chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial information received from a health care professional on 01 November 2012. A 60-year-old female patient had received an intramuscular dose of ADACEL (Batch number: U4393BA, site of vaccination was not reported) on 22 September 2012. The patient's illness at the time of vaccination was none. The patient had no known allergies and no history of medical conditions. Other vaccinations within 4 weeks of vaccination on 22 September 2012 were none. On 23 September 2012, 1 day after vaccination the patient had sore arm and the patient continued to have pain in the arm and she could not life arm without severe pain. Patient visited her HCP and as per the HCP it was from vaccine "which has not absorbed". Laboratory details and corrective treatment were not reported. At time of this report, the patient had not recovered. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial information received from a consumer who is also the patient on 15 March 2013. A 68-year-old female patient who had no illness at the time of vaccination and refused to provide the details of medical history and whose concomitant medications were not reported; had received a intramuscular dose of ADACEL vaccine in left arm (batch number not reported) on 12 March 2013. On 13 March 2013, i.e. 24 hours after vaccination the area became red, tender and lump of about 2 inches in diameter developed and was warm to touch. No laboratory investigations were performed. Corrective treatment details were not reported. The patient's outcome was not reported. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Dysuria, Insomnia
Clinical narrative: Initial information received from a consumer who is also the patient on 26 October 2012 and follow up received on 01 November 2012. A 61-year-old male patient, whose medical history included ADHD and concomitantly received antibiotics; had received intramuscular dose of ADACEL (Lot number and doses not reported) on left deltoid on unspecified date. The reporter stated that after 5 days of vaccination the patient had a temperature of 100.1, which was lasted for 24 hours, patient became achy and had stiffness throughout his body. Patient had difficulty to get up and moving in the AM, walked hunched over. Patient's pain and stiffness were improved, but are still present. The patient had diarrhea since he received the vaccine. Further the reporter stated that he went to doctor on 14 October, 19 October, 21 October and then on 26 October. On 31 October, the pain in the right hip and knee got worse in the evening. That night his temp went up to 99.4 F and then temp went down in the morning. The patient went to the doctor who told him he never saw the symptoms of a swollen knee cap and spasms as he was having. It hurts to sleep and urinate. His neck was stiff and left knee hurts. Laboratory details were not reported. Corrective treatment included LIDODERM patch 5 percent, hydrocodone and a muscle relaxer Tizanidine. Patient's outcome was not recovered. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Joint swelling, Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: Initial information received from a consumer who is also the patient on 26 October 2012 and follow up received on 01 November 2012. A 61-year-old male patient, whose medical history included ADHD and concomitantly received antibiotics; had received intramuscular dose of ADACEL (Lot number and doses not reported) on left deltoid on unspecified date. The reporter stated that after 5 days of vaccination the patient had a temperature of 100.1, which was lasted for 24 hours, patient became achy and had stiffness throughout his body. Patient had difficulty to get up and moving in the AM, walked hunched over. Patient's pain and stiffness were improved, but are still present. The patient had diarrhea since he received the vaccine. Further the reporter stated that he went to doctor on 14 October, 19 October, 21 October and then on 26 October. On 31 October, the pain in the right hip and knee got worse in the evening. That night his temp went up to 99.4 F and then temp went down in the morning. The patient went to the doctor who told him he never saw the symptoms of a swollen knee cap and spasms as he was having. It hurts to sleep and urinate. His neck was stiff and left knee hurts. Laboratory details were not reported. Corrective treatment included LIDODERM patch 5 percent, hydrocodone and a muscle relaxer Tizanidine. Patient's outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non healthcare professional on 24 August 2012. This is a cluster case of 4 patients (same reporter, events after receiving ADACEL lot number: C4104AA) 4 patients (age and gender not specified), whose medical history and concomitant medications were not reported, received a dose of ADACEL (lot number: C4104AA, site of vaccination not reported) intramuscularly on an unspecified date. It was reported that the patients developed large lump at the site of injection with swelling, redness, tenderness and hot to touch area of deltoid, and tenderness going down the arm on an unspecified date. Laboratory investigations and corrective medication were not reported. The outcome of the event was unknown at the time of this event. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Injected limb mobility decreased, Pain
Clinical narrative: Initial report received from a consumer who was also patient on 06 August 2012. A 58-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number, route of administration were not reported) in the left arm on 26 July 2012. On an unspecified date first 3 days after vaccination, the patient experienced exhaustion which was very severe and patient had to be in bed for 3 days. The patient also had fever 101.0 F, headache, chills, body ache and very sore left arm with difficulty in moving arm and increase in pain intensity with movement on unspecified dates. Corrective medications and laboratory investigations were not reported. The event fever was presented for 4 days. The patient currently experiencing, the symptom of very sore left arm, difficulty to move arm, moves arm increase the intensity of pain. Other events were resolved on unspecified date. The patient's outcome was not recovered. List of documents held by sender: None. Follow-up report received on 12 October 2012. Medical history included Allergy to penicillin. Concomitant medications included Calcium Carbonate 500 mg calcium (1.250 mg) tab, EFFEXOR XR 150 mg 24 hr Cap, Simvastatin 20 mg tab, Slow Fe 47.5 mg iron tab, TYLENOL Arthritis 650 mg tab and WELLBUTRIN SR 200mg tab. The patient received ADACEL (batch number: U4325EE) intramuscularly in the left deltoid. It was reported that the patient started that her arm was painful and does not have fully rom. She denied redness or swelling at the injection site or the entire arm. She felt it was slow to improve but not getting worse. She was advised to use cold compress and take OTC pain reliever of choice. The patient stated that she does not like too many medications but would use compress. On 14 August 2012 when contacted by the doctor, the patient stated that pain had improved and rom was better but pain was still present. The patient was encouraged to continue use of MOTRIN or APAP as needed for pain and report if the pain was not improved by the 26th.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a consumer who was also patient on 06 August 2012. A 58-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (lot number, route of administration were not reported) in the left arm on 26 July 2012. On an unspecified date first 3 days after vaccination, the patient experienced exhaustion which was very severe and patient had to be in bed for 3 days. The patient also had fever 101.0 F, headache, chills, body ache and very sore left arm with difficulty in moving arm and increase in pain intensity with movement on unspecified dates. Corrective medications and laboratory investigations were not reported. The event fever was presented for 4 days. The patient currently experiencing, the symptom of very sore left arm, difficulty to move arm, moves arm increase the intensity of pain. Other events were resolved on unspecified date. The patient's outcome was not recovered. List of documents held by sender: None. Follow-up report received on 12 October 2012. Medical history included Allergy to penicillin. Concomitant medications included Calcium Carbonate 500 mg calcium (1.250 mg) tab, EFFEXOR XR 150 mg 24 hr Cap, Simvastatin 20 mg tab, Slow Fe 47.5 mg iron tab, TYLENOL Arthritis 650 mg tab and WELLBUTRIN SR 200mg tab. The patient received ADACEL (batch number: U4325EE) intramuscularly in the left deltoid. It was reported that the patient started that her arm was painful and does not have fully rom. She denied redness or swelling at the injection site or the entire arm. She felt it was slow to improve but not getting worse. She was advised to use cold compress and take OTC pain reliever of choice. The patient stated that she does not like too many medications but would use compress. On 14 August 2012 when contacted by the doctor, the patient stated that pain had improved and rom was better but pain was still present. The patient was encouraged to continue use of MOTRIN or APAP as needed for pain and report if the pain was not improved by the 26th.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from the patient/consumer on 25 June 2012. A female patient on with pre-existing medical condition of irritable bowel syndrome and concomitant medications not reported, had received an intramuscular dose of ADACEL on the left deltoid region (lot number: unknown) on 22 June 2012. The patient received last TD in 2008. On 22 June 2012 i.e. on the same day after vaccination, the patient presented with flu like symptoms of general malaise, swollen lymph nodes and redness, swelling, pain and induration at injection site. The patient self treated herself with ibuprofen. The patient did not seek medical evaluation or treatment. The symptoms had resolved within 48 hours. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: Initial report received from the patient/consumer on 25 June 2012. A female patient on with pre-existing medical condition of irritable bowel syndrome and concomitant medications not reported, had received an intramuscular dose of ADACEL on the left deltoid region (lot number: unknown) on 22 June 2012. The patient received last TD in 2008. On 22 June 2012 i.e. on the same day after vaccination, the patient presented with flu like symptoms of general malaise, swollen lymph nodes and redness, swelling, pain and induration at injection site. The patient self treated herself with ibuprofen. The patient did not seek medical evaluation or treatment. The symptoms had resolved within 48 hours. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Eczema
Clinical narrative: Initial report received from a consumer on 20 Jun 2012. A 75-year-old female patient, whose medical history like several allergies but did not list and concomitant medications was not reported, received ADACEL vaccine (lot number: unknown, route and site of administration was not reported) on 15 Feb 2012. The patient had experienced flare up of eczema on 5 weeks after vaccination. Outcome of the event were not recovered. List of documents held by sender: none. Follow-up information received on 29 August 2012: The patient received ADACEL vaccine on the right arm (deltoid region) with lot number reported as U4308BA. The patient had multiple medical issues (not specified) lifelong or for many years.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: This case is part of cluster of 2 cases (same reporter, same product: ADACEL, lot number C4344AB) and is linked to case number 2013-04002. Initial report received from a healthcare professional on 11 March 2013. A female patient (date of birth: not available and age at the time of vaccination not reported), had received first dose of ADACEL vaccine (batch number: C4344AB, expiry date: 06/04/2015, site of administration was not reported) intramuscularly on 07 March 2013. The patient's pre-existing physician diagnosed allergies, birth defects; medical conditions and illness at the time of vaccination were unknown. The patient's concomitant medications were not reported. On 08 March 2013 (next day of vaccination), the patient felt a knot which was painful at the injection site and had a red rash around the lump with pain in arms both direction. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered from the events. List of documents held by sender was none.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case is part of cluster of 2 cases (same reporter, same product: ADACEL, lot number C4344AB) and is linked to case number 2013-04002. Initial report received from a healthcare professional on 11 March 2013. A female patient (date of birth: not available and age at the time of vaccination not reported), had received first dose of ADACEL vaccine (batch number: C4344AB, expiry date: 06/04/2015, site of administration was not reported) intramuscularly on 07 March 2013. The patient's pre-existing physician diagnosed allergies, birth defects; medical conditions and illness at the time of vaccination were unknown. The patient's concomitant medications were not reported. On 08 March 2013 (next day of vaccination), the patient felt a knot which was painful at the injection site and had a red rash around the lump with pain in arms both direction. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered from the events. List of documents held by sender was none.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that a patient received first dose of GARDASIL on 22-JUL-2014 and second dose of the series on 03-JUL-2015 with GARDASIL 9 (doses and route of administration were not reported). It was also reported that on 30-JUL-2015, the patient was inadvertently administered this third dose of the series with GARDASIL 9-only 27 day interval. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Headache, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Initial information received from a healthcare professional on 17 April 2012. The report was cluster of several patients (individual patient details were not reported) whose medical history and concomitant medication were none, had received ADACEL vaccine (batch number, route and site of administration was not reported) on unspecified date. The reporter stated that several patients had received ADACEL vaccination and experienced sore arm which was difficult to move, fever, nausea, vomiting and headache. Laboratory details none. The outcome of event was reported as recovered. Document held by sender - None. Follow up information received on 11 June 2012: The reporter stated that a cluster of patients were vaccinated with ADACEL vaccine (lot number C3490AA, exp date 16 July 2012) on unspecified dates in September 2010. The events occurred in September 2010. Some patients experienced nausea, vomiting and diarrhea while one patient experienced a sore arm.
Sex: U
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Initial information received from a healthcare professional on 17 April 2012. The report was cluster of several patients (individual patient details were not reported) whose medical history and concomitant medication were none, had received ADACEL vaccine (batch number, route and site of administration was not reported) on unspecified date. The reporter stated that several patients had received ADACEL vaccination and experienced sore arm which was difficult to move, fever, nausea, vomiting and headache. Laboratory details none. The outcome of event was reported as recovered. Document held by sender - None. Follow up information received on 11 June 2012: The reporter stated that a cluster of patients were vaccinated with ADACEL vaccine (lot number C3490AA, exp date 16 July 2012) on unspecified dates in September 2010. The events occurred in September 2010. Some patients experienced nausea, vomiting and diarrhea while one patient experienced a sore arm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Injected limb mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Initial report received from a healthcare professional on 05 June 2012. A 43-year-old female patient, whose medical history and concomitant medications were not reported, received a intramuscular dose of ADACEL (lot number - U4046AA and site of administration right deltoid). It was reported that the patient had injection site pain. The patient was given corrective treatment of MOTRIN in 13 April 2012. On 21 May 2012, the patient called and reported that she had complaint of difficulty moving right arm with pain radiating to right neck, back and shoulder area and also had headache. The patient was seen by physician and prescribed NAPROSYN and advised physical therapy. The reporter stated that patient had refused the treatment. The outcome of events were reported as unknown. Documents held by sender: none. Follow up information was received on 10 August 2012. The patients illness at the time of vaccination were not known.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 05 June 2012. A 43-year-old female patient, whose medical history and concomitant medications were not reported, received a intramuscular dose of ADACEL (lot number - U4046AA and site of administration right deltoid). It was reported that the patient had injection site pain. The patient was given corrective treatment of MOTRIN in 13 April 2012. On 21 May 2012, the patient called and reported that she had complaint of difficulty moving right arm with pain radiating to right neck, back and shoulder area and also had headache. The patient was seen by physician and prescribed NAPROSYN and advised physical therapy. The reporter stated that patient had refused the treatment. The outcome of events were reported as unknown. Documents held by sender: none. Follow up information was received on 10 August 2012. The patients illness at the time of vaccination were not known.
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report received from a healthcare professional on 23 May 2012. This case is linked to AER# 2012-05599. Cluster of 8 patients whose age and gender were not specified, received a dose of ADACEL (lot number: C4051BA route and site of administration were not reported) on 02 May 2012. It was reported that 2 patients developed pain, heat, swallowing and redness at the site with swelling of axillary node. One of these patients was administered antibiotics. Both were better in 2-3 days. 1 patient complained of flu like symptoms with fever and sweat along with large local reaction, and was better symptomatically in couple of days and by 2 weeks he had a small knot left at the site. The remaining 5 complained of more pain as compared to the what they usually got with TD. Outcome of the events was unknown. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 14 year old male patient. None pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 23-MAY-2002, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route of administration, expiration date and lot # were not reported). On 29-JUN-2010, the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX (dose, route of administration, expiration date and lot # were not reported). On 04-AUG-2016, the patient developed shingles. The patient sought medical attention - he was seen in the physician's office and he received the treatment with VALTREX (1g 3 times a day). None lab diagnostics studies were performed. The outcome of shingles was reported as not recovered.  The relatedness between the adverse event and the vaccination with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Initial report received from a healthcare professional, who is also patient's brother, on 30 July 2012. A 58-year-old female patient, whose medical history and concomitant medication was reported as none; had received intramuscular dose of ADACEL vaccine in right deltoid (lot number C3974AA) on 23 July 2012. The patient's ongoing illness included none. On 29 July 2012 i.e. after 6 days, the patient presented swelling under right arm and an area of bruising under the arm, sore from elbow to wrist, and area under arm is painful to touch injection site of arm is not red or swollen. The patient's relevant diagnostic tests and lab data were reported as none. The patient's outcome was not recovered. Documents held by sender: None. The follow-up information received on 15 October 2012 from a healthcare professional, who is also patient's sister. It was reported that within a week of reporting adverse event the patient fully recovered. The swelling and redness were gone and no treatment was necessary.
Age: 0.57
Sex: M
Vaccine: RV5
Symptoms: Gastrostomy, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 19-MAY-2015, the patient was vaccinated with the first dose of ROTATEQ (dose: 2 ml,lot # and expiration date were not reported) through a G-tube (gastrostomy tube). There was no adverse effect reported. Follow-up information has been received from the reporting medical assistant on 20-JUL-2015 and refers to an 8 months old male patient. On 19-MAY-2015 at 11:40 the patient was vaccinated with the second previously reported as first) dose of ROTATEQ (lot # K016311, expiration date unknown). Dates of the first v vaccination and G-tube insertion were not provided. Outcome and causality of gastrostomy were unknown. Additional information is not expected, since all scheduled correspondence was received. Reporter's information, patient tab, suspect therapy, adverse events and narrative were updated.
Age: 1.53
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a healthcare worker concerning a 14 year old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-DEC-2000, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot #, expiration date, dose and route not reported). On 29-AUG-2013, following that administration of vaccine, an unspecified type of blood test was performed for serological testing to confirm the patient's varicella immunity. The results of the blood test determined the patient to be seronegative for varicella titers. It was confirmed by the reporter that the second dose of (Oka/Merck) VARIVAX was not administered. The outcome of seronegative for varicella titers was unknown.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX; lot number L001335 and expiration date 13-JAN-2017 (15 administered), lot number K0296385 and expiration date 15-DEC-2016 (4 administered) lot number L006385 and expiration date 25-FEB-2017 (13 administered) (dose and route of administration not reported). Concomitant therapy was not reported. No adverse experiences had been reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an infant patient of unknown gender. No information on his medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, at 0 months of age, the patient received the first dose in the series of three of RECOMBIVAX HB (dose, route of administration, lot # and expiration date not specified). The second dose was received by the patient on an unspecified date at 3 months of age. The third dose of RECOMBIVAX HB was received at 4 months of age, on an unspecified date. There were not adverse effects reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This is cluster of two cases and linked with AER # 2012-6409 (Adverse event occurred following ADACEL vaccination lot number U4329AA). Initial report received from a consumer on 22 June 2012. A female patient; whose medical history and concomitant medication were not reported; had received 1st dose of intramuscularly ADACEL vaccine (lot number U4329AA) in left arm on 18 June 2012. On 18 June 2012; i.e. same date the patient presented with left arm very sore at the injection site and the upper arm. The lab details and corrective treatment were not reported. The outcome was not recovered. List of documents held by sender:none. Follow-up information was received from healthcare professional on 26 September 2012. The patient had no known allergies and denies any past medical history (PMH). Patient's other medications included: birth control pills (unspecified). The patient ongoing illness included none. The patient did not receive any other vaccines. The relevant laboratory investigations included none. The patient's outcome was recovered on 24 June 2012.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unspecified age and gender.  No medical history and concurrent conditions were reported. On an unspecified dates, the patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K011952 and expiry date: 17-JUN-2016) (dose, route and site of administration was not reported). No concomitant medications were reported. No adverse effect were reported. The outcome of incorrect product storage was not reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients received improperly stored doses of ROTATEQ (lot # K010222, exp. 12-MAY-2016, dose and route of administration not provided) (incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected. No contact details were provided.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients received improperly stored doses of ROTATEQ (lot # K013861, exp. 18-MAY-2016, dose and route of administration not provided) (incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected. no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients received improperly stored doses of GARDASIL (lot # K008931, exp. 04-MAR-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent or medical history was reported. The nurse reported that on 05-AUG-2015, the GARDASIL 9 was withdrawn from a vial and was placed into one of the plastic syringes and was put into the refrigerator. On 06-AUG-2015, in morning, a staff member vaccinated the patient with the same GARDASIL 9 (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of VAQTA (lot # K019560 with expired date on 02-JUN-2017, dose and route were unknown) which were post temperature exucrsion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Nurse Practitioner via a company representative referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. In approximately June 2015, about one month ago, the patient was inadvertently administered (Oka/Merck) VARICELLA instead of ZOSTAVAX (wrong drug administered).  No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of GARDASIL (lot # K023432, expired date, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of RECOMBIVAX HB (lot # K010216 with expired date of 17-SEP-2016, lot# K018180 with unspecified expired date, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. 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 an administrator referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of ROTATEQ (lot # K011948 with expired date on 07-JUN-2016, lot # K013861 with unspecified expired date, lot # reported as K014820 with unspecified expired date, dose and route was unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. Lot number K014820 is an invalid lot number for ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrator referring to an unspecified number of patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of GARDASIL 9 (lot # K026246 with expired date on 28-JAN-2017, dose and route were unknown) which were post temperature excursion. No concomitant medication was reported. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Oropharyngeal pain, Pain, Periorbital oedema
Clinical narrative: Initial report received from a consumer on 21 May 2012. Local reference number: 12-0296. A 52 years female patient, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL on an unspecified date (lot number: C4030AA) on left deltoid on 09 May 2012. It was reported that on 14 May 2012 the patient experienced general malaise, periorbital edema, achyness 5 days post vaccination and sore throat 12 days post vaccination. The patient was evaluated by the physician from 14 May 2012 and 21 May 2012. No treatment was prescribed. The outcome of the adverse reaction was not reported. List of documents held by sender: none.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Bowel movement irregularity
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 29 November 2012 with additional information received on 05 December 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of Sanofi Pasteur. A two-month-old female patient had received the following vaccinations on 07 August 2012: PENTACEL, PREVNAR 13 and ROTARIX (lot number, route and sites not reported). In August 2012, the patient stopped having regular bowel movements. No additional information was provided. Outcome was not reported. Follow-up information received from a healthcare professional on 26 December 2012. The patient had received dose of PENTACEL (Lot number: C3973AA) intramuscular in left thigh, PREVNAR 13 (manufactured by Wyeth, Lot number: F45135) intramuscular in right thigh and ROTARIX (manufactured by GSK, Lot number: A41F6245A) orally. The patient's had no illness at the time of vaccination. The patient had not received any other vaccine within the 4 weeks of vaccination. The patient has two siblings. On 20 December 2012, the patient oucome was recovered.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration
Clinical narrative: Initial report received from a healthcare professional on 12 December 2012. An 18-month old female patient had received subcutaneous fourth dose of PENTACEL vaccine (lot number C4371AA) on left thigh on 04 December 2012. The patient had no illness at the time of vaccination and no concomitant medications. The patient's medical history was unknown. On 04 December 2012, the patient was administered received subcutaneous dose of PENTACEL vaccine on left thigh. On the same day after vaccination, the patient presented erythema and induration inferior to injection site. Laboratory data and corrective medications were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: None.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Body temperature increased
Clinical narrative: Initial report received from a healthcare professional on 28 December 2012. A female patient (age and date of birth were not reported), whose medical history was not reported, had received a dose of PENTACEL vaccine (lot number, anatomical site and route of administration were not reported) on an unspecified date. The reporter stated that the patient had received four previous doses of PENTACEL. It was reported that, the patient had been allergy on an unspecified date, and the patient's tetanus antibody titer was reported as 0.1. The Tetanus antibody titer should be greater than or equal to 0.15 for protection. Laboratory data reported was tetanus antibody titer 0.1 (unit was not reported). The patient's outcome was unknown. Document Held by Sender: None. Follow up information received from a healthcare professional on 15 March 2013. On 02 January 2013, the patient had received booster dose of DTaP vaccine 0.5 ml (lot number- C4286AA) intramuscularly in left thigh and PREVNAR 13 vaccine (manufacturer, lot number, dose number, site and route of administration were not reported). The patient received above vaccines due to low titers. Patient had no known allergies and no significant family history. The patient's body vitals include temperature- 99.9 degree Fahrenheit, weight- 33 pounds, height- 38 inches and BMI- 16.1. The patient's Tetanus Toxoid titres done at the age of 3 years on 25 October 2012 were on lower side <0.10 (Normal: >0.15 IU/ML), Immunoglobulin A level was 47 (Normal: 24-121 mg/dl), Immunoglobulin G level was 605 (Normal: 533-1078 mg/dl), Immunoglobulin M level was 78 (Normal: 26-218 mg/dl) and Immunoglobulin E level was 29 (Normal: < OR =128 Ku/L). It was reported that the titer levels should be up to normal after 4th dose of PENTACEL.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Clostridium test negative
Clinical narrative: Initial report received from a healthcare professional on 28 December 2012. A female patient (age and date of birth were not reported), whose medical history was not reported, had received a dose of PENTACEL vaccine (lot number, anatomical site and route of administration were not reported) on an unspecified date. The reporter stated that the patient had received four previous doses of PENTACEL. It was reported that, the patient had been allergy on an unspecified date, and the patient's tetanus antibody titer was reported as 0.1. The Tetanus antibody titer should be greater than or equal to 0.15 for protection. Laboratory data reported was tetanus antibody titer 0.1 (unit was not reported). The patient's outcome was unknown. Document Held by Sender: None. Follow up information received from a healthcare professional on 15 March 2013. On 02 January 2013, the patient had received booster dose of DTaP vaccine 0.5 ml (lot number- C4286AA) intramuscularly in left thigh and PREVNAR 13 vaccine (manufacturer, lot number, dose number, site and route of administration were not reported). The patient received above vaccines due to low titers. Patient had no known allergies and no significant family history. The patient's body vitals include temperature- 99.9 degree Fahrenheit, weight- 33 pounds, height- 38 inches and BMI- 16.1. The patient's Tetanus Toxoid titres done at the age of 3 years on 25 October 2012 were on lower side <0.10 (Normal: >0.15 IU/ML), Immunoglobulin A level was 47 (Normal: 24-121 mg/dl), Immunoglobulin G level was 605 (Normal: 533-1078 mg/dl), Immunoglobulin M level was 78 (Normal: 26-218 mg/dl) and Immunoglobulin E level was 29 (Normal: < OR =128 Ku/L). It was reported that the titer levels should be up to normal after 4th dose of PENTACEL.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dermatitis atopic, Eczema infantile, Rash, Rash generalised
Clinical narrative: Initial report received from a consumer on 29 May 2012. A 2-month-old male patient with no known allergies or any medical history and whose concomitant medication were not reported, received a dose of PENTACEL (Lot number, route and site of vaccination not reported) on 1 December 2012. On the same day, he also received a dose PREVNAR (Lot number, route and site of vaccination not reported). On an unspecified date, within 1 week post vaccination, the patient developed cluster rash on both legs. Corrective medication was not reported. The event had recovered in approximately 2 weeks. The same patient was given a dose of PENTACEL intramuscularly (Lot number and site of vaccination not reported) and PREVNAR 13 at an age of 4 months. He again developed generalized rash throughout the body. The child was evaluated by a dermatologist and was diagnosed to be suffering with atopic dermatitis with infantile eczema. He was being treated with corticosteroid cream. As of 29 May 2012, the child had not recovered from the events. List of documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Eczema
Clinical narrative: Initial report received from a consumer who is also the patient's parent on 08 February 2013. A 2-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of PENTACEL vaccine (lot number: unknown, number in series, route and anatomical site of administration were not reported) and a dose of Hepatitis B vaccine (Manufacturer: unknown, batch number, number in series, route and anatomical site of administration were not reported) on 04 December 2012. On an unspecified date shortly after vaccination, the patient developed eczema which continued till the date of this report. The reporter was not sure whether the eczema was related to PENTACEL vaccine. The patient's physician was evaluating for "food allergies or autoimmune issues". Corrective treatment and relevant laboratory data were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. On an unspecified dates, the patients were vaccinated with unspecified number of improperly stored doses of RECOMBIVAX HB injection (lot # K0024552 and expiry date: 22-OCT-2016) (dose, route and site of administration was not reported). No concomitant medications were reported. No adverse effect were reported. The outcome of incorrect product storage was not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Amylase, Blood thyroid stimulating hormone, Glycosylated haemoglobin, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a 66 year old female patient who was reporting on herself. The patient did not have pertinent medical history nor drug reactions or allergies. Concomitant therapies included SYNTHROID, vitamin D (unspecified), vitamin B complex, probiotics (unspecified), amethrosol (unspecified) and fish oil. On 23-JUL-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (administered intramuscularly in the left deltoid, dose, lot # and expiration date were not reported). On 26-JUL-2015 (reported as 3 days after vaccination), the patient experienced warmth and burning sensation at the injection site. On an unknown date, liquid profile, hemoglobin A1C, thyroid stimulating hormone and amylase lab tests were performed (results not provided). The patient did not seek medical attention and did not receive any treatment. The patient's outcome was reported as not recovered/not resolved. The relatedness between the events and therapy with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist via a field employee concerning a female patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant medications were not provided. On an unknown date (reported as "in early summer", exact date unspecified), the patient was vaccinated with a dose of ZOSTAVAX, (dose and frequency: 1 injection/once; lot #, expiration date and route not reported). Then the patient traveled to another country. On an unspecified date she developed a rash and returned home with a rash "on her face, hair, and side of head". The outcome of rash was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) stock: lot number L007228 and expiration date 03-AUG-2016 (9 administered), lot number L004005 and expiration date 05-AUG-2016 (6 administered), lot number L009209 and expiration date 17-SEP-2016 (5 administered) and stock: lot number K020751 and expiration date 30-APR-2016 (2 administered) (dose and route of administration not reported). Concomitant therapy was not reported. No adverse experiences had been reported. This is one of the two reports received from the same reporter. 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 registered nurse refers to 24 unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L006383, expiry date 25-FEB-2017; lot # L005299, expiry date 17-FEB-2017, (dose and frequency not provided). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.