chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza, Malaise, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza. On an unknown date, the outcome of the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza were unknown. It was unknown if the reporter considered the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling very sick after receiving SHINGRIX. The symptoms included, fever, body aches, extreme fatigue, weakness, and malaise. According to the doctor this patient felt sick for about 7 days, and reported feeling as though she had the flu.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza. On an unknown date, the outcome of the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza were unknown. It was unknown if the reporter considered the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling very sick after receiving SHINGRIX. The symptoms included, fever, body aches, extreme fatigue, weakness, and malaise. According to the doctor this patient felt sick for about 7 days, and reported feeling as though she had the flu.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza, Pain
Clinical narrative: This case was reported by a consumer via other and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced shingles, pain and flu symptoms. The patient was treated with antivirals for systemic use (Anti-Viral Medication). On an unknown date, the outcome of the shingles, pain and flu symptoms were unknown. It was unknown if the reporter considered the shingles, pain and flu symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had a dose of SHINGRIX shot two weeks before the reporting date. A week and half later the patient had come down with a full blown case of shingles all over right side of head and upper forehead.  The patient was in pain, flu symptoms, etc. The patient was put by dermatologist on an anti viral. The patient reported that he was not a happy camper.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient experienced normal soreness at the injection site. No additional details were available. This case has been linked to the US2018176387, reported by the same reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. On the same day, the patient experienced arm soreness and 1 month later, she still had this adverse event. The batch number reported for SHINGRIX (J4S5J) did not exist and was updated to J4D5J, as per sales database. This case has been linked to the US2018178307, reported by the same reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. On the same day, the patient experienced arm soreness and 1 month later, she still had this adverse event. The batch number reported for SHINGRIX (J4S5J) did not exist and was updated to J4D5J, as per sales database. This case has been linked to the US2018178307, reported by the same reporter.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV mistakenly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given, She has not had FLUBLOK before (gender was taken based on this). On 28-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1816 expiry date: 30-Jun-2019 via unknown route in the left deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: FLUR4, HEPA
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA279742, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740, 2018SA277209 and 2018SA279741 (same reporter). This case involves a 64  years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date;30-Jun-2019  via intramuscular route in the left deltoid on 02-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included a dose of HEPATITIS A VACCINE on an unspecified date (reported as same visit). It was a case of actual medication error due to incorrect product storage (It was reported that shipment was sent to her clinic on 27sep2018 and was received on 01oct2018 and administered to 10 patients). No follow up treatment/symptoms 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: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA279742, 2018SA277209, 2018SA279741, 2018SA279740, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279748 and 2018SA279743 (same reporter). This case involves a patient (age, gender not provided) who received vaccine FLUBLOK QIV which was in shipping excursion as it was sent to her clinic on 27-Sep-2018 and was received on 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via unknown route and site of administration. It was a case of actual medication error due to incorrect product storage. (The reporter did not have details of patient). It was not reported that if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279742, 2018SA279744, 2018SA277209, 2018SA279741, 2018SA279740, 2018SA279745, 2018SA279746, 2018SA279747 and 2018SA279743 (same reporter). This case involves a 45 years old female patient who was vaccinated with vaccine FLUBLOK QIV (lot QFAA1829 and exp. Date 30 Jun 2019) via unknown route in the left deltoid on 02-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to shipping excursion for FLUBLOK QUADRIVALENT and was administered to patient. It was reported that shipment was sent to her clinic on 27-Sep-2018 and was received on 01-Oct-2018 and administered to 10 patients. No symptoms reported. No corrective treatment given. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Alopecia  - hair loss.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received an incorrect vaccine on 10/10/2018 at 5:00pm. The patient has no known side effects or symptoms at this time.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Computerised tomogram head, Full blood count, Gait disturbance, Hypoaesthesia
Clinical narrative: Bilateral lower extremity weakness, numbness, tingling, altered gait.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Muscular weakness, Paraesthesia
Clinical narrative: Bilateral lower extremity weakness, numbness, tingling, altered gait.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain at injection site, significant swelling and redness below injection site, muscle soreness and tenderness.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Pt called pharmacy 10/11/2018 says his arm hurts from the flu shot he got back on 9/26/18. Pt claims he was "injured by a flu shot at hospital few years ago and it feel the same". I advised him to see his MD right away to have his arm checked out, and call the pharmacy's risk management dept. to report the incident.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Reported by Mom and Dad 10/10/18, 4pm noticed hives on face, fever not noted. 10/10/18, bedtime continued hives on face, swelling and redness in hands and feet, swelling not pitting, no fever noted.  Child given children's Benadryl. 10/11/18 parents contacted health center, continued rash on face, swelling and redness in feet, mom described swelling as "puffy", states feet are itchy. No pain, no difficulty breathing, fever 99.9. PHN advised parents to take child to see their primary care provider, if unable to see provider today go to urgent care. If condition worsens or child has difficulty breathing go strait to emergency room. Parents voiced understanding.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient's arm got very red and warm to the touch within the first 24 hours. She had no physical symptoms at that time. Within the next 24 hours (total time of 48 hours) she began running a low grade fever and feeling achy. She went to an urgent care clinic to get checked out and they prescribed her a course of antibiotics (cephalexin) in case there was some sort of infection. I spoke to the patient at 72 hours and she reported that her fever was gone and she was feeling much better. Her left arm where she received the vaccine was still red, but no longer warm to the touch.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swelling and pain at this injections site. The arm is warm to touch. The patient also has been having severe headache starting 2 hours after the shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood blister, Injection site haemorrhage, Injection site swelling
Clinical narrative: Profuse bleeding from injection point, Swelling under the skin due to blood accumulation, ie. blood blister.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Dizziness, nausea, extreme sweating and low grade fever.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Soft tissue mass, Tenderness
Clinical narrative: Initially achy but this resolved and developed a golf ball sized soft tissue mass in the left supraclavicular region. Slightly tender. Does not appear to be a lymph node. No redness or warmth. No fever, nausea, itching, throat or facial swelling or difficulty swallowing.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain, redness at site immediately. 1 hour later noticed swelling and pain radiating to thumb, neck and scapula. Now pain is better but still feels tight. Took ibupofen 10/10/18 and 10/11/18.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Coxsackie viral infection, Crying, Gait inability, Head injury, Incomplete course of vaccination
Clinical narrative: 10/27/2017 12 month well check visit MMR given. No other vaccines given. 10/27/2017 Clinic call, Fever 101.4 since vaccine was administered. Home care for normal vaccine reaction given. 11/5/2017 Clinic call, Hit head on hardwood floor, acting okay after crying, vomited twice and fever 101-101.7, keeping PEDIALYTE down. Home care given. 11/6/2017 Clinic triage call, complains of rash, no fever or vomiting, home care per rash protocol. 12/17/2017 Office visit for URI, No fever or any developmental complaints. 1/2018 Missed 15 month well check visit. 3/11/2018 Office visit for Stye - No other complaints. 3/23/2018 Office visit for Stye - No other complaints. 5/10/2018 Office visit for Otitis Media, No other complaints. 5/18/2018 Cancelled 18-month well check appointment. 7/3/2018 Clinic referral for missed immunizations and well check visits. 7/10/2018 Non-Compliance of Clinic vaccine policy sent. 7/26/2018 Office visit for Pharyngitis.  Physician told mom to return as soon as possible to well check and to update vaccines or she would need to find another practice. Call later by supervisor to get appointment scheduled and mom said she would call back. 8/22/2018 Supervisor called mom again and appointment was scheduled for 9/18/2018. 8/29/2018 Office visit for Coxsackie, no other complaints, nurse discussed need for immunizations. 9/18/2018 No well visit appointment, but Dad did call for Immunization Record. 9/27/2018 23-months old, Office visit for well exam. Received PENTACEL, to return in 1 month for VARIVAX vaccine. Mom and Dad now bringing up concerns about MMR (want Medical Exemption from 4yr MMR). Per parent patient stopped walking for months after MMR (now running and normal). They also believe current speech issues caused by MMR.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Otitis media, Pharyngitis, Pyrexia, Rash, Speech disorder
Clinical narrative: 10/27/2017 12 month well check visit MMR given. No other vaccines given. 10/27/2017 Clinic call, Fever 101.4 since vaccine was administered. Home care for normal vaccine reaction given. 11/5/2017 Clinic call, Hit head on hardwood floor, acting okay after crying, vomited twice and fever 101-101.7, keeping PEDIALYTE down. Home care given. 11/6/2017 Clinic triage call, complains of rash, no fever or vomiting, home care per rash protocol. 12/17/2017 Office visit for URI, No fever or any developmental complaints. 1/2018 Missed 15 month well check visit. 3/11/2018 Office visit for Stye - No other complaints. 3/23/2018 Office visit for Stye - No other complaints. 5/10/2018 Office visit for Otitis Media, No other complaints. 5/18/2018 Cancelled 18-month well check appointment. 7/3/2018 Clinic referral for missed immunizations and well check visits. 7/10/2018 Non-Compliance of Clinic vaccine policy sent. 7/26/2018 Office visit for Pharyngitis.  Physician told mom to return as soon as possible to well check and to update vaccines or she would need to find another practice. Call later by supervisor to get appointment scheduled and mom said she would call back. 8/22/2018 Supervisor called mom again and appointment was scheduled for 9/18/2018. 8/29/2018 Office visit for Coxsackie, no other complaints, nurse discussed need for immunizations. 9/18/2018 No well visit appointment, but Dad did call for Immunization Record. 9/27/2018 23-months old, Office visit for well exam. Received PENTACEL, to return in 1 month for VARIVAX vaccine. Mom and Dad now bringing up concerns about MMR (want Medical Exemption from 4yr MMR). Per parent patient stopped walking for months after MMR (now running and normal). They also believe current speech issues caused by MMR.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: 10/27/2017 12 month well check visit MMR given. No other vaccines given. 10/27/2017 Clinic call, Fever 101.4 since vaccine was administered. Home care for normal vaccine reaction given. 11/5/2017 Clinic call, Hit head on hardwood floor, acting okay after crying, vomited twice and fever 101-101.7, keeping PEDIALYTE down. Home care given. 11/6/2017 Clinic triage call, complains of rash, no fever or vomiting, home care per rash protocol. 12/17/2017 Office visit for URI, No fever or any developmental complaints. 1/2018 Missed 15 month well check visit. 3/11/2018 Office visit for Stye - No other complaints. 3/23/2018 Office visit for Stye - No other complaints. 5/10/2018 Office visit for Otitis Media, No other complaints. 5/18/2018 Cancelled 18-month well check appointment. 7/3/2018 Clinic referral for missed immunizations and well check visits. 7/10/2018 Non-Compliance of Clinic vaccine policy sent. 7/26/2018 Office visit for Pharyngitis.  Physician told mom to return as soon as possible to well check and to update vaccines or she would need to find another practice. Call later by supervisor to get appointment scheduled and mom said she would call back. 8/22/2018 Supervisor called mom again and appointment was scheduled for 9/18/2018. 8/29/2018 Office visit for Coxsackie, no other complaints, nurse discussed need for immunizations. 9/18/2018 No well visit appointment, but Dad did call for Immunization Record. 9/27/2018 23-months old, Office visit for well exam. Received PENTACEL, to return in 1 month for VARIVAX vaccine. Mom and Dad now bringing up concerns about MMR (want Medical Exemption from 4yr MMR). Per parent patient stopped walking for months after MMR (now running and normal). They also believe current speech issues caused by MMR.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: CHILD COMPLAINED TO PARENTS THAT ARM ACHED AND WAS PAINFUL TO THE TOUCH. AFTER 1-2 DAYS, PARENTS LOOKED AT ARM BECAUSE CHILD WAS STILL COMPLAINING, AND ARM WAS RED AND HOT TO THE TOUCH. AREA WAS RED ABOUT 6" IN DIAMETER AROUND INJECTION SITE. PAINFUL TO TOUCH. RED AREA HAS GONE DOWN SLIGHTLY SINCE YESTERDAY, AND CHILD DOES NOT COMPLAIN AS MUCH.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Febrile convulsion, Oral candidiasis, Pyrexia, Seizure
Clinical narrative: The administering nurse, received a phone call on 10/10/2018 at approximately 9:30 p.m. from the child's father. He reported the child felt feverish and seizing. Nurse advised them to take the child to the ER immediately. Upon arrival at ER, he was reported with a temparature of 104 degrees (F) and following administration of antipyretics, the temperature went down 102 degrees (F). Client was sent home with a diagnosis of febrile seizures and oral thrush. Family was advised to alternate between Tylenol and Motrin every 6 hours. The morning of 10/11/2018, the father called nurse again and reported that the child had no further seizures and remains afebrile.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea
Clinical narrative: About 30 minutes after receiving vaccine, she began to have a coughing fit and could not catch her breath or stop coughing. She used her rescue Albuterol inhaler and the coughing started to slow down. When she got to the clinic around 45 minutes after the injection she was still coughing slightly but breath sounds were clear bilaterally and had no difficulty breathing. She chose to go back to her unit, use her inhaler again and if things progressed would go to the ER.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Blood creatine phosphokinase increased, Gait inability, Muscular weakness, Pain in extremity, Rhabdomyolysis
Clinical narrative: Was unable to walk about 30 hours after the vaccine. Went to the Emergency Room about 36 to 40 hours after the vaccine. Diagnosed with rhabdomyolysis, with CPK blood level of 11,600. Was admitted to the hospital for 4 days, with IV fluids to flush the body of the CPK enzymes. My mother still has leg pain and muscles weakness, is using a walker, and has to have physical therapy to regain her leg muscle strength. Prior to this, she used to take daily walks and was otherwise independent.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Walking aid user
Clinical narrative: Was unable to walk about 30 hours after the vaccine. Went to the Emergency Room about 36 to 40 hours after the vaccine. Diagnosed with rhabdomyolysis, with CPK blood level of 11,600. Was admitted to the hospital for 4 days, with IV fluids to flush the body of the CPK enzymes. My mother still has leg pain and muscles weakness, is using a walker, and has to have physical therapy to regain her leg muscle strength. Prior to this, she used to take daily walks and was otherwise independent.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Asthenia, Blood creatine phosphokinase increased, Fatigue, Gait inability, Limb injury
Clinical narrative: Was unable to walk about 30 hours after the vaccine. Went to the Emergency Room about 36 to 40 hours after the vaccine. Diagnosed with rhabdomyolysis, with CPK blood level of 11,600. Was admitted to the hospital for 4 days, with IV fluids to flush the body of the CPK enzymes. My mother still has leg pain and muscles weakness, is using a walker, and has to have physical therapy to regain her leg muscle strength. Prior to this, she used to take daily walks and was otherwise independent.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Loss of personal independence in daily activities, Rhabdomyolysis
Clinical narrative: Was unable to walk about 30 hours after the vaccine. Went to the Emergency Room about 36 to 40 hours after the vaccine. Diagnosed with rhabdomyolysis, with CPK blood level of 11,600. Was admitted to the hospital for 4 days, with IV fluids to flush the body of the CPK enzymes. My mother still has leg pain and muscles weakness, is using a walker, and has to have physical therapy to regain her leg muscle strength. Prior to this, she used to take daily walks and was otherwise independent.
Age: 34.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No symptoms. Patient was given the pediatric instead of the adult dose of Hepatitis A. He was informed that he should get an adult dose in 6 months, and a booster in one year. He was informed that he will not have full immunity against Hep A.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large local rxn: that afternoon: large swelling noted on right arm. By second day- from shoulder to elbow- right arm swollen (extensor surface) 20cm x 13cm at site of reaction, with increased warmth, heat and tenderness, mild itchiness of arm. no systemic sxs.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site, Tendon disorder
Clinical narrative: Patients states that vaccination was given very high on the arm. Patient reports pain started very early the next morning, with difficulty lifting arm. This morning patient visited Urgent Care office because pain has not subsided. Patient states that the practitioner said the vaccination aggravated the tendon.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Pt experienced red rash on upper arm approximately 4-5 inches away from the injection site on the posterior upper arm (injection more so on anterior deltiod of same arm). Came to pharmacy on 10/04 notifying us about possible injection site reaction. Rash slightly warm to touch. I took pt name and phone number down and told her i would follow up next day (today) with a courtsey call to check status of rash. I called pt and she said rash was about the same as yesterday, no better; a few hours later she came to the pharmacy to show status of rash. I told her rash will hopefully subside over the next few days but that i will complete a adverse drug reaction form to fda.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth, Skin infection
Clinical narrative: 24 HOURS AFTER PNEUMONIA VACCINE, PT NOTICED HER LEFT UPPER ARM WAS RED/INFLAMED AND, WARM/HARD TO THE TOUCH. PT CONTACTED HER DR ON 10/11/2018.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: DTaP was indicated for the above patient. DTaP-IPV was given inadvertently. There was no adverse event observed or reported. The purpose of the report is to report a medication error (IPV was not needed or indicated. The child received an extra dose of IPV).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Pt got mild case of shingles 3 weeks after getting 2nd dose of SHINGRIX vaccine. After the vaccine, her arm was sore, but the soreness went away. Then a 2-3 inch rash developed under her left breast.  Visited doctor's office, they evaluated her and will be monitoring for improvement over the next 3 weeks. No additional drugs prescribed.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated injection site was swollen, red, and warm to touch.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: PATIENT GOT A RED MARK AT INJECTION SITE THAT SPREAD INTO A STRIPE ALONG HER ARM ALL AROUND. SHE WAS ADVISED TO TAKE BENADRYL AND TO SEEK MEDICAL CARE WITH PHYSICIAN.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Symptoms: chills, fever (up to 101), headache, nausea. Treatment: Rest, TLC. Outcome: 2.5 days later back to normal.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle twitching
Clinical narrative: Pt received immunization on Tuesday and reports that as of this AM (10/11/2018) she is experiencing twitching in her left arm that is visible. Did not occur immediately after vaccine but just appeared this morning and has not subsided. She is contacting MD on how to proceed.
Age: 58.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Back pain, Neck pain
Clinical narrative: 9/28/2018 (10:20am) Patient reported by phone having neck pain in both sides (left and right) but more discomfort on the right side. On 9/29/2018 (6:20pm) pt returned to pharmacy and complaint about having Neck and upper back pain.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, soreness at injection site expanding down to elbow.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Dysphonia, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling, black line running down arm at site, nausea, diarrhea, stomach pain, hoarseness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site streaking, Injection site swelling, Nausea
Clinical narrative: Pain, redness, swelling, black line running down arm at site, nausea, diarrhea, stomach pain, hoarseness.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications, if any, were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX subcutaneously (which had a lot # of N027628 and an expiration date on 04-OCT-2019; however, dosage number and anatomical site of administration were not provided), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion: 15 degrees Fahrenheit to 46 degrees Fahrenheit (-9 degrees Celsius to 8 degrees Celsius) (-7.8 degrees Celsius)) for 10 minutes on unspecified date. Reportedly, there had been no previous temperature excursions and the aforementioned temperatures were identified due to a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by [name of health care system] for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-FEB-2014, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of long-term shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at an eye care center for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Client received flu vaccination 10/2/18 at 8:35 AM and reported feeling more pain than normal with injection. At 12:00 PM she reports feeling increased soreness with movement. 10/3/18 Started Ibuprofen 400 mg Q4H and ice pack to L arm for increased pain in her shoulder in the AM. 10/4/18 States that the pain has worsened and is now moving from the shoulder to the elbow. 10/5 no change. 10/6/18 States that pain has not improved and is now noticing pain, numbness, and tingling sensations in the pinky finger and ring finger of her L hand. 10/7/18 States that the tingling and numbness have spread to her jaw, teeth, cheek, and L eye. "It feels like it does after the dentist". 10/8/18 Examined by PCP/NP. NP states no weakness in her L arm/hand and her ROM is still WNL. She was instructed to rest, and continue to ice. If no improvement or Sx's worsen to call back for appt. 10/10/18 Client increased Ibuprofen to 600 mg Q8H and she has continued to rest and ice. When talking to me she also stated she is having some numbness and tingling in her L leg and foot. I advised her to make appt. with her PCP for possible PT in the future and possible referral to neurologist. Advised I would file VAERS report and monitor her progress.  Client was appreciative of call and follow up.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: High Fever, chills, severe shaking and headache.
Age: 67.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called pharmacy and reported a rash on her Left arm where her SHINGRIX was administered 2 days ago. Patient was recommended to see her physician.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Developed hives on left arm with some redness and swelling about 5 minutes after administration. Given 12.5ml of Benadryl in the office with improvement and no further spread of rash or any other allergic reaction. Eating and drinking well in the office and active.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt called to complain of sore arm and asked what to do to help relieve pain.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Pt reports getting cellulitis in right arm after receiving PNEUMOVAX. Pt was prescribed doxycycline from MD.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Noticed that wrong vaccine given within ten minutes, informed physician, patient's guardian, and Health Department. Per CDC guidelines, ZOSTAVAX counts as a valid dose toward Varicella immunity.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Father said fever started at 8 PM, and febrile seizure was at 4 AM.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Sleep disorder
Clinical narrative: Patient indicate that the arm is swollen, red, and is taking part of the shoulder. Patient couldnt sleep because of the arm swollen. She took benadryl in case was an allergy reaction and has not see improvement. Is applying cold compress in the area and is getting better.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to pharmacy on 10/11 with a chief complaint of pain and swelling at injection site. There is a very large bruise on the left deltoid that encompasses the injection site. Patient was referred to PCP for further treatment.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling occurred on both arms about 2 hours after shots were given, advised her next day to take some Benadryl, if no relief to go see patient first for medical care.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient came to the pharmacy 2 days after the vaccines were administered to report that she was experiencing pain in her entire right upper arm and shoulder. The skin covering the side of her upper arm was red and warm to the touch. She also said she didn't "feel all that well" yesterday. She said she was fine on the day of the vaccine, but woke up the next day with the pain. Her arm looks and feels better today, and she feels fine today. I recommended cold compresses, BENADRYL and ibuprofen if needed. She said she would just "let it run it's course."
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Tremor
Clinical narrative: Patient fainted after immunization and had a ~15 second episode of shaking/tremors.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: PAIN  AND RASH APPEARED ON VACCINATED ARM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Patient a PNEUMOVAX 23 vaccination and developed redness from her elbow to shoulder around the shot site beginning the evening of the shot. The redness area was getting smaller 2 days later when reported to us.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Ventricular tachycardia
Clinical narrative: Patient stated developing severe ventricular tachycardia after around 30minutes of receiving flu shot when she was shopping. She has heart conditions and has AICD device implant (pacemaker and cardio defibrillator) and decided to cope with it until about 8 hours later and then called 911.   Per patient she was taken to Medical Center. Per patient she was given amiodarone drip but did not work, and the doctor had to do cardio conversion using her AICD device. She was hospitalized and released on Sunday 10/7/18. Patient had filled out consent form for the flu shot, and only allergy information were DILAUDID and MSG. Patient also stated that she's had flu shots before without issues (her profile shows she last received AFLURIA 2016-17 on 10/26/16).
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient became very dizzy, pale, and nauseous after receiving vaccine, I had patient sit and elevate feet, also had patient drink some water. Patient came around in about 5-10 minutes. I had him stay for an additional 15 minutes and walk around for a few minutes and he felt fine after that. I also followed up that evening about 6 PM and patient was fine.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria that is coming and going on multiple areas of my body throughout the days without any apparent pattern that began the day after receiving the flu shot. Large welts that persist for several hours and patches of hives that also persist for several hours.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Discomfort, Fatigue, Headache
Clinical narrative: 14:30 received injection. 17:00 knot in throat (not sure if related, but was not eating), felt like something stuck in throat. 18:30 started to feel fatigued and uncomfortable due to throat, ate dinner. 20:00 started to feel weak and muscle aches, scratchy/tingling in back of throat; knot in throat gradually faded. 20:30 tried to go to bed, feeling severe aches and pains, took two ALEVE and dose of NYQUIL, hot bath, later took two TYLENOL. 22:00-01:00 severe aches and pains, fever-like chills (but normal temperature), mild sore throat, headache, bouts of nausea. Pain was on par with malaria, strongly considered going to hospital, but didn't want to get out of bed -- after 01:00 pain started to subside and I fell asleep. 11:30 woke up, tired and sore like all my muscles had been clenched through the night. Headache remained and scratchy throat, with slighty runny nose. Started to feel normal again about 18:00 the next day, with very slight hint of headache remaining
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain, Pharyngeal paraesthesia
Clinical narrative: 14:30 received injection. 17:00 knot in throat (not sure if related, but was not eating), felt like something stuck in throat. 18:30 started to feel fatigued and uncomfortable due to throat, ate dinner. 20:00 started to feel weak and muscle aches, scratchy/tingling in back of throat; knot in throat gradually faded. 20:30 tried to go to bed, feeling severe aches and pains, took two ALEVE and dose of NYQUIL, hot bath, later took two TYLENOL. 22:00-01:00 severe aches and pains, fever-like chills (but normal temperature), mild sore throat, headache, bouts of nausea. Pain was on par with malaria, strongly considered going to hospital, but didn't want to get out of bed -- after 01:00 pain started to subside and I fell asleep. 11:30 woke up, tired and sore like all my muscles had been clenched through the night. Headache remained and scratchy throat, with slighty runny nose. Started to feel normal again about 18:00 the next day, with very slight hint of headache remaining
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sensation of foreign body, Throat irritation
Clinical narrative: 14:30 received injection. 17:00 knot in throat (not sure if related, but was not eating), felt like something stuck in throat. 18:30 started to feel fatigued and uncomfortable due to throat, ate dinner. 20:00 started to feel weak and muscle aches, scratchy/tingling in back of throat; knot in throat gradually faded. 20:30 tried to go to bed, feeling severe aches and pains, took two ALEVE and dose of NYQUIL, hot bath, later took two TYLENOL. 22:00-01:00 severe aches and pains, fever-like chills (but normal temperature), mild sore throat, headache, bouts of nausea. Pain was on par with malaria, strongly considered going to hospital, but didn't want to get out of bed -- after 01:00 pain started to subside and I fell asleep. 11:30 woke up, tired and sore like all my muscles had been clenched through the night. Headache remained and scratchy throat, with slighty runny nose. Started to feel normal again about 18:00 the next day, with very slight hint of headache remaining
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Ear pain, Injection site inflammation, Injection site swelling, Pain
Clinical narrative: For a day and a half she had the following reactions: stabbing left ear pain, body and joint aches, inflamed right arm and swelling (injection site). She was also in bed for a day and a half. Pt came in on 10/2/18 to recap her reaction and let me know she will not be receiving the second dose.  She said was ok on this date and the pain and swelling were gone.