIZED RASH.  2 DAYS AFTER THE VACCINE THE RASH WAS SOFTBALL SIZED.  3 DAYS AFTER THE VACCINE THE RASH COVERS THE MAJORITY OF THE UPPER ARM AND A QUARTER SIZED BLISTER APPEARED.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Patient states the rash didn't truly present itself until Sunday (10.6.19) morning and that it started to spread from the injection site around down to her armpit. Patient does have an appointment to be evaluated by her PCP today (10.7.19).
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: SORE THROAT
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: generalized rash
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh was red, swollen, and hot to the touch. Mom noticed the redness and swelling  on Saturday when the patient woke up.  Patient came in our office today and his leg was still swollen but not as much as Saturday.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Patient states that 48 hours after receiving Fluad vaccine he developed full body hives. They hives progressively worsened during the day and were described as persistent and large whelps. Patient states that he experienced extreme itching and therefore began taking Benadryl four times daily to alleviate symptoms. Patient states that this is the second time this reaction has occurred after receiving a high-dose flu vaccine. Patient states that he waited until 10/7/19 morning to report to a doctors office to be seen regarding the persistent hives. Patient was prescribed Prednisone 50 mg once daily for 5 days and Hydroxyzine HCL 25 mg three times daily as needed for itching by physician. Patient was sent home and informed to not get another flushot in the future. Patient states that the hives have improved but are still causing slight discomfort which is why he presented to the doctors office 10/7/19.  Previous reaction was discussed with patient prior to receiving vaccine 9/27/19 but patient requested a re-trial with vaccine after discussing with previous MD office.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PER PROVIDER'S ORDER AND DID NOT DOUBLE CHECK THE PATIENT'S AGE, VACCINATED TO EARLY AT THE AGE OF 8
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Left arm swelled from shoulder to below the elbow, it was so sore could not move arm at all.  Lasted for 12 hours, still sore the next day but could move arm. Felt chilled and weak.  I used an ice pack off and on through most of the evening.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient was given MMR on 09/25/19.  Patient contacted the pharmacy on 10/07/19 to inform the pharmacy that she had broken out in a rash and had swelling/soreness in her feet.  Symptom management was advised at this time (antihistamines, NSAIDs, plenty of fluids, etc.) as well as for the patient to follow-up with her PCP.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Basically felt like I got the flu - Nausea, vomiting, fever, dizziness, headache
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Basically felt like I got the flu - Nausea, vomiting, fever, dizziness, headache
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Rash, Sinus congestion
Clinical narrative: Employee stated within a few hours she had watery eyes and sinus congestion.  Next day developed a rash across her back and stomach.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased, Herpes zoster
Clinical narrative: Extremely rapid heartbeat for 3 days, with shortness of breath, dizziness, fatigue, Outbreak of what appeared to be shingles under the left armpit.  Unable to drive or work for 3 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Impaired work ability
Clinical narrative: Extremely rapid heartbeat for 3 days, with shortness of breath, dizziness, fatigue, Outbreak of what appeared to be shingles under the left armpit.  Unable to drive or work for 3 days.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Sudden onset today, 10-4-2019, of redness and swelling developed to left thigh.  Also was scratching the area.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Gingival swelling, Hyperaesthesia, Lethargy, Nodule, Oral discomfort
Clinical narrative: First extreme pain down arm to fingertips then lethargic and severe rash with nodules itching burning in mouth throat gums tounge swelling
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pharyngeal swelling, Pruritus, Rash, Swollen tongue
Clinical narrative: First extreme pain down arm to fingertips then lethargic and severe rash with nodules itching burning in mouth throat gums tounge swelling
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Tooth disorder
Clinical narrative: First extreme pain down arm to fingertips then lethargic and severe rash with nodules itching burning in mouth throat gums tounge swelling
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Injection site reaction. Redness, swelling and pain in left arm. Tylenol used. Swelling and redness has gone away, and patient still unable to sleep on left arm due to pain.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest X-ray normal, Dizziness, Dysstasia, Fatigue
Clinical narrative: Immediately after injection, the patient felt very dizzy and hot. Her face was very flushed and she felt the need to take off her cardigan sweater.  She reached across the chair to me because I was going to take her blood pressure on her left arm, however, she wanted her blood pressure taken on her other arm.  She immediately felt a sharp pain under her shoulder blades in her middle back that traveled down her spine to her lower back. She was arching her back in pain.  She continued to feel dizzy. Her blood pressure was 108/59 with her RIGHT arm.  She stood for a little while while a technician and myself stood on either side of her and holding her arms to make sure she didn't fall. We discussed when she had eaten last.  She said she had not eaten since the night before (19 hours prior to her vaccine).  She was feeling better and sat down on the end of the chair. She ate some almonds and had a glass of water. She left the pharmacy about 25 minutes after her vaccine. She was speaking clearly and refused for us to call someone to pick her up. Patient left our parking lot at 1:05pm.  She went to an auction for about an hour and started to feel very tired. She then went home to take a nap.  Her daughter came to visit and noticed patient was shaking uncontrollably and she had a low grade fever. They decided to take her to Dr.'s office. They sent her to the hospital to have lab tests and a chest XRay.  She was not admitted to the hospital. Patient's labs and chest XRay were normal.  She was feeling better and was instructed to take Ibuprofen 800mg when she got home at 9:00pm and then Ibuprofen 200mg every 4 hours while at home for her back pain and fever. She said her back pain and low grade fever continued through the next day.  By 48 hours later, she was just tired and fatigue. Her fever was gone within 48 hours and her back pain has subsided.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Full blood count normal, Immediate post-injection reaction, Metabolic function test normal
Clinical narrative: Immediately after injection, the patient felt very dizzy and hot. Her face was very flushed and she felt the need to take off her cardigan sweater.  She reached across the chair to me because I was going to take her blood pressure on her left arm, however, she wanted her blood pressure taken on her other arm.  She immediately felt a sharp pain under her shoulder blades in her middle back that traveled down her spine to her lower back. She was arching her back in pain.  She continued to feel dizzy. Her blood pressure was 108/59 with her RIGHT arm.  She stood for a little while while a technician and myself stood on either side of her and holding her arms to make sure she didn't fall. We discussed when she had eaten last.  She said she had not eaten since the night before (19 hours prior to her vaccine).  She was feeling better and sat down on the end of the chair. She ate some almonds and had a glass of water. She left the pharmacy about 25 minutes after her vaccine. She was speaking clearly and refused for us to call someone to pick her up. Patient left our parking lot at 1:05pm.  She went to an auction for about an hour and started to feel very tired. She then went home to take a nap.  Her daughter came to visit and noticed patient was shaking uncontrollably and she had a low grade fever. They decided to take her to Dr.'s office. They sent her to the hospital to have lab tests and a chest XRay.  She was not admitted to the hospital. Patient's labs and chest XRay were normal.  She was feeling better and was instructed to take Ibuprofen 800mg when she got home at 9:00pm and then Ibuprofen 200mg every 4 hours while at home for her back pain and fever. She said her back pain and low grade fever continued through the next day.  By 48 hours later, she was just tired and fatigue. Her fever was gone within 48 hours and her back pain has subsided.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Opisthotonus, Pyrexia, Spinal pain, Tremor
Clinical narrative: Immediately after injection, the patient felt very dizzy and hot. Her face was very flushed and she felt the need to take off her cardigan sweater.  She reached across the chair to me because I was going to take her blood pressure on her left arm, however, she wanted her blood pressure taken on her other arm.  She immediately felt a sharp pain under her shoulder blades in her middle back that traveled down her spine to her lower back. She was arching her back in pain.  She continued to feel dizzy. Her blood pressure was 108/59 with her RIGHT arm.  She stood for a little while while a technician and myself stood on either side of her and holding her arms to make sure she didn't fall. We discussed when she had eaten last.  She said she had not eaten since the night before (19 hours prior to her vaccine).  She was feeling better and sat down on the end of the chair. She ate some almonds and had a glass of water. She left the pharmacy about 25 minutes after her vaccine. She was speaking clearly and refused for us to call someone to pick her up. Patient left our parking lot at 1:05pm.  She went to an auction for about an hour and started to feel very tired. She then went home to take a nap.  Her daughter came to visit and noticed patient was shaking uncontrollably and she had a low grade fever. They decided to take her to Dr.'s office. They sent her to the hospital to have lab tests and a chest XRay.  She was not admitted to the hospital. Patient's labs and chest XRay were normal.  She was feeling better and was instructed to take Ibuprofen 800mg when she got home at 9:00pm and then Ibuprofen 200mg every 4 hours while at home for her back pain and fever. She said her back pain and low grade fever continued through the next day.  By 48 hours later, she was just tired and fatigue. Her fever was gone within 48 hours and her back pain has subsided.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypoaesthesia, Muscular weakness
Clinical narrative: tired, fatigued, numbness in the pinky and ring finger, right arm felt weak
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site haemorrhage, Skin warm
Clinical narrative: small ecchymosis on deltoid area where injection was given 9/17/19. Below there is an approx 5cm x 5cm area of erythema that is warm to touch. No drainage or bleeding as of 9/25/19. Pt advised to continue Tylenol or Advil PRN pain, apply cool compresses, and continue to monitor sx. Call or go to ER if increasing redness, pain, drainage from area, fever, chills, N/V/D, myalgias, weakness, lightheadedness. Pt voiced understanding and agreement with plan.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt states having a red swollen arm with cellulitis (per md) going from injection site up and around to back of neck.  Md diagnosed as cellulitis and gave prescription of Septra DS twice daily for 7 days-
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Pt states having a red swollen arm with cellulitis (per md) going from injection site up and around to back of neck.  Md diagnosed as cellulitis and gave prescription of Septra DS twice daily for 7 days-
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient received vaccine at 1pm. In the evening, He was filling feverish and went to bed early. He woke up in the night to use the bathroom. Patient stated that he was unable to walk. His right leg particularly wouldn't moved. He found himself bracing himself in a doorway until his spouse could come to his aid. His spouse suggested going to ER and re refused. By morning, he claims to no longer feel feverish and leg function had returned. As of today, 24h+ later patient is back to normal function and only complains of a very sore arm.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Blood test, Condition aggravated, Gait disturbance, Immediate post-injection reaction, Injection site joint swelling
Clinical narrative: Immediate rash less than an hour after shots-no treatment given from doctor, joint swelling in fingers and right knee less than a week after shots- told to use ibuprofen, limping started, swelling never went down,  given referral to rheumatologist 3 months after injections
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Joint swelling, Juvenile idiopathic arthritis, Rash
Clinical narrative: Immediate rash less than an hour after shots-no treatment given from doctor, joint swelling in fingers and right knee less than a week after shots- told to use ibuprofen, limping started, swelling never went down,  given referral to rheumatologist 3 months after injections
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Nausea, Pain, Peripheral swelling
Clinical narrative: arm swelling/erythema/induration from shoulder to forearm, along w/ N/V/itching/pain. Went to ER, Rx'd Benadryl. N/V/pain resolved but still swollen/red
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Vomiting
Clinical narrative: arm swelling/erythema/induration from shoulder to forearm, along w/ N/V/itching/pain. Went to ER, Rx'd Benadryl. N/V/pain resolved but still swollen/red
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Flushing, Palpitations
Clinical narrative: Patient was given Pneumovax23 IM shot at 2:30 PM and then left immunization room to purchase others things . She came back to the pharmacy ~minutes later reporting a pounding heartbeat, flushing in the face, and shortness of breath.  I promptly took the patient back into the immunization room and elevated her legs while locating EpiPen. Redness in patient's face diminished over the next 5 to 10 minutes and she no longer reported shortness of breath or racing heart beat. Pt reported that she had been to DR office earlier where she had blood drawn. We provided water and pt had purchased a small candy bar which ate part of. Pt was okay to try and walk to front of store again after about 15 from incident starting. She said she was feeling better and purchased her items and left the store under her own will.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Pt called 9/13/19 with chills, headache and muscle aches.  Pt advised per office to take Advil. Left 2 messages and sent pt message for follow up post vaccine. No follow up from pt received.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, warmth, and itching at injection site