chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Urticaria, Vaccination site swelling
Clinical narrative: Noticed swelling (the size of a baseball) at the site of vaccination, 2 hrs after administration. Took ADVIL to relieve the pain. Developed hives 12 hrs after vaccination. BENADRYL provided no relief. Went to Dr's office on 9/15/14 after hives spread all over body. Was started on a 9 day course of prednisone.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, C-reactive protein increased, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: The pt. received PREVNAR (PCV13) on 7/2/14 and Pneumococcal (PPSV23) Vaccine (Merck Lot J010396) on 9/2/14 in the right upper arm at 1400. The pt was in good health at the time of vaccination; the patient is right handed. At 1600 the pt noted that her right shoulder/arm was sore but nothing unusual after receiving a vaccination. At 1800 the pt stated that the right upper arm was very sore (8/10) and she was unable to feed herself without an increase in pain. She applied an ice pack and took two (2) TYLENOL (650-1000mg). After sleeping for about an hour the pt woke at 2100 in severe pain (10/10)--she experienced shoulder pain with movement of her hand. The pt reported to the ER at 0800. According to the pt she was given DILAUDID and her pain on arrival to our clinic at 1300 was 5/10. The pt has her right arm supported in a sling. On physical exam the right shoulder: Significant tenderness noted with palpation; pt was unable to abduct her arm >15 degree without pain; pt was unable to shrug her shoulder without pain. Slight warmth on noted right deltoid. Pain was elicited with movement (independent or with assistance). The injection site was noted to be high on the deltoid at 1cm from right acromion. The pt was treated with TYLENOL 650mg q4-6prn, NORCO 5-325mg q6prn, ice/heat, sling as needed and gentle exercises as tolerated. At her follow-up visit with her PCM on 9/8/14 she was much improved with complete resolution of her symptoms on 9/11/14.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: The pt. received PREVNAR (PCV13) on 7/2/14 and Pneumococcal (PPSV23) Vaccine (Merck Lot J010396) on 9/2/14 in the right upper arm at 1400. The pt was in good health at the time of vaccination; the patient is right handed. At 1600 the pt noted that her right shoulder/arm was sore but nothing unusual after receiving a vaccination. At 1800 the pt stated that the right upper arm was very sore (8/10) and she was unable to feed herself without an increase in pain. She applied an ice pack and took two (2) TYLENOL (650-1000mg). After sleeping for about an hour the pt woke at 2100 in severe pain (10/10)--she experienced shoulder pain with movement of her hand. The pt reported to the ER at 0800. According to the pt she was given DILAUDID and her pain on arrival to our clinic at 1300 was 5/10. The pt has her right arm supported in a sling. On physical exam the right shoulder: Significant tenderness noted with palpation; pt was unable to abduct her arm >15 degree without pain; pt was unable to shrug her shoulder without pain. Slight warmth on noted right deltoid. Pain was elicited with movement (independent or with assistance). The injection site was noted to be high on the deltoid at 1cm from right acromion. The pt was treated with TYLENOL 650mg q4-6prn, NORCO 5-325mg q6prn, ice/heat, sling as needed and gentle exercises as tolerated. At her follow-up visit with her PCM on 9/8/14 she was much improved with complete resolution of her symptoms on 9/11/14.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Temperature 98.1 Pulse 93 Respiration 20 B/P 105/71. Redness and swelling both upper arms. Left arm - 15 cm x 11 cm red, warm, blanching. Right arm - 9.5 cm x 8 cm red, warm, blanching.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Pain in shoulder area, decrease of usage in deltoid and bicep and numbness. Sleeping is difficult. Believes neck muscle trying to compensate therefore stiff neck.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Hives started PM of 9-9-14, 3 vaccines given PM 9-08-14 - BENADRYL PRN.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of TDap injection on R deltoid.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm to touch, redness, right thigh - x 1 week. Acetaminophin 100 mg; 5ml Q daily, Cetirizine 5 mg, 5 ml Q PRN.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy diagnosed at ER on 9-10-14 vaccination on 9-8-14, symptoms 9-9-14.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Unsure of onset - red spot developed some time after varicella given at injection site. Elevated of office visit 12 days after vaccine administration. Noted to have 3 cm erythematous area on lateral L thigh. Some areas red, others pink. No vesicles, pustules. Slight firmness on palpation. Augmentin Rx' d if Sx's worsen.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local reaction
Clinical narrative: Pt had localized reaction to left arm pneumococcal vaccine (PPV) - secondary cellulitis - tx at ER 9/13/14.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Nausea, Pain in extremity
Clinical narrative: Pt called at 6:30 PM complaining of pain in both arms, raised temp, nausea and headache.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Dizziness, Excessive eye blinking, Headache, Nausea, Photophobia
Clinical narrative: Within 30 minutes of FLUMIST administration developed headache, dizziness, excessive blinking, slight nausea, no fever, no vomiting, slight photophobia, no blurry vision.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: Two days after receiving the pneumonia vaccine, the patient presented soreness, redness and inflammation in the right arm where the shot was given. Also, patient had fever one day. Doctor prescribed CIPRO 500mg.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Paraesthesia, Radial nerve injury, Skin burning sensation
Clinical narrative: (L) arm burning and tingling and weakness progressive since flu vaccine 5 days ago. Radial nerve distribution. Unresponsive to NSAIDs. Dropping objects.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Brachial plexopathy, Neuralgia, Spinal X-ray normal
Clinical narrative: Brachioplexopathy of (R) arm (injected side) lasting >2 weeks. Pain in median, radial and ulnar nerves.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Hyperhidrosis
Clinical narrative: Pt reports being diaphoretic, temp 101. 24 hrs after vaccination. He states he had to be taken via ambulance to emergency care. Pt reports his physician is currently monitoring him.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm got swollen approx. 6 inches, red, hot to the touch.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest X-ray abnormal, Dizziness, Dyspnoea, Hyperhidrosis, Pleural effusion
Clinical narrative: This spontaneous report as received from a 71 year old female patient refers to herself. Patient's pertinent medical history included asthma and unspecified reaction (drug reaction or allergy) to miconazole nitrate cream. On 26-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot/batch number, expiration date, route and anatomical location were not reported). Concomitant therapies included NASONEX, dexamethasone cream (manufacturer unknown), triamcinolone, FLOVENT and fluticasone nasal spray. On 30-JUN-2014, the patient experienced widespread itching. The patient called her physician's office and was prescribed a 6 day course of prednisone. The patient was seen in the office on 10-JUL-2014, and was diagnosed with pneumonia. She was prescribed a 6 day course of azithromycin. On 19-JUL-2014, the patient was evaluated at an unspecified emergency room and on the same day, the chest X-ray was performed which revealed "water in the lungs" and she was prescribed BIAXIN. The patient's symptoms did not improve, so she was seen in her physician's office again and prescribed AUGMENTIN. On 02-SEP-2014, the patient was prescribed another course of azithromycin. The patient stated that at the time of the report she was feeling dizzy, sweaty and had shortness of breath with exertion, all experienced in 2014. It was reported that the treatment was given for the events. The patient sought medical attention (emergency room visit). The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pneumonia, Pruritus
Clinical narrative: This spontaneous report as received from a 71 year old female patient refers to herself. Patient's pertinent medical history included asthma and unspecified reaction (drug reaction or allergy) to miconazole nitrate cream. On 26-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot/batch number, expiration date, route and anatomical location were not reported). Concomitant therapies included NASONEX, dexamethasone cream (manufacturer unknown), triamcinolone, FLOVENT and fluticasone nasal spray. On 30-JUN-2014, the patient experienced widespread itching. The patient called her physician's office and was prescribed a 6 day course of prednisone. The patient was seen in the office on 10-JUL-2014, and was diagnosed with pneumonia. She was prescribed a 6 day course of azithromycin. On 19-JUL-2014, the patient was evaluated at an unspecified emergency room and on the same day, the chest X-ray was performed which revealed "water in the lungs" and she was prescribed BIAXIN. The patient's symptoms did not improve, so she was seen in her physician's office again and prescribed AUGMENTIN. On 02-SEP-2014, the patient was prescribed another course of azithromycin. The patient stated that at the time of the report she was feeling dizzy, sweaty and had shortness of breath with exertion, all experienced in 2014. It was reported that the treatment was given for the events. The patient sought medical attention (emergency room visit). The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was unknown. On 10-SEP-2014 the patient was vaccinated with first dose of PNEUMOVAX 23 (lot number: unknown with expiry date 31-JUL-2014), 0.5 ml, intramuscular. On the same day, patient was vaccinated with second dose of PNEUMOVAX 23 (lot number and expiry date unknown), 0/5 ml subcutaneously. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 ws not reported. Product quality issue was not involved. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: Fever. Chills. Runny nose.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 1.4
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Chest X-ray, Dyspnoea, Full blood count, Injection site erythema
Clinical narrative: Fever (prolonged) x 14 days starting day of administraiton per parent. Temp 101.1 9/9/2014 - Redness left thigh midly tender. Rx: Cephalexin for possible cellulitis.
Age: 1.4
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Pyrexia, Urine analysis normal, Wheezing
Clinical narrative: Fever (prolonged) x 14 days starting day of administraiton per parent. Temp 101.1 9/9/2014 - Redness left thigh midly tender. Rx: Cephalexin for possible cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Erythema of both thighs 2 days after vaccines. Largest ones of erythema L thigh 2 " by 1.5 ".  Non tender - local reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: Patient seen at local ED with n/o swelling both legs - 2 days post vaccines, local allergic reaction diagnosed.  Rx: BENADRYL
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Erythema and wheal formation site of injection few minutes <10 min's of administration of PROQUAD. Left thigh. Rx Diphenhydramine PO in clinic.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 92 or 93 year old female patient. The patient's medical history and past drug history were unknown. On 01-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # J004269 expiration date 12-JUL-2014 in the left arm. No concomitant medication reported. On 01-SEP-2014, patient was given the injection and after that the pharmacist realized it was expired. It was unknown if there was any relevant laboratory data. As of 01-SEP-2014, it was unknown if the patient would receive ZOSTAVAX again and the outcome of receiving an expired ZOSTAVAX was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with third dose of GARDASIL (route of administration and dose were not reported). On an unknown date the patient received third dose of GARDASIL to early; one month after the second dose. No adverse effect reported. Additional information is not expected. Reporter did not wish to be contacted.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with (Oka/Merck) PROQUAD (lot #, expiration date, dose and route unspecified) that were stored improperly. No adverse effects reported. This is one of several reports received from same source. All telephone attempts to obtain follow-up information have been unsuccessful.   Follow-up information was received from an other health profession. It was reported that 4-year old female patient was vaccinated with a dose of (Oka/Merck) PROQUAD on 21-MAR-2014, that was stored incorrectly. Additional information is not expected as no further information is available.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot #, expiration date, dose and route unspecified) that were stored improperly. No adverse effects reported. This is one of several reports received from same source. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received from an other health professional. It was reported that 4-year-old male patient was vaccinated with a dose of PROQUAD (Merck) on 14-FEB-2014. Additional information is not expected as no further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human papilloma virus test positive, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via a company representative referring to approximately 14 year old female patient. Pertinent medical history and concurrent conditions were unspecified. On 27-MAY-2008 the patient received the first dose of GARDASIL, on 17-JUL-2008 received the second dose and on 20-OCT-2010 received dose 3 of GARDASIL. No other concomitant therapies reported. The company representative was told by the physician that he had a patient who called the office upset because she was pregnant (date unspecified) and had been informed that she tested positive for HPV. The LMP and EDD was not known. The patient had not sought medical attention. The pregnancy outcome was pending. The outcome of the events was unknown. The causality of the events was unspecified. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: This spontaneous report as received from a healthcare worker via a field representative refers to a currently 66 year old female patient. On an unknown date the patient was vaccinated with one injection of PNEUMOVAX 23 (lot # J013555, expiration date: 02-MAY-2015, strength, dosage and route unknown). On an unknown date the patient experienced severe injection site reactions including redness and hardness at the injection site. The patient had called the office to seek medical attention. The outcome of the events was unknown. This is one of several reports received from the same reporter. 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 pharmacy student refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was inadvertently vaccinated with PNEUMOVAX 23, lot # H011780 that had expired on 16-FEB-2014 (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several same reporter cases. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL in September 2013 (dose, route, lot # and expired date were not reported). The patient was vaccinated with the second dose of GARDASIL in December 2013 (dose, route, lot # and expired date were not reported). Patient was in the office; however was sent to unspecified primary care physician to complete GARDASIL vaccination series. No adverse effects were reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEPA, MNQ, TYP, VARCEL
Symptoms: Dizziness, Full blood count, Injection site rash, Metabolic function test
Clinical narrative: Rash R upper outer arm 24 hours after immunization given on 9/11 - Dizziness 9/14 in AM that went away. Some light headedness yesterday and today. BENADRYL 25 mg Q4h Rx today.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to 2 patients less than 20 years of age with unknown gender. Patient medical history and historical conditions were not reported. On an unkonwn date, the 2 patients inadvertently received ZOSTAVAX (dose, lot # were not reported) instead of VARIVAX (Merck) and no adverse effect reported. That was related to a staff error. Concomitant therapy was not reported. No PQC was involved. Outcome of events was unknown. The reporter considered patients inadvertently received ZOSTAVAX instead of VARIVAX (Merck) and no adverse effect to be not related to ZOSTAVAX. This case was linked to MARRS # 1409USA005101 (same patient link). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from registered nurse refers to a 44 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. On 10-SEP-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 (dose and route unspecified) (lot number: J011651 with expiry date of 22-AUG-2014). Concomitant medications were unkonwn. The patient sought medical attention. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H015824, expiration date 24-AUG-2014, subcutaneous (dose not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 05-SEP-2014 the patient was vaccinated with and expired dose of PNEUMOVAX 23 lot # J009827, expiration date: 10-AUG-2014, 0.5 ml, intramuscular. No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 20 year old patient with unknown gender. Patient medical history and historical conditions were not reported. On an unknown date, the patient inadvertently received ZOSTAVAX (dose, lot # were not reported) instead of VARIVAX (Merck) and no adverse effect reported. That was related to a staff error. Concomitant therapy was not reported. No PQC was involved. Outcome of events was unknown. The reporter considered patient inadvertently received ZOSTAVAX instead of VARIVAX (Merck) and no adverse effect to be not related to ZOSTAVAX. This case was linked to MARRS # 1409USA006963 (same patient link). 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 04-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # J009827 and expiration date 10-AUG-2014, (route and dose not reported). No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care student refers to a patient of unkonwn demographics. The patient's current conditions or medical history were not reported. On 03-SEP-2014, the patient was vaccinated with an expired dose of M-M-R II (SDV, MDV or additive) subcutaneous injection (lot number reported as J008882, expiration date 27-JUL-2014). No known adverse effects. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. The patient's medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL (Lot #, dose and route were not reported) that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the three patients were administered with GARDASIL (lot number and expiration date not reported). Follow up information has been received from a license practical nurse. The reporter specified the 12 year old patient was vaccinated on 13-AUG-2014 with GARDASIL (Lot # J006850, exp. date 31-MAR-2016). Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. The patient's medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL (Lot #, dose and route were not reported) that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the three patients were administered with GARDASIL (lot number and expiration date not reported). Follow up information has been received from a license practical nurse. The reporter specified the 13 year old patient was vaccinated on 13-AUG-2014 with GARDASIL (Lot # J006850, exp. date 31-MAR-2016). Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient in his 70's, No pertinent medical history or drug reactions/allergies were provided. On an unspecified date in 2006, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided. No co-suspect or concomitant therapies were provided. Shortly after receiving ZOSTAVAX, approximately in 2006, the patient developed a rash on his buttocks. The physician prescribed LYRICA and VALTREX for treatment. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain. Pt went to see prescriber and MD said it was possible tendonitis due to possible influenza vaccine administration into bursa.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 13 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 12 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-SEP-2014 (reported as "one or two days ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous, in the arm (dose, strength, frequency and lot number were not reported). Concomitant therapies included influenza virus vaccine (unspecified), hydroxyzine hydrochloride (manufacturer unknown) for anxiety and BENADRYL for an unknown indication. Hydroxyzine hydrochloride (manufacturer unknown) and BENADRYL were initiated sometime prior the administration of ZOSTAVAX. The pharmacist reported that a physician called him and stated that the patient had developed an injection site reaction of redness and itching in the arm where the ZOSTAVAX vaccine was applied. This has spread to the back of the patient's arm and it was extending down the patient's arm. The patient had no symptoms in the arm that received the influenza virus vaccine (unspecified). The outcome of the events was reported as not recovered. It was reported that the patient went to an immediate care center. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 16 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients. The patient's medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL (Lot #, dose and route were not reported) that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the three patients were administered with GARDASIL (lot number and expiration date not reported). Follow up information has been received from a license practical nurse. The reporter specified the 9 year old patient was vaccinated on 13-AUG-2014 with GARDASIL (Lot # J006850, exp. date 31-MAR-2016). Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 72 year old male patient. The patient's medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route and dose was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced severe case of shingles, after receiving ZOSTAVAX. Sought medical attention. Office visit on an unspecified date. At the time of report outcome of severe case of shingles, after receiving ZOSTAVAX was unknown. The relatedness of the event with the therapy of ZOSTAVAX was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TTOX
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a 65 year old female consumer refers to herself. The patient had no pertinent medical history or drug reactions/allergies. The patient reported that she had received ZOSTAVAX ("standard dose") at the end of "November of 2013". Then in "March of 2014" she had received tetanus toxoid (unspecified dose and unspecified manufacturer). Concomitant medications included ZOCOR and unspecified "thyroid medication". Two days after receiving this tetanus shot, on an unspecified date in March 2014 the patient developed shingles. The patient still had the nerve pain associated with this to "this day" (reporting day on 11-SEP-2014). "Anti-viral" pills was given as the treatment for the events. "Various unspecified tests" were performed. The patient had sought medical attention by seeing physician. Outcome of the events was reported as not recovered. 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 a patient of unkonwn age. On 08-SEP-2014, the patient received improperly stored ZOSTAVAX, (dosage, route and lot number not provided). No adverse symptoms reported. The temperature excursion for the ZOSTAVAX was found to be supported by in-house stability data. 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 physician assistant refers to a patient of unknown age. On 25-AUG-2014, the patient was vaccinated with a expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, route not reported). No adverse effect was reported. 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. Information about concurrent conditions, concomitant medication and medical history was not provided. On 09-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H021941, expiration date 11-JUL-2014, dose and route were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dose and route not reported) lot number J004875 expiration date 17-OCT-2014 that was improperly stored. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an about 5-10 patients of unkonwn age and gender. Medical history was not reported. The pharmacist informed that in August 2014 the patients were vaccinated with ZOSTAVAX, subcutaneous (lot number, expiration date and dosage were not reported) which was improperly exposed to defrost cycling up to 7 F for <1 hour per cycle for 1 cycle per day each day. The date that this ZOSTAVAX was placed into this freezer was unspecified. No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of VAQTA (dose and route not reported) lot number 0628AE expiration date 26-JAN-2015 that was improperly stored. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX (dose and route not reported) that were improperly stored. Lot numbers: H017018, expiration date 11-JUL-2015. H015537, expiration date 09-JUL-2015. And lot number reported as J009746, expiration date 26-JAN-2015. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 14 year old male patient. No pertinent medical history, drug reactions or allergies were reported. On an unknown date in July 2013, the patient was vaccinated with GARDASIL dose 1 (reported as a date therapy started) for vaccination (dose, route, anatomical location, lot number and expiration date were not reported). On 20-AUG-2014, the patient was vaccinated with GARDASIL dose 2, lot # K004204, expiration date 12-JAN-2017, (dose, route and anatomical location were not reported). No concomitant therapies were reported. On 20-AUG-2014, within 20 minutes after administration of the second dose, the patient experienced severe headache and dizziness. The patient sought medical attention by office visit and was given ibuprofen for treatment. The outcome of severe headache and dizziness was reported as recovered on an unspecified date. The outcome of started therapy on July 2013 and second dose of GARDASIL on 20-AUG-2014 was unknown. The relatedness between severe GARDASIL and, headache and dizziness was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 73 year old female patient. Medical history and concurrent conditions were not reported. On 25-AUG-2014, the patient was vaccinated with a second dose of ZOSTAVAX (lot number and expiration date were not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. Pharmacist reported that the patient was vaccinated with two doses of ZOSTAVAX. Patient received the first dose of ZOSTAVAX on an unknown date (reported as a couple of years ago). And the second dose of ZOSTAVAX was administered on 25-AUG-2014. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 11 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. 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 unkonwn age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. On 04-SEP-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014 (also reported as 01-AUG-2014) intramuscular (dose, dose number and anatomical location were not reported). No known adverse effects. No concomitant therapies were reported. The outcome of the event was unknown. Additional information is not expected because reporter refused additional contact.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 18 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. 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 unkonwn age and gender. The patient's current conditions or medical history were not reported. On 03-SEP-2014, the patient was mistakenly vaccinated with an expired dose of PNEUMOVAX 23 injection (dose number and route not reported) lot number J004080, expiration date 22-AUG-2014. No adverse effects required. Additional information is not expected as the reporter did not wanted follow up contact.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 year old female patient with asthma. No other medical history or relevant past drug history was provided. On 30-AUG-2014, the patient was vaccinated with PROQUAD (Merck), (Lot # reported as K0065546, Expiration date: 17-OCT-2015) Injection. Lot number K0065546 is an invalid lot number for PROQUAD (Merck). Concomitant therapies included FLOVENT and XOPENEX for asthma. On 30-AUG-2014, patient was vaccinated with PROQUAD (Merck) because the facility did not have the individual "MMR" and varicella vaccines available and then it was noted in the package insert it was only to be used in patients through 12 years of age. No relevant laboratory testing has been performed. No other adverse event was known at the time of the report. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reaction to shingles vaccine. Bruising discoloration previously noted. When I rested my R tricep (injection site) on the mattress to go to sleep, there was an explosion of intense pain, continued with severe pain for several weeks, radiating into R shoulder and into R hand. Over 90 days since injection, still have moderate to severe chronic ache in R tricep, exacerbated by extension of R arm, pain and burning in top of R hand and wrist. Any touching anywhere on the R arm for the first 30 days caused pain response from entirety of R arm. Pressure to R tricep still causes similar reaction, also less severe than during first 30 days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Reaction to shingles vaccine. Bruising discoloration previously noted. When I rested my R tricep (injection site) on the mattress to go to sleep, there was an explosion of intense pain, continued with severe pain for several weeks, radiating into R shoulder and into R hand. Over 90 days since injection, still have moderate to severe chronic ache in R tricep, exacerbated by extension of R arm, pain and burning in top of R hand and wrist. Any touching anywhere on the R arm for the first 30 days caused pain response from entirety of R arm. Pressure to R tricep still causes similar reaction, also less severe than during first 30 days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Contusion, Injection site pain, Pain
Clinical narrative: Reaction to shingles vaccine. Bruising discoloration previously noted. When I rested my R tricep (injection site) on the mattress to go to sleep, there was an explosion of intense pain, continued with severe pain for several weeks, radiating into R shoulder and into R hand. Over 90 days since injection, still have moderate to severe chronic ache in R tricep, exacerbated by extension of R arm, pain and burning in top of R hand and wrist. Any touching anywhere on the R arm for the first 30 days caused pain response from entirety of R arm. Pressure to R tricep still causes similar reaction, also less severe than during first 30 days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: Reaction to shingles vaccine. Bruising discoloration previously noted. When I rested my R tricep (injection site) on the mattress to go to sleep, there was an explosion of intense pain, continued with severe pain for several weeks, radiating into R shoulder and into R hand. Over 90 days since injection, still have moderate to severe chronic ache in R tricep, exacerbated by extension of R arm, pain and burning in top of R hand and wrist. Any touching anywhere on the R arm for the first 30 days caused pain response from entirety of R arm. Pressure to R tricep still causes similar reaction, also less severe than during first 30 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at site of injection, swelling, redness, heat
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: developed rash at site of Zostavax 2x3cm local treatment  Developed tenderness at site of Pneumovax
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: complaints of scratchy throat after 15min of receiving dose, Benadryl given with some releif and Rx called in for prednisone for 5 days and instructed to pick up benadryl and take 3 days and zantac to take for next 5 days
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope
Age: 3.0
Sex: M
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Fall, Nausea, Pallor
Clinical narrative: After receiving the 6th vaccine, client slid off chair and slumped on the floor but did not completely pass out. He was pale and clammy. A 2nd nurse and myself helped get him to a supine position with knees bend and a pillow propped behind his head. He stated feeling dizzy and nauseated. When questioned, he admitted to not having eating anything yet that day. I turned a fan on to have air blow on his face. After 5 minutes, he wasn't feeling nauseated, and a 3rd nurse got him a juice box to drink. He voiced feeling better once he finished the juice. We continued to have him lay in supine position for 5 minutes longer. At that point, another nurse and myself helped him to a chair where he sat for an additional 5 minutes. Before client and parent left, multiple nurses (myself included) reinforced that he needs to eat a good meal before coming to future immunization appointments.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blister, Injection site erythema
Clinical narrative: Developed large area of redness at site of KINRIX vaccine with few small vesicles adjacent to site. Area was 4 x 5 cm large.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site. Has been getting better since he noticed the reaction