chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Expired drug administered
Clinical narrative: Shot given 6/6/14 - HAVRIX expired 5/30/14 called manufacturer to determine if ok to give another dose. 1st dose invalid ok to give another dose as soon as possible. Called patient and emailed to let know he needs a new immunization.
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Convulsion, Dyskinesia, Full blood count, Hyperhidrosis
Clinical narrative: Aching muscles, joint pain, swollen glands, high fever (102F), jerky convulsions, faintness, sweating. (Dr. administered wrong vaccine, should have given MPSV4). Required hospital emergency room visit on 6/5/14.
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Syncope, Urine analysis
Clinical narrative: Aching muscles, joint pain, swollen glands, high fever (102F), jerky convulsions, faintness, sweating. (Dr. administered wrong vaccine, should have given MPSV4). Required hospital emergency room visit on 6/5/14.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old male patient. There were no pertinent medical history and concurrent conditions reported. On an unknown date that patient was vaccinated with ZOSTAVAX injection (route, lot#, doses not reported). When asked if the patient was using any concomitant medications the representative reported, Yes, but the names of the medications were unknown. The physician reported to the representative that the patient experienced peripheral neuropathy of the hands and feet six weeks after receiving ZOSTAVAX. The patient sought medical attention, office visit on an unspecified date. The outcome of peripheral neuropathy of the hands and feet six weeks after receiving ZOSTAVAX was unknown. It was unspecified whether the patient was not hospitalized due to experience and was life threatening. There was no persistent or significant incapacity. No death. Intervention to prevent serious criteria was not required. Product quality compliant was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information provided regarding medical history and concurrent conditions reported. On 03-JUN-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the area of her stomach (dose number, lot# not reported). No concomitant medications reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ. Concomitant medications were reported. On an unknown date the unspecified number of patients received ROTATEQ doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received ROTATEQ vaccine doses that were stored at 34F for hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003227, 1406USA003839, 1406USA003840 and 1406USA003841 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with VAQTA. Concomitant medications were not reported. On an unknown date the unspecified number of patients received VAQTA doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received VAQTA doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003227, 1406USA003839, 1406USA003841 and 1406USA003842 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant medications were not reported. On an unknown date the unspecified number of patients received PEDVAXHIB doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received PEDVAXHIB doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot number information was ava liable. This case is linked to 1406USA003227, 1406USA003839, 1406USA003840 and 1406USA003842 (same reporter link). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Injection site warmth, Lacrimation increased, Neck pain, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 year old female patient. The patient's pertinent medical history included abnormal pap and thyroid cyst lumpectomy approximately on an unknown date in 1999 (reported as 1999). The patients current condition include similar reactions to unspecified injections in the past but not as severe. On 03-JUN-2014 the patients was vaccinated with GARDASIL (Lot # and expiry date was not provided), first dose of unknown dosage. Other co-suspect and concomitant medications were not reported. On 03-JUN-2014, reported as the moment that the patient received her first dose of vaccine, she could feel warmth on the patients skin at the injection site and within seconds, the patient exhibited a dazed look across her face and her eyes welled up with tears. The patient at that time fainted and the nurse guided her into a chair. The patient sat in the chair for about 15 to 20 minutes, shaking, complaining of pain in the nap of her neck and starting that her vision was impaired as if she could only see static. Nurse placed a cool towel on the back of the patients neck and after 15 to 20 minutes of close monitoring, the reporter states that the patient recovering completely and left the office. The outcome of all the events was reported as recovered on 03-JUN-2014. Product quality issue was not reported. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Visual impairment
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 year old female patient. The patient's pertinent medical history included abnormal pap and thyroid cyst lumpectomy approximately on an unknown date in 1999 (reported as 1999). The patients current condition include similar reactions to unspecified injections in the past but not as severe. On 03-JUN-2014 the patients was vaccinated with GARDASIL (Lot # and expiry date was not provided), first dose of unknown dosage. Other co-suspect and concomitant medications were not reported. On 03-JUN-2014, reported as the moment that the patient received her first dose of vaccine, she could feel warmth on the patients skin at the injection site and within seconds, the patient exhibited a dazed look across her face and her eyes welled up with tears. The patient at that time fainted and the nurse guided her into a chair. The patient sat in the chair for about 15 to 20 minutes, shaking, complaining of pain in the nap of her neck and starting that her vision was impaired as if she could only see static. Nurse placed a cool towel on the back of the patients neck and after 15 to 20 minutes of close monitoring, the reporter states that the patient recovering completely and left the office. The outcome of all the events was reported as recovered on 03-JUN-2014. Product quality issue was not reported. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 patients of unknown age. The patients medical history was not reported. On 02-JUN-2-13 and 03-JUN-2014 6 patients were vaccinated with PEDVAXHIB, (lot#: J013944, exp date: 13-AUG-2016, 0.5 milliliter (ml), intramuscular). Concomitant medications were not reported. On 02-JUN-2013 and 03-JUN-2014, 6 patients were vaccinated with improperly stored PEDVAXHIB. The PEDVAXHIB that had been improperly stored and no adverse effects was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old female patient. The patient's medical history was unspecified. On 02-JUN-2014 or 03-JUN-2014, the patient was vaccinated with GARDASIL (Dose/Frequency: "Standard dose"/"First dose", Therapy Route: Injection). Concomitant medications included TDAP (manufacturer unspecified). On 02-JUN-2014 or 03-JUN-2014, the patient was vaccinated with GARDASIL and TDAP (manufacturer unknown) at the same time. On the same day (02-JUN-2014 or 03-JUN-2014)  the patient experienced very lightheaded and it took few minutes for the patient to recover. Lab Diagnostics Studies Performed were none. The causality was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: The spontaneous prospective pregnancy report as received from a nurse refers to a 31 year old female patient. The patients medical history was none. On 03-APR-2014 the patient was vaccinated with first dose of VARIVAX (Lot# J007953, expiry date: 27-JUN-2015)(Dose/Frequency: 0.5 milliliter (ML), Route: Subcutaneous (SQ)). Concomitant medications were none. On 01-MAY-2014 the patient was vaccinated with second dose of VARIVAX (Lot# J012375, expiry date: 03-OCT-2015) (Dose/Frequency: 0.5 milliliter (ML), Route: Subcutaneous(SQ)). The patient became pregnant with LMP of 03-MAY-2014 and EDD of 07-FEB-2015. The outcome of received 2 doses of VARIVAX and found out she was pregnant was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 42 year old female patient. The patients pertinent medical history and drug allergies were none. On 16-APR-2014 the patient was vaccinated with VARIVAX (lot# H015557, expiry date: 16-AUG-2014, dose: 0.5 milliliter (ml), subcutaneous for titer immunoglobulin G (IgG) was equivocal. Concomitant Medication were none. The patient became pregnant with LMP of 14-APR-2014 and EDD of 19-JAN-2015. Initial exposure to varicella VARIVAX was at week 0 week(s).The pregnancy outcome unknown. On 16-APR-2014, the patient received VARIVAX during early pregnancy. The patient learned of pregnancy on 22-MAY-2014. Lab Diagnostics Studies Performed were none. No adverse event was reported. The outcome of received varicella VARIVAX during early pregnancy and no adverse event was unknown. The patient did no sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB. Concomitant medications were not reported. On an unknown date the unspecified number of patients received RECOMBIVAX HB doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received RECOMBIVAX HB doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003227, 1406USA003840, 1406USA003841 and 1406USA003842 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose: 0.5 milliliter (ml), intramuscularly). Concomitant medications were not reported. On an unknown date the unspecified number of patients received GARDASIL doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received GARDASIL vaccine doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003839, 1406USA003840, 1406USA003841 and 1406USA003842 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient presented with left arm swelling from shoulder to elbow, bruising at injection site with an area of erythema and induration extending in a circle about 3-4cm out from injection site. Patent without fever or pain to arm.
Age: 53.0
Sex: F
Vaccine: MEN, TDAP, TYP
Symptoms: Disorientation, Dizziness, Erythema, Headache, Local swelling
Clinical narrative: Swelling of arms, patches of redness on arms, pain in arms, headache, dissiness, disoriented, fever (103.7).
Age: 53.0
Sex: F
Vaccine: MEN, TDAP, TYP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Swelling of arms, patches of redness on arms, pain in arms, headache, dissiness, disoriented, fever (103.7).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Rash
Clinical narrative: Employee started to feeling tingling to right leg 4 hours after vaccination. Tingling traveled to left leg followed by rash. Tingling and rash spread from bilateral legs to bilateral arms. Employee took Benadryl at 10:19 PM states had no effect for tingling and rash. Employee still has symptoms at this time.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Small red welt at actual injection site. Starting there and then traveling below that is hot, red, very hard circular welt. In the middle of that is a cluster of small, wheepy blisters. The red area takes up most of her upper arm area. It's approximately 4-5 inches in diameter. She has never had a vaccine reaction. She's had no fever, no other symptoms aside from a sore, itchy arm.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Small red welt at actual injection site. Starting there and then traveling below that is hot, red, very hard circular welt. In the middle of that is a cluster of small, wheepy blisters. The red area takes up most of her upper arm area. It's approximately 4-5 inches in diameter. She has never had a vaccine reaction. She's had no fever, no other symptoms aside from a sore, itchy arm.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, 99.8-101.5. Starting 06/07/2014: rash covering body.
Sex: U
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Dyspnoea, Full blood count normal
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient pertinent medical history and drug allergies were not provided. On 02-MAY-2014 the patient was vaccinated with ZOSTAVAX. No other concomitant medications were reported. On 06-MAY-2014 (reported as 4-5 days later) the patient experienced extreme weakness in the body (disability), heart palpitations (disability), dizziness (disability), trouble breathing (disability) and developed irregular heartbeat (disability). Patient waited a couple weeks and it has not gotten any better. Patient was still not recovered. As long as patient is sitting or lying down is ok, but had to sit down 4 or 5 times if the patient was doing house hold chores because the patient was too weak to stand up. Patient body is weak. Patient have not been able to go to church for 3 weeks (disability). Patient took additional B12 vitamins but this is not even helping. The physician reported that the patient had reported that about 4 days after receiving ZOSTAVAX that is on 06-MAY-2014, the patient developed heart palpitations (disability). The palpitations have resolved, but the patient continues to report extreme weakness. The physician stated that the patient's vital signs and blood tests (complete blood count (CBC), "chemistry" and thyroid blood test) are normal. The outcome of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks and developed irregular heartbeat was reported as not recovered/not resolved. The outcome of heart palpitations was reported as recovered/resolved. The causality of the events is not reported no product quality complaint was reported. Upon internal review all the events of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks, heart palpitations and developed irregular heartbeat were considered to be disability. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate irregular, Laboratory test normal, Palpitations, Thyroid function test normal
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient pertinent medical history and drug allergies were not provided. On 02-MAY-2014 the patient was vaccinated with ZOSTAVAX. No other concomitant medications were reported. On 06-MAY-2014 (reported as 4-5 days later) the patient experienced extreme weakness in the body (disability), heart palpitations (disability), dizziness (disability), trouble breathing (disability) and developed irregular heartbeat (disability). Patient waited a couple weeks and it has not gotten any better. Patient was still not recovered. As long as patient is sitting or lying down is ok, but had to sit down 4 or 5 times if the patient was doing house hold chores because the patient was too weak to stand up. Patient body is weak. Patient have not been able to go to church for 3 weeks (disability). Patient took additional B12 vitamins but this is not even helping. The physician reported that the patient had reported that about 4 days after receiving ZOSTAVAX that is on 06-MAY-2014, the patient developed heart palpitations (disability). The palpitations have resolved, but the patient continues to report extreme weakness. The physician stated that the patient's vital signs and blood tests (complete blood count (CBC), "chemistry" and thyroid blood test) are normal. The outcome of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks and developed irregular heartbeat was reported as not recovered/not resolved. The outcome of heart palpitations was reported as recovered/resolved. The causality of the events is not reported no product quality complaint was reported. Upon internal review all the events of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks, heart palpitations and developed irregular heartbeat were considered to be disability. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Patient called me late on 6/6/14 with pain in the arm with injection. Instructed her to take APAP and call me the next day. She came in to see me with pain and numbness in the fingers. Told her to give it one more day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: The spontaneous report as received from a physician via sales representative refers to a 71 year old female patient. The pertinent medical history includes hypertension, glaucoma. Concomitant therapies included hydrochlorothiazide, PRINZIDE, FLONASE and BETIMOL ESTRACE. Approximately on an unknown date in February 2008 the patient was vaccinated with ZOSTAVAX (route, dose not reported). The reporter stated that the patient was seen in the office on 12-MAY-2014 and was diagnosed with ophthalmic shingles which started on 09-MAY-2014. It was also reported that the patient was referred to an unspecified ophthalmologist and was prescribed VALTREX, Prednisone, and NEURONTIN. The outcome of ophthalmic shingles was reported as recovered/resolved on an unknown date with no vision loss. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from healthcare worker (medical assistant) refers to a 1 year old male patient with no pertinent medical history and no drug reactions/allergies. On 27-MAY-2014 the patient was vaccinated with MMR II, 0.5 ml, subcutaneous. There was no concomitant drug. About 10 or 20 minutes before the reporter reported, the injection site and surrounding area of the patient was swelled and became red. The patient was given BENADRYL and kept in the office for evaluation. At the time of reporting, the patient was not recovered. No lab diagnostics studies was performed. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Gastrointestinal disorder, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with drug allergies penicillin (manufacturer unknown) and codeine (manufacturer unknown). The patient's pertinent medical history was none. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J011830, expiry date: 26-DEC-2014, Dose: 0.65 milliliter (ml), subcutaneously). Concomitant medications were none. On 21-MAY-2014, the patient experienced injection site reaction of soreness and redness and also experienced as a systemic reaction including chills, dizziness, lethargy and unspecified bowel related issues, lethargy, dizziness, chills and injection site reaction of soreness. Patient reported that these symptoms were immediate post vaccination. The outcome of chills, injection site reaction of soreness, unspecified bowel related issues, lethargy and dizziness was reported as not recovered. The outcome of injection site redness was reported as recovered. The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with drug allergies penicillin (manufacturer unknown) and codeine (manufacturer unknown). The patient's pertinent medical history was none. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J011830, expiry date: 26-DEC-2014, Dose: 0.65 milliliter (ml), subcutaneously). Concomitant medications were none. On 21-MAY-2014, the patient experienced injection site reaction of soreness and redness and also experienced as a systemic reaction including chills, dizziness, lethargy and unspecified bowel related issues, lethargy, dizziness, chills and injection site reaction of soreness. Patient reported that these symptoms were immediate post vaccination. The outcome of chills, injection site reaction of soreness, unspecified bowel related issues, lethargy and dizziness was reported as not recovered. The outcome of injection site redness was reported as recovered. The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to a patient of unknown age. On 27-MAY-2014 the patient was vaccinated with an expired dose of M-M-R II (HSA), lot no. h009782, expiration date 15-MAY-2014, 0.5 ml, subcutaneously. No adverse effect reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 69 year old male patient. The patient had no pertinent medical history. The patient had no drug allergies. On 15-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # K000726, expiration date 09-JAN-2015, (dose, strength and frequency were unknown) subcutaneous. There were no concomitant medications On 24-MAY-2014, the patient developed pain over the left chest area. The patient sought for medical attention by seeing the physician. No treatment was given. Lab diagnostics studies performed were reported as none. On 25-MAY-2014 the patient developed a rash in that same area. The outcome of the event was not recovered. The causality of the report was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with PNEUMOVAX23 that were stored improperly. No adverse effects reported. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administration were unavailable at this time; however, lot numbers and expiration dates were available: PNEUMOVAX23, lot # J009689, expiration date 29-JAN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient. A one year old patient inadvertently received first dose in series for each vaccine: VARIVAX (Merck) (0.5 ml, subcutaneous, once, lot # were not reported), M-M-R II (dosage, route, lot # and indication were not reported) and PROQUAD (Merck) (dosage, route, lot # and indication were not reported) on 22-MAY-2014. No adverse effects reported. Additional information has been requested.
Age: 1.82
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 22 month old male patient with none medical history and none drug allergies. On 19-MAY-2014 the patient was vaccinated with VARIVAX (lot#J007679, exp 13-JUN-2015 subcutaneous). There was none concomitant drug. On 26-MAY-2014 the patient experienced red pustules at the injection site. The patient's parents called the physician for attention. He was given BACTRIM and BACTROBAN. None lab was performed. He was recovering. This is one of the report from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 12 month old female patient with none medical history and none drug allergies. On 22-MAY-2014 the patient was vaccinated with VARIVAX (lot#J007679, exp 13-JUN-2015 subcutaneous). There was none concomitant drug. On 29-MAY-2014 the patient experienced red pustules at the injection site. The patient's parents called the physician for attention. He was given BACTRIM. None lab was performed. He was recovering. This is one of the reports from the same source. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Fontanelle bulging, Irritability, Lumbar puncture, Vaccination complication
Clinical narrative: Information received on 03 June 2014 from a healthcare profession. A 4 month old male patient was vaccinated on 18 March 2003 with the following vaccines: Dose 2 of TRIPEDIA batch U0846DA, intramuscularly, site not reported, IPOL, batch number, route and site not reported, PCV, Wyeth/Pfizer, batch number, route and site not reported and COMVAX, MSD, batch number, route and site not reported. On 19 March 2003, the patient experienced a pulsating fontanelle and irritability. The patient was evaluated by a physician at a hospital emergency room who determined that the patient "experienced a reaction to the vaccine". A spinal tap was performed on 19 March 2003, results not reported. The patient's concomitant medications and medical history were not reported. The reporter reported this as an "alleged reaction" while inquiring about the batch number for DTaP. The patient outcome was recovered on an unreported date. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abasia, Blood test, Bone scan, Complex regional pain syndrome, Cyanosis
Clinical narrative: Case number PHHY2012US111034 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466315) on 04 Dec 2012 with a follow-up information received from Quality Assurance Department (reference number: 210130) on 30 May 2014. This case refers to a 16-year-old female patient. The patient's medical history included congenital scoliosis. Concomitant medications included TRI SPRINTEC oral contraceptive, NEURONTIN and narcotics. The patient was vaccinated with S-OIV FLUVIRIN (batch number: 97844P2) intramuscularly in left arm on 06 Oct 2009. On 11 Oct 2009, after the vaccination, the patient experienced extreme pain in one leg and inability to walk on that leg. She was taken to emergency room because of cold, purple limb and extreme pain. The patient was hospitalized. She was then shifted to other hospital when the symptoms spread to her another leg. She was hospitalized for 7 days and then referred to a third hospital. The working diagnosis was stated as reflex sympathetic dystrophy or chronic reflexic pain syndrome, but her neurologist disagreed with this diagnosis. She spent 2 months in a wheelchair. After extensive physical therapy she was able to walk, first with crutches then without. MRI, bone scans and many blood tests were done (results not provided). The seriousness of unable to walk was reported as disability. The outcome of events was reported as condition unchanged as of 25 Sep 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned S-OIV FLUVIRIN (batch number: 97844P2) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Peripheral coldness, Skin discolouration
Clinical narrative: Case number PHHY2012US111034 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466315) on 04 Dec 2012 with a follow-up information received from Quality Assurance Department (reference number: 210130) on 30 May 2014. This case refers to a 16-year-old female patient. The patient's medical history included congenital scoliosis. Concomitant medications included TRI SPRINTEC oral contraceptive, NEURONTIN and narcotics. The patient was vaccinated with S-OIV FLUVIRIN (batch number: 97844P2) intramuscularly in left arm on 06 Oct 2009. On 11 Oct 2009, after the vaccination, the patient experienced extreme pain in one leg and inability to walk on that leg. She was taken to emergency room because of cold, purple limb and extreme pain. The patient was hospitalized. She was then shifted to other hospital when the symptoms spread to her another leg. She was hospitalized for 7 days and then referred to a third hospital. The working diagnosis was stated as reflex sympathetic dystrophy or chronic reflexic pain syndrome, but her neurologist disagreed with this diagnosis. She spent 2 months in a wheelchair. After extensive physical therapy she was able to walk, first with crutches then without. MRI, bone scans and many blood tests were done (results not provided). The seriousness of unable to walk was reported as disability. The outcome of events was reported as condition unchanged as of 25 Sep 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned S-OIV FLUVIRIN (batch number: 97844P2) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Case number PHHY2012US111034 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466315) on 04 Dec 2012 with a follow-up information received from Quality Assurance Department (reference number: 210130) on 30 May 2014. This case refers to a 16-year-old female patient. The patient's medical history included congenital scoliosis. Concomitant medications included TRI SPRINTEC oral contraceptive, NEURONTIN and narcotics. The patient was vaccinated with S-OIV FLUVIRIN (batch number: 97844P2) intramuscularly in left arm on 06 Oct 2009. On 11 Oct 2009, after the vaccination, the patient experienced extreme pain in one leg and inability to walk on that leg. She was taken to emergency room because of cold, purple limb and extreme pain. The patient was hospitalized. She was then shifted to other hospital when the symptoms spread to her another leg. She was hospitalized for 7 days and then referred to a third hospital. The working diagnosis was stated as reflex sympathetic dystrophy or chronic reflexic pain syndrome, but her neurologist disagreed with this diagnosis. She spent 2 months in a wheelchair. After extensive physical therapy she was able to walk, first with crutches then without. MRI, bone scans and many blood tests were done (results not provided). The seriousness of unable to walk was reported as disability. The outcome of events was reported as condition unchanged as of 25 Sep 2012. Batch review report concluded that, based on the document review, it was stated that, the concerned S-OIV FLUVIRIN (batch number: 97844P2) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 49.0
Sex: M
Vaccine: FLU3, TDAP, TYP, VARCEL
Symptoms: Ear pain, Ear swelling, Local swelling, Neck pain
Clinical narrative: Case number PHHY2012US111487 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466688) web site on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210294) on 05 Jun 2014. This report refers to a 49-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1205401), ADACEL (batch number: C4136BA, other manufacturer), TYPHIM VI (batch number: G05081, other manufacturer) intramuscularly and VARIVAX (other manufacturer, batch number: H006463) subcutaneously on 11 Sep 2012. On 14 Sep 2012, he experienced pain and swelling around left ear and upper neck. He went to emergency room. The final outcome of the events was reported as complete recovery as of 27 Sep 2012. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received the Quality Assurance Department (reference number: 210294) on 05 Jun 2014: Updated batch review report.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Dyspnoea, Headache, Influenza
Clinical narrative: Case number PHHY2012US111488, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466690) website on 04 Dec 2012 with a follow-up was received from Quality Assurance Department (reference number: 210017) on 30 May 2014. This report refers to a 23 year old female patient. Current conditions of this patient include asthma. She was vaccinated with FLUVIRIN (batch number: 1204901) and PNEUMOVAX (batch number H010515) intramuscularly to her left arm on 07 Sep 2012. On 08 Sep 2012, the patient experienced chest pain, hard time breathing, "noxious", flu and headache. Patient visited emergency room. The event outcome was reported as not recovered. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 1204901) was manufactured in accordance with internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information about seriousness and causality was reported. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Erythema, Malaise, Oedema peripheral
Clinical narrative: Case number PHHY2012US111521 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 467366) on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014. This case refers to a 60-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501, expiry date: May 2013) intramuscularly into her left arm on 25 Sep 2012. On the same day after vaccination she experienced pain in left chest which lasted for an hour. Three days later she reported of malaise, redness and edema in arm. The final outcome was reported as complete recovery on an unspecified date. No other information was available. Based on the document review for the reference number 210052, it was stated that the FLUVIRIN, batch number 1204501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Case number PHHY2012US111618 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467714) website on 04 Dec 2012, and with a follow up report received from QA department (reference number: 210080) on 30 May 2014. This report refers to a 67-year-old female patient. Her medical history included back surgery and arthritis and concomitant medication included Celebrex. She was vaccinated with FLUVIRIN (batch number: 12243P) in to the right arm on 21 Sep 2012 and she left the store without any incident. Shortly after vaccination, she felt pain in left leg then pain in back. In evening she went to Emergency Room (ER), and was admitted for six days in a hospital and was treated. on rehab. Final outcome was reported as condition unchanged at the time of reporting. No further information about seriousness and causality was reported. Based on the document review, it was stated that the FLUVIRIN, batch number 12243P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (reference number: 210080) on 30 May 2014. Updated batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Case number PHHY2012US111699 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467821) on 04 Dec 2012, and with a follow up report received from a QA department (reference number: 210003) on 30 May 2014. This report refers to a 67-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1204801, expiry date: 31 May 2013) intramuscularly on left arm on 28 Aug 2012. On 29 Aug 2012, the patient experienced cough, shortness of breath, fever, body aches and headaches. Outcome of the events were reported as condition unchanged at the time of this report. Seriousness and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1204801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210003) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling of body temperature change, Headache, Hypotension, Muscular weakness
Clinical narrative: Case number PHHY2012US111706 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467976) on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210005) on 30 May 2014. This report refers to a 37-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 123103 and expiry date: 30 Jun 2013) intramuscularly on left arm on 03 Oct 2012. On the same day the patient experienced temple soreness, hypotension, heart palpitations, icy cold/warm feeling, body achiness of entire body and chest/back/shoulder and legs were achy and weak. Outcome of the events were reported as condition unchanged at the time of this report. Seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 123103) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received the Quality Assurance Department (reference number: 210005) on 30 May 2014: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Palpitations
Clinical narrative: Case number PHHY2012US111706 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 467976) on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210005) on 30 May 2014. This report refers to a 37-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 123103 and expiry date: 30 Jun 2013) intramuscularly on left arm on 03 Oct 2012. On the same day the patient experienced temple soreness, hypotension, heart palpitations, icy cold/warm feeling, body achiness of entire body and chest/back/shoulder and legs were achy and weak. Outcome of the events were reported as condition unchanged at the time of this report. Seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 123103) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received the Quality Assurance Department (reference number: 210005) on 30 May 2014: Updated batch review report.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Case number PHHY2012US111583 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System website (VAERS reference number: 468958) on 04 Dec 2012 and a follow up report received from the QA department (QA ref: 210077) received on 30 May 2014: This report refers to a 53-year-old male patient. His pre-existing condition included diabetes. He was vaccinated with FLUVIRIN (batch number: 12241P) in to the left arm on 14 Sep 2012. On 18 Sep 2012, five days after vaccination, he experienced shingles. He had to visit the Emergency Room (ER) following this event. The final outcome was reported as complete recovery. No further information about causality was reported. Based on the document review for the reference number 210077, it was stated that the FLUVIRIN, batch number 12241P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from the QA department on received 30 May 2014: Updated batch review report.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Case number PHHY2012US111605 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System website (VAERS reference number: 468994) on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014: This report refers to a 16-year-old male patient. He was well before receiving the immunization. He was vaccinated with FLUVIRIN (batch number: 1205001) in to the right arm on 28 Sep 2012. After receiving the vaccine he temporarily lost consciousness upon standing. The final outcome was reported as complete recovery of the patient on an undetermined date. No further information about seriousness and causality was reported. Based on the document review for the reference number 210079, it was stated that the FLUVIRIN, batch number 1205001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Case number PHHY2012US111657 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469242) on 04 Dec 2012, and with a follow up report received from a QA department (reference number: 209999) on 30 May 2014. This report refers to a 60-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 123121) intramuscularly on 04 Oct 2012. It was reported that the patient had passed out and because of falling and hitting her head a number of medical issues arose. The patient had extensive work up due to head trauma caused by the fall. Outcome of the events were reported as recovered. It was reported that the issues were due to the fall not the vaccine. Based on the document review, it was stated that the FLUVIRIN, batch number 123121 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 209999) on 30 May 2014. Updated batch review report.