chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Culture stool, Diarrhoea, Diarrhoea haemorrhagic, Full blood count
Clinical narrative: 9 days post rotavirus received pt. developed bloody - gel like diarrhea. Admitted to hospital for 2 days. Dx: presumed intussusception.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen
Clinical narrative: 9 days post rotavirus received pt. developed bloody - gel like diarrhea. Admitted to hospital for 2 days. Dx: presumed intussusception.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid node to (L) arm 4 x 5 area if erythema. Warm to touch discrete tender to touch not involved to forearm. (+) ROM to shoulder.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Very mild, not noticeable lip swelling after 3-5 min after ZOSTAVAX administration. Pt reported no difficulty breathing no major face, mouth, tongue swelling. Gave patient 25 mg diphenhydramine and monitored patient for 1 hour. Asked at several different times if condition was worsening. Patient said no, it was improving.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Swelling and redness on left arm. Pt had immunization on 7/30/13 (DTaP).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: KINRIX give IM to (L) T Also given this day 7-30-13 PQ.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Arm numbness and fatigue following resolution.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Welt at site of immunization - red raised 3 in in diameter. Reported 2 days after immunization.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an approximately 73 year old male patient. In October 2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. The pharmacist informed field representative that the patient (no patient contact details provided) who had reported that he had experienced an outbreak of shingles three (3) times since receiving ZOSTAVAX. The outcome of he had experienced an outbreak of shingles three times since receiving ZOSTAVAX is unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 14-SEP-1994 and 15-OCT-1998 the patient was vaccinated with M-M-R II, 0.5 ml, intramuscular. The patient had titers done for admission to a university and was found to be negative for measles titer. On an unknown date the patient experienced negative for measles titer. Patient did not seek medical attention. The outcome of negative for measles titer is unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Varicella post vaccine
Clinical narrative: This spontaneous report as received from two pharmacists refers to a 13 year old male patient. On 19-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001009 and expiration date: 24-APR-2014) (dose and route were not reported). The pharmacist stated the 13 year old grandson of a patient who was vaccinated with ZOSTAVAX developed chickenpox. At the time of reporting, the outcome of chickenpox was unknown. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient. No medical history or drug reactions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # J001700, exp. date: 08-MAY-2014) (Dose and route not reported) in the left deltoid. On 20-JUL-2013, the patient experienced swelling around the injection site and fever after receiving ZOSTAVAX. The patient spoke to the pharmacist. The events were treated with Ibuprofen (manufacturer unknown) and BENADRYL. The outcome of swelling around the injection site and fever after receiving ZOSTAVAX was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received form a registered nurse refers to a patient of unknown age and gender. On 04-MAY-2010 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). On 20-JUN-2012 the patient received the 2nd dose of GARDASIL (dose, route and lot number not provided) late. On 20-SEP-2012 the patient received the 3rd dose of GARDASIL (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-JUL-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (Lot # reported as G006861, expiration date 20-JUL-2013) (route not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a currently 18 year old female patient. In 2011 the patient was vaccinated with GARDASIL dose 1 (route, dosage and lot number not reported). In 2012 the patient received her GARDASIL second dose (route, dosage and lot number not reported). It was reported that the patient hadn't got her third dose yet. No adverse effect was reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning a 22 year old female patient. On 28-MAR-2013, the patient was vaccinated with GARDASIL dose 1. (Lot number, dose and route not reported). On 02-APR-2013, the patient was vaccinated with GARDASIL dose 2. (Lot number, dose and route not reported). On 04-JUN-2013, the patient was vaccinated with GARDASIL dose 3. (Lot number, dose and route not reported). The patient had not recalled first dose of GARDASIL, prior receiving the second and third doses of GARDASIL. No adverse effect. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a 5 year old patient. On 29-JUL-2013, the patient was vaccinated with an expired 0.5 ml second dose of VARIVAX (Merck) (Lot # 1145AA, expiration date 14-JUL-2013) (route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2013214296 for PNEUMOVAX23. Nurse refers to an adult patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23, (lot number and expiration date unknown), dose number, dose, route and anatomical location unspecified. Concomitant medications were not reported. On an unknown date the patient experienced a local reaction to PNEUMOVAX23. The outcome of local reaction to PNEUMOVAX23 was unknown. The original reporter was a nurse. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 year old patient. The patient's medical history included respiratory failure. On 13-NOV-2001, the patient received the first dose of PNEUMOVAX23 0.5 ml, lot #, route unspecified, when the patient was 59 years old. On 18-OCT-2005, the patient received the second dose of PNEUMOVAX23 0.5 ml, lot #, route unspecified, when the patient was 63 years old. No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a 66 year old female retired nurse practitioner refers to herself with depression and allergic to tetanus toxoid (caused circulatory shutdown), Codeine, Morphine, DEMEROL, MOTRIN, COMPAZINE, PHENERGAN, TOFRANIL. On 05-JUL-2013 the patient was vaccinated subcutaneously with ZOSTAVAX (lot number, expiry date, dose, site unspecified). Concomitant therapies included PROZAC 40 mg once daily and VALIUM 5 mg once daily. On 06-JUL-2013, the patient experienced swelling around the injection site, redness, headache and extreme sensitivity to touch. She also reported that on 10-JUL-2013, she developed a "sensitivity" on the skin of her elbow that is sensitive to "all" touch. The symptoms she developed at the injection site were "gradually going away" and was now just pink at the injection site. The patient did not seek medical attention. She was treated with ALEVE (dosage unspecified). No laboratory diagnostics studies were performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant, via a sales representative, regarding a 4 year old female child. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, the 4 year old female child received a dose of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. No adverse event was reported. 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 licensed practical nurse concerning a patient of unknown age and gender. On 09-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 29-JUL-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse event was reported. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Abdominal pain upper, Back injury, Ligament sprain, Ultrasound abdomen normal
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 19 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 27-JAN-2013 the patient was vaccinated with GARDASIL (lot # not reported) (first dose, intramuscular, 0.5 ml, strength not specified). On 11-APR-2013 the patient was vaccinated with GARDASIL (lot # not reported) (second dose, intramuscular, 0.5 ml, strength not specified). The patient had begun taking unspecified "birth control pills" beginning in February 2013. The patient's mother reported that after the second dose, the patient began experiencing abdominal pain in the left upper and left lower quadrants, for "a couple months". The patient also had a lower back injury on unspecified date where she "pulled her lower back" while exercising. The patient was seen in office on 18-JUN-2013 for abdominal pain. Abdominal and pelvic ultrasounds were performed and were found to be within normal limits. Also a "urine dip" was performed to determine whether a urinary tract infection was present, but the results were negative. No treatment was given, but the abdominal pain had resolved. The outcome of lower back injury was unspecified. The patient had not yet received third dose of GARDASIL. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound pelvis normal, Urine analysis normal
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 19 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 27-JAN-2013 the patient was vaccinated with GARDASIL (lot # not reported) (first dose, intramuscular, 0.5 ml, strength not specified). On 11-APR-2013 the patient was vaccinated with GARDASIL (lot # not reported) (second dose, intramuscular, 0.5 ml, strength not specified). The patient had begun taking unspecified "birth control pills" beginning in February 2013. The patient's mother reported that after the second dose, the patient began experiencing abdominal pain in the left upper and left lower quadrants, for "a couple months". The patient also had a lower back injury on unspecified date where she "pulled her lower back" while exercising. The patient was seen in office on 18-JUN-2013 for abdominal pain. Abdominal and pelvic ultrasounds were performed and were found to be within normal limits. Also a "urine dip" was performed to determine whether a urinary tract infection was present, but the results were negative. No treatment was given, but the abdominal pain had resolved. The outcome of lower back injury was unspecified. The patient had not yet received third dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Haematochezia, Irritability
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to an unknown age and gender patients. Approximately in 2010 ("about 3 years ago" as reported) the patients were vaccinated with a dose of ROTATEQ (lot#batch# unspecified), formulation, route and dose unknown. The patients developed irritability, crying, loose and bloody stools after receiving the first and only dose of ROTATEQ. This was 2 of 2 cases reported for ROTATEQ. The patient had sought medical attention. On an unspecified date, the patient recovered from irritability, crying, loose and bloody stools. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-AUG-2010 the patient was vaccinated with GARDASIL dose 1 (route, dosage and lot number unknown). The nurse reported that the second dose of GARDASIL dose 2 (route, dosage and lot number unknown) was going to be administered on 29-JUL-2013. No adverse effect reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Skin reaction
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (injection, lot #, dose/frequency, duration were unspecified) via the intradermal route. The patient currently reports no adverse effects. The outcome was unknown. Follow up information has been received from a Certified Medical Assistant. It was reported that a male patient with currently 28 years old had a pertinent medical history of seasonal allergies and allergy to penicillin. Also it was reported that on 10-JUL-2013 the patient developed a localized reaction that resolved in 2 days, on 12-JUL-2013. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 74 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 11-JUN-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H015780, expiration date  11-JUN-2014) 0.5 ml, intramuscular. Concomitant therapy was not reported. On 12-JUN-2013, the patient experienced injection site reactions after receiving PNEUMOVAX23, redness and swelling at the injection site. The patient did not receive treatment. The patient called the office and the office informed to monitor the injection site and to call back in 24 hours to follow up with the condition of her arm. It was reported that therapy with PNEUMOVAX23 was continued. At the time of the report the patient was recovering. This is one of two reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 66 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 11-JUN-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H015780, expiration date 11-JUN-2014) 0.5 ml, intramuscular. Concomitant therapy was not reported. On 12-JUN-2013, the patient experienced injection site reactions after receiving PNEUMOVAX23, redness and swelling at the injection site. The patient did not receive treatment. The patient called the office and the office informed to monitor the injection site and to call back in 24 hours to follow up with the condition of her arm. It was reported that therapy with PNEUMOVAX23 was continued. At the time of the report the patient was recovering.  This is one of two cases from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Case number PHHY2013US069552 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 479427) web site on 03 Jul 2013 with the follow-up received from the Quality Assurance Department (reference number: 238920) on 26 Jul 2013. This report refers to a 27-year-old female patient. She was pregnant. Her concomitant medications were not reported. She was vaccinated FLUVIRIN (batch number: 1206901) intramuscularly in the left arm on 06 Dec 2012. On 20 Dec 2012, approximately two weeks after vaccine administration she had a miscarriage. The doctor said that the vaccine might have caused miscarriage because of the gestational age of the fetus (gestational age was not reported). It was reported that the patient had not yet recovered as of 27 Dec 2012. Based on the batch review report received from the quality assurance department on 26 Jul 2013, it was concluded that this FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from the Quality Assurance Department (reference number: 238920) on 26 Jul 2013: Updated batch review report.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 29-JUN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in lower region of the upper arm per doctor's recommendation. Patient's concomitant therapy included unspecified blood pressure medication. After a couple of days, the patient developed an unspecified "local reaction". The pharmacist reported that the patient had recovered from the "local reaction" but she now had a scar at the injection site. Outcome of the scar at the injection site was unknown. The patient went to physician's office on an unspecified date to seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site scar, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 29-JUN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in lower region of the upper arm per doctor's recommendation. Patient's concomitant therapy included unspecified blood pressure medication. After a couple of days, the patient developed an unspecified "local reaction". The pharmacist reported that the patient had recovered from the "local reaction" but she now had a scar at the injection site. Outcome of the scar at the injection site was unknown. The patient went to physician's office on an unspecified date to seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 29-JUN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in lower region of the upper arm per doctor's recommendation. Patient's concomitant therapy included unspecified blood pressure medication. After a couple of days, the patient developed an unspecified "local reaction". The pharmacist reported that the patient had recovered from the "local reaction" but she now had a scar at the injection site. Outcome of the scar at the injection site was unknown. The patient went to physician's office on an unspecified date to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a currently 39 years old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, route reported as injection (dose was not reported), (lot number J005011, exp. date 04-DEC-2014). On an unknown date the patient experienced fever, swelling of the left deltoid and back pain. The patient sought medical attention via visited physician. The patient was not treated for the events. The outcome of back pain, fever and swelling of the left deltoid was not reported. The relatedness between fever, swelling of the left deltoid, back pain and PNEUMOVAX23 was not reported. It was reported that therapy was not reintroduced. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Myalgia
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a currently 39 years old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, route reported as injection (dose was not reported), (lot number J005011, exp. date 04-DEC-2014). On an unknown date the patient experienced fever, swelling of the left deltoid and back pain. The patient sought medical attention via visited physician. The patient was not treated for the events. The outcome of back pain, fever and swelling of the left deltoid was not reported. The relatedness between fever, swelling of the left deltoid, back pain and PNEUMOVAX23 was not reported. It was reported that therapy was not reintroduced. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a currently 39 years old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23, route reported as injection (dose was not reported), (lot number J005011, exp. date 04-DEC-2014). On an unknown date the patient experienced fever, swelling of the left deltoid and back pain. The patient sought medical attention via visited physician. The patient was not treated for the events. The outcome of back pain, fever and swelling of the left deltoid was not reported. The relatedness between fever, swelling of the left deltoid, back pain and PNEUMOVAX23 was not reported. It was reported that therapy was not reintroduced. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Extreme pain in upper arm limited movement/ER visit 2 dr visits, therapy. Patient was given a Tdap vaccination in late July 2013. She saw me in clinic about 10 days later due to persistent severe pain and inability to use her (R) dominant arm. On examination she was markedly tender over the entire deltoid. The deltoid was slightly enlarged relative to the (L). Most remarkable was the general consistency of the deltoid on the (R) - boggy. There was no erythema or increased warmth. It appears that patient has had a significant myopathy from the Tdap injection. It may be that her underlying OTC, metabolic disorder has contributed to an atypical reaction.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Mobility decreased, Myopathy
Clinical narrative: Extreme pain in upper arm limited movement/ER visit 2 dr visits, therapy. Patient was given a Tdap vaccination in late July 2013. She saw me in clinic about 10 days later due to persistent severe pain and inability to use her (R) dominant arm. On examination she was markedly tender over the entire deltoid. The deltoid was slightly enlarged relative to the (L). Most remarkable was the general consistency of the deltoid on the (R) - boggy. There was no erythema or increased warmth. It appears that patient has had a significant myopathy from the Tdap injection. It may be that her underlying OTC, metabolic disorder has contributed to an atypical reaction.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Extreme pain in upper arm limited movement/ER visit 2 dr visits, therapy. Patient was given a Tdap vaccination in late July 2013. She saw me in clinic about 10 days later due to persistent severe pain and inability to use her (R) dominant arm. On examination she was markedly tender over the entire deltoid. The deltoid was slightly enlarged relative to the (L). Most remarkable was the general consistency of the deltoid on the (R) - boggy. There was no erythema or increased warmth. It appears that patient has had a significant myopathy from the Tdap injection. It may be that her underlying OTC, metabolic disorder has contributed to an atypical reaction.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old female daughter. ON 29-JUL-2013 the patient was vaccinated intramuscularly by mistake with first dose of 0.5 ml GARDASIL (lot number, expiry date unspecified). On 29-JUL-2013, the patient exhibited signs of fatigue and dizziness, but was resting comfortably after a night's rest. The outcome of the events was unknown. The patient did not seek medical attention. No treatment was given. Therapy with GARDASIL was reported as stopped on 29-JUL-2013. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old female daughter. ON 29-JUL-2013 the patient was vaccinated intramuscularly by mistake with first dose of 0.5 ml GARDASIL (lot number, expiry date unspecified). On 29-JUL-2013, the patient exhibited signs of fatigue and dizziness, but was resting comfortably after a night's rest. The outcome of the events was unknown. The patient did not seek medical attention. No treatment was given. Therapy with GARDASIL was reported as stopped on 29-JUL-2013. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Burning sensation, Drug hypersensitivity, Pain, Rash generalised, Rash maculo-papular
Clinical narrative: Patient recieved the smallpox vaccination on July 18, 2013, with no restrictions. Then on 29 July she developed a widespread macular, papular rash to her chest, abdomen, lower extremities and upper arms. The rash originated in her left lower leg.  The rash was accompanied with itense itching along with body aches.  Patient described pain as a burning sensation.  She did have a hx of chickenpox as a child.  Initial treatment consisted of Benadryl, calamine lotion and oral acyclovir, as recommended by the CDC.  On 31 July the rash hand intensified, so I had the patient seen by a physician upon pulling into port.  The clinic physician agreed with the current treatment plan and consulted with a dermatologist. Who called the reaction a benign hypersensitivity to vaccinia and prescribed topical triamcinolone and oral Atarax/Claritin.  Upon futher questioning of the patient, we found out that she had a history as a child of hypersensitivity to detergents and other skin conditions.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash pruritic
Clinical narrative: Patient recieved the smallpox vaccination on July 18, 2013, with no restrictions. Then on 29 July she developed a widespread macular, papular rash to her chest, abdomen, lower extremities and upper arms. The rash originated in her left lower leg.  The rash was accompanied with itense itching along with body aches.  Patient described pain as a burning sensation.  She did have a hx of chickenpox as a child.  Initial treatment consisted of Benadryl, calamine lotion and oral acyclovir, as recommended by the CDC.  On 31 July the rash hand intensified, so I had the patient seen by a physician upon pulling into port.  The clinic physician agreed with the current treatment plan and consulted with a dermatologist. Who called the reaction a benign hypersensitivity to vaccinia and prescribed topical triamcinolone and oral Atarax/Claritin.  Upon futher questioning of the patient, we found out that she had a history as a child of hypersensitivity to detergents and other skin conditions.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Computerised tomogram, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Elevated temperature with left deltoid inflammation, pain and redness hospital admit; IV antibiotics; CAT scan and lumbar puncture - 3 days stay.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Lumbar puncture
Clinical narrative: Elevated temperature with left deltoid inflammation, pain and redness hospital admit; IV antibiotics; CAT scan and lumbar puncture - 3 days stay.
Age: 85.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood bilirubin increased, Hepatic failure
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in 2013 (reported within the past few weeks), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiry, route, dose not reported) by a local (unspecified) pharmacist. On an unknown date in 2013 (reported as within the past few weeks), the patient had severely elevated bilirubin levels and was diagnosed with symptoms of liver failure after taking PNEUMOVAX 23. Patient sought medical attention (unspecified). The outcome of liver failure and severely elevated bilirubin levels was unknown. Upon internal review the event liver failure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Blood bilirubin increased, Hepatic failure
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in 2013 (reported within the past few weeks), the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiry, route, dose not reported) by a local (unspecified) pharmacist. On an unknown date in 2013 (reported as within the past few weeks), the patient had severely elevated bilirubin levels and was diagnosed with symptoms of liver failure after taking PNEUMOVAX23. Patient sought medical attention (unspecified). The outcome of liver failure and severely elevated bilirubin levels was unknown. Upon internal review the event liver failure was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Came in with 3 in x 3 in red circular welt on arm at site of injection. Stated it was warm to the touch but not painful. No other problems to report.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Dyspnoea, Muscle spasms, Palpitations
Clinical narrative: Patient woke up at about midnight c/o heart racing, leg spasms, teeth chattering, having trouble taking deep breaths. Leg spasms continued while asleep. Patient woke up feeling much better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient had high fever nothing else going on with him just fever.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: On 7-30-13 Mom stated that the patient had a local reaction to flu vaccine given on 1-18-13 the size of a soft ball. He had no other reactions or complaints. Mom did not have pt checked at the time.
Age: 70.0
Sex: M
Vaccine: MEN
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Computerised tomogram abdomen normal, Fatigue
Clinical narrative: Extreme fatigue, flu like symptoms, fever, transaminitis.
Age: 70.0
Sex: M
Vaccine: MEN
Symptoms: Influenza like illness, Pyrexia, Transaminases increased, Ultrasound abdomen normal
Clinical narrative: Extreme fatigue, flu like symptoms, fever, transaminitis.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Amylase increased, Lipase increased, Pancreatitis acute, Ultrasound abdomen normal
Clinical narrative: Previously healthy 17 year male with acute pancreatitis 4 days following his first dose of GARDASIL HPV vaccine. Symptoms included sudden onset vomiting and epigastric/LUQ abdominal pain. Treated with intravenous antiemetics, analgesics, hydration.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urinary system x-ray normal, Vomiting
Clinical narrative: Previously healthy 17 year male with acute pancreatitis 4 days following his first dose of GARDASIL HPV vaccine. Symptoms included sudden onset vomiting and epigastric/LUQ abdominal pain. Treated with intravenous antiemetics, analgesics, hydration.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Pancreatic enzymes increased, Pancreatitis acute, Ultrasound scan normal
Clinical narrative: Previously healthy 17 year male with acute pancreatitis 4 days following his first dose of GARDASIL HPV vaccine. Symptoms included sudden onset vomiting and epigastric/LUQ abdominal pain. Treated with intravenous antiemetics, analgesics, hydration.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vomiting, X-ray normal
Clinical narrative: Previously healthy 17 year male with acute pancreatitis 4 days following his first dose of GARDASIL HPV vaccine. Symptoms included sudden onset vomiting and epigastric/LUQ abdominal pain. Treated with intravenous antiemetics, analgesics, hydration.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upper left arm got swollen, red 24 hours after vaccination. Patient experienced pain in the area and ended up in the ER.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test normal, Crying, Decorticate posture, Feeling abnormal, Flushing
Clinical narrative: At 1000, KINRIX by SKB AC20B213AA expires 08/29/2014 0.5 ml IM was given in the RVL and MMRV PROQUAD MSD H017885 expires 4/1/2014 0.5ml was given in the left lateral thigh SQ, by APN, CPNP. Child did not cry after either immunization. After the first immunization of DTaP/IPV child states "that felt weird". Almost immediately after completion of the MMRV injection, child slumped, hands were fisted and pulled toward face in a decorticate manner, elbows bent, eyes veered off to the left, face flushed but no cyanosis. Child was laid flat on exam table and immediately came to. Event lasted less than 1 minute. Child then voided and began crying. He did report pain at his injection sites and a faint rash was noted around the injection site of the left thigh. VS- pulsox 100% on RA, pulse 106 and blood pressure 116/85. Child continues to cry and complain of pain. Child and mother instructed to remain in room for observation. Dr. notified. VAERS form completed. 1015- Mother states child continues to cry and say he feels "weird" and try to remove his clothes. At this point another set of VS taken- pulsox 99% RA, heart rate 113, respiratory 34 blood pressure 119/61. It was decided to transport child to hospital for further evaluation via ambulance and 911 called. 1020- ambulance arrives and child transported without incident. He is awake and alert during this time. No rash is still noted. Dr. on call called and informed of events. Filled in on history and described incident in detail. She states that it sounds like a vasovagal response. 1300- Emergency Room called and spoke with Dr. who states child was discharged home after all scans and blood work negative and child doing much better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site rash, Loss of consciousness, Posture abnormal, Presyncope
Clinical narrative: At 1000, KINRIX by SKB AC20B213AA expires 08/29/2014 0.5 ml IM was given in the RVL and MMRV PROQUAD MSD H017885 expires 4/1/2014 0.5ml was given in the left lateral thigh SQ, by APN, CPNP. Child did not cry after either immunization. After the first immunization of DTaP/IPV child states "that felt weird". Almost immediately after completion of the MMRV injection, child slumped, hands were fisted and pulled toward face in a decorticate manner, elbows bent, eyes veered off to the left, face flushed but no cyanosis. Child was laid flat on exam table and immediately came to. Event lasted less than 1 minute. Child then voided and began crying. He did report pain at his injection sites and a faint rash was noted around the injection site of the left thigh. VS- pulsox 100% on RA, pulse 106 and blood pressure 116/85. Child continues to cry and complain of pain. Child and mother instructed to remain in room for observation. Dr. notified. VAERS form completed. 1015- Mother states child continues to cry and say he feels "weird" and try to remove his clothes. At this point another set of VS taken- pulsox 99% RA, heart rate 113, respiratory 34 blood pressure 119/61. It was decided to transport child to hospital for further evaluation via ambulance and 911 called. 1020- ambulance arrives and child transported without incident. He is awake and alert during this time. No rash is still noted. Dr. on call called and informed of events. Filled in on history and described incident in detail. She states that it sounds like a vasovagal response. 1300- Emergency Room called and spoke with Dr. who states child was discharged home after all scans and blood work negative and child doing much better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Scan normal, Urinary incontinence
Clinical narrative: At 1000, KINRIX by SKB AC20B213AA expires 08/29/2014 0.5 ml IM was given in the RVL and MMRV PROQUAD MSD H017885 expires 4/1/2014 0.5ml was given in the left lateral thigh SQ, by APN, CPNP. Child did not cry after either immunization. After the first immunization of DTaP/IPV child states "that felt weird". Almost immediately after completion of the MMRV injection, child slumped, hands were fisted and pulled toward face in a decorticate manner, elbows bent, eyes veered off to the left, face flushed but no cyanosis. Child was laid flat on exam table and immediately came to. Event lasted less than 1 minute. Child then voided and began crying. He did report pain at his injection sites and a faint rash was noted around the injection site of the left thigh. VS- pulsox 100% on RA, pulse 106 and blood pressure 116/85. Child continues to cry and complain of pain. Child and mother instructed to remain in room for observation. Dr. notified. VAERS form completed. 1015- Mother states child continues to cry and say he feels "weird" and try to remove his clothes. At this point another set of VS taken- pulsox 99% RA, heart rate 113, respiratory 34 blood pressure 119/61. It was decided to transport child to hospital for further evaluation via ambulance and 911 called. 1020- ambulance arrives and child transported without incident. He is awake and alert during this time. No rash is still noted. Dr. on call called and informed of events. Filled in on history and described incident in detail. She states that it sounds like a vasovagal response. 1300- Emergency Room called and spoke with Dr. who states child was discharged home after all scans and blood work negative and child doing much better.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Facial pain, Fall, Nausea, Syncope
Clinical narrative: Syncope. Rc'd immunizations. Upon standing pt felt dizzy, nauseous and fell to floor. Soreness Lt cheek from fall. Checked BP. Gave him some water. Waited 10-15 more minutes. Patient felt fine to leave.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Here for 4 y/o physical on 7/30/13. Given IZ's and (L) upper outer arm swollen, hot, red 5 cm x 8 cm area when here. KINRIX and Varicella given on (L) arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Mobility decreased, Skin warm
Clinical narrative: KINRIX administered on 7/24/13 noted by parent's localized reaction 7/26/13. Would not use shoulder or arm, red, warm to touch in office visit 7/27/13, using arm today. Approx area 15 cm x 17 cm involved, still red.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Musculoskeletal stiffness
Clinical narrative: Patient received the vaccine (BOOSTRIX) on 7-5-13. Reported that arm felt stiff or tight that night and remained that way. On 7-10-13 he noticed that the arm was swollen and called to see if that was normal. I referred him to his physician.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Face injury, Fall, Heart rate decreased, Syncope
Clinical narrative: 10/15/12 - received vaccine. 10/16/12 0645- Fainting episode occurred, where pt. fell face first to floor, hitting face - nose, decreased BP, decreased pulse, throat tightness. Pt taken to E.R. per ambulance. BENADRYL, TYLENOL given. Sent home, hives developing, tightness in throat remained until 10/18/12 A.M. F/U with family physician 10/18/12 2:30 p.m. BENADRYL et TYLENOL taken x 2 around clock.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: 10/15/12 - received vaccine. 10/16/12 0645- Fainting episode occurred, where pt. fell face first to floor, hitting face - nose, decreased BP, decreased pulse, throat tightness. Pt taken to E.R. per ambulance. BENADRYL, TYLENOL given. Sent home, hives developing, tightness in throat remained until 10/18/12 A.M. F/U with family physician 10/18/12 2:30 p.m. BENADRYL et TYLENOL taken x 2 around clock.
Age: 18.0
Sex: M
Vaccine: HPV4, MMR, MNQ, HPV4, MMR, MNQ
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: Pt became diaphoretic. C/O "dizziness and blurred vision. 10:53am BP 74/42; 10:58am 84/44; 11:03am 110/54. This is atypical reaction for this patient.
Age: 18.0
Sex: M
Vaccine: HPV4, MMR, MNQ, HPV4, MMR, MNQ
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Pt became diaphoretic. C/O "dizziness and blurred vision. 10:53am BP 74/42; 10:58am 84/44; 11:03am 110/54. This is atypical reaction for this patient.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site swelling, Local swelling, Pyrexia, Vomiting
Clinical narrative: Swelling at injection site immediately vomiting after 30 minutes x 5 for 4 hours total. Fever of 99. Arm still swollen.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Sluggishness
Clinical narrative: 60 hours post-vaccine (12:30 am Sat morning). I had serious diarrhea and stomach cramps that lasted 48 hours. Clear fluid, throat, banana. Felt weak 2 more days and sluggish.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Joint swelling, Oedema peripheral, Pain, Pruritus
Clinical narrative: Armpit and below swollen - itching - stinging. Elbow red and swollen. Used CLARITIN during day and I believe she said BENADRYL at night. Getting better slowly.
Age: 59.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Patient contacted me 7/29/13 stating she had broken out in "bumps" that itch and are red, like hives. States she noticed them evening after receiving vaccines earlier that afternoon. States they are on her face. arms chest and right leg and more. Keep developing. She states they are not painful, but just itch. These lasted 2-3 days and she reports they are much better now. 8/1/13 only treated with "CORT AID".
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Myalgia, Pyrexia, Skin warm
Clinical narrative: States 8-10 hrs post vaccination of Tdap - L arm became red, hot, swollen in biceps and triceps area, not injection site and developed fever of 101 degrees F and myalgia which persists 2 days later.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient with swelling and redness at injection site (Left arm) did not want to use her arm 2" x 1.5 " induration.
Age: 0.13
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Oedema peripheral, Pyrexia, Ultrasound abdomen normal
Clinical narrative: Received vaccines in AM.  That PM, came back to office with fussiness and leg swelling. That night, continued to have fussiness, leg swelling and low grade fevers.  On 7/23/13 went to ED for fussiness, evaluated for intussusception - work up negative. Seen again in office on 7/24/13.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient reported to RN on 4/10/2013 AM that right upper arm was sore with large area of hard tissue noted around injection site.  Patient reported the area of hard tissue had increased overnight.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Pt complain of pain at site of injection.  RN noted posterior deltoid reddened, swollen and warm to touch.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling from the elbow to the shoulder, redness, heat and a gray spot where the shot was adminstered. The reaction is still present 3 days post injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated, Rash, Skin lesion
Clinical narrative: Disseminated zoster- majority of rash in V1 distribution, with other lesions on arms and chin.
Age: 0.53
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: RASH TX WITH BENADRYL PROGRESSIVE WORSE. SEEN FACILITY DX ERYTHEMA MULTIFORME, UNSPECIFIED.
Age: 0.53
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: RASH TX WITH BENADRYL PROGRESSIVE WORSE. SEEN FACILITY DX ERYTHEMA MULTIFORME, UNSPECIFIED.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Pruritus, Urticaria
Clinical narrative: Dizzy disoriented. Evening had itching in scalp base progressing to entire scalp. Next day had hives on chest.