chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Biopsy skin abnormal, Dermatitis acneiform, Eczema, Folliculitis
Clinical narrative: This case was reported by a consumer and described the occurrence of skin necrosis in a 42-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. Previously administered products included hepatitis B vaccine with an associated reaction of no adverse event (1st dose). On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine (unknown) and the 3rd dose of Hepatitis B vaccine (unknown). On an unknown date, 48 hours after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced skin necrosis (serious criteria GSK medically significant), skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection. On an unknown date, the outcome of the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection were not recovered/not resolved. It was unknown if the reporter considered the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional information: The female patient was vaccinated with a HepB vaccine series received 5 years ago at age 42. Within 48 hours after the second shot of Hepatitis B vaccine, her skin began breaking out in wounds. She had scars on her shoulders in the similar pattern of the shots (double as much on the left) but her main problem was her head. She had never ending acneiform lesions from ruptured hair follicles with chronic Granulomatous Inflammation and Necrosis. She got a biopsy that confirmed the above scalp issues. She hasn't scars on legs, hands, face or stomach. She was given the 3rd of the series despite having alopecia, skin lesion (head and arms), and treatment for 3 infectious diseases between the second and 3rd shot. Additionally, she had an area in her head that went pure white too and she heard this was due to trauma. At this point, her head/scalp had white acneiform lesions, prurigo nodules, ruptured hair follicles, viscid fluid, granulomatous inflammation, and necrotic tissue. She also get ID reactions (autoeczematization) at other sites of body from it.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Granuloma, Infection, Inflammation, Neurodermatitis, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of skin necrosis in a 42-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. Previously administered products included hepatitis B vaccine with an associated reaction of no adverse event (1st dose). On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine (unknown) and the 3rd dose of Hepatitis B vaccine (unknown). On an unknown date, 48 hours after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced skin necrosis (serious criteria GSK medically significant), skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection. On an unknown date, the outcome of the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection were not recovered/not resolved. It was unknown if the reporter considered the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional information: The female patient was vaccinated with a HepB vaccine series received 5 years ago at age 42. Within 48 hours after the second shot of Hepatitis B vaccine, her skin began breaking out in wounds. She had scars on her shoulders in the similar pattern of the shots (double as much on the left) but her main problem was her head. She had never ending acneiform lesions from ruptured hair follicles with chronic Granulomatous Inflammation and Necrosis. She got a biopsy that confirmed the above scalp issues. She hasn't scars on legs, hands, face or stomach. She was given the 3rd of the series despite having alopecia, skin lesion (head and arms), and treatment for 3 infectious diseases between the second and 3rd shot. Additionally, she had an area in her head that went pure white too and she heard this was due to trauma. At this point, her head/scalp had white acneiform lesions, prurigo nodules, ruptured hair follicles, viscid fluid, granulomatous inflammation, and necrotic tissue. She also get ID reactions (autoeczematization) at other sites of body from it.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Scar, Skin lesion, Skin necrosis, Wound
Clinical narrative: This case was reported by a consumer and described the occurrence of skin necrosis in a 42-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. Previously administered products included hepatitis B vaccine with an associated reaction of no adverse event (1st dose). On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine (unknown) and the 3rd dose of Hepatitis B vaccine (unknown). On an unknown date, 48 hours after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced skin necrosis (serious criteria GSK medically significant), skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection. On an unknown date, the outcome of the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection were not recovered/not resolved. It was unknown if the reporter considered the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional information: The female patient was vaccinated with a HepB vaccine series received 5 years ago at age 42. Within 48 hours after the second shot of Hepatitis B vaccine, her skin began breaking out in wounds. She had scars on her shoulders in the similar pattern of the shots (double as much on the left) but her main problem was her head. She had never ending acneiform lesions from ruptured hair follicles with chronic Granulomatous Inflammation and Necrosis. She got a biopsy that confirmed the above scalp issues. She hasn't scars on legs, hands, face or stomach. She was given the 3rd of the series despite having alopecia, skin lesion (head and arms), and treatment for 3 infectious diseases between the second and 3rd shot. Additionally, she had an area in her head that went pure white too and she heard this was due to trauma. At this point, her head/scalp had white acneiform lesions, prurigo nodules, ruptured hair follicles, viscid fluid, granulomatous inflammation, and necrotic tissue. She also get ID reactions (autoeczematization) at other sites of body from it.
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 weeks and 2 days old female infant. The pertinent medical history and concomitant medications were not reported. On 17-MAR-2015, the patient was vaccinated with ROTATEQ dose 1, 2 ml, oral. No adverse event was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Immunized 3/3 returned on 3/5 with warm diffuse swelling of (R) arm- no fever, no itch, mild pain.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: Non-stop crying, localized reaction to left leg, redness to left lower extremity.
Age: 4.0
Sex: M
Vaccine: RV5
Symptoms: Clostridium test, Diarrhoea, Full blood count, Metabolic function test, Nausea
Clinical narrative: Information has been received from a medical assistant refers to a 4 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a 2 ml dose of ROTATEQ (lot # 668036/0594Z, Exp date 23-MAR-2012, oral). There were no concomitant medications. On unspecified dates, it had been tested with positive for Rotavirus. Medical assistant reported that on 04-MAR-2015 the patient was seen in the nurse practitioner's office after experiencing diarrhoea, nausea and vomiting. A stool sample was collected and did test positive for Rotavirus. Medical assistant reported that a basic metabolic panel, complete blood count and a stool test for Clostridium difficile was also performed on the child without result provided. The patient sought medical attention and the child was treated with oral fluids. The outcome of nausea, vomiting, diarrhoea and rotavirus test positive was unknown. This is one of the several reports from same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a medical assistant refers to a 4 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a 2 ml dose of ROTATEQ (lot # 668036/0594Z, Exp date 23-MAR-2012, oral). There were no concomitant medications. On unspecified dates, it had been tested with positive for Rotavirus. Medical assistant reported that on 04-MAR-2015 the patient was seen in the nurse practitioner's office after experiencing diarrhoea, nausea and vomiting. A stool sample was collected and did test positive for Rotavirus. Medical assistant reported that a basic metabolic panel, complete blood count and a stool test for Clostridium difficile was also performed on the child without result provided. The patient sought medical attention and the child was treated with oral fluids. The outcome of nausea, vomiting, diarrhoea and rotavirus test positive was unknown. This is one of the several reports from same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash
Clinical narrative: Pt came in for a Tdap (ADACEL) shot on 3/10/15. When I went through allergies she had allergy to latex. I told her I was uncomfortable and did not want to give it to her because the cap had latex in it. She wanted to proceed and have me call her Dr. I called her Dr and he wanted pt to go ahead and get but while taking 50mg of BENADRYL. On 3-11-15 pt called stated all was ok no problems to report. On 3-18-15 pt called and stated she had a rash at the injected site and took BENADRYL. I called on 3-19-15 she stated the rash was small and almost gone and she did not want to go to the dr or call the dr.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, MMRV, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives and fever continuing til today. Controlled for a few hours with BENADRYL and ibuprofen. Further w/o pending.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: (+) 3cm x 3cm indurated erythematous area.
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling and pain at injection site (varicella injection site).
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling and pain at injection site (varicella injection site).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. On 26-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported). On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced burning red mark on arm at the injection site. The outcome of burning red mark on arm at the injection site was reported as not recovered/not resolved. Causality between burning red mark on arm at the injection site and ZOSTAVAX was not provided. Additional information is not expected as no patient's physician's contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 18-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, MMRV, MMR, MMRV
Symptoms: Extra dose administered, Irritability
Clinical narrative: This spontaneous report was received from a health professional refers to a 12 month old female patient. No pertinent medical history or any known allergies were reported. On 17-MAR-2015 the patient was inadvertently vaccinated with PROQUAD (Merck), IPV (unspecified) and M-M-R II. Patient's parent stated that the patient was fussy before nap time. Patient sought medical attention and nurse was called. No lab diagnostic studies were performed. No treatment was given for the adverse events. Outcome of the events were unknown. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, MMRV, MMR, MMRV
Symptoms: Irritability
Clinical narrative: This spontaneous report was received from a health professional refers to a 12 month old female patient. No pertinent medical history or any known allergies were reported. On 17-MAR-2015 the patient was inadvertently vaccinated with PROQUAD (Merck), IPV (unspecified) and M-M-R II. Patient's parent stated that the patient was fussy before nap time. Patient sought medical attention and nurse was called. No lab diagnostic studies were performed. No treatment was given for the adverse events. Outcome of the events were unknown. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 24-SEP-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Neck pain, Pain in extremity, Rash
Clinical narrative: Patient came to the pharmacy because she had adverse reaction to ZOSTAVAX vaccine. The symptoms were redness at the injection site, rash that extend the left side of the body and pain that extends from the neck to left arm. She visited emergency room and the treatment was Azithromycin 250 mg and CATAFLAM 50 mg. The day after, she states the rash gone and pain was reduced a lot.
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 05-FEB-2015 (also reported as approximately 5 weeks ago) the patient received the second dose of RECOMBIVAX HB (route, dose, frequency and lot # not reported) and was experiencing at the time of the report (also reported as now) headaches and joint tenderness without swelling. Onset of these symptoms was unknown. The outcomes of the events were reported as not recovered. The relatedness between the events and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date of 2015 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (injection, expiration date 17-FEB-2015, lot#, dose, route and strength were not provided). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected as the reporter didn't want to be contact.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to three patients of unknown age and gender. On unknown dates of 2015 the patients was vaccinated with a dose of PNEUMOVAX 23, (injection, lot # J013345, expiration date 11-JAN-2015, dose, route and strength were not provided). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected as the reporter didn't want to be contact.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Back pain, Blood alkaline phosphatase increased, Blood bilirubin increased
Clinical narrative: Normal ALT/AST and bilirubin lab values and non-reactive Hepatitis Panel on 1/26/2015. Pt. received TWINRIX Hep A and Hep B at our clinic on 2/23/15. Pt called on 2/25/15 complaining of hematuria, vague sickness, and a sore back. Went to E.R. Labs: Alk Phos 310; AST 2203; ALT 3194 -> Dx as unspecified hepatitis. Follow up at our clinic on 3/03/15 for hepatitis. Labs: Alk Phos: 207; AST-2072; ALT 2359; bilirubin, total-7.7. Hep Panels non reactive for A-B-C.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Haematuria, Hepatitis, Hepatitis viral test negative, Malaise
Clinical narrative: Normal ALT/AST and bilirubin lab values and non-reactive Hepatitis Panel on 1/26/2015. Pt. received TWINRIX Hep A and Hep B at our clinic on 2/23/15. Pt called on 2/25/15 complaining of hematuria, vague sickness, and a sore back. Went to E.R. Labs: Alk Phos 310; AST 2203; ALT 3194 -> Dx as unspecified hepatitis. Follow up at our clinic on 3/03/15 for hepatitis. Labs: Alk Phos: 207; AST-2072; ALT 2359; bilirubin, total-7.7. Hep Panels non reactive for A-B-C.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in September 2014 (reported as Fall 2014) the patient was vaccinated with VARIVAX (Merck) (dose and lot number unknown). No concomitant medications were reported. On an unknown date in December 2014 (reported as after 2 to 3 months) the patient experienced negative titers. Lab tests included serology titer for varicella. The outcome of the event was unknown. Patient sought medical attention, saw pharmacist. No product quality complaint was involved. The outcome of the event negative titers was unknown. The reporter causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse refers to two unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of an improperly stored VARIVAX (Merck) (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female patient. The patient's pertinent medical history included "upper respiratory type stuff". There was no drug reactions/allergies reported. In OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route not reported). On 26-FEB-2015 the patient was vaccinated with another 0.5 ml dose of PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016, subcutaneous). Other suspect therapies included a vaccination of ZOSTAVAX that occurred in JAN-2015. Concomitant therapies included SYMBICORT. On 27-FEB-2015 the patient called into the pharmacy stating that she developed a "red and swollen area that was 3 or 4 inches" at the injection site. There was no treatment given for the event and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered from the event. Additional information has been requested.
Sex: U
Vaccine: MMRV, MMRV
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 25-FEB-2015 the patient was vaccinated with PROQUAD (Merck) (dose 1; dosage, route and lot number unknown). The nurse reported that on 12-MAR-2015 the patient received a 2nd dose of PROQUAD (Merck) (dose 2; dosage, route and lot number unknown). No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 3" x 5", red raised area, hot to touch, sore.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Fall, Loss of consciousness, Nervousness, Tremor
Clinical narrative: Pt. received PCV-13 in clinic today at 11:00 am. Reports that he felt shaky after injection. About 4 hrs later while walking around store, his "eyes blacked out" and he dropped to floor. No LOC. One hr. later he feels better but still shaky.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dry throat, Erythema, Head discomfort, Pruritus, Rash erythematous
Clinical narrative: 9:10 am PREVNAR given, 9:25 she stated felt funny in the head, itch hands, feet with face and neck red, felt swollen. 10:33 am overall skin red blotchy, throat felt dry and right side throat felt like some thing in it. 11:02am returned to clinic. Blotchy red rash undersurface of arms bilaterally, chest abdomen and legs. No breathing diff. SOLUMEDROL given. Improvement noted in 20 mins. BENADRYL also as prescribed by provider.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular, Sensation of foreign body, Swelling
Clinical narrative: 9:10 am PREVNAR given, 9:25 she stated felt funny in the head, itch hands, feet with face and neck red, felt swollen. 10:33 am overall skin red blotchy, throat felt dry and right side throat felt like some thing in it. 11:02am returned to clinic. Blotchy red rash undersurface of arms bilaterally, chest abdomen and legs. No breathing diff. SOLUMEDROL given. Improvement noted in 20 mins. BENADRYL also as prescribed by provider.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm red and warm to touch.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history ws not reported. On 29-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received vaccine on Tuesday 3-17-15 and called to report swelling, redness, and tenderness at injection site Friday 3-20-15. Patient said swelling was size of apple or palm of her hand.
Age: 1.04
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Irritability, Pyrexia, Rash
Clinical narrative: High fever, fussiness, rash, not acting herself. Received MMR#1, varicella #1, PCV13#4 on 2/18/14. On 3/1 fever, rash. Completely better 3/10/15.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced, redness, swelling and heat to injection site, advised to use heat to affected area, offered antibiotic but patient refused.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: I broke out in a rash on my torso the next day-it lasted about 8 or 9 days-llittle red bumps and itchy (not measles!).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with VARIVAX (Merck) (route, dosage, dose number and lot number unknown). The healthcare worker reported that since unknown date improperly stored doses of VARIVAX (Merck) were given to unspecified patients. No adverse effects were noted. Additional information is not expected because there is no permission to contact physician.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Pruritus, Rash
Clinical narrative: 24hrs after getting Hep B shot pt felt left leg arm sensation "ardor" 2 days later she noticed itching and now has rash-located on left inner upper forearm and left lateral palm area. Pain and itching continues.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender who on 18-MAR-2015 the patent was vaccinated with an improperly stored of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red and warm to the touch. Warm compresses. Triamcinolone acetonide 0/1% cream apply 2-3x's 8d.
Age: 80.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red and warm to the touch. Warm compresses. Triamcinolone acetonide 0/1% cream apply 2-3x's 8d.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEPAB, MMR, PPV, TDAP, VARCEL
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Employee from agency called 3/19/15 explaining pt had red in area of injections in left arm, as well as rashes and itching since vaccination was given. Has been taking BENADRYL and has been working. Informed to see dr. if problem worsens or does not go away.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 23-DEC-2014 the patient was vaccinated with MMR II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one several reports received from the same source. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Haematochezia, Pyrexia
Clinical narrative: Non stop crying for 4 hrs than on/off crying until 4 am! Then slept most of 3/1/13. Fever of 102.2 in evening of 2/28/13 and 102.1 in arm on 3/1/13. Blood in stool day after and for 2 days (03/01/13 and 03/02/13).
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Pain, Pain in extremity, Skin warm
Clinical narrative: Hives on (L) upper arm and around underarm below where I had the pneumonia vaccine. (L) arm hot and painful to raise (L) arm soreness in arm lasted 4 day? Hives for about a week. No treatment.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 31-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia
Clinical narrative: 5 days after admin. pt experienced numbnes in left arm. Described as a dead arm. Went to ER. No treatment given. MD determined possible side effect of vaccine.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Joint range of motion decreased, Pain, Pruritus, Swelling
Clinical narrative: Vaccinated 3/18 same day itching. 3/19 swelling redness, pain, tenderness, ROM limited.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Vaccinated 3/18 same day itching. 3/19 swelling redness, pain, tenderness, ROM limited.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician and health care worker via company representative refers to a 66 year old male patient. Patient medical history and current condition was not reported. On 19-FEB-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml and patient experienced injection site adverse reactions right after receiving the PNEUMOVAX 23 on the same day. Patient developed redness and swelling around the injection site. Also reported that the site was painful, large and the injection site was very hard. The patient was provided treatment with ice on the injection site. The outcome of the events was reported as recovered (date unspecified). Causality assessment was not provided by the reporter. This case is one of the two reports from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 73 year old female consumer referring to herself who had no drug reactions/allergies. On 16-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). On the same day the patient developed injection site reaction (a red oval shape circle "about 3 inches in diameter"). The injection site was puffy, itching and developed a fever and painful. The patient had sought medical attention via speaking to pharmacist. Ice pack and BENADRYL clear gel were given for the events. No lab diagnostics studies were performed. At time of this reporting, the patient did not recover from the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two patients of unknown age and gender. On unknown dates of 2015 the patients was vaccinated with a dose of expired PNEUMOVAX 23 (injection, expiration date 25-FEB-2015, lot#, dose, route and strength were not provided). No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected as the reporter didn't want to be contact.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Alopecia, Chills, Hair colour changes, Headache, Injection site discolouration
Clinical narrative: Received two (2) Varicella vaccines exactly 4 weeks apart, as instructed.  Developed severe itchy warm welt at injection site, along with migraine, photosensitivity, nausea, chills, hives and off/on low grade fever over the next few hours.  Next morning woke up to a huge, hot red itchy raised welt w/wide white ring around it and welt continued to travel all the way down my arm to my elbow over the next 2 weeks.  Went to clinic about 2-3 days after injection to show nurse.  She said to give it a few more days then call my Dr. I did and was told same to give it more time, they would see it at my checkup.  Don't remember the day I went to Dr. All in all, welt took 3-4 weeks to fully disappear, just in time for 2nd required injection. Red welt this time didn't last more than 2 weeks; however, over next 6 months suffered on/off lethargy, rapid greying and hair loss, headaches, unexplained irritability and foggy memory. I never saw such a strong reaction at injection site with white ring around it before.  I thought it was ringworm, but that didn't make sense!  Was told with no warning I had to have Chicken Pox vaccine for fertility cycle to move forward.  I wish I knew my rights then.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Injection site warmth, Irritability, Lethargy, Memory impairment
Clinical narrative: Received two (2) Varicella vaccines exactly 4 weeks apart, as instructed.  Developed severe itchy warm welt at injection site, along with migraine, photosensitivity, nausea, chills, hives and off/on low grade fever over the next few hours.  Next morning woke up to a huge, hot red itchy raised welt w/wide white ring around it and welt continued to travel all the way down my arm to my elbow over the next 2 weeks.  Went to clinic about 2-3 days after injection to show nurse.  She said to give it a few more days then call my Dr. I did and was told same to give it more time, they would see it at my checkup.  Don't remember the day I went to Dr. All in all, welt took 3-4 weeks to fully disappear, just in time for 2nd required injection. Red welt this time didn't last more than 2 weeks; however, over next 6 months suffered on/off lethargy, rapid greying and hair loss, headaches, unexplained irritability and foggy memory. I never saw such a strong reaction at injection site with white ring around it before.  I thought it was ringworm, but that didn't make sense!  Was told with no warning I had to have Chicken Pox vaccine for fertility cycle to move forward.  I wish I knew my rights then.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Migraine, Nausea, Photosensitivity reaction, Pyrexia, Urticaria
Clinical narrative: Received two (2) Varicella vaccines exactly 4 weeks apart, as instructed.  Developed severe itchy warm welt at injection site, along with migraine, photosensitivity, nausea, chills, hives and off/on low grade fever over the next few hours.  Next morning woke up to a huge, hot red itchy raised welt w/wide white ring around it and welt continued to travel all the way down my arm to my elbow over the next 2 weeks.  Went to clinic about 2-3 days after injection to show nurse.  She said to give it a few more days then call my Dr. I did and was told same to give it more time, they would see it at my checkup.  Don't remember the day I went to Dr. All in all, welt took 3-4 weeks to fully disappear, just in time for 2nd required injection. Red welt this time didn't last more than 2 weeks; however, over next 6 months suffered on/off lethargy, rapid greying and hair loss, headaches, unexplained irritability and foggy memory. I never saw such a strong reaction at injection site with white ring around it before.  I thought it was ringworm, but that didn't make sense!  Was told with no warning I had to have Chicken Pox vaccine for fertility cycle to move forward.  I wish I knew my rights then.
Age: 1.59
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous
Clinical narrative: Small red bumps (RASH) on his belly/chest, back and cheeks!
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Patient reports to clinic on this date (03/21/2015) and reports prolonged swelling of lymph nodes under L) armpit and tenderness. Patient reports pain scale 5/10. Patient evaluated by Dr. on this date. Patient instructed to return to clinic for follow-up evaluation on 3/23/2015 to R/O abscess. Patient also prescribed Doxycycline 100mg.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Amnesia, Dizziness, Fatigue, Nausea
Clinical narrative: Progressive short term memory loss beginning 4 days after IM flu shot into the deltoid. Ultra short term memory has been affected the most. Associated symptoms include nausea, dizziness, and continuous tiredness that is not relieved by sleep. Symptoms have fluctuated but, slowly worsened over the last 2 months.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes - left year.
Age: 48.0
Sex: F
Vaccine: TYP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Slowly developed itchy rash of course of treatment. 1 pill a every other day - total 4 pills. Rash progressed across back, legs, more welt-like bumps on lower face.
Age: 75.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: The dose was expired (05/30/14), but patient did NOT suffer any ill effects from the vaccine. The dose was repeated on 03/07/2015 as per CDC guidelines.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Fatigue, Pneumonia, Pyrexia
Clinical narrative: Lightheadedness, fatigue and dizziness. This lasted most of the day on the 18th and 19th. Then on the 20th, in addition, I started to get a lot of mucus build-up, heaviness in the chest and fever. It felt like Pneumonia. I almost went to emergency on the night of the 20th, but went to bed instead with 2 Tylenol and most of the symptoms disappeared by morning on the 21st. But it was scary!
Age: 50.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fevers too 100.0F, Chills, Myalgias, Nausea, Vomiting x5.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Concomitant therapies included prednisone 40 mg. On an unknown date, the patient experienced adverse reaction after the patient received ZOSTAVAX vaccination. The adverse experience was described as "a bad reaction" to the vaccination. The patient was in nurse office when the adverse event happened. It was not confirmed what type of "bad reaction" the patient had. Subsequently on unknown date the patient was admitted to the hospital. The outcome of adverse reaction was unknown. The reaction was related to ZOSTAVAX (reported as: reaction to the vaccine). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of ROTATEQ (lot #, expiration date and dose were not reported) route default as oral. No concomitant mediation was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses or ROTATEQ (therapy route default to oral, dose and frequency were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored ROTATEQ orally (dose, frequency and lot number were not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Epistaxis, Haemoptysis, Mass, Migraine, Nausea
Clinical narrative: Information has been received from a certified medical assistant referring to a female patient of unknown age. On an unknown date the patient was vaccinated with MMR II (dose, route, lot# and expiration date not provided. On an unknown date the patient experienced an unspecified adverse event. The patient's present status was unknown. The causality of adverse event was not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash, Vision blurred
Clinical narrative: Information has been received from a certified medical assistant referring to a female patient of unknown age. On an unknown date the patient was vaccinated with MMR II (dose, route, lot# and expiration date not provided. On an unknown date the patient experienced an unspecified adverse event. The patient's present status was unknown. The causality of adverse event was not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a female patient of unknown age. On an unknown date the patient was vaccinated with MMR II (dose, route, lot# and expiration date not provided. On an unknown date the patient experienced an unspecified adverse event. The patient's present status was unknown. The causality of adverse event was not provided. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 03-DEC-2014, the patient was vaccinated with a dose of MMR II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to an unspecified number of unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of GARDASIL (dose, frequency and therapy route were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 26-NOV-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with VAQTA (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.