chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 37 year old female patient. There were no pertinent medical history and drug reactions or allergies. In approximately January 2016 (reported as "about a month ago"), the patient was vaccinated with one dose of VARIVAX (Merck) (lot # L027287, expiration date 21-JUL-2017, dose unknown, intramuscular) at an unspecified facility. There was no concomitant medicine. On an unknown date, following the administration, the patient developed soreness around the injection site. The patient sought medical attention via contacting the pharmacist. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was unknown. The causality between the injection site pain and VARIVAX (Merck) was unspecified. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning two unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the two unspecified patients received doses of improperly stored VAQTA (lot # L039659 with expire date 15-MAR-2017) (dosage and route not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. Nurse practitioner reported that the patient received their first two doses of GARDASIL on unspecified dates and received their final dose in the series 7 years later on an unspecified date. The final dose give to complete the series was GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74 year old female patient who was allergic to unspecified macrolide antibiotics. On 08-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L031271, exp date 19-NOV-2016) 0.65 ml, subcutaneously. Concomitant therapies included ADDERALL and an unspecified benzodiazepine. In 2016, a month or so later, the patient developed shingles. In February 2016, the patient came in to the pharmacy and reported the reaction to her. No lab diagnostics studies were performed. At the time of the report, the outcome of event was unknown. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 15-JAN-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided) and the first dose of VAQTA, injection, 50/1.0 U/ml (route of administration, lot # and expiration date were not provided). On 16-FEB-2016, the patient was supposed to receive the second dose of RECOMBIVAX HB but instead received the second dose of VAQTA (reason was not provided). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L034370, expiration date 08-SEP-2017 (dose and route of administration were not reported). There was no adverse effects reported. The administered doses of VARIVAX (Merck) experienced a temperature of maximum 6 degrees Celsius for 260 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. On an unknown date since February 2016, the patients were vaccinated with oral, ROTATEQ lot # K017576, which were improperly stored, the temperature excursion recorded was 47.3 degree Fahrenheit for 71 hours and 50 minutes (time frame/date of excursion: 11-JAN-2016). No adverse effects were reported. No product quality issue involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a newborn patient of unknown age and gender. On an unknown date, the patient was vaccinated with a first dose of RECOMBIVAX HB (strength, dose, route and site of administration, lot# and expiry date were not reported) and then 12 hours later inadvertently received another dose of RECOMBIVAX HB (strength, dose, route and site of administration, lot# and expiry date were not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursions and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history was not reported. On an unspecified dates in February 2016 (reported as since 02-FEB-2016), an unspecified number of unspecified patients had been administered with doses of ROTATEQ vial (strength unspecified) lot # L027726 with expiration date 10-MAY-2017, via oral route (dose number and dosage unspecified), which were improperly stored. The vaccine ROTATEQ was exposed to a temperature of 9.3 degrees C with the time frame of 1 hour and 15 minutes. Outcome of excursion was reported as supported. The vaccine did not undergo previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4C for 22 hours 52 minutes and 8.6C for 112 hours and 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified amounts of children of unknown age and gender. On an unknown dates, the children received doses of improperly stored VARIVAX (Merck) (lot # L028276 with expire date 28-JUL-2017) (dose and route unspecified). The vaccines were stored in refrigerator temperature of 36 to 46F for 48 hours. Then they were stored at 48.7F for 18 minutes. There was no previous temperature excursion. No adverse effect was reported at this time. This was one of several reports received from same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning  multiple unspecified amounts of children with unknown age and gender. On an unknown dates, the children received doses of improperly stored M-M-R II injection (lot # K012472 with expire date 11-JUN-2016) (dose and route unspecified). The products were stored in temperature of refrigerator 48.7F for 18 minutes. There was no previous temperature excursion. No adverse effect was reported at this time. This was one of several reports received from same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # K018172 with expiration date of 12-DEC-2015, dose, strength and route unknown). No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Skin lesion, Smallpox
Clinical narrative: This unsolicited case was received on 10-Feb-2016 via a third party query tool search on the VAERS database, under reference number 604099. This case involves a 73-years old male patient who received the following vaccinations on 04-Apr-2012: A dose of ACAM2000, (lot number was "not reported", manufacturer: Sanofi Pasteur Biologics Co) in the unknown site via a "not reported" route. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Patient medical history includes myasthenia gravis; pulmonary embolism and hip replacement and illness at the time of vaccination was reported as none. No information regarding prior vaccinations was not reported. Concomitant medications were not reported. On an unspecified date, three years post vaccination; patient developed small pox (severe) pain and lesions. Laboratory investigations and corrective treatments were not reported. The outcome of the events was reported as recovered. Upon medical review, the case was considered as serious due to important medical event: small pox, lesions and severe pain. List of documents held by sender: none. Sender's Comments: Patient experienced small pox three years after vaccination with SMALLPOX (VACCINIA) LIVE VACCINE. The event smallpox along with its lesions and pain are unlisted for SMALLPOX (VACCINIA) LIVE VACCINE. Smallpox vaccine does not contain smallpox virus (variola) and cannot spread or cause smallpox. In this case, very limited information was provided. No information regarding relevant medical history, concomitant conditions and investigational results, if any were  provided. Based on the available information causality cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Glossodynia, Loss of consciousness, Oxygen saturation decreased, Salivary hypersecretion
Clinical narrative: Within minutes, before leaving the pediatrician's office, patient complained of "tongue hurting", began hyper-salivating and started to cough. He was brought back into the exam room, and his pulse Ox began to drop. He started losing color in his hands and lips, and started to lose consciousness. Dr. administered EpiPen Jr. and symptoms resolved immediately. He was then observed in the ED; on arrival (7 minutes) to local ED, he was covered in hives. This resolved with oral steroids, Benadryl; Zyrtec.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Within minutes, before leaving the pediatrician's office, patient complained of "tongue hurting", began hyper-salivating and started to cough. He was brought back into the exam room, and his pulse Ox began to drop. He started losing color in his hands and lips, and started to lose consciousness. Dr. administered EpiPen Jr. and symptoms resolved immediately. He was then observed in the ED; on arrival (7 minutes) to local ED, he was covered in hives. This resolved with oral steroids, Benadryl; Zyrtec.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Glossodynia, Hyperventilation, Loss of consciousness, Oxygen saturation decreased
Clinical narrative: Within minutes, before leaving the pediatrician's office, patient complained of "tongue hurting", began hyper-salivating and started to cough. He was brought back into the exam room, and his pulse Ox began to drop. He started losing color in his hands and lips, and started to lose consciousness. Dr. administered EpiPen Jr. and symptoms resolved immediately. He was then observed in the ED; on arrival (7 minutes) to local ED, he was covered in hives. This resolved with oral steroids, Benadryl; Zyrtec.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: Within minutes, before leaving the pediatrician's office, patient complained of "tongue hurting", began hyper-salivating and started to cough. He was brought back into the exam room, and his pulse Ox began to drop. He started losing color in his hands and lips, and started to lose consciousness. Dr. administered EpiPen Jr. and symptoms resolved immediately. He was then observed in the ED; on arrival (7 minutes) to local ED, he was covered in hives. This resolved with oral steroids, Benadryl; Zyrtec.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Glossodynia, Loss of consciousness, Oxygen saturation decreased, Salivary hypersecretion
Clinical narrative: Patient complained of "tongue hurting" within minutes of receiving his vaccines. He began to hypersalivate, developed a cough. Nurse brought him back into the exam room from the hallway. She checked his pulse ox, which started to drop, his color went pale and then he began to lose consciousness. His pediatrician treated him immediately with EPI Jr. Pen with immediate recovery and completed recovery in ED.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Patient complained of "tongue hurting" within minutes of receiving his vaccines. He began to hypersalivate, developed a cough. Nurse brought him back into the exam room from the hallway. She checked his pulse ox, which started to drop, his color went pale and then he began to lose consciousness. His pediatrician treated him immediately with EPI Jr. Pen with immediate recovery and completed recovery in ED.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Glossodynia, Hyperventilation, Loss of consciousness, Oxygen saturation decreased
Clinical narrative: Patient complained of "tongue hurting" within minutes of receiving his vaccines. He began to hypersalivate, developed a cough. Nurse brought him back into the exam room from the hallway. She checked his pulse ox, which started to drop, his color went pale and then he began to lose consciousness. His pediatrician treated him immediately with EPI Jr. Pen with immediate recovery and completed recovery in ED.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: Patient complained of "tongue hurting" within minutes of receiving his vaccines. He began to hypersalivate, developed a cough. Nurse brought him back into the exam room from the hallway. She checked his pulse ox, which started to drop, his color went pale and then he began to lose consciousness. His pediatrician treated him immediately with EPI Jr. Pen with immediate recovery and completed recovery in ED.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, SWELLING, AND PAIN AT INJECTION SITE.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Epistaxis, Haematochezia, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: On 8/9/2015 we noticed large, thick bruises on patient's legs.  On 8/11/2015 there was a bruise on the inside of his lower lip, small amount of blood while wiping after a bowel movement, petechiae around his eyes, and he experienced several nosebleeds lasting about 10 minutes. 8/13/2015 platelet count was done at the doctor's office with a result of 15,000.  Patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) and admitted to the hospital, with additional platelet counts on 8/13/2015 and 8/14/2015 showing results from 19,000-20,000. On the evening of 8/14/2015 IVIG treatment was given. 8/15/2015 patient was discharged from the hospital with a platelet count of 63,000. 8/21/2015 platelet count was rechecked and was 323,000. Several counts have been done since, with results all above 150,000.  Patient has had no symptoms of ITP since treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: On 8/9/2015 we noticed large, thick bruises on patient's legs.  On 8/11/2015 there was a bruise on the inside of his lower lip, small amount of blood while wiping after a bowel movement, petechiae around his eyes, and he experienced several nosebleeds lasting about 10 minutes. 8/13/2015 platelet count was done at the doctor's office with a result of 15,000.  Patient was diagnosed with idiopathic thrombocytopenic purpura (ITP) and admitted to the hospital, with additional platelet counts on 8/13/2015 and 8/14/2015 showing results from 19,000-20,000. On the evening of 8/14/2015 IVIG treatment was given. 8/15/2015 patient was discharged from the hospital with a platelet count of 63,000. 8/21/2015 platelet count was rechecked and was 323,000. Several counts have been done since, with results all above 150,000.  Patient has had no symptoms of ITP since treatment.
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Disturbance in attention, Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site haematoma
Clinical narrative: The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site nodule, Injection site oedema, Injection site pain, Injection site pruritus, Sensation of foreign body
Clinical narrative: The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Stress
Clinical narrative: The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Disturbance in attention, Dizziness, Erythema, Immediate post-injection reaction, Injection site nodule
Clinical narrative: The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Age: 42.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Oedema, Pruritus
Clinical narrative: The patient is a 42 yo healthy female who experienced immediate pain, local erythema, pruritis, edema and nodule formation at the injection site after receipt of IIV to her (R) deltoid, with brief systemic symptoms of mild light headedness and loss of focus to events and a 'lump in her throat.' The clinical history and clinical exam are not consistent with IgE mediated event as the symptoms were localized and not urticarial. I suspect her systemic symptoms were in response to pain and stress. Per report of clinic RN vital signs were stable. Her presentation is most consistent with formation of a hematoma secondary to injection. Aspiration is no longer a recommended technique due to the absence of any large vessels in the deltoid. The patient is not on any blood thinners or has any known coagulopathy. The injection site was consistent with appropriate technique. The patient was educated on self care of continued ice, followed by heat in 1-2 days, rest, (with caution to maintain ROM in the shoulder to prevent freezing), and ibuprofen tid (take with food).
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Non-itching rash beginning on side, spreading over trunk of patient. Onset the day after receiving Prevnar vaccine. Pt seen by MD and prescribed Medrol dosepak. After 4 days of treatment pt reports the rash is slowly clearing and she is not having any other adverse effects.
Age: 42.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Initial unsolicited report received from a consumer in the United States on 30 October 2015. This case involves a 42 years-old female patient whose was vaccinated with a dose of Fluzone QIV (batch number, dose, dose number and site were not reported) via intramuscular route on 29 October 2015. Patient's medical history includes allergic to Avalox and concomitant medications were not reported. On 29 October 2015, same day after vaccination patient developed pain at the injection site that radiates to her neck, swollen lymph node about 1 cm in size which is soft, movable, tender to touch and vaccination site reaction. It was reported that patient had received influenza vaccine last year and experienced the same symptoms. No laboratory investigations were performed and corrective treatment was not reported. At the time of this report patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 17 February 2016. It was reported that the patient received FLUZONE QIV in the left arm. Patient's medical history includes seasonal allergies, asthma and allergic reactions due to fluoroquinolones. Vaccines administered within 4 weeks prior to FLUZONE QIV was reported none. Patient's concomitant medication includes yaz, Valtrex, allegra, symbicort and Nasacort. It was reported that symptoms ended ten days after vaccination and no further medical treatment needed. On an unspecified date the patient got recovered.
Age: 42.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Lymphadenopathy, Neck pain, Tenderness
Clinical narrative: Initial unsolicited report received from a consumer in the United States on 30 October 2015. This case involves a 42 years-old female patient whose was vaccinated with a dose of Fluzone QIV (batch number, dose, dose number and site were not reported) via intramuscular route on 29 October 2015. Patient's medical history includes allergic to Avalox and concomitant medications were not reported. On 29 October 2015, same day after vaccination patient developed pain at the injection site that radiates to her neck, swollen lymph node about 1 cm in size which is soft, movable, tender to touch and vaccination site reaction. It was reported that patient had received influenza vaccine last year and experienced the same symptoms. No laboratory investigations were performed and corrective treatment was not reported. At the time of this report patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 17 February 2016. It was reported that the patient received FLUZONE QIV in the left arm. Patient's medical history includes seasonal allergies, asthma and allergic reactions due to fluoroquinolones. Vaccines administered within 4 weeks prior to FLUZONE QIV was reported none. Patient's concomitant medication includes yaz, Valtrex, allegra, symbicort and Nasacort. It was reported that symptoms ended ten days after vaccination and no further medical treatment needed. On an unspecified date the patient got recovered.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Insomnia, Muscle atrophy, Musculoskeletal disorder
Clinical narrative: It started on 9-10-15 at 1:00A.M. A burning pain in one spot on my back between my right shoulder blade and my spine. For the next 2 days I had increased pain that traveled up my back to my neck and over to my right shoulder. On 9-12-15 I went to E.R. with a level 10 pain. They gave me a morphine shot, muscle relaxer pills and pain pills. On 9-13-15 I was groggie and couldn't use my right arm. On 9-14-15 I was back in E.R. because I completely loss the use of my right arm. They checked my heart, checked my right arm for a blood clot, everything was o.k, then they saw a rash on my arm and realized I had shingles. The E.R. doctor took me off the other pain pills and gave me pills to help with the virus. The rash went from my wrist under arm to my elbow then up to my shoulder, across the top of my shoulder and spread out over my shoulder blade down to where the pain started. For the next 3-4 weeks I could only sleep for 30 min. at a time because of the burning pain in my arm and shoulder. In Nov. I called Dr. office and they gave me gabapentin 100 mg. For nerve pain. Mid November I could touch my arm so I started Phy. therapy, 3 x a week. In mid Dec. Dr office made an appointment (at P.T. request) for me to see a Neurologist. That appointment was for 1-28-16 with Dr. She examined me and was surprised to see how bad my shoulder muscles had atrophied. She increased the Gabapentin to 300 mg. for pain and healing, have an MRI on Feb 5th, (that's done) see an Occ. Therapist on Feb 9th (did that) have an EMG on Feb. 23 (next week) and continue with P.T. My right arm is still not working correctly.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Neuralgia, Nuclear magnetic resonance imaging, Pain
Clinical narrative: It started on 9-10-15 at 1:00A.M. A burning pain in one spot on my back between my right shoulder blade and my spine. For the next 2 days I had increased pain that traveled up my back to my neck and over to my right shoulder. On 9-12-15 I went to E.R. with a level 10 pain. They gave me a morphine shot, muscle relaxer pills and pain pills. On 9-13-15 I was groggie and couldn't use my right arm. On 9-14-15 I was back in E.R. because I completely loss the use of my right arm. They checked my heart, checked my right arm for a blood clot, everything was o.k, then they saw a rash on my arm and realized I had shingles. The E.R. doctor took me off the other pain pills and gave me pills to help with the virus. The rash went from my wrist under arm to my elbow then up to my shoulder, across the top of my shoulder and spread out over my shoulder blade down to where the pain started. For the next 3-4 weeks I could only sleep for 30 min. at a time because of the burning pain in my arm and shoulder. In Nov. I called Dr. office and they gave me gabapentin 100 mg. For nerve pain. Mid November I could touch my arm so I started Phy. therapy, 3 x a week. In mid Dec. Dr office made an appointment (at P.T. request) for me to see a Neurologist. That appointment was for 1-28-16 with Dr. She examined me and was surprised to see how bad my shoulder muscles had atrophied. She increased the Gabapentin to 300 mg. for pain and healing, have an MRI on Feb 5th, (that's done) see an Occ. Therapist on Feb 9th (did that) have an EMG on Feb. 23 (next week) and continue with P.T. My right arm is still not working correctly.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Somnolence
Clinical narrative: It started on 9-10-15 at 1:00A.M. A burning pain in one spot on my back between my right shoulder blade and my spine. For the next 2 days I had increased pain that traveled up my back to my neck and over to my right shoulder. On 9-12-15 I went to E.R. with a level 10 pain. They gave me a morphine shot, muscle relaxer pills and pain pills. On 9-13-15 I was groggie and couldn't use my right arm. On 9-14-15 I was back in E.R. because I completely loss the use of my right arm. They checked my heart, checked my right arm for a blood clot, everything was o.k, then they saw a rash on my arm and realized I had shingles. The E.R. doctor took me off the other pain pills and gave me pills to help with the virus. The rash went from my wrist under arm to my elbow then up to my shoulder, across the top of my shoulder and spread out over my shoulder blade down to where the pain started. For the next 3-4 weeks I could only sleep for 30 min. at a time because of the burning pain in my arm and shoulder. In Nov. I called Dr. office and they gave me gabapentin 100 mg. For nerve pain. Mid November I could touch my arm so I started Phy. therapy, 3 x a week. In mid Dec. Dr office made an appointment (at P.T. request) for me to see a Neurologist. That appointment was for 1-28-16 with Dr. She examined me and was surprised to see how bad my shoulder muscles had atrophied. She increased the Gabapentin to 300 mg. for pain and healing, have an MRI on Feb 5th, (that's done) see an Occ. Therapist on Feb 9th (did that) have an EMG on Feb. 23 (next week) and continue with P.T. My right arm is still not working correctly.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Ongoing pain in shoulder and arm.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: I received the shingles vaccine a week ago.  The next day, my upper arm was totally swollen.  A huge red blotch was in the center where the shot was given, and there was redness all around that.  There was significant pain, and it was awfully itchy.  It got worse over the next few days.  I couldn't sleep for three nights because of the swelling and pain.   Yesterday, the swelling had totally subsided and the red center blotch turned somewhat black and blue, so I know it is going away.  But when I initially asked about any side effects of the vaccine, I was told there might be a few hours of swelling and redness, and that wasn't the majority of people.  After my symptoms worried me, I asked another person about her experience with the vaccine, and she had the same outcome as I did.  So I am reporting this to make sure that you know this is not an uncommon reaction to the shingles vaccine, and the truth should be told to those asking about potential reactions to the vaccine.  I have never had an adverse reaction to any other medications/vaccines...only this one.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling, Rash macular, Sleep disorder
Clinical narrative: I received the shingles vaccine a week ago.  The next day, my upper arm was totally swollen.  A huge red blotch was in the center where the shot was given, and there was redness all around that.  There was significant pain, and it was awfully itchy.  It got worse over the next few days.  I couldn't sleep for three nights because of the swelling and pain.   Yesterday, the swelling had totally subsided and the red center blotch turned somewhat black and blue, so I know it is going away.  But when I initially asked about any side effects of the vaccine, I was told there might be a few hours of swelling and redness, and that wasn't the majority of people.  After my symptoms worried me, I asked another person about her experience with the vaccine, and she had the same outcome as I did.  So I am reporting this to make sure that you know this is not an uncommon reaction to the shingles vaccine, and the truth should be told to those asking about potential reactions to the vaccine.  I have never had an adverse reaction to any other medications/vaccines...only this one.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea
Clinical narrative: 10/27/15 - immunized 11/14/15 / 11/17/15 - hospital admission > severe diarrhea/dehydration.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: I have never had any problem with my annual Flu shot. On Sept 9, 2015 I was given the high dose shot because of my age. This was not an allergic reaction, but days of weakness and full body pain which gradually abated. 6 mo later I still have pain in that arm and lack full range of motion!
Age: 1.05
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Irritability, Parotid gland enlargement, Pyrexia, Swelling face
Clinical narrative: Mom noted pt was crankier than normal, noticed facial swelling on the right side of his face. Obvious swelling noted on right parotid obscuring the jaw. Reddened skin noted on right side of jaw. Also had low grade fever of 100.5 degrees F. Treatment is cephalexin x 7 days.
Age: 72.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm. Did not go away.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Abnormal behaviour, Feeding disorder, Insomnia, Irritability
Clinical narrative: Fever (103), uncharacteristic behavior: unable to sleep, unable to eat, irritable, complained of severe abdominal pain for several days, visibly affected by the vaccine; emailed doctor and sought medical attention.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fever (103), uncharacteristic behavior: unable to sleep, unable to eat, irritable, complained of severe abdominal pain for several days, visibly affected by the vaccine; emailed doctor and sought medical attention.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pruritus generalised
Clinical narrative: 2/18/2016 at 4:00 PM: Mild itching on palms of both hands and between fingers. By 1:00 AM on 2-19-2016, symptoms had become severe itching all over body, but without rash. High doses of Benadryl and Zyrtec had little initial effect. Doctor of allergy medicine became involved at 8:00 AM on 2-19-2016 who prescribed Benadryl and Zyrtec every 4 hours until symptoms subsided. Did not consider Prednisone which would counteract Hep B vaccination. Symptoms continued until 2/20/2016 and was mild to nonexistent by 2/21/2016.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pruritus generalised
Clinical narrative: Itching all over body, Patient took Benadryl.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain, Musculoskeletal pain
Clinical narrative: Intense pain upon initial vaccination. Subsequent pain and discomfort for approx 10 weeks following vaccination. All pain in shoulder area (deltoid).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Eye pain, Headache, Herpes zoster, Malaise
Clinical narrative: Headache, malaise (expected); developed eye pain, localized to left eye; saw ophthalmologist, no dx on 10/28/15. Developed shingles rash, blistering scalp, forehead, nose, around left eye by 11/3/15 saw PCP and ophthalmologist again, Dx rx - 7 days valacyclovir. PCP 11/3 3 dr visits: 10/28/15 and 11/3/15 and consulted w/neurologist 11/3/15.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ophthalmic herpes zoster, Rash
Clinical narrative: Headache, malaise (expected); developed eye pain, localized to left eye; saw ophthalmologist, no dx on 10/28/15. Developed shingles rash, blistering scalp, forehead, nose, around left eye by 11/3/15 saw PCP and ophthalmologist again, Dx rx - 7 days valacyclovir. PCP 11/3 3 dr visits: 10/28/15 and 11/3/15 and consulted w/neurologist 11/3/15.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Somnolence
Clinical narrative: Myalgias, fatigue, falling asleep during the day while at work. Sx lasted for three weeks.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Blood pressure decreased, Dizziness, Pallor, Vomiting
Clinical narrative: Lightheaded, pallor, decreased BP, vomited x 1. Rest, hydration.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Neck pain
Clinical narrative: Received Influenza vac split quad susp. 0.5ml in right deltoid. Became swollen, felt warm to touch, swollen and very sore from elbow to clavicle neck area. Rec'd inj on 9/25/2015 -> present - site is still sore and stiff from elbow to shoulder.
Age: 80.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Received Influenza vac split quad susp. 0.5ml in right deltoid. Became swollen, felt warm to touch, swollen and very sore from elbow to clavicle neck area. Rec'd inj on 9/25/2015 -> present - site is still sore and stiff from elbow to shoulder.
Age: 73.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Injection site pain, Mobility decreased, Myalgia
Clinical narrative: Received flu shot Oct 2014 it hurt but by December arm muscles hurt so much I told my doctor, I don't think they believe me now 15 months later I have half of movement back but I'm still limited on what I can do.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Back pain, Dysarthria, Fatigue, Guillain-Barre syndrome
Clinical narrative: Tingling and weakness in feet and legs, severe pain in back. Numbness and tingling in hands, fingers, toes, weakness that spread to upper body. I couldn't walk and barely move arms, fatigue. Had facial drooping and slurage speech. Hospitalized and given IVIG treatments, therapy and rehab.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Tingling and weakness in feet and legs, severe pain in back. Numbness and tingling in hands, fingers, toes, weakness that spread to upper body. I couldn't walk and barely move arms, fatigue. Had facial drooping and slurage speech. Hospitalized and given IVIG treatments, therapy and rehab.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: Tingling and weakness in feet and legs, severe pain in back. Numbness and tingling in hands, fingers, toes, weakness that spread to upper body. I couldn't walk and barely move arms, fatigue. Had facial drooping and slurage speech. Hospitalized and given IVIG treatments, therapy and rehab.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient brought in by father on 02/22/2016 to Health Center c/o of redness, swelling, and warmth at the site of injection a day after the vaccine was given (02/11/2016). Father states he applied iodine to the site to relieve the swelling, pain, and redness. When assessed by nurse at the clinic on 02/22/2016, patient had a 2cmx2cm reddened, tender, indurated area on the left outer aspect of the arm. Father denied any fever. Nurse advised to apply ice to the site and follow-up with primary doctor. On 2/23/2016, nurse followed-up with patient via telephone. Per brother, patient's arm is still swollen with tenderness. He states they did not apply ice to the site and have not followed-up with primary doctor. Nurse encouraged to apply ice to the site as advised and follow-up with PMD today. Brother verbalized understanding and states he will take the patient to see the doctor today. Will follow-up tomorrow.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Pyrexia, Rash, Ultrasound kidney, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) reporting on her 12 month old son. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 19-JAN-2016, the patient was vaccinated with VARIVAX (Merck) in the right leg. On the same day the physician accidentally administered PROQUAD (Merck) in the left leg. The reporter stated that "because the physician administered a high dosage of varicella, her son had a severe adverse reaction". On 25-JAN-2016, the patient started to develop a high fever. On 30-JAN-2016, the reporter took her son to the physician's office. Once they were at the physician's office, the patient's fever became worse and then he was rushed to hospital. The patient had a fever of 107 degrees and had developed chicken pox as well. She stated that he was "highly contagious". The patient was on the antibiotic (CEFDINIR), for two weeks. The patient came home from the hospital on 03-FEB-2016. He has recovered from the fever, but he still has "bumps on his legs" from the chicken pox (recovering). The reporter did not provide the relatedness of the events with VARIVAX (Merck) and PROQUAD (Merck). Additional information has been requested
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient, male subject, height: 43.5 in; weight: 40.0 pounds, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. The patient's concurrent disease(s) included allergic rhinitis and eczema. The patient received FLUMIST QUADRIVALENT on 16-Nov-2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours. FLUMIST QUADRIVALENT (intranasal) was discontinued on 16-Nov-2015. The outcome of the event of consumer received FLUMIST QUADRIVALENT on 16NOV2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours is unknown. The reporter's description of the event(s) was as follows: HCP reported that consumer has a past medical history of allergic rhinitis and eczema. The report was considered to be non-serious by company physician.
Age: 0.6
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 7 month old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that administered to 7 month old. The outcome of the event of ADMINISTERED TO 7 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Drug administration error
Clinical narrative: A spontaneous report has been received from a Health professional concerning a 53 year old, female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient had been received FLUMIST (intranasal), 0.2 millilitres, once/single administration started on 19-Nov-2015 for flu vaccination. The patient experienced given to patient over 49 yo and gave whole dose in one nostril which started on unknown date. The outcome of the events of given to patient over 49 yo and gave whole dose in one nostril was unknown. The company physician considered the events of given to patient over 49 yo and gave whole dose in one nostril to be non-serious.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 33 year old Female patient, who had been received Nasal FLUMIST (INTRANASAL), 0.2 Milliltres, Once/Single administration for INFLUENZA PREVENTION. FLUMIST, INTRANASAL started on an unknown date for INFLUENZA PREVENTION. It was reported that FLUMIST was inadvertently administration to pregnant female patient. The outcome of the event of FLUMIST ADMINISTERED TO PREGNANT WOMAN is unknown. The report was considered to be non-serious by the company physician.