chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEP, HEPA, HIBV, IPV, PNC13, RV5
Symptoms: Abnormal behaviour, Diarrhoea, Fatigue, Hypersomnia, Laryngitis
Clinical narrative: Severe diarrhea, through all clothes 5 times that day/night (so saturated had to cut clothes off), upset sleep all night, legs thrashing hard, stiffening up sporadically, the following 2 days very upset, lethargic, seemed like a completely different child, sleeping more than usual, Saturday night (7/12) developed laryngitis/viral infection, today (7/14)still sleeping a lot, laryngitis. Called dr's office with each development. Said leg thrashing, tiredness, "unlike self" can be a side effect. Suggested Tylenol.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEP, HEPA, HIBV, IPV, PNC13, RV5
Symptoms: Lethargy, Musculoskeletal stiffness, Viral infection
Clinical narrative: Severe diarrhea, through all clothes 5 times that day/night (so saturated had to cut clothes off), upset sleep all night, legs thrashing hard, stiffening up sporadically, the following 2 days very upset, lethargic, seemed like a completely different child, sleeping more than usual, Saturday night (7/12) developed laryngitis/viral infection, today (7/14)still sleeping a lot, laryngitis. Called dr's office with each development. Said leg thrashing, tiredness, "unlike self" can be a side effect. Suggested Tylenol.
Age: 17.0
Sex: M
Vaccine: RAB
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: The injection caused pain in the shoulder area. Affecting the whole shoulder joint. Was not able to extend, swing, or move my should for at least a few months with out plans.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Developed fever, rapidly rising to 102.5.  Stayed between 102.3 and 102.5 for approximately 42 hours despite Tylenol taken at rate of 1 gram per 6 hours.  Accompanied by swelling in injection site sufficient to make arm movement painful, along with tenderness, redness and heat.  Fever did not completely return to normal until approximately 75 hours after injection, though last 24 hours of fever it was dropping rapidly.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Developed fever, rapidly rising to 102.5.  Stayed between 102.3 and 102.5 for approximately 42 hours despite Tylenol taken at rate of 1 gram per 6 hours.  Accompanied by swelling in injection site sufficient to make arm movement painful, along with tenderness, redness and heat.  Fever did not completely return to normal until approximately 75 hours after injection, though last 24 hours of fever it was dropping rapidly.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Antiphospholipid antibodies, Cataract, Laboratory test, Neurological examination, Neuropathy peripheral
Clinical narrative: This spontaneous consumer report (initial receipt- 30-Jun-2014) concerns a 57-year-old female patient. The patient had a medical history of anxiety and penicillin allergy. She received gabapentin (300 mg three times daily) concomitantly. On 07-Nov-2013, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date in Nov-2013, after vaccination, the patient experienced hives, cataracts and was diagnosed with neuropathy. The patient underwent neuropathy and lupus tests. The outcome was reported as not recovered.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This spontaneous consumer report (initial receipt- 30-Jun-2014) concerns a 57-year-old female patient. The patient had a medical history of anxiety and penicillin allergy. She received gabapentin (300 mg three times daily) concomitantly. On 07-Nov-2013, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date in Nov-2013, after vaccination, the patient experienced hives, cataracts and was diagnosed with neuropathy. The patient underwent neuropathy and lupus tests. The outcome was reported as not recovered.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 11-JUN-2014 the patient was vaccinated with a dose of MMR II (injection, therapy type, lot#, dose, route were not specified) that expired on 30-JAN-2014. No adverse effects were reported. The outcome was unknown. This is one of the three reports that received from the same source. 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 Registered Nurse refers to a patient of unknown age. On 07-MAY-2014 the patient was vaccinated with a dose of MMR II (injection, therapy type, lot#, dose, route were not specified) that expired on 30-JAN-2014. No adverse effects were reported. The outcome was unknown. This is one of the three reports that received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Impaired driving ability
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative reported that an unspecified doctor in their office stated that his daughter's friend (female, age unknown) who on an unspecified date was vaccinated with GARDASIL (dose, route and lot # not reported). It was unknown which of the three-doses in the series was received by the patient, and if the GARDASIL series was completed. On an unspecified date after receiving GARDASIL, the patient experienced a seizure. It was reported that the patient was no longer able to drive and also had other unspecified incapacities after the event occurred. The outcome of the adverse event was unknown. The healthcare worker considered the event to be significant disability or incapacity. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Adverse reaction, Blood test, Cyanosis, Dyspnoea, Pallor
Clinical narrative: This spontaneous report as received from a patient's mother concerning her daughter, 1 year old female patient with anaphylactic allergy to eggs. On 09-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), on unspecified thigh. Concomitant medications were not reported. On 09-JUL-2014, patient experienced severe reaction 30 minutes after receiving a dose of VARIVAX (Merck). The patient began to wheeze and had difficulty breathing as soon as they got home after receiving VARIVAX (Merck) and PREVNAR 13. The reporter and her husband rushed the patient back to the physician's practice where she received the immunizations, and the patient received Epinephrine, "three times the amount that an adult should receive." The patient turned pale, her lips turned blue, and she was rushed by ambulance to the Emergency Department of hospital. The patient was provided Oxygen therapy, and was administered Benadryl. The reporter states that some of the blood tests that were done in the Emergency Department included a thyroid test. The patient sought medical attention. She reports that the patient was stabilized and released five hours later. She states that her daughter has an appointment with her allergist next week. The outcome of the events was reported as recovering/resolving. The causality of the events with VARIVAX (Merck) was not reported. Product quality issues was not involved. Upon internal review, all the events were considered medically significant. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Thyroid function test, Wheezing
Clinical narrative: This spontaneous report as received from a patient's mother concerning her daughter, 1 year old female patient with anaphylactic allergy to eggs. On 09-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), on unspecified thigh. Concomitant medications were not reported. On 09-JUL-2014, patient experienced severe reaction 30 minutes after receiving a dose of VARIVAX (Merck). The patient began to wheeze and had difficulty breathing as soon as they got home after receiving VARIVAX (Merck) and PREVNAR 13. The reporter and her husband rushed the patient back to the physician's practice where she received the immunizations, and the patient received Epinephrine, "three times the amount that an adult should receive." The patient turned pale, her lips turned blue, and she was rushed by ambulance to the Emergency Department of hospital. The patient was provided Oxygen therapy, and was administered Benadryl. The reporter states that some of the blood tests that were done in the Emergency Department included a thyroid test. The patient sought medical attention. She reports that the patient was stabilized and released five hours later. She states that her daughter has an appointment with her allergist next week. The outcome of the events was reported as recovering/resolving. The causality of the events with VARIVAX (Merck) was not reported. Product quality issues was not involved. Upon internal review, all the events were considered medically significant. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Abdominal discomfort, Flushing, Pruritus, Stridor, Urticaria
Clinical narrative: This spontaneous report as received from a patient's mother concerning her daughter, 1 year old female patient with anaphylactic allergy to eggs. On 09-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), on unspecified thigh. Concomitant medications were not reported. On 09-JUL-2014, patient experienced severe reaction 30 minutes after receiving a dose of VARIVAX (Merck). The patient began to wheeze and had difficulty breathing as soon as they got home after receiving VARIVAX (Merck) and PREVNAR 13. The reporter and her husband rushed the patient back to the physician's practice where she received the immunizations, and the patient received Epinephrine, "three times the amount that an adult should receive." The patient turned pale, her lips turned blue, and she was rushed by ambulance to the Emergency Department of hospital. The patient was provided Oxygen therapy, and was administered Benadryl. The reporter states that some of the blood tests that were done in the Emergency Department included a thyroid test. The patient sought medical attention. She reports that the patient was stabilized and released five hours later. She states that her daughter has an appointment with her allergist next week. The outcome of the events was reported as recovering/resolving. The causality of the events with VARIVAX (Merck) was not reported. Product quality issues was not involved. Upon internal review, all the events were considered medically significant. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Renal disorder
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 8 year old male patient. On an unknown dates, the patient was vaccinated with a series of RECOMBIVAX HB (thimerosal content: unspecified) (dose, frequency and route of administration: not reported) (lot #, exp date: unknown). On approximately 30-JUN-2014, the patient was negative for Hepatitis B titers. The reporter stated that an unspecified renal physician was evaluating the patient for a kidney transplant. It was not reported whether the kidney condition was congenital or it developed since the patient received RECOMBIVAX HB. The outcome of Hepatitis B titers negative and kidney condition was not reported. Relatedness between Hepatitis B titers negative and kidney condition and RECOMBIVAX HB was not specified. Upon internal review, kidney condition requiring evaluation for kidney transplant was considered to be medically significant. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Fatigue
Clinical narrative: Tiredness, Temp of 100 on 7/14/2014 at PM, stomach ache, and temp of 102.2 on 7/15/2014 at AM.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Lethargy, Pyrexia
Clinical narrative: Per child's mom, night of vaccination date child spiked fever of 104.6 - 105.1 and acted lethargic. Called pediatrician who told mom that fever is expected after vaccination and to medicate with Tylenol and Motrin.  Mom stated that gave medication and cool baths but fever continued so she took child to pediatrician following day. Per mom, fever lasted 3 days following vaccination.  Discussed with doctor and decided to wait on vaccines until school-age. Child did receive Rotavirus vaccine on 7/27/12 with no reaction.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Pt. received MENACTRA yesterday; went to gym for work-out and sauna. Had small red bump on (R) arm at bedtime, awoke with 9.5 x 10cm red, warmth swollen area at site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Localized redness and warmth around injection sites <24 hours after vaccines persisting for > 48 hours.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blood glucose normal, Cold sweat, Dyskinesia, Musculoskeletal stiffness, Mydriasis
Clinical narrative: Approx. 2 minutes after vaccines, pt. began to stiffen up and arms were flexed and jerking. Eyes open with dilated pupils. Pt. pale and clammy. Lasted <2 minutes. Pt. placed supine with legs elevated. Given juice and crackers. Monitored for 30 minutes and stable.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pallor
Clinical narrative: Approx. 2 minutes after vaccines, pt. began to stiffen up and arms were flexed and jerking. Eyes open with dilated pupils. Pt. pale and clammy. Lasted <2 minutes. Pt. placed supine with legs elevated. Given juice and crackers. Monitored for 30 minutes and stable.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: ZOSTAVAX administered SQ right arm on 7/7/14. Pt noticed "hard, red rash" surrounding inj site 7/8/14. Denied fever, pain. No itching. Rash about the size of a dollar bill.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 101.0 degrees F chills lasted from 5pm to 2 am. Took 2 ADVIL at 11pm.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Left deltoid swollen, red, warm to touch. Pt states swollen nodes in axilla.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Feeling hot, Swelling, Swelling face
Clinical narrative: Large (7 cm x 6 cm)  area of redness, swelling, heat and discomfort onset within 24 hs after vaccine and pt report of hives on face with sl swelling of left cheek.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Large (7 cm x 6 cm)  area of redness, swelling, heat and discomfort onset within 24 hs after vaccine and pt report of hives on face with sl swelling of left cheek.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Since the night of 7-7-14, experiencing fever (up to 103.5), chills, sweating excessively, nausea, headaches.
Age: 1.41
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site mass
Clinical narrative: Mother states she felt a lump on left arm on vaccine site two days after vaccine was given. No other symptoms such as redness, fever or restriction of movement.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Migraine, Nausea
Clinical narrative: Sick - stomach and back ache, migraine type headache. Lasted whole day and left me exhausted for another day.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Flu shot administered caused frozen shoulder requiring 6 months physical therapy. Arm is almost back to normal but not quite.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Within 4 mins of receiving vaccine pt became pale and diaphoretic and stated, "I think what you said it happening now but I am ok." Pt and mom waited remainder of recommended time after 2 mins and glass of water pt said, "It's gone now".
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash, primarily of the abdomen. Pruritis.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Eye swelling, Influenza like illness, Malaise, Pain, Swelling face
Clinical narrative: Mom stated that patient felt sick the night of receiving the vaccine. Symptoms included soreness flu-like symptoms. The next day she had swollen eyes, cheeks and tongue swelling. Mom gave her BENADRYL and she was ok the next day.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Swollen tongue
Clinical narrative: Mom stated that patient felt sick the night of receiving the vaccine. Symptoms included soreness flu-like symptoms. The next day she had swollen eyes, cheeks and tongue swelling. Mom gave her BENADRYL and she was ok the next day.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Local induration pain at injection site 4 inch diameter x 3 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Fever 100 degrees. Weakness. Aches. Lasted 18 hrs. Took 1000 mg TYLENOL. Symptoms started day after shot.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Swelling
Clinical narrative: Low grade fever, swelling, tenderness at injection site.
Age: 1.53
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red/swollen area on right leg on 7/3/14 and resolved on 7/7/14 no treatment needed.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 17-DEC-2007, the patient was vaccinated with the first dose of GARDASIL (lot# was reported as 0234U with expiry date: 30-SEP-2009). On 14-MAR-2008, the patient was vaccinated with the second does of GARDASIL (lot#: 655604/0052X with expiry date: 08-JUN-2009) and with the third dose on 26-JUN-2008 (lot#: 654272/0073X with expiry date: 18-JAN-2009) (dose, route of administration and indication unspecified for all). No concomitant medications were reported. All of GARDASIL products listed were stored at 12C for a 6 month time frame. Excursion was not supported. No adverse effects were noted by patient. The pharmacist wanted to know if revaccination was required. Lot number 0234U is an invalid lot number for quadrivalent human papillomavirus recomb vaccine. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old male patient with no drug reactions or allergies. On 07-JUL-2014, the patient was vaccinated with ZOSTAVAX (lot # J011830, exp. date 26-DEC-2014, dose 0.65 ml, subcutaneous). On 07-JUL-2014, later that day that ZOSTAVAX was administered, the patient experienced swelling and redness at injection site. The pharmacist was informed by the patient that the redness was about the size of a baseball. The patient called in to the pharmacy on 09-JUL-2014 to inform the pharmacy what he developed. She also stated that the patient was seen by his physician on the same day. No treatment was given for the events and there were no laboratory diagnostic studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Axillary pain, Chest pain, Chills, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Patient reports that approx 5 hrs after vaccine he felt feverish and had pain in his (R) arm from shoulder to elbow across (R) chest down th axilla. Over the next 24 hrs the pain intensified, he had fever, shaking, chills and drenching sweat. The pain was so intense he was unable to lift his arm. He reports the injection site was red and warm to touch, he isn't sure if it was swollen. Patient reports he no longer had fever, chills, sweats but arm was still sore.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, Tremor
Clinical narrative: Patient reports that approx 5 hrs after vaccine he felt feverish and had pain in his (R) arm from shoulder to elbow across (R) chest down th axilla. Over the next 24 hrs the pain intensified, he had fever, shaking, chills and drenching sweat. The pain was so intense he was unable to lift his arm. He reports the injection site was red and warm to touch, he isn't sure if it was swollen. Patient reports he no longer had fever, chills, sweats but arm was still sore.
Sex: U
Vaccine: RV1
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of ROTATEQ dose 1 (site and route of injection, lot# and expiration date not reported). On an unknown date the patient received ROTARIX as a second dose of rotavirus vaccine. No adverse effects were reported. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Oropharyngeal pain, Pyrexia, Rash generalised
Clinical narrative: Client states that she started having a rash on face, neck, torso, and right upper leg. Also report of fever and sore throat. Did not seek medical treatment, used over the counter Benadryl.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Progressive, muscle pain that worsens with physical activity and is not relieved by OTC ibuprofen.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Lipodystrophy acquired
Clinical narrative: Lipodystrophy of right shoulder/deltoid. No pain, red color, no scarring.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient received the GARDASIL vaccine and was standing approx. 5 minutes later performing a vision exam when she had a syncopal event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Phone call received from clients mother informing that client has a red, raised bump on the outside of her left leg. Mom states that it does not bother the client and she has not complained about it.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Headache, Pyrexia
Clinical narrative: Phone call received from clients grandmothers stating client arose w/fever and abdominal pain today (5.28.14). Temp of 101.7 F cotrolled by TYLENOL. Grand mother denied client c/o pain, redness, inflammation at injection site. State client c/o headache intially but not any longer.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Computerised tomogram head, Computerised tomogram normal, Hallucination, visual, Injection site abscess, Middle insomnia
Clinical narrative: Pt. began to awaken at night with hallucinations (visual), which persisted all day long x 2 different occasions. Pt's personality changed also. Also had abscess where shot given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Personality change
Clinical narrative: Pt. began to awaken at night with hallucinations (visual), which persisted all day long x 2 different occasions. Pt's personality changed also. Also had abscess where shot given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, practice manager refers to unknown number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with PNEUMOVAX 23 (dose number, route of administration, anatomical location, lot number were not provided). The health care worker reported, the storage compartments that contained PNEUMOVAX 23 were not monitored at all from 03-MAY-2014 until the report time (10-JUN-2014). Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager stated that would provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present (date of this report 10-JUN-2014). She stated that her practice has not been informed of any adverse experiences. On 17-JUN-2014 follow-up information has been received. All telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patient identifiers, lot numbers, expiration dates and dates of administration. Follow up information was received on 23-JUN-2014 from registered nurse. The nurse stated that there were 10 doses of (trade name not provided) previously reported as PNEUMOVAX 23, lot # K004930, expiry date 16-MAR-2015 stored in refrigerator that were not monitored at all from 03-MAY-2014 until the report time (10-JUN-2014). This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On 26-JUN-2014 (reported as yesterday), The patient was vaccinated with a repeat dose of PNEUMOVAX23 25microgram/0.5ml injection, standard package vial of 2.5 ml, subcutaneously in her rear left deltoid region (dose, indication, lot#, expiry date unspecified). No concomitant medications were reported. Since receiving this injection (26-JUN-2014), the patient experienced itching red oval at injection site. This progressed to involve entire back of left arm and fluid was spending to elbow point. Area was red and tender. The patient sought medical attention. No care had been given at time of call. Physician commented that he had seen this before with one or two other patients after receiving PNEUMOVAX23. The outcome of events was unknown. The relatedness between event and PNEUMOVAX23 was not reported. This is one of several reports from the same source. Additional information is not expected. Permission for follow up was not obtained as the physician abruptly disconnected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose of (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the event was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 6 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 16-DEC-2013, at age of 5 years old, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperatures warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: After injection I had severe pain in arm/shoulder could not lift it past my shoulder level, I could not do simple everyday things, picking up anything, dressing, bathing, sleeping, typing. The bad pain lasted for 3 weeks with now occasionally without notice it will hurt or I will have sudden pain.
Sex: U
Vaccine: VARZOS
Symptoms: 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. Concomitant medication and pertinent medical history were not provided. On an unspecified date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were unknown). On 07-JUL-2014 the patient was vaccinated an additional 0.65 ml dose of ZOSTAVAX subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 45 year old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 26-JUN-2014 the patient was vaccinated with a dose of expired MMR II, lot # H011898, expiration date 25-JUN-2014 (dose, site and route of injection not reported). The patient did not report or demonstrate any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. It was reported that the unspecified number of patients received (Oka/Merck) VARIVAX (injection, 0.5 ml once, subcutaneous, dose unspecified in series, lot# was unspecified) that underwent multiple temperature excursions. Nurse stated (Oka/Merck) VARIVAX was exposed to a maximum of SF for cumulative 194 hours. Nurse stated excursions and (Oka/Merck) VARIVAX administrations occurred between 19-NOV-2013 and 28-FEB-2014. Nurse stated she currently had no patient data. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 4 patient of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the events was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 6 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 20-DEC-2013, at age of 5 years old, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperatures warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that a new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to a 4 year old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # J007929, EXP date 28-JUN-2015) and a dose of (Oka/Merck) VARIVAX (lot# reported as H015224, EXP date 10-AUG-2014). It was unknown if the patient sought medical attention. There was no adverse event reported. At the time of report, the status of patient was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of liquid PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 11 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 08-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified), (dose, frequency and location unspecified) for "medication error" as reported instead of a first dose of (Oka/Merck) VARIVAX. No concomitant therapies were reported. Pharmacist stated the patient developed localized redness and swelling at the injection site on an unspecified date in July 2014. No treatment was given for the adverse events. No lab diagnostics studies performed. At the time of the report, the outcome of the localized redness and swelling at the injection site was recovering. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a male patient of unknown age. There was no information on medical history and drug reactions or allergies. On 06-FEB-2014, the patient was administered with first dose of GARDASIL intramuscular injection, dose 0.5 ml (millilitre) intramuscularly (anatomical location not reported) and second dose on 08-APR-2014 and the third dose on an unknown date on 2014 earlier than recommended in the prescribing information on 11-JUL-2014. No adverse events was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a female patient of unknown age. In March 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dosage, route and unknown). On unspecified date, in 2014, the patient developed unspecified symptoms after receiving ZOSTAVAX. The patient was treated with VALTREX. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose of (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the events was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 4 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 28-APR-2014, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperature warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that a new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, No adverse event
Clinical narrative: This spontaneous report as received from a 56 year old nurse female patient concerning herself. On an unknown date (also reported as at an unspecified time in the past), patient had received MMR II booster (strength, dose and indication was not provided) and had measles in the past. Nurse stated, at an unspecified time approximately in 2013 (also reported as last year), she had equivocal (serologic testing) completed for MMR. Her measles titer came back negative when equivocal report was received. At an unspecified time approximately in 2013 (also reported as last year), patient received booster for MMRII (strength, dose and indication was not provided) based on equivocal results. No adverse effects reported. Product quality complaint (PQC) was not involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site extravasation, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician refers to one or two patients of unknown age. No concurrent conditions or medical history were provided. On an unknown date, the patient (s) was (were) vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, indication, lot#, expiry date unspecified). No concomitant medications were reported. On an unknown date, the patient (s) experienced itching red oval at injection site. This progressed to involve entire back of left arm and fluid was spending to elbow point. Area was red and tender. The outcome of events was unknown. The relatedness between event and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information is not expected. Permission for follow up was not obtained as the physician abruptly disconnected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 04-FEB-2014 the patient was vaccinated with a dose of MMR II (injection, therapy type, lot#, dose, route were unspecified) that expired on 30-JAN-2014. No adverse effects were reported. The outcome was unknown. This is one of the three reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 26-JUN-2014 the patient was vaccinated with a dose of M-M-R II (dose, site and route of administration, lot# and expiration date not provided) and a dose of (Oka/Merck) VARIVAX (dose, site and route of administration, lot# and expiration date not provided), which were reconstituted with expired sterile water diluent, lot# H004949, expiration date 31-JAN-2014 (also reported as January 2014). No adverse effects were reported. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 year old patient of unknown gender. On 23-JUN-2014 a dose of GARDASIL (dose, route of administration, LOT# and expiration date were not provided) was inadvertently administered to the patient (who was younger that the age that is indicated for GARDASIL). No adverse effects were observed. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Dyskinesia, Electroencephalogram normal
Clinical narrative: Pt had fever and jerking episodes that required hospital admission. Work up was negative including LP and EEG. Episodes occurred the evening of her 2 mo shots. They have recurred since without fever.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Pt had fever and jerking episodes that required hospital admission. Work up was negative including LP and EEG. Episodes occurred the evening of her 2 mo shots. They have recurred since without fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Chills, Malaise, Vomiting
Clinical narrative: 4AM on 6/24/14 feeling sick, vomiting and chills - Temp 101.5 - now at 9:37AM. (R) and (L) upper arms are not swollen, red, or tender to touch. 6-24-14 9:47AM I spoke with Dr and explained child's illness. She said to have mom give TYLENOL and ice chips and Gatorade. I then called and spoke with older brother and told him to tell mom to give ice chips slowly and give TYLENOL. Then to start sips of Gatorade if vomiting stops. I told brother I would call back in 2 hours to check on patient. 6-24-14 11:51AM Spoke with 15 yr older brother and he states patient's keeping down water and Gatorade. Brother states patient is feeling better and resting. I told brother someone would call tomorrow. 6-25-14 - TC at 8AM no answer. 6-25-14 10:15AM TC - no answer. 6-26-14 - 11:40AM TC to home. I spoke with brother and he states patient was Ok yesterday. He reports no more fever, nausea or vomiting.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Numbness in left arm that spread to neck and upper back. Pt also had a cold feeling in left arm. Phone call to PCP who felt it was a nerve issue and did not recommend treatment.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Fall, Skin injury
Clinical narrative: Patient was given the hep A vaccine was light headed afterwards, had her lay down for 15 minutes. Check to see if she was okay to leave she stated she was fine. Left clinic fell outside front door of clinic and scraped left knee.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Local swelling, Mobility decreased, Muscle tightness, Myalgia
Clinical narrative: Arm is extremely sore. Cannot lift arm above shoulder height.  On 7/13/14 shoulder and neck became swollen.  Today 7/15/14 pt still cannot move arm above shoulder height.  Very sore still like tight muscle soreness.  Has been taking Ibuprofen and Tylenol for the pain.  Helping when taken.  Has not taken any Benadryl or has not put ice on it or heat.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm is extremely sore. Cannot lift arm above shoulder height.  On 7/13/14 shoulder and neck became swollen.  Today 7/15/14 pt still cannot move arm above shoulder height.  Very sore still like tight muscle soreness.  Has been taking Ibuprofen and Tylenol for the pain.  Helping when taken.  Has not taken any Benadryl or has not put ice on it or heat.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal discomfort, Cold sweat, Inappropriate schedule of drug administration, Nausea, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old female patient. The patient's concurrent conditions included penicillin allergy. On 18-MAY-2010, the patient was vaccinated with her first dose of GARDASIL (route, lot number and expiration date not reported). ON 30-JUN-2014 the patient was vaccinated with her second dose of GARDASIL (route, lot number and expiration date not reported). No concomitant medication or pertinent medical history were reported. On 01-JUL-2014, the patient presented nausea, felt sick to her stomach and "clammy". On 02-JUL-2014 the patient fainted while taking a shower and then fainted again when getting dressed. Patient did not have fever and was eating and drinking well. No treatment was given for the adverse event. The patient sought medical attention. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling/redness of site of vaccination.
Age: 1.24
Sex: M
Vaccine: MMRV
Symptoms: Contusion, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Presented with bruising, petichiae and thrombocytopenia (platelets 4K).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling/redness.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10x9 cm circular area of redness and slight swelling on the right thigh. Non-tender. Vaccine given 7-11-14. Redness started 7-12-14. Still present 7-14-14. Treated with AUGMENTIN for vaccine reaction vs. early cellulitis.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported a patient received expired PNEUMOVAX23 on 11-JUL-2014. Pharmacist reported the PNEUMOVAX23 in question did not have any previous temperature excursions and the patient did not report any adverse symptoms. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Acupuncture, Facial pain, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Facial nerve palsy. Intractable facial pain (entire right side). Acupunture and LYRICA.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Facial nerve palsy. Intractable facial pain (entire right side). Acupunture and LYRICA.