chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of GARDASIL lot # K006960, expiration date 10-MAY-2017 and lot # K006960, expiration date in February 2017, also reported as 29-FEB-2017 (strength, dose #, dose, route of administration, anatomical location were not reported). There was not a product quality complaint (PQC) involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 15 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot# L004439; expiration date: 15-FEB-2016. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, refers to multiple unspecified patients of unknown age and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB lot # J014232, expiration date 29-AUG-2015 (strength, dose#, dose, route of administration, anatomical location were not reported). There was not a product quality complaint (PQC) involved. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was reported from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA lot# L001445, expiration date 15-FEB-2016 (strength, dose#, dose, route of administration, anatomical location were not reported). There was not a product quality complaint (PQC) involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored of PNEUMOVAX 23 lot # L010598, expiration date 06-AUG-2016 (strength, dose #, dose, route of administration, anatomical location were not reported). There was not a product quality complaint involved. No adverse effect were reported. This is one of several reported from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at inj site. No fever.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, refers to multiple unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored of ROTATEQ lot # J015063, expiration date 24-OCT-2015 (strength, dose #, dose, route of administration, anatomical location were not reported). There was not a product quality complaint involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency,route and lot # were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, inflammation (warmth) (severe) at injection site more so than a normal site reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Drug dose omission, No adverse event, Product container issue
Clinical narrative: Information has been received from a nurse (also reported as a healthcare worker) referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with (Oka/Merck) (dose, frequency were not reported). The reporter reported that 3 vials of (Oka/Merck) VARIVAX were completely shattered in the box (product container damaged). The 3 vials came in a package of 10. Due to this, the patient missed a dose. The patient did not seek for medical attention. Product quality complaint (PQC) was filed. No additional adverse event information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pain and redness round site of MENACTRA vaccine 2 days after vaccine. Fever to "100-101". On 8/17/15-doctor saw patient. No redness or warmth at site. No fever. Advised to monitor symptoms and see Infectious Disease if symptoms persist.
Age: 0.7
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 months 29 days old female patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant mediations were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a  healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K023863; expiration date: 03-ARP-2016. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Indurated skin, red, swollen area 4 cm x 5 cm, in left upper arm, area (initially it was "bumpy" as well).
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: 60 seconds after receiving varicella vaccine, pt developed trunk itching and then rash over her trunk, pt was given 25 mg diphenhydramine and this all resolved. Pt then was observed for 1 hour in office.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and unknown gender. From 16-JUN-2015, the unspecified number of unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K009757a ane expiry date: 08-JUL-2016). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Dermatitis, Erythema, Skin warm
Clinical narrative: Warm red dermatitis-TAC Rx provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also an office manager) referring to unspecified patients of unknown age and gender. There was not medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (therapy type, dosage, strength, lot# and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reported received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Chills, Fatigue, Headache, Pain
Clinical narrative: 4 hrs after chills and shaking (2 hrs), headache, body aches, and fever of 103.2. Headache too severe to read missed work Thurs and Fri (would have missed more if not a weekend). Lasted four days/exhaustion.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Tremor
Clinical narrative: 4 hrs after chills and shaking (2 hrs), headache, body aches, and fever of 103.2. Headache too severe to read missed work Thurs and Fri (would have missed more if not a weekend). Lasted four days/exhaustion.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (batch#/lot# L005563, expiration date 03-NOV-2016, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown age and unknown gender. From 16-JUN-2015, the unspecified number of unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# J006511 and  expiry date: 28-JUN-2016. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Painful upper arm, then wrist, with redness, swelling, warmth-over a 9-10 day period, spread to the upper chest.
Age: 5.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 years 5 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Hypoacusis
Clinical narrative: 05/15/15 vaccine given; 5/20/15 appointment for arm pain, decreased strength since 5/16; 6/12/15 Entire body aching pain to walk; Rx prednisone; 6/16/15 persisting body aches no help with prednisone sed rate 54; 6/23/15 Dizzy, decreased hearing; imbalance; no nausea/vomiting - rheum referral transferred; 6/29/15 problems breathing - to ER; 8/21/15 Rheumatology appt dx myositis - Rx gabapentin.
Age: 79.0
Sex: M
Vaccine: PNC
Symptoms: Myositis, Pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: 05/15/15 vaccine given; 5/20/15 appointment for arm pain, decreased strength since 5/16; 6/12/15 Entire body aching pain to walk; Rx prednisone; 6/16/15 persisting body aches no help with prednisone sed rate 54; 6/23/15 Dizzy, decreased hearing; imbalance; no nausea/vomiting - rheum referral transferred; 6/29/15 problems breathing - to ER; 8/21/15 Rheumatology appt dx myositis - Rx gabapentin.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Incorrect route of drug administration
Clinical narrative: Reaction unknown-vaccine for PREVNAR 13 give SQ instead of IM-tried contacting patient and left message-have not heard back. I called manufacturer...no need to revaccinate but may cause mild site reaction.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Ear swelling, Erythema, Eye swelling, Lethargy
Clinical narrative: Rash, hives, itching, swollen eyes, bridge of her nose, ear lobes swollen cheeks. Pain, redness, lethargic, loss of appetite.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pain, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Rash, hives, itching, swollen eyes, bridge of her nose, ear lobes swollen cheeks. Pain, redness, lethargic, loss of appetite.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 months 15 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site pruritus, Loss of consciousness
Clinical narrative: Pt/mom indicated no known allergy. Was given chickenpox vaccine. Pt was nervous before the vaccination. Immediately after vaccination she complained it was itching at the site of injection. Patient standing by. Patient looked like she was about to fall on floor and I was able to hold her with help from her mom. She gained consciousness. Activated 911. Pt taken to emergency room.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Guest was given FLUARIX which she also received the previous year with no issues. She stayed in store for a little bit afterwards and when she got home (at least 20 minutes) after she noticed a rash all over her body. Recommended she take BENADRYL (2 tab). Watch for s/s of trouble breathing, increased HR or BP go to ER. If rash gets worse on BENADRYL call family MD or go to ER.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of an unknown age and gender. There was no information about patients' concomitant medications pertinent medical histories, drug reactions and allergies provided. On unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, L006386, expiration date 25-FEB-2017; lot # L000454, expiration date 06-JAN-2017; lot # K020760,, expiration date 31-OCT-2016; lot # K016128, expiration date 23-SEP-2016; doses, routes and sites of administration were not reported). No adverse events were reported. No product quality complaints (PQC) were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Pain, Swelling
Clinical narrative: Patient states she started having pain 8/29/15 ice was applied due to being swollen, and also got a blister 8/29/15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. Or an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L004655 with expiration date 11-FEB-2017, lot #L009203 with expiration date 17-MAR-2017; lot reported as L017145 with expiration date 13-MAY-2017, lot # L002869 with expiration date 27-JAN-2017, lot # K011085 with expiration date 08-AUG-2016,  strength, dose, dose # and route not provided )(incorrect product storage). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Received Tdap in ED on 8/22/15 - c/o redness, swelling and heat to (L) arm where vaccine was given since 8/24/15.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Information has been received from a physician via a company representative referring to a 35 year old non-pregnant female patient. The patient had underwent a splenectomy prior and was immunocompromised currently. Drug reactions/allergies were not reported. On an unknown date, the prescribing physician recommended ZOSTAVAX to the patient because the patient was immunocompromised. On an unknown date the patient was vaccinated with 1 vial regular dose of ZOSTAVAX (dose frequency, lot # and expiration date were not reported) in an unknown pharmacy (inappropriate schedule of drug administrating, medication error). On an unknown date in August 2015 "last week", the patient had a reaction from the elbow to the shoulder on an unspecified arm. The affected area was red, warm, swollen and "tender to the touch". On an unknown date, the patient sought medical attention and prednisone (manufacturer unknown) and an unspecified antibiotic were given as treatment. The outcome of the events was unknown. The relatedness of erythema, feeling hot pain in extremity and peripheral swelling to ZOSTAVAX was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Eye swelling, Headache, Injection site pain
Clinical narrative: Pain and tenderness at injection site. Severe headache by 1 PM. 5 p Body aches and weakness. 6 p Bad sore throat, cough. 102 degree fever-7 p. On 8/31 woke with swollen eyes, 100 degree temp, aches.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Pain and tenderness at injection site. Severe headache by 1 PM. 5 p Body aches and weakness. 6 p Bad sore throat, cough. 102 degree fever-7 p. On 8/31 woke with swollen eyes, 100 degree temp, aches.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (lot# L017140 with expiration date 13-NOV-2016, lot# reported as K009893 with expiration date 11-JAN-2016, lot# L005297 with expiration date 17-AUG-2016, strength, dose, dose# and route not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 cm area of erythema and warmth and mild induration on the upper right arm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified patient of unknown demographics. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL injection (lot # K016966; expiry: 10-MAY-2017) (dose and route unspecified). No medical history, concurrent conditions or concomitant therapies were reported. No adverse effect reported. No additional information provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, cough and congestion no fever. (had indicated at time of vaccination that she was getting over cold or allergy).
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Muscular weakness, Nausea, Tremor
Clinical narrative: Muscle weakness; nausea; tremors; chills. Within minutes of administration (+) chills, nauseated x 2 hrs; I felt 2 hours after (L) frontal headache x 2 hours.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Rash papular
Clinical narrative: 14 days after vaccines the patient erupted in a papule rash, mainly on the trunk. Some of the lesions had pinpoint fluid filled vesicles. Rash seemed to spread in waves/caps.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a four unspecified patients of unknown age and gender. No concurrent conditions and medical history reported. On 21-JUL-2015, four unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L012034, expire date 07-APR-2017. No concomitant medications reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to 4 patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. Over the last four years, on unspecified dates, four patients were vaccinated with GARDASIL (lot#, dose, route and dose number were unspecified). On unspecified dates, the 4 patients experienced syncope after receiving GARDASIL. The outcome of the event was unspecified. Additional information is not expected because there was no consent to contact physician.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient c/o chills, pain in left arm, increase redness and swelling at injection site.
Age: 83.0
Sex: U
Vaccine: PPV
Symptoms: Infection, Nodule, Pain in extremity
Clinical narrative: Patient had a nodule and soreness in arm.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: After vaccination patient developed blisters/rash on arm, back of neck, and head. He was seen by his primary care MD who verified it was shingles. Patient was treated with VALTREX and gabapentin. Still has rash as of 8/23/15.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging spinal, Paraesthesia, Urinary retention
Clinical narrative: Foot tingling started about 8 days after injection, quickly went up entire leg (left) went to ER, afterwards noticed same sxs in (R) leg eventually went up both legs to the waistline. No feeling and unable to urinate. Hospitalized 3/22/13.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 years old female patient. No concurrent condition, medical history, or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 16 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have  been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Breath sounds abnormal, Dry throat, Headache, Neck pain
Clinical narrative: Pt. received flu vaccine to left thigh around 03:40 PM, 8/20/2015. He woke the next morning at 3:00 AM with dry throat, loud breathing, neck and back pain and general body aches. Transported to Emergency Room via EMS. Pt also c/o head pain and vomited x 1. Symptoms completely resolved at ER and pt. discharged home with parents.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Vomiting
Clinical narrative: Pt. received flu vaccine to left thigh around 03:40 PM, 8/20/2015. He woke the next morning at 3:00 AM with dry throat, loud breathing, neck and back pain and general body aches. Transported to Emergency Room via EMS. Pt also c/o head pain and vomited x 1. Symptoms completely resolved at ER and pt. discharged home with parents.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JUL-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Pt had TYLENOL 1 1/2 hrs before vaccine administered. Pt received another dose of TYLENOL at 3 pm, 7 pm and then fever of 104.4 (forehead) noted around 10:30 pm. Another dose of TYLENOL at midnight. Fever stayed higher than 102 all night. Broke in the morning 100.9. Pt saw FNP this morning. Continue TYLENOL q 6 hrs.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Blindness unilateral, Cold sweat, Eye operation, Eye pain, Headache
Clinical narrative: On Feb. 24, 2015 at 12:15 P.M. received shot, 3 days later unable to see out of left eye, torn. Contacted office all adverse reactions occurred shoulder swelled up, fever, head and eye pain, temples, weak muscle pain shoulder still has pain. Shoulder pain left and returned. Future eye(s) surgery. (Ongoing rash). Hot-cold sweats.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Laboratory test abnormal, Muscular weakness, Musculoskeletal pain, Pyrexia
Clinical narrative: On Feb. 24, 2015 at 12:15 P.M. received shot, 3 days later unable to see out of left eye, torn. Contacted office all adverse reactions occurred shoulder swelled up, fever, head and eye pain, temples, weak muscle pain shoulder still has pain. Shoulder pain left and returned. Future eye(s) surgery. (Ongoing rash). Hot-cold sweats.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Retinal tear, Swelling
Clinical narrative: On Feb. 24, 2015 at 12:15 P.M. received shot, 3 days later unable to see out of left eye, torn. Contacted office all adverse reactions occurred shoulder swelled up, fever, head and eye pain, temples, weak muscle pain shoulder still has pain. Shoulder pain left and returned. Future eye(s) surgery. (Ongoing rash). Hot-cold sweats.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Erythema, Injection site cellulitis
Clinical narrative: Patient with cellulitis to left upper arm at site to PREVNAR injection. Tmax 100.0 x 2 days and firmness now resolved. Had chills x 2 days now resolved. Redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Rash on face and arms 8/21/15 comes and goes-no medication.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years 9 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years 10 months old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not the expected, no contact details were provided.
Age: 1.26
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: Pt with erythematous, blanching maculopapular rash to torso, back, and thighs no vesicles.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Pruritus, Urticaria
Clinical narrative: Patient present with rash on upper part of left arm. Also reports urticaria that started on 8/28/15. Father advised that he was not aware of anything until 8/30/15. He gave her BENADRYL last night that did help with itching. No signs of redness. No swelling noted.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 months 29 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 18 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-JUN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # K010440 (expiration date, dose and route not reported). which was improperly stored. No adverse effects were reported. This is one of several reports received from the same  source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Vaccine administered at 9:15AM, rash reported from cheeks down to torso by mother at 6PM; rec. MD antihistamines (fexofenadine).
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever (102 degrees F) from evening of 8/29/15 until she woke the next morning. Body aches and headache through Sunday 8/30/15. Symptoms resolved.
Age: 9.0
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a 9 months 6 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medication were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt said a shingles like rash developed on forearm the ZOSTAVAX was given.
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Dyspnoea
Clinical narrative: Patient here for Kindergarten injections. Pt here 20-30 min after injections. Went home with father. Stopped for ice cream on way. Pt was complaining of SOB. Father brought pt back to clinic. Pt seen by Dr. He prescribed PEDIPRED .5 mg that evening et again next AM et BENADRYL OTC per age.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Band neutrophil percentage, Chest X-ray abnormal, Echocardiogram normal, Electrocardiogram normal, Laboratory test normal
Clinical narrative: Following shots-pt became tachypneic. At office RR-60's with tachycardia 150's-170's. Peds cardiology saw-sinus tachycardia. NL Echo CXR-mild vascular congestion CBC 16.7 with 2% bands.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Respiratory tract congestion, Sinus tachycardia, Tachycardia, Tachypnoea, White blood cell count normal
Clinical narrative: Following shots-pt became tachypneic. At office RR-60's with tachycardia 150's-170's. Peds cardiology saw-sinus tachycardia. NL Echo CXR-mild vascular congestion CBC 16.7 with 2% bands.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 21-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 29-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L013546; expiration date 17-JUL-2016), dose and route of administration were not reported. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician, refers to multiple patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with a dose improperly stored of M-M-R II lot # L002873, expiration date 27-JAN-2017 (strength, dose#, dose, route of administration, anatomical location and albumin status were not reported). There was not a product quality complaint (PQC) involved. No adverse effect were reported. This is one of several reported from the same source.  Lot number L002873 has been verified to be a valid  lot number for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patient were vaccinated with improperly stored doses of ROTATEQ lot # K016275; expiration date: 20-APR-2016 and lot# K020182; expiration date: 25-JUN-2016. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source.  Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUN-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.29
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 15 month old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440 dxpiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (immunization official) referring to a 13 old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387(expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 8 days old female patient. No concurrent condition, medical history of allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.