chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from an other health professional refers to a 52 year old female patient. On 17-DEC-2013 the patient was vaccinated at Public health clinic/hospital, purchased with Private funds, with PNEUMOVAX 23 lot # J011651, subcutaneous in the arm and ZOSTAVAX lot # J011338, subcutaneous in the arm. No other medications were used. On 17-DEC-2013 the patient experienced chills, aching, nausea, fever and the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly. The patient had recovered on an unspecified date. Causality assessment was not provided. This case is linked to the following cases from same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003252 and 1403USA003253. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: This spontaneous report as received from an other health professional refers to a 55 year old female patient (also reported as "59 year old"). On 17-DEC-2013 the patient was vaccinated at Public health clinic/hospital, purchased with Private funds, with PNEUMOVAX 23 lot # J011651, subcutaneous in the left arm. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneous in the left arm and BOOSTRIX, lot # T25EG, intramuscular, in the left deltoid. No other medications were used. On 17-DEC-2013, the patient experienced aching, soreness at site, chills and the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly. The patient had recovered on an unspecified date. Causality assessment was not provided. This case is linked to the following cases from same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Headache, Injection site pain, Local swelling, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old female patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Dose and frequency were not provided. Other suspect therapies included ZOSTAVAX subcutaneously in the right arm and Booster (Tdap) (manufacturer unknown) intramuscularly in the right deltoid. Dose and frequency were not provided. On an unknown date the patient experienced headaches, arm swollen and sore at site, vomiting, nausea and chills. The outcome of headaches, arm swollen and sore at site, vomiting, nausea and chills was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old female patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Dose and frequency were not provided. Other suspect therapies included ZOSTAVAX subcutaneously in the right arm and Booster (Tdap) (manufacturer unknown) intramuscularly in the right deltoid. Dose and frequency were not provided. On an unknown date the patient experienced headaches, arm swollen and sore at site, vomiting, nausea and chills. The outcome of headaches, arm swollen and sore at site, vomiting, nausea and chills was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Feeling cold, Muscular weakness
Clinical narrative: This spontaneous report as received from an other health professional refers to a 57 year old male patient. On 17-DEC-2013 the patient was vaccinated in Public health clinic/hospital, purchased with Private funds, with PNEUMOVAX 23 lot # J011651, subcutaneous, in the right arm. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneous, in the right arm and BOOSTRIX, lot # 31S2B, intramuscular, in the right deltoid. No other medications were used. On 17-DEC-2013, the patient experienced chills, freezing, legs weak and the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly. On an unspecified date the patient had recovered. Causality assessment was not provided. This case is linked to the following cases from the same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2014US027592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518166) website on 06 Mar 2014 with a follow up report received from the quality assurance department on 12 Mar 2014. This report refers to a 73-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 14 Oct 2013. On 11 Nov 2013, he experienced low back pain. It was reported that over the course of weeks, he noted progressive lower extremity weakness associated with the low back pain which radiates to legs and across buttocks. Also he experienced numbness sensation in hands. He was admitted in the hospital on 11 Nov 2013 and discharged on 21 Nov 2013. On 27 Nov 2013, he was again admitted to the hospital and discharged on 04 Dec 2013. On the both occasions during the hospital stay, he was treated with plasmapheresis for five days. The final outcome of the events was condition unchanged. The seriousness and causality were not reported. Follow up report received from the quality assurance department on 12 Mar 2014: Upon follow up, it was reported that, the reported FLUVIRIN batch number (00349611A) does not belong to Novartis vaccines. Hence the batch investigation would not be performed with the unknown batch number.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Plasmapheresis
Clinical narrative: Case number PHHY2014US027592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518166) website on 06 Mar 2014 with a follow up report received from the quality assurance department on 12 Mar 2014. This report refers to a 73-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 14 Oct 2013. On 11 Nov 2013, he experienced low back pain. It was reported that over the course of weeks, he noted progressive lower extremity weakness associated with the low back pain which radiates to legs and across buttocks. Also he experienced numbness sensation in hands. He was admitted in the hospital on 11 Nov 2013 and discharged on 21 Nov 2013. On 27 Nov 2013, he was again admitted to the hospital and discharged on 04 Dec 2013. On the both occasions during the hospital stay, he was treated with plasmapheresis for five days. The final outcome of the events was condition unchanged. The seriousness and causality were not reported. Follow up report received from the quality assurance department on 12 Mar 2014: Upon follow up, it was reported that, the reported FLUVIRIN batch number (00349611A) does not belong to Novartis vaccines. Hence the batch investigation would not be performed with the unknown batch number.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Headache, Injection site infection, Injection site swelling, Local swelling
Clinical narrative: Case number PHHY2014US027619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518347) website on 06 Mar 2014 with a follow up information received from the quality assurance department (QA reference number: 286664) on 12 Mar 2014 and a follow up information received from the quality assurance department on 13 Mar 2014. This report refers to a 46-years-old female patient. Her past medical history was not reported. Her concomitant medications included hormone replacement therapy medicines and thyroid medicines. On 03 Nov 2013, she was vaccinated with the third dose of FLUVIRIN (batch number: not reported) along with PNEUMOVAX (other manufacturer, batch number: not reported) in the left arm at a dose of 0.5 ml. Following the vaccination, on 04 Nov 2013 (24 hours later), she experienced vomiting, headache along with a severe body temperature of 104 degrees. She also experienced swelling and infection in her vaccinated arm. Following the events, on an unspecified date, she visited the emergency room. Since her temperature was not going down, 48 hours later she was hospitalized for three days with fever. She underwent laboratory tests which showed severe reaction. The final outcome was reported as completely recovery. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 286664), it was reported that since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the compliant production, testing, and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up information received from the quality assurance department on 12 Mar 2014: QA number updated. Follow up information received from the quality assurance department on 13 Mar 2014: Batch summary updated.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US027619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518347) website on 06 Mar 2014 with a follow up information received from the quality assurance department (QA reference number: 286664) on 12 Mar 2014 and a follow up information received from the quality assurance department on 13 Mar 2014. This report refers to a 46-years-old female patient. Her past medical history was not reported. Her concomitant medications included hormone replacement therapy medicines and thyroid medicines. On 03 Nov 2013, she was vaccinated with the third dose of FLUVIRIN (batch number: not reported) along with PNEUMOVAX (other manufacturer, batch number: not reported) in the left arm at a dose of 0.5 ml. Following the vaccination, on 04 Nov 2013 (24 hours later), she experienced vomiting, headache along with a severe body temperature of 104 degrees. She also experienced swelling and infection in her vaccinated arm. Following the events, on an unspecified date, she visited the emergency room. Since her temperature was not going down, 48 hours later she was hospitalized for three days with fever. She underwent laboratory tests which showed severe reaction. The final outcome was reported as completely recovery. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 286664), it was reported that since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the compliant production, testing, and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up information received from the quality assurance department on 12 Mar 2014: QA number updated. Follow up information received from the quality assurance department on 13 Mar 2014: Batch summary updated.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Infection, Local swelling, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US027619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518347) website on 06 Mar 2014 with a follow up information received from the quality assurance department (QA reference number: 286664) on 12 Mar 2014 and a follow up information received from the quality assurance department on 13 Mar 2014. This report refers to a 46-years-old female patient. Her past medical history was not reported. Her concomitant medications included hormone replacement therapy medicines and thyroid medicines. On 03 Nov 2013, she was vaccinated with the third dose of FLUVIRIN (batch number: not reported) along with PNEUMOVAX (other manufacturer, batch number: not reported) in the left arm at a dose of 0.5 ml. Following the vaccination, on 04 Nov 2013 (24 hours later), she experienced vomiting, headache along with a severe body temperature of 104 degrees. She also experienced swelling and infection in her vaccinated arm. Following the events, on an unspecified date, she visited the emergency room. Since her temperature was not going down, 48 hours later she was hospitalized for three days with fever. She underwent laboratory tests which showed severe reaction. The final outcome was reported as completely recovery. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 286664), it was reported that since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the compliant production, testing, and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non significant follow up information received from the quality assurance department on 12 Mar 2014: QA number updated. Follow up information received from the quality assurance department on 13 Mar 2014: Batch summary updated.
Age: 75.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site pain, Local swelling, Pain
Clinical narrative: Stiffness and pain on left arm from 10/31/13 to present time.
Age: 75.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiffness and pain on left arm from 10/31/13 to present time.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Initial case received from a nurse practitioner, who is also the patient, on 13 March 2014. A 56-year-old female patient, with no reported medical history and no reported concomitant drug, had received an intramuscular dose of FLUZONE on the left deltoid on 01 October 2013 (batch number UH909AA). She had received the vaccine from employee health nurse as part of employee health program for the hospital where she works. She had received several previous doses of FLUZONE (exact number not reported). On 01 October 2013, the same day of the vaccination, she had some initial soreness at the injection site. On the next day, she experienced left upper arm muscle spasms. She continued to have intermittent muscle spasms in her left arm which extended upward to her shoulder and extended down to her elbow. She did not consult any health care professional for evaluation or treatment of upper arm muscle spasms. At the time of the report, the patient had not recovered. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 16 year old female patient. On 10-FEB-2014 the patient was vaccinated with VARIVAX (Merck), subcutaneously (lot number J007029, expiry date unknown) (dosing regimen and frequency unknown) subcutaneously. No concomitant medications were reported. The patient became pregnant with Last Menstrual Period of 02-JAN-2014 and Estimated Date of Delivery of 09-OCT-2014. Initial exposure to VARIVAX (Merck) was at 5 week(s). The pregnancy outcome was outcome pending. On 10-FEB-2014, the patient's urine pregnancy test was performed which was positive. No adverse event was reported. The outcome of pregnancy was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. No product quality issue was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician and her medical assistant via a sales representative refers to a female patient of unknown age. Pertinent medical history, drug reactions and allergies, concomitant medication were not specified by reporter. On an unknown day in March 2014, (within the last 48 hours), the patient was vaccinated with ZOSTAVAX (dose, route of administration and expiration date were not reported). On an unknown day in March 2014, (within the last 48 hours) the patient developed redness, swelling and severe itching at the injection site, exceeding around her upper arm. There were no lesions. The patient self-treated with a topical steroid cream without improvement of symptoms. The patient had an appointment in the office on 12-MAR-2014, for evaluation. No lab diagnostic studies were performed. The outcome of events arm was reported as not recovered. The relatedness between the ZOSTAVAX and events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of GARDASIL, ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot# and expiry unknown) between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse effects reported. The case is linked to 1403USA008918, 1403USA008919 and 1403USA005434 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of oral ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot # and expiry unknown) between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse effects reported. The case is linked to 1403USA008919, 1403USA008920 and 1403USA005434 (same reporter link). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a 21 year old female patient reporting on herself. Patient did not have any pertinent medical history, drug reactions and allergies. The patient was not pregnant. The patient stated that she had received all three GARDASIL vaccines starting in 2008 first dose (dose and Lot number not reported, route reporting as injection). (Second injection and third doses were administered on an unspecified dates). No concomitant medication was reported. In approximately March 2014 (reported as "last week") the patient was tested positive for HPV. The patient sought medical attention by visiting her doctor. No treatment was given. The physician was performing a biopsy for a patient (in an approximately March 2014, result not provided). The outcome of positive HPV test was reported as not recovered. Action taken was not reported. Relatedness between event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of GARDASIL, oral ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot # and expiry unknown) between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse events reported. This case is linked to 1403USA008919, 1403USA008920 and 1403USA005434 (same reporter link). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 28-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX single dose, subcutaneous in the left arm. On 30-JAN-2014, the patient developed an itchy, red, raised area at the injection site. The patient was evaluated by her physician and no medical treatment was prescribed. At the time of the report, the itchiness had resolved but the red, raised area at the injection site persists (also reported the outcome of the events was recovering). There was no treatment given for the event. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 9 year old patient of unknown gender. No medical history or concurrent conditions reported. On 12-MAR-2014, patient was vaccinated with VAQTA, 50/1.0 U/ML, injection (dose, route and lot number not provided). Co-suspect or concomitant therapies were not reported. The child patient received an adult dose of VAQTA. No adverse event reported. No product confusion just medication error. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Injection site swelling, Lymphadenopathy, Oropharyngeal pain, Rash pustular
Clinical narrative: L arm swelling at site of smallpox vaccine inoculation.  New pustular acne-like lesions that spread from L shoulder to upper chest, back, and R shoulder.  Also felt fatigued with sore throat and swollen cervical lymph nodes x24hr.  Symptoms resolved with Advil prn and rash resolving within 24-48h.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Acne pustular, Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: L arm swelling at site of smallpox vaccine inoculation.  New pustular acne-like lesions that spread from L shoulder to upper chest, back, and R shoulder.  Also felt fatigued with sore throat and swollen cervical lymph nodes x24hr.  Symptoms resolved with Advil prn and rash resolving within 24-48h.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oropharyngeal pain
Clinical narrative: L arm swelling at site of smallpox vaccine inoculation.  New pustular acne-like lesions that spread from L shoulder to upper chest, back, and R shoulder.  Also felt fatigued with sore throat and swollen cervical lymph nodes x24hr.  Symptoms resolved with Advil prn and rash resolving within 24-48h.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: A couple days after tetanus booster severe pain in collar bone and shoulder blade area. No pain in the injection site or when the injection was given. Throbbing pain and it is hard to lift arm up. It has been almost 2 weeks now.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cataract, Eye swelling, Rash, Swelling face
Clinical narrative: A crown of very watery blisters appeared at the top of my head. A rash developed across my forehead a few days later that still persists. The area between my eyebrows swelled to give a "lioness" appearance to my eye area. A few weeks after a blurring developed in my right eye that I had check out and it was said to be an "odd" type of cataract. The blurring persists.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: A crown of very watery blisters appeared at the top of my head. A rash developed across my forehead a few days later that still persists. The area between my eyebrows swelled to give a "lioness" appearance to my eye area. A few weeks after a blurring developed in my right eye that I had check out and it was said to be an "odd" type of cataract. The blurring persists.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccinated pregnant female with vaccine containing thimerisol.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding
Clinical narrative: Vaccinated nursing mother with vaccine containing thimerisol.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccinated pregnant woman with vaccine containing thimerisol.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Participant experienced swelling after vaccination/no epi administered/participant stated they had history of allergies and would self-medicate with Benadryl.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PT experienced itching/swelling at injection site. After 1 hour itching subsided/redness decreased.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling to injection site, reported by step mom, no pain, no itching.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Anion gap, Anxiety, Asthenia, Cardiac enzymes, Dyspnoea
Clinical narrative: Received injection in Left Deltoid. 5 hours later had extreme pain in the whole arm. Cound not lift arm up. Pain radiated across shoulder and could not move neck. Became Short of breath, weak, sick to stomach and anxious with heart racing. 3 days later still doesn't feel like self.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Full blood count, Injected limb mobility decreased, Injection site pain, Metabolic function test
Clinical narrative: Received injection in Left Deltoid. 5 hours later had extreme pain in the whole arm. Cound not lift arm up. Pain radiated across shoulder and could not move neck. Became Short of breath, weak, sick to stomach and anxious with heart racing. 3 days later still doesn't feel like self.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity, Palpitations
Clinical narrative: Received injection in Left Deltoid. 5 hours later had extreme pain in the whole arm. Cound not lift arm up. Pain radiated across shoulder and could not move neck. Became Short of breath, weak, sick to stomach and anxious with heart racing. 3 days later still doesn't feel like self.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-MAR-2014 (also reported as today) the patient was vaccinated with second dose of PROQUAD (Merck), 0.5 ml subcutaneously (lot number unknown, expiry date 23-FEB-2014) (dosing regimen and frequency unknown) which had expired on 23-FEB-2014. No adverse event was reported. The action taken with the therapy with PROQUAD (Merck) was unknown. No product quality issue was reported. Additional information has been requested.
Age: 0.77
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Rash
Clinical narrative: RASH AND SWOLLEN EYES.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Eye pruritus, Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: Eyes were red, swelling and itching. Rash on eyelids. Mildly dizzy. Injection site mildly red and swollen.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Ocular hyperaemia
Clinical narrative: Eyes were red, swelling and itching. Rash on eyelids. Mildly dizzy. Injection site mildly red and swollen.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 49 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and frequency unknown) (dosing regimen and frequency unknown) for shingles vaccine. No concomitant medications were reported. On an unknown date the patient experienced red rash around the injection site. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of red rash around the injection site was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. It was reported that the event lasted a couple of weeks. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown demography. On 14-MAR-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular that was improperly stored. No adverse effects reported. No further information provided. This case is linked to the case 1403USA008864 (same reporter link). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 14 year old male patient. On an unknown date in May 2013, the patient was vaccinated with GARDASIL (lot#, expiry not reported) dose 1, 0.5 ml, intramuscular route. On 13-MAR-2014, the patient was supposed to received his second dose of GARDASIL but was inadvertently administered CERVARIX. No adverse effects reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown demography. On 14-MAR-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular that was improperly stored. No adverse effects reported. No further information provided. This case is linked to the case 1403USA008790 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to several patients of unknown age and gender. The healthcare worker reported that several patients have been administered with a dose of GARDASIL, oral ROTATEQ, RECOMBIVAX HB and VARIVAX (Merck) (lot # and expiry unknown) for vaccination between 04-MAR-2014 and 06-MAR-2014 which were exposed to temperatures outside the prescribing information although supported. No adverse effects reported. This case is linked to 1403USA008918, 1403USA008919 and 1403USA008920 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Eye discharge, Injection site erythema, Injection site swelling, Iritis, Ocular hyperaemia
Clinical narrative: Day after vaccines given, (R) deltoid became red and swollen and (R) eye became red with drainage. Day 4, arm swelling and redness decreased, but eye redness worsened. Seen by ophthalmologist and diagnosed w/ iritis (R) eye - it improved at f/u but appeared in (L) eye several weeks later around 3/5/14 - pt is still following up w/ ophthalmologist.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse via company representative refers to a 18 year old female patient. No medical history was reported. In 2014 (exact date was not reported, the company representative believed the doses were administered today (17-MAR-2014) but she could not confirm) the patient was vaccinated with GARDASIL (lot number, expiration date, strength, dose, route were not reported). Other suspect therapies included VARIVAX (lot number, expiration date, strength, dose, route and indication were not reported) administered on unspecified date in 2014 (exact date was not reported, the company representative believed the doses were administered today(17-MAR-2014) but she could not confirm). No concomitant medications were reported. The nurse stated that after receiving the vaccines, the patient called the office and stated that she was four months pregnant, with last menstruation period (LMP) in approximately November 2013. Date of conception and estimated delivery date (EDD) were unknown. No adverse effect was reported at the time of the report. The pregnancy outcome was pending. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid redness, swelling, hot to touch, painful - localized. Cellulitis.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Itching about 30 min. after injection. Redness, swelling, warmth and pain. SOA.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Neck pain, Pain in extremity, Spinal pain
Clinical narrative: Pt given meningitis vaccine #2 on 3/13/14. First dose given 2/24/10. Within hours developed intense headache, pain down spine into legs, neck pain down arms per patient. HA improved with Ibuprofen. No rash or fever.
Age: 0.38
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Patient had a mild rash which parents feels occurred immediately after administration of Rotavirus vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Pain, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old female patient with pertinent medical history of hypertension. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route unspecified) on her right arm. The patient developed an area of redness, swelling, soreness, and induration 6 inches below the injection site on the right arm after administration of ZOSTAVAX. The patient was evaluated in the office today, on 14-MAR-2014, and was prescribed KEFLEX to treat cellulitis. The outcome of cellulitis was reported as not recoveered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 13-MAR-2014 the patient was vaccinated with PEDVAX (lot number, dose and frequency not provided), intramuscular. The patient received the vaccine which was exposed to 39 degrees F for 1 hour. No known adverse effects. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tinnitus
Clinical narrative: Pt reported dizziness, ringing in ears, and sweating right after administering vaccines. Symptoms lasted for 5-10 min. Resolved after few minutes. Gave water to drink. Physical assessment performed by RN the vaccine administering nurse includes, bilateral upper extremities strength checks; assessing ability to comprehend and follow instructions; and informal vision test by standing in the opposite corner of the room and asked patient to count my fingers which patient done correctly.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Tinnitus
Clinical narrative: Immediately after immunizations, patient started feeling dizziness, ringing in ears and sweating.  Symptoms lasted approx. 10 minutes then resolved.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Alopecia, Anxiety, Blood alkaline phosphatase decreased, Blood thyroid stimulating hormone decreased
Clinical narrative: My daughter received two doses of the GARDASIL vaccine which has resulted in Thyroid disease, fainting, tingling, anxiety, sweating, dizziness, hair loss, low monocyte count, and low alkaline phosphatase count, Gluten intolerance, and gastrointestinal distress. She suffers from fatigue.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Dizziness, Fatigue, Food allergy, Hyperhidrosis
Clinical narrative: My daughter received two doses of the GARDASIL vaccine which has resulted in Thyroid disease, fainting, tingling, anxiety, sweating, dizziness, hair loss, low monocyte count, and low alkaline phosphatase count, Gluten intolerance, and gastrointestinal distress. She suffers from fatigue.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lactose intolerance, Monocyte count decreased, Mycotic allergy, Paraesthesia, Syncope
Clinical narrative: My daughter received two doses of the GARDASIL vaccine which has resulted in Thyroid disease, fainting, tingling, anxiety, sweating, dizziness, hair loss, low monocyte count, and low alkaline phosphatase count, Gluten intolerance, and gastrointestinal distress. She suffers from fatigue.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: My daughter received two doses of the GARDASIL vaccine which has resulted in Thyroid disease, fainting, tingling, anxiety, sweating, dizziness, hair loss, low monocyte count, and low alkaline phosphatase count, Gluten intolerance, and gastrointestinal distress. She suffers from fatigue.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Fatigue, Mobility decreased, Pain, Pruritus
Clinical narrative: Felt tired, was very sore, had trouble lifting arm. 4th day became swollen, red, w/ hives and was itching. Dr. prescribed cephalexin 500 mg. 2/times per day for 7 days also antihistamine.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling, Urticaria
Clinical narrative: Felt tired, was very sore, had trouble lifting arm. 4th day became swollen, red, w/ hives and was itching. Dr. prescribed cephalexin 500 mg. 2/times per day for 7 days also antihistamine.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Rash
Clinical narrative: Pt broke out in rash on both hands and both elbows x3 wks after vaccinated. Rash not red or itchy.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP, SMALL, TYP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt broke out in rash on both hands and both elbows x3 wks after vaccinated. Rash not red or itchy.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Measles, Rash generalised
Clinical narrative: This spontaneous report was received from a physician concerning an 18 month old patient of unknown gender. No medical history or concurrent conditions were reported. On 24-FEB-2014, patient was vaccinated with MMR II (dose, route and strength not provided). Co-suspect or concomitant therapies were not reported. On 06-MAR-2014, patient experienced generalized measles rash. At the time of the report, the outcome of the event was unknown. The causal relationship between MMR II and the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, possible "fluid", pt rec'd KEFLEX rx (500 mg 4x daily x 10 days) on 3/15/14. Pt was seen by family dr 3/17/14, rx for BACTROBAN crm AA TID. Dx cellulitis.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Child starting with rash on lower legs several hours after vaccine admin. Rash spread to arms, neck, face within 24 hrs. Given BENADRYL 12.5/5ml rx.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Headache, Syncope, Tremor, Urine analysis normal
Clinical narrative: shakiness; lack of appetite but not necessarily nausea; syncope; headache; low grade temperature of 99F.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 12-MAR-2014 the patient was vaccinated with GARDASIL (lot number, dose and frequency not provided), intramuscular. The patient received the vaccine which was exposed to 49 degrees F for 1 hour. No known adverse effects. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Antinuclear antibody negative, Borrelia test negative, Convulsion, Cytomegalovirus test negative, Electroencephalogram normal
Clinical narrative: Had well visit 2/17/14 and was given HPV #1 and Flu shots. Developed headache within a few days of the visit, followed by nausea, emesis, and altered speech. Had seizures, was admitted to Hosp. 3/2/14-3/5/14 w/ encephalitis. MRI with left temporo-occipital abnormality.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Encephalitis, Epstein-Barr virus antibody positive, Headache, Herpes simplex serology negative, Human herpes virus 6 serology negative
Clinical narrative: Had well visit 2/17/14 and was given HPV #1 and Flu shots. Developed headache within a few days of the visit, followed by nausea, emesis, and altered speech. Had seizures, was admitted to Hosp. 3/2/14-3/5/14 w/ encephalitis. MRI with left temporo-occipital abnormality.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Mycoplasma test, Nausea, Nuclear magnetic resonance imaging brain abnormal, Parvovirus B19 test negative, Speech disorder
Clinical narrative: Had well visit 2/17/14 and was given HPV #1 and Flu shots. Developed headache within a few days of the visit, followed by nausea, emesis, and altered speech. Had seizures, was admitted to Hosp. 3/2/14-3/5/14 w/ encephalitis. MRI with left temporo-occipital abnormality.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Vomiting
Clinical narrative: Had well visit 2/17/14 and was given HPV #1 and Flu shots. Developed headache within a few days of the visit, followed by nausea, emesis, and altered speech. Had seizures, was admitted to Hosp. 3/2/14-3/5/14 w/ encephalitis. MRI with left temporo-occipital abnormality.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Impaired driving ability, Neck pain, Pain, Pain in extremity
Clinical narrative: I had a painful, delayed reaction to the shot...about 2 hours after I received it as I was driving home, I felt a very painful burning sensation that traveled up my arm to my neck and made it so I couldn't drive.  Since then, the arm has been very painful to lift anything heavier than a small bottle of tea, using it to push myself up off the couch or out of the bathtub, laying on it to sleep, reaching for items that are higher than my hips, and other times when I'm not using it.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: I had a painful, delayed reaction to the shot...about 2 hours after I received it as I was driving home, I felt a very painful burning sensation that traveled up my arm to my neck and made it so I couldn't drive.  Since then, the arm has been very painful to lift anything heavier than a small bottle of tea, using it to push myself up off the couch or out of the bathtub, laying on it to sleep, reaching for items that are higher than my hips, and other times when I'm not using it.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Skin discolouration
Clinical narrative: Chills and skin discoloration.
Age: 0.45
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Balance disorder, Childhood disintegrative disorder
Clinical narrative: Mother states that 5 days after her 2 month shots (previous shots) child stopped lifting her head for approx. 1 month.  This was not reported so no VAERS report was done.  Mother called approx. 2 months after her next set of shots (1/07/14 at 5 1/2 months) to tell us that child stopped holding bottle and seemed more "wobbly" when sitting up.  States child would roll her fingers back and pull arms back like "wings" at intervals. At time of this report (3/17/2014), child was seen in clinic and no abnormal activity was observed, child sitting normally, no finger rolling or pulling back of arms. Child made good eye contact and responded to tactile and verbal stimuli.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Angina pectoris, Ear swelling, Erythema, Feeling abnormal, Infection
Clinical narrative: Horribly, not sure how long it took for me to decided to go, because weeks before I was having, Bells palsy signs then thoat with white spots swelling, ears, infected, heart, hurting so bad, and lungs felt like my body was swelled so bad that I was getting where I was having a hard time moving hurt inside. First was given Indocin and shot of pencicillin, and Augmentin to take, was not getting better went back on  October 30, inflammation was so bad, and I was so sick and hurting I went back to the clinic, they then gave me preidsone an Zpak, the N.P. called me the next morning to check on me, I could not believe after taking the prescription he gave me I felt my body relieve. Felt like person came out of me.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mobility decreased, Pharyngeal disorder, Swelling, VIIth nerve paralysis
Clinical narrative: Horribly, not sure how long it took for me to decided to go, because weeks before I was having, Bells palsy signs then thoat with white spots swelling, ears, infected, heart, hurting so bad, and lungs felt like my body was swelled so bad that I was getting where I was having a hard time moving hurt inside. First was given Indocin and shot of pencicillin, and Augmentin to take, was not getting better went back on  October 30, inflammation was so bad, and I was so sick and hurting I went back to the clinic, they then gave me preidsone an Zpak, the N.P. called me the next morning to check on me, I could not believe after taking the prescription he gave me I felt my body relieve. Felt like person came out of me.