chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt received a shingrix and fluzone on 09/29/20. pt called back on 10/10/20 to report a possible allergic reaction that started on 10/08/20.  she experienced a rash on her face and neck. she was not certain that it was caused from the shingrix shot, but wanted to report to the pharmacy.  she has taken benadryl and the rash has gone away. she has had several flu shots in the past and has never had a reaction.
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Burning sensation, Dizziness, Feeling hot, Pain
Clinical narrative: For lunch that day, I ate 2 fried eggs. Immediately after, I felt a burning sensation in my shoulders,neck, face, and head.  I was very hot and a bit dizzy.   Since I could breathe OK and swallow, I felt I did not need to go to hosp, per your instructions on printed sheet. So I drank a glass of cold water, put a cold washcloth on my face, and lie down. In 30 minutes, I felt better and was able to stand up.  However, today is 4 days later, and I still feel quite weak.
Age: 67.0
Sex: M
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Feeling abnormal, Ocular discomfort
Clinical narrative: Patient called the day after his vaccinations to say he was feeling foggy. He stated that when he went to lie down he felt pressure behind his eyes. I called him about 3 hours later and he said that there had been no change. I told him that I would follow up the next day to see how he is doing.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Patient presented to the pharmacy with a 5 inch in diameter hive/rash just below the injection site.  Patient received the vaccine 3 days ago and started have reaction 2 days ago.  Advised patient to seek medical treat as hive could go larger.  Patient will take benadryl until he sees a provider.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Passed out after shot
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patients arm exhibited redness and swelling within 24 hours of vaccination.  Advised to seek care at walk-in clinic.  Was seen on 10/8/20 and prescribed doxycycline.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Flushing, Impaired work ability
Clinical narrative: About 24 hours after I received the vaccination, I had chills and also was extremely exhausted to the point that I missed an evening work engagement to go home. Later in the evening, I began running a fever of about 101 degrees. I was exhausted and chilled all evening, face flushed and red. By 9:00 a.m. the next morning, I was fine with no more fever.  For 7 days, my arm was red, about the size of a 3x3 post-it note. Also, about days 4-7, my arm was very itchy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: About 24 hours after I received the vaccination, I had chills and also was extremely exhausted to the point that I missed an evening work engagement to go home. Later in the evening, I began running a fever of about 101 degrees. I was exhausted and chilled all evening, face flushed and red. By 9:00 a.m. the next morning, I was fine with no more fever.  For 7 days, my arm was red, about the size of a 3x3 post-it note. Also, about days 4-7, my arm was very itchy.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoacusis, Paraesthesia, Speech disorder, Visual impairment
Clinical narrative: Two minutes after receiving Fluarix the patient reported vision changes, muted hearing, tingling legs, trouble speaking and trouble walking.  These adverse effects resolved within 5 minutes.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Oropharyngeal pain
Clinical narrative: Dizziness after injection (assumed due to lack of food prior to). Intense severe dizziness 24 hours after injection and continuous up to 48 hours post injection . Severe headache 24 hours after injection. Sore throat 36 hours after injection and continuous
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Hypotension, Loss of consciousness
Clinical narrative: Administered shingrix and flu shot to patient. Shortly after, patient stated that she felt light headed. I stayed by her side throughout whole incident. She kept saying she was light headed in the chair. She exhibited no signs of allergic reactions like difficulty breathing or hives. She passed in chair for a few seconds. We positioned her on the ground and we called 911 for assistance. EMTs were sent. I went into the pharmacy to get epinephrine and benadryl. I came back out and she was sitting up. She was breathing fine with no symptoms of anaphylaxis. She was speaking to me throughout the rest of the duration. She was breathing fine and I asked her to verify. She stated that she was breathing fine and that she still felt light headed. I gave her a single dose of liquid benadryl and monitored her to see if I would need to use epinephrine. I did need to use epinephrine. I relayed info. to EMTS when they arrived. EMTs stated patient had low bp and took her to hospital.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site reaction, Injection site vesicles, Injection site warmth, Rash erythematous
Clinical narrative: patient developed red rash around injection site that was hot to touch the day after injection then progressed to a small blister 2 days after injection
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Vaccine was give to the wrong patient. We had multiple customers waiting for vaccines and intern had mistakenly given this shot to a kid instead of the older man who came before the kid.  Kid is doing ok so far.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Few hours after receiving dose, extreme pain from shoulder to hand w/ numbness and tingling. Inability to sleep. Took Ibuprofen which helped with pain. Following day numbness subsided, pain continued in arm. inability to sleep. by 3rd day noted swelling/ warmth to puncture site and red bruising. Contacted MD. as unable to lift arm up. fourth day continue to have bruising, swelling, pain and now added itching to site
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Few hours after receiving dose, extreme pain from shoulder to hand w/ numbness and tingling. Inability to sleep. Took Ibuprofen which helped with pain. Following day numbness subsided, pain continued in arm. inability to sleep. by 3rd day noted swelling/ warmth to puncture site and red bruising. Contacted MD. as unable to lift arm up. fourth day continue to have bruising, swelling, pain and now added itching to site
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Few hours after receiving dose, extreme pain from shoulder to hand w/ numbness and tingling. Inability to sleep. Took Ibuprofen which helped with pain. Following day numbness subsided, pain continued in arm. inability to sleep. by 3rd day noted swelling/ warmth to puncture site and red bruising. Contacted MD. as unable to lift arm up. fourth day continue to have bruising, swelling, pain and now added itching to site
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDNESS, PAIN AND WARMTH AT SITE OF INJECTION
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Within 6 days of the Flumist, he started having a pain on his side and developed a rash on his left side, which turned out to be shingles. With Covid-19 we pretty much stay in the house.  He is a healthy 12 year old boy. He did get the chicken pox vaccine when he was younger, but never had the chicken pox.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives on legs, arms, neck, face, elbows, knees, scalp....Basically all over my body. Benadryl isn't doing much.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint noise
Clinical narrative: Right upper arm with severe swelling, shoulder pain with clicking noise in the shoulder, that gradually increased from time of injection until seen in the office later in the day when pt returned with concerns. The right upper arm was very warm to touch, no redness. Injection given at 0800 pt returned to the office at 1600 with concerns.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pain and a decreased range of motion.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Herpes zoster, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: 10/01/20 The evening receiving the vaccine, started muscle stiffness in right arm, under arm to chest. 10/02/20 Red raised rash on right forearm, fatigue. 10/03/20 Red raised rash was found on right forearm, elbow, upper arm, under arm, and right upper back. pain on right arm where rashes, right hand  and, chest mid-sternum are with breathing. 10/03-07/20 self treated area of the rash with anti histamine gel and ointment, Made an appointment with a dermatology clinic. 10/08/20 Visited the dermatologist, By visual examination,  I was told that I have Shingles from the vaccine.  Anti viral medication "Valacyclovir, 1GM, #30. Started the medication on the day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Rash, Rash erythematous, Rash papular
Clinical narrative: 10/01/20 The evening receiving the vaccine, started muscle stiffness in right arm, under arm to chest. 10/02/20 Red raised rash on right forearm, fatigue. 10/03/20 Red raised rash was found on right forearm, elbow, upper arm, under arm, and right upper back. pain on right arm where rashes, right hand  and, chest mid-sternum are with breathing. 10/03-07/20 self treated area of the rash with anti histamine gel and ointment, Made an appointment with a dermatology clinic. 10/08/20 Visited the dermatologist, By visual examination,  I was told that I have Shingles from the vaccine.  Anti viral medication "Valacyclovir, 1GM, #30. Started the medication on the day.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: I feel like I get zapped by an electric current on my arm,right above the hand along side the right side along a bone that is there, not on the upper arm.   I have no pain just the discomfort of having this strange feeling of like being hit by an electric volt. It lasts for a split second and then it goes away. In the beginning, it was more infrequent. Now it's more often. I don't feel it if I am resting my arm on the couch but if I get up to so something, there it is, again. I'm worried because I don't know what to do about it. I tried to massage the area a little bit but that's of no help. I never had anything like that in my life. It started shortly after I had the flu shot on my left upper arm.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus
Clinical narrative: patient described itching and tingling on trunk, both front and back, beginning about 7 pm the night of the vaccination.  Symptoms had continued into the next evening when it was reported at the pharmacy.  It was recommended the patient try benadryl for the itching, and contact the doctor if symptoms progressed or did not resolve.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Back pain, Gait disturbance, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient complained of excruciating, radiating pain in lower back that shot down to her legs along with tingling followed by weakness in her legs of which the patient said she decided to lay down cause she felt like she was going to fall because she couldn't move her legs. Patient laid down with head elevated and continued to state that she felt excruciating pain that continued in back and legs. EMS came and patient was taken to Hospital. Patient was contacted on 10/10/2020 5:00pm via telephone for follow up. Pt stated that Hospital discharged her with a diagnosis of chronic pain, no other interventions given. Patient stated that she can walk but is being cautious and no longer in pain.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Paraesthesia
Clinical narrative: Patient complained of excruciating, radiating pain in lower back that shot down to her legs along with tingling followed by weakness in her legs of which the patient said she decided to lay down cause she felt like she was going to fall because she couldn't move her legs. Patient laid down with head elevated and continued to state that she felt excruciating pain that continued in back and legs. EMS came and patient was taken to Hospital. Patient was contacted on 10/10/2020 5:00pm via telephone for follow up. Pt stated that Hospital discharged her with a diagnosis of chronic pain, no other interventions given. Patient stated that she can walk but is being cautious and no longer in pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Vaccination site pain, X-ray limb normal
Clinical narrative: Pain after vaccine lingering and limiting  range of motion for over 2 weeks Patient seen by orthopedic doctor who prescribed Naproxen 375mg BID. MD didn't see orthopedic type injury or  problem of joint in x-rays. Patient was seen also by internist and will have ultrasound to check for tendonitis (scheduled for October)
Age: 43.0
Sex: F
Vaccine: ANTH, FLU4, TYP
Symptoms: Injection site discharge, Injection site vesicles, Local reaction, Skin abrasion
Clinical narrative: I took off the band aid and the skin ripped off with the band aid and two other puss bubbles busted when I put pressure to wipe liquid No odor, minimal serosanguineous Local skin reaction, dime size area drainage where skin came off & 2 fluid filled small blisters, neosporin & bandaid.
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Injection site streaking
Clinical narrative: Red line From inj site within 3 hours. Patient went to MD who said nothing to worry AbouT. IT is Almost All resolved 10-11-20
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Decreased appetite, Dysgeusia, Insomnia, Nausea, Parosmia
Clinical narrative: Pt reports a bitter smell/taste beginning the night of vaccination. This has led to nausea and trouble eating/sleeping. Pt reported reaction was continuing 10 days post vaccination. Has tried mouthwash with no relief. Suggested sugar-free candies and follow-up with primary Md.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Muscle tightness, Pharyngeal swelling
Clinical narrative: heat rushed down arm after shot numbness of face lips neck squeezing throat swelling
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness - 3 inches in circumference, mild swelling, very itchy
Sex: F
Vaccine: HPVX, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Crying, Vision blurred
Clinical narrative: Her vision was blurry; impaired vision; This spontaneous report has been received from a physician referring to a 16 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 25-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, intramuscular (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included meningococcal acyw conj vaccine (crm197)(MENVEO) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli)(BEXSERO). On the same date, the patient had an eye exam which result was reported as "passed".  On 26-SEP-2020, the patient woke up, she found that her vision was blurry (vision blurred and visual impairment) it was mentioned that the patient had trouble seeing the screen on the computer and that she could not see very far and that she could see as far as her extended hand. The patient sought medical attention but did not received any treatment.The outcome of vision blurred and visual impairment was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPVX, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Her vision was blurry; impaired vision; This spontaneous report has been received from a physician referring to a 16 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 25-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, intramuscular (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included meningococcal acyw conj vaccine (crm197)(MENVEO) and meningococcal b rfhbp rnada rnhba omv vaccine (e. coli)(BEXSERO). On the same date, the patient had an eye exam which result was reported as "passed".  On 26-SEP-2020, the patient woke up, she found that her vision was blurry (vision blurred and visual impairment) it was mentioned that the patient had trouble seeing the screen on the computer and that she could not see very far and that she could see as far as her extended hand. The patient sought medical attention but did not received any treatment.The outcome of vision blurred and visual impairment was unknown. The causality assessment was not provided.
Age: 78.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two-doses of the Fluzone Quadrivalent high dose in the same flue season due to staff error, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 78 years old female patient who received 0.7 ml  two-doses of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ461AA ,UJ484B and expiration date:30-Jun-2021) in the same flue season due to staff error, via intramuscular route in the left arm for prophylactic vaccination.The initial Fluzone Quadrivalent high dose was on 23-Sep-2020 and that the second injection occurred on 01-Oct-2020 (PT:extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included B12  injection [CYANOCOBALAMIN]) on 01-Oct-2020.  It was an actual medication error case due to extra dose administered.  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: 13.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered
Clinical narrative: expired FLUZONE QUADRIVALENT was given to the patient, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 13 years old male patient who received 0.5 ml dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6756NA and expiration date: 30-Jun-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Sep-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had received no concomitant or no other vaccines.   It was an actual medication error case due to expired vaccine used (same day latency),as the flu vaccine was left in the refrigerator from last season and it was inadvertently administered to 3 patients.  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: 13.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired FLUZONE QUADRIVALENT was given to the patient, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 13 years old male patient who received 0.5 ml dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6756NA and expiration date: 30-Jun-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Sep-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had received no concomitant or no other vaccines.   It was an actual medication error case due to expired vaccine used (same day latency),as the flu vaccine was left in the refrigerator from last season and it was inadvertently administered to 3 patients.  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.
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Lip swelling
Clinical narrative: You listed all side effect (1) pain arms (2) paint (Off x On): Nosia, cough. Temperature. 3 day later: Vomit, diarrlea (like water) after fu shot: cough very bad. Each year got this 2015 I had same problem after same high dose I went immergency. Took antibotic: Azithromycin USP So, this time wait out
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Allergy to vaccine, Cough, Diarrhoea, Nausea, Pain
Clinical narrative: You listed all side effect (1) pain arms (2) paint (Off x On): Nosia, cough. Temperature. 3 day later: Vomit, diarrlea (like water) after fu shot: cough very bad. Each year got this 2015 I had same problem after same high dose I went immergency. Took antibotic: Azithromycin USP So, this time wait out
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: You listed all side effect (1) pain arms (2) paint (Off x On): Nosia, cough. Temperature. 3 day later: Vomit, diarrlea (like water) after fu shot: cough very bad. Each year got this 2015 I had same problem after same high dose I went immergency. Took antibotic: Azithromycin USP So, this time wait out
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Blister, Gingival blister, Herpes zoster, Influenza, Lip blister
Clinical narrative: You listed all side effect (1) pain arms (2) paint (Off x On): Nosia, cough. Temperature. 3 day later: Vomit, diarrlea (like water) after fu shot: cough very bad. Each year got this 2015 I had same problem after same high dose I went immergency. Took antibotic: Azithromycin USP So, this time wait out
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Oral mucosal blistering, Pain, Pain in extremity, Sleep disorder, Tongue blistering
Clinical narrative: You listed all side effect (1) pain arms (2) paint (Off x On): Nosia, cough. Temperature. 3 day later: Vomit, diarrlea (like water) after fu shot: cough very bad. Each year got this 2015 I had same problem after same high dose I went immergency. Took antibotic: Azithromycin USP So, this time wait out
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea within 4 hours, vomiting within 48 hours.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Herpes zoster, Malaise
Clinical narrative: No reaction to influenza vaccine  Reaction to recombinant Zoster (Shingles) Vaccine: within hours of shot broke out in goosebumps, chills/ shivering/ loss of appetite/ fatigue (no fever recorded)  within 24 hours developed painful rash starting on right breast and ribcage/ in bed/ incapacitated Friday Oct. 9, 2020 tired and sore felt sick  Saturday Oct. 10, 2020 tired but able to function  Sunday Oct. 11, 2020 rash filled with blisters, shooting pains all the way to toes and fingertips, painful breathing on right side of chest, went to urgent care, they refused to examine referred straight to ER. Emergency Department Doctor diagnosed shingles subsequent to vaccination "Herpes Zoster without complication" prescribed antiviral famciclovir and predniSONE
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Painful respiration, Piloerection, Rash, Rash vesicular
Clinical narrative: No reaction to influenza vaccine  Reaction to recombinant Zoster (Shingles) Vaccine: within hours of shot broke out in goosebumps, chills/ shivering/ loss of appetite/ fatigue (no fever recorded)  within 24 hours developed painful rash starting on right breast and ribcage/ in bed/ incapacitated Friday Oct. 9, 2020 tired and sore felt sick  Saturday Oct. 10, 2020 tired but able to function  Sunday Oct. 11, 2020 rash filled with blisters, shooting pains all the way to toes and fingertips, painful breathing on right side of chest, went to urgent care, they refused to examine referred straight to ER. Emergency Department Doctor diagnosed shingles subsequent to vaccination "Herpes Zoster without complication" prescribed antiviral famciclovir and predniSONE
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination error- patient under 65 administered Fluzone High-Dose: Patient was administered a Fluzone High-Dose vaccination at an immunization event due to incorrect date of birth written on patient questionnaire/consent form. Patient came to event with his wife, who's birth year is 1954 and filled out his own form with a DOB of 03/09/1954. Patient reports no adverse reaction from vaccination, reports he feels well as of 10/11/2020.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Redness about half size of fist, mild swelling, hardness at injection site.  Fever up to 100f.  Elevated pulse up to 110.
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: severe pain; She reports severe pain and immobility, to include not being able to pull her clothes off on her own or do certain daily activities; This spontaneous report has been received from a 67 years old female patient, referring to herself. The patient had no concomitant medication and no pertinent medical history. The patient's drug reactions or allergies included seasonal hay fevere allergies.  On 19-SEP-2020 the patient was vaccinated with pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml injection; strength, route, lot number and expiration date were unknown) for prophylaxis (reported as pneumonia).  The symptoms arrived 4 hours later on the same day (conflicting information: also reported as 18-SEP-2020), the patient reported severe pain and immobility,included not being able to pull her clothes off on her own or do certain daily activities. Over the last few days, the patient had seen improvement in mobility and pain. Treatment was not given for the events. The lab diagnostics or studies were not performed. The outcome of pain and mobility decreased was reported as recovering. The causality assessment between pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: what the dosing schedule is for the vaccine; what the dosing schedule is for the vaccine; the patient had a reaction and broke out in hives; the patient had a reaction and broke out in hives; This spontaneous report was received from a consumer (the patient's parent), referring to a 17-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. It was reported that the patient had allergy to tree nuts.  On an unspecified date in 2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) route of administration reported as "injection" (dose, anatomical site of vaccination, lot number or expiration date were not reported) as the pediatrician recommended it (prophylaxis).  On the same day, the patient had a reaction and broke out in hives (urticaria and vaccination complication). The patient sought medical attention and went to the emergency room; as treatment she was administered an unspecified steroid. As soon as she received the steroid, the patient recovered from the events. The reporter wanted to know if "tree nut" could be in the vaccine components,  that could have caused the reaction; she also asked what the dosing schedule for the vaccine was (circumstance or information capable of leading to medication error and inappropriate schedule of product administration).  The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the events urticaria and vaccination complication, was not reported.
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Illness, Impaired work ability, Injection site scar, Malaise
Clinical narrative: they had a "bad reaction" to the PNEUMOVAX 23 / they "almost died" and were sick for 10 days/ they missed 10 days of work dut to this adverse experience; were sick for 10 days; left arm swellep up to 3 times its size; migraines/they continue to experience migraines/ the patient also went to an eye doctor for the migraines; scar on their left arm at the injection site; This spontaneous report has been received from a 59-year-old female patient, referring to herself. The patient's concurrent conditions included migraines and a drug reaction or allergy to penicillin, prochlorperazine (COMPAZINE) and sumatriptan (IMITREX). Historical conditions and concomitant medications were not provided.  On 20-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) subcutaneously in the left arm once yearly (dose, lot number and expiration date were not provided) for prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine; furthermore, on the same date, the patient was vaccinated with a flu shot (dose, frequency, route, lot number, expiration date and indication were not provided) and a COVID test.  On 20-SEP-2020, the patient experienced a bad reaction to the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the reporter stated that she almost died and were sick for 10 days following administration of the vaccines and COVID test (adverse drug reaction). The patient missed 10 days of work due to this adverse experience but were back to work at the time of the reporting. The patient stated that their left arm swelled up to 3 times in size (peripheral swelling) and scar on their left arm at the injection site (injection site scar); Moreover, the patient developed migraines for 10 days and went to an eye doctor which was treated with ibuprofen (MOTRIN) 600 mg. The patient stated that there was still a scar and felt sick (malaise), she continued to experienced migraines and the swelling had gone down a lot but was still swollen. Subsequently, on an unknown date in 2020, the patient was hospitalized due to the adverse events. The reporter stated that she filled a claim.  The outcome of adverse drug reaction, injection site scar, migraine, peripheral swelling and malaise was reported as not resolved.   The reporter considered adverse drug reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal relationship between injection site scar, migraine, peripheral swelling, malaise and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Migraine, Near death experience, Peripheral swelling, SARS-CoV-2 test, Vaccination complication
Clinical narrative: they had a "bad reaction" to the PNEUMOVAX 23 / they "almost died" and were sick for 10 days/ they missed 10 days of work dut to this adverse experience; were sick for 10 days; left arm swellep up to 3 times its size; migraines/they continue to experience migraines/ the patient also went to an eye doctor for the migraines; scar on their left arm at the injection site; This spontaneous report has been received from a 59-year-old female patient, referring to herself. The patient's concurrent conditions included migraines and a drug reaction or allergy to penicillin, prochlorperazine (COMPAZINE) and sumatriptan (IMITREX). Historical conditions and concomitant medications were not provided.  On 20-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) subcutaneously in the left arm once yearly (dose, lot number and expiration date were not provided) for prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine; furthermore, on the same date, the patient was vaccinated with a flu shot (dose, frequency, route, lot number, expiration date and indication were not provided) and a COVID test.  On 20-SEP-2020, the patient experienced a bad reaction to the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the reporter stated that she almost died and were sick for 10 days following administration of the vaccines and COVID test (adverse drug reaction). The patient missed 10 days of work due to this adverse experience but were back to work at the time of the reporting. The patient stated that their left arm swelled up to 3 times in size (peripheral swelling) and scar on their left arm at the injection site (injection site scar); Moreover, the patient developed migraines for 10 days and went to an eye doctor which was treated with ibuprofen (MOTRIN) 600 mg. The patient stated that there was still a scar and felt sick (malaise), she continued to experienced migraines and the swelling had gone down a lot but was still swollen. Subsequently, on an unknown date in 2020, the patient was hospitalized due to the adverse events. The reporter stated that she filled a claim.  The outcome of adverse drug reaction, injection site scar, migraine, peripheral swelling and malaise was reported as not resolved.   The reporter considered adverse drug reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal relationship between injection site scar, migraine, peripheral swelling, malaise and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown  age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In or around 12-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not reported) for routine health maintenance and for it's intended purpose the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), Plaintiff suffered a painful itchy rash on his back which was diagnosed as herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result Plaintiff sustained severe and permanent personal injuries. Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknow age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 28-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location  and route of administration were not provided), as prescribed and/or administered by a healthcare provider at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at an urgent care service, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from an attorney regarding a case in litigation. This case refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In 2013, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX), (dosage, route, anatomical location, lot number and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) at the physician's office. Shortly after receiving the vaccine, the patient was treated by a healthcare professional for shingles. As a direct and proximate result of patient's vaccination, the patient had and would continue to suffer ongoing injuries but not limited to medical and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring treatment, medications and supplies. At the time of the report, the patient had not recovered from the event. The reporter considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Product appearance confusion, Product name confusion, Wrong product administered
Clinical narrative: Caller states that the 2 month old is well without any residual effects or side effects; PNEUMOVAX 23 was given to a 2 month old instead of PCV 13. Caller states that this was a sound alike look alike medication error; PNEUMOVAX 23 was given to a 2 month old instead of PCV 13. Caller states that this was a sound alike look alike medication error; 2-months old patient was vaccinated with Pneumovax23; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.     On 22-SEP-2020, the patient was vaccinated with first dose in the series of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as prophylaxis  (concentration, route and anatomical location of administration were not reported; lot number S029916 and expiration date  12-JUN-2021) instead of pneumococcal 13v conj vaccine (crm197)(PNEUMOCOCCAL 13V CONJ VACCINE (CRM197)) (reported as PCV 13). The reporter stated that this was a sound alike look alike medication error (product name confusion, product administered to patient of inappropriate age and interchange of vaccine product), also it was reported that, the 2-month-old was well without any residual effects or side effects.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-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; Sender's Comments:  US-009507513-2010USA002605:
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; a dose of MMRII administered only 20 days after receiving "varicellla"; This spontaneous report was received from a nurse, regarding a 5-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 17-MAY-2016, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (strength, dose, scheme, route of administration, anatomical site of vaccination, lot number or expiration date were not provided); 20 days later, on 06-JUN-2016, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at a dose of 0.5 milliliter (ml) (scheme, route of administration, anatomical site of vaccination, lot number or expiration date were not provided) both vaccines administered as prophylaxis (inappropriate schedule of product administration). On 10-SEP-2020, the patient was vaccinated again with varicella virus vaccine live (manufacturer unknown) (strength, dose, scheme, lot number or expiration date were not reported) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml  (scheme, rout of administration, anatomical site of vaccination, lot number or expiration date were not reported) as prophylaxis. The physician was advised to repeat the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose at least 28 days after the most recently administered dose. No adverse event was reported.
Sex: M
Vaccine: HPV4
Symptoms: Product preparation issue
Clinical narrative: The MA who gave him the shot did not roll or agitate the vial before drawing it up into the syringe and administering the vaccine; This spontaneous report was received from a nurse prescriber and refers to an adult male patient of unknown age. No information regarding his concurrent conditions, medical history, drug allergies/reactions and concomitant medications were provided.      On an unknown date, the patient was vaccinated with the three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported).   The nurse reported that the patient noticed the medical assistant who vaccinated him did not roll or agitate the vial before drawing it up into the syringe and administering the vaccine (product preparation issue).
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: A four year old was administered an improperly stored MMRII Vaccine; No additional AE; This spontaneous report was received from a physician referring to a 4-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis.   The vaccine went through a temperature excursion above 9 degrees Celsius (°C), with an average of 8.81°C for 1 hour and 30 minutes, and a cumulative timeframe of 16 hours. The vaccine had 2 previous temperature excursions as follows: above 9°C, with an average of 8.69°C for 1 hour and 30 minutes, and 9°C with an average of 8.68°C for 13 hours. The call was due to a digital data logger.   The physician requested more stability studies regarding measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; a dose of expired varivax was inadvertently administered to the patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 06-OCT-2020, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R027993, expiration date 01-OCT-2020, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: A 12 month old was administered an improperly stored MMRil Vaccine and an improperly stored VAQTA Vaccine; No additional AE; This spontaneous report was received from a physician referring to a 12-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On an unknown dates, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA)  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location, lot number and expiration date were not provided) (product storage error).  No adverse events were reported for the patient.      According to the reporter, the temperature excursion was above 9 degrees Celsius (8.81 degrees Celsius) for a time frame of 1 hour and 30 minutes on an unspecified date, with previous temperature excursion of above 9 degrees Celsius (8.69 degrees Celsius) for a time frame of 1 hour and 30 minutes, and above 9 degrees Celsius (8.68 degrees Celsius) for a time frame of 13 hours; which was detected by a digital data logger.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2010USA002664: