chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid function disorder, Headache, Hypoaesthesia oral, Ophthalmological examination, Pain in extremity
Clinical narrative: Developed Bell's Palsy 3-4 weeks after taking ZOSTAVAX (shingles vaccine). November 20, 2015 had ZOSTAVAX. Left arm very sore and red for two weeks. Dec. 15, 2015 headache and right eye burning. Went to ophthalmologist who said the eye lid doesn't close when you blink. He put lubricating gel in the eye and patched it over night. As the day progressed so did symptoms. Nothing I ate tasted right all day which developed into numbness on right side of my mouth, liquids drooled out, I bit my lip when I chewed and couldn't smile right. December 16, 2015 went back to ophthalmologist who confirmed I had Bell's Palsy. At 1100 I went to neurologist who also confirmed I had Bell's Palsy. He order me drop dose pack and acyclovir. Literature says Bell's often preceded by a virus. I am not diabetic.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Developed Bell's Palsy 3-4 weeks after taking ZOSTAVAX (shingles vaccine). November 20, 2015 had ZOSTAVAX. Left arm very sore and red for two weeks. Dec. 15, 2015 headache and right eye burning. Went to ophthalmologist who said the eye lid doesn't close when you blink. He put lubricating gel in the eye and patched it over night. As the day progressed so did symptoms. Nothing I ate tasted right all day which developed into numbness on right side of my mouth, liquids drooled out, I bit my lip when I chewed and couldn't smile right. December 16, 2015 went back to ophthalmologist who confirmed I had Bell's Palsy. At 1100 I went to neurologist who also confirmed I had Bell's Palsy. He order me drop dose pack and acyclovir. Literature says Bell's often preceded by a virus. I am not diabetic.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site mass, Injection site pain
Clinical narrative: The shot produces a large painful lump under the skin. The lump is smaller but the skin is discolored and it's 3 months later. It looks/feels like a scar or bruise.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: Upper arm and shoulder very sore.  Limited mobility.  Shoulder freezes up after laying down for an extended period of time, or if circulation is diminished.  Takes lots of motion to get pain to go away, but still with limited motion.  Icy Hot, Ice, and Heat.  No lasting improvement.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen hot to touch rash to site.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Injection site papule, Injection site rash
Clinical narrative: Rash with 4 papules on R ant thigh at site of VZV vaccine admin.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Seizure
Clinical narrative: 2 prolonged seizures requiring emergency medication (diastat) and ER visit. No seizures previously in almost a year. In usual state of health (well) before the visit. At this point I do not know if he will be hospitalized.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Inflammatory marker increased, Muscular weakness, Pyrexia, White blood cell count normal
Clinical narrative: Progressive bilateral weakness of lower and upper extremities. Fever of 102. She had severe fatigue as well.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Amnesia, Blood pressure decreased, Disturbance in attention, Headache, Musculoskeletal stiffness
Clinical narrative: Child was seen to become stiff and slump to the side. Had 2-3 minutes of amnesia. Laid flat Measure BP low. Woke spontaneously with bad headache. Headache has now improved after 6 days to moderate, but persists. Child reuses acetaminophen of ibuprofen. Mom says she has trouble concentrating.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Posture abnormal
Clinical narrative: Child was seen to become stiff and slump to the side. Had 2-3 minutes of amnesia. Laid flat Measure BP low. Woke spontaneously with bad headache. Headache has now improved after 6 days to moderate, but persists. Child reuses acetaminophen of ibuprofen. Mom says she has trouble concentrating.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Redness around vaccination area, legs hurt and had some edema in the right foot.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Left deltoid pain, swelling, redness, decreased ROM. Advised ALEVE BID, pending MRI.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Severe constant pain (L) arm, could not lift x 3 days. Legs were weak, no walking x 1 day. Severe Headache x 3 days. Emesis x 1. Very tired.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Severe constant pain (L) arm, could not lift x 3 days. Legs were weak, no walking x 1 day. Severe Headache x 3 days. Emesis x 1. Very tired.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Injected limb mobility decreased, Nodule, Pain in extremity
Clinical narrative: Soreness in left arm, difficulty grasping objects, knot in muscle, difficulty in lifting arm above shoulder soreness began with immunization and has persisted.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Skin rash. Cetirizine 10 mg every day, prednisone 20 mg UD.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to unspecified number of patients. On unknown dates ranging from 15-JUN-2015 through 07-DEC-2015 the patients were vaccinated with improperly stored GARDASIL (dose and route not reported, lot # K011562, expired date: 10-MAY-2017; J015378, expired date: 09-APR-2016). No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Eyelid oedema, Injection site swelling
Clinical narrative: SWOLLEN RT UPPER EYELID AND SWOLLEN SITE OF RT. DELTOID WHERE 2 SHOTS (PROQUAD AND PEDIARIX) WERE GIVEN. CAREGIVER BROUGHT BACK TO CLINIC AT ABOUT 4:45 P.M. AND EVALUATED BY DOCTOR TO HAVE THE ABOVE - NO WHEEZING OR SOB NOTED; JUST THE ABOVE SSX) AND GIVEN EPIPEN 0.15 MG IN RT. THIGH. ABOUT 15 MIN. LATER CHILD STATED SHE COULD FEEL SWELLING COMING DOWN IN EYELID AND RT. FOREARM AND NOTED TO HAVE DECREASED SWELLING, AND SHE WAS D/C HOME.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site warmth, Pyrexia
Clinical narrative: HAD FEVER, redness and site is warm to touch was treated on 12/22/15 Septra 800 mg -160 mg 1 tab BId.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Burning sensation, Chest X-ray, Chest discomfort, Computerised tomogram head
Clinical narrative: Afternoon was flushed, burning face. 12/09/15 didn't feel well. 12/10/15 racing heart; tightness in chest and left axilla, flush, pounding, pulsing in head.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Echocardiogram, Electrocardiogram, Flushing, Headache, Malaise
Clinical narrative: Afternoon was flushed, burning face. 12/09/15 didn't feel well. 12/10/15 racing heart; tightness in chest and left axilla, flush, pounding, pulsing in head.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Urine analysis
Clinical narrative: Afternoon was flushed, burning face. 12/09/15 didn't feel well. 12/10/15 racing heart; tightness in chest and left axilla, flush, pounding, pulsing in head.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Patient states 10 days after injection a sharp jab-like pain occurred at the injection site and radiated down to her wrist, pain dissipated as it traveled. Patient then noticed she felt a knot under the skin where the pain occurred at the injection site. Patient states this occurs on and off since that date and came into the pharmacy on 12/22/2015, where she received the vaccine, to report this to the pharmacist who administered the vaccine. She stated the most recent incident was earlier that day while driving. There is no numbness in fingers and was clear that pain stopped at wrist.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pain in extremity
Clinical narrative: Pt developed acute weakness and pain in both legs prompting admission to hospital 10/25/15 - 11/6/15 MRI brain normal.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Culture throat, Rash pruritic, Rhinorrhoea, Streptococcus test
Clinical narrative: Itchy rash, mild runny nose day of admin. Rash appeared next day. Antihystamine helping.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Laboratory test, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Extreme pain at site. Continued pain with movement of arm - across body or over head. Received testing, 2 courses of prednisone. Pain continues.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 8x5 cm local site reaction - red warm swollen area around site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site - started 12/20/15.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Muscle twitching, Pallor, Posture abnormal
Clinical narrative: Approximately 2 min after HPV given in (L) deltoid pt. (sitting on exam table) slumped over in (R) side and twitched several times, episode lasting at 1-2 min, then pale and clammy for at 20 min.
Age: 1.07
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Patient developed a sore on her arm that expanded into a possible cellulitis. She complained of itching and was seen at the ER. She was prescribed BACTRIM DS and BENADRYL.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # K024700, expiration date 30-JUL-2016, lot # L008051, expiration date 17-NOV-2016, lot # L008057, expiration date 01-DEC-2016, lot # L013192, expiration date 19-JAN-2017, route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US013490 is an initial spontaneous report from a healthcare professional received on 08 Jul 2015, with follow up report received on 28 Sep 2015. This report refers to a 12 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with MENVEO (batch number: A14070, expiry date: Nov 2015) subcutaneously into right deltoid which was stored at a temperature below recommended range at a dose of 0.5 ml on 29 Jun 2015. No adverse event reported following this medication errors. Follow up report from a healthcare professional received on 28 Sep 2015: New event was added. Site of administration and dosage of MENVEO was updated. Follow up report from a healthcare professional received on 4 November 2015: The patient had no concomitant medication and no adverse event following subcutaneous administration of 1st dose of MENVEO.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Incorrect route of drug administration PROQUAD vaccine, given IM not subcutaneous. No adverse reaction/event. Reported to Merck 8/26/15. Merck aware, MARRS#1508USA012135.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site pallor
Clinical narrative: PREVNAR (Lot 88275) administered in left deltoid, patient presented the next day with soreness, 4-5 cm erythematous round area about the injection site, central pallor mild induration and warm. No swollen, tender lymph nodes, temp 99.9, no systemic symptoms.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: PREVNAR (Lot 88275) administered in left deltoid, patient presented the next day with soreness, 4-5 cm erythematous round area about the injection site, central pallor mild induration and warm. No swollen, tender lymph nodes, temp 99.9, no systemic symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Rash erythematous
Clinical narrative: Had shingles vaccine Friday, Dec 18th. Saturday, Dec 19th had large, red, raised rash measuring 6 inches from top to bottom, and around 4 inches wide. Itchy. Sore to touch. Called pharmacist who gave injection, she recommended BENADRYL and cortisone cream. Sunday, Dec 20, the area of redness had grown and was more tender to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Had shingles vaccine Friday, Dec 18th. Saturday, Dec 19th had large, red, raised rash measuring 6 inches from top to bottom, and around 4 inches wide. Itchy. Sore to touch. Called pharmacist who gave injection, she recommended BENADRYL and cortisone cream. Sunday, Dec 20, the area of redness had grown and was more tender to touch.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation, Pain
Clinical narrative: ZOSTAVAX immunization administered by pharmacist on 12/1/2015 left arm on 61 year old male. Increasing soreness and redness. Increasing size of redness to greater than 7 mm on back of left arm. Tissue beyond turned ink. Sought medical care on 4th day. Cellulitis mostly likely diagnosis. KEFLEX rxed qid. 7 days later improved, however, redness of inflamed area has now reduced to 5 mm in diameter. Adjacent tissue is now normal.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot # K012457, expiration date 04-JUN-2017, lot # K018181, expiration date 04-JUN-2017, lot # L002717, expiration date 02-JUN-2017, route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 16-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot number # K010967, expiry date: 06-NOV-2015 (dose not reported) via subcutaneous route. No adverse effect was reported. No further information was available. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Heart rate increased, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, increased H.., arm pain severe all night.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored PNEUMOVAX23 (lot# L012042, expiration date 18-NOV-2016) (route, dose and frequency not reported). No adverse effect was reported. This one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of ROTATEQ (lot # K009900, expiry date 04-MAY-2016; lot @ K011948, expiry date 07-JUN-2016, lot# was reported as K016775 (invalid). expiry date 20-APR-2016; lot# K024700, expiry date 30-JUL-2016, lot #L001316, expiry date 10-NOV-2016; lot # L00453, expiry date 27-MAY-2016, lot # L013192, expiry date 19-JAN-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L016427, expiration date 03-APR-2017, lot # L018501, expiration date 22-JUN-2017, lot # L025738, expiration date 14-AUG-2017, route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 46 year old female patient reporting on herself, via Pfizer Inc. The patient's current conditions included Crohn's Disease, decreased immune responsiveness and a medical history of pneumonia. On 11-NOV-2015, the patient sought for vaccination to prevent pneumonia, so she went to a pharmacy and asked for it. It was not confirmed if she was vaccinated with PNEUMOVAX 23 injection, 25 mcg/0.5 ml (route, dose number, frequency and site of vaccination were not provide) or PREVNAR 13  (dose, frequency, route, dose number and site of vaccination were not provided) or both of them at the same time. Concomitant therapies included FLUARIX and LOMOTIL. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Pt. experienced itch approx. 24 hours after vaccination. Red raised rash, hot to touch. No fever/pain. Pt. was told PREVNAR given in the affected arm. Vaccine screening form showed ZOSTAVAX given in this arm.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hypoaesthesia, Pain in extremity
Clinical narrative: Starting approximately 2 hours after administration, patient states arm he received vaccine in went numb. Since numbness has subsided, arm has been in excruciating pain. Patient also felt "woozy".
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient developed significant forceful vomiting that gradually improved over the course of 2 weeks.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Right deltoid (site of Tdap and MCV 4) redness/swelling tender warm skin/pain - large local reaction.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Muscular weakness, Nausea, Neck pain
Clinical narrative: Fever, chills, headache, nausea, weakness in extremity that had injection, neck and arm pain. Persisting into day 7 s/p injection. Onset was 4 hours s/p injection 1 week prior to this visit.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, headache, nausea, weakness in extremity that had injection, neck and arm pain. Persisting into day 7 s/p injection. Onset was 4 hours s/p injection 1 week prior to this visit.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# K008410, expiry date 26-FEB-2016; lot # K020215, expiry date 15-MAY-2016, lot # L019835, expiry date 23-MAR-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot # L007560, expiration date 15-JUN-2017, lot # L013429, expiration date 21-JUL-2017, route not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: PREVNAR 13 was administered in left deltoid on 10/21/15, when the patient was admitted for surgery on 10/26/15, it was noted that the patient had marked edema, erythema and tenderness about the left shoulder. Surgery was well tolerated.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Red and painful. Loratadine 10 mg every day, Methylprednisolone 4 mg UD.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer, referring herself, a 58 year old female patient. The patient's concurrent conditions included drug reactions/allergies to penicillin and sulfa drugs. The patient did not have any medical history. On 15-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date were not reported) (route, dose and indication were not provided). The patient did not have any concomitant therapy. On an unspecified date in 2015, few hours after the administration the patient experienced "redness and swelling at the insertion site". The patient did not received treatment for the events and she did not sought medical attention. It was not performed any lab diagnostic studies. It was also reported that it was not involved a product quality complaint. At the time of the report, the outcome of injection site erythema and vaccination site swelling was reported as recovering. Additional information is not expected because it was not possible to contact the physician.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache and joint pain, myalgias, leukocytosis, pain/swelling/erythema at deltoid where PNEUMOVAX administered. Ceftriaxone 2 gm BID, acyclovir 500 mg once, dexamethasone 4 mg every day.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Leukocytosis, Myalgia, White blood cell count increased
Clinical narrative: Headache and joint pain, myalgias, leukocytosis, pain/swelling/erythema at deltoid where PNEUMOVAX administered. Ceftriaxone 2 gm BID, acyclovir 500 mg once, dexamethasone 4 mg every day.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L013429 and expiration date 21-JUL-2017, lot # L014415 and expiration date 25-JUL-2017, lot # L016429 and expiration date 09-AUG-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. 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 healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L025738 and expiration date 14-AUG-2017, lot # L018501 and expiration date 22-JUN-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received 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 received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L023936 and expiration date 15-MAR-2017, lot # L007559 and expiration date 01-JUN-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 16 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 17-AUG-2015 at 2:52 p.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (subcutaneously, in left arm, lot # L010145; dose and expiration date were not reported) that was improperly stored. On 17-AUG-2015 at 2:52 p.m., the patient was also concomitantly vaccinated with the second dose of ENGERIX B (intramuscularly, in left arm, lot # 33705; dose and expiration date were not reported), MMR II (albumin status rHA, subcutaneously, in right arm, lot # K006141; dose and expiration date were not reported) and IPOL (intramuscularly, in right arm, lot # K16941; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Age: 0.2
Sex: M
Vaccine: HEP, HIBV
Symptoms: Erythema, Expired product administered, Flushing
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 9 weeks old male patient. No patient's pertinent medical history, concomitant medications and drug reactions or allergies were reported. On 30-JUN-2015, the patient was vaccinated with expired dose of RECOMBIVAX HB injection (lot# K024552, expiration date 22-OCT-2013, dose, anatomical location and route of administration were not reported). On the same day, he was vaccinated with PEDVAXHIB (lot# reported as K017576, expiration date 12-JUN-2016, dose, anatomical location and route of administration were not reported). On an unknown date in 2015, the patient "turned red with associated facial flushing". No lab diagnostics studies were performed. The outcome of the events was reported as recovered (on an unknown date in 2015). The relatedness between the events and vaccination with RECOMBIVAX HB and PEDVAXHIB was not reported. Lot# K017576 was verified to be an invalid lot# for PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored ROTATEQ, (lot# K005394, expiration date 23-FEB-2016; lot# K024700, expiration date 30-JUL-2016) (orally, dose and frequency not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 4 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 18-NOV-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (subcutaneously, in right thigh, lot # K008185, albumin status HSA; dose and expiration date were not reported) that was improperly stored. On the same day, the patient was also concomitantly vaccinated with the first dose of KINRIX (intramuscularly, in left thigh, lot # 5412R; dose and expiration date were not reported) and with the fourth dose of PREVNAR 13 (intramuscularly, in right thigh, lot # J80528; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L010596 and expiration date 06-APR-2017, lot # K016966 and expiration date 10-MAY-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. 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 (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L026740 and expiration date 16-APR-2017, lot # L008574 and expiration date 22-NOV-2016, exact doses were not reported, orally). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site mass, Local reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 60 year old female patient. The patient's medical history and current conditions were not provided. On 19-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L017139 expiration date 13-AUG-2016. The nurse reports that the patient was inadvertently administered a dose of ZOSTAVAX intradermally. Nurse reports that immediately upon administration "local reaction" was seen described as "a lump where you could visibly see the medication under the patient's skin". There was no treatment given for skin lump. The outcome of skin lump was reported as recovered on an unknown date approximately in 2015. The relatedness between skin lump and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
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. The unspecified patients were administered MMRII (lot# L012479, expiration date 10-APR-2017; lot# L005291, expiration date 17-FEB-2017) (dose, route and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored GARDASIL (dose, route and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram, Muscular weakness, Musculoskeletal pain, Rash, X-ray
Clinical narrative: This spontaneous report was received from a 72 year old female patient reporting on herself. The patient had no drug reactions or allergies. The patient's concurrent condition was diabetes mellitus. The patient's concomitant medications included LANTUS, APIDRA, aspirin, lisinopril (manufacturer unknown), ranitidine, metoprolol (also reported as "metropolol"), simvastatin (manufacturer unknown), unspecified medications reported as "hydrochloride" and "L-thiayzol". On 03-MAY-2013, the patient was vaccinated in a pharmacy with a dose of ZOSTAVAX lot # H018091, expiry date 04-JAN-2014, dose reported as "single shoot", intramuscularly (dose and site of administration were not reported). On 13-MAY-2013, the patient experienced a rash on arm and then pain in upper shoulder area, followed by muscle weakness thereby preventing patient's ability to fully close her hand. On an unknown date, the patient visited a primary physician who referred her to a neurologist. The neurologist gave a diagnosis of possible Parsonage-Turner Syndrome (also reported as Parsons-Turner Syndrome). The patient received unspecified treatment for the events. Lab diagnostics studies were performed and included X-Ray and electroencephalogram (EEG). At the time of reporting, the outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no contact details provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored VARIVAX (dose, route and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patients of unknown age. On an unknown date, the patients were exposed to temperatures outside of the recommended range, have been vaccinated with MMRII since 01-OCT-2015. No adverse experience has been reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored ROTATEQ oral (dose and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On 09-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly, lot # L007560, expiry date 15-JUN-2017. The reporter did not specify if the dose administered was the first, second, or third dose in the series. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
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. The unspecified patients were administered RECOMBIVAX HB (lot# L016427, expiration date 13-APR-2017; lot# L004754, expiration date 10-NOV-2016) (dose and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ, orally, lot # L013190 with expiration date 16-NOV-2016 and lot # L020861 with expiration date 25-JAN-2017 (dose was not reported). No adverse effects were reported. This is one of the several reports 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 as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of RECOMBIVAX HB injection, lot# K020216 with expiration date 17-SEP-2016, lot# reported as L0014156 with expiration date 22-OCT-2016, lot# L004754 with expiration date 10-NOV-2016, lot# L016427 with expiration date 13-APR-2017, lot# L029631 with expiration date 14-AUG-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the 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 as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of VAQTA lot # K012457 with expiration date 04-JUN-2017 and lot# L039659 with expiration date 15-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). 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: No adverse event, Product preparation error
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 06-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L026415, expiry date 15-OCT-2015) (dose and route unspecified), that was reconstituted 30 hours before on 05-DEC-2015. No adverse effect reported. Additional information has been requested.
Age: 0.46
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 month and 14 day old patient of unknown gender. There was no medical history or drug reaction/allergies reported. On 20-AUG-2015 the patient was vaccinated with a dose of VARIVAX (lot# K015994 with expired date 23-SEP-2016, 0.5 ml, subcutaneous). No concomitant therapy was provided. No adverse effects were reported. Follow up information has been received from the medical assistant on 30-NOV-2015 referring to the female patient. She had 8 siblings and had no illness at time of vaccination. On 20-AUG-2015, at 5:33 pm, the patient was vaccinated her first dose of VARIVAX intramuscularly (previously reported as subcutaneous) in left thigh in public health clinic/hospital with public funds. Additional information is not expected as all required correspondence was received. Patient's information, product, event and narrative were updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, a health care worker refers to patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The reporter stated that on an unspecified date, the patients were vaccinated with improperly stored PROQUAD (Merck) Lot # L033692 EXP: 28-FEB-2017 (unknown how many). No adverse effects reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. The patients were vaccinated with incorrectly stored GARDASIL 9 lot number # L013429, expiry date 21-JUL-2017) since 28-JUL-2015. Concomitant medications of the patients were unknown. No other adverse events were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the five reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL 9 injection, lot # L018351 with expiration date 11-AUG-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL injection, lot # K011562 with expiration date 08-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The unspecified patients were administered GARDASIL (lot # K016966, expiration date 10-MAY-2017; lot # K008931, expiration date 04-MAR-10`7; lot # K011325, expiration date 08-APR-2017)( dose and frequency not reported), which were exposed to temperature outside of the recommended range since 05-NOV-2015. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.