chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Fatigue, Infection, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: After being seen I went home and suddenly felt tired and feverish. I got up at 4 o'clock that even and my right arm was heavy and painful. I had spiked a temp of 103.6 at the time. My Friday 12/23/2016 my fever got worst. I spiked a temp of 104.3. I was take to the hospital and was take to surgery. I stayed in the hospital a few days.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: After being seen I went home and suddenly felt tired and feverish. I got up at 4 o'clock that even and my right arm was heavy and painful. I had spiked a temp of 103.6 at the time. My Friday 12/23/2016 my fever got worst. I spiked a temp of 104.3. I was take to the hospital and was take to surgery. I stayed in the hospital a few days.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Sleep disorder
Clinical narrative: Case number PHEH2017US003444, is an initial spontaneous report received from a consumer on 01 Feb 2017. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN prefilled syringe (PFS) (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 30 Jan 2017. After vaccination, that night, she took XANAX to help her sleep. She had problems sleeping throughout the night and she mentioned that reaction was strange because the XANAX usually allowed her to have hours of continual sleep. Patient stated that Monday and Tuesday combined, she had two hours of sleep and it happened 2 nights in a row. She also stated that the shot was the only thing different she had done. Patient believed that the FLUVIRIN had caused her abnormal sleeping patterns. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as serious (disability and medically significant). The causality of the event was reported as suspected by the consumer.
Age: 69.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia, Arthralgia and muscle/joint pain in shoulders/hips/knees.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Knot on leg from injection a week after shot. Swelling and pain on (R) back of thigh, hard, firm, red swelling/bruising of around 2cm by 2cm. DX with vaccination reaction swelling, treated with TYLENOL/MOTRIN/ice.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Knot on leg from injection a week after shot. Swelling and pain on (R) back of thigh, hard, firm, red swelling/bruising of around 2cm by 2cm. DX with vaccination reaction swelling, treated with TYLENOL/MOTRIN/ice.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Adverse drug reaction, Dizziness, Nausea, Paraesthesia
Clinical narrative: Pt. reported feeling dizzy, nauseous, light headed and tingling all over body. 15 minutes after vaccine - still feeling same. 1 hour later - taken to ED for evaluation. Dx: Adverse drug reaction and D/C stable.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Optic neuritis
Clinical narrative: Optic Neuritis.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Reoccurring pain in left arm after PREVNAR vaccine administered 8/13/16 and continuing as of 2/3/17; patient has sought no medical attention against pharmacists advice to do so.
Age: 81.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: No adverse event
Clinical narrative: No adverse events.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2015US173944, is an initial spontaneous report received form the Vaccine Adverse Event Reporting System (VAERS reference number: 603461) website on 29 Dec 2015. This report refers to a 52-years-old-female patient. Past medical history included pre diabetes and coronary artery disease (CAD). Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 15 Oct 2015. She was also vaccinated with PNEUMOVAX (batch number: L012521) intramuscularly in right arm on 15 Oct 2015. On 16 Oct 2015, she experienced redness and swelling in arm within 24 hrs. She visited to emergency room as redness worsened and treated with KEFLEX. She was treated with prednisone (manufacturer unknown), BENADRYL and ZANTAC. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Crying, Inflammation, Pain, Paraesthesia, Rash
Clinical narrative: Case number PHHY2015US173909, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 607495) website on 29 Dec 2015. This report refers to a 41 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 23 Oct 2015. On 30 Oct 2015, the patient experienced tingling and prickling, inflammation close to eye causing weeping, pain and developed secretion discharge. On 01 Nov 2015, the patient experienced rash appeared in band like shapes on the right side of body. The patient treated with Acyclovir. The patient visited to the emergency room. The outcome of the events was reported as condition unchanged. The serious of the events was reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Secretion discharge
Clinical narrative: Case number PHHY2015US173909, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 607495) website on 29 Dec 2015. This report refers to a 41 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 23 Oct 2015. On 30 Oct 2015, the patient experienced tingling and prickling, inflammation close to eye causing weeping, pain and developed secretion discharge. On 01 Nov 2015, the patient experienced rash appeared in band like shapes on the right side of body. The patient treated with Acyclovir. The patient visited to the emergency room. The outcome of the events was reported as condition unchanged. The serious of the events was reported as non-serious. The causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood folate decreased, Blood iron decreased, Body temperature increased, Cellulitis, Dysphonia
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Dyspnoea, Erythema, Fatigue, Folate deficiency, Injection site injury
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site swelling, Iron deficiency, Laboratory test normal, Local swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Pulmonary function test normal, Skin discolouration, Vitamin B12 decreased, Vitamin B12 deficiency, Vitamin D decreased
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Vitamin D deficiency
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Dyspnoea, Fatigue, Folate deficiency, Iron deficiency, Laboratory test normal
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Local swelling, Peripheral swelling, Pulmonary function test normal, Skin discolouration, Vitamin B12 decreased
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Vitamin B12 deficiency, Vitamin D decreased, Vitamin D deficiency
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (manufacturer report number: 2017014189) referring a 65 year old female patient. The patient's medical history include cowpox (reported as "cox pox") after receiving an unspecified small pox vaccine. Her concurrent conditions included thyroid disease. On 20-APR-2016, the patient was vaccinated with ZOSTER VACCINE LIVE and PREVNAR 13; both in the left arm, dose and route unknown, for medicare wellness check-up (prophylaxis). Concomitant therapies included ARMOUR THYROID. The patient thought that the nurse who administered it hit a nerve or the bone. Subsequently within 2 days in, April 2016, the patient experienced cellulitis and within a week she had a 102 degree temperature and swelling that started in her left arm went up and around her neck then back down her right arm. The swelling also developed a red-purple hue. The cellulitis and temperature had gone away, but the swelling and red-purple would comes back anytime her body was under duress or she exerts herself doing something really physical, but the recurrences had lessened with the colder weather. Starting around August 2016, she began to experience breathlessness, feeling very fatigued and experiencing a hoarse throat that was not sore. She had multiple done tests and had her pulmonary function tested and nothing was detected as being wrong. She also had blood work done in December 2016 and it was discovered that she had developed vitamin deficiencies. She was deficient in vitamin B12, vitamin D, iron and folic acid. The outcome of cellulitis and body temperature increased was reported as recovered, while swelling and skin discoloration were indicated to be recovering. The outcome of dyspnoea, folate deficiency, iron deficiency, vitamin D deficiency, vitamin B12 deficiency and dysphonia was reported as not recovered. The relatedness of the events with the vaccines was not assessed. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vaccination site infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for two patients. This is the second of two reports. A 69-year-old female patient of an unspecified race received PREVNAR 13 (lot N97935, exp. date Dec2017) for immunization on 30Nov2016 via intramuscular route into the left deltoid at 0.5ml single dose. On the same date the patient also received FLUZONE (Manufacturer: Sanofi, Lot Number: UI689AA, Expiry Date:26Apr2017), via intramuscular into right deltoid. Medical history and concomitant medication were unknown. On an unknown date the patient experienced vaccination site infection about three weeks after receiving the product. The patient was prescribed BACTRIM DS, 800/160mg one tablet by mouth twice daily for 7 days to treat injection site infection. Start date of this treatment was 07Dec2016. The outcome of the event was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017050791 same reporter, different patient, same drug/event.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of two reports. A 76 year old female patient of an unspecified race and ethnicity received, on 18Jan2017, the first dose of PREVNAR 13(Lot. N97935, Expiration date: Dec2017, NDC number: 00005197102) intramuscularly, in the left deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient was not ill at the time of vaccination. On an unspecified date, in Jan2017, the patient experienced infection at the injection site. Clinical outcome of the event was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017050795 Same reporter, different patient, same drug/event.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site infection
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of two reports. A 76 year old female patient of an unspecified race and ethnicity received, on 18Jan2017, the first dose of PREVNAR 13(Lot. N97935, Expiration date: Dec2017, NDC number: 00005197102) intramuscularly, in the left deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient was not ill at the time of vaccination. On an unspecified date, in Jan2017, the patient experienced infection at the injection site. Clinical outcome of the event was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017050795 Same reporter, different patient, same drug/event.
Age: 1.17
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying a 14-month-old male patient who received KINRIX. On 24th January 2017, the patient received KINRIX. On 24th January 2017, several hours after receiving KINRIX, the patient experienced crying, tremor, irritability, difficulty sleeping and inappropriate age at vaccine administration. On 25th January 2017, the patient experienced walking difficulty. On an unknown date, the outcome of the crying, tremor, walking difficulty, irritability, difficulty sleeping and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying, tremor, walking difficulty, irritability and difficulty sleeping to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The patient never had an issue with previous vaccines before. Mother of the patient reported that her son received the KINRIX vaccine in error at the age of 14 months. Thus, it led to inappropriate age at vaccine administration as the dosage was for 4 to 6 years olds. On the same day, the patient received four other shots along with the polio shot. The patient was crying, fussy, shaking and had difficulty sleeping in the night of 24th January 2016. The patient finally fell asleep and in the morning could not walk or move. He could sit up and crawl but he could not get up to walk. The patient's mother claimed he wasn't like that prior to KINRIX vaccine and was usually a happy baby. It was reported that, additional information provided after call review since the information was not captured by medical information during their initial phone conversation. When the Mother was transferred to the response center, she claimed that she already provided the information to Medical Information. No additional information was available.
Age: 1.17
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Crying, Drug administered to patient of inappropriate age, Gait disturbance, Insomnia, Irritability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying a 14-month-old male patient who received KINRIX. On 24th January 2017, the patient received KINRIX. On 24th January 2017, several hours after receiving KINRIX, the patient experienced crying, tremor, irritability, difficulty sleeping and inappropriate age at vaccine administration. On 25th January 2017, the patient experienced walking difficulty. On an unknown date, the outcome of the crying, tremor, walking difficulty, irritability, difficulty sleeping and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying, tremor, walking difficulty, irritability and difficulty sleeping to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The patient never had an issue with previous vaccines before. Mother of the patient reported that her son received the KINRIX vaccine in error at the age of 14 months. Thus, it led to inappropriate age at vaccine administration as the dosage was for 4 to 6 years olds. On the same day, the patient received four other shots along with the polio shot. The patient was crying, fussy, shaking and had difficulty sleeping in the night of 24th January 2016. The patient finally fell asleep and in the morning could not walk or move. He could sit up and crawl but he could not get up to walk. The patient's mother claimed he wasn't like that prior to KINRIX vaccine and was usually a happy baby. It was reported that, additional information provided after call review since the information was not captured by medical information during their initial phone conversation. When the Mother was transferred to the response center, she claimed that she already provided the information to Medical Information. No additional information was available.
Age: 1.17
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying a 14-month-old male patient who received KINRIX. On 24th January 2017, the patient received KINRIX. On 24th January 2017, several hours after receiving KINRIX, the patient experienced crying, tremor, irritability, difficulty sleeping and inappropriate age at vaccine administration. On 25th January 2017, the patient experienced walking difficulty. On an unknown date, the outcome of the crying, tremor, walking difficulty, irritability, difficulty sleeping and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying, tremor, walking difficulty, irritability and difficulty sleeping to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The patient never had an issue with previous vaccines before. Mother of the patient reported that her son received the KINRIX vaccine in error at the age of 14 months. Thus, it led to inappropriate age at vaccine administration as the dosage was for 4 to 6 years olds. On the same day, the patient received four other shots along with the polio shot. The patient was crying, fussy, shaking and had difficulty sleeping in the night of 24th January 2016. The patient finally fell asleep and in the morning could not walk or move. He could sit up and crawl but he could not get up to walk. The patient's mother claimed he wasn't like that prior to KINRIX vaccine and was usually a happy baby. It was reported that, additional information provided after call review since the information was not captured by medical information during their initial phone conversation. When the Mother was transferred to the response center, she claimed that she already provided the information to Medical Information. No additional information was available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood culture, Chest X-ray normal, Culture urine, Full blood count normal, Influenza virus test negative
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient did not have pertinent medical history, drug allergies or reactions. On 25-JAN-2017, the patient was vaccinated with VARIVAX (which had the lot # M027342, expiration date 01-JUN-2018) subcutaneously in the left thigh, for routine vaccination. On the same date, the patient was vaccinated with M-M-R II (which had the lot # reported as M028130, expiration date 03-JUN-2018) subcutaneously, in the right thigh, for routine vaccination. Dosage information was not reported for both vaccines. There was no concomitant medication. On an unknown date in January 2017 (reported as "on an unspecified date before experiencing the seizure but after 25-JAN-2017"), the patient experienced diarrhoea and a fever of 103F. Subsequently, on 31-JAN-2017, the patient experienced seizure. The patient was taken to the emergency department where she received an unspecified dose of ROCEPHIN for treatment. While in the emergency department, the following studies were performed: Complete Blood Count, blood culture, C-reactive protein, Chest x-ray, Respiratory Syncytial Virus, influenza, and urine culture, however the results were unknown. The patient was not admitted to the hospital. On 02-FEB-2017, during an examination the physician noted that the injection site of the VARIVAX exhibited a "large welt, like a big hive, but there was no rash" (vaccination site urticaria). The physician also noted that the patient appeared to have an ear infection. The patient was currently recovering but was "still fussy". When the physician was asked if the adverse experience was life threatening, the physician stated, "A seizure was a moderate risk". There was no product quality complaint. The causality assessment between VARIVAX and M-M-R II and the reported events was not provided. Upon internal review the event seizure was determined to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site urticaria, Pyrexia, Respiratory syncytial virus test negative, Seizure, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient did not have pertinent medical history, drug allergies or reactions. On 25-JAN-2017, the patient was vaccinated with VARIVAX (which had the lot # M027342, expiration date 01-JUN-2018) subcutaneously in the left thigh, for routine vaccination. On the same date, the patient was vaccinated with M-M-R II (which had the lot # reported as M028130, expiration date 03-JUN-2018) subcutaneously, in the right thigh, for routine vaccination. Dosage information was not reported for both vaccines. There was no concomitant medication. On an unknown date in January 2017 (reported as "on an unspecified date before experiencing the seizure but after 25-JAN-2017"), the patient experienced diarrhoea and a fever of 103F. Subsequently, on 31-JAN-2017, the patient experienced seizure. The patient was taken to the emergency department where she received an unspecified dose of ROCEPHIN for treatment. While in the emergency department, the following studies were performed: Complete Blood Count, blood culture, C-reactive protein, Chest x-ray, Respiratory Syncytial Virus, influenza, and urine culture, however the results were unknown. The patient was not admitted to the hospital. On 02-FEB-2017, during an examination the physician noted that the injection site of the VARIVAX exhibited a "large welt, like a big hive, but there was no rash" (vaccination site urticaria). The physician also noted that the patient appeared to have an ear infection. The patient was currently recovering but was "still fussy". When the physician was asked if the adverse experience was life threatening, the physician stated, "A seizure was a moderate risk". There was no product quality complaint. The causality assessment between VARIVAX and M-M-R II and the reported events was not provided. Upon internal review the event seizure was determined to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Diarrhoea
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient did not have pertinent medical history, drug allergies or reactions. On 25-JAN-2017, the patient was vaccinated with VARIVAX (which had the lot # M027342, expiration date 01-JUN-2018) subcutaneously in the left thigh, for routine vaccination. On the same date, the patient was vaccinated with M-M-R II (which had the lot # reported as M028130, expiration date 03-JUN-2018) subcutaneously, in the right thigh, for routine vaccination. Dosage information was not reported for both vaccines. There was no concomitant medication. On an unknown date in January 2017 (reported as "on an unspecified date before experiencing the seizure but after 25-JAN-2017"), the patient experienced diarrhoea and a fever of 103F. Subsequently, on 31-JAN-2017, the patient experienced seizure. The patient was taken to the emergency department where she received an unspecified dose of ROCEPHIN for treatment. While in the emergency department, the following studies were performed: Complete Blood Count, blood culture, C-reactive protein, Chest x-ray, Respiratory Syncytial Virus, influenza, and urine culture, however the results were unknown. The patient was not admitted to the hospital. On 02-FEB-2017, during an examination the physician noted that the injection site of the VARIVAX exhibited a "large welt, like a big hive, but there was no rash" (vaccination site urticaria). The physician also noted that the patient appeared to have an ear infection. The patient was currently recovering but was "still fussy". When the physician was asked if the adverse experience was life threatening, the physician stated, "A seizure was a moderate risk". There was no product quality complaint. The causality assessment between VARIVAX and M-M-R II and the reported events was not provided. Upon internal review the event seizure was determined to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Ear infection, Full blood count, Influenza virus test, Injection site reaction, Injection site urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient did not have pertinent medical history, drug allergies or reactions. On 25-JAN-2017, the patient was vaccinated with VARIVAX (which had the lot # M027342, expiration date 01-JUN-2018) subcutaneously in the left thigh, for routine vaccination. On the same date, the patient was vaccinated with M-M-R II (which had the lot # reported as M028130, expiration date 03-JUN-2018) subcutaneously, in the right thigh, for routine vaccination. Dosage information was not reported for both vaccines. There was no concomitant medication. On an unknown date in January 2017 (reported as "on an unspecified date before experiencing the seizure but after 25-JAN-2017"), the patient experienced diarrhoea and a fever of 103F. Subsequently, on 31-JAN-2017, the patient experienced seizure. The patient was taken to the emergency department where she received an unspecified dose of ROCEPHIN for treatment. While in the emergency department, the following studies were performed: Complete Blood Count, blood culture, C-reactive protein, Chest x-ray, Respiratory Syncytial Virus, influenza, and urine culture, however the results were unknown. The patient was not admitted to the hospital. On 02-FEB-2017, during an examination the physician noted that the injection site of the VARIVAX exhibited a "large welt, like a big hive, but there was no rash" (vaccination site urticaria). The physician also noted that the patient appeared to have an ear infection. The patient was currently recovering but was "still fussy". When the physician was asked if the adverse experience was life threatening, the physician stated, "A seizure was a moderate risk". There was no product quality complaint. The causality assessment between VARIVAX and M-M-R II and the reported events was not provided. Upon internal review the event seizure was determined to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Respiratory syncytial virus test, Seizure, Urticaria
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient did not have pertinent medical history, drug allergies or reactions. On 25-JAN-2017, the patient was vaccinated with VARIVAX (which had the lot # M027342, expiration date 01-JUN-2018) subcutaneously in the left thigh, for routine vaccination. On the same date, the patient was vaccinated with M-M-R II (which had the lot # reported as M028130, expiration date 03-JUN-2018) subcutaneously, in the right thigh, for routine vaccination. Dosage information was not reported for both vaccines. There was no concomitant medication. On an unknown date in January 2017 (reported as "on an unspecified date before experiencing the seizure but after 25-JAN-2017"), the patient experienced diarrhoea and a fever of 103F. Subsequently, on 31-JAN-2017, the patient experienced seizure. The patient was taken to the emergency department where she received an unspecified dose of ROCEPHIN for treatment. While in the emergency department, the following studies were performed: Complete Blood Count, blood culture, C-reactive protein, Chest x-ray, Respiratory Syncytial Virus, influenza, and urine culture, however the results were unknown. The patient was not admitted to the hospital. On 02-FEB-2017, during an examination the physician noted that the injection site of the VARIVAX exhibited a "large welt, like a big hive, but there was no rash" (vaccination site urticaria). The physician also noted that the patient appeared to have an ear infection. The patient was currently recovering but was "still fussy". When the physician was asked if the adverse experience was life threatening, the physician stated, "A seizure was a moderate risk". There was no product quality complaint. The causality assessment between VARIVAX and M-M-R II and the reported events was not provided. Upon internal review the event seizure was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 09-MAY-2012, the patient was vaccinated with one dose of GARDASIL (strength, route of administration, dose, frequency, lot # reported as L027282 and expiration date were not provided) for prophylaxis, then on 26-APR-2016, the patient received a second dose of GARDASIL (strength, route of administration, dose, frequency, lot# and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). Also the nurse reported that, on 27-MAY-2016, the patient was vaccinated with one dose of GARDASIL 9(strength, route of administration, dose, frequency, lot# M007728 and expiration date were not provided) for prophylaxis, and subsequently on 28-JUN-2016 received a second dose of GARDASIL 9 (strength, route of administration, dose, frequency, lot# and expiration date were not provided) for prophylaxis (interchange of vaccine products). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 09-MAY-2012, the patient was vaccinated with one dose of GARDASIL (strength, route of administration, dose, frequency, lot # reported as L027282 and expiration date were not provided) for prophylaxis, then on 26-APR-2016, the patient received a second dose of GARDASIL (strength, route of administration, dose, frequency, lot# and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). Also the nurse reported that, on 27-MAY-2016, the patient was vaccinated with one dose of GARDASIL 9(strength, route of administration, dose, frequency, lot# M007728 and expiration date were not provided) for prophylaxis, and subsequently on 28-JUN-2016 received a second dose of GARDASIL 9 (strength, route of administration, dose, frequency, lot# and expiration date were not provided) for prophylaxis (interchange of vaccine products). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Reddened face, burning cheeks, itching behind ears.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site plaque, Injection site vesicles, Rash vesicular
Clinical narrative: Information has been received from a pediatric dermatology fellow concerning a 15 month old boy patient. The patient did not have pertinent medical history or drug reactions/allergies. On an unknown date in 2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot#, expiration date, strength, dose, frequency route were not reported) for prophylaxis on left thigh. On an unknown date (90 days following the varicella vaccine), the patient experienced numerous vesicles on erythematous plaques on two left thighs (medical), knee extending onto anterolateral skin L4 L5 derivational dermatan distribution. The outcome of vesicular rash was unknown. The causality assessment between the event and varicella virus vaccine live (oka/merck) (manufacturer unknown) was unknown. Additional information has been requested.