chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Body temperature increased, Full blood count, Liver function test
Clinical narrative: After the SHINGRIX 1st shot in the morning, I developed 101.6F temperature and joints pain. At about 10 pm, I developed itchy hives on my face, neck, check and both arms, tongue felt a little tingling. I called Insurance 24 hrs. nurse line, she advised me to call 911 to ER. I finally called car service to go to med. ctr. ER at. I arrived ER at about 12:15 am on 8/18/2018. ER doctor gave me three medications and observed me for 5 hours until hives went down then sent me home. I still had hive the next few days here and there on my face and body. I texted my Primary Dr., she advised me to continue to take BENADRYL if itchiness occurred. After a few days, condition still on, I texted to Dr. again and she advised me to take ZYRTEC 10 mg a day. I took it for three days and everyday I still have hives so I stopped it just took BENADRYL. I went to see Dr. On 9/5/2018, she gave me some blood test and told me to get SARNA lotion to apply on the itchy spots. Up to today, I still have itchiness on my face. She told me she will report my reaction to the authority.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: After the SHINGRIX 1st shot in the morning, I developed 101.6F temperature and joints pain. At about 10 pm, I developed itchy hives on my face, neck, check and both arms, tongue felt a little tingling. I called Insurance 24 hrs. nurse line, she advised me to call 911 to ER. I finally called car service to go to med. ctr. ER at. I arrived ER at about 12:15 am on 8/18/2018. ER doctor gave me three medications and observed me for 5 hours until hives went down then sent me home. I still had hive the next few days here and there on my face and body. I texted my Primary Dr., she advised me to continue to take BENADRYL if itchiness occurred. After a few days, condition still on, I texted to Dr. again and she advised me to take ZYRTEC 10 mg a day. I took it for three days and everyday I still have hives so I stopped it just took BENADRYL. I went to see Dr. On 9/5/2018, she gave me some blood test and told me to get SARNA lotion to apply on the itchy spots. Up to today, I still have itchiness on my face. She told me she will report my reaction to the authority.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: Generalized itching. Employee given dose of 25mg of diphenhydramine after no response after 30 min, another dose of 25mg of diphenhydramine was given. Employee stopped itching and remained asymptomatic.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm swelling - redness/pain temp 99.5. Received PNEUMOVAX 1/23/18 at PCP office.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Lymph node pain
Clinical narrative: Site redness induration and pain 4x4 cm area with referred pain under arm, shoulder, neck lymph nodes sore as well started day after vaccination continuing 3 days later as well as subjective fever and chills.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Site redness induration and pain 4x4 cm area with referred pain under arm, shoulder, neck lymph nodes sore as well started day after vaccination continuing 3 days later as well as subjective fever and chills.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Carbon dioxide decreased, Differential white blood cell count abnormal, Dyspnoea, Full blood count abnormal, Haematocrit decreased
Clinical narrative: Woke up at 6:00 AM with a headache throughout the day she had difficulty breathing. She felt like she was breathing quick. She had some tingling in her hands and feet. She received 1 dose of VALIUM in the ER which resolved the trouble breathing. 1 dose of ibuprofen did not help with the headaches, she developed a fever of 102.6F while in the hospital.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Mean cell haemoglobin increased, Metabolic function test abnormal, Mononucleosis heterophile test positive, Paraesthesia
Clinical narrative: Woke up at 6:00 AM with a headache throughout the day she had difficulty breathing. She felt like she was breathing quick. She had some tingling in her hands and feet. She received 1 dose of VALIUM in the ER which resolved the trouble breathing. 1 dose of ibuprofen did not help with the headaches, she developed a fever of 102.6F while in the hospital.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Red blood cell count decreased, Respiratory rate increased, Streptococcus test negative
Clinical narrative: Woke up at 6:00 AM with a headache throughout the day she had difficulty breathing. She felt like she was breathing quick. She had some tingling in her hands and feet. She received 1 dose of VALIUM in the ER which resolved the trouble breathing. 1 dose of ibuprofen did not help with the headaches, she developed a fever of 102.6F while in the hospital.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: Anaphylaxis: Throat swelled, difficulty breathing. She went to urgent care on her way home, they administered EPI x2 and gave her a steroid injection.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: States she was seen at Emergency Room for redness, swelling, itching and pain at injection site. Stated the Physician told her that the vaccine gave her Chicken Pox at the injection site.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: States she was seen at Emergency Room for redness, swelling, itching and pain at injection site. Stated the Physician told her that the vaccine gave her Chicken Pox at the injection site.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Itching and single hive at injection site. Tx with BENADRYL and.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 23-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified day in 2007 (reported as 11 years ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number, expiration date were not reported). It was reported that on 14-AUG-2018, the patient was in the office to receive her second dose of GARDASIL 9 (unspecified lot and expiration date). There were no adverse effects.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist, via a company representative, referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first and second doses of PNEUMOVAX 23 (anatomical location, administration route, lot number and expiration dates were not reported) both doses for prophylaxis. The pharmacist stated that the patient was "over the age of 65", when she received the second dose of PNEUMOVAX 23 and "before the age of 65" when she was vaccinated with the first dose. On unspecified dates, the patient experienced a "common injection site reaction" and also stated that the patient "experienced more pain and swelling at the injection site with the second dose" of PNEUMOVAX 23. The outcome of the common injection site reaction, the injection site swelling and injection site pain was unknown and the causality between these and the vaccination with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # R012501, expiration date 08-JAN-2020 (dose and route of administration were not reported). The details (temperature and time frame) of temperature excursion were not reported. Data logger was not involved. There were no previous excursions reported. There were no adverse effects.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical assistant). This case involves a 73 years old male patient who had received an expired dose of FLUZONE HIGH DOSE inadvertently. The patients past medical history, concomitant medication and family history were not provided. On 30-Aug-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI885AB, expiry date 29-May-2018 via intramuscular route in right arm. It was a case of actual medication error due to expired vaccine used. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via eye contact, Eye irritation
Clinical narrative: Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient (age not reported) who experienced left eye is irritated, when he snapped the cap off a prefilled syringe of FLUZONE HIGH DOSE, he was splashed with fluid in his left eye on an unspecified date. The patients past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was an occupational exposure case due to accidental occupational exposure to product and medication error case due to exposure via eye contact and the only symptom he reported was his left eye was irritated (date not reported). He administered the FLUZONE after the incident. It was not reported if any lab investigations were performed or any corrective treatment was received. Final diagnosis was left eye is irritated. It was not reported if the patient received any corrective treatment. The outcome of left eye irritation was not 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. List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 01-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to 2018SA248519 (Same reporter). This case involves a 15 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUBLOK QIV (batch number QFAA1801, expiration date and route of administration not reported) in the left deltoid on 01-Sep-2018 instead of FLUZONE QUADRIVALENT (batch number and expiry date not reported). The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong drug administered and drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 01-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to 2018SA248513 (Same reporter). This case involves a 16 years old patient (gender not reported) who was vaccinated with 0.5 ml dose of FLUBLOK QIV (batch number QFAA1801, frequency once) expiration date and route of administration not reported) in the right deltoid on 01-Sep-2018 instead of FLUZONE QUADRIVALENT. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong drug administered and drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Feeling abnormal, Incorrect route of product administration, Palpitations
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer (registered nurse). This case is linked to 2018SA250156 (Same reporter). This case involves a 59 years old female patient who experienced fuzzy head, feeling off, heart pounding, feeling weak and received FLUBLOK subcutaneous instead of intramuscular, while she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2018, the patient received 0.5 mL dose of suspect FLUBLOK QIV lot number was unknown, frequency once, via subcutaneous route in the left arm. On 04-Sep-2018, same day post vaccination patient developed a non-serious fuzzy headed, feeling off heart pounding and feeling weak. It was also the case of actual medication error due to Inappropriate route of vaccination (received FLUBLOK subcutaneous instead of intramuscular). Relevant tests were not reported. Final diagnosis was feeling weak, heart pounding,  feeling off, fuzzy head. It was not reported if the patient received a corrective treatment. The outcome of the events were unknown. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Feeling abnormal, Incorrect route of product administration
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer (registered nurse). This case is linked to 2018SA250129 (Same reporter). This case involves a 62 years old male patient who experienced fuzzy, felt funny, strange and received FLUBLOK subcutaneous instead of intramuscular, while she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2018, the patient received 0.5 mL dose of suspect FLUBLOK QIV lot number was unknown, frequency once, via subcutaneous route in the left arm. On 04-Sep-2018, same day post vaccination patient developed a non-serious fuzzy, felt funny and strange. It was also the case of actual medication error due to inappropriate route of vaccination (received FLUBLOK subcutaneous instead of intramuscular). Relevant tests were not reported. Final diagnosis was fuzzy, felt funny and strange. It was not reported if the patient received a corrective treatment. The outcome of the events were unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 50.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a Consumer (non-health care professional) via phone. This case is linked to case 2018SA250332 (same reporter). This case involves a 50 years old patient (gender not reported) who received 0.5 ml expired dose of FLUZONE QUADRIVALENT (frequency once, lot number UI852AD, expiry date and route of administration were not reported) in right deltoid on 04 Sep 2018. 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 expired vaccine used. Reporter thought that they sent back all of the out dated vaccines. But, there must have a bottle left. Patient had not reported any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to case 2018SA250328 (same reporter). This case involves a 34 years old patient (gender not reported) who received 0.5 ml expired dose of FLUZONE QUADRIVALENT (frequency once, lot number UI852AD, expiry date and route of administration were not reported) in the right deltoid on 04 Sep 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. Patient had not reported any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA251031 and 2018SA251068 (same reporter). This case involves 19 patients of an unknown demographics who received a 0.5 mL dose of ADACEL lot U5898AA, expiry date: 20-Mar-2020 (dose, route and site of administration were not reported) which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was also reported that refrigerator temp reached 56 F for 15 days from 01-Aug-2018 to 15-Aug-2018. It was not reported if the patients experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA251031 and 2018SA251067 (same reporter). This case involves a patient an unknown demographics who was vaccinated with a dose of ACT-HIB (Batch number: A111A, expiration date: 19-Sep-2020, dose, route and site of administration were not reported) on an unknown date, which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was also reported that refrigerator temp reached 56 F for 15 days from 01-Aug-2018 to 15-Aug-2018. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm to touch, swollen right leg.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Very sore arm beginning 2 or 3 hours after injection, lasted 24+ hours. Headache beginning three hours after injection and continuing for 24 hours; only slightly relieved by TYLENOL. Fever and chills at 12 hours after injection and continuing for several hours. Achy, flu-like feeling at 12 hours continuing for 12 hours. Felt much better at 24 hours except for headache. Following first dose (7/2/18), only experienced sore arm and headache. Side effects much worse with second dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Very sore arm beginning 2 or 3 hours after injection, lasted 24+ hours. Headache beginning three hours after injection and continuing for 24 hours; only slightly relieved by TYLENOL. Fever and chills at 12 hours after injection and continuing for several hours. Achy, flu-like feeling at 12 hours continuing for 12 hours. Felt much better at 24 hours except for headache. Following first dose (7/2/18), only experienced sore arm and headache. Side effects much worse with second dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Herpes zoster, Rash
Clinical narrative: Severe eye itching, rash on various parts of both, at urgent care that felt the rash I have on my right hip buttocks is "shingles".
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: After leaving the clinic, patient began having a rash on her arms / legs and torso. Treated with one dose PO Benadryl.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Incorrect route of product administration, Injection site erythema
Clinical narrative: Nurse administered vaccine IMPROPERLY via SQ instead of intramuscular on fleshy underside of right arm. This caused me to have a reaction of tired, headache, slight fever, light-headed, red and painful swelling of right arm that extended from elbow to armpit. The arm stayed red for a week but other symptoms were gone after 48 hours. Nurse was unfamiliar with vaccine and said it was live vaccine. This vaccine was extremely painful being administered to incorrect area under arm. I followed up with Doctor on Sep 4th.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site, Pyrexia
Clinical narrative: Nurse administered vaccine IMPROPERLY via SQ instead of intramuscular on fleshy underside of right arm. This caused me to have a reaction of tired, headache, slight fever, light-headed, red and painful swelling of right arm that extended from elbow to armpit. The arm stayed red for a week but other symptoms were gone after 48 hours. Nurse was unfamiliar with vaccine and said it was live vaccine. This vaccine was extremely painful being administered to incorrect area under arm. I followed up with Doctor on Sep 4th.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling in left thigh down to knee.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient presented to pharmacy today 9/10/18 complaining of pain at injection site since the injection was given 7/12/18. She stated she did visit her primary care about it and the doctor wants her to follow up in 2 more months if the pain is still present.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is not 65, no symptoms, patient tolerated well.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Contusion, Erythema, Hypersensitivity, Local reaction, Pruritus
Clinical narrative: Hypersensitivity local reaction, redness, itchy, warm to touch, small amount of bruising steroid cream given.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Skin warm
Clinical narrative: Hypersensitivity local reaction, redness, itchy, warm to touch, small amount of bruising steroid cream given.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Erythema, Headache, Nausea
Clinical narrative: 08/16/18 Client developed severe headache about 9:00 pm followed by nausea/chills/fever (101F) and backache about 11:30 pm. On 08/17/18 about 5:00 pm she took 1 OTC BENADRYL which helped lessened the symptoms some but they still continued until 08/18/18 around noon when she started feeling much better. On 08/19/18 only her left arm was sore with some tingling. On 08/20/18 night about 9:00 pm she developed another headache but not as severe as one on 08/16/18. Today (08/21/2018) she woke up with fever/redness/tingling in her left arm so she took another BENADRYL around 11:00 am and that has helped some with these symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 08/16/18 Client developed severe headache about 9:00 pm followed by nausea/chills/fever (101F) and backache about 11:30 pm. On 08/17/18 about 5:00 pm she took 1 OTC BENADRYL which helped lessened the symptoms some but they still continued until 08/18/18 around noon when she started feeling much better. On 08/19/18 only her left arm was sore with some tingling. On 08/20/18 night about 9:00 pm she developed another headache but not as severe as one on 08/16/18. Today (08/21/2018) she woke up with fever/redness/tingling in her left arm so she took another BENADRYL around 11:00 am and that has helped some with these symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Tinnitus. Blurred vision.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Swollen arm. Pain for 2 weeks. Broke out in red patches.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TD, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Loss of consciousness (syncope).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Per patient, she had a rash on her one side of her abdomen. She went to her doctor when the rash was still present after 3 days. But her doctor did not know what it was per the patient. It has cleared since. This was not observed by the pharmacy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception treated with air enema in the ED and resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood chloride, Blood creatinine, Blood glucose, Carbon dioxide, Differential white blood cell count
Clinical narrative: Intussusception treated with air enema in the ED and resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Full blood count, Haematocrit, Intussusception, Occult blood
Clinical narrative: Intussusception treated with air enema in the ED and resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: Intussusception treated with air enema in the ED and resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Pt developed intusseception approximately 1 week after receiving vaccine. Diagnosed with U/S and supported by KUB imaging, pt underwent therapeutic enema.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood chloride, Blood creatinine, Blood glucose, Carbon dioxide, Differential white blood cell count
Clinical narrative: Pt developed intusseception approximately 1 week after receiving vaccine. Diagnosed with U/S and supported by KUB imaging, pt underwent therapeutic enema.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Full blood count, Haematocrit, Intussusception, Occult blood
Clinical narrative: Pt developed intusseception approximately 1 week after receiving vaccine. Diagnosed with U/S and supported by KUB imaging, pt underwent therapeutic enema.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system X-ray
Clinical narrative: Pt developed intusseception approximately 1 week after receiving vaccine. Diagnosed with U/S and supported by KUB imaging, pt underwent therapeutic enema.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Cough, Dysphonia, Dyspnoea, Erythema
Clinical narrative: Approximately 45 mins after the vaccines were administered my daughter told me that her hands itched very badly. Then a few minutes after that she started itching her head. She then started to break out in a bright red rash all over her back that then spread to her neck and chest. A few minutes after the rash hives appeared. They were all over her back, neck and face. Her ears were then so red they almost looked purple and itches her tremendous. She then started coughing and her voice went hoarse and told me she was having a hard time breathing. I immediately rushed her to the ER (thankfully it was only 2 minutes away) where they brought me back immediately as they could see she was in distress. The Doctor immediately administered epinephrine as she could see she was having an anaphylactic reaction. Benadryl and prednisone was also administered. We were sent home with an epi pen and prednisone for 5 days. We were told to follow up with an allergist. We are going on 9/11/2018 for allergy testing.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Approximately 45 mins after the vaccines were administered my daughter told me that her hands itched very badly. Then a few minutes after that she started itching her head. She then started to break out in a bright red rash all over her back that then spread to her neck and chest. A few minutes after the rash hives appeared. They were all over her back, neck and face. Her ears were then so red they almost looked purple and itches her tremendous. She then started coughing and her voice went hoarse and told me she was having a hard time breathing. I immediately rushed her to the ER (thankfully it was only 2 minutes away) where they brought me back immediately as they could see she was in distress. The Doctor immediately administered epinephrine as she could see she was having an anaphylactic reaction. Benadryl and prednisone was also administered. We were sent home with an epi pen and prednisone for 5 days. We were told to follow up with an allergist. We are going on 9/11/2018 for allergy testing.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pain, Pyrexia, Vaccination site discolouration, Vaccination site induration, Vaccination site oedema
Clinical narrative: Mother contacted clinic c/o child having fever, swelling and discoloration at vax sites, painful ambulation. Pt was seen at clinic the next day by staff provider for care. Pt was afebrile at the time, all vitals taken were within normal limits. Per provider, "Firm, edematous areas on bilateral thighs where vaccines were given ." "No rash noted. " Prescribed Tx included ice packs, MOTRIN.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Mother contacted clinic c/o child having fever, swelling and discoloration at vax sites, painful ambulation. Pt was seen at clinic the next day by staff provider for care. Pt was afebrile at the time, all vitals taken were within normal limits. Per provider, "Firm, edematous areas on bilateral thighs where vaccines were given ." "No rash noted. " Prescribed Tx included ice packs, MOTRIN.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness
Clinical narrative: Patient experienced severe dizziness that she said was different than the unsteadiness she typically has. She said the dizziness was over by the next afternoon and she feels fine now.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Patients states left shoulder pain and limited ROM since receiving vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Emotional distress, Excessive eye blinking, Irregular breathing, Irritability
Clinical narrative: The day of the vaccine, 08/29/2018, patient went to sleep at 1500. She slept to the next day. On the the next day, 08/30/2018, she was very irritable and unconsolable. She was moaning and mumbled a lot and not herself. She was blinking a lot and it did not seem normal, as if forced. It seemed obvious. She also exhibited irregular breathing. These symptoms continued for several day and and at 1 week she started to improve.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Moaning, Speech disorder
Clinical narrative: The day of the vaccine, 08/29/2018, patient went to sleep at 1500. She slept to the next day. On the the next day, 08/30/2018, she was very irritable and unconsolable. She was moaning and mumbled a lot and not herself. She was blinking a lot and it did not seem normal, as if forced. It seemed obvious. She also exhibited irregular breathing. These symptoms continued for several day and and at 1 week she started to improve.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Nodule, Pruritus
Clinical narrative: Employee had localized itching and nodule formation.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Local reaction
Clinical narrative: Local reaction with cellulitis. Required urgent care visit 9/8/18 and antibiotic treatment for 10 days.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Skin haemorrhage, Underdose
Clinical narrative: This spontaneous report was received from a clinical medical assistant, regarding a 15 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-AUG-2018, the medical assistant administered M-M-R II and sterile diluent(MERCK) for vaccination to the patient (frequency, route, anatomical location, lot # and expiration date were not provided). On the same day, while the medical assistant was administering the vaccine, the patient moved and the needle scratched the patient's arm (scratch). On an unspecified date, the scratch was fine and just bled a little bit (skin haemorrhage). However, only a little bit of the contents of the vaccine was injected into the patient's arm (accidental underdose). The patient did not received any treatment. At the reporting time, the outcome of scratch, skin haemorrhage and accidental underdose was unknown. The reporter did not assess the relatedness between M-M-R II and sterile diluent(MERCK) and the scratch or skin haemorrhage.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, PPV, RV5
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) referring to a 3 month old female patient with no pertinent medical history or drug reactions/allergies. On 17-AUG-2018 the patient was vaccinated with PEDVAXHIB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On the same day, other suspect therapies included ROTATEQ for prophylaxis (dose, route of administration, lot number and expiration date were not reported), an unknown hepatitis vaccine (manufacturer unknown) for prophylaxis (dose, lot number and expiration date were not reported), an unspecified pneumococcal vaccine "PCV"(manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), unspecified "DTAP" for prophylaxis (dose, route of administration, lot number and expiration date were not reported), and poliovirus vaccine inactivated ("IPV") for prophylaxis (dose, route of administration, lot number and expiration date were not reported). There was no concomitant medication. On 17-AUG-2018, within 5 to 10 minutes after vaccination, the patient experienced facial urticaria. The patient sought medical attention by an office visit. No treatment was given for the adverse event. No laboratory diagnostic test were performed. The outcome of urticaria was reported as recovered. The reporter did not assess the causal relationship between suspect therapies and the event.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Diplopia, Myasthenia gravis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myasthenia gravis aggravated in a 82-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. The patient's past medical history included myasthenia gravis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myasthenia gravis aggravated (serious criteria GSK medically significant) and double vision. On an unknown date, the outcome of the myasthenia gravis aggravated and double vision were unknown. It was unknown if the reporter considered the myasthenia gravis aggravated and double vision to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing double vision. The patient noted about having a history of myasthenia gravis and it might be reactivating as a result of the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Polyarthritis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized arthritis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized arthritis (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the generalized arthritis and pain were unknown. It was unknown if the reporter considered the generalized arthritis and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The caller was a consumer who heard from an acquaintance that she received 1st dose of SHINGRIX and experienced feeling very achy and went to see physician and was diagnosed with arthritis all over her body and was in constant pain. The caller declined to provide address or other identifiers for the patient. No further information was available. This case has been linked with case US2018158686, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphopenia, Thrombocytopenia
Clinical narrative: This case was reported by a physician and described the occurrence of thrombocytopenia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced thrombocytopenia (serious criteria GSK medically significant) and lymphopenia. On an unknown date, the outcome of the thrombocytopenia and lymphopenia were unknown. It was unknown if the reporter considered the thrombocytopenia and lymphopenia to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the sister of GSK employee. The age at vaccination was not reported. The reporter observed lymphopenia and thrombocytopenia in the patient recently vaccinated with SHINGRIX.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: The initial case was missing the following minimum criteria: This case has been considered invalid as unspecified adverse event. Upon receipt of follow-up information on 04Sep2018, this case now contains all required information to be considered valid. This is a spontaneous report obtained from a contactable nurse. A 66-year-old female patient received, 03Sep2018, PREVNAR 13 at single dose and SHINGRIX, both for immunization. Relevant medical history and concomitant medications were unknown. The patient received, on an unspecified date, in May2017, PREVNAR 13 for immunization. On an unspecified date, in Sep2018, the patient experienced sickness and she was feeling quite ill and feverish. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. An elderly female patient received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration on 14Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash extending from injection site towards the neck on 14Aug2018. The outcome of the event was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Loss of consciousness
Clinical narrative: Initial information received on 29-Aug-2018 regarding an unsolicited valid serious case received from a physician. This case involves a 71 years old female patient who was passed out, weak and felt overheated, while she received vaccine FLUZONE HIGH DOSE. 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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UJ004AA and route of administration not reported). On an unknown date, the patient developed a serious overheated (pyrexia), weak (asthenia) and passed out (loss of consciousness) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event. No clear etiology for syncopal event. Relevant tests were not reported. Final diagnosis was felt overheated, passed out and weak. It was not reported if the patient received the corrective treatment. The patient was recovering from the events. List of documents held by sender: none.; Sender's Comments: This case involves a 71 years old patient who developed weakness, felt overheated and passed out post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Additional information including patient's medical history, condition at the time of vaccination, latency information, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 1.67
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given 0.5mL of Flu vaccination on 09/10/2018 at 11:30AM, no known symptoms or signs noted.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Patient was to the clinic for STD testing. Pt was stuck x 3 to obtain blood for the testing, Hepatitis A vaccine was given then the ROCEPHIN injection was given. After the patient was sitting down and stated I don't feel so well, patient passed out for about 5 seconds. Once patient came to, patient stated he had only drank one cup of coffee this AM. Patient was given water and peanut butter crackers. Sat for about 10 more minutes then completed the taking the medication as was ordered (azithromycin). Stated he felt fine. Just should have eaten before he came.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Ear disorder, Ear tube insertion, Lethargy, Nuclear magnetic resonance imaging
Clinical narrative: I cannot remember initial reactions but we were always told "that is normal". Fevers, lethargy etc. Tremors started years later as minimal and progressed. Upon researching I became concerned that the hand tremors and ear problems were due to vaccinations. After many tests we were told by a nurse, confirming my suspicions that this is probably a vaccine injury.