chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Palpitations, Throat tightness
Clinical narrative: Immediate numbness in my left pinky and then my arm; Racing heart; Weakness; Throat constriction; Difficulty taking a deep breath; Feeling faint; Allergic reaction; This spontaneous case was received on 28-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-04424) and concerned a 40-year-old, female patient.  The patient was healthy and had no medical history. The patient was not taking any concomitant medications. The patient had Flu shots for decades and never had any allergic reaction.   On 09-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prophylaxis. The batch number reported was 276578.  On the same day, immediately after receiving Flucelvax QIV, the patient had an allergic reaction which included immediate numbness in his left pinky and then in arm, heart racing, weakness, throat constriction, difficulty taking a deep breath, and the patient felt faint. The patient was treated in the emergency room (ER), and he received prednisone and Benadryl (diphenhydramine hydrochloride).  On an unspecified date in Oct-2020, the patient recovered from the events. It was reported that his symptoms lasted for about nine days.  The reporter considered the events as related to Flucelvax QIV. Reporter stated that after receiving flu shot he had an allergic reaction immediately, and that he get the flu shot every season, for over a decade, and never had any allergic reactions.   The reporter assessed the events as serious due to the criterion of medically significance.  Company comment: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: I received a flu shot manufactured by your company at my local pharmacy on 10/9/2020 and had an allergic reaction immediately. I'm writing because I am a dental hygienist and got the flu shot every season, for over a decade, and never had any allergic reactions.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the injection site
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Pain, numbness, tingling, weakness in arm
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Bexsero mennigicoccal B was given in error instead of the Menveo ,
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm (much more than normal), headache, aches, tired and low fever.    Symptoms started about 8 hours from the shot and continued for 30 hours
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain
Clinical narrative: Patient reports at 16 days post injection, she is still having shooting pains that radiate up the neck. No swelling or redness but pain bad enough that she is having difficulty sleeping. She has contacted her physician, and is awaiting a call back.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Disorientation, Injected limb mobility decreased, Injection site pain, Mobility decreased
Clinical narrative: Two or three hrs after injection, pain began in entire left arm, continue to get worse until arm couldn't be in use. Got home, pain was in whole body. Throbbing pain in shoulders, and wrists, even down to ankles. Became disoriented, had problems getting up using the bathroom. Same night, no sleep, in extreme pain. Was really disoriented and had no clue of what was going on. Lasted until 8am the next morning. Symptoms were improving as next day came along. Still have mild pain in joints.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Two or three hrs after injection, pain began in entire left arm, continue to get worse until arm couldn't be in use. Got home, pain was in whole body. Throbbing pain in shoulders, and wrists, even down to ankles. Became disoriented, had problems getting up using the bathroom. Same night, no sleep, in extreme pain. Was really disoriented and had no clue of what was going on. Lasted until 8am the next morning. Symptoms were improving as next day came along. Still have mild pain in joints.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Glycosylated haemoglobin normal, Injection site muscle weakness, Pain
Clinical narrative: Developed pain, weakness to the left shoulder and left upper arm approximately 8 hours after injection of vaccine. On 11/5/2020 came to the walk in clinic because pain continues and not better. Labs, US ordered and xray of the left shoulder and upper arm. Will refer to Orthopedic. Given toradol IM in office , and Prescription of Meloxacam.  Will follow up and monitor response. z
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain, X-ray
Clinical narrative: continued soreness to vaccine site left shoulder x 2 months
Age: 25.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Culture, Headache, Malaise, Nausea, SARS-CoV-2 test negative
Clinical narrative: Patient is a 25M His last visit was 10/7/2020 Today he reports by doxy virtual visit with concerns for HPV vaccination. "the next day after I got it I had nausea, headache and malaise". He references the first week of October. Daily headache, nausea, mild vertigo lasting up to all day without fever. COVID testing completed 6 days ago was negative with a saliva test ("for asymptomatic people") Today - "is the best I've felt over the last month. No fullness to the abdomen or sensation that he cannot take a deep breath. There may be arrhythmia but no heart pain. Denies weight gain or loss.
Age: 25.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Vertigo
Clinical narrative: Patient is a 25M His last visit was 10/7/2020 Today he reports by doxy virtual visit with concerns for HPV vaccination. "the next day after I got it I had nausea, headache and malaise". He references the first week of October. Daily headache, nausea, mild vertigo lasting up to all day without fever. COVID testing completed 6 days ago was negative with a saliva test ("for asymptomatic people") Today - "is the best I've felt over the last month. No fullness to the abdomen or sensation that he cannot take a deep breath. There may be arrhythmia but no heart pain. Denies weight gain or loss.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: After injection, I had normal mild pain at injection site for 2 days.  But rather than diminishing, pain and weakness in my shoulder and upper arm increased.  When it became hard to remove a T-shirt, I went to my doctor.  He recommended a course of ibuprofen which reduced pain somewhat.  Then physical therapy which I have just started. I CANNOT BE SURE THAT MY PAIN AND LIMITED MOTION IN MY LEFT ARM RESULTED FROM THE INJECTION.  I MAY HAVE UNKNOWINGLY INJURED IT IN SOME OTHER WAY.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling about 2 and 1/2 inches below injection site (described as 3 inches long, 2 inches wide); patient currently applying ice pack
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient received PPSV23 and influenza vaccines in office on 11/03/20. Patient contacted on call provider in the evening on 11/04/20 with complaints of redness and pain to site. Patient was instructed to take 600mg Ibuprofen, apply ice 20 minutes on and 20 minutes off and to drawn line around the redness. Patient came into the office to be evaluated on 11/05/20 - diagnosed with cellulitis - prescribed Clindamycin 300mg
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: No adverse event; A patient received a dose of PNEUMOVAX 23 that was recalled; A patient received a dose of PNEUMOVAX 23 that was recalled; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 13-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036495, expiration date reported and validated as 13-SEP-2021), at a dose of 0.5 milliliters (mL) as prophylaxis (route and site of administration were not reported) that was recalled (incorrect product storage, recalled product administered). No adverse events were reported.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: lip was swelling / spread to his forehead, eyes, nose, cheeks and jaw.; lip was swelling / spread to his forehead, eyes, nose, cheeks and jaw.; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 58-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Previously administered products included Havrix (patient received his first dose of Havrix (Lot N34BM) in January of 2020 and had no issues).   On 30th October 2020, the patient received the 2nd dose of Havrix (intramuscular). On 30th October 2020, 7 hrs after receiving Havrix, the patient experienced lip swelling and facial swelling. The patient was treated with benadryl (nos) (Benadryl) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the lip swelling and facial swelling were not recovered/not resolved.   The reporter considered the lip swelling and facial swelling to be related to Havrix.  Additional details were provided as follows: The patient received his first dose of Havrix (Lot N34BM) in January of 2020 and had no issues.   The patient received the 2nd dose was administered morning at 10:00 AM.   Around 4:00pm, he noticed his lip was swelling. It has now spread to his forehead, eyes, nose, cheeks and jaw.   He consulted with his primary doctor who advised him to take Benadryl and Zyrtec. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incorrect dose administered, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: itching around the injection site; chills; fever of 100 degrees; nausea; pain at the injection site on the right arm / pain at the injection site on the left arm; was injected in the right arm with the adjuvant solution only; injected / with the adjuvant solution only / nurse/ administered the correct mixture / in / left arm.; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th October 2020, less than a day after receiving Shingrix, the patient experienced nausea, injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On 1st November 2020, the patient experienced chills and fever. On 2nd November 2020, the patient experienced injection site itching. On 1st November 2020, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the chills, injection site pain and injection site itching were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the chills, fever, nausea, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and was injected in the right arm with the  adjuvant solution only which led Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient reported itching around the injection site on the right arm that started on 2nd November 2020 and was still ongoing.  The patient reported pain at the injection site on the right arm that began on 30th October 2020 and was still ongoing but was subsiding.  The patient reported the nurse at doctor's office administered the correct mixture of Shingrix vaccine on 30th October 2020 in the patient's left arm.  The patient reported pain at the injection site on the left arm that started the same day the vaccine was given and is still ongoing today but is subsiding. The patient had a fever of 100 degrees and this had resolved.  The patient reported chills that began on 01st November 2020 and were still ongoing at this time of reporting. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue, Pyrexia
Clinical narrative: itching around the injection site; chills; fever of 100 degrees; nausea; pain at the injection site on the right arm / pain at the injection site on the left arm; was injected in the right arm with the adjuvant solution only; injected / with the adjuvant solution only / nurse/ administered the correct mixture / in / left arm.; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th October 2020, less than a day after receiving Shingrix, the patient experienced nausea, injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On 1st November 2020, the patient experienced chills and fever. On 2nd November 2020, the patient experienced injection site itching. On 1st November 2020, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the chills, injection site pain and injection site itching were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the chills, fever, nausea, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and was injected in the right arm with the  adjuvant solution only which led Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient reported itching around the injection site on the right arm that started on 2nd November 2020 and was still ongoing.  The patient reported pain at the injection site on the right arm that began on 30th October 2020 and was still ongoing but was subsiding.  The patient reported the nurse at doctor's office administered the correct mixture of Shingrix vaccine on 30th October 2020 in the patient's left arm.  The patient reported pain at the injection site on the left arm that started the same day the vaccine was given and is still ongoing today but is subsiding. The patient had a fever of 100 degrees and this had resolved.  The patient reported chills that began on 01st November 2020 and were still ongoing at this time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included anaphylactic reaction (anaphylactic reaction to azithromycin). Concurrent medical conditions included systemic antibacterial therapy (allergic to antibiotics), bee sting and poison ivy rash.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, 1 day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shingles and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and an unspecified flu vaccine in September 2020 and about 1 to 2 days later he developed a possible shingles rash. Treatment included Benadryl and the rash has resolved.  The patient had a history of being allergic to antibiotics, bee stings, poison ivy, and had a prior anaphylactic reaction to azithromycin.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Immunized 11 patients with expired flu vaccine/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-health professional via email.  This case involves 11 patients (unknown age and gender) who were vaccinated with an expired dose of INFLUENZA VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency was on same day at the time of vaccination).  At the time of reporting, patients had not experienced adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 61 year old patient was administered Fluzone HD by mistake/no AE; 61 year old patient was administered Fluzone HD by mistake/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional in.  This case involves a 61 year old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [lot number and expiry date not reported] via an unknown route at an unknown administration site, on an unknown date by mistake, for prophylactic vaccination (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of overdose and actual medication error due to Inappropriate age at vaccine administration.(Latency: at the same time of vaccination)  At the time of reporting, patient had not experienced adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: shivering and chills; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.   This case involves a patient of an unknown demographics who experienced shivering and having chills (chills), after the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medications 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 (batch number and expiry date not reported) via an unknown route and at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious shivering and having chills (chills), one hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: tingling, numbness at the injection site; numbness at the injection site; Initial information regarding this valid unsolicited non-serious case was received from pharmacist via Global Medical Information (GMI) (Reference number- 00299080) on 02-Oct-2020 and transmitted to Sanofi on 05-Oct-2020.  This case involves an unknown aged female patient who experienced tingling, numbness at the injection site (injection site hypoaesthesia and Injection site paraesthesia ), after she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations and family history were not provided. No other vaccine was given.   On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Lot number and expiration date not reported, pre-filled syringe) via intramuscular route in the arm for prophylactic vaccination.  On 01-Oct-2020, the patient experienced tingling, numbness at the injection site (injection site hypoaesthesia and Injection site paraesthesia), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No relevant laboratory data was reported.  The patient was prescribed prednisone by the doctor and was sent home.  At the time of reporting the outcome of the events were unknown.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient received a dose of PENTACEL on 22Oct2020 that had expired on 11Oct2020, no AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional..  This case involves patient who received a 0.5 ml expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number of one part was U6469AB and other was UJ134AA with the expiration date of 11-Oct-2020) via intramuscular route in unknown administration site for prophylactic vaccination on 22-Oct-2020 (expired product administered).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Balance disorder, Dizziness, Pain in extremity
Clinical narrative: 2 hours after flu vaccine experienced light headiness and sore arm, lost balance.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pt said arm hurt during vaccine and still hurts
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Myalgia, X-ray limb normal
Clinical narrative: After the vaccination in the right upper arm the patient experienced pain in the muscle and and shoulder joint. The aching pain persisted for two weeks after the initial vaccination. He was evaluated on 10/26/2020 with continued pain and did have an Xray of the right shoulder that was unremarkable and was referred to physical therapy for pain of the right shoulder.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site nodule, Skin warm
Clinical narrative: Patient received vaccine in office on 11/03/20 around 8:30am. Patient contacted office later that evening (approx. 4:40pm) stating that the injection site was hard and had a football size knot across arm - warm to touch. Patient advised to Benadryl and cool compress. 11/04/20 - patient was contacted. He states arm is improving just hard lump at injection site. Area is not warm to touch or red.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: right arm , red swollen, it hurts real bad, swollen and hard, redness is spreading,
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in the left arm that radiates to the shoulder.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Blood glucose normal, Dizziness, Dyskinesia, Eye movement disorder
Clinical narrative: Patient is here for high dose flu shot and pneumonia injection. Vaccination questions completed with patient. Vaccinations given, one in each arm. Patient monitored for a few minutes after stating he wanted to rest for a moment after receiving injections. Stated he was feeling fine but has felt faint before after receiving injections. Nurse left room for less than 30 seconds and returned to gross movement of arms and legs, rapid eye movement and groaning. Called for doctor. Drs  arrived. Patient appropriately answered multiple questions by provider, but patient was pale, diaphoretic and weak. Patient sipped water and cold compresses applied to forehead and neck. Patient vomited. Vital signs and glucose obtained. Glucose = 140. Continued to monitor patient. Patient attempted to sit up after approximately 10 minutes. Patient returned to an slightly elevated position after feeling faint and nauseous again. Patient again vomited. Vital signs obtained again (see documentation). Patient rested another 15 minutes and was cleared to leave by Dr. Per, follow up in 3 weeks.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Hyperhidrosis, Moaning, Nausea, Pallor, Vomiting
Clinical narrative: Patient is here for high dose flu shot and pneumonia injection. Vaccination questions completed with patient. Vaccinations given, one in each arm. Patient monitored for a few minutes after stating he wanted to rest for a moment after receiving injections. Stated he was feeling fine but has felt faint before after receiving injections. Nurse left room for less than 30 seconds and returned to gross movement of arms and legs, rapid eye movement and groaning. Called for doctor. Drs  arrived. Patient appropriately answered multiple questions by provider, but patient was pale, diaphoretic and weak. Patient sipped water and cold compresses applied to forehead and neck. Patient vomited. Vital signs and glucose obtained. Glucose = 140. Continued to monitor patient. Patient attempted to sit up after approximately 10 minutes. Patient returned to an slightly elevated position after feeling faint and nauseous again. Patient again vomited. Vital signs obtained again (see documentation). Patient rested another 15 minutes and was cleared to leave by Dr. Per, follow up in 3 weeks.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site urticaria, Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, shoulder, reduced range of motion, hives spreading from injection site.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Muscle twitching
Clinical narrative: eye and mouth twitching 1 hr to 1 hr and a half after administration , is seeing a doctor - needs head scan
Age: 80.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Paralysis
Clinical narrative: GBS distal UE and LE weakness/paralysis developed w/in 3-4 days after immunization
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pruritus, Rash, Rash erythematous
Clinical narrative: I got the actual vaccine at Pharmacy  on 10/15/20.  I had a mild flu-like reaction to the injection on 10/17 that lasted for about a day and a half, which is a known reaction to the injection so I wasn't concerned.  However, about a week  later I noticed small red welts on my right torso and upper right thigh.  Red and itchy.  I thought they were bug bites at first and treated them as such.  However they did not improve.   On Wednesday 10/28 I woke up with a bumpy red rash on my left torso, which began to spread to my left back, and my back shoulders on both sides.  My skin turned red and itchy but was not in pain.  I went to my doctor on 10/29 to find out if it was shingles.   He observed the rash and because it was on both sides of my body did not think it was shingles.   He asked me to return in a couple of days to observe before treatment.  I came back on Monday 11/2 and by then the rash was bright red on one side.  We are currently treating with Prednisone and at the moment it seems to be responding.  Please follow up with doctor for final confirmation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I got the actual vaccine at Pharmacy  on 10/15/20.  I had a mild flu-like reaction to the injection on 10/17 that lasted for about a day and a half, which is a known reaction to the injection so I wasn't concerned.  However, about a week  later I noticed small red welts on my right torso and upper right thigh.  Red and itchy.  I thought they were bug bites at first and treated them as such.  However they did not improve.   On Wednesday 10/28 I woke up with a bumpy red rash on my left torso, which began to spread to my left back, and my back shoulders on both sides.  My skin turned red and itchy but was not in pain.  I went to my doctor on 10/29 to find out if it was shingles.   He observed the rash and because it was on both sides of my body did not think it was shingles.   He asked me to return in a couple of days to observe before treatment.  I came back on Monday 11/2 and by then the rash was bright red on one side.  We are currently treating with Prednisone and at the moment it seems to be responding.  Please follow up with doctor for final confirmation.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: After injection patients arm was sore, patient applied tiger balm to help with soreness helped with soreness but then arm started to get red and itchy has now gone away.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on arm
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: dad called following day and said she had headache,fever and vomiting
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Grip strength decreased, Hypoaesthesia, Iontophoresis, Magnetic resonance imaging abnormal
Clinical narrative: I received my flu vaccination in my left arm on 11/13/2018 as a requirement for work.   I did not feel the injection, but I began to feel increased pain before I left the exam room.  Soon after the injection I felt pain in my upper arm and tingling going down my arm into my hand.  Over the next hours and days the pain in my arm increased and tingling increased down to my 4th and 5th fingers. Arm movement, especially above my head and lifting,  became very painful. My arm and grip felt weak.  At the time of injury, Dr. recommended I start taking NSAIDS. However, I was already taking due to my Ankylosing Spondylitis. So I continued. I started physical therapy 1/2019.  I had worsening symptoms after 9 PT sessions and was referred to a sports med MD, in March 2019, Pain at 8/10. Tingling to 4th and finger continued, but was not as severe. Started Medrol Dose pack. Numbness/tingling improved steadily after  steroids lessening up my arm. Pain in upper shoulder continued.  3 PT sessions starting on 5/8/19 with dry needling.  Some improvement following. Pain at 2/10. Continued home exercise program. Pain was consistent at 2/10 and increased to 4-8/10. Steroid injections x 1/2020, 5/2020. Started PT6/2020 with iontophoresis. Had good results. Pain at 2/10 following Pt. Continued on home exercise program.   10/7/2020 aggressive shoulder exam followed increased pain (6-7/10 at times). Shoulder steroid injection 11/6/2020.  NSAIDS- Meloxicam 15mg daily PT- 9 sessions home exercises 12/27/18-2/27/19 Medrol Dose pack-3/15/19 PT-3 sessions(dry needling)  5/8/19-6/3/19 home exercise program Steroid injection left shoulder 1/28/20, 5/25/20 PT-5 sessions (iontophoresis)  6/10/20-7/14/20 continued home exercise program Steroid injection 11/6/20
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nerve conduction studies normal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I received my flu vaccination in my left arm on 11/13/2018 as a requirement for work.   I did not feel the injection, but I began to feel increased pain before I left the exam room.  Soon after the injection I felt pain in my upper arm and tingling going down my arm into my hand.  Over the next hours and days the pain in my arm increased and tingling increased down to my 4th and 5th fingers. Arm movement, especially above my head and lifting,  became very painful. My arm and grip felt weak.  At the time of injury, Dr. recommended I start taking NSAIDS. However, I was already taking due to my Ankylosing Spondylitis. So I continued. I started physical therapy 1/2019.  I had worsening symptoms after 9 PT sessions and was referred to a sports med MD, in March 2019, Pain at 8/10. Tingling to 4th and finger continued, but was not as severe. Started Medrol Dose pack. Numbness/tingling improved steadily after  steroids lessening up my arm. Pain in upper shoulder continued.  3 PT sessions starting on 5/8/19 with dry needling.  Some improvement following. Pain at 2/10. Continued home exercise program. Pain was consistent at 2/10 and increased to 4-8/10. Steroid injections x 1/2020, 5/2020. Started PT6/2020 with iontophoresis. Had good results. Pain at 2/10 following Pt. Continued on home exercise program.   10/7/2020 aggressive shoulder exam followed increased pain (6-7/10 at times). Shoulder steroid injection 11/6/2020.  NSAIDS- Meloxicam 15mg daily PT- 9 sessions home exercises 12/27/18-2/27/19 Medrol Dose pack-3/15/19 PT-3 sessions(dry needling)  5/8/19-6/3/19 home exercise program Steroid injection left shoulder 1/28/20, 5/25/20 PT-5 sessions (iontophoresis)  6/10/20-7/14/20 continued home exercise program Steroid injection 11/6/20
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, X-ray normal
Clinical narrative: I received my flu vaccination in my left arm on 11/13/2018 as a requirement for work.   I did not feel the injection, but I began to feel increased pain before I left the exam room.  Soon after the injection I felt pain in my upper arm and tingling going down my arm into my hand.  Over the next hours and days the pain in my arm increased and tingling increased down to my 4th and 5th fingers. Arm movement, especially above my head and lifting,  became very painful. My arm and grip felt weak.  At the time of injury, Dr. recommended I start taking NSAIDS. However, I was already taking due to my Ankylosing Spondylitis. So I continued. I started physical therapy 1/2019.  I had worsening symptoms after 9 PT sessions and was referred to a sports med MD, in March 2019, Pain at 8/10. Tingling to 4th and finger continued, but was not as severe. Started Medrol Dose pack. Numbness/tingling improved steadily after  steroids lessening up my arm. Pain in upper shoulder continued.  3 PT sessions starting on 5/8/19 with dry needling.  Some improvement following. Pain at 2/10. Continued home exercise program. Pain was consistent at 2/10 and increased to 4-8/10. Steroid injections x 1/2020, 5/2020. Started PT6/2020 with iontophoresis. Had good results. Pain at 2/10 following Pt. Continued on home exercise program.   10/7/2020 aggressive shoulder exam followed increased pain (6-7/10 at times). Shoulder steroid injection 11/6/2020.  NSAIDS- Meloxicam 15mg daily PT- 9 sessions home exercises 12/27/18-2/27/19 Medrol Dose pack-3/15/19 PT-3 sessions(dry needling)  5/8/19-6/3/19 home exercise program Steroid injection left shoulder 1/28/20, 5/25/20 PT-5 sessions (iontophoresis)  6/10/20-7/14/20 continued home exercise program Steroid injection 11/6/20
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Arthralgia, C-reactive protein abnormal, Hepatic enzyme abnormal, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: fever followed by severe pain and stiffness left knee followed by severe pain in bilateral shoulders and stiffness of bilateral shoulders
Age: 65.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Pyrexia, Red blood cell sedimentation rate abnormal
Clinical narrative: fever followed by severe pain and stiffness left knee followed by severe pain in bilateral shoulders and stiffness of bilateral shoulders
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria, Pharyngeal swelling
Clinical narrative: 20 minutes after receiving the flu vaccine, patient began to develop erythema and hives at the site. Patient began to feel swelling in the throat. Patient took a dose of Benadryl.  An ambulance was contacted, and employee was transported by ambulance to medical center. She was evaluated in the ED and discharged to home later in the day. She had a follow up appointment with her primary physician within the week. The allergic reaction to the flu vaccine was annotated in patient's employee medical record. Employee was advised to obtain a medical waiver signed by her primary physician rather than receiving the flu vaccination in the future.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Shortly after receiving the vaccine I was lightheaded.  That evening I was achy and nauseous. The next day I had a fever of 101 along with exhaustion, headache and body aches.  I also had a  heartbeat of 120.  The fever broke that night but I still felt unwell the following day.  The injection site welted.  The 2nd night the fever returned but not as high.  Today is the 3rd day.  The fever is gone for now.  The injection site is still red and hot and now itchy.  Welt size is 5 inches by 3 inches.  Still a little nauseous and headachy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Malaise, Nausea, Pain
Clinical narrative: Shortly after receiving the vaccine I was lightheaded.  That evening I was achy and nauseous. The next day I had a fever of 101 along with exhaustion, headache and body aches.  I also had a  heartbeat of 120.  The fever broke that night but I still felt unwell the following day.  The injection site welted.  The 2nd night the fever returned but not as high.  Today is the 3rd day.  The fever is gone for now.  The injection site is still red and hot and now itchy.  Welt size is 5 inches by 3 inches.  Still a little nauseous and headachy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Shortly after receiving the vaccine I was lightheaded.  That evening I was achy and nauseous. The next day I had a fever of 101 along with exhaustion, headache and body aches.  I also had a  heartbeat of 120.  The fever broke that night but I still felt unwell the following day.  The injection site welted.  The 2nd night the fever returned but not as high.  Today is the 3rd day.  The fever is gone for now.  The injection site is still red and hot and now itchy.  Welt size is 5 inches by 3 inches.  Still a little nauseous and headachy.
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Dysstasia, Gait inability, Hyperhidrosis, Retching
Clinical narrative: Rec. 1st shingle vax. Started getting dizzy room was spinning and then progressively got worse. Couldn't walk. Attempted to stand up but could not was stumbling. Had to catch breath. sweating profusely. Went to bathroom and was dry heaving. also had Blurry vision. Called MD next day twice and has not gotten response. All symptoms gone just feeling exsaughted.   Rec Flu shot 10/6/20  At workplace Hospital.
Sex: M
Vaccine: UNK
Symptoms: Vertigo, Vision blurred
Clinical narrative: Rec. 1st shingle vax. Started getting dizzy room was spinning and then progressively got worse. Couldn't walk. Attempted to stand up but could not was stumbling. Had to catch breath. sweating profusely. Went to bathroom and was dry heaving. also had Blurry vision. Called MD next day twice and has not gotten response. All symptoms gone just feeling exsaughted.   Rec Flu shot 10/6/20  At workplace Hospital.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reports that approximately 2 weeks after receiving the flu shot that she began to have pain in her shoulder/arm. She said that she did not have any stiffness or soreness immediately or within a few days after getting the immunization. She now reports having pain that sometimes radiates down the inside of her arm to her elbow. If she puts pressure her deltoid she feels pain and sometimes has difficulty lifting her arm. She reports never having a had a bad reaction to the flu shot before. I instructed her to reach out to her primary care provider.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Decreased appetite, Injection site pain, Weight decreased
Clinical narrative: Patient continues to speak of soreness in the left upper arm.  Patient also states that since having the Fluad injection she has experienced loss of appetite and weight loss.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy, Wrong product administered
Clinical narrative: Patient was immunized wilh GARDASIL 9 at 37 weeks, 1 day gestation; no adverse reactions; received Gardasil instead of influenza vaccine; Preparation for Adiministration: medication selection/verification error of medical assistant administering vaccine; This spontaneous report was received from a nurse and a clinical manager referring to a 35 years old (also reported as 30 (units not reported)) pregnant female patient. The patient's concurrent condition included diabetes. There was no information about the patient's drug reactions, allergies, medical history, and concomitant therapies provided.   On 02-OCT-2020, the patient at 37 weeks and 1 day gestation, who was erroneously vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)) (0.5 ml, intramuscularly in the left deltoid, lot # S023475 with expiration date 26-MAR-2022) for prophylaxis (reported as routine immunization) instead of influenza virus vaccine (unspecified) during pregnancy. It was due to a medication selection/verification error of medical assistant administering vaccine (product preparation error). It was not ordered by provider. The last menstrual period (LMP) was calculated to 16-JAN-2020. The estimated date of delivery (EDD) was calculated to 22-OCT-2020. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse reactions noted. The vaccine was not available for return/evaluation due to it was disposed after administration. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability