chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 28-OCT-2019, the patient received rotavirus vaccine, live, oral, pentavalent(ROTATEQ)(lot # and expiration date were not reported) orally for prophylaxis, following a temperature excursion. The vaccine was exposed to temperature excursions of below 36 degree Fahrenheit/2 degree Celsius(35F)(lowest temperature) for 430 minutes. There was no previous temperature excursion and no a "data logger" was involved. No adverse effects were reported in the patient.
Sex: M
Vaccine: MMRV
Symptoms: Ear swelling, Rash erythematous, Swelling of eyelid
Clinical narrative: patient "developed a red rash, with eyelid and ear swelling"; patient "developed a red rash, with eyelid and ear swelling"; patient "developed a red rash, with eyelid and ear swelling"; This spontaneous report was received from a nurse regarding a 12-months-old male patient. The patient did not have medical history, drug reactions, allergies or concomitant medications.   On 27-JUN-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030803, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 22-APR-2020) (dose and route of administration were not provided); diluted in sterile diluent (STERILE DILUENT MRK INJ) (dose, lot # and expiration date was not reported) as prophylaxis.  On 29-JUN-2019, he developed a red rash on an unspecified location, with eyelid and ear swelling. On 01-JUL-2019, the patient recovered from the events after receiving diphenhydramine hydrochloride (BENADRYL). There were no diagnostics laboratories or studies performed.   The reported causality between Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), sterile diluent (STERILE DILUENT MRK INJ) and the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 18 year old patient was administered a dose of PROQUAD; This spontaneous report was received from a nurse regarding an 18 year old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. On an unknown date in November 2019 (reported as last week), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, anatomical location, lot # and expiration date were unknown) taken subcutaneously for prophylaxis (product administered to patient of inappropriate age).
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Customer not able to administer full .5ml dose / no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff).  This case involves a patient (demographics not reported) who was not able to administer full 0.5ml dose, while the patient received QUADRIVALENT INFLUENZA VACCINE (Flu unit dose vials) (Lot number U6655AA).  It was an actual medication error due to vaccine underdose.  It was reported that the customer was not able to administer full 0.5 ml dose. The office has contacted medical affairs department regarding the issue, unsure if it is a customer administering error or not.  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Infection
Clinical narrative: patient had an infection 2 days later; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves adult patient who experienced patient had an infection 2 days later, while he/she received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious patient had an infection 2 days later (infection) following the administration of influenza quadrival A-B vaccine.  (Other lab test was not provided).  Final diagnosis was patient had an infection 2 days later.   The patient was treated with prednisone.  The patient outcome is reported as Unknown for patient had an infection 2 days later.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: big localized injection site reaction described as redness, swelling, and pain; redness; swelling; pain; Initial information received regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 08-Nov-2019.  This case involved 2 child patient of unknown demographics who experienced big localized injection site reaction described as redness, swelling, and pain (Vaccination site inflammation) and redness (Erythema), swelling (Swelling) and pain (Pain) while the patient received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.   On 07-Nov-2019, after receiving the vaccine the patient experienced big localized injection site reaction described as redness, swelling, and pain (Vaccination site inflammation) and redness (Erythema), swelling (Swelling) and pain (Pain).  Other relevant tests included No lab data was reported.  Corrective treatment was not reported.  Outcome of the event was unknown at the time of reporting.
Age: 15.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 15 year old male patient received a dose of Flublok Quadrivalent in error instead of Fluzone Quadrivalent/No AE; a 15 year old male patient received a dose of Flublok Quadrivalent in error instead of Fluzone Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional (medical assistant).  This case involves a 15 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1936, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid on 07-Nov-2019 in error instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: kid received the ActHIB vaccine and instead of using the diluent, they used sterile water, no AE; Initial information on 11-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who received a 0.5 ml dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) vaccine with sterile water instead of using the diluent lot UI973AAA and expiry: 25-JUL-2020 via intramuscular route in the left vastus lateralis on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  It was an actual medication error due to Product preparation error .  At the time of reporting no adverse events was reported.  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.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: seven patients were given Flublok with ages ranging from 2 years and 5 months to 15 years old,no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves seven patients (gender unknown) with ages ranging from 2 years and 5 months to 15 years old, which were given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number, expiry and dosage not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  Information on the batch number was requested.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 10 year old male was administered Flublok Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who was administered a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1962, expiry date: 30-Jun-2020 via intramuscular route in the right arm on 09-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: person wasn't able to receive vaccine so it was put back in refrigerator with the date and time so they could use it for a different patient, next morning a new nurse administered this same 0.25 ml prefilled syringe to a 6 month old/no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who received 0.25 mL vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after the 24-hour mark.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Incorrect product storage. The nurse states that the 0.25 ml prefilled syringe was ordered for a person on Friday. They accessed the syringe by putting a sterile needle on it and then the cap back on. She states that something happened and the person was not able to receive it so it was put back in refrigerator with the date and time so they could use it for a different patient. She states that no other 6-35 month old required it that day and it should have been wasted but that didn't happen. She states that it was a breach in their protocol. She states that this morning a new nurse administered this same 0.25 ml prefilled syringe to a 6 month old.  It was unknown whether the vaccines were administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to patient  instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316261, 2019SA316263, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316286, 2019SA316288, 2019SA316289 and 2019SA316290 (same reporter).  This case involves a 80 years old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms 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: HIBV
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Syringe issue
Clinical narrative: vaccine to splash back on her face and in her eyes, no AE; during administering Hib vaccine and the needle and syringe came apart after injecting, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient (age not reported) who while injecting the vaccine HAEMOPHILUS TYPE B (HIB) VACCINE the needle and syringe came apart after injecting and caused some of the vaccine to splash back on her face and in her eyes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of occupational exposure to product and syringe issue.  It was reported that she immediately flushed her eyes with water and is not having any eye discomfort or vision problem.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Seizure
Clinical narrative: Seizure
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: onset of  shoulder pain with persistence over 3 weeks, including deltoid, triceps, pectoralis minor and posterior deltoid. Dx SIRVA
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: arm soreness and weakness that has not improved since time of vaccination- about three weeks now
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gastrointestinal pain, Headache, Influenza like illness
Clinical narrative: Flu like symptoms,  headache, joint pain, muscle spasms, nausea, arm tenderness, fatigue, intestinal pain, lasting over a week.  To the point that it interfered with my normal function of life
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Nausea, Tenderness
Clinical narrative: Flu like symptoms,  headache, joint pain, muscle spasms, nausea, arm tenderness, fatigue, intestinal pain, lasting over a week.  To the point that it interfered with my normal function of life
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Culture, Diarrhoea, Genital rash, Pruritus
Clinical narrative: I had some itchiness on my body ( hands) and then I had explosive diarrhea. This happened about 8 days after vaccine was given. Then I noticed a rash starting on my body. It was on my back, chest. Also. Seemed to start in genital area. Because of this I went to gyneco.ogist and GI APRN because of swelling and severe itch. Also went to Urgent Care where I was given Prednisone for 7 days. GYN GAVE cream to apply(Clortrima/BetaMeth. Later test revealed No yeast infection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: I had some itchiness on my body ( hands) and then I had explosive diarrhea. This happened about 8 days after vaccine was given. Then I noticed a rash starting on my body. It was on my back, chest. Also. Seemed to start in genital area. Because of this I went to gyneco.ogist and GI APRN because of swelling and severe itch. Also went to Urgent Care where I was given Prednisone for 7 days. GYN GAVE cream to apply(Clortrima/BetaMeth. Later test revealed No yeast infection.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Pyrexia, Somnolence
Clinical narrative: Dizziness, low grade fever , sleepy
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Initial insomnia, Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: That afternoon I experienced usually pain(not the usually discomfort you feel with a flu shoot)  in my left arm at site of injection,  felt like the needle was still there. Kind of burning and throbbing, pain continued to intensify. The pan traveled into the shoulder and down the arm. That night I was feeling more pain and had some difficulty  falling asleep.  The pain continued the next day and the left shoulder felt a throbbing pain and again still felt the injection site. Also I started to have swollen areas on my left arm as well as hives, that were becoming itchy. The pain in arm become intense and I was unable to lift it up or move it much, the pain become a 8 and I was totally unable to sleep. I went back to same doctor on 10/30 for the pain and swollen arm. Was prescribed Prednisone for 5 days, this helped a bit, but only while medication was in my system.  Once the s days past the pain went right back to a 5-8. I'm unable to take Advil or other pain medications due to CKD. I was now suffering with pain all day and specially at night. I continued to use ice and heat to relieve the pain and to be able to move my left arm. I went back to same doctor again on 11/15 and was diagnosis with frozen shoulder (Adhesive Capsulitis of the left shoulder/Cervical Lymphadenopathy) I will start physical therapy next week, in hope this will help me be able to move my left arm without pain. The pain is still there and goes from a 4 to an 8 at night.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Periarthritis, Peripheral swelling, Pruritus
Clinical narrative: That afternoon I experienced usually pain(not the usually discomfort you feel with a flu shoot)  in my left arm at site of injection,  felt like the needle was still there. Kind of burning and throbbing, pain continued to intensify. The pan traveled into the shoulder and down the arm. That night I was feeling more pain and had some difficulty  falling asleep.  The pain continued the next day and the left shoulder felt a throbbing pain and again still felt the injection site. Also I started to have swollen areas on my left arm as well as hives, that were becoming itchy. The pain in arm become intense and I was unable to lift it up or move it much, the pain become a 8 and I was totally unable to sleep. I went back to same doctor on 10/30 for the pain and swollen arm. Was prescribed Prednisone for 5 days, this helped a bit, but only while medication was in my system.  Once the s days past the pain went right back to a 5-8. I'm unable to take Advil or other pain medications due to CKD. I was now suffering with pain all day and specially at night. I continued to use ice and heat to relieve the pain and to be able to move my left arm. I went back to same doctor again on 11/15 and was diagnosis with frozen shoulder (Adhesive Capsulitis of the left shoulder/Cervical Lymphadenopathy) I will start physical therapy next week, in hope this will help me be able to move my left arm without pain. The pain is still there and goes from a 4 to an 8 at night.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: That afternoon I experienced usually pain(not the usually discomfort you feel with a flu shoot)  in my left arm at site of injection,  felt like the needle was still there. Kind of burning and throbbing, pain continued to intensify. The pan traveled into the shoulder and down the arm. That night I was feeling more pain and had some difficulty  falling asleep.  The pain continued the next day and the left shoulder felt a throbbing pain and again still felt the injection site. Also I started to have swollen areas on my left arm as well as hives, that were becoming itchy. The pain in arm become intense and I was unable to lift it up or move it much, the pain become a 8 and I was totally unable to sleep. I went back to same doctor on 10/30 for the pain and swollen arm. Was prescribed Prednisone for 5 days, this helped a bit, but only while medication was in my system.  Once the s days past the pain went right back to a 5-8. I'm unable to take Advil or other pain medications due to CKD. I was now suffering with pain all day and specially at night. I continued to use ice and heat to relieve the pain and to be able to move my left arm. I went back to same doctor again on 11/15 and was diagnosis with frozen shoulder (Adhesive Capsulitis of the left shoulder/Cervical Lymphadenopathy) I will start physical therapy next week, in hope this will help me be able to move my left arm without pain. The pain is still there and goes from a 4 to an 8 at night.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: Onset of persistent L shoulder pain beginning right after vaccination, getting worse for 2-3 days, and persisting since. Unable to sleep on L side.  Exam notable for pain w Jobe test, Hawkins-Kennedy test; tenderness posterolateral sub-acromial area.  To use ice, ibuprofen prn, return to clinic in 4 weeks
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dysphonia, Fatigue, Hypersomnia, Rhinorrhoea
Clinical narrative: 1 week of deep fatigue (sleeping all day, no energy), slight runny nose, hoarseness
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient stated she developed muscle aches and joint pain for days
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Palpitations, Wheezing
Clinical narrative: Developed shortness of breath, heart palpitations, lightheadedness with wheezing approx 48 hours after vaccine administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: One week of extreme fatigue (in bed all day), felt feverish but temp. just slightly elevated, hoarse voice, clear nasal discharge
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Myalgia, Pica
Clinical narrative: Pt complained of fever of 101, joint pain, muscle pain, sore arms, headache, amd a stiff neck.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt complained of fever of 101, joint pain, muscle pain, sore arms, headache, amd a stiff neck.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out approx. 5 mins after receiving multiple vaccines
Age: 0.17
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE REACTION REPORTED, DOSE WAS GIVEN TO EARLY
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm soreness, radiating pain, fever, chills, decreased mobility lasting 24 hours after injection.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: Woke up day after shot feeling general malaise, body aches, very sore at injection sight.  Took Naproxum sodium, slept it off in afternoon and feel better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Aldolase normal, Alopecia, Antibody test negative, Antinuclear antibody negative, Asthenia
Clinical narrative: Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium normal, Blood magnesium normal, Blood parathyroid hormone increased, C-reactive protein normal, Complement factor C3
Clinical narrative: Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Complement factor C4, Dysstasia, Electrophoresis protein, Exercise tolerance decreased, Immunology test
Clinical narrative: Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunology test normal, Light chain analysis normal, Loss of personal independence in daily activities, Mobility decreased, Myalgia
Clinical narrative: Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tetany
Clinical narrative: Fever and myalgia that started 24 hours later.  As a physician, I assumed these to be normal and expected side effects. However, I had progressive worsening of muscle pain and stiffness that limited my ability to function.  Ten days after the vaccination,  I developed tetany of my elbows and could not straighten them at all for about 10 minutes and it took about 6 hours for that to completely resolve.  I was severely affected for 6-8 weeks with horrible muscle pain and stiffness.  The latter was so bad that I had trouble standing from a seated position and exercise performance deteriorated.  My energy level declined.  My hair started falling out.  It took a full 3 months for me to return to my level of functioning and relative pain free state that I was enjoying in the 2 weeks prior to my Shingrix shot.   I had difficulties with muscle pain and stiffness for about 7 years prior to the vaccination, however, my symptoms had improved tremendously over the last several years and I was nearly asymptomatic at the time of the injection.  I do not know if this was a true adverse reaction to the Shingrix shot or if the Shingrix vaccination really exacerbated my underlying condition.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Blood glucose increased, Blood pH decreased, Dehydration, Diabetic ketoacidosis
Clinical narrative: vaccine was on 10/12/19  and patient per father started with symtoms on 10/19/2019   Patient started with  frequent urination during the day and night, and 2 weeks later   started with abdominal pain  ,  frequent drinking   , was seen at my office on 11/07/19 with polyuria , polyuria ,weight loss of 10 lbs and moderate to severe dehydration,  high blood pressure, and was diagnosed with new onset diabetes at the office +urine test and was sent to ER  where  diagnosed was confirm DM type I  and DKA, Patient was admitted to PICU.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Glucose urine present, Hypertension, Intensive care, PCO2 decreased, Pollakiuria
Clinical narrative: vaccine was on 10/12/19  and patient per father started with symtoms on 10/19/2019   Patient started with  frequent urination during the day and night, and 2 weeks later   started with abdominal pain  ,  frequent drinking   , was seen at my office on 11/07/19 with polyuria , polyuria ,weight loss of 10 lbs and moderate to severe dehydration,  high blood pressure, and was diagnosed with new onset diabetes at the office +urine test and was sent to ER  where  diagnosed was confirm DM type I  and DKA, Patient was admitted to PICU.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Polydipsia, Polyuria, Type 1 diabetes mellitus, Urine ketone body present, Weight decreased
Clinical narrative: vaccine was on 10/12/19  and patient per father started with symtoms on 10/19/2019   Patient started with  frequent urination during the day and night, and 2 weeks later   started with abdominal pain  ,  frequent drinking   , was seen at my office on 11/07/19 with polyuria , polyuria ,weight loss of 10 lbs and moderate to severe dehydration,  high blood pressure, and was diagnosed with new onset diabetes at the office +urine test and was sent to ER  where  diagnosed was confirm DM type I  and DKA, Patient was admitted to PICU.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Headache, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Patient received Fluzone, Pneumovax and Shingrix on the same day. Fluzone and Pneumovax was given in her left arm and Shingrix was given in her right arm. She ended up going to the emergency room due to severe back pain, fever, muscle aches, headache and elevated WBC. They were able to resolve her WBC and fever and prescribed her migraine medicine. She went to ER on the 11-15-19 and was discharged on 11-17-19.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Condition aggravated, Fatigue, Pain, Pyrexia
Clinical narrative: Completed 2nd dose of Shingrix on 11/18/19. Chest pains worsened but had been experienced for 2 weeks prior. Seen in urgent care and sent home. Patient then called Tuesday 11/19 to also c/o fever <100, fatigue and body aches. and wondering if ALL symptoms could be related to Shingrix series.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Pruritus, Vaccination complication
Clinical narrative: Patient was given the Tdap vaccine in her left arm, at least 6 inches below the left deltoid triangle area it should have been administered in.  This was an error performed by our Medical Assistant.   She developed cellulitis and came to the office on November 11th and saw FNP-BC -she was given cephalexin 500mg qid x 7 days.  On 11/12/19 the patient reported that she felt it was getting worse and went to the ER (she has had a reaction to the flu shot in the past) and was discharged with Vaccine complication.  She was given Prednisone 20mg, 2 tablets by mouth daily for 5 days, and hydroxazine 25mg, tid as needed for itching.  She was seen again on 11/13/19 in our office and was reported to be doing better.  As of today, the patient states she is better - not 100% - but getting there.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: patient came at pharmacy at 11/19/19 at 11:13am and he mentioned that his arm is painful when he got shingrix shot at 9/26/16 and he went to doctor office at 11/16/19 and he got pain medicines but he came here to report adverse reaction because his doctor told him
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: patient came at pharmacy at 11/19/19 at 11:13am and he mentioned that his arm is painful when he got shingrix shot at 9/26/16 and he went to doctor office at 11/16/19 and he got pain medicines but he came here to report adverse reaction because his doctor told him
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: SMALL PINPOINT HIVES WITH SEVERE ITCHING. EMPLOYEE STATES SHE DID NOT TREAT ITCHING OR HIVES. ITCHING RESOLVED IN ONE DAY. PINPOINT HIVES ARE STILL PRESENT.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hypotension, Nausea, Pyrexia
Clinical narrative: Chills, lightheadedness, nausea, low blood pressure 90/65, fever 101.6  My shot was given yesterday morning at 9:30 AM. It is now almost 3:30 PM the day after. I no longer feel lightheaded or faint but I?m still running fever and just have a general feeling of nausea.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Atrial tachycardia, Bundle branch block right, Cardiac monitoring
Clinical narrative: Patient experienced etopic atrial tachycardia 1-2 weeks after the vaccine was administered.  She experienced incomplete right bundle branch block that resolved after a couple of months.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of improperly store VAQTA; No adverse effect reported; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot #S009943 has been verified to be a valid lot number hepatitis a vaccine, inactivated, expiration date reported and establish as 26-JUL-2020) (strength, dose, route of administration and frequency were not provided).   The temperature of storage and time frame of the excursion were above 47° Fahrenheit and 37 minutes. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: titer is negative for measles; This spontaneous information has been received from a male patient of unknown age, concerning himself. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unspecified date (reported as a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date, an unspecified test result showed his titer was negative for meales (measles antibody negative). The outcome of the measles antibody negative was not provided.  The causal relationship between the measles antibody negative and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: Maliese, extreme fatigue, confusion, nausea, diarrhea
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pain, Tendonitis
Clinical narrative: Patient states that after injection experienced extreme burning in her arm and shoulder which did not go away.  It became worse and she states she has gone to her doctor and is still in extreme pain, tendonitis and is continued pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Chills, fever, sweats and body aches.  Symptoms started at 2.am. and are still present.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Per patient mother, 30 minutes after the injection was given the patient started to have trouble breathing and hives formed all over the body. Patient was taken to closest hospital and given Benadryl, zantac, zyrtec, steriod and epi-pen. Hives disappeared and airway opened quickly so that patient was cleared to go home and no hospitalization was required.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Delayed onset about 5 days later. Redness, heat, rash that extended to elbow
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sepsis, Vaccination complication
Clinical narrative: pt reported that within several hours after the vaccination was administered, she was rushed to the local hospital and diagnosed with vaccine-induced sepsis.
Age: 88.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Laboratory test normal, Vertigo, Vomiting
Clinical narrative: Patient called the Health Department on 11/19/19, to tell us that the day after her flu shot, she began to feel dizzy. The dizziness has continued to this date, and she did vomit once on 11/12/19. She has had no other symptoms, and has been seen and treated by her family physician (Name unknown)
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pain
Clinical narrative: can turn neck, stiff, overall doesn't feel good and in pain.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red spot on the injection site (on the vaccination date) Pt felt warm and little pain on the area (from vaccination date) Pt applied ice bag and took tyrenol (from vaccination date) Pt still has a 4-5 inches round circle (7th date from vaccination) Pt said red spot got bigger and still painful.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient report body rash of upper torso a day after receiving the vaccine. Rash resolved by time of reporting to pharmacy on 11/19/19
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cold sweat, Impaired work ability, Malaise
Clinical narrative: Felt great at first and cleaned the house, scrubbing the bathroom with only right arm. About 6 hours after left arm vaccine, bedridden for 1 day; except quick bathroom breaks. Fever, chills, clammy, severe malaise for about 12 hours with hands and feet ice cold feeling like my circulation was shutting down. Minor aching in muscles and joints. Wondered if I should go to ER and afraid I might die that night 10/29/19, but felt too sick to go anywhere and lie freezing cold in an ER, so risked it. Too sick to get a thermometer. Interrupted sleep. Felt the same when I had H1N1 flu a few years back, although no vomiting or nausea or cough.  Moderate malaise for remaining 12 hours. Lost As quick as it came on, it went away. Disability: Lost one day of work. No claim of loss, just want you to know you need to warn people it could take them out of work/activities for a day or so. I had no idea. Thought it would be similar to previous vaccines, which were no problem other than sore arm. Didn't research ahead of time and was not warned.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Peripheral coldness, Pyrexia, Sleep disorder
Clinical narrative: Felt great at first and cleaned the house, scrubbing the bathroom with only right arm. About 6 hours after left arm vaccine, bedridden for 1 day; except quick bathroom breaks. Fever, chills, clammy, severe malaise for about 12 hours with hands and feet ice cold feeling like my circulation was shutting down. Minor aching in muscles and joints. Wondered if I should go to ER and afraid I might die that night 10/29/19, but felt too sick to go anywhere and lie freezing cold in an ER, so risked it. Too sick to get a thermometer. Interrupted sleep. Felt the same when I had H1N1 flu a few years back, although no vomiting or nausea or cough.  Moderate malaise for remaining 12 hours. Lost As quick as it came on, it went away. Disability: Lost one day of work. No claim of loss, just want you to know you need to warn people it could take them out of work/activities for a day or so. I had no idea. Thought it would be similar to previous vaccines, which were no problem other than sore arm. Didn't research ahead of time and was not warned.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: The patient had a swollen red arm, and some shortness of breath. Went to ER and was treated.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Hypersensitivity, Hypopnoea, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Today 11/19/19, patient contacted myself at the pharmacy and reported symptoms. I advised her to seek medical attention. Her symptoms are as follows. On the first day, she experienced shallow breathing and broke out in rash as well as soreness in the arm. The following day she experienced increased swelling at the sight of injection. On the third day the swelling felt like it went further under the skin, decreasing mobility and increasing pain. Today, she expressed that the injection site had turned black and blue and the skin felt rough to the touch. The husband came and reported she had gone to the ER per my recommendation today 11/19/19. The ER confirmed it was an allergic reaction to the Prevnar 13 shot. She was given Clindamycin and Hydrocodone. She is to return for a follow-up appointment in 2 days to make sure it does not need to be drained.