chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 53 year old female patient refers to herself. None of pertinent medical history was reported. None of drug reactions/allergies were reported. On 24-SEP-2014, at 6:00 PM, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously in the right arm (dose number and lot # not reported) at an unspecified pharmacy by an unspecified pharmacist. Concomitant therapies included hormonal contraceptives ("unspecified birth control pill"), Omeprazole, EFFEXOR XR. On 25-SEP-2014, patient experienced a "tiny raised area" appeared on her right arm where the injection site was, and she also reported itchiness and warmth at the injection site, and the patient further reported pain that spanned her entire right arm into her finger tips. On 26-FEB-2014, the patient reported that there was an orange size area around the injection site that was red and inflamed. The outcome of events was reported as not recovered/not resolved. The ZOSTAVAX was not reintroduced. The causality was not reported.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a 53 year old female patient refers to herself. None of pertinent medical history was reported. None of drug reactions/allergies were reported. On 24-SEP-2014, at 6:00 PM, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously in the right arm (dose number and lot # not reported) at an unspecified pharmacy by an unspecified pharmacist. Concomitant therapies included hormonal contraceptives ("unspecified birth control pill"), Omeprazole, EFFEXOR XR. On 25-SEP-2014, patient experienced a "tiny raised area" appeared on her right arm where the injection site was, and she also reported itchiness and warmth at the injection site, and the patient further reported pain that spanned her entire right arm into her finger tips. On 26-FEB-2014, the patient reported that there was an orange size area around the injection site that was red and inflamed. The outcome of events was reported as not recovered/not resolved. The ZOSTAVAX was not reintroduced. The causality was not reported.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from registered referring to a 64 year old female patient. On 29-SEP-2014 the patient was vaccinated with PROQUAD (Lot# was reported as K002481, expired on 08-AUG-2015), 0.5 ml, subcutaneous, which was instead of ZOSTAVAX. The nurse states that the error occurred because she had rearranged the contents of the freezer, and she grabbed the wrong vaccine. She states that there was no confusion over the labeling of the PROQUAD and the ZOSTAVAX; she didn't check the vaccine before she administered the dose of PROQUAD to the patient in error. No adverse effects have been observed or reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning about 5 patients. Starting on 18-AUG-2014, GARDASIL (lot: J006236; expiration: 25-FEB-2016), VAQTA (lot: K001792; expiration: 22-OCT-2015), RECOMBIVAX HB (lot: J005078; expiration: 20-SEP-2015), PNEUMOVAX 23 (an unsealed/opened multi-dose vial) (lot: K007773; expiration: 01-MAY-2015), and ROTATEQ (lot: J012954; expiration: 31-MAR-2015) were improperly exposed to 28F for 12 hours, and to 30-34 F over 10 separate occasions (on unspecified dates) for a cumulative of 24 hours. About 5 patients received at least one of the above vaccines on unspecified dates since 18-AUG-2014. No known adverse effects occurred. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Pain, Urticaria
Clinical narrative: This spontaneous report as received 81 year old female patient refers to herself. The patient's medical history included glaucoma. The patient had no drug reactions/allergies. On an unknown date in 2005 the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot# and expiration date was unknown) for prevention of shingles. Concomitant therapies included ibuprofen and TYLENOL. On an unknown date in August 2014 the patient experienced shingles. At the time of reporting, the patient was in her fourth week of shingles, and she described painful burning welts all over her body and she was miserable. Treatment was given for the adverse events. None lab diagnostics were performed. The patient sought for medical attention by going to clinic. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In approximately September 2014 (reported as "about week ago") the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. In approximately September 2014 (also reported as "now") the patient experienced redness at the injection site. It was also reported that injection site was red and swelling "with the head". Reporter stated that there were no rash or lesions. No treatment was given for adverse events. No lab diagnostic studies were performed. The outcome of events was reported as not recovered/not resolved. Relatedness between events and vaccination was not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a pharmacy technician (also reported as healthcare worker) refers to a 71 year old male patient. On 01-OCT-2014 the patient was vaccinated with expired ZOSTAVAX (subcutaneous, in the left upper arm, dose: 0.65 ml, lot#: H019042, expiry date: 17-JAN-2014. It was reported that the box lot and expiry date were different than the expiration on the vial itself. No adverse effect was reported at the time of the report. Product quality issue (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expire date 10-AUG-2014, dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Age: 1.54
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Patient to be evaluated for rash. This has been a problem for the past one to two days. The rash has not occurred previously. It is located primarily over the left leg and the right leg. He describes the rash as red and distributed in irregularly shaped patches. The rash has been essentially asymptomatic. He denies any associated symptoms. Possible contributing factors include received 2 vaccines yesterday (PCV and Hib). Pertinent past medical history is unremarkable.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Patient states her left middle finger turned black/purple. Patient saw her primary doctor. No treatment needed.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, lightheaded, weak for a couple days. Patient better now.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles 9 months after VARIVAX immunization.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old female patient, who had a diagnosis of autistic disorder and had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 24-JAN-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was going to be revaccinated at no charge. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: 2 inch diameter bruise, soreness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified patients of unknown age and gender. Medical assistant reported that an unspecified number of patients have received improperly stored M-M-R II (dose, route of administration, lot numbers and expiration dates were not provided) during the past 11 days. No symptoms reported. This is one of several reports from the same source. Additional information is not expected, because there was no consent to contact physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to a patient of unknown age. On 12-SEP-2014, the patient was vaccinated with M-M-R II vaccine (0.5 ml, subcutaneously). No concomitant medication was reported. It was noticed that on 12-SEP-2014, the patient was administered with a dose that had been improperly stored. No adverse effects were reported. The outcomes of the event were unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that "sometime last week", approximately in September 2014, an unspecified number of patients received improperly stored ZOSTAVAX vial (dose, route and lot numbers not provided) due to the freezer experiencing defrost cycles. No adverse event symptoms reported. Additional information is not expected because there was no consent to follow up.
Age: 1.3
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Erythema, Injection site induration, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician refers to his 15 month old daughter. The patient had no relevant medical history. The patient had no history of reactions to vaccines. On 11-SEP-2014 the patient was vaccinated with VARIVAX (Merck) in the thigh (dose, frequency, route and lot # unknown). Concomitant therapies included M-M-R (manufacturer unknown) and PCV (unspecified) on 11-SEP-2014 in the thigh.On 19-SEP-2014 the patient developed subcutaneous induration about the size of a walnut, about 7.5 cm, and a tiny vesicle around the site of administration. Topical cortisone cream was applied to the induration. On 20-SEP-2014, the patient experienced erythema. The physician wasn't sure if it was an insect bite, hematoma, or a reaction to the VARIVAX (Merck), since the onset of events were 8 days after the vaccine. The physician read in the prescribing information that if erythema developed after VARIVAX (Merck), it would be within 2 days. The patient had been acting normally. There was no relevant lab data. As of 20-SEP-2014, it was unknown if his daughter would receive VARIVAX (Merck) again and the size of induration had decreased, erythema persisted, and the outcome of tiny vesicle was unknown. The physician did not have the lot number or expiration date when asked. The relationship between events and VARIVAX (Merck) was unknown). Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown age. On 23-SEP-2014 the patient was subcutaneously vaccinated for the first time with M-M-R II albumin status HSA (0.5 ml, lot # J000202, expiry date: 09-JAN-2015). No adverse effects reported. The reporter stated that that for unspecified reason the patient did not receive M-M-R II at 12-15 months of age (as recommended in prescribing information) and received first dose at age 5. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse who refers to an unspecified group of patients of unknown age and gender. Patient's medical histories were not provided. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration and indication were not provided) (lot # K003422, 06-MAR-2015). Concomitant medication was not reported. Firstly it was reported that (Oka/Merck) VARIVAX was stored at 75F. The reporting nurse subsequently called back and corrected the temperature range in which the (Oka/Merck) VARIVAX was improperly stored to 14.5F. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. On 16-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 injection with lot number J006242 and expiry date 03-AUG-2014 (0.5 ml, subcutaneously) as vaccine. No concomitant medication was reported. It was noticed that, on 16-SEP-2014, the patient was administered with expired PNEUMOVAX 23. Potency supported and no adverse effects were experienced by the patient. The outcome of the events were unknown. The patient did not sought medical attention. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 17-SEP-2014, the patient was vaccinated with M-M-R II (dose number was not reported) lot # H017027, expiration date 14-SEP-2014, 0.5 ml, subcutaneous. Medical assistant reported that an expired dose of M-M-R II was administered to a patient on 17-SEP-2014. No adverse effects reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Red, non tender patch of about 6 cm x 2 cm. No evidence of systemic reaction or cellulitis.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16 year old patient of unknown gender, allergic to nuts and rice / grass and who had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 05-FEB-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (0.65 ml, subcutaneously). No concomitant medication was reported. On an unknown date, approximately 3 days after vaccination the patient experienced exacerbation of his psoriasis. The outcome and causality of the event was unknown for ZOSTAVAX. The patient sought medical attention. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Contusion, Headache, Pain, Swelling
Clinical narrative: Vaccinated with FLUC 10/2/14 at 4pm; pt reports awaking with pain, swelling, bruising and headache.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from the registered nurse regarding male patient who on 14-JUN-2014 at 16:31 P.M was vaccinated with improperly stored first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21), vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8. This is one of several cases received from the same reporter. Additional information is not expected because all follow up information was received.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse regarding female patient who on 10-JUN-2014 at 10:46 A.M was vaccinated with improperly store first dose of RECOMBIVAX HB (Thimerosal Free) (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates (between May 14 and July 21, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8. The patient did not seek medical attention. Additional information is not expected because all follow up information was received.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hallucination, visual, Head discomfort, Malaise, Visual impairment
Clinical narrative: On 10/1/14 am pt reported "I don't feel well, I feel funny, my head is bothering me. I'm seeing colors and things." The symptoms subsided on 10/3/14 am. Pt's daughter reports pt has visual hallucinations after taking ADVIL.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Right arm swollen at upper arm, bright red, hot to the touch. Pt stated arm hurt, but moving/using arm fine. Mom called PCP - waiting to hear what she needed to do. Had called Hosp - advised to take to urgent care.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Rash generalised, Urticaria
Clinical narrative: Received flu vaccine on 9/26/14. Developed hives/rash around the injection site (R thigh) on 9/27/14 and it progressed to cover entire body on 9/28/14.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty ban-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reported for the same vaccine and same events. Follow-up information received on 25 October 2014: QUAL number updated.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: The day of vaccination the patient experienced shoulder pain that migrated to this arm and side. He reporeted having to take OTC pain medication every 6 hours for 2 days. His symptom had started to improve by 09/29/14. Symptom onset once patient was back at home.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Injection site pruritus, Tenderness
Clinical narrative: 1600-1700 9-30-14 red area 10cm. Denies fever. No swelling. Painful to touch. C/O slight numbness to left ring finger. C/O itching to injection site.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: 9-29-2014 4 cm redness at injection site, rash up rt. side of neck. Itching. Denied fever. Denied numbness and tingling.
Age: 12.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Hep B given on 9-30-14 LD; pt came to clinic 10.2.14 when symptoms appeared that morning. Arm reddened, warm, and hard, pt stated it was itching. Ice pack applied via instructions by provider.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Pyrexia
Clinical narrative: Arm swelled and had a fever of 100.6. She was in bed all day. Patient feels better now. Swelling/pain started day of vaccine and sxs lasting until 9/28/14.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient has experienced pain and immobility in the vaccinated arm. Administered on 9/30, has become worse since onset. Patient is concerned damage has occurred.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Musculoskeletal pain, Vomiting
Clinical narrative: Pt complains of pain in shoulder area when he tries to lift arm. Also experienced diarrhea and vomiting.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Pruritus, Rash pruritic, Swelling face
Clinical narrative: Itching - rash - (face, neck, arms, legs). Funny taste tongue - salty. Face swollen, itching.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch, upper arm to elbow and into chest area. Couldn't wear tight fitting clothing soreness.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Pt received vaccine at clinic at work (3rd shift). She received shot and immediately felt pain. It throbbed throughout the night. She could barely lift arm next morning. RPh told her to take TYLENOL or Ibuprofen and use ice pack and watch for next few hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Injection site reaction swelling; treatment Ice/Benadryl/monitoring per physician's office; Reported to MD by patient on 10/3/14.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever, red raised rash about 2x2 inches, redness around raise area, extending 1 1/2 inches around raise area.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient had shingles vaccination on 9/18/14. Pt became ill on 9/22/14, with fever, chills.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site discharge, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from an office manager via company representative refers to a male patient of unknown age. In April 2014 the patient received a dose of ZOSTAVAX (lot #, dose and route not reported). Concomitant therapy was not reported. In approximately April 2014 (reported as while using ZOSTAVAX), the patient experienced left arm pain from the shoulder to wrist, swelling at the injection site, drainage at the injection site and cellulitis while using ZOSTAVAX. The patient sought medical attention and received intravenous (IV) antibiotic as treatment for the adverse events. The outcome of left arm pain from the shoulder to wrist, swelling at the injection site, drainage at the injection site and cellulitis was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: L arm weakness, pain
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US112308 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 533026) website on 03 Sep 2014, with a follow-up information received from Quality Assurance Department (reference number: 323713) on 22 Sep 2014. This report refers to a 10 years old male patient. His medical history included allergy to cats, amoxicillin and penicillin. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12124 and expiry date: Aug 2014) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: N2K27) intramuscularly in the left arm on 02 Jun 2014. On 03 Jun 2014, he had cellulitis with weepy, red, swollen right arm. He was put on BACTRIM and on 04 Jun 2014, he had massive cellulitis. He was sent to emergency room. It was reported that his arm was red, hot and swollen from elbow to deltoid. His left arm was with 3x3 cm erythema and slightly firm. The final outcome was unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M12124) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323713) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323713) on 22 Sep 2014: Updated MENVEO expiry date and batch review report.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site warmth, Local swelling, Secretion discharge
Clinical narrative: Case number PHHY2014US112308 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 533026) website on 03 Sep 2014, with a follow-up information received from Quality Assurance Department (reference number: 323713) on 22 Sep 2014. This report refers to a 10 years old male patient. His medical history included allergy to cats, amoxicillin and penicillin. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12124 and expiry date: Aug 2014) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: N2K27) intramuscularly in the left arm on 02 Jun 2014. On 03 Jun 2014, he had cellulitis with weepy, red, swollen right arm. He was put on BACTRIM and on 04 Jun 2014, he had massive cellulitis. He was sent to emergency room. It was reported that his arm was red, hot and swollen from elbow to deltoid. His left arm was with 3x3 cm erythema and slightly firm. The final outcome was unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M12124) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323713) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323713) on 22 Sep 2014: Updated MENVEO expiry date and batch review report.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Induration, Local swelling, Secretion discharge
Clinical narrative: Case number PHHY2014US112308 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 533026) website on 03 Sep 2014, with a follow-up information received from Quality Assurance Department (reference number: 323713) on 22 Sep 2014. This report refers to a 10 years old male patient. His medical history included allergy to cats, amoxicillin and penicillin. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12124 and expiry date: Aug 2014) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: N2K27) intramuscularly in the left arm on 02 Jun 2014. On 03 Jun 2014, he had cellulitis with weepy, red, swollen right arm. He was put on BACTRIM and on 04 Jun 2014, he had massive cellulitis. He was sent to emergency room. It was reported that his arm was red, hot and swollen from elbow to deltoid. His left arm was with 3x3 cm erythema and slightly firm. The final outcome was unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M12124) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323713) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323713) on 22 Sep 2014: Updated MENVEO expiry date and batch review report.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Case number PHHY2014US112308 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 533026) website on 03 Sep 2014, with a follow-up information received from Quality Assurance Department (reference number: 323713) on 22 Sep 2014. This report refers to a 10 years old male patient. His medical history included allergy to cats, amoxicillin and penicillin. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12124 and expiry date: Aug 2014) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: N2K27) intramuscularly in the left arm on 02 Jun 2014. On 03 Jun 2014, he had cellulitis with weepy, red, swollen right arm. He was put on BACTRIM and on 04 Jun 2014, he had massive cellulitis. He was sent to emergency room. It was reported that his arm was red, hot and swollen from elbow to deltoid. His left arm was with 3x3 cm erythema and slightly firm. The final outcome was unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality of the event was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M12124) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323713) on 08 Sep 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 323713) on 22 Sep 2014: Updated MENVEO expiry date and batch review report.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Blood test, Dizziness, Electrocardiogram, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from medical assistant refers to her 13 year old daughter who is the female patient. Patient's concurrent conditions and relevant medical history was none. Patient had drug reactions/allergies to penicillin and amoxicillin. On 15-AUG-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications was reported as none. The reporter stated that when her daughter received the GARDASIL, the patient felt like she was on fire. The patient has also been experiencing seizures (medically significant), dizzy spells and was not doing well. The patient has been seen in an unspecified emergency room on an unspecified date. The patient sought medical attention but was not admitted to the unspecified hospital. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. Upon internal review, seizure was determined to be medically significant. This is one of the two reports received regarding the same patient. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Paraesthesia, Skin burning sensation, Syncope, Tremor
Clinical narrative: This spontaneous report as received from medical assistant refers to her 13 year old daughter who is the female patient. Patient's concurrent conditions and relevant medical history was none. Patient had drug reactions/allergies to penicillin and amoxicillin. On 15-AUG-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications was reported as none. The reporter stated that when her daughter received the GARDASIL, the patient felt like she was on fire. The patient has also been experiencing seizures (medically significant), dizzy spells and was not doing well. The patient has been seen in an unspecified emergency room on an unspecified date. The patient sought medical attention but was not admitted to the unspecified hospital. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. Upon internal review, seizure was determined to be medically significant. This is one of the two reports received regarding the same patient. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MNQ, HPV4
Symptoms: Burning sensation, Convulsion, Dizziness, Malaise
Clinical narrative: This spontaneous report as received from medical assistant refers to her 13 year old daughter who is the female patient. Patient's concurrent conditions and relevant medical history was none. Patient had drug reactions/allergies to penicillin and amoxicillin. On 15-AUG-2014, the patient was vaccinated with first dose of GARDASIL (lot number, dose and route unspecified). Concomitant medications was reported as none. The reporter stated that when her daughter received the GARDASIL, the patient felt like she was on fire. The patient has also been experiencing seizures (medically significant), dizzy spells and was not doing well. The patient has been seen in an unspecified emergency room on an unspecified date. The patient sought medical attention but was not admitted to the unspecified hospital. The outcome of the events was reported as not recovered/not resolved. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. Upon internal review, seizure was determined to be medically significant. This is one of the two reports received regarding the same patient. Additional information has been requested.
Sex: U
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. In August 2013 (exact date unknown), the patient was vaccinated with the first dose of ZOSTAVAX and then, on 30-SEP-2014, received inadvertently the second dose of ZOSTAVAX injection (dose, route of administration, indication, lot # and expiry date unspecified for both shots). No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Chills, body ache, fever, dizziness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever of 104, seizure
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Pain
Clinical narrative: Pain in shoulder from injection site radiating down arm to elbow joint. Extreme pain.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Malaise, Pain in extremity
Clinical narrative: ARM PAIN LAST FOR 7 DAYS, GENERAL MALAISE AND SLEEPLESSNESS FOR 7 DAYS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Conjunctivitis infective, Fatigue, Headache, Injection site reaction
Clinical narrative: Chills, fever of 100, severe injection site muscle soreness, nausea, aching, headache, nausea, purulent conjunctivitis, fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever of 100, severe injection site muscle soreness, nausea, aching, headache, nausea, purulent conjunctivitis, fatigue.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Ache, chills, fever.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Flushing, sweating, dizziness
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Anthrax vaccine on 30 Sep 14. She stated that symptoms first developed on 01 Oct 14. She presented to the clinic on 4 Oct 14 with a complaint of adverse reaction to Anthrax vaccine. She had a softball sized, red, swollen patch on her left deltoid that was hot to touch. She denied any other symptoms.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Headache, Injected limb mobility decreased, Listless
Clinical narrative: LEFT ARM (VACCINATION ARM)UNABLE TO MOVE DULL HEADACHE LEFT ARM PAIN/ACHE FEVER 100F X36 HOURS ONE DAY MISSED WORK LISTLESS/TIRED X72 HOURS LOCAL TENDERNESS OF UPPER ARM X72 HOURS
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: LEFT ARM (VACCINATION ARM)UNABLE TO MOVE DULL HEADACHE LEFT ARM PAIN/ACHE FEVER 100F X36 HOURS ONE DAY MISSED WORK LISTLESS/TIRED X72 HOURS LOCAL TENDERNESS OF UPPER ARM X72 HOURS
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Throat irritation, Tic
Clinical narrative: Started with unusual throat clearing, facial tics started several days later.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed 2 days after the shot that she had a large (approx 2-3" in diameter) round bump where shot was administered.  Patient reported that it was hot to the touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Diarrhoea, Dizziness, Dysstasia
Clinical narrative: Sore arm; progressed into dizziness & weakness; by 10 PM, was unable to walk or stand without feeling faint; had fever and sweating all night; had "goo" in eyes which caused them to stick shut; this went on all the next day and partially the third day.  Also had diarrhea; was unable to walk without a cane or walker.  Each day beginning the third, felt a little better, but was incredibly weak.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Night sweats, Pain in extremity, Pyrexia, Walking aid user
Clinical narrative: Sore arm; progressed into dizziness & weakness; by 10 PM, was unable to walk or stand without feeling faint; had fever and sweating all night; had "goo" in eyes which caused them to stick shut; this went on all the next day and partially the third day.  Also had diarrhea; was unable to walk without a cane or walker.  Each day beginning the third, felt a little better, but was incredibly weak.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Hyperhidrosis, Nausea
Clinical narrative: Sudden sweating-heavy, nasal drainage causing coughing attack, nausea, vomiting for several hours and subsequent fever chills horrible body aches , fever broke 10:00AM, still weak achy as of 2:00PM.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Sudden sweating-heavy, nasal drainage causing coughing attack, nausea, vomiting for several hours and subsequent fever chills horrible body aches , fever broke 10:00AM, still weak achy as of 2:00PM.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Feeling cold
Clinical narrative: INJECTION SITE (ARM) VERY SORE, BODY VERY COLD, SHIVERING, BLOOD PRESSURE HIGH, HEART PALPITATIONS, CONFUSION, VISION CHANGE, DIZZINESS, EXHAUSTION.  COULDN'T SLEEP MOST OF NIGHT.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Insomnia, Pain in extremity, Palpitations, Visual impairment
Clinical narrative: INJECTION SITE (ARM) VERY SORE, BODY VERY COLD, SHIVERING, BLOOD PRESSURE HIGH, HEART PALPITATIONS, CONFUSION, VISION CHANGE, DIZZINESS, EXHAUSTION.  COULDN'T SLEEP MOST OF NIGHT.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Rash
Clinical narrative: Initially, flank pain R radiating to front. On 10/04/2014 rash of Herpes Zoster appeared.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Chest pain, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10/1/14-~received flu shot in left deltoid area ~1:40pm. 10/4-cx presents with redness & swelling on the left bicep area, (~3" x 5") & states that area "hurts"& a reaction was from the flu shot. States that her arm hurt her upon receiving the injection on 10/1 but the redness & swelling did not appear in the bicep area until the evening of 10/1. She states that 10/3 evening thru 10/4 am, she was in the hospital for chest pain, unrelated to the reaction, & notified the nurse of the area but no treatment was given. I advised her to follow up with primary doctor.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Headache, Malaise
Clinical narrative: Woke up next morning with severe headache. Feeling sick when standing. No appetite in 2 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Local reaction
Clinical narrative: Patient experiencing a local reaction at the injection site consisting of a red, swollen hard knot that lasted about 3 days.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash all over hands and forearms. no itching present. still persisting 10 days later. patient advised to take antihistamine until clear.
Age: 79.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cough, Respiratory tract congestion, Wheezing
Clinical narrative: Chest congestion, wheezing, cough.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Rash, Skin warm
Clinical narrative: Soreness at injection side. Rash developing down arm with redness and warmth.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pallor, Somnolence, Vomiting
Clinical narrative: The patient was somnolent for over 5 hours.  On attempted arousal he vomited and became pale.  He aroused spontaneously after triage in the emergency room.  No treatment given.
Age: 35.0
Sex: M
Vaccine: FLUC3
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, nausea, aching joints, rash
Age: 35.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Fever, chills, headache, nausea, aching joints, rash
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Pain
Clinical narrative: WEAKNESS, ACHES, DIZZY, LOSS OF APPETITE, SYMPTONS LASTED 48 HOURS.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Cough, Dizziness, Hyperhidrosis
Clinical narrative: Chills, profuse sweating at about 8:30,continuing overnight.  Aches, nausea 10pm. Racing heartbeat lasted over 24 hours. By morning vomiting, dizziness and weakness. Injection site swollen and raised -area about 6inches across. Hives up shoulder and down injected arm. 10/03/2014. Have developed a cough but that could be caused by vomiting.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site urticaria, Nausea, Pain, Palpitations
Clinical narrative: Chills, profuse sweating at about 8:30,continuing overnight.  Aches, nausea 10pm. Racing heartbeat lasted over 24 hours. By morning vomiting, dizziness and weakness. Injection site swollen and raised -area about 6inches across. Hives up shoulder and down injected arm. 10/03/2014. Have developed a cough but that could be caused by vomiting.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Chills, profuse sweating at about 8:30,continuing overnight.  Aches, nausea 10pm. Racing heartbeat lasted over 24 hours. By morning vomiting, dizziness and weakness. Injection site swollen and raised -area about 6inches across. Hives up shoulder and down injected arm. 10/03/2014. Have developed a cough but that could be caused by vomiting.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Lip swelling, Ocular hyperaemia, Sensation of foreign body
Clinical narrative: I FEEL LIKE SOMETHING WAS ON MY THROAT, COUGHING AND LOWER LIPS GOT SWOLLEN, EYE RED IRRITATED.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pharyngeal oedema, Swelling face
Clinical narrative: Patient reported to mother she felt like and elephant was sitting on her chest.  So mother took her to emergancy department. Her throat continued to swell along with her face.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chills, Heart rate increased, Pyrexia, Urine analysis
Clinical narrative: Morning after injection: High fever, chills, elevated heart rate.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aches.